|Regeneron Announces FDA Acceptance of EYLEA®; Palatin Presents Positive New Data Analyses Demonstrating Efficacy of Bremelanotide|
|By Staff and Wire Reports|
|Monday, 24 February 2014 20:13|
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the U.S. FDA has accepted for standard review the Company's supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection for the treatment of Macular Edema following Branch Retinal Vein Occlusion (BRVO). Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an sBLA is ten months from submission, for a target action date of October 23, 2014.
"We are pleased that the FDA has accepted the sBLA for EYLEA for the treatment of macular edema following BRVO, an important cause of vision loss," said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "This is the fourth regulatory submission in the U.S. for EYLEA and, if approved, we hope it will provide a new treatment option for patients with macular edema following BRVO."
The EYLEA sBLA submission in this indication is based on the positive results from the Phase 3 VIBRANT trial, which was a double-masked, randomized, active-controlled study of 183 patients with Macular Edema following Branch Retinal Vein Occlusion. Patients received either intravitreal EYLEA 2 milligrams (mg) every four weeks or laser treatment for 24 weeks. The primary objective of the study was to evaluate the efficacy and safety of EYLEA in improving best-corrected visual acuity compared to laser treatment at week 24. The study is ongoing through week 52.
EYLEA was approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD) in November 2011 and for Macular Edema following Central Retinal Vein Occlusion (CRVO) in September 2012. EYLEA has also been approved in the European Union (EU) and other countries for use in wet AMD and Macular Edema following CRVO. Regulatory submissions have also been made in the U.S. and the EU for EYLEA for the treatment of Diabetic Macular Edema.
Bayer HealthCare and Regeneron are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLEA, except for Japan where Regeneron receives a percentage of net sales.
Palatin Technologies (NYSE: PTN) presented new analyses from its Phase 2b clinical trial of bremelanotide, which demonstrated dose-dependent improvements in sexual desire and treatment satisfaction in premenopausal women with hypoactive sexual desire disorder (HSDD) and combined HSDD/female sexual arousal disorder (FSAD), both which are forms of female sexual dysfunction (FSD).1,2,3
The data from three clinical abstracts were presented Saturday, February 22, 2014 at the International Society for the Study of Women's Sexual Health (ISSWSH) conference in San Diego. Bremelanotide is a first-in-class, investigative melanocortin agonist being developed for treatment of female sexual dysfunction (FSD).
"We are excited by the potential that bremelanotide may offer women in treating HSDD, a condition that has been recognized for more than 30 years but for which there is no FDA-approved therapy," said Carl Spana, Ph.D., President and CEO of Palatin. "Unlike other investigational therapies in development for FSD, bremelanotide is an on-demand medication that has been shown to work within 30 to 60 minutes of administration. That would allow women to take it when they need it, providing them with a quick response, greater control and flexibility in their treatment."
In one abstract, responder analyses showed bremelanotide had a statistically significant increase in the percentage of women whose total score on the Female Sexual Function Index (FSFI) – a measure of overall sexual functioning – improved: 69% for 1.75 mg versus 46% for placebo (p<0.05).1 In addition, a significantly higher percentage of women on bremelanotide versus placebo achieved at least one satisfying sexual event (SSE): 55% for 1.75 mg versus 37% for placebo (p<0.05).1
A second abstract, presenting data from the episodic questionnaire, Female Sexual Encounter Profile – Revised (FSEP-R), demonstrated greater mean increases in SSEs within 24 hours of dosing with bremelanotide 1.75 mg (mean increase: 0.7; p=0.0443) versus placebo (mean increase: 0.1). As-needed administration of bremelanotide 1.75 mg versus placebo also demonstrated episodic increases in levels of desire (0.4 vs. 0.0, respectively) and in the women's satisfaction with their levels of desire (0.6 vs. 0.1, respectively).2
In a third abstract, data collected from the Women's Inventory of Treatment Satisfaction (WITS-9) showed women who completed treatment were significantly more satisfied with bremelanotide 1.75 mg (0.77; p=0.0204) versus placebo (0.17).3
"Additional analyses continue to yield robust, positive data for bremelanotide, which shows promise in addressing an important unmet need for women living with HSDD," said David J. Portman, MD, Principal Investigator at the Columbus Center for Women's Health Research, and in private practice with Portman Obstetrics and Gynecology. "The findings from these abstracts show that bremelanotide can significantly improve desire and sexual functioning. More importantly, women were satisfied with treatment, which is a predictor not just of satisfaction but with compliance and the continuation of treatment."
Bremelanotide was well-tolerated during the trial. The most common types of treatment-emergent adverse events reported more frequently in the bremelanotide arms were facial flushing, nausea and emesis, which were mainly mild-to-moderate in severity. The study dosed 394 patients. Adverse events that most commonly led to discontinuation were nausea and emesis. No serious adverse events were attributed to bremelanotide during the trial.
Palatin anticipates commencing enrolling patients in Phase 3 clinical trials in the second half of this year.
3D Systems (NYSE:DDD) today announced its ProJet® 3510 MP 3D printer and proprietary VisiJet® Stoneplast dental materials have been optimized for dental "drill guide" production.
ActiveCare, Inc. (OTCQB:ACAR), a leader in diabetes management and wellness services for self-insured employers nationwide, today reported financial results for the first quarter of fiscal year 2014 ended December 31, 2013.
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Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, today announced that it will host a conference call with members of Amarin senior management to discuss the company's fourth quarter and year-end 2013 financial results and provide an operational update on Thursday, February 27, 2014, at 4:30 p.m. ET.
Amarantus Bioscience Holdings, Inc. (OTCQB: AMBS), a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to endoplasmic reticulum stress, cell cycle dysregulation, neurodegeneration and apoptosis, today announced that it has appointed Kerry Segal as Head of Business Development and Tiffini Clark as Head of Regulatory Affairs.
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Biota Pharmaceuticals, Inc. (Nasdaq:BOTA) today announced that its President and Chief Executive Officer, Russell H. Plumb, will present an update on the company at the 26th Annual ROTH Conference at 12:30 p.m. PDT, March 11, 2014, at The Ritz-Carlton, Dana Point in California.
Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based diagnostics, announced that new data that further validates its UroGenRA™-Kidney diagnostic test for renal cell cancer will be presented at the annual United States & Canadian Academy of Pathology (USCAP) meeting on March 3rd in San Diego, CA.
Cesca Therapeutics Inc. (Nasdaq:KOOL), formerly known as ThermoGenesis Corp., announced today that they have entered a supply agreement with Cook Medical.
Celladon Corporation (Nasdaq:CLDN), a clinical-stage biotechnology company focused on developing novel therapies by applying its leadership position in the field of SERCA enzymes, today announced that Celladon and Servier have entered into an option agreement for a potential worldwide ex-U.S. research collaboration and license agreement for the discovery and development of novel SERCA2b modulators for the treatment of type 2 diabetes and other metabolic diseases.
Cellular Biomedicine Group, Inc. (OTCQB:CBMG) today announced updated analysis of its Phase I/IIa clinical trial for human adipose-derived mesenchymal precursor cell (haMPC) therapy for Knee Osteoarthritis (KOA), which tests the safety and efficacy of intra-articular injections of autologous haMPCs in order to reduce inflammation and repair damaged joint cartilage.
Cellular Dynamics International, Inc. (Nasdaq:ICEL), today announced that Chief Executive Officer Bob Palay is scheduled to present at the Cowen Group's 34th Annual Health Care Conference at 3:30 p.m. EST, Monday, March 3, in Boston.
Covisint Corporation (Nasdaq:COVS), provider of the leading cloud engagement platform, today expanded its healthcare platform globally to support the growing international need for secure health information exchange.
Diversicare Healthcare Services, Inc. (Nasdaq:DVCR) today announced that it is scheduled to report financial results for its fourth quarter ended December 31, 2013, on Thursday, March 6, 2014, after the market closes.
Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company and leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy in cancer and other serious diseases, today announced financial results for the fourth quarter ending Dec. 31, 2013, and provided a business update.
Eternity Healthcare (OTCBB:ETAH) a Medical Device and Diagnostic company today announced to sell 800,000 Common Stock for the total proceed of $500,000.00 USD exempt for registration under the Securities and Exchange under the Regulation S.
Galectin Therapeutics Inc. (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that the Company will present at the Nonalcoholic Steatohepatitis (NASH) Workshop hosted by JMP Securities on Thursday, February 27, 2014 in New York, NY.
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Hyperion Therapeutics, Inc. (Nasdaq:HPTX) today announced that it will report fourth quarter and full year 2013 financial results after market closes on Thursday, February 27, 2014.
LeMaitre Vascular, Inc. (Nasdaq:LMAT) announced today that it will be participating in three upcoming investor conferences. The first is the Cowen and Company Healthcare Conference at the Boston Marriott Copley Place in Boston, MA, on Monday, March 3, 2014.
Medical Marijuana, Inc. (OTC Pink:MJNA) is pleased to inform shareholders and the general public that HempMedsPX™—a corporate portfolio company of Medical Marijuana, Inc. and the exclusive master distributor and contracted marketing company for CannaVest Corp. and Medical Marijuana, Inc.— is the first cannabidiol (CBD)-rich hemp oil company to be accepted by the American Herbal Products Association (AHPA) for membership.
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Micromem Technologies Inc. (CSE:MRM) (OTCQB:MMTIF) announces Brian Von Herzen, Ph.D. has been appointed by the Board of Directors as an Independent Director.
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that its presentation at the Cowen and Company 34th Annual Health Care Conference will be webcast on Monday, March 3 at 3:30 p.m. ET.
MRI Interventions, Inc. (OTCQB:MRIC) and Siemens Healthcare announced today an agreement to co-develop and commercialize a next generation software platform that will enable minimally invasive catheter-based procedures to be performed under real-time magnetic resonance imaging (MRI) guidance.
Natural Health Trends Corp. (OTCQB:NHTC), a leading direct selling company that markets premium quality personal care, wellness and "quality of life" products under the NHT Global brand, today announced that management will conduct a conference call to discuss its financial results for the quarter and full year ended December 31, 2013.
OraSure Technologies, Inc. (Nasdaq:OSUR) today announced that Douglas A. Michels, President and CEO, will speak to the investment community at the Raymond James 35th Annual Institutional Investors Conference in Orlando, Florida. The conference will be simultaneously webcast over the Internet.
Oxford Immunotec Global PLC (Nasdaq: OXFD) today announced that it plans to release fourth quarter and full year 2013 financial results prior to market open on Tuesday, March 4, 2014.
Polypore International, Inc. (NYSE:PPO), a global high technology filtration company specializing in microporous membranes, today reported its financial results for the fourth quarter and full year ended December 28, 2013.
Portola Pharmaceuticals (Nasdaq:PTLA) today announced that William Lis, chief executive officer, will present at the Cowen and Company 34th Annual Health Care Conference on Monday, March 3, 2014, at 2:10 p.m. Eastern Time in Boston.
Raptor Pharmaceutical Corp. (Nasdaq:RPTP) today announced that company management will present at two upcoming investor conferences.
Sabra Health Care REIT, Inc. (Nasdaq:SBRA) (Nasdaq:SBRAP) announced today that Rick Matros, the company's Chairman and Chief Executive Officer, will present at the 2014 Citi Global Property CEO Conference at The Westin Diplomat in Hollywood, Florida on Tuesday March 4, 2014 at 8:10 AM Eastern time.
The Spectranetics Corporation (Nasdaq:SPNC) today announced that the EXCITE ISR trial achieved the statistical endpoints of the adjunct analysis. The trial evaluates laser atherectomy plus Percutaneous Transluminal Angioplasty (PTA) compared with PTA alone for the treatment of in-stent restenosis (ISR) in patients suffering from peripheral artery disease (PAD).
Tornier N.V. (Nasdaq:TRNX), a global medical device company focused on providing surgical solutions to orthopaedic extremity specialists, announced today the commencement of a proposed underwritten public offering of 5,125,000 ordinary shares by TMG Holdings Coöperatief U.A., an affiliate of Warburg Pincus LLC.
VIVUS, Inc. (Nasdaq:VVUS), a biopharmaceutical company commercializing Qsymia® (phentermine and topiramate extended-release) capsules CIV for the treatment of obesity, today provided a business update and reported its financial results for the fourth quarter and year ended December 31, 2013.
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced today gevokizumab, the Company's IL-1 beta modulating antibody, has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for the treatment of pyoderma gangrenosum (PG).