Upcoming FDA Decisions and Clinical Trials: Prevacid Goes OTC, Swine Flu Test

by: Mike Havrilla

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

Cadence Pharma (CADX): On 5/14/09, CADX announced the 505(b)(2) NDA submission for Acetavance (the Company's proprietary intravenous formulation of acetaminophen) for the treatment of acute pain and fever in adults and children. If approved, Acetavance would become the first new intravenous analgesic approved in the U.S. in more than 20 years and the only approved intravenous agent for the treatment of fever in this country.

The NDA filing includes data from one pivotal clinical trial for the treatment of acute pain in patients following orthopedic surger, one pivotal clinical trial for the treatment of endotoxin-induced fever, and is also supported by data from a total of nine placebo-controlled clinical trials, four active-controlled clinical trials, and seven other safety or pharmacokinetic clinical trials. The submission includes safety data from over 1,400 patients who received Acetavance in clinical trials, including 350 children, and data from safety reports that collectively represent more than 53 million patient exposures to intravenous acetaminophen in countries outside the United States.

Novartis (NYSE:NVS): Novartis announced yesterday that Prevacid 24HR (lansoprazole delayed-release capsules 15 mg) has been approved by the FDA as the first over-the-counter (OTC) Proton Pump Inhibitor (PPI) for the treatment of frequent heartburn since 2003 (Prilosec OTC). Prevacid 24HR is expected to be available over-the-counter later this year.

Osmetech [LON:OMH] announced yesterday that it has submitted a request to the FDA for Emergency Use Authorization for its Respiratory Pathogen Test Panel test to be used to screen for the swine flu virus. Osmetech’s Respiratory Pathogen Test Panel test, which is expected to be launched as a research use only product during 3Q09, detects and differentiates between 18 common bacterial and viral infections, including the Influenza A virus and its H1N1 subtype.

Osmetech is currently developing an extension to the Respiratory Pathogen Test that will differentiate this H1N1 subtype between the human and swine forms of the virus. The Respiratory Pathogen Test Panel test has been adapted from QIAGEN’s (NASDAQ:QGEN) QIAplex-based respiratory viral test for use on Osmetech’s eSensor XT-8 molecular diagnostics system under the terms of an agreement signed during 3Q08.

Allos Therapeutics (NASDAQ:ALTH) announced yesterday that updated data from its pivotal Phase 2 PROPEL study of pralatrexate (PDX) in patients with relapsed or refractory peripheral T-cell lymphoma will be presented at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) on 5/30/09. The final results from the PROPEL study were reported in early February and formed the basis of the Company’s NDA filing for FDA approval in March 2009. The poster presentation at ASCO will include analyses of response rate and durability of response, as well as overall survival.

On 5/13/09, Belgium-based UCB SA (OTCPK:UCBJF) announced that it received FDA approval for an injectable drug to treat arthritis. Cimzia was approved for patients with moderate to severe rheumatoid arthritis, expanding the drug's label from a previous approval to treat Crohn's disease in April 2008.

As a result of the Cimzia approval for arthritis, XOMA Ltd. (NASDAQ:XOMA) will receive royalty payments on sales of CIMZIA for this indication (in addition to the royalties for sales of the drug to treat Crohn's disease). XOMA's bacterial cell expression technology is licensed to UCB as an enabling biotechnology for the discovery and manufacturing of antibodies and other proteins.

Disclosure: No positions.