Archive for January, 2014
(PPHM) Receives FDA Fast Track Designation for Bavituximab in Lung Cancer
SUNRISE Pivotal Phase III Trial of Bavituximab in Second-Line NSCLC Underway
TUSTIN, CA–(Jan 6, 2014) – Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), today announced that the company has received Fast Track designation by the U.S. Food and Drug Administration (FDA) for its lead investigational immunotherapy bavituximab for the potential treatment of second-line non-small cell lung cancer (NSCLC). Recently, the company initiated SUNRISE, a pivotal Phase III clinical trial comparing bavituximab plus the chemotherapy docetaxel against placebo plus docetaxel in this indication.
“The fast track designation is a milestone for the SUNRISE trial program and represents a step closer to bringing bavituximab to the market,” said Robert Garnick, Ph.D., head of regulatory affairs at Peregrine. “We are very pleased that the FDA has recognized the potential of this novel therapy as a treatment for this serious and devastating type of cancer and look forward to working closely with them to ensure the most efficient review process.”
The Fast Track programs of the FDA are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track status enables a sponsor to have more frequent and timely communication and meetings with the FDA regarding product development plans and may also result in eligibility for priority review of New Drug Applications. Fast track designation does not apply to a product alone but a combination of a product and specific indication.
SUNRISE (“Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study”) is a Phase III, global, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, tolerability and efficacy of bavituximab plus docetaxel in patients with second-line non-small cell lung cancer (NSCLC). The trial is evaluating bavituximab plus docetaxel versus docetaxel plus placebo in approximately 600 patients at more than 100 clinical sites worldwide. Patients with Stage IIIb/IV non-squamous, NSCLC who have progressed after standard front-line treatment are eligible for enrollment. Patients will be randomized into 1 of 2 treatment arms. All patients will receive up to six 21-day cycles of docetaxel (75 mg/m2) plus weekly infusions of either bavituximab (3mg/kg) or placebo until progression or toxicity. The primary endpoint of the trial will be overall survival. For additional information about the SUNRISE trial please visit www.sunrisetrial.com or ClinicalTrials.gov using Identifier NCT01999673.
About Bavituximab: A Targeted Immunotherapy
Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that represents a new approach to treating cancer. PS is a highly immunosuppressive molecule usually located inside the membrane of healthy cells, but “flips” and becomes exposed on the outside of cells that line tumor blood vessels, creating a specific target for anti-cancer treatments. PS-targeting antibodies target and bind to PS and block this immunosuppressive signal, thereby enabling the immune system to recognize and fight the tumor. These data detailing the immune-stimulatory mechanism of action of PS-targeting antibodies, such as the company’s lead drug candidate bavituximab, are the subject of a manuscript published in the October 2013 issue of the American Association for Cancer Research (AACR) peer-reviewed journal, Cancer Immunology Research. Bavituximab is currently being evaluated in several solid tumor indications, including non-small cell lung cancer, breast cancer, liver cancer and rectal cancer with a trial in advanced melanoma anticipated to initiate in the near future.
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials focused on the treatment and diagnosis of cancer. The company is pursuing multiple clinical programs in cancer with its lead immunotherapy candidate bavituximab while seeking a partner to further advance its novel brain cancer agent Cotara®. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and third-party customers. Additional information about Peregrine can be found at www.peregrineinc.com.
Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals’ intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that enrollment of the Phase III trial may experience delays or take longer than anticipated, the risk that the results from the Phase III trial may not support a future Biologics License Application (BLA) submission, the risk that the company may not have or raise adequate financial resources to complete the Phase III trial and the risk that the company may not find a suitable partner for the Phase III trial or the PS program. It is important to note that the company’s actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in our reports filed with the Securities and Exchange Commission including, but not limited to, our annual report on Form 10-K for the fiscal year ended April 30, 2013 and quarterly report on Form 10-Q for the quarter ended October 31, 2013. The company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.
Contact:
Christopher Keenan or Jay Carlson
Peregrine Pharmaceuticals
(800) 987-8256
info@peregrineinc.com
(OXBT) Announces Key Details of Phase 3 Trial Protocol for levosimendan
Oxygen Biotherapeutics, Inc. (“OBI”) (NASDAQ: OXBT) a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, today announced that the protocol of their phase 3 trial for levosimendan has been published on ClinicalTrials.gov, “Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Heart Surgery on Cardiopulmonary Bypass.” http://www.clinicaltrials.gov/ct2/show/NCT02025621?term=levosimendan&rank=12
Oxygen Biotherapeutics previously announced that it had selected Duke University’s Duke Clinical Research Institute (DCRI) to conduct the Phase 3 trial of the levosimendan. The Phase 3 trial will be conducted in approximately 50 major cardiac surgery centers in North America. The trial will enroll patients undergoing coronary artery bypass grafts (CABG) and/or mitral valve surgery who are at risk for developing low cardiac output syndrome (LCOS). The trial is a double blind, randomized, placebo controlled study seeking to enroll 760 patients.
The number of patients to be enrolled in the trial is an estimate. This is an event driven trial, and will be stopped when the event rate reaches that identified in the study power calculations. Thus, the number of patients could be less than 760 or higher if the event rate is higher or lower than expected.
The protocol includes a review of the control arm event rate for the first 200 patients randomized in the trial. The study population can be enriched to a higher percentage of patients with a greater degree of left ventricular dysfunction to increase the control event rate.
Two interim analyses will test for efficacy or futility after 50% and 70% of the planned primary endpoint events have been recorded.
John Kelley, CEO of Oxygen Biotherapeutics stated: “We are excited to communicate the details of our innovative and efficient trial design , and we look forward to enrolling the first patients in this important trial later this year.”
About Levosimendan
Levosimendan was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland. Levosimendan is a calcium sensitizer developed for intra-venous use in hospitalized patients with acutely decompensated heart failure. It is currently approved in over 50 countries for this indication and not available in the United States. It is under development in North America for reduction in morbidity and mortality of cardiac surgery patients at risk of low cardiac output syndrome (LCOS). The acquisition brings to Oxygen Biotherapeutics not only the exclusive rights in North America to develop and commercialize levosimendan for the specific indication of prevention and treatment of LCOS, but also the FDA’s approval of Fast Track status for a Phase 3 trial, and the FDA’s SPA which represents agreement with the Phase III clinical trial’s study protocol. The FDA has provided guidance that a single successful trial will be sufficient to support approval of levosimendan in this indication.
About Oxygen Biotherapeutics
Oxygen Biotherapeutics, Inc. is developing medical products for the acute care market. The company recently acquired the North American rights to develop and commercialize levosimendan. The United States Food and Drug Administration (FDA) has granted Fast Track status for levosimendan for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome (LCOS). In addition, the FDA has agreed to a Phase 3 protocol design under Special Protocol Assessment (SPA), and provided guidance that a single successful trial will be sufficient to support approval of levosimendan in this indication. The company also has developed a proprietary perfluorocarbon (PFC) therapeutic oxygen carrier called Oxycyte® that is currently in clinical and preclinical studies for intravenous delivery for indications such as traumatic brain injury, decompression sickness and stroke.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by the company that involve risks and uncertainties and reflect the company’s judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, the finalization of definitive agreements with DCRI, matters beyond the company’s control that could lead to delays in the clinical study, delays in new product introductions and customer acceptance of these new products, and other risks and uncertainties as described in the company’s filings with the Securities and Exchange Commission, including in its quarterly report on Form 10-Q filed on December 17, 2013, and annual report on Form 10-K filed on June 26, 2013, as well as its other filings with the SEC. The company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
(NBIX) Announces Positive Results of VMAT2 Inhibitor NBI-98854 in Kinect 2 Study
Plans to submit end of phase II meeting request to FDA Company to host conference call and webcast Monday, January 6th at 5:00pm ET / 2:00pm PT
SAN DIEGO, Jan. 6, 2014 — Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that NBI-98854, a small molecule VMAT2 inhibitor, showed a statistically significant and clinically meaningful reduction in tardive dyskinesia symptoms in the Phase IIb Kinect 2 study. The pre-specified primary endpoint was the change-from-baseline in the Abnormal Involuntary Movement Scale (AIMS) at Week 6 as assessed by central blinded video raters.
At Week 6, AIMS scores were reduced by 2.6 points in the NBI-98854 intention-to-treat (ITT) group compared to a reduction of 0.2 points in the placebo arm (p<0.001). Additionally, the responder rate (>= 50% improvement from baseline) was 49% in the NBI-98854 ITT group compared to 18% in placebo (p=0.002). In the per-protocol (PP) group AIMS scores were reduced by 3.3 points for those subjects taking NBI-98854 (p<0.001), with a corresponding responder rate of 59% (p<0.001).
“The profound response in this Kinect 2 study demonstrates the potential of NBI-98854 as both a safe and highly effective treatment for patients suffering from tardive dyskinesia,” said Christopher F. O’Brien, Chief Medical Officer of Neurocrine Biosciences. “It is clear from these results that the use of blinded central AIMS raters coupled with the ability to titrate up to 75 mg of NBI-98854 were both critical to the success of this trial.”
The improvement in Week 6 AIMS was also corroborated by the Clinical Global Impression–Tardive Dyskinesia (CGI-TD). Treating clinicians determined that approximately 67% of the subjects taking NBI-98854 were “much improved” or “very much improved” at Week 6 compared to only 16% of the placebo subjects (p<0.001) in this pre-specified key secondary efficacy endpoint.
“The data from this Kinect 2 study allows us to submit an End of Phase II meeting request as well as finalize the initial draft of a Phase III protocol, both of which we anticipate filing with the FDA in the first half of 2014,” said Kevin C. Gorman, President and Chief Executive Officer of Neurocrine. “Our Phase II studies of NBI-98854 have served to define the study population, elucidate the primary endpoint, refine our dosing regimen and provide the necessary efficacy and safety data to enable pivotal studies.”
The pre-specified statistical analysis plan included three data sets: a safety set (all subjects with at least one dose), an ITT set (all subjects who had an AIMS assessment at Week 6) and a PP set (all ITT subjects except those with no detectable drug levels at the evaluation time point). The table below summarizes the primary endpoint, LS Mean change-from-baseline AIMS, for both the ITT and PP populations at Week 6, as well as the responder analyses.
Week 6 | ||||
Placebo | NBI-98854 | p-value | ||
AIMS Change from Baseline | ||||
Baseline AIMS | 7.9 | 8.0 | – | |
LS Mean AIMS ANCOVA (ITT) | -0.2 | -2.6 | <0.001 | |
LS Mean AIMS ANCOVA (PP) | -0.3 | -3.3 | <0.001 | |
Responder Rate (ITT)* | 18% | 49% | 0.002 | |
Responder Rate (PP)* | 18% | 59% | <0.001 |
* a responder is defined as 50% or greater reduction in AIMS
The table below summarizes the key secondary endpoint, CGI-TD, for both the ITT and PP populations at Week 6.
Week 6 | ||||
CGI-TD | Placebo | NBI-98854 | p-value | |
LS Mean Score (ITT) | 3.1 | 2.2 | <0.001 | |
LS Mean Score (PP) | 3.1 | 2.2 | <0.001 | |
Responder Rate (ITT)* | 16% | 67% | <0.001 | |
Responder Rate (PP)* | 16% | 68% | <0.001 |
*a responder is defined as “much improved” or “very much improved” (a “2” or “1”, respectively) on the CGI-TD. A “4” on the CGI-TD indicates “no change”
Subject Profile
The Kinect 2 study randomized 102 subjects. At Week 6, the ITT population included 44 placebo subjects and 45 subjects who were randomized to NBI-98854. By Week 6, approximately 70% of the ITT population, randomized to NBI-98854, were titrated to the 75 mg dose, approximately 20% were titrated to the 50mg dose and the remaining subjects received 25 mg of NBI-98854. At Week 6 the PP population consisted of 44 placebo subjects and 34 subjects randomized to NBI-98854. The PP Week 6 final titrated dose level of NBI-98854 was similar to that of the ITT population. The PP population excluded eleven subjects whose plasma concentrations of NBI-98854 were below the lower limit of quantitation (i.e., not detectable). Given the timing of serum samples collections and the pharmacokinetic profile of NBI-98854, it was determined that these subjects had not ingested the study drug. The subjects in the Kinect 2 study had moderate to severe tardive dyskinesia with a mean baseline video AIMS score of 8.0. Similar to previous studies, the average age of the trial participants was 56 years with an average age at onset of tardive dyskinesia of 49 years. Approximately 60% of the subjects were male.
Safety Profile
In this study NBI-98854 was generally safe and well tolerated. During the six-week treatment period the frequency of treatment-emergent adverse events was 33% for placebo and 43% for NBI-98854. There were no drug related serious adverse events. The most common treatment emergent adverse events were fatigue in five subjects (9.8%) randomized to NBI-98854 vs. two subjects (4.1%) in the placebo group, and headache reported by four subjects (7.8%) on NBI-98854 vs. two subjects (4.1%) on placebo. Discontinuation rates were similar in both the NBI-98854 and placebo treatment groups with five per study arm (none of which were study drug related).
Participants were assessed utilizing the Barnes Akathisia Ratings Scale (BARS) for akathisia and the Simpson-Angus Scale (SAS) for parkinsonism. Both of these scales documented minimal symptoms at baseline and there was no worsening during the six weeks of treatment. Clinical hematology, chemistry and ECG monitoring indicated no emergent safety signals.
There were no drug-drug interactions identified in subjects who were utilizing a range of psychotropic and other concomitant medications.
Next Steps for NBI-98854
Data from the Kinect 2 study will be integrated with the Kinect study data to inform the ultimate design of the next study, Kinect 3. The Company will work with its consultants and scientific advisors to expand and refine the pharmacokinetic/pharmacodynamic models as well as to complete the remaining safety and efficacy analyses from both Kinect and Kinect 2. These data will form the basis for an End of Phase II briefing package along with the proposed Phase III protocol.
Kinect 2 Study Design
The Kinect 2 Study was a randomized, parallel, double-blind, placebo-controlled, dose titration Phase IIb clinical trial utilizing the capsule formulation of NBI-98854 in moderate to severe tardive dyskinesia patients with an underlying mood disorder (e.g., bipolar disorder), schizophrenia or schizoaffective disorder, or a gastrointestinal disorder with exposure to metoclopramide. This 100 subject study assessed once-daily NBI-98854 over a six-week placebo-controlled dosing period. Half of the randomized subjects received placebo and half received NBI-98854. The NBI-98854 dosing regimen began with a once-daily dose of 25 mg for the initial two weeks. At the completion of the initial two weeks of dosing, based on certain efficacy and safety criteria, patients were titrated to a once-daily 50 mg dose, or continued on the once-daily 25 mg dose for the following two-week period. At the completion of the second two weeks of treatment another efficacy and safety assessment was performed and patients were eligible to be titrated to a once-daily 75 mg, 50 mg or 25 mg dose for the final two weeks of treatment. The primary endpoint of the study was a comparison of placebo vs. active scores utilizing the AIMS at the end of Week 6 by blinded central raters.
About the Abnormal Involuntary Movement Scale (AIMS)
The AIMS is a structured neurological examination that was developed in 1976 and has been used extensively in movement disorder assessments. It consists of ten distinct ratings of regional involuntary body movements that are scored on a zero to four scale with zero being rated as none and four being rated as severe. The primary endpoint of the Kinect 2 Study is the video AIMS total dyskinesia score, items one through seven which rate facial, extremity and trunk movement severity as assessed by blinded central raters. The raters were movement disorder neurologists with expertise in dyskinesia assessment.
About Tardive Dyskinesia
Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities: lip smacking, grimacing, tongue protrusion, facial movements or blinking, puckering and pursing of the lips, or involuntary movements of the limbs. These symptoms are rarely reversible and there is currently no approved treatment.
About NBI-98854
VMAT2 is a protein concentrated in the human brain that is primarily responsible for re-packaging and transporting monoamines (dopamine, norepinephrine, serotonin, and histamine) in pre-synaptic neurons. NBI-98854, developed in the Neurocrine laboratories, is a novel, highly-selective VMAT2 inhibitor that modulates dopamine release during nerve communication, while at the same time having minimal impact on the other monoamines, thereby reducing the likelihood of “off target” side effects. NBI-98854 is designed to provide low, sustained, plasma and brain concentrations of active drug to minimize side effects associated with excessive monoamine depletion. The Company has completed nine-month in-vivo toxicology studies to support longer dosing regimens in humans.
NBI-98854 may also be useful in other disorders such as Huntington’s chorea, schizophrenia, Tourette’s syndrome, and tardive dystonia.
Conference Call and Webcast Information
The Company will host a live conference call and webcast to provide additional details of this study on, Monday January 6, 2014 at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants can access the live conference call by dialing 800-894-5910 (US) or 785-424-1051 (International) using the conference ID: NBIX. The call can also be accessed via the webcast through the Company’s website at http://www.neurocrine.com. Slides will also be made available through www.neurocrine.com for the conference call and webcast. If you are unable to attend the webcast and would like further information on this announcement please contact the Investor Relations Department at Neurocrine Biosciences at (858) 617-7600. A replay of the Conference Call will be available approximately one hour after the conclusion of the call by dialing 800-688-4915 (US) or 402-220-1319 (International) using the conference ID: NBIX. The call will be archived for three weeks.
About Neurocrine Biosciences
Neurocrine Biosciences, Inc. is a clinical stage drug discovery company primarily focused on neurological and endocrine based diseases and disorders. The Company discovers and develops innovative pharmaceuticals, in diseases with high unmet medical needs or where the existing drug classes are inadequate, through a disciplined yet entrepreneurial process. Utilizing a portfolio approach to drug discovery, Neurocrine has multiple small molecule drug candidates at various stages of pharmaceutical development. Neurocrine’s two lead late stage clinical programs are elagolix, a GnRH antagonist for women’s health that is partnered with AbbVie Inc., and a wholly owned VMAT2 inhibitor for the treatment of movement disorders. Neurocrine Biosciences, Inc. news releases are available through the Company’s website via the internet at http://www.neurocrine.com.
In addition to historical facts, this press release may contain forward-looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with Neurocrine’s business and finances in general, as well as risks and uncertainties associated with the Company’s VMAT2 program and Company overall. Specifically, the risks and uncertainties the Company faces with respect to the Company’s VMAT2 program include, but are not limited to; risk that NBI-98854 will not proceed to later stage clinical trials and risk that the Company’s clinical trials will fail to demonstrate that NBI-98854 is safe and effective. With respect to its pipeline overall, the Company faces risk that it will be unable to raise additional funding required to complete development of all of its product candidates; risk relating to the Company’s dependence on contract manufacturers for clinical drug supply; risks associated with the Company’s dependence on corporate partners for development, commercial manufacturing and marketing and sales activities for the Company’s partnered programs; uncertainties relating to patent protection and intellectual property rights of third parties; risks and uncertainties relating to competitive products and technological changes that may limit demand for the Company’s products; and the other risks described in the Company’s report on Form 10-K for the year ended December 31, 2012 and on Form 10-Q for the quarter ended September 30, 2013. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.
(QUNR) Air Ticket Bookings Exceed 60,000 in a Day
Company Also Named Top Ticket Booking App by Downloads and Usage
BEIJING, Jan. 3, 2014 — Qunar Cayman Islands Limited (Nasdaq:QUNR) (“Qunar” or the “Company”), China’s leading search-based travel commerce platform, today announced that it achieved a single-day record for air ticket bookings, with more than 60,000 over the New Year holiday.
The Company also provided updates on progress of its mobile strategy. Qunar’s mobile hotel bookings reached 50% of total hotel bookings, while its mobile taxi-booking service, Cheche, has expanded coverage to over 42 cities in China. The announcement followed the publication of reports by CTCNN which named Qunar the leading app by November downloads, and by TalkingData which names the Company the market leader for both December mobile app user coverage and usage rates for Android devices.
In a report issued on Tuesday, Deutsche Bank analyst Alan Hellawell also noted that Qunar Travel has become the most popular ticket-booking app in China. According to a research survey conducted by Enfodesk, 63.6% of respondents named Qunar Travel as the most frequently used ticket-booking app for air-ticket bookings, train-ticket bookings and tourist attraction-related bookings, followed by 54.5% for its closest competitor.
Qunar has taken steps to improve its mobile offering with recent moves such as connecting its popular travel app to social media service WeChat’s mobile payment system and launching voice recognition for hotel search.
About Qunar
Qunar Cayman Islands Limited is the leading search-based commerce platform for the travel industry in China. Qunar’s goal is to empower Chinese travelers to define their travel experience. Founded in May 2005 and headquartered in Beijing, Qunar is committed to providing travelers with a one-stop travel information source on both PC and mobile devices. The Company enables travelers to find the best-value deals by aggregating and processing highly fragmented travel product information from tens of thousands of travel service providers into an organized and user-friendly display through its proprietary technology. According to research firm iResearch, Qunar has ranked No. 1 among all non-state-owned online travel companies in China in terms of monthly unique visitors since November 2010. Qunar’s mobile application “Qunar Travel” was ranked the most frequently used mobile travel application in China by China Internet Network Information Center in September 2012.
Leveraging its large user base and advanced technologies, the Company provides an attractive value proposition to its customers, which include travel service providers and display advertisers.
Qunar means “where to go” in Mandarin Chinese.
CONTACT: For more information, please contact: China Jenna Qian Qunar Tel: +86-10-5760-3609 press@qunar.com Nick Beswick Brunswick Group Tel: +86-10-5960-8600 Email: qunar@brunswickgroup.com U.S. Cindy Zheng Brunswick Group Tel: +1-212-333-3810 Email: qunar@brunswickgroup.com
(LCAV) Reports Fourth Quarter Procedure Volume up 4% Over Prior Year
Marks Second Consecutive Quarter of Year-over-Year Growth Financial Results Conference Call Set for February 18th at 10:00 a.m. Eastern Time
CINCINNATI, Jan. 3, 2014 — LCA-Vision Inc. (NASDAQ: LCAV), a leading provider of laser vision correction services under the LasikPlus® brand, today reported that 12,033 procedures were performed during the fourth quarter of 2013, an increase of 4% over the 11,613 procedures performed during the fourth quarter of 2012. This is the second consecutive quarter of year-over-year growth in procedure volume.
Michael Celebrezze, chief executive officer of LCA-Vision, said, “Although the quarter started off slowly with sluggish appointment bookings during the federal government shutdown in October, we are very encouraged by the strong rebound in our business during the remainder of the fourth quarter. Our team worked hard to increase procedure volume for the second consecutive quarter, reversing the negative comparisons we experienced in the first half of the year. With the cost savings initiatives instituted throughout the year, coupled with revenue increases in the second half, we expect to report a significant improvement in financial performance from our core LASIK business in 2013.”
LCA-Vision will release fourth quarter 2013 financial results prior to the market open on Tuesday, February 18, 2014, with a conference call and webcast to follow at 10:00 a.m. Eastern time.
To access the conference call, dial 866-322-1352 (within the United States and Canada) or 706-643-6246 (international callers). The webcast will be available at the investor relations section of LCA-Vision’s website. A replay of the call and webcast will begin approximately two hours after the live call has ended. To access the replay, dial 855-859-2056 (within the United States and Canada) or 404-537-3406 (international callers) and enter the conference ID number: 29984536.
About LCA-Vision Inc./LasikPlus®
LCA-Vision Inc., a leading provider of laser vision correction services under the LasikPlus® brand, operates 61 LasikPlus® vision centers in the United States: 52 full-service LasikPlus® fixed-site laser vision correction centers and nine pre- and post-operative LasikPlus® satellite centers. Since U.S. approval, more than 1.3 million laser vision correction procedures have been performed at the company’s vision centers.
For Additional Information
Company Contact: | Investor Relations Contact: |
Barb Kise, LCA-Vision | Kim Sutton Golodetz, LHA |
513-792-9292 | 212-838-3777 |
kgolodetz@lhai.com | |
@LHA_IR_PR |
(PXLW) Skyworth Selects PA168 MotionEngine Processors for Ultra HD 4K TVs
Pixelworks, Inc. (NASDAQ: PXLW), an innovative provider of video display processing technology, today announced that its PA168 MotionEngine™ video display processor has been selected to power Skyworth’s Ultra HD 4Kx2K Dual Core Android 3D Smart TVs. These new high-end flat panels will deliver the very highest picture quality and an immersive TV viewing experience for the Chinese market.
“Pixelworks is very pleased to work with Skyworth to lead the way in delivering Ultra HD 4Kx2K TVs to the China market,” said Graham Loveridge, SVP Strategic Marketing and Business Development of Pixelworks. “The combination of unprecedentedly high resolution, price point, and superior video display processing will quickly affirm Skyworth’s leadership position in this all-important market.”
Pixelworks’ PA168 MotionEngine was designed from the ground up to address the Ultra HD market and solves the most complex and persistent problems associated with displaying video at high resolutions and refresh rates. Pixelworks’ advanced video display solutions include patented Motion Estimation and Motion Compensation (MEMC) technologies and the industry’s only Halo-Free Frame Rate Conversion (FRC).
“Skyworth’s choice of Pixelworks’ video display processor enables unparalleled video performance in our Ultra HD 55E780U Dual-Core Android Smart TV at a very compelling price point,” said a Skyworth company spokesperson. “We believe this industry-leading technology differentiates our products, delivering greater value and quality to our Chinese consumers.”
The PA168 MotionEngine contains a combination of industry-leading technical capabilities, including Pixelworks’ 6th generation Halo-Free FRC technology; an innovative cascading architecture that allows platforms to be scaled for significantly higher resolutions and refresh rates; proprietary n2m™ technology for smooth playback of low-frame internet video content, support for major 3D formats; and real-time 2D to 3D conversion.
For additional information on new products, as well as product demos, 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 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 MotionEngine are all registered trademarks of Pixelworks, Inc.
About Skyworth
Skyworth Digital Holdings Ltd. (HKEX stock code:0751) established in 1988. It is the leading PRC TV manufacturer based in Shenzhen, with a mission to be the No. 1 Display Technology in the PRC. Skyworth is specialized in TV production with a focus on high-end digital products, including LCD TV, HD CRT TV, slim CRT TV, Plasma TV, digital set-top box, mobile phones, car electronics, security monitors and small size LCD modules. In 2006/07, Skyworth’s total sales volume of TV and group turnover reached 8.6 million units and HK$12.6 billion, respectively. According to the survey conducted by Gfk Asia Pte. Ltd. in 2006, Skyworth ranked No. 1 among national and foreign brands in terms of sales amount in 100 major cities in the PRC. In December 2003 Skyworth firstly launched the self-developed V12 digital engine for high definition TV in China. In 2004-2005, 6 basic colors technology has been widely applied to Skyworth’s TV. In May 2006, the Group introduced the recordable LCD TV, 3G-USB LCD TV, auto-adjustable LCD backlight technology in September 2006 and the stabilizing technology to improve the response time of motion pictures and CooCaa TV in the first and third quarter of 2007, respectively. Being the first PRC TV manufacturer explored the overseas market in 1993, Skyworth’s quality OEM products have been recognized by international brands. Overseas markets contributed 9.7% in total turnover in 2006/07. Skyworth’s R&D is led by experienced electronics engineers and it cooperates with well-known suppliers: Real Media Networks, Trident, Pixelworks, Texas Instruments, LG, Fujitsu and Epson in application software, industrial design and plant management. Skyworth’s Science Industrial Park with a total area of over 640,000 square meters, located in Shiyan, Shenzhen, has commenced production of flat-panel TV and high-end electronics products in October 2006. Meanwhile, the new regional production plant at Ruyi district of Huhhot, Inner Mongolia has also started operation. The two new plants give Skyworth additional production capacity of totally 4 million units. Skyworth was listed on The Stock Exchange of Hong Kong Limited (0751) in April 2000. Please visit http://www.skyworth.com for more information.
(FEYE) Announces Acquisition of Mandiant
Combination Creates Industry-leading Vendor With a Complete Solution for Detecting, Resolving, and Preventing Advanced Threats
MILPITAS, Calif., Jan. 2, 2014 — FireEye (Nasdaq:FEYE), the leader in stopping today’s advanced cyber attacks, announced today that it has acquired privately held Mandiant, the leading provider of advanced endpoint security products and security incident response management solutions. The acquisition, which recognizes the ever-increasing intensity of cyber attacks and follows nearly two years of collaboration, creates the industry’s leading advanced threat protection vendor with the ability to find and stop attacks at every stage of the attack life cycle. The transaction closed on December 30, 2013.
The combination of FireEye and Mandiant brings together two highly complementary companies, each a recognized leader and innovator in security, and creates an organization uniquely qualified to meet organizations’ needs for real-time detection, contextual threat intelligence, and rapid incident response. FireEye pioneered the use of virtual machine technology in security with the introduction of its purpose-built virtual machine-based Multi-Vector Virtual Execution (MVX) engine. With more than two million virtual machines deployed worldwide, the company’s virtual machine-based Web, email, data center, and mobile security solutions provide real-time, dynamic threat protection to more than 1,500 government, enterprise, and small and mid-sized customers.
Mandiant is an acknowledged leader in endpoint security, incident response, and remediation, with more than two million endpoints installed globally. As a trusted security advisor to more than one-third of the Fortune 100, Mandiant’s experts have responded to hundreds of high-profile security incidents and bring deep security and incident response expertise to FireEye. The combined organization unifies the critical components required to provide state-of-the-art cyber security: the most complete library of actionable threat intelligence on advanced threats and a product suite that can apply that intelligence to detect and prevent attacks on both the network and on endpoints.
This powerful combination of security products and threat intelligence is enhanced by expert security consulting, incident response, and managed security services enabling organizations to improve their security posture and resolve security incidents whenever and wherever they arise.
“Organizations today are faced with knitting together a patchwork of point products and services to protect their assets from advanced threats,” said David DeWalt, chairman of the board and chief executive officer of FireEye. “Together, the size and global reach of FireEye and Mandiant will enable us to innovate faster, create a more comprehensive solution, and deliver it to organizations around the world at a pace that is unmatched by other security vendors.”
Mandiant expands FireEye’s ability to stop advanced attacks at the earliest phases of the attack life cycle with:
- Endpoint Threat Detection, Response, and Remediation Products
Mandiant pioneered and continues to lead the industry for endpoint-based advanced threat detection and response. Mandiant’s endpoint products, which are already integrated with the FireEye platform, enable security teams to make faster, more accurate decisions about potential security incidents while eliminating blind spots by connecting the dots with the FireEye network-based threat detection and prevention platform. - Advanced Threat Intelligence
Mandiant brings unrivaled depth in intelligence on next-generation attacks, which is continually gathered from ongoing monitoring of more than two million endpoints and by incident response and remediation teams who serve on the front lines combating the most advanced attacks. When this depth of threat intelligence is paired with the breadth of the FireEye real-time threat intelligence gathered from more than two million virtual machines, organizations will have unmatched detection and contextual information about attempted attacks, including the level of risk, the identity of the attackers, and the intended target of the attack. - Incident Response and Security Consulting Services
Endpoint protection, security incident response, and remediation have been Mandiant’s primary focus and expertise since its inception. Mandiant’s extensive team of highly skilled incident response experts has performed hundreds of incident response investigations across all industries and at organizations of all sizes. In addition, Mandiant brings its Mandiant Managed Defense monitoring service to FireEye. The addition of these skills and expertise significantly expand the ability of FireEye to offer value-added services on the FireEye Oculus platform.
Mandiant has been a strategic alliance partner of FireEye since April 2012. The combination of the two companies is a natural extension of this partnership and their integrated product offering, which both companies announced in February 2013.
Kevin Mandia, Mandiant’s founder and chief executive officer prior to the acquisition, has been appointed by the FireEye board of directors to the position of senior vice president and chief operating officer of FireEye. Mr. Mandia has been profiled on the cover of Fortune magazine and recognized by Foreign Policy magazine as one of the 100 leading global thinkers of 2013.
“The combination of FireEye and Mandiant will deliver end-to-end protection and meaningful value to customers,” said Mr. Mandia. “By joining FireEye and Mandiant, we will be able to deliver fully integrated products and services that help organizations protect themselves from attacks. The combined product portfolio will cover all the major attack points within an organization, and our expanded services capacity will allow us to quickly pivot to incident response when necessary to reduce the impact of security breaches.”
Mandiant will be integrated with FireEye to provide global services and cloud solutions, including security consulting, incident response, and managed services. Mandiant’s endpoint threat detection and response products will be incorporated as a core element of the FireEye Oculus platform.
Financial Terms of the Transaction
The acquisition was approved by the shareholders of Mandiant and the boards of directors of both companies. Under the terms of the merger agreement, FireEye will issue an aggregate of 21.5 million shares and options to purchase shares of FireEye stock and pay approximately $106.5 million of net cash in the transaction to the former Mandiant security holders. In addition, FireEye granted certain performance-based retention equity incentives.
Webcast and Conference Call Information
FireEye will host a live webcast with slides to discuss the transaction on January 2, 2014 at 2:00 P.M. Pacific time (5:00 P.M. Eastern time). The webcast may be accessed from the Investor Relations section of the FireEye website at http://investors.FireEye.com. Additionally, interested parties may access an audio-only conference call by dialing toll free 1-877-312-5521 within the U.S., or 1-678-894-3048 from international locations.
The archived webcast will be available via the Investor Relations section of the FireEye website at http://investors.FireEye.com. A conference call replay will be available approximately one hour after the conclusion of the event on January 2 through January 9, 2014 by dialing toll free 1-855-859-2056 within the U.S. or 1-404-537-3406 from international locations, and entering conference code 30005211.
About FireEye, Inc.
FireEye has invented a purpose-built, virtual machine-based security platform that provides real-time threat protection to enterprises and governments worldwide against the next generation of cyber attacks. These highly sophisticated cyber attacks easily circumvent traditional signature-based defenses, such as next-generation firewalls, IPS, anti-virus, and gateways. The FireEye Threat Prevention Platform provides real-time, dynamic threat protection without the use of signatures to protect an organization across the primary threat vectors and across the different stages of an attack life cycle. The core of the FireEye platform is a virtual execution engine, complemented by dynamic threat intelligence, to identify and block cyber attacks in real time. FireEye has over 1,500 customers across more than 40 countries, including over 100 of the Fortune 500.
About Mandiant
Mandiant was founded in 2004. The company was named “Best Security Company” by SC Magazine in 2012 and 2013 and counts more than 33 percent of the Fortune 100 as clients. Bloomberg BusinessWeek profiled Mandiant as the “go-to responder for cyber-espionage attacks”, and the company received widespread coverage in February 2013 for its report, “APT1: Exposing One of China’s Cyber Espionage Units”, which traced attacks on 141 companies to Unit 61398 of the People’s Liberation Army, supporting allegations of China’s involvement in state-sponsored espionage.
Forward-Looking Statements
This press release contains forward-looking statements about the expectations, beliefs, plans, intentions and strategies of FireEye relating to FireEye’s acquisition of Mandiant. Such forward-looking statements include statements regarding future product offerings; expected benefits to FireEye, Mandiant and their respective customers; expected financial impact of the acquisition on FireEye; and plans regarding Mandiant and Mandiant personnel. These statements reflect the current beliefs of FireEye and are based on current information available to us as of the date hereof, and we do not assume any obligation to update the forward-looking statements provided to reflect events that occur or circumstances that exist after the date on which they were made. The ability of FireEye to achieve these business objectives involves many risks and uncertainties that could cause actual outcomes and results to differ materially and adversely from those expressed in any forward-looking statements. These risks and uncertainties include the failure to achieve expected synergies and efficiencies of operations between FireEye and Mandiant; the ability of FireEye and Mandiant to successfully integrate their respective market opportunities, technology, products, personnel and operations; the failure to timely develop and achieve market acceptance of combined products and services; the potential impact on the business of Mandiant as a result of the acquisition; the loss of any Mandiant customers; the ability to coordinate strategy and resources between FireEye and Mandiant; the ability of FireEye and Mandiant to retain and motivate key employees of Mandiant; general economic conditions; as well as those risks and uncertainties included under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our Form 10-Q filed with the Securities and Exchange Commission on November 14, 2013 for the quarter ended September 30, 2013, which is available on the Investor Relations section of our website at investors.FireEye.com and on the SEC website at www.sec.gov.
© 2014 FireEye, Inc. All rights reserved. FireEye, Multi-Vector Virtual Execution and Oculus are registered trademarks or trademarks of FireEye, Inc. in the United States and other countries. All other brands, products, or service names are or may be trademarks or service marks of their respective owners.
CONTACT: Investor Contact Kate Patterson FireEye, Inc. kate.patterson@fireeye.com 408-321-4957 Media Contact Vitor De Souza FireEye, Inc. vitor.desouza@fireeye.com 415-699-9838
(SEED) to Announce Fiscal 2013 Annual Financial Results on January 8th
BEIJING, Jan. 3, 2014 — Origin Agritech Limited (NASDAQ: SEED) (“Origin” or the “Company”), a technology-focused supplier of crop seeds in China, today announced that the Company will report results for its fiscal year 2013 ended September 30, 2013, before the market opens on Wednesday, January 8, 2014.
The Company will host a teleconference on January 8, 2014, at 8:00 a.m. ET / 9:00 p.m. Beijing time to discuss the results. To participate in the call, please dial +1-877-870-4263 in North America, or +1-412-317-0790 internationally, approximately 5 minutes prior to the scheduled start time.
A replay of the call will be available shortly after the conference call through 9:00 a.m. ET on February 15, 2014. The replay dial-in numbers are: U.S. toll free number +1-877-344-7529, or the international number is +1-412-317-0088; using Conference Number “10038866” to access the replay.
About Origin
Founded in 1997 and headquartered in Zhong-Guan-Cun (ZGC) Life Science Park in Beijing, Origin Agritech Limited (NASDAQ GS: SEED) is China’s leading agricultural biotechnology company, specializing in crop seed breeding and genetic improvement, seed production, processing, distribution, and related technical services. Leading the development of Genetically Modified (GM) technology, Origin Agritech’s phytase corn was the first transgenic corn to receive the Bio-Safety Certificate from China’s Ministry of Agriculture. Over the years, Origin has established a robust GM seed pipeline including products with glyphosate tolerance and pest resistance (Bt) traits. Origin operates production centers, processing centers and breeding stations nationwide with sales centers located in key crop-planting regions. Product lines are vertically integrated for corn, rice and canola seeds. For further information, please log on to the Company’s website at: www.originseed.com.cn.
Forward Looking Statement
This release contains forward-looking statements. All forward-looking statements included in this release are based on information available to us on the date hereof. These statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results to differ materially from those implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “targets,” “goals,” “projects,” “continue,” or variations of such words, similar expressions, or the negative of these terms or other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. Neither we nor any other person can assume responsibility for the accuracy and completeness of forward-looking statements. Important factors that may cause actual results to differ from expectations include, but are not limited to, those risk factors discussed in Origin’s filings with the SEC including its annual report on Form 20-F to be filed. We undertake no obligation to revise or update publicly any forward-looking statements for any reason.
CONTACT:
Origin Agritech Limited
Dr. James Chen
Chief Financial Officer
james.chen@originseed.com.cn
or
Kay Liu
Investor Relations
ke.liu@originseed.com.cn
+86-138-1193-7764
(CSIQ) Completes the Sale of Mississippi Mills Solar Power Plant to TransCanada
GUELPH, Ontario, Jan. 2, 2014 — Canadian Solar Inc. (the “Company”, or “Canadian Solar”) (NASDAQ: CSIQ), one of the world’s largest solar power companies, today announced that its wholly owned subsidiary, Canadian Solar Solutions Inc., has completed the sale of Mississippi Mills, a 10 megawatt AC solar power plant valued at over C$61.0 million to TransCanada Corporation (TSX, NYSE: TRP) (“TransCanada”) on December 31, 2013
“This is the fourth of nine solar power plants totaling 86MW AC that we agreed to build and sell to TransCanada for approximately C$500 million,” said Dr. Shawn Qu, Chairman and Chief Executive Officer of Canadian Solar. “Our ability to successfully execute on this multi-facility project reflects the strength of Canadian Solar’s team and our partners. This should give investors added confidence in our ability to execute on our broader late-stage project backlog, which now stands at over 1.0 GW.”
The Mississippi Mills 10 megawatt AC solar power plant is located in the town of Mississippi Mills in Eastern Ontario. Canadian Solar Solutions Inc. will provide turnkey engineering, procurement and construction services to each of the nine projects. This latest sale follows the previously announced closing of the sale of Brockville 1 on June 28, 2013, in addition to Brockville 2 and Burritts Rapids on September 30, 2013.
About TransCanada
With more than 60 years’ experience, TransCanada is a leader in the responsible development and reliable operation of North American energy infrastructure including natural gas and oil pipelines, power generation and gas storage facilities. TransCanada operates a network of natural gas pipelines that extends more than 68,500 kilometres (42,500 miles), tapping into virtually all major gas supply basins in North America. TransCanada is one of the continent’s largest providers of gas storage and related services with more than 400 billion cubic feet of storage capacity. A growing independent power producer, TransCanada owns or has interests in over 11,800 megawatts of power generation in Canada and the United States. TransCanada is developing one of North America’s largest oil delivery systems. TransCanada’s common shares trade on the Toronto and New York stock exchanges under the symbol TRP. For more information visit: www.transcanada.com or check us out on Twitter @TransCanada or http://blog.transcanada.com.
About Canadian Solar
Founded in 2001 in Canada, Canadian Solar Inc. (NASDAQ: CSIQ) is one of the world’s largest and foremost solar power companies. As a leading vertically integrated provider of solar modules, specialized solar products and solar power plants with operations in North America, South America, Europe, Africa, the Middle East, Australia and Asia, Canadian Solar has delivered more than 6GW of premium quality solar modules to customers in over 70 countries. Canadian Solar is committed to improve the environment and dedicated to provide advanced solar energy products, solutions and services to enable sustainable development around the world. For more information, please visit www.canadiansolar.com.
Safe Harbor/Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties that could cause actual results to differ materially. These statements are made under the “Safe Harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by such terms as “believes,” “expects,” “anticipates,” “intends,” “estimates,” the negative of these terms, or other comparable terminology. Factors that could cause actual results to differ include the risks regarding general business and economic conditions and the state of the solar industry; governmental support for the deployment of solar power; future available supplies of high-purity silicon; demand for end-use products by consumers and inventory levels of such products in the supply chain; changes in demand from significant customers; changes in demand in our project markets, including Canada; changes in customer order patterns; capacity utilization; level of competition; pricing pressure and declines in average selling prices; delays in new product introduction; continued success in technological innovations and delivery of products with the features customers demand; utility-scale project approval process; delays in utility-scale project construction; shortage in supply of materials or capacity requirements; availability of financing; exchange rate fluctuations; litigation and other risks as described in the Company’s SEC filings, including its annual report on Form 20-F filed on April 26, 2013. Although the Company believes that the expectations reflected in the forward looking statements are reasonable, it cannot guarantee future results, level of activity, performance, or achievements. You should not place undue reliance on these forward-looking statements. All information provided in this press release is as of today’s date, unless otherwise stated, and Canadian Solar undertakes no duty to update such information, except as required under applicable law.
(ORMP) Receives Patent Allowance in Israel and Australia for Platform Technology
JERUSALEM, January 2, 2014 — Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that it has received Notices of Allowance from the Israel and Australian Patent Offices. The patent entitled, “Methods and Compositions for Oral Administrations of Proteins” covers a core concept of the company’s technology for the oral delivery of drugs and vaccines currently delivered via injection. The allowance in Israel marks the second from the Israel Patent Office in the past 30 days. Additionally, this is Oramed’s second Australian patent allowance, following the grant of a different patent in May 2012. The patent has also been approved in Japan, China, Russia, and New Zealand.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs and vaccines currently delivered via injection. Established in 2006, Oramed’s Protein Oral Delivery (POD[TM]) technology is based on over 30 years of research by top research scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801) currently in Phase 2 clinical trials on patients with type 2 diabetes (T2DM) under an Investigational New Drug application with the U.S. Food and Drug Administration, and with its oral exenatide capsule (ORMD-0901; a GLP-1 analog), with trials underway. Oramed is also moving forward with clinical trials of ORMD-0801 for the treatment of type 1 diabetes. The company’s corporate and R&D headquarters are based in Jerusalem.
For more information, the content of which is not part of this press release, please visit http://www.oramed.com
Forward-looking statements: This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss our clinical trials or revolutionizing the treatment of diabetes with our products. These forward-looking statements and their implications are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results that do not translate to equally good results in real settings; our patents may not be sufficient; and final that products may harm recipients, all of which could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Oramed 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. For a more detailed description of the risks and uncertainties affecting Oramed, reference is made to Oramed’s reports filed from time to time with the Securities and Exchange Commission.
Company Contact:
Oramed Pharmaceuticals
Aviva Sherman
Office: +972-2-566-0001
Email: aviva@oramed.com
(HSOL) to Supply 11.5 MW to Ikaros Solar
Leading Belgian solar company to install high-quality modules in UK
Hanwha SolarOne Co., Ltd. (the “Company”, or “Hanwha SolarOne”), a top-10 global photovoltaic manufacturer of high-quality, cost-competitive solar modules, today announced that it will supply 11.5 MW of high quality solar modules to Ikaros Solar Belgium NV (the “Ikaros Solar”). The modules are scheduled for delivery in January and February 2014. Ikaros intends to install the modules in a solar park in Norfolk County, United Kingdom. Hanwha SolarOne will supply its 72-cell module HSL-72, characterized by excellent real-life performance and extended durability.
Ikaros Solar operates as a project planner and wholesaler and is active in both large-scale and rooftop segments. Based in Belgium, Ikaros Solar has evolved into an international company with a global network of offices. Hanwha SolarOne has delivered high-quality PV modules to a number of solar projects constructed by Ikaros Solar.
“In Hanwha SolarOne, we have found a partner that can ensure both high quality and financial stability,” said Yves Devis, CEO at Ikaros Solar. “The PV modules from Hanwha SolarOne have demonstrated high performance and durability in our past projects. With the improved features of the new HSL-module series providing further benefits, Hanwha SolarOne was a natural choice for our latest large-scale project.”
“This project is the result of a strong, long-term collaboration with Ikaros Solar, a leading solar company in the Benelux region,” said Laurent Bodin, Director Sales France and Benelux at Hanwha SolarOne. “The partnership is based on mutual respect between two reliable companies that share the highest quality requirements. We look forward to contributing to more successful Ikaros projects in the future.”
Ikaros intends to start the construction of the new solar park in January 2014 and connect the new solar park to the grid by the end of March 2014. The solar park will include 38,334 modules supplied by Hanwha SolarOne.
About Hanwha SolarOne
Hanwha SolarOne Co., Ltd. (NASDAQ: HSOL) is one of the top 10 photovoltaic module manufacturers in the world, providing cost-competitive, high quality PV modules. It is a flagship company of Hanwha Group, one of the largest business enterprises in South Korea. Hanwha SolarOne serves the utility, commercial, government and residential markets through a growing network of third-party distributors, OEM manufacturers and system integrators. The company maintains a strong presence worldwide, with a global business network spanning Europe, North America, Asia, South America, Africa and the Middle East. As a responsible company committed to sustainability, Hanwha SolarOne is an active member of the PV Cycle take-back and recycling program. For more information, please visit: www.hanwha-solarone.com.
About Ikaros Solar
Ikaros Solar, headquartered in Schoten, is one of Belgium’s top companies operating in the PV market. It provides PV solutions for companies and the residential market. In addition, it is a wholesaler for certified installers. It offers its clients a total service during the selection and installation of solar energy and for maintenance and monitoring afterwards. Ikaros Solar was founded in 2006 and has evolved into an international company with offices in Belgium, Great Britain, Portugal, India, Mexico and Turkey. Ikaros Solar has installed more than 2,000 private PV systems and supplied installations to many public authorities and companies including IKEA, Carrefour, Philips, Janssen Pharmaceutica, DP World and Molenbergnatie. Furthermore, Ikaros Solar has partnerships with certified installers for the private sector. For more information, please visit: http://www.ikaros-solar.eu/
Safe-Harbor Statement
This press release contains forward-looking statements. These statements constitute “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, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Among other things, the quotations from management in this press release and the Company’s operations and business outlook, contain forward-looking statements. Such statements involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Further information regarding these and other risks is included in Hanwha SolarOne’s filings with the U.S. Securities and Exchange Commission, including its annual report on Form 20-F. Except as required by law, the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Hanwha SolarOne has not independently verified any information in “About Ikaros Solar” or any other information regarding the market position of Ikaros Solar. Hanwha SolarOne makes no representations regarding the accuracy or completeness of any such information.
(PLUG) Meets Projected Order Targets for Fourth Quarter of 2013
$32 Million in Unit Orders, Service and Hydrogen Contracts; Company Signs First Large Turnkey GenDrive Solution Customer
LATHAM, N.Y., Jan. 2, 2014 — Plug Power Inc. (Nasdaq:PLUG), a leader in providing clean, reliable energy solutions, today announces it has met order targets set for the fourth quarter of 2013. Orders for the fourth quarter of 2013 totaled approximately $32 million, and includes contracts with Walmart, Kroger, Procter & Gamble, Bridgestone, BMW, Sysco, Ace Hardware, CVS, Mercedes Benz, Lowes, Stihl, and Coke.
Key highlights associated with Plug Power’s fourth quarter bookings include:
- A contract to deploy multiple sites with a single food distribution customer using Plug Power’s turnkey GenDrive solution which includes products, service, and hydrogen;
- Repeat business with key material handling giants like Walmart, Kroger, Mercedes Benz, and BMW, resulting in fleet expansion and follow-on orders. These orders include both products and recurring revenue for service;
- And, addition of new customers to Plug Power’s growing customer list.
“Plug Power has continued to deliver value to material handling customers through its GenDrive product suite,” said Andy Marsh, CEO at Plug Power. “Moving forward, as we significantly grow the business, Plug Power will increase its value-add for each customer through building our product base and establishing recurring revenue streams through hydrogen and service. Plug Power has seen significant traction closing out 2013, and we expect the first quarter of 2014 bookings to meet or exceed the fourth quarter of 2013.”
Actual financial results and further overview of customer success will be presented and reviewed on the Company’s fourth quarter and year-end conference call. The Company will be holding its next business update conference call on Tuesday, January 14 at 10:00 am ET. Details to access the conference call will be posted on the homepage of Plug Power’s web site, www.plugpower.com.
About Plug Power Inc.
The architects of modern fuel cell technology, Plug Power is revolutionizing the industry with cost-effective power solutions that increase productivity, lower operating costs and reduce carbon footprints. Long-standing relationships with industry leaders forged the path for Plug Power’s key accounts, including Walmart, Sysco, P&G and Mercedes. With more than 4,000 GenDrive units deployed to material handling customers, accumulating over 16 million hours of runtime, Plug Power manufactures tomorrow’s incumbent power solutions today. Additional information about Plug Power is available at www.plugpower.com.
Plug Power Inc. Safe Harbor Statement
This communication contains statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements contain projections of our future results of operations or of our financial position or state other forward-looking information. These forward-looking statements include, without limitation, statements regarding financial expectations for the fourth quarter of 2013 and the year 2014, growth prospects for future orders, bookings and revenues, EBITDA projections, reductions in material and service costs and alternative supply sources. We believe that it is important to communicate our future expectations to our investors. However, there may be events in the future that we are not able to accurately predict or control and that may cause our actual results to differ materially from the expectations we describe in our forward-looking statements. Investors are cautioned not to unduly rely on forward-looking statements because they involve risks and uncertainties, and actual results may differ materially from those discussed as a result of various factors, including, but not limited to: the risk that we continue to incur losses and might never achieve or maintain profitability, the risk that we expect we will need to raise additional capital to fund our operations and such capital may not be available to us; the risk that we do not have enough cash to fund our operations to profitability and if we are unable to secure additional capital, we may need to reduce and/or cease our operations; the risk that a “going concern” opinion from our auditors, KPMG LLP, could impair our ability to finance its operations through the sale of equity, incurring debt, or other financing alternatives; the recent restructuring plan we adopted may adversely impact management’s ability to meet financial reporting requirements; our lack of extensive experience in manufacturing and marketing products may impact our ability to manufacture and market products on a profitable and large-scale commercial basis; the risk that unit orders will not ship, be installed and/or converted to revenue; the risk that pending orders may not convert to purchase orders; the risk that our continued failure to comply with NASDAQ’s listing standards may result in our common stock being delisted from the NASDAQ stock market, which may severely limit our ability to raise additional capital; the cost and timing of developing, marketing and selling our products and our ability to raise the necessary capital to fund such costs; the ability to achieve the forecasted gross margin on the sale of our products; the actual net cash used for operating expenses may exceed the projected net cash for operating expenses; the cost and availability of fuel and fueling infrastructures for our products; market acceptance of our GenDrive systems; our ability to establish and maintain relationships with third parties with respect to product development, manufacturing, distribution and servicing and the supply of key product components; the cost and availability of components and parts for our products; our ability to develop commercially viable products; our ability to reduce product and manufacturing costs; our ability to successfully expand our product lines; our ability to improve system reliability for our GenDrive systems; competitive factors, such as price competition and competition from other traditional and alternative energy companies; our ability to protect our intellectual property; the cost of complying with current and future federal, state and international governmental regulations; and other risks and uncertainties discussed under “Item IA—Risk Factors” in Plug Power’s annual report on Form 10-K for the fiscal year ended December 31, 2012, filed with the Securities and Exchange Commission (“SEC”) on April 1, 2013 and as amended on April 30, 2013 and the reports Plug Power filed from time to time with the SEC. These forward-looking statements speak only as of the date on which the statements were made and are not guarantees of future performance. Except as may be required by applicable law, we do not undertake or intend to update any forward-looking statements after the date of this communication.
CONTACT: Teal Vivacqua 518.738.0269 media@plugpower.com
(HOTR) Acquisition of Two Hooters Restaurants in Oregon and Washington State
CHARLOTTE, NC–(January 02, 2014) – Chanticleer Holdings, Inc. (NASDAQ: HOTR) (Chanticleer Holdings, or the “Company”), a minority holder in the privately held parent company of the Hooters® brand Hooters Of America, and a franchisee of international Hooters restaurants, has announced that it has executed an Agreement and Plan of Merger (the “Merger Agreement”) for the acquisition of two Hooters restaurants in the U.S. Pacific Northwest.
Chanticleer has executed the Meger Agreement to acquire 100% of the shares of Tacoma Wings, LLC and Hooters of Oregon Partners, LLC, owners and operators of the two locations in Portland, OR and Tacoma, WA. All leasehold and current franchise rights to the Hooters locations in Oregon and Washington will be transferred to the Company, with final closing expected to occur before January 31, 2014. Management has begun evaluating locations around the Portland and Seattle areas for future restaurant openings.
Mike Pruitt, Chairman and Chief Executive Officer, commented, “We believe the northwest presents a great strategic opportunity for Chanticleer to grow the Hooters brand as well as some of our other concepts we own. We are fortunate to inherit an experienced management team that will help make our growth possible.”
For more information on the transaction, please refer to Chanticleer Holdings 8-K filing at www.sec.gov.
About Chanticleer Holdings, Inc
Headquartered in a Charlotte, NC, Chanticleer Holdings (HOTR), together with its subsidiaries, owns and operates restaurant brands in the United States and internationally. The Company is a franchisee owner of Hooters® restaurants in international markets including England, South Africa, Hungary, and Brazil and has joint ventured with the current Hooters franchisee in Australia. Chanticleer is evaluating several additional international opportunities. The Company also owns and operates American Roadside Burgers and owns a majority interest in Just Fresh restaurants in the U.S.
For further information, please visit www.chanticleerholdings.com
Facebook: www.Facebook.com/ChanticleerHOTR
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Forward-Looking Statements:
Any statements that are not historical facts contained in this release are “forward-looking statements” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning. Such forward-looking statements are based on current expectations, involve known and unknown risks, a reliance on third parties for information, transactions or orders that may be cancelled, and other factors that may cause our actual results, performance or achievements, or developments in our industry, to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from anticipated results include risks and uncertainties related to the fluctuation of global economic conditions, the performance of management and our employees, our ability to obtain financing or required licenses, competition, general economic conditions and other factors that are detailed in our periodic reports and on documents we file from time to time with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and the companies do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
Press Information:
Chanticleer Holdings, Inc.
Investor Relations
Phone: 704.366.5122
ir@chanticleerholdings.com
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