(MRVL) Announces Senior Leadership Transition

CEO Sehat Sutardja and President Weili Dai Depart from Management Positions, Effective Immediately Board Forms Interim Office of the Chief Executive to Lead Company until Replacements are Appointed

SANTA CLARA, Calif., April 5, 2016 — Marvell Technology Group Ltd. (NASDAQ: MRVL), a global leader in integrated silicon solutions, today announced the departure of Chief Executive Officer Sehat Sutardja and President Weili Dai from their management positions, effective immediately.  Dr. Sutardja and Ms. Dai will remain on the Board of Directors, with Dr. Sutardja continuing as Chairman.  The Board, in conjunction with a leading executive search firm, will conduct a search for a new CEO and President.

The Board has formed an Interim Office of the Chief Executive to oversee day-to-day leadership of the Company’s operations.  The Interim Office of the Chief Executive will be headed by Ms. Maya Strelar-Migotti, Executive Vice President, Smart Networked Devices and Solutions (SNDS) Business Group and Dr. Pantelis Alexopoulos, Executive Vice President of the Storage Business Group, as Interim Co-Chief Executive Officers.  Each has the authority to exercise all powers of the Chief Executive Officer.

The other members of the Interim Office of the Chief Executive include Dr. Zining Wu, Chief Technology Officer; Mr. David Eichler, Interim Chief Financial Officer; Mr. Tom Savage, Senior Vice President and General Counsel; and Mr. William Valle, Vice President, Global Human Resources.

Arturo Krueger, Marvell’s lead outside director, said, “The Board would like to thank Sehat and Weili for their enormous contributions and service since they founded Marvell in 1995.  Marvell has revolutionized the world through its innovative technology and breakthrough designs in the semiconductor industry.  However, the Board believes that the time has come to move in a new leadership direction.  The Company’s highest priority is to leverage Marvell’s strong core business and technology to drive the next stage of product innovation and profitable growth.  The Board has full confidence in the proven ability of Maya and Pantelis, together with the other members of the Interim Office of the Chief Executive and all of Marvell’s employees, to continue providing world-class research and development and customer support during this time of transition.  We look forward to demonstrating our continuing commitment to excellence in our products and service, as well as to creating value for our shareholders.”

On February 22, 2016, the Audit Committee approved the engagement of Deloitte & Touche LLP as the Company’s new independent public accounting firm.  On March 1, 2016, the Company reported the results of the Audit Committee’s independent investigation of certain accounting and internal control matters.  With these two key matters completed, the Company is working diligently to complete the preparation and filing of its Annual Report on Form 10-K for fiscal 2016 and its Quarterly Reports on Form 10-Q for the second and third quarters of fiscal 2016 as soon as practicable.  As previously announced, a search for a permanent Chief Financial Officer and additional independent board members is underway with the assistance of an international executive search firm.

Forward-Looking Statements under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements within the meaning of the federal securities laws that involve risks and uncertainties. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “can,” “will” and similar expressions identify such forward-looking statements.  These statements are not guarantees of results and should not be considered as an indication of future activity or future performance. Actual events or results may differ materially from those described in this press release due to a number of risks and uncertainties, including, among others: the interim performance of Interim Office of the Chief Executive; Marvell’s ability to recruit new executive leadership in a timely manner and, if they are recruited, their performance, the timing of Marvell’s regaining of compliance with its SEC reporting obligations, any matters arising out of the review and audit of Marvell’s financial statements by Marvell’s new independent registered public accounting firm, the results of further review by the Audit Committee of certain matters that came to the Audit Committee’s attention during the course of its now-completed investigation,  adverse impact of litigation or regulatory activities, and other risks detailed in Marvell’s SEC filings from time to time.  For other factors that could cause Marvell’s results to vary from expectations, please see the risk factors identified in the Marvell’s latest Annual Report on Form 10-K for the year ended January 31, 2015 and its latest Quarterly Report on Form 10-Q for the quarter ended May 2, 2015 as filed with the SEC, and other factors detailed from time to time in Marvell’s filings with the SEC. Marvell undertakes no obligation to revise or update publicly any forward-looking statements.

About Marvell
Marvell (NASDAQ: MRVL) is a global leader in providing complete silicon solutions and Kinoma software enabling the “Smart Life and Smart Lifestyle.” From storage to Internet of Things (IoT), cloud infrastructure, digital entertainment and in-home content delivery, Marvell’s diverse product portfolio aligns complete platform designs with industry-leading performance, security, reliability and efficiency. At the core of the world’s most powerful consumer, network and enterprise systems, Marvell empowers partners and their customers to always stand at the forefront of innovation, performance and mass appeal. By providing people around the world with mobility and ease of access to services adding value to their social, private and work lives, Marvell is committed to enhancing the human experience.

As used in this release, the term “Marvell” refers to Marvell Technology Group Ltd. and its subsidiaries. For more information, please visit www.Marvell.com.

Marvell, the M logo, ARMADA, Avastar and Kinoma are registered trademarks of Marvell and/or its affiliates. Other names and brands may be claimed as the property of others.

(TISA) US Patent Application Allowed for Issuance as a Patent

TIS Invents Unique Method for Mail Classification and Automatic Response Generation

TEL AVIV, Israel and PLANO, Texas, April 05, 2016  — Top Image Systems, Ltd. (NASDAQ:TISA), a global innovator of intelligent content processing solutions, announced today that the United States Patent and Trademark Office has examined the application filed by TIS in 2013 to protect our unique method for mail classification and automatic response generation and has allowed for its issuance as a patent.

This patent will protect TIS’ research and development in the area of automated document understanding, empowering eFLOW® software to more closely mimic human comprehension of content and context. These developments will advance future-forward technologies in the Digital Mailroom arena, enabling enhanced intelligent document recognition and extremely accurate classification capabilities that will improve automated customer communications management, contributing to enhanced customer engagement, satisfaction and retention.

In today’s expanding digital mailroom market, TIS collaborates with strategic partners to offer enterprises complete end-to-end Digital Mailroom solutions. These solutions effectively capture and process incoming documents, on the one hand enabling efficient, economic straight-through-processing of those documents that can be managed automatically, while on the other hand rapidly and accurately classifying, prioritizing and routing significant customer communications to the right processes and persons to facilitate customer-centric business operations.

“To maintain our technological edge, Top Image Systems continually invests in innovative R&D that lets us bring to market increasingly intelligent document automation capabilities,” remarked Carsten Nelk, CTO, Top Image Systems. “The issuance of this patent positions TIS far ahead of our competition in the automated mail management space. We are confident that advanced classification and response generation will be key in business process automation solutions going forward and expect TIS to continue to be an important player in this market.”

About Top Image Systems

Top Image Systems™ (TIS™) Ltd. is a leading innovator of enterprise solutions for capturing and validating structured and unstructured content entering organizations from various sources and managing content-driven business processes. Whether originating from mobile, electronic, paper or other sources, TIS solutions automatically capture, process and deliver content across enterprise applications. TIS’ flagship eFLOW platform and diverse business process and mobile image processing solutions are marketed in more than 40 countries through a multi-tier network of distributors, system integrators, value-added resellers and strategic partners. Visit the company’s website at http://www.TopImageSystems.com for more information.

Caution Concerning Forward-Looking Statements

Certain matters discussed in this news release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from any future results expressed or implied in those forward looking statements. Words such as “will,” “expects,” “anticipates,” “estimates,” and words and terms of similar substance in connection with any discussion of future operating or financial performance identify forward-looking statements. These statements are based on management’s current expectations or beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially including, but not limited to, risks in product development, approval and introduction plans and schedules, rapid technological change, customer acceptance of new products, the impact of competitive products and pricing, the lengthy sales cycle, proprietary rights of TIS and its competitors, risk of operations in Israel, government regulation, litigation, general economic conditions and other risk factors detailed in the Company’s most recent annual report on Form 20-F and other subsequent filings with the United States Securities and Exchange Commission. We are under no obligation to, and expressly disclaim any obligation to, update or alter our forward-looking statements, whether as a result of new information, future events or otherwise.

Company Contact: 
Shelli Zargary
Director of Corporate Marketing and Investor Relations
shelli.zargary@topimagesystems.com
+972 3 767 9114

Investors: 
James Carbonara
Regional Vice President, Hayden IR
james@haydenir.com
+ 1 646 755 7412

(DRWI) Announces Harmony Care Offering

The successful launch of Harmony Care includes five initial customer orders

Media Contact:
Nadine Kittle
Marketing Communications
DragonWave Inc.
613-599-9991 ext. 2262
nkittle@dragonwaveinc.com

Media Contact:
Becky Obbema
Interprose Public Relations
(for DragonWave)
(408) 778-2024
Becky.Obbema@interprosepr.com

Investor Contact:
Peter Allen
President & CEO
DragonWave Inc.
613-599-9991 ext. 2222
Investor@dragonwaveinc.com

(NAVB) Updates Clinical Development Plan for Lymphoseek® IV

Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB) announced today that based on its very recent meeting with the U.S. Food and Drug Administration (FDA), the Company will begin the clinical trial development process for its intravenous (IV) injection protocols for use of Lymphoseek® (technetium Tc 99m tilmanocept) injection in rheumatoid arthritis (RA) and other disease states. Lymphoseek is Navidea’s first commercial product from its Manocept™ platform.

“Our efforts to continue to unlock the significant value of the Manocept platform are well underway as we seek to expand Lymphoseek’s label so it can be used as an immunodiagnostic for additional diseases,” said Rick Gonzalez, President and CEO of Navidea. “This collaborative meeting with FDA has enabled us to continue to advance the regulatory process and begin to implement our clinical program in rheumatoid arthritis, an indication that has an addressable market that is substantially larger than the current Lymphoseek indications. We look forward to reporting our progress throughout the year.”

Over the past year Navidea conducted a series of meetings and communications with the FDA to gain clarity on a path to extend the current Lymphoseek IND to support IV administration of Lymphoseek. In parallel the Company initiated its clinical development efforts and has already completed six required non-clinical animal studies for this new route of administration, submitted the summary results in a briefing package to the FDA, and secured NIH grants in RA and Kaposi’s Sarcoma, worth up to $3.8 million to support further development through Phase 2 studies.

Based upon the feedback from the latest meeting, Navidea expects to submit an IND amendment to the FDA that will allow initiation of Phase 1/2 IV studies of Lymphoseek. The addition of this new route of administration would enable further development of Lymphoseek in broader immunodiagnostic disease applications including rheumatoid arthritis. The timing is expected to be consistent with Navidea’s previously disclosed development plans to initiate a multi-center Phase 1/2 registrational trial employing IV-administration to evaluate Lymphoseek for the primary diagnosis of rheumatoid arthritis and to aid in the differential diagnosis of rheumatoid arthritis from other types of inflammatory arthritis during the second half of 2016. In addition, we expect to begin the Phase 1 pilot trial evaluating subcutaneous injection of Lymphoseek in active RA subjects in the second quarter of 2016.

About Lymphoseek

Lymphoseek® (technetium Tc 99m tilmanocept) injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by the U.S. Food and Drug Administration (FDA) for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.

Accurate diagnostic evaluation of cancer is critical, as results guide therapy decisions and determine patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 600,000 new cases of breast cancer, 160,000 new cases of melanoma and 100,000 new cases of head and neck/oral cancer diagnosed annually.

Lymphoseek Indication and Important Safety Information

Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:

• Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.

• Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.

Important Safety Information

In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).

Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.

Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers. In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).

FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT:
WWW.LYMPHOSEEK.COM

About Navidea

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a biopharmaceutical company focused on the development and commercialization of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products and platforms including Manocept™ and NAV4694 to help identify the sites and pathways of undetected disease and enable better diagnostic accuracy, clinical decision-making, targeted treatment and, ultimately, patient care. Lymphoseek® (technetium Tc 99m tilmanocept) injection, Navidea’s first commercial product from the Manocept platform, was approved by the FDA in March 2013 and in Europe in November 2014. The development activities of the Manocept immunotherapeutic platform will be conducted by Navidea in conjunction with its subsidiary, Macrophage Therapeutics. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit www.navidea.com.

The Private Securities Litigation Reform Act of 1995 (the Act) provides a safe harbor for forward-looking statements made by or on behalf of the Company. Statements in this news release, which relate to other than strictly historical facts, such as statements about the Company’s plans and strategies, expectations for future financial performance, new and existing products and technologies, anticipated clinical and regulatory pathways, and markets for the Company’s products are forward-looking statements within the meaning of the Act. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, the Company’s continuing operating losses, uncertainty of market acceptance of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience, risks of development of new products, regulatory risks and other risks detailed in the Company’s most recent Annual Report on Form 10-K and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements.

Navidea Biopharmaceuticals
Investors & Media
Sharon Correia, 978-655-2686
Senior Director, Corporate Communications
or
David Schull, 858-717-2310
david.schull@russopartnersllc.com

(FLXN) Pivotal Phase 2b and Phase 3 Clinical Trials for Zilretta™

• Positive data from Zilretta Phase 2b and Phase 3 clinical trials demonstrate consistent efficacy across both studies with substantial and persistent pain relief
• In the Phase 3 trial Zilretta, in contrast to immediate-release triamcinolone acetonide (TCA), exceeds American Academy of Orthopedic Surgeons (AAOS) criteria for clinically important effects on pain and function
• Safety data from these studies are comparable to placebo and immediate-release TCA
• CONFERENCE CALL TODAY APRIL 4, 2016 AT 9:00 A.M. EDT

BURLINGTON, Mass., April 04, 2016  — Results from two Flexion Therapeutics, Inc. (Nasdaq:FLXN) sponsored pivotal clinical trials showed that its lead drug candidate Zilretta (also known as FX006) provided sustained and significant pain relief in patients with moderate to severe osteoarthritis (OA) knee pain. Professor Philip Conaghan, M.B., B.S., Ph.D., F.R.A.C.P., F.R.C.P., Chair of Musculoskeletal Medicine at the University of Leeds, presented the results at the OARSI 2016 World Congress in Amsterdam in a podium presentation that is available at http://flexiontherapeutics.com/programs-pipeline/scientific-publications.

Following the presentation Professor Conaghan said, “Consistent results across two pivotal clinical trials with Zilretta suggest that, at last, we have a long-lasting intra-articular therapy that is highly effective and has the potential to change the treatment paradigm for osteoarthritis.”

“We are delighted to be able to now share the detailed data from these studies which clearly demonstrate clinically meaningful and statistically significant pain relief in patients with knee OA. In addition, we are especially gratified by the Phase 3 data that demonstrate clear differentiation of Zilretta from immediate-release TCA,” said Michael Clayman, M.D., Flexion Therapeutics’ President and CEO. “Based on these data we have scheduled a pre-New Drug Application (NDA) meeting in May with the U.S. Food and Drug Administration (FDA) with the intent to gain the Agency’s endorsement to submit an NDA in the second half of 2016.”

The Phase 3 trial was a randomized, double-blind, placebo-controlled, active-comparator trial that enrolled 486 patients at approximately 40 centers worldwide. Patients were randomized to one of three treatment groups (1:1:1) and received either a single intra-articular injection of 40 mg of Zilretta, normal saline (placebo) or 40 mg of immediate-release TCA. Each patient was evaluated for efficacy and safety during seven outpatient visits over 24 weeks after receiving an injection. The primary objective of the study was to assess the magnitude of pain relief of Zilretta at 12 weeks against placebo as measured by the weekly mean of the average daily pain (ADP) score. The secondary objectives of the study assessed the magnitude and duration of pain relief and effect of Zilretta against placebo and immediate-release TCA in additional pre-specified measures.

Phase 3 study data from the OARSI podium presentation and from additional company analyses are summarized below and posted to the Flexion website at http://flexiontherapeutics.com/programs-pipeline/scientific-publications.

In the Phase 3 study, Zilretta:

• Met its primary endpoint at week 12, demonstrating highly significant (p < 0.0001, 2-sided) and clinically meaningful pain relief against placebo as measured by the weekly mean of the ADP score.
• Achieved statistically significant pain relief against placebo as measured by the weekly mean of the ADP score at weeks 1 through 16 and demonstrated, on average, an approximately 50 percent reduction in pain from baseline over weeks 1 through 12.
• Achieved numerically superior pain relief against immediate-release TCA at weeks 2 through 12 as measured by the weekly mean of the ADP score, but did not achieve statistical significance in that measure.
• Achieved statistical significance against placebo and immediate-release TCA at each time point through 12 weeks on WOMAC A (pain), WOMAC B (stiffness) and WOMAC C (function) and the Knee injury and Osteoarthritis Outcome Score (KOOS) quality of life subscale.
• Demonstrated in a pre-specified subset analysis of patients with unilateral knee pain (35 percent of subjects in the study), substantially magnified effects in the weekly mean of the ADP score, WOMAC A, B and C and KOOS quality of life and significantly enhanced separation from placebo and immediate-release TCA in all of these measures.
• Demonstrated reduced rescue medicine consumption compared with placebo and immediate-release TCA.

The Phase 3 data were also evaluated for clinical relevance by applying established AAOS criteria. In its 2013 publication, “Evidence-Based Guideline: Treatment of Osteoarthritis of the Knee,” the AAOS comprehensively reviewed the available literature on existing treatments and determined a minimal relative improvement in WOMAC A, B and C measures that would be meaningful to patients. This is referred to as the Minimal Clinically Important Improvement (MCII). The Phase 3 data show that Zilretta exceeds the MCII in WOMAC A, B and C and thus demonstrates a clinically important effect, whereas immediate-release TCA in this study does not.

The Phase 2b trial enrolled 310 participants in a multi-center, randomized, double-blind study, in which the participants received an injection of either 40 mg or 20 mg of FX006, or a placebo (saline). The 40 mg arm of Zilretta, compared to placebo, demonstrated statistical significance in average pain relief over weeks 1 through 12 (p = 0.0012; 2-sided) and over weeks 1 through 24 (p = 0.0209; 2-sided). At weekly time points, 40 mg of Zilretta also demonstrated superiority to placebo in pain relief beginning at week 1, continuing to week 11 and also at week 13 (p < 0.05 at each time point; 2-sided). The primary endpoint of the trial, superiority in pain relief at 12 weeks, did not reach statistical significance (p = 0.0821; 2-sided). A pre-specified, commonly applied sensitivity analysis (Baseline Observation Carried Forward/Last Observation Carried Forward (BOCF/LOCF)) that addresses patient dropouts, however, did demonstrate statistical significance for the primary endpoint at 12-weeks (p = 0.042).

Across both the Phase 2b and Phase 3 studies, there were no drug related serious adverse events for Zilretta and the frequency of treatment-related side effects was comparable across all study arms.

Conference Call

Flexion’s management will host a conference call today at 9:00 a.m. EDT. The dial-in number for the conference call is (855) 770-0022 for domestic participants and (908) 982-4677 for international participants, with Conference ID # 84943960. A live webcast of the conference call can also be accessed through the “Investors” tab on the Flexion Therapeutics website. A webcast replay will be available online after the call.

About Osteoarthritis of the Knee

OA is a common joint disease that affects 27 million Americans, and the prevalence of the disease is expected to significantly grow as a result of aging, obesity and sports injuries. OA is a type of degenerative arthritis that is caused by the progressive breakdown and eventual loss of cartilage in one or more joints. OA is characterized by pain, swelling, stiffness and decreased mobility of the affected joint. While OA is being diagnosed at increasingly younger ages, prevalence rises after age 45, and the knee is one of the most commonly affected joints. In 2014, more than 12 million Americans were diagnosed with OA of the knee. OA has a significant impact on the daily lives of patients, and it commonly affects large weight-bearing joints like the knees and hip but also occurs in the shoulders, hands, feet and spine. As the disease progresses, it becomes increasingly painful and debilitating, culminating, in many cases, in the need for total joint replacement.

Each year, at least five million OA patients in the U.S. receive immediate-release corticosteroid and hyaluronic acid IA injections for knee pain, but these injections generally provide limited relief, and no alternative injectable therapy has been approved in more than a decade. Opioids are another treatment option, and as many as 40 percent of Medicare patients are prescribed opioids for chronic OA pain.

About Zilretta

Zilretta is being investigated as the first intra-articular (IA) sustained-release, non-opioid treatment for patients with moderate to severe 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, over 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. The company is also investigating another product candidate, FX007, a locally administered TrkA receptor antagonist for post-operative pain.

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 and our other product candidates; 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; Zilretta’s market potential; and the potential therapeutic and other benefits of Zilretta and our other product candidates, 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 and our other product candidates, which could delay or limit their 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 of our 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 and our other product candidates; competition from alternative therapies; regulatory developments and safety issues, including difficulties or delays in obtaining regulatory approvals to market Zilretta or our other product candidates; 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 Relations Contact
David Carey
Lazar Partners LTD
T: 212-867-1768 
dcarey@lazarpartners.com

Media Relations 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

(UNAM) Announces Review of Strategic Alternatives

Unico American Corporation (NASDAQ: UNAM) (“Unico” or the “Company”) today announced its Board of Directors has authorized a review of strategic alternatives for the Company aimed at enhancing shareholder value. The Board of Directors has established a Special Committee consisting entirely of independent directors to oversee the review of strategic alternatives and potential opportunities. Willis Capital Markets & Advisory has been retained as exclusive financial advisor to the Special Committee. No assurance can be given as to whether, when or on what terms any possible transaction might occur. The Company does not intend to make any further statements regarding this process unless and until a definitive agreement has been reached, or until the process of exploring strategic alternatives has ended.

Headquartered in Calabasas, California, Unico is an insurance holding company that underwrites property and casualty insurance through its insurance company subsidiary; provides property, casualty, and health insurance through its agency subsidiaries; and through its other subsidiaries provides insurance premium financing and membership association services. Unico has conducted the majority of its operations through its subsidiary Crusader Insurance Company since 1985. For more information concerning Crusader Insurance Company, please visit the Crusader’s Web site at www.crusaderinsurance.com.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: Certain statements contained herein that are not historical facts are forward-looking. These statements, which may be identified by forward-looking words or phrases such as “anticipate,” “appears,” “believe,” ”expect,” “intend,” “may,” “should,” and “would,” involve risks and uncertainties, many of which are beyond the control of the Company. Such risks and uncertainties could cause actual results to differ materially from these forward-looking statements. Factors which could cause actual results to differ materially include underwriting actions not being effective, rate increases for coverages not being sufficient, premium rate adequacy relating to competition or regulation, actual versus estimated claim experience, regulatory changes or developments, unforeseen calamities, general market conditions, and the Company’s ability to introduce new profitable products.

(OCX) and The Wistar Institute Announce Positive Results w/ Blood-based Lung Cancer Test

ALAMEDA, Calif., April 04, 2016  — OncoCyte Corporation (NYSE MKT:OCX), a developer of novel, non-invasive blood based tests for the early detection of cancer, and The Wistar Institute, an international biomedical research leader in cancer, immunology and infectious diseases, today announced positive research results for a lung cancer diagnostic test being developed at Wistar. This study of 620 subjects replicates a previous study that was carried out at Wistar, which was presented at the American Thoracic Society conference in May 2015. The results of this study mark a successful transition of the assay platform from Illumina microarrays to a Nanostring nCounter^TM machine, which is the platform that OncoCyte intends to use for commercialization.

OncoCyte must now independently validate these results in its own follow-up study based on the results of Wistar’s latest study. OncoCyte will attempt to finalize and lock down both the assay and the classifier or algorithm that interprets test results. If successful, OncoCyte will initiate an internal analytical validation study, a process to confirm whether the test results can be reproduced in its laboratory. OncoCyte’s validation study will examine samples that it collects and analyzes independently using its own facility and equipment. The Company anticipates that the validation study will begin in the third quarter of 2016 and will be completed during the fourth quarter. If the validation study is successful, OncoCyte will be ready to implement its commercialization plans, including  hiring its sales force, building out its commercial infrastructure, moving towards completion and obtaining CLIA certification of a diagnostic laboratory and ultimately launching its lung cancer diagnostic test in the first half of 2017.

“This data confirms the findings of Wistar’s previous study on the effectiveness of this non-invasive diagnostic for the early detection of lung cancer and represents a significant milestone in OncoCyte’s plan to commercially launch the test in 2017,” commented William Annett, Chief Executive Officer of OncoCyte. “Lung cancer results in 160,000 deaths annually in the U.S., in part because there is no effective test to reliably diagnose lung cancer at an early enough stage to enable effective treatment. OncoCyte’s non-invasive lung cancer diagnostic could therefore represent an important improvement for patients, doctors and payors by improving outcomes and lowering costs. We look forward to continuing the next steps in the product development process and providing additional updates in the coming months.”

About OncoCyte Corporation
OncoCyte is primarily focused on the development and commercialization of novel, non-invasive blood and urine (“liquid biopsy”) diagnostic tests for the early detection of cancer to improve health outcomes through earlier diagnoses, to reduce the cost of care through the avoidance of more costly diagnostic procedures, including invasive biopsy and cystoscopic procedures, and to improve the quality of life for cancer patients. While current biopsy tests use invasive surgical procedures to provide tissue samples in order to determine if a tumor is benign or malignant, OncoCyte is developing a next generation of diagnostic tests that will be based on liquid biopsies using blood or urine samples. OncoCyte’s pipeline products are intended to be confirmatory diagnostics for detecting lung, bladder and breast cancer. OncoCyte’s diagnostic tests are being developed using proprietary sets of genetic and protein markers that differentially express in specific types of cancer.

About The Wistar Institute
The Wistar Institute is an international leader in biomedical research with special expertise in cancer research and vaccine development.  Founded in 1892 as the first independent nonprofit biomedical research institute in the country,  Wistar has held the prestigious National Cancer Institute Cancer Center designation since 1972, and works actively to ensure that research advances move from the laboratory to the clinic as quickly as possible. Wistar’s Business Development team is dedicated to advancing Wistar Science and Technology Development through creative partnerships. www.wistar.org

Forward Looking Statements
Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for OncoCyte, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of OncoCyte, particularly those mentioned in the cautionary statements found in OncoCyte’s Securities and Exchange Commission filings. OncoCyte disclaims any intent or obligation to update these forward-looking statements.

Investor Contact:
EVC Group, Inc.
Michael Polyviou/Chris Dailey
646-445-4800
mpolyviou@evcgroup.com /cdailey@evcgroup.com

Media Contact:
EVC Group, Inc.
Dave Schemelia
646-445-4800
dave@evcgroup.com

(STXS) U.S. Hospital Surpasses 1,000 Procedures using Stereotaxis Niobe® System

Saint Francis Leads New England in Treatment with Remote Magnetic Navigation

ST. LOUIS, April 04, 2016  — Stereotaxis, Inc. (NASDAQ:STXS), a global leader in innovative technologies for the treatment of cardiac arrhythmias, today announced that the Hoffman Heart and Vascular Institute at Saint Francis Hospital and Medical Center in Hartford, CT has completed more than 1,000 cardiac ablation procedures using its Niobe^® remote magnetic navigation system. Drs. Joseph Dell’Orfano and Aneesh Tolat, electrophysiologists with Arrhythmia Consultants of Connecticut, were among the early adopters of the Niobe system and each has surpassed 500 procedures on the system, making the hospital the leading site in New England to use Stereotaxis technology.

“Utilizing the Niobe ES system, we can navigate a catheter safely and accurately within any of the four chambers of the heart, with nearly no danger of perforation and more consistent contact between the catheter and heart wall, resulting in more effective ablations,” said Dr. Dell’Orfano.

“The benefits of Stereotaxis technology are far greater than conventional methods used to treat arrhythmias. The unique design of remote magnetic navigation has greatly advanced our capabilities and reputation as a best-in-class institution for cardiac electrophysiology,” added Dr. Tolat.

Saint Francis first installed the Niobe system in 2007 and then in early 2012 upgraded to the Niobe ES, the latest generation magnetic navigation platform. The hospital helped pioneer the practice of remote magnetic navigation for electrophysiology procedures in New England, providing feedback and expertise during early usage. Led by Drs. Tolat and Dell’Orfano, Saint Francis has performed more procedures with the Niobe system than any hospital in the region, primarily for complex left atrial and supraventricular tachycardia cases.

About Electrophysiology
Electrophysiology (EP) is often used to help correct heart arrhythmias through catheter ablation, which is a treatment that cauterizes (burns) cardiac tissue to eliminate rhythm abnormalities in patients. During an EP procedure, the electrophysiologist (a cardiologist with specialized training in the electrical system of the heart) threads special electrode catheters (long, thin, flexible wire assemblies) to the heart, normally gaining access to the vasculature through the groin area. Once the area of the heart responsible for the arrhythmia is identified, a special wire carrying radiofrequency energy is used to ablate the site.

About Saint Francis
Saint Francis Hospital and Medical Center has been an anchor institution in north central Connecticut since 1897. In 2015, Saint Francis became part of Trinity Health-New England, an integrated health care delivery system that is a member of Trinity Health, Livonia, MI, one of the largest multi-institutional Catholic health care delivery systems in the nation. Saint Francis Hospital is a major teaching hospital and the largest Catholic hospital in New England. Other Saint Francis entities include the Comprehensive Women’s Health Center, the Connecticut Joint Replacement Institute, the Hoffman Heart and Vascular Institute of Connecticut, Smilow Cancer Hospital Yale-New Haven at Saint Francis, and Saint Francis Medical Group.

About Stereotaxis
Stereotaxis is a healthcare technology and innovation leader in the development of robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional lab. Over 100 issued patents support the Stereotaxis platform, which helps physicians around the world provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Stereotaxis’ core Epoch^® Solution includes the Niobe^® ES remote magnetic navigation system, the Odyssey^® portfolio of lab optimization, networking and patient information management systems, and the Vdrive^® robotic navigation system and consumables.

The core components of Stereotaxis’ systems have received regulatory clearance in the United States, European Union, Canada, China, Japan, and elsewhere. The V-Sono^™ ICE catheter manipulator, V-Loop^™ variable loop catheter manipulator, and V-CAS^™ catheter advancement system have received clearance in the United States, Canada, and the European Union. For more information, please visit www.stereotaxis.com.

This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to raise additional capital on a timely basis and on terms that are acceptable, its continued listing on the NASDAQ Capital Market, its ability to continue to manage expenses and cash burn rate at sustainable levels, its ability to continue to work with lenders to extend, repay or refinance indebtedness on acceptable terms, continued acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its systems and the timing of such purchases, competitive factors, changes resulting from the recently enacted healthcare reform in the United States, including changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approvals, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control. In addition, these orders and commitments may be revised, modified, delayed or canceled, either by their express terms, as a result of negotiations, or by overall project changes or delays.

STXS Company Contact:	
Martin Stammer		
Chief Financial Officer	
314-678-6155			

STXS Investor Contact:	
Todd Kehrli / Jim Byers	
MKR Group, Inc.		
323-468-2300			
stxs@mkr-group.com		

Saint Francis Contact:
Fiona Phelan
Media Relations Manager
860-714-1076
fphelan@stfranciscare.org

(OGES) Successful First Quarter Q1, 2016 Revenues Exceed Guidance

Oakridge Global Energy Solutions: A New Era In Battery Manufacturing

Oakridge Successful First Quarter

Q1, 2016 Revenues Exceed Guidance

FOR IMMEDIATE RELEASE

Oakridge Pro Series Battery Production

April 4, 2016 Palm Bay, Florida – Oakridge Global Energy Solutions, Inc. (OTCQB: “OGES”) is excited to announce the very successful completion of the first quarter of 2016 with the company now in commercial production of its game-changing lithium-ion battery products.  In continuing with the many successes previously announced Oakridge had its highest quarterly revenues in the history of the company by closing out the first quarter 2016 with $263,427 in revenues.

During what will clearly be seen as one of the most significant quarters in company history to date, Oakridge was able to continue to build momentum off its previously announced successes by generating the company’s first commercial revenues.

Other previously announced milestones for the first quarter, 2016, were the successful launch of production operations; the signing of a Strategic Business Alliance Agreement with the major global Japanese company, Sojitz Machinery Corporation; the production release of the Liberty Series motorsports starter battery; the first regular commercial production shipments of the Pro Series golf car battery; the strategic business alliance with Maritime Tactical Systems, Inc.; and the  start-up of second shift production operations at the Company’s new Palm Bay, Florida, manufacturing facility.

Each of these events is further demonstration of the successful business that has been created by the major restructuring process that the company undertook during the previous 18 months.

In mid-March Oakridge was able to provide the first revenue guidance in the company’s history to the markets.  This will become a trend as the company will now regularly provide revenue guidance for each quarter, as the company continues to build commercial production momentum throughout the remainder of the year by virtue of its offering customer focused, market leading products and service on a global scale.

Oakridge also looks to begin production shipments on its powerful Freedom IV series of living space power products in Q2 as well as continue product development and refinements in its  Pro Series, Liberty Series and Patriot Series of Golf Car, Power Sports, and Unmanned Vehicle battery product ranges..

“This is a very exciting time to be part of Oakridge,” said Oakridge Executive Chairman and CEO, Steve Barber. “We have, for the first time in company history (which dates back to the 1980’s), generated significant commercial revenues in Q1, 2016, and in doing so have exceeded our guidance of $250,000 in expected Q1 revenues.  We have an amazing team and an amazing product line.  Our team really pulled it all together in the first quarter and we are very proud of them.  We have passed the turning point after our lengthy restructure and transition of the company from an R&D company to a fully-fledged commercial production and manufacturing business and are looking forward to a very successful year in 2016.”

The Oakridge product development team has been working diligently to develop additional products for release throughout the balance of 2016.  Additional capacity has been added by nearly tripling the capacity in cell formation, and much more high speed automation equipment is on order for delivery before the end of 2016.

“We have some truly amazing products, powerful strategic alliances, and some highly synergistic acquisition opportunities in the queue to be announced in the very near future.  We aren’t ready to announce these quite yet, but you will need to keep an eye on our near term announcements, as they are likely to be truly transformative for the company” adds Mr. Barber.

http://www.globenewswire.com/NewsRoom/AttachmentNg/8d665128-2bd1-4e44-aaa0-72d768155739

http://www.globenewswire.com/NewsRoom/AttachmentNg/1998371a-e4c7-4313-adf1-ecbc29a5cde1

Oakridge Pro Series Batteries on pallet being readied for shipment

http://www.globenewswire.com/NewsRoom/AttachmentNg/67155504-435e-49db-8b85-1c6103a9b304

The Final Shipment of product for the First Quarter leaving the plant enroute to customers

http://www.globenewswire.com/NewsRoom/AttachmentNg/ada55fb6-25b1-43bd-b9f8-854c81d0b121

Oakridge Production Team readying products for Shipment

About Oakridge Global Energy Solutions, Inc.

Oakridge Global Energy Solutions Inc., is a publicly traded company, trading symbol: OGES on the OTCQB with a market capitalization of approximately USD $ 200,000,000, whose primary business is the development, manufacturing and marketing of energy storage products. Additional information can be accessed on the company’s website www.oakridgeglobalenergy.com

Forward-Looking Statements Disclaimer: 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. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this press release. This press release should be considered in light of all filings of the Company that are contained in the Edgar Archives of the Securities and Exchange Commission at www.sec.gov.

Contact:

Oakridge Global Energy Solutions, Inc.
www.oakridgeglobalenergy.com
3520 Dixie Highway
Palm Bay, 32905, Florida, USA
Ph: (321) 610-7959
Email: ir@oakg.net

Investor Inquiries:

Benchmark Advisory Partners LLC
Timothy Connor
Toll Free: (866) 703-4778
admin@bmarkadvisory.com

And:

Dutch DeWaard
Business Development
DreamTeamNetwork (DTN)
Austin, TX
www.DreamTeamNetwork.com
512.758.8877 Office
480.734.5834 Mobile
Dutch@DTN.fm

And:

Mike King
Princeton Research
www.princetonresearch.com
702.650.3000
mike@princetonresearch.com

(AEZS) Announces At the Market Issuance Program

Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the “Company”) announced today that it has entered into an At Market Issuance (“ATM”) Sales Agreement, dated April 1, 2016, with H.C. Wainwright & Co., LLC (the “Sales Agent”), under which the Company may, at its discretion, from time to time during the term of the ATM Sales Agreement, sell up to a maximum of 3,000,000 of its common shares through ATM issuances on the NASDAQ Stock Market, up to an aggregate amount of approximately $10 million. The Sales Agent will act as sales agent for any sales made under this new ATM program. The common shares will be sold at market prices prevailing at the time of the sale of the common shares and, as a result, sale prices may vary.

In connection with the execution of the ATM Sales Agreement with the Sales Agent, the Company has filed with the United States Securities and Exchange Commission (the “SEC”) a prospectus supplement to its shelf registration statement on Form F-3 (333-194547) filed with the SEC on March 14, 2014, which was declared effective by the SEC on March 28, 2014.

The shelf registration statement on Form F-3 and the prospectus supplement for this offering are available on the SEC’s website (www.sec.gov). Alternatively, the Sales Agent will provide copies of these documents upon request by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 4th Floor, New York, NY 10022 at placements@hcwco.com.

This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any of the common shares, nor shall there be any sale of the common shares 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.

About Aeterna Zentaris

Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women’s health. We are engaged in drug development activities and in the promotion of products for others. We are now conducting Phase 3 studies of two internally developed compounds. The focus of our business development efforts is the acquisition of licenses to products that are relevant to our therapeutic areas of focus. We also intend to license out certain commercial rights of internally developed products to licensees in territories where such out-licensing would enable us to ensure development, registration and launch of our product candidates. Our goal is to become a growth-oriented specialty biopharmaceutical company by pursuing successful development and commercialization of our product portfolio, achieving successful commercial presence and growth, while consistently delivering value to our shareholders, employees and the medical providers and patients who will benefit from our products. For more information, visit www.aezsinc.com.

Aeterna Zentaris Inc.
Philip A. Theodore
Senior Vice President
843-900-3223
ir@aezsinc.com

(RIGL) Completes Enrollment of FIT Phase 3 Program for Fostamatinib in ITP

SOUTH SAN FRANCISCO, Calif., April 1, 2016  — Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced it has completed enrollment for both studies in the FIT Phase 3 clinical program of fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, in immune thromboycytopenic purpura (ITP).  The first study in this program completed enrollment at the end of January and the second study has now completed enrollment.  The results from the first study are expected in the middle of 2016, with the results for the second study expected shortly thereafter.

Earlier this year Rigel initiated a Phase 2 clinical trial in a second autoimmune disorder of the blood, autoimmune hemolytic anemia (AIHA).  The purpose of this clinical trial is to evaluate the safety and efficacy of fostamatinib in patients with chronic AIHA. This disorder affects an estimated 40,000 Americans, for whom no approved treatment options currently exist.

FIT Phase 3 Program of Fostamatinib in ITP
The FIT program consists of two identical studies of approximately 75 patients each. The patients have been diagnosed with persistent or chronic ITP, and have blood platelet counts consistently below 30,000 per microliter of blood.  Study subjects remain on treatment for up to 24 weeks.  The primary efficacy endpoint of this program is a stable platelet response by week 24 with platelet counts at or above 50,000 per microliter of blood for at least four of the final six qualifying blood draws.

Fostamatinib and ITP
In patients with ITP, the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing.  ITP patients can suffer extraordinary bruising, bleeding and fatigue as a result of low platelet counts.  Current therapies for ITP include steroids, blood platelet production boosters (TPOs) and splenectomy.  Rigel believes that fostamatinib may address the autoimmune basis of the disease.

Fostamatinib and AIHA
AIHA is a rare, serious blood disorder where the immune system produces antibodies that result in the destruction of the body’s own red blood cells.  Symptoms can include fatigue, shortness of breath, rapid heartbeat, jaundice or enlarged spleen.  While no medical treatments are currently approved for AIHA, physicians generally treat acute and chronic cases of the disorder with corticosteroids, other immuno-suppressants, or splenectomy.  Research has shown that inhibiting SYK with fostamatinib may reduce the destruction of red blood cells.

About Rigel (www.rigel.com)
Rigel Pharmaceuticals, Inc. is a clinical-stage biotechnology company dedicated to the discovery and development of novel, targeted drugs in the therapeutic areas of immunology, oncology and immuno-oncology. Rigel’s pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company’s current clinical programs include fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, which is in Phase 3 clinical trials for ITP; a Phase 2 clinical trial for autoimmune hemolytic anemia (AIHA); and a Phase 2 clinical trial for IgA nephropathy (IgAN). In addition, Rigel has two oncology product candidates in Phase 1 development with partners BerGenBio AS and Daiichi Sankyo.

This press release contains “forward-looking” statements, including, without limitation, statements related to Rigel’s clinical development plans, including the timing, design and nature of planned clinical trials and the timing and nature of results of those trials, as well as the potential activity of fostamatinib with respect to ITP. 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 “planned,” “will,” “may,” “expect,” and similar expressions are intended to identify these forward-looking statements.  These forward-looking statements are based on Rigel’s 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, the availability of resources to develop Rigel’s product candidates, Rigel’s need for additional capital in the future to sufficiently fund Rigel’s operations and research, the uncertain timing of completion of and the success of clinical trials, risks associated with and Rigel’s dependence on Rigel’s corporate partnerships, as well as other risks detailed from time to time in Rigel’s reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2015. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

Contact: Raul Rodriguez
Phone: 650.624.1302
Email: invrel@rigel.com

Media Contact: Susan C. Rogers, Rivily, Inc.
Phone: 650.430.3777
Email: susan@rivily.com

(RDUS) Results on Fracture Risk Reduction in Phase 3 ACTIVE Trial of Abaloparatide-SC

– Data demonstrate that abaloparatide-SC reduced the risk of osteoporotic fractures and increased bone mineral density across a broad group of postmenopausal women with osteoporosis regardless of baseline characteristics –

Media Contact:
Lori Gorski
Email: Lgorski@radiuspharm.com
Phone: 617-551-4096

Investor Relations Contact:
Barbara Ryan
Email: bryan@radiuspharm.com
Phone: 203-274-2825

(REGN) and Sanofi Announce Positive Dupilumab Topline Results

Dupilumab is first systemic therapy to show positive Phase 3 results in patients with moderate-to-severe atopic dermatitis, a serious, chronic inflammatory skin disease marked by widespread rash, itching and associated psychosocial comorbidities U.S. regulatory submission for dupilumab planned for Q3 of 2016

TARRYTOWN, N.Y and PARIS, April 1, 2016  — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that two placebo-controlled Phase 3 studies evaluating investigational dupilumab in adult patients with inadequately controlled moderate-to-severe atopic dermatitis (AD) met their primary endpoints. In the studies, known as LIBERTY AD SOLO 1 and SOLO 2, treatment with dupilumab as monotherapy significantly improved measures of overall disease severity, skin clearing, itching, quality of life, and mental health.

“These are the first Phase 3 studies of a systemic therapy to demonstrate a significant improvement in moderate-to-severe atopic dermatitis, a chronic, debilitating inflammatory disease that impacts over one million Americans,” said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. “These data provide strong evidence that the IL-4 and IL-13 signaling pathway is a fundamental driver of inflammation in atopic dermatitis. Dupilumab is the first in a new class of immunotherapies – in these 16 week trials, dupilumab blocked the aberrant activation of this pathway, resulting in significant efficacy without evidence of immune-suppressing side effects. We continue to evaluate the role of IL-4 and IL-13 signaling in related inflammatory conditions, including asthma and nasal polyposis, where we have ongoing dupilumab clinical development.”

“There are no approved systemic therapies in the U.S. for people with moderate-to-severe atopic dermatitis, underscoring the clear unmet need. These results may bring new hope to atopic dermatitis patients, many of whom have suffered for years,” said Elias Zerhouni, M.D., President, Global R&D, Sanofi. “In the U.S., where dupilumab in AD has been granted Breakthrough Therapy designation by the U.S. FDA, we plan to submit a regulatory application in the third quarter of this year and will work to bring this innovative therapy to patients as quickly as possible.”

A total of 1,379 adult patients with moderate-to-severe AD were enrolled in the identically-designed SOLO 1 and SOLO 2 trials. Patients were enrolled if they were not adequately controlled with topical medications, or if topical treatment was not medically advisable. All patients were assessed via the 5-point Investigator’s Global Assessment (IGA) scale, ranging from 0 (clear) to 4 (severe); entry criteria required a baseline score of 3 or 4. Patients were also assessed using the Eczema Area and Severity Index (EASI) and other measures. Patients were randomized into one of three treatment groups: dupilumab 300 mg subcutaneously once per week, dupilumab 300 mg subcutaneously every two weeks, or placebo for 16 weeks following an initial dupilumab loading dose of 600 mg subcutaneously, or placebo. Results at 16 weeks included the following:

• For SOLO 1 and SOLO 2, respectively, 37 and 36 percent of patients who received dupilumab 300 mg weekly, and 38 and 36 percent of patients who received dupilumab 300 mg every two weeks, achieved clearing or near-clearing of skin lesions (IGA 0 or 1), compared to 10 and 8.5 percent with placebo (p less than 0.0001). This was the primary endpoint of the study in the U.S.
• For SOLO 1 and SOLO 2, respectively, the percent improvement in EASI from baseline was 72 and 69 percent in patients who received the 300 mg weekly dose, and 72 and 67 percent for patients who received dupilumab 300 mg every two weeks, compared to 38 and 31 percent for placebo (p less than 0.0001).
• For SOLO 1 and SOLO 2, respectively, 52.5 and 48 percent of patients who received dupilumab 300 mg weekly, and 51 and 44 percent of patients who received dupilumab 300 mg every two weeks, achieved EASI-75 compared to 15 and 12 percent with placebo (p less than 0.0001). This was the key secondary endpoint in the US and one of the primary endpoints in the EU.

For the 16-week treatment period, the overall rate of adverse events (65-73 percent dupilumab and 65-72 percent placebo) was comparable between the dupilumab groups and the placebo groups. The proportion of patients who completed the treatment period was 88-94 percent for dupilumab and 80.5-82 percent for placebo. The rate of serious adverse events was 1-3 percent for dupilumab and 5-6 percent for placebo. Serious and severe infections were also numerically higher in the placebo groups in both studies (0.5-1 percent dupilumab and 2-3 percent placebo). Adverse events that were noted to have a higher rate with dupilumab treatment across both studies included injection site reactions (10-20 percent dupilumab; 7-8 percent placebo) and conjunctivitis (7-12 percent dupilumab; 2 percent placebo); approximately 26 percent of patients in both studies reported a history of allergic conjunctivitis at study entry. No patient discontinued therapy due to injection site reactions and only one patient discontinued therapy due to conjunctivitis.

More detailed results from SOLO 1 and SOLO 2 will be submitted for presentation at a future medical congress.

The U.S. Food and Drug Administration (FDA) granted dupilumab Breakthrough Therapy designation in AD in November 2014. Dupilumab is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.

The LIBERTY AD Phase 3 clinical program consists of five trials of patients with moderate-to-severe AD at sites worldwide.

About Atopic Dermatitis
Atopic dermatitis – a serious form of eczema – is a chronic inflammatory disease characterized by itchy, inflamed skin that can be present on any part of the body. Though symptoms appear externally, atopic dermatitis is characterized by underlying systemic inflammation. Atopic dermatitis affects approximately 7-8 million adults in the U.S. and 1-3 percent of adults worldwide. Based on a survey of 200 physicians, there are approximately 1.6 million moderate-to-severe diagnosed and treated patients in the U.S. with uncontrolled disease. About 70 percent of people with atopic dermatitis have a family history of other common atopic diseases, such as asthma or hay fever. The intense itching, scratching and skin damage associated with the disease can sometimes lead to infections, caused by bacteria, such as Staphylococcus aureus. In addition, the physical manifestations of the disease can lead to anxiety, depression, and feelings of social isolation.

About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for high LDL cholesterol, eye diseases, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2015. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Regeneron Forward-Looking Statements and Use of Digital Media
This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements.  Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words.  These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron’s products, product candidates, and research and clinical programs now underway or planned, including without limitation dupilumab; unforeseen safety issues resulting from the administration of products and product candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s product candidates in clinical trials, such as the clinical development programs evaluating dupilumab; the likelihood and timing of possible regulatory approval and commercial launch of Regeneron’s late-stage product candidates, such as dupilumab for atopic dermatitis or other indications; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s products and product candidates, such as dupilumab; ongoing regulatory obligations and oversight impacting Regeneron’s marketed products, research and clinical programs, and business, including those relating to patient privacy; competing drugs and product candidates that may be superior to Regeneron’s products and product candidates; uncertainty of market acceptance and commercial success of Regeneron’s products and product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the commercial success of Regeneron’s products and product candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; coverage and reimbursement determinations by third-party payers, including Medicare and Medicaid; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including Regeneron’s agreements with Sanofi and Bayer HealthCare LLC, to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto.  A more complete description of these and other material risks can be found in Regeneron’s filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2015.  Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron’s media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron).

(RTK) Retires Senior Obligations, Improves Liquidity, and Directs Focus on its Wood Fibre Assets

Rentech, Inc. (NASDAQ: RTK) announced today that the closing of the Rentech Nitrogen Partners, L.P.-CVR Partners, LP (CVR) merger (Transaction) has enabled it to retire approximately $142 million of senior obligations to GSO Capital Partners (GSO), improve its liquidity, reduce future interest expense, and better position itself to maximize the value of its investments in the wood fibre processing industry.

Transaction Proceeds

Rentech received $261.9 million in gross consideration for its approximately 59% interest in Rentech Nitrogen Partners following today’s closing of the Transaction. The consideration was comprised of $59.8 million in cash and 24.18 million units of CVR valued at $202.1 million based on CVR’s closing price yesterday of $8.36 per unit.

GSO Exchange

Rentech utilized a portion of the Transaction proceeds to retire all $100 million of its Series E Preferred Stock and to repay approximately $42 million of term debt held by GSO. Under newly modified terms of the GSO agreement, these repayments were accomplished by Rentech delivering to GSO 17.0 million CVR units and $10.0 million in cash. Rentech’s obligations to GSO have been reduced from $195 million to approximately $53 million. The remaining $53 million of term debt with GSO will bear an interest rate of LIBOR plus 700 basis points per annum, with a LIBOR floor of 1.00% and will mature on April 9, 2019.

Rentech will retain 7.18 million CVR units of the Transaction consideration. These units, along with other Rentech assets, are pledged to GSO as collateral for the term loan. Rentech will receive the cash distributions paid by CVR on the 7.18 million retained units.

The final exchange terms with GSO were different than originally agreed to last year and as amended on March 14, 2016. GSO and Rentech agreed to set the final exchange price of CVR units at $7.75 per unit in lieu of using the pricing mechanism in the prior agreement. The original pricing mechanism would have valued the exchanged CVR units at $5.62 per unit based on a 15% discount to CVR’s 60-day volume weighted average price two days prior to closing. The parties also agreed that Rentech would use cash to repay a portion of the obligations and to retire approximately $142 million instead of $140 million of the obligations. The revised exchange terms enabled Rentech to retain units equivalent to a 6.3% ownership interest in CVR and to minimize taxable gains associated with the Transaction and exchange of units. GSO eliminated the one-time option granted to Rentech under the original transaction which would have enabled Rentech to repurchase CVR units at a future date six to twelve months following the closing. Additional details about the terms of the agreements with GSO will be provided in a Form 8-K that Rentech will file with the Securities and Exchange Commission.

Net Proceeds Following GSO Exchange

As a result of the Transaction and GSO exchange, Rentech retained $109.8 million of the total pre-tax proceeds received in the Transaction, comprised of $49.8 million of cash and 7.18 million CVR units valued at $60.0 million based on yesterday’s closing price of $8.36 per unit.

Rentech expects to pay $5 – $15 million in estimated cash taxes related to the Transaction, GSO exchange and the earlier sale of the Pasadena facility. The estimated tax payments take into consideration existing net operating loss carryforwards, which were $196.1 million as of December 31, 2015, and an estimate of operating losses expected to accrue this year.

Keith Forman, Rentech’s President and CEO, stated, “The transactions announced today represent a milestone for Rentech. We say goodbye to a business that has served our shareholders well and to a team of dedicated professionals at our East Dubuque facility who have been conscientious guardians and operators of this asset. We thank them.”

“This transaction affords Rentech the opportunity to reposition and intensify the focus on our investments in the wood fibre processing industry. It does so by providing us the liquidity and strengthened balance sheet to complete the construction and ramp-up of our Canadian facilities. This outcome would not have been possible save for the active willingness of GSO Capital to work with us on the terms of the exchange; both at the inception, in allowing for repayment of senior obligations in exchange for equity, and today in further modifying the terms of our agreements to allow for an outcome of less debt, greater liquidity, and less dilution than originally called for. As a result, we retain a meaningful stake in the “new” CVR Partners. We wish CVR well and we are confident that they will be good stewards of this asset as we have tried to be,” added Mr. Forman.

Financials

The table below illustrates the pro forma impact as if the foregoing transactions were completed on December 31, 2015.

¹ Increase in cash is pre-tax; includes initial proceeds from sale of Pasadena and excludes future working capital proceeds and potential milestone payments related to the sale.
² As of March 31, 2016; cost basis of CVR units estimated to be $0 at time of transaction.
³ Cash amount owed under the obligation is $13.7MM; see Note 15 in our 2015 10-K.

The table below provides Rentech’s anticipated debt service for 2016.

The table below provides Rentech’s estimated cash taxes and capital expenditures for 2016.

¹ Represents estimated taxes to be paid in 2016.

About Rentech, Inc.

Rentech, Inc. (NASDAQ: RTK) owns and operates wood fibre processing and wood pellet production businesses. Rentech offers a full range of integrated wood fibre services for commercial and industrial customers around the world, including wood chipping services, operations, marketing, trading and vessel loading, through its subsidiary, Fulghum Fibres. The Company’s New England Wood Pellet subsidiary is a leading producer of bagged wood pellets for the U.S. heating market. Rentech’s industrial wood pellet facilities supply wood pellets used as fuel for power generation in Canada and the United Kingdom. Please visit www.rentechinc.com for more information.

Safe Harbor Statement

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995 about matters such as: our estimated debt service, taxes and capital expenditures; and our ability to maintain our market positions and complete ramp-up of the Canadian wood pellet plants to full capacity. These statements are based on management’s current expectations and actual results may differ materially as a result of various risks and uncertainties. Other factors that could cause actual results to differ from those reflected in the forward-looking statements are set forth in the Company’s prior press releases and periodic public filings with the Securities and Exchange Commission, which are available via Rentech’s website at www.rentechinc.com. The forward-looking statements in this press release are made as of the date of this press release and Rentech does not undertake to revise or update these forward-looking statements, except to the extent that it is required to do so under applicable law.