|Omeros' OMS302 Achieves Primary and Secondary Endpoints; Cornerstone Receives FDA Acceptance|
|By Staff and Wire Reports|
|Tuesday, 13 March 2012 20:04|
Omeros Corporation (NASDAQ: OMER) reported positive data from its Phase 3 clinical trial evaluating OMS302 in patients undergoing intraocular lens replacement surgery. OMS302 met its primary endpoint by demonstrating statistically significant (p<0.00001) maintenance of intraoperative mydriasis (pupil dilation). OMS302 also demonstrated statistical superiority (p<0.00001) over placebo in reduction of pain in the early postoperative period. The data for both endpoints are clinically meaningful. OMS302, added to standard irrigation solution used during ophthalmological procedures, is Omeros' proprietary PharmacoSurgery™ product designed to maintain intraoperative mydriasis and reduce postoperative pain and irritation resulting from cataract and other lens replacement surgery.
This multicenter, double-blind, Phase 3 clinical trial enrolled 405 patients randomized 1:1 to receive either OMS302 or placebo. The primary endpoint was maintenance of intraoperative mydriasis (pupil dilation), which is critical to the safety and surgical ease of lens replacement surgery. Pupil constriction during surgery increases the risk of injury to intraocular structures and can substantially prolong surgical time. In addition to statistical superiority over placebo in maintenance of mydriasis and the secondary endpoint of reduced postoperative pain, OMS302 achieved p values of less than 0.05 in a series of other clinically relevant measures.
In this study, OMS302 was well-tolerated. The most common adverse events were those related to surgery, specifically eye pain, eye inflammation, headache and increased intraocular pressure. The incidence of these adverse events was similar between OMS302- and placebo-treated patients. The complete data are expected to be presented at an upcoming major ophthalmology meeting. Omeros also plans to publish the data in a leading peer-reviewed ophthalmology journal.
"The data from this study are compelling and demonstrate that OMS302 addresses a universal need in lens replacement surgery," stated Alan S. Crandall, M.D., director of glaucoma and cataract, senior vice chairman of ophthalmology and visual sciences at the Moran Eye Center, University of Utah, and past president of the American Society of Cataract and Refractive Surgery. "Ophthalmologic surgeons are committed to successful outcomes for their patients, and maintenance of mydriasis and pain management are central to that success. Given the drug's demonstrated effects on these two challenges facing all lens replacement surgeons, I expect that OMS302 could become widely used."
"Maintenance of mydriasis throughout the procedure is essential for the safety of lens replacement surgery," stated Mark I. Rosenblatt, M.D., Ph.D., associate professor of ophthalmology, Weill Cornell Medical College. "A constricted pupil decreases the surgeon's operative field, which can make the procedure more difficult to perform and potentially increases the rates of complications, including rents in the lens capsule or the retention of cortical lens material with more frequent posterior capsular opacification or lens dislocation. In addition, the pain relief from this drug combination improves the surgical experience for the patient and assists the surgeon in pain management during the critical early postoperative period."
"This is an important day for Omeros. This achievement marks our transition to a company preparing, rather than hoping, to commercialize our first product," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "Following our recent successful meetings with U.S. and European regulators, we plan to begin enrolling patients in our second Phase 3 trial early next month and to submit marketing applications in both the U.S. and Europe in the first part of 2013."
Cornerstone Therapeutics Inc. (NASDAQ: CRTX), a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products for the hospital, niche respiratory and related specialty markets, announced the U.S. Food and Drug Administration (FDA) accepted a New Drug Application (NDA) for CRTX 080, Cornerstone's product candidate for the treatment of hyponatremia. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 29, 2012.
"This event marks another critical milestone in the focused execution of our strategic plan," said Craig A. Collard, Cornerstone's Chief Executive Officer. "CRTX 080 is an important addition to our hospital product portfolio. The hyponatremia market increased 86% in 2011, and we look forward to launching CRTX 080 into this rapidly expanding market."
Hyponatremia affects up to six million people in the U.S. with direct medical costs estimated to range between $1.6 and $3.6 billion annually. CRTX 080 is a highly potent, non-peptide, oral capsule that works by reducing the action of a hormone (vasopressin) that blocks fluid excretion. CRTX 080 acts specifically on the vasopressin-2 receptor in the kidneys, causing water to be excreted while sparing sodium without affecting other electrolytes.
"We are pleased that CRTX 080 has passed this critical threshold in the drug development cycle," said Alan Roberts, Cornerstone's Vice President, Scientific Affairs. "The FDA's acceptance of our NDA brings Cornerstone one step closer to being able to provide an effective, well-studied treatment option for this complex condition that affects millions of patients."
Advanced Cell Technology, Inc. (OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the company’s chairman and CEO, Gary Rabin, will be presenting at Roth Capital Partners’ 24th Annual ROTH Conference, March 11-14.
Alkermes plc (NASDAQ: ALKS) (“Alkermes”) today announced the completion of an underwritten public offering of 24,150,000 ordinary shares held by a subsidiary of Elan Corporation, plc (“Elan”) at a price to the public of $16.50 per share, which includes 3,150,000 ordinary shares in connection with the full exercise by the underwriters of their option to purchase additional shares.
Anacor Pharmaceuticals (NASDAQ:ANAC) announced today its financial results for the fourth quarter and year ended December 31, 2011.
Biomagnetics Diagnostics Corp., (PINK SHEETS:BMGP) a developer of revolutionary diagnostic systems and technology for HIV, hepatitis, tuberculosis and malaria detection, and other innovative technologies, today announced the Company has signed an agreement to sell the Company's interest in the Chinese biodegradable plastic to Global Bio Energy Corp.
BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today reported its financial results as of and for the three and twelve months ended December 31, 2011.
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced financial results for the year ended December 31, 2011 and additional corporate highlights.
Cannabis Science, Inc. (OTCBB:CBIS), a pioneering U.S. biotech company developing pharmaceutical cannabis (marijuana) products, is excited to be embarking on a medical marijuana documentary project. Pre-production of this groundbreaking educational film is currently underway.
Codexis, Inc. (NASDAQ:CDXS), a developer of industrial enzymes to enable the production of biofuels, bio-based chemicals, and pharmaceutical intermediates, today announced that Peter Strumph, interim Chief Executive Officer, will be presenting at the Sidoti & Company 16th Annual Emerging Growth Institutional Investor Forum, to be held in New York, NY on Tuesday, March 20, 2012 at 2:40 p.m. ET.
Columbia Laboratories Inc. (Nasdaq: CBRX) has engaged Cowen and Company, LLC (“Cowen”) as its independent financial advisor to assist the Company with its stated goal to evaluate possible strategic transactions.
Cortex Pharmaceuticals, Inc. (OTCBB:CORX) announced the issuance by The United States Patent and Trademark Office (USPTO) of two key patents that protect the next generation of AMPAKINE® compounds.
Covidien plc (NYSE: COV) announced the results from today’s Annual General Meeting. Seven proposals were on the meeting agenda.
CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical company specializing in oncology, today reported financial results for the 12 months ended December 31, 2011, and provided a business update.
Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, today announced that at the Novation Supplier Summit Conference in February the Company’s MEDIHONEY was recognized as a finalist for the Novation 2011 Innovative Technology Award.
Elan Corporation, plc (NYSE: ELN) today raised approximately $381 million in net proceeds from the sale of 76% (24.15 million ordinary shares) of its shareholding in Alkermes plc (NASDAQ: ALKS), net of underwriter fees.
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today highlighted its clinical and financial outlook and announced its full-year and fourth quarter 2011 financial results.
InVivo Therapeutics Holdings Corp. (OTC/BB: NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today announced that CEO Frank Reynolds is scheduled to appear on KVVU-TV’s Fox 5 News: Live in Las Vegas on Friday, March 16th at 8:45am PDT.
IntelliCell Biosciences, Inc. (OTCQB: SVFC) (PINKSHEETS: SVFC); (“IntelliCell”) or the (“Company”), Dr. Steven Victor, Chairman of IntelliCell Biosciences will be presenting at Roth Conference on March 14, 2012 at 9:30 a.m. (PT), at the Ritz Carlton, 1 Ritz Carlton Drive, Dana Point, CA 92629.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Luciano Rossetti, senior vice president of Global Scientific Strategy at Merck Research Laboratories, is scheduled to present at the Barclays Capital 2012 Global Healthcare Conference in Miami, Fla. on March 14 at 9:30 a.m. EDT.
Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, discussed today the proprietary Cell-in-a-Box® technology, being acquired from SG Austria, that was used for the pancreatic cancer clinical trial and may have an effect on downstream micro metastatic disease.
Orgenesis Inc., (OTCBB: ORGS) (the “Company”) announced today that pursuant to a licensing agreement dated February 2, 2012 with Tel Hashomer - Medical Research, Infrastructure and Services Ltd. ("Tel Hashomer" or "THM), the Company has an exclusive license to develop and commercialize THM's rights in functional autologous insulin producing cells (AIPC) regeneration technology.
PharMerica Corporation (NYSE: PMC), a national provider of institutional pharmacy and hospital pharmacy management services, today announced that Gregory S. Weishar, Chief Executive Officer, will make a presentation regarding the Company at the Barclays Capital 2012 Global Healthcare Conference in Miami, Florida, on Wednesday, March 14, 2012, at 3:45 p.m. Eastern Time.
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced that it has entered into a technology evaluation agreement for its bioerodible Durasert™ drug delivery technology in ophthalmology with Neuron Systems, Inc., an ocular drug development company based in Burlington, MA.
Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced that it has enrolled the first subject in its exploratory Phase I clinical trial of RX-3117 in cancer patients.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received a request for additional information, often referred to as a “second request,” from the Federal Trade Commission (“FTC”) in connection with Roche’s proposed acquisition of Illumina, Inc. (NASDAQ: ILMN).
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the pricing of its offering of $600 million aggregate principal amount of 1.5% convertible senior notes due 2019 to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”).
Sucampo Pharmaceuticals, Inc., (NASDAQ: SCMP), a global pharmaceutical company, today reported its consolidated financial results for the quarter and full year ended December 31, 2011.