|Omeros Announces INDA for OMS824 Cleared by FDA; Celgene Announces FDA Grants Priority Review for ABRAXANE|
|By Staff and Wire Reports|
|Thursday, 23 May 2013 21:08|
Omeros Corporation (NASDAQ: OMER) announced its Investigational New Drug Application (IND) to evaluate OMS824 in Huntington's disease has been cleared by the U.S. FDA. OMS824 selectively inhibits phosphodiesterase 10 (PDE10), an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including Huntington's disease and schizophrenia. OMS824 has shown promising results in animal models directly relevant to Huntington's disease and, as previously announced, OMS824 was well tolerated and exhibited favorable pharmacokinetic properties in a Phase 1 clinical program. Omeros plans to advance OMS824 into Phase 2 clinical trials for Huntington's disease next quarter and for schizophrenia later this year, the OMS824 IND for use in patients with schizophrenia having already been cleared by the FDA.
Omeros also announced today that it has requested Orphan Drug Designation from the FDA for OMS824 in the treatment of Huntington's disease. Orphan-designated drugs are eligible for incentives such as a faster approval process and additional market exclusivity. This designation is granted to drugs that are expected to provide significant therapeutic advantage over existing treatments and that target conditions affecting 200,000 or fewer U.S. patients annually. Huntington's disease is estimated to affect approximately 31,000 U.S. patients annually, and the only FDA‑approved treatment for the disease is tetrabenazine, which is indicated for Huntington's-related movement disorders. Omeros recently announced that it has requested Fast Track designation for OMS824 in the treatment for Huntington's disease. Fast Track designation is reserved for drugs being developed to treat life-threatening conditions with the potential to address unmet medical needs and typically provides priority review status.
"Cognitive impairment is a hallmark of Huntington's disease and schizophrenia, and there currently are no drugs that improve cognition in either disorder," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "In Huntington's disease, OMS824 also has the potential to improve motor control and to reduce the rate of neurodegeneration, slowing disease progression. We are pleased that the FDA has now cleared the way for us to evaluate OMS824 in both patients with Huntington's disease and schizophrenia, and we look forward to initiating enrollment in our Phase 2 clinical trials."
Celgene International Sàrl, a subsidiary of Celgene Corporation (Celgene) (NASDAQ: CELG) announced that the U.S. Food FDA has assigned a Priority Review designation to the supplemental New Drug Application (sNDA) for the use of ABRAXANE^® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine for the first–line treatment of patients with advanced pancreatic cancer.
The FDA grants Priority Review to medicines that, if approved, have the potential to offer significant improvement compared to marketed products or provide a treatment where no adequate therapy exists. The goal for completing a Priority Review is six months. The Prescription Drug User Fee Act (PDUFA) date for the sNDA for ABRAXANE is set for September 21, 2013.
In April 2013, the European Medicines Agency (EMA) has also accepted for review a Type II Variation to the current Marketing Authorization Application (MAA) for ABRAXANE, in combination with gemcitabine, for the first–line treatment of patients with advanced pancreatic cancer. Celgene plans to submit dossiers for registration in other countries/regions during 2013.
Both applications included data from an open-label, phase III, randomized, international study, Metastatic Pancreatic Adenocarcinoma Clinical Trial (MPACT) involving 861 patients with metastatic pancreatic cancer. Results from this study were recently presented at the American Society of Clinical Oncology's (ASCO) 2013 Gastrointestinal Cancers Symposium in January.
Celgene is preparing a development plan for a phase III, international, multicenter, randomized controlled trial evaluating the activity of ABRAXANE plus gemcitabine in the adjuvant pancreatic cancer setting.
ABRAXANE is not currently approved for the treatment of advanced pancreatic cancer.
Advanced Cell Technology, Inc. (OTCQB: ACTC), a leader in the field of regenerative medicine, today announced the appointment of Edward “Ted” Myles, CPA, as Chief Financial Officer and Executive Vice President of Corporate Development. Myles joins the Company with nearly 20 years of progressive finance and operations experience in the life sciences industry.
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that the following posters will be presented on AEZS-108, the Company's lead oncology compound, at the upcoming American Society of Clinical Oncology ("ASCO") annual meeting, which will be held May 31 to June 4, 2013, in Chicago.
Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that Vikas Sinha, Chief Financial Officer of Alexion Pharmaceuticals, will present at the Deutsche Bank 38th Annual dbAccess Health Care Conference in Boston at 3:30 p.m. Eastern time on Thursday, May 30, 2013.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will present at the Deutsche Bank 38th Annual Healthcare Conference being held in Boston. Harvey J. Berger, M.D., chairman and chief executive officer, will provide an overview of the Company’s business on Thursday, May 30, 2013 at 10:00 a.m. (ET).
Baxter International Inc. (NYSE: BAX) announced today that it will present at the Goldman Sachs 34th Annual Global Healthcare Conference on Tuesday, June 11, 2013 at 4:40 p.m. (CT).
Biogen Idec (NASDAQ:BIIB) today announced that Spyros Artavanis-Tsakonas, Ph.D., has been named the company’s Chief Scientific Officer (CSO). Dr. Artavanis-Tsakonas had served as interim CSO while on sabbatical from Harvard Medical School.
BioLife Solutions, Inc. (OTC:BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media for cells and tissues, and contract aseptic media manufacturer, today announced its participation at the Terrapinn World Stem Cells & Regenerative Medicine Congress 2013 this week in London.
BioScrip, Inc. (NASDAQ: BIOS) today announced that the Company will present at the Jefferies 2013 Global Healthcare Conference to be held June 3-6, 2013 at the Grand Hyatt New York.
BioTime, Inc. (NYSE MKT: BTX) today announced that at a Special Meeting held on May 21, 2013, its shareholders approved the proposals related to the planned acquisition of stem cell related assets from Geron Corporation by BioTime’s subsidiary Asterias Biotherapeutics, Inc. (“Asterias”).
BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced that The Wall Street Analyst conducted an audio interview yesterday with the Company's Chief Executive Officer Alon Natanson.
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, announced that President and CEO Steven A. Kriegsman will present at the 2nd Annual Marcum MicroCap Conference on Thursday, May 30, 2013, at 10:00 a.m. Eastern time (7:00 a.m. Pacific time).
Echo Therapeutics, Inc. (Nasdaq: ECTE), a company developing its needle-free Symphony® CGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system, today announced the successful unveiling and demonstration of its Symphony CGM System during a live webcast following yesterday's annual stockholders meeting.
Elan Corporation, plc (NYSE: ELN) (Elan) today announced that its Board of Directors, after careful review and consideration and with the assistance of its executive management team as well as outside financial and legal advisors, has determined that privately held investment firm Royalty Pharma's revised offer (“Royalty Pharma Offer") announced on Monday May 20, 2013 to acquire all of Elan's shares for $12.50 per share through its shell subsidiary Echo Pharma Acquisition Limited, substantially undervalues the company.
ERBA Diagnostics, Inc. (NYSE MKT: ERB), a fully integrated in vitro diagnostics company, is pleased to announce its participation at the Euromedlab conference in Milan, Italy, May 19th thru May 23rd.
Hadasit Bio-Holdings Ltd. (TASE: HDST, OTC: HADSY), a publicly traded portfolio of biotech companies, based on intellectual property developed and owned by Hadassah University Hospital, Israel's foremost medical research center, today announced that its portfolio company, Cell Cure Neurosciences Ltd., received significant funding from the Israeli Ministry of Industry and Commerce, Office of the Chief Scientist (OCS) to support product development and advance clinical trials.
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced the appointment of David A. Ramsay as Chief Financial Officer.
InspireMD, Inc. (NYSE MKT: NSPR), the leader in embolic protection stents, today announced new 6-month results from the MASTER (MGuard for Acute ST Elevation Reperfusion) trial demonstrating that the MGuard Embolic Protection Stent (EPS) outperformed bare metal and drug eluting stents in all-cause mortality in ST segment elevation myocardial infarction (STEMI) patients.
Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) (Intercept), a clinical stage biopharmaceutical company focused on the development and commercialization of novel bile acid therapeutics to treat chronic liver diseases, such as primary biliary cirrhosis, today announced that Mark Pruzanski, MD, President and Chief Executive Officer, will present at the Deutsche Bank Securities 38th Annual Health Care Conference in Boston on Wednesday, May 29, 2013 at 4:10 p.m. ET.
La Jolla Pharmaceutical Company (OTCBB: LJPC) ("La Jolla" and "Company"), a leader in the development of therapeutics targeting galectin proteins, released data today detailing the ability of lead product candidate GCS-100 to improve renal function.
Lightlake Therapeutics Inc. (OTCBB: LLTP) (the “Company”, “We” or “Lightlake”), a biopharmaceutical company developing addiction treatments based on its expertise in opioid antagonists, announced today that results of the Company’s Phase II clinical trial of its nasal spray treatment for Binge Eating Disorder (“BED”) were presented at the American Psychiatric Association (“APA”) Annual Meeting in San Francisco by Professor Hannu Alho, MD, professor of addiction medicine at the University of Helsinki and Principal Investigator for the trial.
MGC Diagnostics Corporation (NASDAQ: MGCD) (formerly Angeion Corporation), a global medical technology company, today scheduled a conference call to discuss its financial results for the second quarter of fiscal year 2013, ended April 30, 2013.
Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that it will use its exhibit at this year's American Society Of Clinical Oncology (ASCO) meeting in Chicago to highlight its leadership role in immune therapy.
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced plans for the initiation of the Cedar™ clinical trial, an investigator-sponsored, randomized, open-label Phase 2 trial evaluating OGX-427 in previously untreated patients with advanced squamous cell lung cancer.
PAREXEL International Corporation (NASDAQ: PRXL) announced today that it will be presenting at the Jefferies Healthcare Conference in New York.
PuraMed BioScience®, Inc., (OTCBB: PMBS) a researcher, developer, and marketer of over-the-counter (OTC) medicinal and healthcare products, announced that Ludlow Research re-issued its research opinion on the company based on low market capitalization valuation.
Senior Scientific, LLC, a unit of Manhattan Scientifics (OTCQB: MHTX) and a developer of molecular imaging and nanobiotechnology for the early detection and localization of cancer and other human diseases, today announced that the United States Patent Office (USPTO) has issued U.S. Patent No. 8,447,379 entitled “Detection, measurement, and imaging of cells such as cancer and other biologic substances using targeted nanoparticles and magnetic properties thereof.”
Ventripoint Diagnostics Ltd. (TSX VENTURE:VPT) (OTCQX:VPTDF) announces that it has completed the first of its two previously announced non-brokered private placements.
Verenium Corporation (Nasdaq: VRNM), a leading industrial biotechnology company focused on the development and commercialization of high-performance enzymes, today announced that Jeffrey Black, Chief Financial Officer, will present at two upcoming conferences.
Z Trim Holdings, Inc. (OTC Markets: ZTHO), a bio-technology company providing value-added ingredients to a variety of industries, announced that Chef Erin Ryan participated in a panel discussion at this year's National Restaurant Association ("NRA") NRA Show, which was held on May 20-21, 2013, on behalf of the Research Chefs Association.