Archive for May, 2016

(MRUS) Announces Closing of Partial Exercise of Underwriters’ Over-Allotment Option

UTRECHT, the Netherlands, May 31, 2016 — Merus N.V. (“Merus”) (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics, today announced the closing of a partial exercise of the over-allotment option by the underwriters of its previously announced initial public offering in the amount of an additional 639,926 common shares at the initial public offering price of $10.00 per share. The sale of the additional shares closed on May 26, 2016, bringing the total number of common shares sold by Merus in its initial public offering to 6,139,926. Including the proceeds from the sale of the additional shares, the total net proceeds, after deducting the underwriting discounts and commissions and estimated offering expenses, to Merus from its initial public offering are approximately $53.3 million.

Citigroup Global Markets Inc. and Jefferies LLC acted as joint book-running managers for the offering, Guggenheim Securities, LLC acted as lead manager for the offering and Wedbush PacGrow acted as co-manager for the offering.

A registration statement relating to these securities was declared effective by the U.S. Securities and Exchange Commission on May 18, 2016. The offering was made only by means of a prospectus.  Copies of the final prospectus relating to the offering may be obtained by contacting Citigroup by mail, c/o Broadridge Financial Solutions, at 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at (800) 831-9146, or by email at prospectus@citi.com; or Jefferies LLC, by mail at 520 Madison Avenue, 2nd Floor, New York, New York 10022, Attention: Equity Syndicate Prospectus Department, by telephone at (877) 547-6340 or by email at prospectus_department@jefferies.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

Contact Information:

Investor Relations
Argot Partners
Eliza Schleifstein – eliza@argotpartners.com
1-917-763-8106

Tuesday, May 31st, 2016 Uncategorized Comments Off on (MRUS) Announces Closing of Partial Exercise of Underwriters’ Over-Allotment Option

(PXLW) Enhancement Chip Makes Smartphone Debut in ASUS ZenFone 3 Ultra

New ASUS 6.8” smartphone utilizes Pixelworks’ True Clarity® video display processing technology to bring HDTV experience to mobile

Pixelworks, Inc. (NASDAQ:PXLW), an innovative provider of video display processing technology, today announced that ASUS, a leading enterprise in the new digital era, is launching the world’s first smartphone using the Pixelworks Iris video display processor with True Clarity® video enhancement features. Incorporating the Iris processor in the 6.8” phone, dubbed the ZenFone 3 Ultra, will establish a new standard for HDTV quality mobile video, and in the process provide a more enjoyable user experience.

“We’re very pleased to be the first to offer a smartphone with Pixelworks’ Iris video enhancement processor,” said Rangoon Chang, ASUS General Manager, Mobile Computing Business Unit. “Mobile video is extremely important to our customers and every indication suggests this trend will only accelerate. Being able to watch true HD quality video on this larger screen ZenFone 3 Ultra will be a real pleasure, and consumers will be treated to a dramatically different viewing experience.”

In addition to the video quality enhancement provided by Iris, the ASUS ZenFone 3 Ultra sports a gorgeous 6.8” LCD panel with full HD (1920×1080) resolution, and a state-of-the-art QCOM 8976 applications processor. Iris also offers back light control to extend battery life and usage time of the ZenFone 3 Ultra, an essential capability given the larger screen.

“Pixelworks has always been about improving picture quality, regardless of the screen it’s viewed on or the technology used to deliver it,” said Richard Miller, Pixelworks Executive Vice President. “We’re very pleased that Iris and our True Clarity technology is able to help ASUS bring their vision of an industry-changing video viewing experience to life.”

Pixelworks’ Iris family of mobile display processors work at the pixel level to dramatically improve the mobile viewing experience by removing annoying video artifacts that degrade the viewing experience, while freeing the central processor of these tasks. In fact, this advanced technology improves all aspects of the mobile viewing experience, including gaming, video, photos, web browsing and productivity.

With Iris’ True Clarity video enhancement features on the ZenFone 3 Ultra, consumers can look forward to live sports, for instance, that will be easier and more enjoyable to watch; users will now be able to follow the ball and read scrolling news across the bottom of the screen, free of judder and motion blur.

For additional information on Iris family of video display processors, as well as a product demo, please contact your local Pixelworks office (http://www.pixelworks.com/locations.php) to obtain an invitation.

About Pixelworks, Inc.

Pixelworks creates, develops and markets video display processing technology for digital video applications that demand the very highest quality images. At design centers around the world, Pixelworks engineers constantly push video performance to keep manufacturers of consumer electronics, mobile devices and professional displays worldwide on the leading edge. The company is headquartered in San Jose, CA. For more information, please visit the company’s Web site at www.pixelworks.com.

Note: Pixelworks, the Pixelworks logo, and True Clarity are registered trademarks of Pixelworks, Inc. All other names and brands are trademarks or registered trademarks of their respective holders.

 

Pixelworks, Inc.
Investor Contact:
Shelton Group
Brett L Perry, +1-214-272-0070
bperry@sheltongroup.com
or
Media Contact:
Pixelworks, Inc.
info@pixelworks.com

Tuesday, May 31st, 2016 Uncategorized Comments Off on (PXLW) Enhancement Chip Makes Smartphone Debut in ASUS ZenFone 3 Ultra

(PARN) Announces Contract Manufacturing Agreement with Merial

OVERLAND PARK, Kan., May 31, 2016 — Parnell Pharmaceuticals Holdings Ltd (NASDAQ:PARN), a fully integrated, commercial-stage pharmaceutical company focused on developing, manufacturing and marketing innovative animal health solutions, today announced the commencement of a Contract Manufacturing Agreement with Merial, the animal health division of Sanofi.

Under the terms of the Contract Manufacturing Agreement, Merial will purchase certain sterile injectable products, exclusively from Parnell, with minimum annual purchase commitments over the 10-year term of the agreement.  Merial will pay an upfront establishment fee in return for Parnell commencing immediate supply of product.  Parnell estimates the total value of the agreement between USD$7 million and USD$20 million depending on volume of product purchased by Merial over the 10-year term.

Robert Joseph, President and CEO said “We are very pleased to announce the commencement of our first contract manufacturing agreement with a major multinational.  Merial has a fantastic reputation in the industry and we are excited that Parnell will be supplying sterile injectable products from our state-of-the-art, FDA and EMA approved manufacturing facility.  Our Business Development team has been pursuing contract manufacturing opportunities to leverage the 75% available capacity we have in our facility, and this agreement with Merial generates cashflows that will contribute to our goal of seeing our manufacturing division become a profit center for us in the future.  We hope to announce further contract manufacturing deals in 2016.”

About Parnell

Parnell (PARN) is a fully integrated, veterinary pharmaceutical company focused on developing, manufacturing and commercializing innovative animal health solutions. Parnell currently markets five products for companion animals and production animals in 14 countries and augments its pharmaceutical products with proprietary digital technologies – FETCH™ and mySYNCH®. These innovative solutions are designed to enhance the quality of life and/or performance of animals and provide a differentiated value proposition to our customers.  Parnell also has a pipeline of 7 drug products covering valuable therapeutic areas in orthopedics, dermatology, anesthesiology, nutraceuticals and metabolic disorders for companion animals as well as reproduction and mastitis for cattle.

For more information on the company and its products, please visit www.parnell.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements and information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Words such as “may,” “anticipate,” “estimate,” “expects,” “projects,” “intends,” “plans,” “develops,” “believes,” and words and terms of similar substance used in connection with any discussion of future operating or financial performance identify forward-looking statements. Forward-looking statements represent management’s present judgment regarding future events and are subject to a number of risk and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks include, but are not limited to, Parnell’s expectations regarding the completion, timing and size of the public offering and the expected proceeds therefrom, risks and uncertainties regarding Parnell’s research and development activities, its ability to conduct clinical trials of product candidates and the results of such trials, as well as risks and uncertainties relating to litigation, government regulation, economic conditions, markets, products, competition, intellectual property, services and prices, key employees, future capital needs, dependence on third parties, and other factors, including those described in Parnell’s Annual Report on Form 20-F filed with the Securities and Exchange Commission, or SEC, on March 4, 2016, along with its other reports filed with the SEC. In light of these assumptions, risks, and uncertainties, the results and events discussed in any forward-looking statements contained in this press release might not occur. Investors are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Parnell is under no obligation, and expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events, or otherwise.

CONTACT: For more information, contact:

Parnell Pharmaceuticals Holdings
Robert Joseph, 913-274-2100
info@parnell.com
Tuesday, May 31st, 2016 Uncategorized Comments Off on (PARN) Announces Contract Manufacturing Agreement with Merial

(ELRC) and Platinum Equity Sign Definitive Merger Agreement

– Platinum Equity to Acquire Electro Rent for $13.12 per Share in All Cash Transaction –

Platinum Equity and Electro Rent Corporation (Nasdaq:ELRC) today announced that they have entered into a definitive agreement under which Electro Rent would be acquired by Platinum Equity for approximately $323.4 million.

Under the agreement, Platinum Equity would acquire all of Electro Rent’s common stock. Electro Rent stockholders will receive $13.12 per share, representing a premium of 24.4% over the closing price on May 27, 2016, and 34.8% over the average closing price of Electro Rent’s common stock over the past three (3) months. In light of the agreement, Electro Rent will not pay its next quarterly common stock dividend scheduled for July 2016.

The agreement followed the unanimous recommendation of Electro Rent’s board of directors. Completion of the transaction, which is expected to close in the next 90 to 120 days, is subject to customary closing conditions, including approval of Electro Rent’s stockholders and various regulatory agencies.

Electro Rent Chairman Daniel Greenberg and a member of his immediate family, who collectively own approximately 29% of the company’s outstanding shares of common stock, have entered into voting agreements in support of the sale and have granted an affiliate of Platinum Equity irrevocable proxies to execute those agreements.

Steven Markheim, recently named Chief Executive Officer of Electro Rent, and Allen Sciarillo, recently named Chief Financial Officer, will retain their current roles under the ownership of Platinum Equity.

Upon completion of the transaction, Electro Rent’s common stock will cease to be publicly traded. Houlihan Lokey acted as financial advisor to the Strategic Alternatives Committee of the Board of Directors of Electro Rent and Sheppard Mullin acted as Electro Rent’s legal counsel. Latham & Watkins LLP is serving as legal counsel to Platinum Equity.

“Electro Rent has built an excellent reputation as one of the most well respected companies in its industry. Its team of dedicated employees will continue to play an essential role in providing Electro Rent’s customers and OEM partners with the first-class service for which the company is known,” said Platinum Equity Partner Louis Samson. “We look forward to working closely with the company’s experienced leadership to put Electro Rent in the best position to take full advantage of future opportunities.”

“We are excited to begin this new phase in Electro Rent’s history, and look forward to partnering with Platinum as we continue to meet and exceed the needs of our customers and manufacturing partners around the globe,” said Markheim. “The transaction presents an outstanding opportunity for all of our stakeholders, as we should greatly benefit from additional resources and experience to further enhance our already high inventory, service and support standards. Platinum is fully committed to our industry and to ensuring Electro Rent’s success.”

About Platinum Equity

Founded in 1995 by Tom Gores, Platinum Equity (www.platinumequity.com) is a global investment firm with more than $6 billion of assets under management and a portfolio of more than 25 operating companies that serve customers around the world. Platinum Equity specializes in mergers, acquisitions and operations – a trademarked strategy it calls M&A&O® – acquiring and operating companies in a broad range of business markets, including manufacturing, distribution, transportation and logistics, equipment rental, metals services, media and entertainment, technology, telecommunications and other industries. Over the past 20 years Platinum Equity has completed more than 175 acquisitions.

About Electro Rent

Electro Rent Corporation (www.ElectroRent.com) is one of the largest global organizations devoted to the rental, leasing and sales of general purpose electronic test equipment, personal computers and servers.

Important Additional Information will be Filed with the SEC

In connection with the proposed transaction, Electro Rent Corporation will file or furnish relevant documents, including a proxy statement, concerning the proposed transaction with the SEC. Investors and stockholders of Electro Rent Corporation are urged to read the proxy statement and other relevant materials when they become available because they will contain important information about Electro Rent Corporation and the proposed transaction. The final proxy statement will be mailed to the company’s stockholders.

Investors and stockholders may obtain a free copy of the proxy statement and any other relevant documents filed or furnished by Electro Rent Corporation with the SEC (when available) at the SEC’s Web site at www.sec.gov. In addition, copies of the proxy statement and other filings made by the Company with the SEC can also be obtained, free of charge, by directing a request to Electro Rent Corporation, 6060 Sepulveda Boulevard, Van Nuys, CA 91411, Attention: Corporate Secretary.

Electro Rent Corporation and its directors and certain executive officers may be deemed to be participants in the solicitation of proxies from Electro Rent Corporation stockholders in respect of the proposed transaction. Information about the directors and executive officers of Electro Rent Corporation and their respective interests in Electro Rent Corporation by security holdings or otherwise is set forth in its proxy statement for the 2015 Annual Meeting of Stockholders, which was filed with the SEC on September 9, 2015 and its Annual Report on Form 10-K for the year ended May 31, 2015, which was filed with the SEC on August 13, 2015. Stockholders may obtain additional information regarding the interests of Electro Rent Corporation and its directors and executive officers in the Merger, which may be different than those of Electro Rent Corporation’s stockholders generally, by reading the proxy statement and other relevant documents regarding the Merger, when filed with the SEC. Each of these documents is, or will be, available as described above.

“Safe Harbor” Statement

Except for the historical statements and discussions in this press release, the company’s statements above constitute forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934. These forward-looking statements reflect Electro Rent’s management’s views and expectations at this time with respect to future events and financial performance, based on currently available information. Forward looking statements in this press release include statements regarding the completion of the sale transaction to Platinum Equity. When used, the words “anticipate”, “believe”, “expect” and “will” and other similar expressions identify forward-looking statements. Forward-looking statements are based on assumptions about future operations and market conditions, and are subject to certain risks and uncertainties. The company believes its assumptions are reasonable; nonetheless, it is likely that at least some of these assumptions will not come true. Accordingly, Electro Rent’s actual results will differ from the outcomes contained in any forward-looking statement, and those differences could be material. Factors that could cause or contribute to these differences include, among others, those risks and uncertainties discussed in the company’s periodic reports on Form 10-K and 10-Q and in its other filings with the Securities and Exchange Commission, including: general macroeconomic conditions may not improve or may deteriorate; U.S. federal government spending with respect to defense and other research and development activities may not increase or may decline; Electro Rent may not succeed in retaining its key sales or other personnel; competition may cause the company to lower prices and margins to effectively compete; and manufacturers of test and measurement equipment may not be willing to enter reseller arrangements with Electro Rent or those agreements may not succeed to the level anticipated. Should one or more of the risks discussed, or any other risks, materialize, or should one or more of our underlying assumptions prove incorrect, the company’s actual results may vary materially from those anticipated, estimated, expected or projected. In light of the risks and uncertainties, there can be no assurance that any forward-looking statement will in fact prove to be correct. You should not put undue reliance on these statements. Electro Rent undertakes no obligation to update or revise any forward-looking statements.

 

PondelWilkinson Inc.
Roger Pondel/Laurie Berman, 310-279-5980
pwinvestor@pondel.com

Tuesday, May 31st, 2016 Uncategorized Comments Off on (ELRC) and Platinum Equity Sign Definitive Merger Agreement

(SQI) to be Acquired by Accel-KKR for $17.75 per Share, All-Cash

SciQuest to be Acquired by Accel-KKR for $17.75 per Share in an All-Cash Transaction Valued at Approximately $509 Million

MORRISVILLE, N.C., May 31, 2016  — SciQuest, Inc. (Nasdaq:SQI), the leading public provider of spend management solutions delivering value beyond savings, today announced that it has entered into a definitive agreement to be acquired by affiliates of Accel-KKR (“AKKR”), a leading technology-focused private equity firm, for $17.75 per share in cash, representing a total equity value of approximately $509 million.

The offer represents a 34% premium over the Company’s closing pricing on May 27, 2016. Upon closing, AKKR will own 100% of the outstanding shares of SciQuest common stock. AKKR, which has been a stockholder since 2014, currently owns 4.9% of SciQuest’s outstanding shares.

“This transaction provides SciQuest’s stockholders with a significant premium over the pre-announcement market price and we believe it will allow us to increase our focus on long-term success that will benefit customers, employees, partners and suppliers. As a private company, we expect to continue to accelerate innovation, increase efficiency and expand our solution suite,” said Stephen Wiehe, Chief Executive Officer of SciQuest.

“As long-standing and significant investors in SciQuest, we have been impressed by the breadth, depth and cohesiveness of the Company’s leading technology,” said Tom Barnds, Managing Director of Accel-KKR. “We look forward to partnering with the SciQuest team to continue to accelerate innovation and bring value to customers in this large and growing market.”

SciQuest’s Board of Directors unanimously approved the proposed transaction and resolved to recommend that stockholders vote their shares in favor of this transaction at a stockholders meeting to be held at a later date.

The transaction, which is expected to close in the third quarter of 2016, is subject to customary closing conditions, including approval of SciQuest’s stockholders and required regulatory approvals. Under the terms of the agreement, SciQuest may solicit alternative acquisition proposals from third parties during a 25-day “go-shop” period, following the date of execution of the merger agreement. There is no guarantee that this process will result in a superior proposal, and the merger agreement provides AKKR with a customary right to match a superior proposal. The Company does not intend to disclose any developments with respect to this process unless and until its Board of Directors makes a decision regarding a potential superior proposal. Upon closing, SciQuest will become a privately held company with its headquarters remaining in Morrisville, NC.

Stifel, Nicolaus & Company, Incorporated and Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, LLP are serving as SciQuest’s financial and legal advisors, respectively, for this transaction. Kirkland & Ellis LLP is serving as AKKR’s legal advisor.

About SciQuest

SciQuest (Nasdaq:SQI) is the leading public provider of spend management solutions delivering value beyond savings. Through the continued release of key innovative technology and a fanatical drive toward making our customers successful, we deliver exceptional value in user experience, productivity and operational efficiency. Our cloud-based, mobile-enabled, source-to-settle platform addresses all stages of procurement from the automation of core processes to enabling sophisticated, strategic and multifaceted sourcing solutions. We specialize in handling simple procurement needs to the most advanced supplier and supply chain requirements. SciQuest serves a wide range of industries and organizations including many of the Global Fortune 500. For more information visit http://www.sciquest.com

To join the conversation, please visit our blog at http://www.sciquest.com/blog or follow us on Twitter @SciQuest.

About Accel-KKR

Accel-KKR is a technology-focused investment firm with $4.0 billion in capital commitments. The firm invests in software and IT enabled businesses well-positioned for topline and bottom-line growth. At the core of Accel-KKR’s investment strategy is a commitment to developing strong partnerships with the management teams of its portfolio companies and a focus on building value through significant resources available through the Accel-KKR network. Accel-KKR focuses on middle-market companies and provides a broad range of capital solutions from minority-growth investments to buyouts, recapitalizations, divisional carve-outs and going-private transactions. The firm has offices in Menlo Park, Atlanta and London. For more information, please visit www.accel-kkr.com.

Additional Information

This communication may be deemed to be a solicitation of proxies in respect of the proposed acquisition of SciQuest.  In connection with the proposed acquisition, SciQuest intends to file a proxy statement and other relevant materials with the Securities and Exchange Commission (the “SEC”).  Investors and stockholders of SciQuest are urged to read the proxy statement (including any amendments or supplements) and other relevant materials filed with the SEC when they become available because they will contain important information about SciQuest and the proposed acquisition.  The definitive proxy statement and a proxy card will be mailed to each stockholder entitled to vote at the special meeting relating to the proposed acquisition.  Investors and stockholders may obtain a free copy of the proxy statement when it becomes available, and other documents filed by SciQuest, at the SEC’s website, www.sec.gov. In addition, these documents (when they are available) may also be obtained by investors and stockholders free of charge at SciQuest’s website, www.sciquest.com, or from SciQuest upon written request to its Investor Relations at 3020 Carrington Mill Boulevard, Suite 100, Morrisville, NC 27560.

Participants in the Solicitation

SciQuest and its directors and executive officers, under SEC rules, may be deemed to be participants in the solicitation of proxies from stockholders of SciQuest in connection with the proposed acquisition. Information about SciQuest’s directors and executive officers may be found in SciQuest’s proxy statement on Schedule 14A relating to its 2016 Annual Meeting of Stockholders, which was filed with the SEC on March 14, 2016, and SciQuest’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015, which was filed on February 22, 2016.  Additional information regarding the interests of such potential participants in the solicitation of proxies in connection with the proposed acquisition will be included in the proxy statement related to the proposed acquisition to be filed with the SEC.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on beliefs and assumptions of SciQuest’s management and on information currently available to SciQuest’s management and that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements include information concerning SciQuest’s possible or assumed future results of operations, business strategies, financing plans, competitive position, industry environment, potential growth opportunities, potential market opportunities, the successful closing of this transaction, effects of the transaction, operations as a private company and the location of its headquarters and the effects of competition. Forward-looking statements consist of all statements that are not historical facts and can be identified by terms such as “accelerates,” “anticipates,” “believes,” “could,” “seeks,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions and the negatives of those terms. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including, without limitation, (1) the occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement; (2) the possibility that the consummation of the proposed acquisition described in this communication does not occur or is delayed, either due to the failure of closing conditions, including approval of SciQuest’s stockholders, the failure to obtain required regulatory approvals or other reasons; (3) the risk that the proposed acquisition disrupts current plans and operations or increases operating costs and the potential difficulties in customer loss and employee retention as a result of the announcement and consummation of such acquisition; (4) the outcome of any legal proceedings that may be instituted against the SciQuest, the potential acquiror or others following announcement of the merger agreement and transactions contemplated therein; and (5) those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of SciQuest’s most recently filed Annual Report on Form 10-K and SciQuest’s subsequently filed Quarterly Reports on Form 10-Q. SciQuest urges you to consider those risks and uncertainties in evaluating its forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as otherwise required by the federal securities laws, SciQuest disclaims any obligation or undertaking to publicly release or otherwise provide any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in SciQuest’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

SQI-F

SciQuest Media contact:

SciQuest, Inc.
Roberta Patterson, 919-659-2230
rpatterson@SciQuest.com

Edelman for SciQuest
Megan Smith, 404-832-6776
Megan.smith3@edelman.com

SciQuest Investor contact:

Jamie Andelman
SciQuest, Inc., 919-659-2322
jandelman@sciquest.com

Accel-KKR Media contact:

KEKST for Accel-KKR
Todd Fogarty, 212-521-4854
Todd.fogarty@kekst.com

Tuesday, May 31st, 2016 Uncategorized Comments Off on (SQI) to be Acquired by Accel-KKR for $17.75 per Share, All-Cash

(CPXX) & (JAZZ) Acquisition Agreement, $30.25 Per Share

Transaction would add VYXEOS™, an investigational product in development as a treatment for Acute Myeloid Leukemia (AML), to Jazz Pharmaceuticals’ portfolio U.S. regulatory submission for VYXEOS planned by end of third quarter 2016 Jazz Pharmaceuticals to host investor conference call today, May 31, 2016 at 8:30 AM EDT (1:30 PM IST)

DUBLIN and EWING, N.J., May 31, 2016  — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) today announced that they have entered into a definitive agreement for Jazz Pharmaceuticals to acquire Celator for $30.25 per share in cash, or approximately $1.5 billion.

The transaction with Celator is well-suited to advance Jazz Pharmaceuticals’ growth strategy.

  • VYXEOS is the first product candidate to demonstrate a statistically significant improvement in Overall Survival in patients with high-risk (secondary) AML1
  • U.S. FDA Breakthrough Therapy designation granted for VYXEOS2
  • U.S. FDA and European Commission Orphan Drug designation for VYXEOS for the treatment of AML
  • VYXEOS is an innovative product candidate based on the Celator CombiPlex® platform
  • Anticipated long-lived exclusivity for VYXEOS
  • Broadens Jazz Pharmaceuticals’ hematology/oncology portfolio
  • Worldwide development and commercialization rights to VYXEOS
  • Synergies with Jazz Pharmaceuticals’ commercial expertise and infrastructure
  • Transaction expected to close in the third quarter of 2016
  • Transaction expected to be accretive to Non-GAAP adjusted EPS beginning in 2018 and beyond
1 Included secondary AML and de novo AML with a karyotype characteristic of myelodysplastic syndrome (MDS)
2 U.S. FDA Breakthrough Therapy designation granted for VYXEOS for the treatment of adults with therapy-related AML or AML with myelodysplasia-related changes

“Celator Pharmaceuticals is a strong strategic fit with Jazz Pharmaceuticals. VYXEOS will further diversify our product portfolio and is complementary to our clinical and commercial expertise in hematology/oncology,” said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals plc. “As Celator is currently preparing a regulatory submission in the U.S. for VYXEOS, this acquisition would add a new orphan product with the potential for short- and long-term revenue generation and expansion of our international commercial platform.”

“The planned combination of Jazz and Celator is highly complementary, as both companies are dedicated to bringing differentiated therapies to patients who have high unmet medical needs,” said Scott Jackson, chief executive officer of Celator Pharmaceuticals.  “We believe that Jazz Pharmaceuticals’ clinical and commercial expertise in hematology/oncology and existing international infrastructure will help realize the value of VYXEOS as a treatment to patients with AML.  After thoroughly evaluating our strategic options, our board of directors has unanimously determined that this all-cash transaction is in the best interest of our stockholders.”

Transaction Closing
The transaction is structured as a tender offer and second step merger.  The closing of the tender offer is conditioned upon customary conditions, including the tender of a majority of the outstanding shares of Celator common stock and expiration or termination of the Hart Scott Rodino waiting period.  The transaction is expected to close in the third quarter of 2016.

Certain stockholders of Celator holding approximately 18.4 percent of Celator’s outstanding shares of common stock, including executive officers, members of the Celator board of directors and certain investment funds affiliated with the members of the board of directors, have agreed to tender their shares in the tender offer.

Financing
Jazz Pharmaceuticals expects to finance the transaction with a combination of cash on hand and borrowings under its senior secured credit facility.

Advisors
Jazz Pharmaceuticals’ financial advisor for the transaction is RBC Capital Markets, and its primary legal advisor is Cooley LLP.

Celator Pharmaceuticals’ financial advisor for the transaction is MTS Health Partners, and its primary legal advisor is Kirkland and Ellis LLP.

Conference Call Details
Jazz Pharmaceuticals will host a conference call and live audio webcast today at 8:30 am EDT/1:30 pm IST to discuss this transaction. Interested parties may access the live audio webcast and slide presentation via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be archived on the website for one week.

Audio webcast/conference call:
U.S. Dial-In Number: +1 503 343 6056
Outside the U.S. Dial-In Number: +1 855 353 7924
Passcode:  20942393

A replay of the conference call will be available through June 7, 2016 and accessible through one of the following telephone numbers and entering the passcode:

Replay U.S. Dial-In Number: +1 404 537 3406
Replay Outside the U.S. Dial-In Number: +1 855 859 2056
Passcode:  20942393

About Jazz Pharmaceuticals plc
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. The company has a diverse portfolio of products and product candidates, with a focus in the areas of sleep and hematology/oncology. In these areas, Jazz Pharmaceuticals markets Xyrem® (sodium oxybate) oral solution, Erwinaze® (asparaginase Erwinia chrysanthemi) and Defitelio® (defibrotide sodium) in the U.S. and markets Erwinase® and Defitelio® (defibrotide) in countries outside the U.S.  For more information, please visit www.jazzpharmaceuticals.com.

About Celator Pharmaceuticals, Inc.
Celator Pharmaceuticals, Inc., with locations in Ewing, N.J., and Vancouver, B.C., is an oncology-focused biopharmaceutical company that is transforming the science of combination therapy, and developing products to improve patient outcomes in cancer. Celator’s proprietary technology platform, CombiPlex®, enables the rational design and rapid evaluation of optimized combinations of anti-cancer drugs, incorporating traditional chemotherapies as well as molecularly targeted agents to deliver enhanced anti-cancer activity.  CombiPlex addresses several fundamental shortcomings of conventional combination regimens, as well as the challenges inherent in combination drug development, by identifying the most effective synergistic molar ratio of the drugs being combined in vitro, and fixing this ratio in a nano-scale drug delivery complex to maintain the optimized combination after administration and ensuring exposure of this ratio to the tumor.

Celator’s lead product is VYXEOS™ (also known as CPX-351), a nano-scale liposomal formulation of cytarabine:daunorubicin that has completed a Phase 3 trial for the treatment of acute myeloid leukemia.  Celator has also conducted clinical development on CPX-1, a nano-scale liposomal formulation of irinotecan:floxuridine studied in colorectal cancer; and have a preclinical stage product candidate, CPX-8, a hydrophobic docetaxel prodrug nanoparticle formulation.  More recently, Celator has advanced its CombiPlex platform and broadened its application to include molecularly targeted therapies.  For more information, please visit Celator’s website at www.celatorpharma.com.

About VYXEOS
VYXEOS (cytarabine:daunorubicin) Liposome for Injection, also known as CPX-351, is a nano-scale liposomal co-formulation of cytarabine and daunorubicin at a synergistic 5:1 molar ratio.  VYXEOS represents a novel approach to developing combinations of drugs in which molar ratios of two drugs with synergistic anti-tumor activity are encapsulated in a nanoscale liposome in order to maintain the desired ratio following administration. The FDA granted Breakthrough Therapy designation to VYXEOS for the treatment of adults with therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).  VYXEOS was granted orphan drug status for the treatment of AML by the FDA and the European Commission.  VYXEOS was also granted Fast Track designation for the treatment of elderly patients with secondary AML by the FDA.

In a Phase 3 trial in patients with high-risk (secondary) AML, the median overall survival for patients treated with VYXEOS in the study was 9.56 months compared to 5.95 months for patients receiving the standard of care regimen of cytarabine and daunorubicin known as 7+3, representing a 3.61-month improvement in favor of VYXEOS.  The hazard ratio (HR) was 0.69 (p=0.005), which represents a 31% reduction in the risk of death versus 7+3.  The percentage of patients alive 12 months after randomization was 41.5% on the VYXEOS arm compared to 27.6% on the 7+3 arm.  The percentage of patients alive 24 months after randomization was 31.1% on the VYXEOS arm compared to 12.3% on the 7+3 arm.

Sixty-day all-cause mortality was 13.7% versus 21.2%, in favor of patients treated with VYXEOS.  No substantial difference in Grade 3 or higher adverse events was observed between VYXEOS and 7+3.  In the intent-to-treat population, Grade 3-5, hematologic adverse events were similar for overall infections, febrile neutropenia, and bleeding events.  In the intent-to-treat population, Grade 3-5, non-hematologic adverse events were similar across all organ systems, including cardiac, gastrointestinal, general systems, metabolic disorders, musculoskeletal, nervous system, respiratory, skin and renal.

The final Phase 3 clinical trial data will be presented at the American Society of Clinical Oncology on June 4, 2016 and at the European Hematology Association Annual Congress on June 11, 2016.

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements regarding Jazz Pharmaceuticals and Celator Pharmaceuticals, including, but not limited to, statements related to the anticipated consummation of the tender offer for Celator common stock and the timing and benefits thereof, and estimated future financial results, regulatory submissions and performance of VYXEOS, as well as other statements that are not historical facts.  These forward-looking statements are based on each of the companies’ current expectations and inherently involve significant risks and uncertainties.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to Jazz Pharmaceuticals’ ability to complete the tender offer on the proposed terms and schedule, including risks and uncertainties related to the satisfaction of closing conditions; the possibility that competing offers will be made; risks associated with business combination transactions, such as the risk that the acquired business will not be integrated successfully or that such integration may be more difficult, time-consuming or costly than expected; risks related to future opportunities and plans for the combined company, including uncertainty of the expected future regulatory filings, financial performance and results of the combined company following completion of the proposed transaction; disruption from the proposed acquisition, making it more difficult to conduct business as usual or maintain relationships with customers, employees or suppliers; and the possibility that if Jazz Pharmaceuticals does not achieve the perceived benefits of the proposed acquisition as rapidly or to the extent anticipated by financial analysts or investors, the market price of Jazz Pharmaceuticals’ ordinary shares could decline; and those other risks detailed under the caption “Risk Factors” and elsewhere in Jazz Pharmaceuticals’  and  Celator’s U.S. Securities and Exchange Commission (“SEC”) filings and reports, including in Jazz Pharmaceuticals’ and Celator Pharmaceuticals’ Quarterly Reports on Form 10-Q for the quarter ended March 31, 2016, each of which is filed with the SEC, and future filings and reports by either company. Neither Jazz Pharmaceuticals nor Celator undertakes any duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events or changes in its expectations.

Additional Information and Where to Find It
The tender offer described in this communication (the “Offer”) has not yet commenced and this communication is neither an offer to purchase nor a solicitation of an offer to sell shares of Celator or other securities, nor is it a substitute for the tender offer materials that Jazz Pharmaceuticals and its acquisition subsidiary will file with the SEC upon commencement of the tender offer.  At the time the Offer is commenced, Jazz Pharmaceuticals and its acquisition subsidiary will file tender offer materials on Schedule TO, and Celator will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the Offer.  The tender offer materials (including an Offer to Purchase, a related Letter of Transmittal and certain other tender offer documents) and the Solicitation/Recommendation Statement, as they may be amended from time to time, will contain important information.  Holders of Celator securities are urged to read these documents when they become available because they will contain important information that holders of Celator securities should consider before making any decision regarding tendering their securities.  The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, will be made available to all holders of Celator securities at no expense to them.  Investors and security holders may obtain free copies of these documents (when they are available) and other related documents filed with the SEC at the SEC’s web site at http://www.sec.gov or by (i) directing a request to Jazz Pharmaceuticals plc, c/o Jazz Pharmaceuticals, Inc., 3180 Porter Drive, Palo Alto, California 94304, U.S.A., Attention: Investor Relations, (ii) calling +353 1 634 7892 (Ireland) or + 1 650 496 2800 (U.S.) or (iii) sending an email to investorinfo@jazzpharma.com.  Investors and security holders may also obtain free copies of the documents filed with the SEC on Jazz Pharmaceuticals’ website at www.jazzpharmaceuticals.com under the heading “Investors” and then under the heading “SEC Filings.”

Tuesday, May 31st, 2016 Uncategorized Comments Off on (CPXX) & (JAZZ) Acquisition Agreement, $30.25 Per Share

(REGI) Prices Offering of $132 Million of Convertible Senior Notes

Renewable Energy Group, Inc. (REG) (NASDAQ:REGI) announced today the pricing of its offering of $132 million aggregate principal amount of 4.00% convertible senior notes due 2036 (the “Notes”) in a private placement to qualified institutional buyers pursuant to an exemption from the registration requirements of the Securities Act of 1933. In connection with the offering, REG has granted the initial purchasers an option to purchase up to an additional $20 million aggregate principal amount of Notes on the same terms and conditions. The sale of the Notes is scheduled to close on June 2, 2016, subject to satisfaction of customary closing conditions.

REG estimates that the net proceeds from the offering will be approximately $127.5 million, after deducting the initial purchasers’ discount and estimated offering expenses payable by REG, assuming no exercise of the initial purchasers’ option to purchase additional Notes.

Concurrently with the offering, in separate transactions, REG intends to use approximately $62.0 million of the net proceeds from the offering to repurchase approximately $63.9 million principal amount of REG’s outstanding 2.75% convertible senior notes due 2019 (the “2019 Notes”), including accrued but unpaid interest and commissions, through one of the initial purchasers or its affiliate as REG’s agent. In addition, concurrently with the offering, in separate transactions, REG intends to use approximately $35.0 million of the net proceeds from the offering to repurchase approximately 4.1 million shares of its common stock through one of the initial purchasers or its affiliate as REG’s agent. REG intends to use the remainder of the net proceeds from the offering for working capital and other general corporate purposes, which may include additional repurchases of the 2019 Notes and shares of REG’s common stock and financing potential strategic transactions. Any repurchase of the 2019 Notes could have the effect of raising or maintaining the market price of REG’s common stock above levels that would otherwise have prevailed, or preventing or retarding a decline in the market price of REG’s common stock. In particular, REG expects that certain of the sellers of 2019 Notes that REG repurchases may purchase shares of common stock in the market in connection with those sales of 2019 Notes. Any repurchase of REG’s common stock could have the effect of raising or maintaining the market price of REG’s common stock above levels that would otherwise have prevailed, or preventing or retarding a decline in the market price of REG’s common stock.

The Notes will be senior unsecured obligations of REG and will pay interest semi-annually at a rate of 4.00% per annum. The Notes will mature on June 15, 2036 unless earlier redeemed, repurchased or converted. On or after June 15, 2021, REG may redeem for cash all or part of the Notes at a redemption price equal the principal amount thereof, plus accrued and unpaid interest, if any. Unless the Notes have been called for redemption, holders may require REG to repurchase the Notes, in cash, on June 15, 2021, June 15, 2026 and June 15, 2031 or upon the occurrence of certain fundamental changes at a repurchase price equal to the principal amount thereof, plus accrued and unpaid interest, if any.

The Notes will be convertible, upon satisfaction of certain conditions, at an initial conversion rate of 92.8074 shares per $1,000 principal amount of Notes, which is equivalent to an initial conversion price of approximately $10.78 per share, and will be subject to adjustment upon the occurrence of certain events. The initial conversion price represents a conversion premium of approximately 25.0% over the last reported sale price of $8.62 per share of REG’s common stock on The NASDAQ Global Select Market on May 26, 2016. Prior to December 15, 2035, the Notes will be convertible only under certain circumstances and during certain periods. On or after December 15, 2035, the Notes will be convertible at any time until the close of business on the second scheduled trading day immediately preceding the maturity date. REG will settle conversions of the Notes by paying or delivering, as the case may be, cash, shares of its common stock, or a combination of cash and shares of its common stock, at its election. However, unless REG obtains stockholder approval in accordance with applicable rules of The NASDAQ Stock Market to permit settlement in stock, REG will be required to settle conversions by paying cash or, subject to certain limitations, a combination of cash and shares of its common stock.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale is unlawful. The offer and sale of the Notes and the common stock, if any, issuable upon conversion of the Notes have not been registered under the Securities Act of 1933 or applicable state securities laws and, unless so registered, the Notes and such common stock, if any, may not be offered or sold in the United States or to U.S. persons except pursuant to an exemption from the registration requirements of the Securities Act of 1933 and applicable state securities laws.

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as amended, including statements regarding the expected closing date of the offering and expected timing of the repurchase transactions, the expected uses of net proceeds from the offering, and the possible effects of the repurchase transactions. These forward-looking statements are based on current expectations, estimates, assumptions and projections that are subject to change, and actual results may differ materially from the forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, difficulties or delays in closing the offering and repurchases, fluctuations in the price of REG’s common stock, satisfaction of the conditions to closing of the offering, the fact that REG’s management will have broad discretion in the use of the proceeds from any sale of the Notes, factors affecting REG’s business that may affect REG’s liquidity and working capital requirements, and other risks and uncertainties described from time to time in REG’s annual report on Form 10-K, quarterly reports on Forms 10-Q and other periodic filings with the Securities and Exchange Commission. All forward-looking statements are made as of the date of this press release and REG does not undertake to update any forward-looking statements based on new developments or changes in its expectations, except as required by law.

 

Renewable Energy Group, Inc.

Friday, May 27th, 2016 Uncategorized Comments Off on (REGI) Prices Offering of $132 Million of Convertible Senior Notes

(PTLA) to Present Results of Phase 3 APEX Study of Betrixaban

–Company Plans to Submit NDA and MAA for Betrixaban in Second Half of 2016–

–Webcast with APEX Study Executive Committee Members Today at 11 a.m. ET–

MONTPELLIER, France, and SOUTH SAN FRANCISCO, Calif. , May 27, 2016  — Portola Pharmaceuticals Inc.® (NASDAQ:PTLA) announced that the full results of its pivotal Phase 3 APEX (Acute Medically Ill VTE Prevention with Extended Duration Betrixaban) Study were presented today for the first time in a late-breaking clinical trial session (http://investors.portola.com/) at the 62nd Annual International Society on Thrombosis and Haemostasis (ISTH) Scientific and Standardization Committee (SSC) Meeting. Full results from the APEX trial were published simultaneously online in The New England Journal of Medicine (http://www.nejm.org/doi/full/10.1056/NEJMoa1601747). Portola announced topline results (http://topline.portola.com) from the APEX trial in March 2016.

APEX, which enrolled 7,513 patients at more than 450 clinical sites worldwide, assessed the superiority of extended-duration betrixaban for 35 days compared to standard-duration enoxaparin for 10+4 days. The trial was designed in cooperation with the FDA and EMA to incorporate a novel patient enrichment and statistical analysis plan derived from the 2012 FDA guidance document on enrichment strategies for clinical trials.

“In a pre-specified subgroup of medically ill patients who were D-dimer positive, extended- duration betrixaban demonstrated a reduction in VTE events approaching statistical significance. In the pre-specified exploratory analyses of central lab D-dimer values and in progressively larger cohorts, including all study patients, the data demonstrated a consistent and significant reduction in VTE with betrixaban with no statistical difference in major bleeding between the betrixaban and enoxaparin arms,” said C. Michael Gibson, M.S., M.D., senior author of the NEJM publication and APEX Executive Committee Member and Steering Committee Chairman.

Betrixaban, an investigational drug, is an oral, once-daily Factor Xa inhibitor anticoagulant. It is an FDA-designated Fast Track therapy for extended-duration VTE prophylaxis in acute medically ill patients. Acute medically ill patients are hospitalized for serious common medical conditions, such as heart failure, stroke, infection and pulmonary disease. Despite the use of standard of care anticoagulation, a significant number of patients will suffer a VTE event. Over half of these events will occur after discontinuation of enoxaparin and hospital discharge. Currently no anticoagulant, including any of the marketed oral Factor Xa inhibitors, is approved or guideline-recommended for extended-duration VTE prophylaxis in this patient population.

“The APEX Study results show consistent evidence that VTE events can be reduced with betrixaban with no statistical difference in major bleeding between the betrixaban and enoxaparin arms. This is particularly true for the most clinically relevant symptomatic disease where we observed a 30 to 45 percent reduction in events over the duration of the study,” said lead author of the NEJM publication Alexander (Ander) T. Cohen, MBBS, M.Sc., M.D., FRACP, APEX Co-Principal Investigator and Co-Chairman of the APEX Executive Committee and Consultant Physician at Guy’s and St Thomas’ NHS Foundation Trust. “Such meaningful results in an area where there is currently no available recommended therapy offer important potential benefits for public health worldwide. Based on the number of reduced events in APEX, this could translate into preventing over 100,000 additional VTE events per year and over 50,000 deaths from pulmonary embolism in the G7 countries if betrixaban is approved.”

Later this year, Portola plans to submit the APEX Study data as part of a New Drug Application (NDA) for betrixaban in the United States and as part of a Marketing Authorization Application (MAA) in the EU.

“We recently held a pre-NDA meeting with the FDA where we reconfirmed Fast Track Designation for betrixaban in this indication and agreed to upcoming meetings in preparation for an NDA submission in the second half of 2016,” said Bill Lis, chief executive officer of Portola.

About VTE in Acute Medically Ill Patients
An estimated 20 million acute medically ill patients in the G7 countries are at risk of developing VTE either while in the hospital or following discharge. Each year, more than 1 million VTEs and 150,000 VTE-related deaths occur in acute medically ill patients in the G7 countries, despite the standard use of injectable enoxaparin and other heparins in the hospital. Although more than half of VTE events occur after the patient is discharged from the hospital, no anticoagulant, including enoxaparin or any of the marketed oral Factor Xa inhibitors, is approved for extended VTE prophylaxis in the more than 24 million medically ill patients hospitalized in the G7 countries annually.

About Betrixaban
Betrixaban directly inhibits the activity of Factor Xa, an important validated target in the blood coagulation pathway, to prevent life-threatening thrombosis. Betrixaban has distinct properties that may allow it to demonstrate clinical benefit without the significant imbalance in the risk of major bleeding seen with other agents in the class. These include a 19-25-hour half-life for once-daily dosing; a low peak-to-trough drug concentration ratio that minimizes anticoagulant variability; low renal clearance; and no significant CYP3A4 metabolism, which may reduce the risk of drug-drug interactions.

Webcast Details
Portola will host an investor event today, May 27, 2016, at 5:00-6:00 p.m. CEST/11 a.m.-12 p.m. EDT in which members of the Company’s senior management team and Drs. Gibson and Cohen will present and discuss the full APEX Study data. Webcast participants will be able to participate in a live Q&A session via the webcast portal. To access the webcast of the live event, go to the Investor Relations section of the Company’s website at investors.portola.com. A replay will be available on the Company’s website for 30 days following the live event, also at investors.portola.com.

About Portola Pharmaceuticals, Inc.
Portola Pharmaceuticals is a biopharmaceutical company developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases. The Company is advancing three programs, including betrixaban, an oral, once-daily Factor Xa inhibitor; AndexXa™ (andexanet alfa), a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and cerdulatinib, a Syk/JAK inhibitor in development to treat hematologic cancers. Portola’s partnered program is focused on developing selective Syk inhibitors for inflammatory conditions. For more information, visit portola.com and follow the Company on Twitter @Portola_Pharma.

Forward-looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the potential for study results to support an application for regulatory approval of betrixaban, the potential for betrixaban, subject to regulatory approval, to play a role in both in-hospital and post-discharge reduction of VTE events and deaths, our interpretation and characterization of APEX Study results and the anticipated timing of our submission of filings seeking regulatory approval. Risks that contribute to the uncertain nature of the forward-looking statements include the results of discussions with regulatory authorities regarding interpretation of full APEX Study results, that the FDA and other regulatory authorities may not approve betrixaban, whether the clinical results of betrixaban will meet the regulatory requirements for approval, whether regulatory submissions will occur or will be submitted in a timely manner and that marketing approvals may not be granted or, if granted, may have significant limitations on their use or require additional studies. These and other risks and uncertainties are described more fully in our most recent filings with the Securities and Exchange Commission, including our most recent quarterly report on Form 10-Q, which was filed on May 6, 2016. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

 

Investor Contact: 
Ana Kapor 
Portola Pharmaceuticals
ir@portola.com
1.650.246.7252 

Media Contact:
Julie Normart
W2O Group
jnormart@w2ogroup.com
1.559.974.3245
Friday, May 27th, 2016 Uncategorized Comments Off on (PTLA) to Present Results of Phase 3 APEX Study of Betrixaban

(VIA) Renews Comprehensive Carriage Agreement with Cox Communications

Viacom (NASDAQ:VIAB)(NASDAQ:VIA) today announced the renewal and expansion of its distribution agreement with Cox Communications for carriage of Viacom’s media networks across Cox’s subscriber base.

In addition to carriage of 22 popular Viacom cable networks and EPIX, Cox subscribers will have access to an expanded selection of on-demand, full-length programming across all platforms, including television and mobile devices.

Philippe Dauman, Viacom Executive Chairman and CEO, said, “Cox has consistently been a leader in offering advanced features and services to their subscribers, and Viacom’s networks are favorites among those audiences who consume programming on digital devices, whenever and wherever they choose. Viacom and Cox have worked together for many years to provide industry-leading offerings, and are pleased to continue our strong relationship for many years to come.”

Terms of the deal were not disclosed.

About Viacom

Viacom is home to premier global media brands that create compelling television programs, motion pictures, short-form content, apps, games, consumer products, social media experiences, and other entertainment content for audiences in 180 countries. Viacom’s media networks, including Nickelodeon, Comedy Central, MTV, VH1, Spike, BET, CMT, TV Land, Nick at Nite, Nick Jr., Channel 5 (UK), Logo, Nicktoons, TeenNick and Paramount Channel, reach over 3.5 billion cumulative television subscribers worldwide. Paramount Pictures is a major global producer and distributor of filmed entertainment.

For more information about Viacom and its businesses, visit www.viacom.com. Keep up with Viacom news by following Viacom’s blog at blog.viacom.com and Twitter feed at www.twitter.com/viacom.

 

Viacom
Jeremy Zweig, 212-846-7503
jeremy@viacom.com

Friday, May 27th, 2016 Uncategorized Comments Off on (VIA) Renews Comprehensive Carriage Agreement with Cox Communications

(TGTX) Enters into a Global Collaboration Over Jubilant Biosys’ BET Inhibitors

NEW YORK, May 27, 2016  — TG Therapeutics, Inc. (Nasdaq:TGTX), announced today that as part of a broader agreement with Jubilant Biosys (“Jubilant”), an Indian biotechnology company, TG Therapeutics entered into a sub-license agreement with Checkpoint Therapeutics, Inc. (“Checkpoint”), a Fortress Biotech company, to develop and commercialize Jubilant’s novel BET inhibitor program in the field of hematological malignancies.  Checkpoint will develop and commercialize these small molecule inhibitors in solid tumors.  The BET inhibitor program is the subject of an exclusive, worldwide license agreement pursuant to which Checkpoint in-licensed from Jubilant a family of patents covering compounds that inhibit BRD4, a member of the BET (Bromodomain and Extra Terminal) domain for cancer treatment.

Under the terms of the agreement, TG Therapeutics will pay an up-front licensing fee of $1 million and make additional payments contingent on certain preclinical, clinical, and regulatory milestones, including commercial milestones totaling up to approximately $177 million and a single-digit royalty on net sales.  TG Therapeutics will also provide funding to support certain targeted research efforts at Jubilant Biosys.

Mr. Michael S. Weiss, Executive Chairman, Interim CEO and President stated, “We are very excited to add this BET inhibitor program to our growing portfolio of agents targeting hematological malignancies.  BET inhibitors have shown early promise in the treatment of relapsed and refractory Non-Hodgkin lymphomas, which remains a significant area of unmet medical need. There is emerging preclinical data showing BET inhibitors may enhance the activity of immuno-oncology agents, such as anti-PD-1/PD-L1 antibodies, providing multiple opportunities for us to combine this novel mechanism within our portfolio.  Epigenetic targeted agents, especially BET inhibitors, have been an area of great interest of ours for some time and are particularly attractive to us because of their effects on c-Myc driven tumors, like aggressive GCB-subtype DLBCL, an area we have seen early activity with TGR-1202 and our proprietary combination referred to as TG-1303.  We want to thank our collaborators at Checkpoint for introducing us to this opportunity.”  Mr. Weiss continued, “As we prepare to launch our registration directed studies in DLBCL and Follicular Lymphoma, we continue to look toward next steps in the evolution of patient care and believe the best outcome will be achieved only through the combination of multiple novel agents.”

ABOUT TG THERAPEUTICS, INC.

TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies, with TG-1101 recently entering clinical development for autoimmune disorders. The Company also has pre-clinical programs to develop IRAK4 inhibitors, and anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City.

About Jubilant Drug Discovery Solutions

Jubilant Drug Discovery Solutions (JDDS) comprises of Jubilant Biosys, Jubilant Chemsys and Jubilant Innovation and has presence in India, in Bangalore and Noida, and in Malvern (USA). These subsidiaries of Jubilant Life Sciences Ltd employ over 625 employees and have demonstrated expertise in multiple therapeutic areas of Oncology, Metabolic Disorders, Pain & Inflammation, CNS and others. The business model includes proprietary in-house innovation, strategic investments as well as drug discovery services as the core components which are available for collaborative research, partnership and out-licensing.

For more info: www.jubilantbiosys.comwww.Jchemsys.com

About Checkpoint Therapeutics

Checkpoint Therapeutics, Inc. (“Checkpoint”), a subsidiary of Fortress Biotech Company, is an immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel, non-chemotherapy, immune-enhanced combination treatments for patients with solid tumor cancers. Checkpoint aims to acquire rights to these technologies by licensing the rights or otherwise acquiring an ownership interest in the technologies, funding their research and development and eventually either out-licensing or bringing the technologies to market. Currently, Checkpoint is developing a portfolio of fully human immuno-oncology targeted antibodies generated in the laboratory of Dr. Wayne Marasco, MD, PhD, a professor in the Department of Cancer Immunology and AIDS at the Dana-Farber Cancer Institute (“Dana-Farber”). The portfolio of antibodies Checkpoint licensed from Dana-Farber includes antibodies targeting programmed death-ligand 1 (“PD-L1”), glucocorticoid-induced TNFR related protein (“GITR”) and carbonic anhydrase IX (“CAIX”). Checkpoint plans to develop these novel immuno-oncology and checkpoint inhibitor antibodies on their own and in combination with each other, as published literature suggests that combinations of these targets may work synergistically together. Checkpoint has also licensed and is developing two oral targeted anti-cancer therapies, consisting of a small molecule inhibitor of poly (ADP-ribose) polymerase (“PARP”) and a small molecule inhibitor of epidermal growth factor receptor (“EGFR”) mutations. Additionally, Checkpoint will seek to add additional immuno-oncology drugs as well as other targeted therapies to create wholly-owned proprietary combinations that leverage the immune system and other complimentary mechanisms. Checkpoint is headquartered in New York City.  For more information, visit www.checkpointtx.com.

Cautionary Statement

Some of the statements included in this press release, particularly those anticipating future clinical trials, timing of clinical trials for BET inhibitors and business prospects and potential uses for BET inhibitors may be forward-looking statements that involve a number of risks and uncertainties.  For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to identify BET inhibitors suitable for clinical development, our ability to successfully and cost-effectively complete pre-clinical and clinical trials for BET inhibitors; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data analyses from prior pre-clinical and clinical trials; the risk that early pre-clinical and clinical results that supported our decision to move forward with TG-1101 and TGR-1202 will not be reproduced in additional patients or in future studies; the risk that trends observed which underlie certain assumptions of future performance of TGR-1202 will not continue, the risk that the combination of TG-1101 and TGR-1202, referred to as TG-1303, will not prove to be a safe and efficacious backbone for triple and quad combination therapies; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission.  Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

TGTX – G

CONTACT: Jenna Bosco
Director- Investor Relations
TG Therapeutics, Inc.
Telephone: 212.554.4351
Email: ir@tgtxinc.com
Friday, May 27th, 2016 Uncategorized Comments Off on (TGTX) Enters into a Global Collaboration Over Jubilant Biosys’ BET Inhibitors

(NVET) Provides Update on Upcoming Investor Symposium at Irish Biomanufacturing Facility

DUBLIN, Ireland, May 27, 2016  — Nexvet Biopharma (Nasdaq:NVET), a veterinary biologic therapeutics company, is pleased to provide an update on its Investor Symposium, which will be held on Friday June 3, 2016 at BioNua, its veterinary biologics manufacturing facility in Tullamore, Ireland.

The Symposium’s presentations and Q&A session will be held from 9:30AM – 10:30AM IST. In addition to providing an overview of the BioNua facility and its capabilities, the company will present a corporate and clinical update. Key topics will include progress on ranevetmab (NV-01) and NV-02, Nexvet’s anti-nerve growth factor (NGF) monoclonal antibody (mAb) therapies being developed as monthly subcutaneous injectables for the control of pain associated with osteoarthritis in dogs and cats, respectively.

“Dedicated in-house manufacturing is an important element of Nexvet’s strategy for furthering our leadership position in the emerging field of veterinary biopharmaceuticals. The BioNua facility is an asset which we anticipate will provide added control, cost advantages and overall enhanced efficiency in manufacturing, both for our advanced pain product candidates for dogs and cats as well as our emerging pipeline in immuno-oncology, allergy and inflammation. These advantages are particularly important as we plan further pivotal studies and prepare our commercial infrastructure,” commented Dr. Mark Heffernan, Chief Executive Officer of Nexvet.

The audio and presentations from this event will be made available for 30 days on the Investor Relations section of the Nexvet website at www.ir.nexvet.com.

To register to attend Nexvet’s Investor Symposium in Tullamore, please RSVP to IR@nexvet.com with your name, company and phone number.

About Nexvet (www.nexvet.com)

Nexvet is a veterinary biologics developer focused on transforming the therapeutic market for companion animals, such as dogs and cats, by developing and commercializing novel, species-specific biologics. Nexvet’s proprietary PETization™ platform is designed to rapidly design monoclonal antibodies (mAbs) that are recognized as “self” or “native” by an animal’s immune system, a property Nexvet refers to as “100% species-specificity.” Nexvet’s product candidates also build upon the safety and efficacy data from clinically tested human therapies, thereby reducing clinical risk and development cost.

Nexvet is leveraging diverse global expertise and incentives to build a vertically integrated biopharmaceutical company, which conducts drug discovery in Australia, conducts clinical development in the United States and Europe and is growing its biomanufacturing capabilities in Ireland.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements consist of all statements other than statements of historical fact, including statements regarding our future results of operations and financial position, results of any current or future pivotal safety and efficacy study, future expenditures relating to our lead product candidates, time for completion of any of our studies or facilities updates, ability to develop our pipeline of product candidates, business strategy, prospective products, ability to successfully manufacture our own product candidates, ability to meet conditions for the receipt of government grants, ability to qualify for conditional licensure or obtain product approvals, research and development costs, timing and likelihood of success, plans and objectives of management for future operations, and future results of current and anticipated products. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.  The words “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “plan,” “potential,” “predict,” “project,” “position,” “seek,” “should,” “target,” “will,” “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.  These forward-looking statements are based on current expectations, estimates, forecasts and projections about our business and the industry in which we operate, and management’s beliefs and assumptions are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors.

Factors that could cause actual results to differ materially from our expectations expressed in this report include those summarized under Risk Factors in our reports on Forms 10-Q and 10-K and the other documents we file from time to time with the Securities and Exchange Commission. Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent management’s beliefs and assumptions only as of the date of this press release. Except as required by law, we do not intend, and undertake no obligation, to revise or update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

Further information:

Investors                                                                       
Candice Knoll                                                                 
Blueprint Life Science Group                                         
+1 415-375-3340 Ext. 4                                                                      
cknoll@bplifescience.com                                            

Media
Jessica Burns
Berry & Company Public Relations
+1 212-253-8881
jburns@berrypr.com
Friday, May 27th, 2016 Uncategorized Comments Off on (NVET) Provides Update on Upcoming Investor Symposium at Irish Biomanufacturing Facility

(MCFT) Declares Special Cash Dividend of $4.30 Per Share

VONORE, Tenn., May 27, 2016  — MasterCraft (NASDAQ:MCFT) today announced that its Board of Directors has declared a special cash dividend of $4.30 per share of common stock. The dividend, totaling an aggregate payment of approximately $80.0 million, will be paid on June 10, 2016, to shareholders of record as of the close of business on June 6, 2016. The special dividend will be funded through existing cash and borrowings under a new credit facility.

Terry McNew, MasterCraft’s President and Chief Executive Officer, commented, “As we stated when we announced our share repurchase program in February, MasterCraft’s Board is committed to consistently evaluating the most prudent uses of the company’s strong balance sheet and free cash flow in order to maximize shareholder value, and  today’s announcement demonstrates that commitment. Our currently unlevered balance sheet and access to attractive financing allow us to recognize and reward shareholders with a meaningful return of capital.  In addition, our new capital structure will allow us to create additional equity value going forward by utilizing free cash flow to repay debt.”

Continued McNew, “As our investors know, MasterCraft has a very efficient business model which generates meaningful free cash flow.  We believe this transaction is a prudent way to leverage that cash flow to provide a current return to our shareholders while continuing to drive long-term value creation through the sustained growth of our business.”

The special dividend will be funded with cash on hand and borrowings under an amended and restated senior secured credit facility provided by the company’s existing lenders.  The amended and restated facility provides the company with a new $50 million term loan, in addition to maintaining its capacity under its existing $30 million revolving credit facility.  On a pro-forma basis that reflects the transaction, MasterCraft expects to have total debt of less than 1.4x reported Adjusted EBITDA for the 12 months ended March 27, 2016, and liquidity of approximately $25 million.

Commented McNew, “Following completion of this transaction we will maintain a very conservative balance sheet, ample liquidity, and strong cash generation.  Most important, we preserve the financial and operational flexibility to pursue our key strategic growth initiatives and to continue driving the sustainable, profitable growth and margin expansion our investors have come to expect from MasterCraft.”

At $4.30 per share, MasterCraft’s special dividend represents approximately 33 percent of the company’s closing stock price on May 26, 2016. Pursuant to NASDAQ rules, when a dividend is declared in a per share amount that exceeds 25 percent of its stock price, the date its shares will begin to trade without the dividend, or ex-dividend, is the first business day following the payable date. The company expects NASDAQ to apply this rule and the ex-dividend date as set by NASDAQ will be June 13, 2016, the first business day following the dividend’s payable date. Stockholders of record on the record date who sell their shares prior to the ex-dividend date will not receive the special cash dividend.

The company expects that a portion of the special dividend will be in excess of its current and accumulated earnings and profits, with this excess amount treated as a nondividend distribution for U.S. federal income tax purposes, which will reduce the tax basis of a shareholder’s common shares. If the nondividend distribution exceeds the shareholder’s basis in its common stock, the remainder of the nondividend distribution in excess of the shareholder’s basis will be treated as a capital gain. MasterCraft intends to provide a preliminary estimate of its accumulated earnings and profits through fiscal year end June 30, 2016 on or prior to July 25, 2016 in the Investor Relations section of its website (www.mastercraft.com).  Since the earnings and profits amount will not be finalized until MasterCraft completes its corporate income tax returns for the June 30, 2016, fiscal year, the Company expects to provide final information as soon as it is available, but no later than January 2017.

The U.S. federal income tax treatment of holding common stock to any particular stockholder will depend on the stockholder’s particular tax circumstances. MasterCraft’s stockholders are urged to consult their tax advisor regarding the U.S. federal, state, local and foreign income and other tax consequences to them, in light of their particular investment or tax circumstances, of the receipt of the special dividend.

Forward-Looking Statements
This press release contains statements that may constitute “forward-looking statements” within the meaning of the federal securities laws. Statements regarding future events and future performance, as well as our expectations relating to the future, are forward-looking statements within the meaning of these laws. We believe these forward-looking statements are reasonable; however, you should not place undue reliance on these statements.  These statements are based on current expectations and speak only as of the date of such statements. Important risk factors regarding the company and these statements are included in the reports we file with the SEC.

About MCBC Holdings, Inc.:
Headquartered in Vonore, Tenn., MCBC Holdings, Inc. (NASDAQ:MCFT) is the parent of MasterCraft Boat Company, a world-renowned innovator, designer, manufacturer, and marketer of premium performance sport boats. Founded in 1968, MasterCraft has cultivated its iconic brand image through a rich history of industry-leading innovation, and more than four decades after the original MasterCraft made its debut the company’s goal remains the same – to continue building the world’s best ski, wakeboard, wakesurf and luxury performance powerboats. For more information, visit www.mastercraft.com.

CONTACT: 
Tim Oxley
Chief Financial Officer
(423) 884-2221
Tim.Oxley@mastercraft.com 

Matt Sullivan
(612) 455-1709
Matt.Sullivan@padillacrt.com
Friday, May 27th, 2016 Uncategorized Comments Off on (MCFT) Declares Special Cash Dividend of $4.30 Per Share

(SPIL) & (ASE) Joint Share Exchange Memorandum of Understanding Statement

TAIPEI, Taiwan, May 26, 2016  — Advanced Semiconductor Engineering, Inc. (TWSE Code: 2311, NYSE Code: ASX) (“ASE“) and Siliconware Precision Industries Co., Ltd. (“SPIL“)(Taiwan Stock Exchange: 2325, NASDAQ: SPIL) announced today that the boards of directors of ASE and SPIL have separately passed resolutions today for the execution by ASE and SPIL of the “Joint Share Exchange Memorandum of Understanding.” Both companies agree to promote plans for the establishment of a holding company (“HoldCo“). The main terms and purpose of the plans to jointly establish HoldCo are as follows:

1.     HoldCo will be jointly established by ASE and SPIL, and will be listed on the Taiwan Stock Exchange (American depositary shares of HoldCo will be listed on the New York Stock Exchange). Upon the completion of its establishment, HoldCo will simultaneously hold 100% equity interests in both ASE and SPIL (the “Transaction” or “Joint Share Exchange“). As parallel sibling companies under HoldCo, ASE and SPIL can, through maintaining an operating model which incentivizes healthy competition while promoting cooperation between the two companies, improve their individual operating efficiencies and economies of scale as well as research innovation achievements. In doing so, both companies will jointly create a mutually beneficial platform that can strengthen competitiveness, improve the performance of HoldCo, and seek to attain the goals of improving customer service quality, creating shareholder value and improving employee well-being.

2.     After the establishment of HoldCo, ASE and SPIL will each maintain its separate legal entity status, retain its legal entity name, and maintain its current independent operations and operating model. ASE and SPIL will each retain its full management team and employees, and their current organizational structure, compensation, relevant benefits and personnel regulations will continue to remain unchanged.

3.     The Joint Share Exchange will result in (1) Holdco issuing new HoldCo shares as consideration in exchange for all of ASE’s shares at the exchange ratio of 1 ASE common share in exchange for 0.5 HoldCo common shares and (2) HoldCo paying NT$55 in cash per SPIL common share as consideration for all of SPIL’s shares. HoldCo will simultaneously hold 100% equity interests in both ASE and SPIL upon the consummation of the Transaction.

4.     The Joint Share Exchange Memorandum of Understanding is not binding. After separately convening their respective boards of directors to approve the Transaction, both parties will execute a “Joint Share Exchange Agreement” on or before June 25, 2016. The completion of the Transaction is conditioned upon the completion of the execution of the Joint Share Exchange Agreement, all necessary approvals from foreign and domestic competent authorities and the satisfaction of all other closing conditions.

After sincere communication and exchange of opinions, the management teams of ASE and SPIL have agreed to jointly plan, with utmost sincerity and determination and on the basis of equality, reciprocity and mutual benefit, the establishment of HoldCo to consolidate the current operating models and excellent talents of ASE and SPIL. The collaboration between the parties will result in synergies that can create a high point and opportunities for the future development and sustained operations of the semiconductor industry by enhancing efficiency and economies of scale as well strengthening deep research and development and innovation capabilities, thereby providing customers with higher quality, more efficient, and well-rounded packaging and testing services. ASE and SPIL have always strived to innovate research and development and improve economies of scale and operating efficiency to maximize shareholder value. Both parties believe their main task and social responsibility is to continue maintaining and improving the semiconductor packaging and testing industry’s advantage, and at the same time consolidate the excellent talents nurtured over the decades.

Safe Harbor Notice:

This press release contains “forward-looking statements” within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended, including statements regarding ASE’s or HoldCo’s future results of operations and business prospects. Although these forward-looking statements, which may include statements regarding ASE’s or HoldCo’s (if established) future results of operations, financial condition or business prospects, are based on ASE’s or HoldCo’s (if established) own information and information from other sources we believe to be reliable, you should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan” and similar expressions, as they relate to ASE or HoldCo (if established), are intended to identify these forward-looking statements in this press release. These statements discuss future expectations, identify strategies, contain projections of results of operations of ASE’s or HoldCo’s (if established) financial condition, or state other forward-looking information. Known and unknown risks, uncertainties and other factors could cause the actual results to differ materially from those contained in any forward-looking statement. ASE cannot promise that its expectations expressed in these forward-looking statements will turn out to be correct. ASE’s or HoldCo’s (if established)actual results could be materially different from and worse than those expectations. For a discussion of important risks and factors that could cause ASE’s or HoldCo’s (if established) actual results to be materially different from its expectations, please see the documents we file from time to time with the U.S. Securities and Exchange Commission (“U.S. SEC”), including ASE’s 2015 Annual Report on Form 20-F filed on April 29, 2016.

This press release is not an offering of securities for sale in any jurisdiction:

ASE may file a registration statement on Form F-4 with the U.S. SEC in connection with the proposed Joint Share Exchange. The Form F-4 (if filed) will contain a prospectus and other documents. The Form F-4 (if filed) and prospectus, as they may be amended from time to time, will contain important information about ASE, SPIL, the Joint Share Exchange and related matters. U.S. shareholders of ASE are urged to read the Form F-4 (if filed), the prospectus and the other documents, as they may be amended from time to time, that may be filed with the U.S. SEC in connection with the Joint Share Exchange carefully before they make any decision at any shareholders’ meeting of ASE with respect to the Joint Share Exchange. The Form F-4 (if filed), the prospectus and all other documents filed with the U.S. SEC in connection with the Joint Share Exchange will be available when filed, free of charge, on the U.S. SEC’s website at www.sec.gov. In addition, the Form F-4 (if filed), the prospectus and all other documents filed with the U.S. SEC in connection with the Joint Share Exchange will be made available, free of charge, to U.S. shareholders of ASE who make a written request to ir@aseglobal.com.

Investor Relations Contact:

Advanced Semiconductor Engineering, Inc. Siliconware Precision Industries Co., Ltd.
Iris Wu, Manager Mike Ma, Spokesperson
irissh_wu@aseglobal.com mikema@spil.com.tw
Tel: +886.2.6636.5678 Tel: +886.4.2554.5527#5601
Thursday, May 26th, 2016 Uncategorized Comments Off on (SPIL) & (ASE) Joint Share Exchange Memorandum of Understanding Statement

(MARA) to Present at the LD Micro Invitational

LOS ANGELES, CA / May 26, 2016 / Marathon Patent Group, Inc. (NASDAQ: MARA) (“Marathon”), a patent licensing and commercialization company, announced today that it will be presenting at the 6th annual LD Micro Invitational on Wednesday, June 8 at 10 AM PST / 1 PM EST. Doug Croxall, Marathon’s Chief Executive Officer, will be giving the presentation and meeting with investors.

The presentation will be webcast and will be available here: http://wsw.com/webcast/ldmicro10/mara

The conference will be held at the Luxe Sunset Bel Air Hotel and will feature 195 companies in the small / micro-cap space.

View Marathon Patent Group’s profile here: http://www.ldmicro.com/profile/MARA

Profiles powered by LD Micro – News Compliments of Accesswire

About Marathon Patent Group

Marathon is a patent licensing and commercialization company. The Company acquires patents from a wide-range of patent holders from individual inventors to Fortune 500 companies. Marathon’s strategy of acquiring patents that cover a wide-range of subject matter allows the Company to achieve diversity within its patent asset portfolio. Marathon generates revenue with its diversified portfolio through actively managed concurrent patent rights enforcement campaigns. This approach is expected to result in a long-term, diversified revenue stream. The Company’s commercialization division is focused on the full commercialization lifecycle which includes discovering opportunities, performing due diligence, providing capital, managing development, protecting and developing IP, assisting in execution of the business plan, and realizing shareholder value. To learn more about Marathon Patent Group, visit www.marathonpg.com.

About LD Micro

LD Micro was founded in 2006 with the sole purpose of being an independent resource in the microcap space. What started out as a newsletter highlighting unique companies has transformed into an event platform hosting several influential conferences annually (Invitational, Summit, and Main Event).

In 2015, LDM launched the first pure microcap index (the LDMi) to exclusively provide intraday information on the entire sector. LD will continue to provide valuable tools for the benefit of everyone in the small and microcap universe.

For those interested in attending, please contact David Scher at david@ldmicro.com or visit www.ldmicro.com for more information.

Contact:

Marathon Patent Group
Jason Assad
678-570-6791
Jason@marathonpg.com

Thursday, May 26th, 2016 Uncategorized Comments Off on (MARA) to Present at the LD Micro Invitational

(PAVMU) to Present at 2016 Marcum MicroCap Conference on June 2, 2016

PAVmed Inc. (Nasdaq:PAVMU), an innovative, multi-product medical device company developing and commercializing a diversified pipeline of innovative products utilizing a groundbreaking business model focused on capital efficiency and speed to market, today announced that Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer, will present at the 2016 Marcum MicroCap Conference on Thursday, June 2, 2016, at 3:30pm ET taking place in New York City. Dr. Aklog will provide a corporate overview, discuss the company’s innovative business model and review PAVmed’s five lead products.

To access the live webcast of the presentation, please click here. A replay will be available following the presentation.

About PAVmed

PAVmed Inc. is an innovative, multi-product medical device company developing and commercializing a diversified pipeline of innovative products which address unmet clinical needs. The Company’s goal is to enhance and accelerate value creation by employing a business model focused on capital efficiency and speed to market. PAVmed is building a deep development product pipeline with attractive regulatory pathways and market opportunities encompassing a broad spectrum of clinical areas including carpal tunnel syndrome, medical infusions, interventional radiology, tissue ablation, and cardiovascular intervention. The Company is further expanding its pipeline through engagements with clinician innovators and leading academic medical centers.

Forward-Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of the Company’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements.

 

For PAVmed:
Investors:
Matthew Ventimiglia, 212-599-1265
mventimiglia@lazarpartners.com
or
Media:
Erich Sandoval, 213-908-6226
esandoval@lazarpartners.com

Thursday, May 26th, 2016 Uncategorized Comments Off on (PAVMU) to Present at 2016 Marcum MicroCap Conference on June 2, 2016

(ERN) Announces Results of Annual Meeting of Shareholders

Highlights changes to the board and management

Erin Energy Corporation (“Erin Energy” or the “Company”) (NYSE MKT:ERN) (JSE:ERN) announced today the results of the Company’s Annual Meeting of Shareholders held on May 25, 2016 and changes to its board of directors (Board) and management team.

  • John Hofmeister named Chairman of the Board
  • Segun Omidele named CEO
  • Pannell Kerr Foster of Texas, P.C. appointed as the Company’s auditors for 2016

Chairman of Erin Energy, John Hofmeister commented: “It is an honor to inherit the determined leadership of our former Chairman, Kase Lawal. Despite challenging market conditions we will pursue both near and longer term opportunities to strengthen and grow the Company and to reward shareholders with sustained value creating initiatives. Our Board, new Chief Executive, Segun Omidele, other executive leaders, Erin Energy people, plans, and assets are aligned, organized and focused on the tasks at hand to do just that.”

Mr. Segun Omidele has been with Erin Energy since 2011 and previously served as its COO. He will now assume the role of CEO and serve as an executive director on the Company’s Board. Prior to Erin Energy, Mr. Omidele worked for 28 years with Shell in various leadership roles.

Mr. Michael Stinson and Mr. Omidele were elected to fill vacancies resulting from the retirement of Dr. Kase Lawal and Ms. Hazel O’Leary. Mr. Stinson gained more than 37 years of multi-national E&P experience from a career at ConocoPhillips and its predecessor company, Conoco, Inc. Mr. Stinson’s operational experience is substantial in the fields of exploration and production, pipelines and storage, natural gas, gas liquids processing and commercial operations, and marine scheduling. He has extensive capabilities in new business development, mergers and acquisitions, corporate planning, and corporate communications. He will serve on the Company’s Board as an independent director.

About Erin Energy

Erin Energy Corporation is an independent oil and gas exploration and production company focused on energy resources in sub-Saharan Africa. Its asset portfolio consists of 9 licenses across 4 countries covering an area of 40,000 square kilometers (10 million acres), including current production and other exploration projects offshore Nigeria, as well as exploration licenses offshore Ghana, Kenya and Gambia, and onshore Kenya. Erin Energy is headquartered in Houston, Texas, and is listed on the New York and Johannesburg Stock Exchanges under the ticker symbol ERN.

 

Erin Energy Corporation
Lionel McBee, +1 713-797-2960
Director, Investor Relations and Corporate Communications
lionel.mcbee@erinenergy.com

Thursday, May 26th, 2016 Uncategorized Comments Off on (ERN) Announces Results of Annual Meeting of Shareholders

(FLXN) Positive Guidance from FDA on Zilretta™ for Osteoarthritis NDA

BURLINGTON, Mass., May 26, 2016  — Flexion Therapeutics, Inc. (Nasdaq:FLXN) announces that yesterday it received written responses from the U.S. Food & Drug Administration (FDA) to questions the company had submitted in advance of a pre-NDA meeting regarding Flexion’s lead product candidate, Zilretta (also known as FX006). The FDA clearly indicates in its responses that the safety and efficacy data from the registration program for Zilretta are “acceptable to support filing of an NDA submission.” Based on this positive FDA feedback, the in-person pre-NDA meeting has become unnecessary and the FDA responses will serve as the official meeting minutes.

Michael Clayman, M.D., President and Chief Executive Officer of Flexion, stated, “The endorsement from the FDA for the Zilretta NDA submission represents a major milestone in the development of this drug candidate and brings us one step closer to making it available to the many millions of knee osteoarthritis (OA) patients who lack good pain-relief options. We intend to submit the NDA in the fourth quarter of this year.”

About Zilretta

Zilretta is being investigated as the first intra-articular sustained-release, non-opioid treatment for patients with moderate to severe knee OA pain. Zilretta employs proprietary microsphere technology combining TCA — a commonly administered, short-acting corticosteroid — with a polymer (PLGA) intended to provide persistent concentrations of drug locally to both amplify the magnitude and prolong the duration of pain relief.

To date, more than 600 patients have been treated with Zilretta in clinical trials. No drug-related serious adverse events have been observed in these trials and adverse events have typically been localized, mild and comparable to those observed with immediate-release TCA and placebo. The data from these trials are consistent with Zilretta providing meaningful and durable pain relief.

About Flexion Therapeutics

Flexion is a specialty pharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with OA. The company’s lead product candidate, Zilretta, is being investigated for its potential to provide improved analgesic therapy for the millions of U.S. patients who receive IA injections for knee OA annually.

Forward-Looking Statements

Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; our ongoing development of Zilretta; our interpretation of the data and results from our Zilretta clinical trials; our plans for, and the expected timing of, our Zilretta NDA submission with the FDA; our plans to commercialize Zilretta and its market potential; and the potential therapeutic and other benefits of Zilretta, are forward-looking statements. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks associated with the process of discovering, developing, manufacturing and obtaining regulatory approval for drugs that are safe and effective for use as human therapeutics; the fact that results of past clinical trials may not be predictive of subsequent trials; our reliance on third parties to manufacture and conduct clinical trials of Zilretta, which could delay or limit its future development or regulatory approval; our ability to meet anticipated clinical trial commencement, enrollment and completion dates and regulatory filing dates for Zilretta; the fact that we will require additional capital, including prior to commercializing Zilretta or any other product candidates, and may be unable to obtain such additional capital in sufficient amounts or on terms acceptable to us; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to Zilretta; competition from alternative therapies; regulatory developments and safety issues, including difficulties or delays in obtaining regulatory approvals to market Zilretta; the risk that the FDA and foreign regulatory authorities may not agree with our interpretation of the data from our clinical trials of Zilretta and may require us to conduct additional clinical trials; Zilretta may not receive regulatory approval or be successfully commercialized, including as a result of the FDA’s or other regulatory authorities’ decisions regarding labeling and other matters that could affect its availability or commercial potential; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

Investor Contact
David Carey
Lazar Partners LTD
T: 212-867-1768 
dcarey@lazarpartners.com

Media Contact
Mariann Caprino
TogoRun
T: 917.242.1087  
M.Caprino@togorun.com

Corporate Contact
Fred Driscoll
Chief Financial Officer
Flexion Therapeutics, Inc.
T: 781-305-7763
fdriscoll@flexiontherapeutics.com
Thursday, May 26th, 2016 Uncategorized Comments Off on (FLXN) Positive Guidance from FDA on Zilretta™ for Osteoarthritis NDA

(NERV) Positive Results, Phase IIB Trial of MIN-101, Phase IIA Trial of MIN-117

Positive Results From Phase IIB Trial of MIN-101 Monotherapy in Schizophrenia

MIN-101 meets primary and secondary endpoints

  • Statistically significant improvement in PANSS negative symptoms and total PANSS scores observed
  • MIN-101 shown to be statistically superior on key secondary endpoints
  • Effect of MIN-101 demonstrated to be specific for negative symptoms and not secondary to improvement in other symptoms

WALTHAM, Mass., May 26, 2016  — Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced positive top line results from a prospective Phase IIb, 12-week, randomized, double-blind, placebo-controlled parallel clinical trial evaluating the efficacy, safety and tolerability of MIN-101 in patients with negative symptoms of schizophrenia.  These negative symptoms, for which no approved treatment is currently available, affect the majority of schizophrenic patients and can persist over their lifetimes.

The study successfully achieved its primary endpoint, demonstrating the statistically significant benefit of MIN-101 over placebo in improving negative symptoms as measured by the pentagonal structure model (PSM) of the Positive and Negative Syndrome Scale (PANSS). The effect was shown for both doses tested: 32 mg: p less than or equal to 0.022 with an effect size of 0.45, and 64 mg: p less than or equal to 0.003 with effect size of 0.58.

The study also demonstrated statistically significant benefit of MIN-101 over placebo on the PANSS three factors negative symptoms subscale for both doses tested: 32 mg: p less than or equal to 0.006, with an effect size of 0.55, and 64 mg: p less than or equal to 0.001 with an effect size of 0.70. Furthermore, the statistically significant benefit of MIN-101 over placebo was demonstrated on the PANSS total score (not significant for the 32 mg dose; p less than or equal to 0.003 for the 64 mg dose), with effect sizes of 0.35 and 0.59, respectively.

The consistency and robustness of the effect was also supported by the demonstrated statistically significant benefit of MIN-101 over placebo in multiple secondary endpoints as measured by the following: the PANSS general psychopathology subscale, Brief Negative Symptoms Scale (BNSS) total score, Clinical Global Impression of Severity (CGI-S), Clinical Global Impression of Improvement (CGI-I), Personal and Social Performance (PSP) total score and Brief Assessment of Cognition in Schizophrenia (BACS). Positive symptoms were observed to remain stable, and the absence of extra-pyramidal symptoms throughout the three month trial is consistent with the hypothesis that MIN-101 has a direct and specific effect on negative symptoms rather than an indirect effect mediated by improvements of positive symptoms.

MIN-101 was generally reported to be well tolerated, and the incidence and types of side effects did not differ significantly between the MIN-101 group and the placebo group. Based upon previous non-clinical and clinical experience, QTcF, a measurement of cardiac function, was closely monitored. Discontinuation criteria based on QTcF prolongation were incorporated in the protocol. Two patients out of 162 who received MIN-101 were discontinued based upon these criteria; both of these patients received the higher dose (64 mg). Unlike many currently marketed antipsychotic drugs, no metabolic adverse effects, no weight gain and no extra-pyramidal symptoms were observed.

“We believe the results from this trial constitute a key step forward in the development of a novel treatment for schizophrenia and specifically the negative symptoms of the disease, which represent a significant unmet medical need,” said Dr. Remy Luthringer, president and chief executive officer of Minerva. “Negative symptoms contribute substantially to poor quality of life and functional outcomes of schizophrenic patients.

“We also observed consistent improvements in multiple secondary endpoints,” said Dr. Luthringer.  “This broad impact underscores the potential of MIN-101, a molecule that combines sigma2 antagonism and 5-HT2a antagonism, as a promising differentiated treatment for a debilitating disease affecting large numbers of underserved patients worldwide.  Because negative symptoms are not only present in schizophrenia but also in brain degenerative disorders and other mental illnesses, we believe that MIN-101 may be a candidate for the potential treatment of other indications.”

About this study (https://www.clinicaltrialsregister.eu, EudraCT Number: 2014-004878-42)

This was a prospective trial designed to evaluate the efficacy of MIN-101 monotherapy on negative symptoms using the pentagonal structure model (PSM) of the Positive and Negative Syndrome Scale (PANSS) as the primary endpoint. A total of 244 patients were randomized in equal groups to receive daily doses of MIN-101 32 mg, MIN-101 64 mg or placebo at 32 clinical sites in Russia and five European countries. To participate in the trial, patients were required to have stable positive and negative symptoms for three months prior to entry, a PANSS negative sub-score greater than or equal to 20, and scores < 4 on the following PANSS items: excitement, hyperactivity, hostility, suspiciousness, uncooperativeness and poor impulse control.  All three cohorts were balanced with respect to demographic and baseline disease characteristics.

Secondary and exploratory outcomes included PANSS total and subscale scores, the Brief Assessment of Cognition in Schizophrenia (BACS), Brief Negative Symptoms Scale (BNSS), Clinical Global Impression of Severity (CGI-S), Clinical Global Impression of Improvement (CGI-I), the Calgary Depression Scale for Schizophrenia (CDSS), the Personal and Social Performance (PSP), and the Pittsburgh Sleep Quality Index (PSQI).

Patients who completed the 12-week double-blind core phase of this study were provided the opportunity to enter into the ongoing 24-week, open-label extension phase, which will provide additional long term safety and efficacy data.  During the extension phase, all patients are receiving either 32 mg or 64 mg of MIN-101.  Patients who received placebo in the core study were randomized to one of these two doses.   The extension phase is expected to be completed during the third quarter of 2016.

About schizophrenia and the impact of negative symptoms

Schizophrenia remains among the top ten disabling conditions worldwide for young adults and affects more than 21 million people worldwide.  According to Datamonitor, an independent market research firm, in 2015 approximately 3.2 million people suffered from schizophrenia in the United States, Japan and the five major European Union markets of France, Germany, Italy, Spain and the United Kingdom.

Although positive psychotic symptoms are characteristic of schizophrenia, negative symptoms constitute the main burden of illness, represent an important treatment target and are responsible for the poor vocational and social capabilities of these patients.  These symptoms, which include a-motivation, avolition, lack of initiative, and restricted personal interaction, are associated with poor psychosocial functioning.

Most current pharmacological therapies ameliorate positive, psychotic symptoms in most but not all schizophrenic patients.  However, there currently exists no effective treatment for negative symptoms.

About MIN-101

MIN-101 is a drug candidate with equipotent affinities for sigma 2 and 5-hydroxytryptamine-2A (5-HT2A) and lower affinity at alpha 1-adrenergic receptors. In preclinical studies and in a phase IIa trial, MIN-101 showed significant efficacy against negative symptoms.

Positive Results in Phase IIA Trial of MIN-117 in Major Depressive Disorder

MIN-117 meets primary and secondary endpoints

  • Reduction in depressive symptoms demonstrated
  • Good tolerability and safety profile observed
  • Positive effect on sleep architecture shown
  • Differentiated mechanism of action

WALTHAM, Mass., May 26, 2016  — Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced positive top line results from a Phase IIa clinical trial in major depressive disorder (MDD) with MIN-117, an antidepressant drug candidate with a differentiated mechanism of action targeting adrenergic alpha 1a, alpha 1b, 5-HT1A, 5-HT2A receptors, serotonin and the dopamine transporter.

Results demonstrated dose-dependent superiority of MIN-117 over placebo as measured by change in the Montgomery-Asberg Depression Rating Scale (MADRS).  Data show that MIN-117 at the 0.5 milligrams (mg) daily dose had an effect size (magnitude of difference) as compared to the placebo group of 0.23 while the 2.5 mg daily dose had an effect size of 0.33.  This magnitude of effect size is similar to those observed with currently marketed antidepressants.  Improvement in MADRS with MIN-117 against placebo was observed at two weeks. Furthermore, data also show that 24 percent of the patients treated with 2.5 mg of MIN-117 achieved remission as prospectively defined.

Both doses of MIN-117 demonstrated a favorable tolerability profile, and the incidence and types of side effects did not differ significantly between the MIN-117 group and the placebo group.  No unexpected adverse events were reported. Preliminary analysis shows that treatment with MIN-117 is not associated with cognitive impairment, sexual dysfunction, suicidal ideation or weight gain.

Pharmacodynamic measurements based on sleep recordings show that MIN-117 preserved sleep continuity and architecture and therefore is not expected to have detrimental effects on rapid eye movement (REM) sleep distribution and duration unlike most marketed antidepressants.

“We believe these results show a meaningful clinical benefit and support further development of MIN-117, an antidepressant with a differentiated mechanism of action and a favorable tolerability profile,” said Dr. Remy Luthringer, president and chief executive officer of Minerva. “These promising results, combined with the drug’s distinctive pharmacology, lay the foundation to potentially address unmet needs not currently served by existing therapies in the treatment of mood disorders and other central nervous system indications.”

About this study (https://www.clinicaltrials register.eu, EudraCT Number: 2015-000306-18)

This study was a four-arm, parallel-group, randomized double-blind, placebo- and positive-control trial which tested two daily administered doses of MIN-117: 0.5 mg and 2.5 mg. The study included 84 patients (21 per arm) with moderate to severe MDD in four European countries. The goals of the trial were to test efficacy, safety and tolerability of MIN-117 over six weeks of treatment. The antidepressant paroxetine was used as an active control and confirmed assay sensitivity. Change on the MADRS, a scale measuring severity of depression, was used as the main outcome measurement. As established prospectively in the statistical analysis plan, this trial was designed for signal detection and effect size estimation.  As such, the study was not powered to demonstrate statistically significant differences between MIN-117 and placebo.

About Major Depressive Disorder

Major depressive disorder (also referred to as major depression) is one of the most common mental disorders worldwide, with an estimated 350 million people affected. According to the World Health Organization, it is the leading cause of disability worldwide and a major contributor to the overall global disease burden. In the U.S. in 2014, an estimated 15.7 million adults aged 18 or older, representing 6.7 percent of all adults, had at least one major depressive in the past. Shortcomings of many current antidepressant therapies include a large number of treatment non-responders, delayed onset of action, sexual dysfunction and weight gain, all potentially leading to poor compliance with therapy.

About Minerva Neurosciences

Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of products to treat CNS diseases.  Minerva’s proprietary compounds include: MIN-101, in Phase IIb development for schizophrenia; MIN-202 (JNJ-42847922), which has completed Phase IIa and Phase Ib clinical trials in insomnia and the adjunctive treatment of major depressive disorder (MDD), respectively; MIN-117, in Phase IIa development for MDD; and MIN-301, in pre-clinical development for Parkinson’s disease.  Minerva’s common stock is listed on the NASDAQ Global Market under the symbol “NERV.”  For more information, please visitwww.minervaneurosciences.com.

Forward-Looking Safe Harbor Statement

This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended.  Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties.  Forward-looking statements include statements herein with respect to the timing and results of future clinical milestones with MIN-117; the clinical and therapeutic potential of MIN-117; our ability to successfully develop and commercialize MIN-117; and management’s ability to successfully achieve its goals.  These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, whether MIN-117 will advance further in the clinical trials process and whether and when, if at all, it will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether the results of future clinical trials of MIN-117, if any, will be consistent with the results of past clinical trials; whether MIN-117 will be successfully marketed if approved; whether our therapeutic product discovery and development efforts with MIN-117 will be successful; our ability to achieve the results contemplated by our co-development agreements; management’s ability to successfully achieve its goals; our ability to raise additional capital to fund our operations on terms acceptable to us; and general economic conditions.  These and other potential risks and uncertainties that could cause actual results to differ from the results predicted are more fully detailed under the caption “Risk Factors” in our filings with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, filed with the Securities and Exchange Commission on May 3, 2016.  Copies of reports filed with the SEC are posted on our website at www.minervaneurosciences.com. The forward-looking statements in this press release are based on information available to us as of the date hereof, and we disclaim any obligation to update any forward-looking statements, except as required by law.

Contact:

William B. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376

Thursday, May 26th, 2016 Uncategorized Comments Off on (NERV) Positive Results, Phase IIB Trial of MIN-101, Phase IIA Trial of MIN-117

(AXAS) Exercise of Over-Allotment Option and Closing of Public Offering

Abraxas Petroleum Corporation (“Abraxas” or the “Company”) (NASDAQ:AXAS) today announced the closing of its public offering of 28,750,000 shares of common stock including 3,750,000 shares sold pursuant to the full exercise of the underwriters option to purchase additional shares at a price of $1.00 per share, less applicable underwriting discounts.

The offering was made pursuant to an effective shelf registration statement on Form S-3 previously filed by the Company with the SEC. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. This offering was made by means of a prospectus supplement and related base prospectus.

Johnson Rice & Company L.L.C., Canaccord Genuity Inc. and Stephens Inc. are acting as joint book-running managers for the offering. Copies of the preliminary prospectus supplement for the offering may be obtained on the website of the Securities and Exchange Commission, www.sec.gov, or by contacting Johnson Rice & Company L.L.C., ATTN: Syndicate Department, 639 Loyola Avenue, Suite 2775, New Orleans, LA 70113, or by telephone at (800) 443-5924; Canaccord Genuity Inc., ATTN: Syndicate Department, 99 High Street, 12th Floor, Boston, MA 02110, or by telephone at (617) 371-3900; or Stephens Inc.’s Prospectus Department at Stephens Inc., 111 Center Street, Little Rock, AR 72201, ATTN: Prospectus Department (prospectus@stephens.com) or by telephone at (501) 377-2131.

The common stock will be issued and sold pursuant to an effective shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. This offering may only be made by means of a prospectus supplement and related base prospectus.

Abraxas Petroleum Corporation is a San Antonio based crude oil and natural gas exploration and production company with operations across the Rocky Mountain, Permian Basin and onshore Gulf Coast regions of the United States.

Safe Harbor for forward-looking statements: Statements in this release looking forward in time involve known and unknown risks and uncertainties, which may cause Abraxas’ actual results in future periods to be materially different from any future performance suggested in this release. Such factors may include, but may not be necessarily limited to, changes in the prices received by Abraxas for crude oil and natural gas. In addition, Abraxas’ future crude oil and natural gas production is highly dependent upon Abraxas’ level of success in acquiring or finding additional reserves. Further, Abraxas operates in an industry sector where the value of securities is highly volatile and may be influenced by economic and other factors beyond Abraxas’ control. In the context of forward-looking information provided for in this release, reference is made to the discussion of risk factors detailed in Abraxas’ filings with the Securities and Exchange Commission during the past 12 months.

Abraxas Petroleum Corporation
Geoffrey King, 210-490-4788
Vice President – Chief Financial Officer
gking@abraxaspetroleum.com
www.abraxaspetroleum.com

Wednesday, May 25th, 2016 Uncategorized Comments Off on (AXAS) Exercise of Over-Allotment Option and Closing of Public Offering

(CLRB) USPTO Issues Patent for New Phospholipid Drug Conjugate (PDC) with Paclitaxel

Patent Covers Paclitaxel  Drug Conjugate for Targeted Delivery of Paclitaxel to Cancer Cells

MADISON, Wis., May 25, 2016  — Cellectar Biosciences, Inc. (Nasdaq:CLRB) (“the Company”), an oncology-focused biotechnology company, today announces that the United States Patent and Trademark Office has issued U.S. Patent No. 9,345,718 on May 24, 2016, which covers CLR 1603, a phospholipid ether-paclitaxel conjugate.

This specific PDC product patent is based on one of a series of patent applications designed to protect both composition of matter and method of use for phospholipid drug conjugates, or PDCs, developed with Cellectar’s proprietary phospholipid-ether delivery vehicle conjugated with any existing or future cytotoxic agents, including chemotherapeutics such as paclitaxel, for targeted delivery to cancer cells and cancer stem cells.  Phospholipid ethers act as a cancer targeting drug vehicle delivering cytotoxic compounds like paclitaxel directly to cancer cells, thus limiting the drug’s exposure to healthy cells and increasing the potency of the drug at lower concentrations.

“This first issued patent under our CLR CTX Chemotherapeutic program provides Cellectar and any future partners intellectual property (IP) protection through at least November 2035, allowing significant runway for product development and commercialization,” said Jim Caruso, president and CEO of Cellectar.  “Importantly, this IP protection further validates our delivery platform and strengthens the value-optimizing potential of our CLR CTX chemotherapeutic conjugate R&D program.”

The objective of the CLR CTX franchise is to develop PDC chemotherapeutics through conjugation of non-targeted anti-cancer agents with the Company’s novel delivery vehicle with the goal of improving therapeutic indices, enhancing product profiles and expanding potential indications through targeted cancer cell delivery of chemotherapeutic payloads.

About Phospholipid Drug Conjugates (PDCs)

Cellectar’s PDC platform has demonstrated highly selective cancer targeting both preclinically in over 60 in vivo cancer models, and subsequently confirmed clinically in over 10 cancer types. The platform’s payload diversity has been validated using cytotoxic radioisotopes for cancer therapy; PET imaging isotopes for cancer imaging; fluorophores for image-guided surgery, and the company has recently expanded its payload portfolio to chemotherapeutics with further research of paclitaxel and other non-targeted anti-cancer agents through both in-house and collaborative R&D efforts.

About Cellectar Biosciences, Inc.
Cellectar Biosciences is developing phospholipid drug conjugates (PDCs) designed to provide cancer targeted delivery of diverse oncologic payloads to a broad range of cancers and cancer stem cells. Cellectar’s PDC Delivery Platform is based on the company’s proprietary phospholipid ether analogs. These novel small-molecules have demonstrated highly selective uptake and retention in a broad range of cancers. Cellectar’s PDC pipeline includes product candidates for cancer therapy and cancer diagnostic imaging. The company’s lead therapeutic PDC, CLR 131, utilizes iodine-131, a cytotoxic radioisotope, as its payload. CLR 131 is currently being evaluated under an orphan drug designated Phase 1 study in patients with relapsed or refractory multiple myeloma. The company is also developing PDCs for targeted delivery of chemotherapeutics such as paclitaxel (CLR 1603-PTX), a preclinical stage product candidate, and plans to expand its PDC chemotherapeutic pipeline through both in-house and collaborative R&D efforts. For additional information please visit www.cellectarbiosciences.com.

This news release contains forward-looking statements. You can identify these statements by our use of words such as “may,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” “continue,” “plans,” or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators’ ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2015. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.

INVESTOR AND MEDIA CONTACT:

Jules Abraham
JQA Partners
917-885-7378
jabraham@jqapartners.com
Wednesday, May 25th, 2016 Uncategorized Comments Off on (CLRB) USPTO Issues Patent for New Phospholipid Drug Conjugate (PDC) with Paclitaxel

(NNDM) and Accellta Joined Forces to Successfully BioPrint Stem Cell-Derived Tissues

By Combining high speed, high precision inkjet with massive stem cell production and differentiation technologies the companies plan to enable high volume advanced 3D bioprinting

NESS ZIONA, Israel, May 25, 2016  — Nano Dimension Ltd. (NASDAQ, TASE: NNDM), a leader in the area of 3D Printed Electronics, today announced it has successfully lab-tested a proof of concept 3D Bioprinter for stem cells. The trial was conducted in collaboration with Accellta Ltd., a company headquartered in Haifa, Israel, that has developed proprietary technologies for the unique production of high quality media, stem cells, progenitors and differentiated cells for drug discovery, regenerative medicine and research.

The feasibility study, conducted in Q2 2016, confirmed that the combined know-how and technologies of the companies enabled printing of viable stem cells using an adapted 3D printer.

“3D printing of living cells is a technology that is already playing a significant role in medical research, but in order to reach its full potential, for the field to evolve further, there is a need to improve printing speeds, print resolution, cell control and viability as well as cell availability and bio-ink technologies,” said Amit Dror, CEO of Nano Dimension. “By combining our high speed, high precision inkjet capabilities with Accellta’s stem cell suspension technologies and induced differentiation capabilities led by a world-renown group of experienced engineers and scientists, we can enable 3D printing at high resolution and high volumes.”

The companies will consider the formation of a new entity for these future solutions and do not intend to invest significant capital directly to expand this activity. Such funds would be raised by and for the use of the joint entity.

3D bioprinting enabled by the two companies’ technologies, means that Nano Dimension and Accellta have the potential to accelerate high fidelity and high viability manufacturing of living cellular products. Accellta’s unique, robust and reproducible suspension-based cell culturing systems produce billions of high quality stem cells per batch and represent a transformative step in terms of stem cell production. Accellta’s technology can deliver large quantities of high quality cells which can be an enabler for printing even large and complex tissues and organs.

“Accellta and Nano Dimension have joined forces in this initial trial to evaluate and adapt the joint potential of our technologies. We hope and believe that this will bring the mutual capabilities and know-how of both companies to create 3D bioprinting solutions that combine a high precision, high-throughput printer with dedicated bio-ink technologies, derived from stem cells,” said Dr. Itzchak Angel, Chairman and CEO of Accellta. “By enabling high precision 3D bioprinting and differentiation of stem cells into required tissues, our combined technologies have the potential to enable vast areas of development. We are very excited about these initial results and what the future holds.”

IDTechEx forecasts the market for 3D bioprinting to grow rapidly over the next decade from a market size of USD $481 million in 2014 to as much as USD $6 billion in 2024. Developments in these emerging fields are progressing at a swift pace, and the healthcare industry is clamoring to participate. The technology has tremendous value for areas such as pre-clinical drug discovery and testing, cosmetics safety testing, toxicology assays, tissue printing and ‘organs on chips’.

Advanced 3D inkjet technology, the core competence of Nano Dimension, enables rapid printing of complex multi-material objects such as those needed for next generation bioprinting. Nano Dimension’s novel capabilities, developed for its state-of-the-art 3D printed electronics technology for printed circuit boards (PCBs) may pave the way to other advanced multi-material printing domains such as 3D bioprinting. This latest development is consistent with Nano Dimension’s strategy of offering commercial solutions to help companies and partners develop innovative products through advanced 3D printing and multi-material technology.

About Nano Dimension Ltd.

Nano Dimension, founded in 2012, focuses on development of advanced 3D printed electronics systems and advanced additive manufacturing. Nano Dimension’s unique products combine three advanced technologies: 3D inkjet, 3D software and nanomaterials. The company’s primary products include the first 3D printer dedicated to printing multi-layer PCBs (printed circuit boards) and advanced nanotechnology-based conductive and dielectric inks.

In addition to the trading of the company’s American Depositary Shares on NASDAQ, the company’s ordinary shares are also traded on the TASE in Israel. The Bank of New York Mellon serves as the depositary for Nano Dimension.

About Accellta

The company was founded in 2012 by the Alfred Mann Institute at Technion (AMIT) on the basis of two decades of research at the Stem Cell Center in the Technion’s Rappaport Faculty of Medicine. Amongst its shareholders are the Technion Fund, the AMIT and Horizons Ventures. Accellta specializes in innovative, high quality and cost-effective media and custom-made technologies for culturing and differentiation of human stem cells in unique 3D suspension culture systems, using bioreactors, with no animal products, no feeder cells or micro-carriers and serum-free. The company presently sells and markets several media formulations, through several agreements with major companies, as based on their proprietary patents. The potential uses of culturing and differentiation of very high quantities and densities of consistent, well-defined and homogeneous cell population are numerous, and include the development of cell-based medical therapies, research tools and methods, drug screening and development (as an alternative for animal-based assays), bio-fabrication and tissue engineering.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. Because such statements deal with future events and are based on Nano Dimension’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Nano Dimension could differ materially from those described in or implied by the statements in this press release.

For example, Nano Dimension is using forward-looking statements when it discusses collaboration with Accellta, the potential of such collaboration, the formation of a new entity for future solutions and funding for such entity. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading “Risk Factors” in Nano Dimension’s Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 8, 2016, and in any subsequent filings with the SEC. Except as otherwise required by law, Nano Dimension undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

CONTACT INVESTOR RELATIONS:
Miri Segal-Scharia
Hayden/ MS-IR LLC
917-607-8654
msegal@ms-ir.com

Wednesday, May 25th, 2016 Uncategorized Comments Off on (NNDM) and Accellta Joined Forces to Successfully BioPrint Stem Cell-Derived Tissues

(PEIX) to Participate in the 13th Annual Craig-Hallum Institutional Investor Conference

SACRAMENTO, Calif., May 25, 2016  — Pacific Ethanol, Inc. (NASDAQ:PEIX), a leading producer and marketer of low-carbon renewable fuels in the United States, announced it will participate in the 13th Annual Craig-Hallum Institutional Investor Conference on June 1st in Minneapolis, MN.

CFO Bryon McGregor will host one-on-one meetings throughout the day. To schedule a meeting, please contact your Craig-Hallum representative or call Becky Herrick of LHA at (415) 433-3777. A copy of management’s most recent investor presentation will be available online in the investor section of Pacific Ethanol’s website at www.pacificethanol.com.

About Pacific Ethanol, Inc.
Pacific Ethanol, Inc. (PEIX) is the leading producer and marketer of low-carbon renewable fuels in the Western United States. With the addition of four Midwestern ethanol plants in July 2015, Pacific Ethanol more than doubled the scale of its operations, entered new markets, and expanded its mission to advance its position as an industry leader in the production and marketing of low carbon renewable fuels. Pacific Ethanol owns and operates eight ethanol production facilities, four in the Western states of California, Oregon and Idaho, and four in the Midwestern states of Illinois and Nebraska. The plants have a combined production capacity of 515 million gallons per year, produce over one million tons per year of ethanol co-products such as wet and dry distillers grains, wet and dry corn gluten feed, condensed distillers solubles, corn gluten meal, corn germ, corn oil, distillers yeast and CO2. Pacific Ethanol markets and distributes ethanol and co-products domestically and internationally. Pacific Ethanol’s subsidiary, Kinergy Marketing LLC, markets all ethanol for Pacific Ethanol’s plants as well as for third parties, with over 800 million gallons of ethanol marketed annually based on historical volumes. Pacific Ethanol’s subsidiary, Pacific Ag. Products LLC, markets wet and dry distillers grains. For more information please visit www.pacificethanol.com.

Company IR Contact:
Pacific Ethanol, Inc.
916-403-2755
866-508-4969
Investorrelations@pacificethanol.com

IR Agency Contact:
Becky Herrick
LHA
415-433-3777

Media Contact:
Paul Koehler
Pacific Ethanol, Inc.
916-403-2790
paulk@pacificethanol.com
Wednesday, May 25th, 2016 Uncategorized Comments Off on (PEIX) to Participate in the 13th Annual Craig-Hallum Institutional Investor Conference

(SRPT) Announces FDA Will Not Complete Review of Eteplirsen NDA

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that they are continuing their review and internal discussions related to our pending NDA for eteplirsen and will not be able to complete their work by the Prescription Drug User Fee Act (PDUFA) goal date of May 26, 2016. The FDA has communicated that they will continue to work past the PDUFA goal date and strive to complete their work in as timely a manner as possible.

About Sarepta Therapeutics

Sarepta Therapeutics is a biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare, infectious and other diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates, including its lead DMD product candidate, eteplirsen, designed to skip exon 51. Sarepta is also developing therapeutics for the treatment of rare, infectious and other diseases. For more information, please visit us at www.sarepta.com.

About Eteplirsen

Eteplirsen is designed to address the underlying cause of DMD by restoring the dystrophin messenger RNA (mRNA) reading frame, thus enabling the production of a shorter, functional form of the dystrophin protein. Eteplirsen uses Sarepta’s proprietary phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to skip exon 51 of the dystrophin gene. Approximately 13 percent of the DMD population is amenable to exon 51 skipping. Data from clinical studies of eteplirsen in DMD patients have demonstrated a consistent safety and tolerability profile and have also shown measurable dystrophin protein expression. Promoting the synthesis of a shorter dystrophin protein is intended to slow the decline of ambulation and mobility seen in DMD patients. There currently is no approved treatment in the United States for DMD and eteplirsen has not been approved by the FDA or any regulatory authority for the treatment of DMD.

About Duchenne Muscular Dystrophy

DMD is an X-linked rare degenerative neuromuscular disorder causing severe progressive muscle loss and premature death. One of the most common fatal genetic disorders, DMD affects approximately one in every 3,500-5,000 males worldwide. A devastating and incurable muscle-wasting disease, DMD is associated with specific errors in the gene that codes for dystrophin, a protein that plays a key structural role in muscle fiber function. Progressive muscle weakness in the lower limbs spreads to the arms, neck and other areas. Eventually, increasing difficulty in breathing due to respiratory muscle dysfunction requires ventilation support, and cardiac dysfunction can lead to heart failure. The condition is universally fatal, and death usually occurs before the age of 30.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements regarding the FDA not completing its review of the eteplirsen NDA by the PDUFA date of May 26, 2016, additional review and internal FDA discussions relating to the NDA, and the timing for the FDA completing its work and reaching a decision with respect to the Company’s eteplirsen NDA. Forward-looking statements also include those regarding Sarepta’s future business developments and actions and the timing of the same.

These forward-looking statements involve risks and uncertainties, many of which are beyond Sarepta’s control. Known risk factors include, among others: the FDA may further delay its decision on the eteplirsen NDA or may not provide marketing approval for eteplirsen; we may not be able to comply with all FDA requests, including with respect to our eteplirsen NDA submission and the addendums we have submitted to the FDA or with respect to our ongoing or planned clinical trials, in a timely manner or at all; we may not be able to complete clinical trials required by the FDA for approval of our products or any submissions made in connection with our pipeline of product candidates; the results of our ongoing research and development efforts and clinical trials for our product candidates including eteplirsen and our technologies may not be positive or consistent with prior results or demonstrate a safe treatment benefit or support an NDA filing, positive advisory committee recommendation or marketing approval by the FDA or other regulatory authority; we may not be able to execute on our business plans including meeting our expected or planned regulatory milestones and timelines, clinical development plans and bringing our product candidates to market, including the planned commercialization of eteplirsen, for various reasons, including factors outside of the Company’s control, including possible limitations of Company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner or at all, and regulatory, court or agency decisions, such as decisions by the United States Patent and Trademark Office with respect to patents that cover our product candidates; and those risks identified under the heading “Risk Factors” in Sarepta’s most recent Annual Report on Form 10-K for the year ended December 31, 2015 or Quarterly Report on Form 10-Q for the quarter ended March 31, 2016 filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by Sarepta which you are encouraged to review.

Any of the foregoing risks could materially and adversely affect Sarepta’s business, results of operations and the trading price of Sarepta’s common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the Company’s filings with the SEC. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.

Internet Posting of Information

We routinely post information that may be important to investors in the ‘For Investors’ section of our website at www.sarepta.com. We encourage investors and potential investors to consult our website regularly for important information about us.

 

Sarepta Therapeutics, Inc.
Media and Investors:
Ian Estepan, 617-274-4052
iestepan@sarepta.com
or
W2O Group
Ryan Flinn, 415-946-1059
Mobile: 510-207-7616
rflinn@w2ogroup.com

Wednesday, May 25th, 2016 Uncategorized Comments Off on (SRPT) Announces FDA Will Not Complete Review of Eteplirsen NDA

(INNL) Announces XARACOLL® Meets Primary Endpoint in Both Pivotal Phase 3 Trials

  • First long-acting, opioid-sparing, local analgesic to meet primary endpoints of Phase 3 clinical trials in hernia repair
  • Data supports on-schedule NDA filing this year
  • Results validate the Innocoll technology platform
  • Conference call and webcast on top-line results scheduled for today at 8:30 a.m. Eastern Daylight Time

ATHLONE, Ireland, May 25, 2016  —  Innocoll (NASDAQ:INNL), a global, commercial-stage, specialty pharmaceutical company, today announced that two placebo-controlled Phase 3 pivotal studies evaluating XARACOLL® (bupivacaine-collagen bioresorbable implant) each achieved the primary endpoint as a postoperative pain relief treatment immediately following open abdominal hernia repair. XARACOLL showed consistency across both studies in treatment effect for pain reduction and opioid reduction.

The primary efficacy endpoint, the sum of pain intensity over 24 hours (SPI24) comparing XARACOLL to placebo, met statistical significance in both the MATRIX-1 (p=0.0004) and MATRIX-2 (p<0.0001) studies. These highly statistically significant results make XARACOLL the first long-acting, opioid-sparing, local analgesic to meet primary endpoints of Phase 3 clinical trials in hernia repair, a highly painful and commonly performed surgery.

A key secondary endpoint in the MATRIX trials was the sum of pain intensity over 48 hours (SPI48). The pooled data of the two MATRIX studies were statistically significant for this endpoint (p=0.0033). MATRIX-2 achieved a statistically significant result (p=0.0270), and MATRIX-1 trended toward, but did not achieve statistical significance (p=0.0568).

Another key secondary endpoint was the sum of pain intensity over 72 hours (SPI72). The pooled data of the two MATRIX studies for this endpoint were statistically significant, although neither individual study achieved statistical significance for SPI72.

The MATRIX studies also looked at multiple opioid-sparing secondary endpoints. Both trials demonstrated that XARACOLL significantly reduces total opioid consumption and significantly increases the time prior to the first use of opioids. To preserve the company’s plan to publish the full analysis of the Phase 3 MATRIX studies at future medical meetings and in peer-reviewed publications, further details regarding secondary endpoints will not be released at this time.

XARACOLL was well tolerated in both studies. Incidence of overall adverse events was similar to the placebo arm of each study. There were no XARACOLL-related serious adverse events. Opioid-related adverse events were higher in the placebo arms of both studies.

Based on these results, Innocoll plans to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) this year.

“We are very pleased by these positive top-line results for XARACOLL,” said Innocoll CEO Tony Zook. “These two successful postoperative pain studies validate our proprietary collagen-based technology platform. We are committed to filing our NDA this year and bringing this innovative new treatment to market. Our manufacturing expansion and commercial readiness activities are on-track to support an anticipated launch in 2017.”

XARACOLL, a surgically implantable and bioresorbable bupivacaine-collagen matrix, is applied through a simple insertion into the incision and is being developed to provide sustained pain relief by delivering bupivacaine HCl directly at the site of surgical trauma. Bupivacaine HCl is a local anesthetic with a well-characterized safety and efficacy profile. The data collected on the MATRIX-1 and MATRIX-2 studies show that the use of our XARACOLL proprietary collagen implant as a delivery vehicle for bupivacaine HCl appeared to be safe.

“Available therapies for postoperative pain relief are heavily reliant on opioids, which may cause costly and problematic side effects, and further subject patients to long-term opioid use and abuse,” said Harold S. Minkowitz, MD, Department of Anesthesiology, Memorial Hermann Memorial City Medical Center, Houston, TX. “XARACOLL’s success in a commonly performed and highly painful surgery suggests that XARACOLL could become an important option for the surgical and anesthesia communities in addressing patient satisfaction with pain management options and the need for opioid-sparing approaches to pain reduction.”

Webcast and Conference Call Today, May 25, 2016, at 8:30 a.m. Eastern Daylight Time
The Innocoll management team will host a webcast and conference call to discuss the top-line results at 8:30 a.m. ET on May 25, 2016. Interested parties may access the webcast through the Investors section of our website, direct through the registration link, or by dialing 1-877-407-4018 (toll-free); 1-201-689-8471 (international); 1-800-904-100 (Ireland toll-free) and referencing the confirmation number 13638130. A replay of the call will be available on the Innocoll website later in the day, and the replay will be available for approximately one month following the call.

About XARACOLL®
XARACOLL® is a surgically implantable and bioresorbable bupivacaine-collagen matrix that utilizes our CollaRx® proprietary collagen-based delivery technology and is being developed to provide sustained postoperative pain relief directly into the surgical site. XARACOLL is also designed to reduce the need for systemic opioids and their associated risks.

About Postoperative Pain
Postoperative pain is a complex response to tissue trauma during surgery that stimulates hypersensitivity of the central nervous system, resulting in pain within the surgical cavity and in other areas directly affected by the surgical procedure (incision site). The current standard of care relies heavily on the use of opioids supplemented by other classes of pain medications, the combination of which is known as multi-modal pain therapy. However, according to a survey published in the journal of Anesthesia & Analgesia and a 2014 Decision Resources Postoperative Pain Survey, 75 percent of patients receiving standard treatments still report inadequate postoperative pain relief and 79 percent of patients report adverse events from these medications. Given the negative side effects of opioids in particular, there is increasing focus on treatments that reduce opioid use in the treatment of postoperative pain.

About MATRIX-1 and MATRIX-2
MATRIX-1 and MATRIX-2 Phase 3 studies are two identical, randomized, placebo-controlled, double-blinded studies to investigate the safety and efficacy of a surgically implantable and bioresorbable bupivacaine-collagen matrix in treating acute postoperative pain associated with hernia repair. Each study enrolled over 300 patients aged 18 and older in the United States (U.S.). Patients with a unilateral inguinal hernia undergoing open hernioplasty were randomized in a 2:1 ratio to one of two treatment groups per study: three 100 mg XARACOLL matrices for a total dose of 300 mg of bupivacaine HCl or three placebo matrices. The matrices were placed at multiple layers within the hernia repair site in order to provide local levels of bupivacaine HCl directly at the location of surgical trauma. All patients received 650 mg of acetaminophen three times a day and could receive rescue opioids as needed. The primary efficacy endpoint was the sum of pain intensity (SPI) over 24 hours comparing the XARACOLL matrix to placebo. Safety was evaluated through the collection of adverse events through 30 days postoperatively.

About Innocoll
Innocoll is a global, commercial-stage, specialty pharmaceutical company that is dedicated to engineering better medicines. Our proprietary, biocompatible, and biodegradable collagen products are precision-engineered for targeted use. Applied locally to wound and/or surgery sites, they are designed to provide a range of benefits. The company’s late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XARACOLL for the treatment of postoperative pain; INL-002, a gentamicin-collagen topical matrix for the adjuvant treatment of diabetic foot infections; and INL-003, a barrier for the prevention of post-surgical adhesions.

Our currently approved products include: COLLAGUARD® (ex-US), COLLATAMP® G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®, some of which are sold globally through strategic partnerships, including those with Takeda, EUSA Pharma, Pioneer, Biomet 3i and Biomet. All of our native collagen products—from extraction/purification of type-1 collagen through final delivery form—are manufactured at our certified, integrated plant in Saal, Germany.

For more information, please visit www.innocoll.com.

Ongoing Pipeline Studies
Innocoll is also conducting two identical Phase 3 trials, one in the U.S. (COACT-1) and the second in the U.S., Europe and Australia (COACT-2), to evaluate the safety and efficacy of INL-002, a topical gentamicin administered via our proprietary collagen matrix, in patients with diabetic foot infections. The primary endpoint is the percent of patients achieving resolution of all clinical signs and symptoms of infection, evaluated by the clinician 10 to 14 days after completion of treatment, compared to placebo arms. Top-line data from these studies are anticipated to be available later in 2016.

INL-002 received QIPD designation for the adjunctive treatment of moderate and severe diabetic foot infection from the FDA.

Additionally, a clinical program is under development for INL-003, a collagen barrier for the prevention of post-surgical adhesions, to support approval in the U.S. The nonclinical program is ongoing and will be completed and reported prior to the filing of an IDE application planned for second half of 2016, with the Pilot (Feasibility) Clinical Study to be initiated immediately thereafter, upon availability of financial resources. For more information on our pipeline studies, please visit www.innocoll.com/products.aspx.

Forward-looking Statements
Any statements in this press release about our ongoing development of XARACOLL and our other product candidates; our interpretation of the data and results from our MATRIX-1 and MATRIX-2 clinical trials; our plans for, and the expected timing of, our XARACOLL NDA submission with the FDA; our plans to develop and commercialize XARACOLL and its market potential; the potential therapeutic and other benefits of XARACOLL and our other product candidates; Innocoll’s current expectations regarding future events, including statements regarding the therapeutic benefit, safety profile and commercial value of XARACOLL, plans and objectives for present and future clinical trials and results of such trials, the risk that the FDA may not accept pooled data, plans and objectives for regulatory approval and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “goal,” “may”, “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties including, but not limited to, the risk that the FDA and foreign regulatory authorities may not agree with our interpretation of the data from our clinical trials of XARACOLL and may require us to conduct additional clinical trials; XARACOLL may not receive regulatory approval or be successfully commercialized, including as a result of the FDA’s or other regulatory authorities’ decisions regarding labeling and other matters that could affect its availability or commercial potential; our plans to develop and manufacture XARACOLL; the size and growth of the potential markets for XARACOLL and our ability to serve those markets; our manufacturing and marketing capabilities; or other actions and factors discussed in the “Risk Factors” section of our Annual Report on Form 20-F for the year ended December 31, 2015, which is on file with the Securities and Exchange Commission. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. In addition, the forward-looking statements included in this press release represent our views as of the date of this release. We anticipate that subsequent events and developments will cause our views to change. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

The scientific information discussed in this news release related to Innocoll’s product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

Corporate:
Pepe Carmona
Chief Financial Officer
(215) 983-3362
pcarmona@innocoll.com  

Jeannie Sorenson, M.D.
Vice President, Investor Relations
(314) 458-7355
jsorenson@innocoll.com   

Media Contact:
Shelly Orlacchio
(215) 564-3200, ext 118
Sorlacchio@Gobraithwaite.com
Wednesday, May 25th, 2016 Uncategorized Comments Off on (INNL) Announces XARACOLL® Meets Primary Endpoint in Both Pivotal Phase 3 Trials

(TBBK) Board of Directors Announces Damian Kozlowski as New CEO and President

The Board of Directors of The Bancorp, Inc. (NASDAQ: TBBK), and The Bancorp Bank, today announced that Damian Kozlowski has been appointed Chief Executive Officer of The Bancorp, Inc., President of The Bancorp Bank and a Director of the company and the bank, effective June 1, 2016. Mr. Kozlowski succeeds Interim Chief Executive Officer John C. Chrystal, who will work with Mr. Kozlowski to ensure a smooth transition. Mr. Chrystal will remain a Director of both the company and the bank.

Damian Kozlowski joins The Bancorp as CEO, effective June 1, 2016 (Photo: Business Wire)

Daniel Cohen, The Bancorp’s Chairman of the Board and Executive Vice President, commented, “Damian brings to The Bancorp well-rounded knowledge of the business of banking and deep understanding of its regulatory complexities. His experience in both smaller and larger financial institutions has given him the unique perspective that’s required of The Bancorp’s business model within the financial services and technology sectors.”

According to Mr. Kozlowski, “I am eager to become part of The Bancorp, a widely recognized leader in financial services and technology solutions. The experience and knowledge that I bring, combined with the expertise of the outstanding executive leadership team currently in place, will help drive the company to achieve its fullest potential, both fiscally and operationally.”

Mr. Kozlowski joins The Bancorp after having served, since 2010, as Chief Executive Officer, President, and Director of Modern Bank, N.A. Previously, Mr. Kozlowski served as Chairman and Chief Executive Officer of Alpha Capital Financial Group, Inc. (2007-2010). From 2000 to 2007, Mr. Kozlowski was responsible for developing The Citigroup Private Bank’s global growth strategy to significantly build position in the high net worth wealth management market. At Citigroup Private Bank, Mr. Kozlowski managed 4500 employees in 98 offices in 31 countries; he served as Chief Executive Officer, Global Private Bank (2005-2007); President, US Private Bank (2002-2005); Chief Operating Officer and Chief Financial Officer (2001-2002); and Global Head of Business Development and Strategy (2000-2001). Mr. Kozlowski served as a member of Citigroup’s Operating and Management Committees, and was the ranking business leader on the Global Anti-Money Laundering Council. His prior experience includes positions held at Banc of America Securities, Marakon Associates, Rostra Holdings and US Trust, which have equipped him with deep expertise in private equity, wealth management, and investment banking.

As Managing Director of Payment Solutions, The Bancorp’s largest division, Jeremy Kuiper commented, “The Bancorp is on an exciting trajectory that will now be further fueled by Damian’s exceptional track record. We welcome his leadership in shaping and bringing The Bancorp’s strategic vision to fruition.”

The Bancorp is widely recognized for its dedication to serving the needs of non-bank financial service companies, ranging from entrepreneurial start-ups to those on the Fortune 500. With total assets of $4.379 billion, the company has over recent years strategically refocused its services to the payments industry as well as to a handful of highly specialized, lower-risk lending categories, including: Institutional Banking, Government Guaranteed Lending, Commercial Fleet Leasing and Commercial Mortgage-Backed Securitization. During this same time, the company has made significant capital investments in fortifying its operational infrastructure.

About The Bancorp

With operations in the US and Europe, The Bancorp, Inc. (NASDAQ: TBBK) is dedicated to serving the unique needs of non-bank financial service companies, ranging from entrepreneurial start-ups to those on the Fortune 500. The company’s chief financial institution, The Bancorp Bank (Member FDIC, Equal Housing Lender), has been repeatedly recognized in the payments industry as the Top Issuer of Prepaid Cards (US), a top merchant sponsor bank, and a top ACH originator. Specialized lending distinctions include National Preferred SBA Lender, a leading provider of securities-backed lines of credit, and one of the few bank-owned commercial leasing groups in the nation. For more information, please visit www.thebancorp.com.

 

The Bancorp, Inc.
Andres Viroslav, 215-861-7990
aviroslav@thebancorp.com

Tuesday, May 24th, 2016 Uncategorized Comments Off on (TBBK) Board of Directors Announces Damian Kozlowski as New CEO and President