Below is a summary of updates to the
<font> BioMedReports.com </font> database of over 200 entries included in the
<font> FDA and Clinical Trial Calendars </font> . 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.
The Medicines Company (NASDAQ:MDCO) : MDCO announced on 5/13/09 the discontinuation of its Phase 3 CHAMPION clinical trial program (which consisted of two trials) of cangrelor in patients undergoing percutaneous coronary intervention (PCI) as interim analyses of the study indicate the drug will not meet efficacy endpoints. The program's independent Interim Analysis Review Committee (IARC) recommended that MDCO should consider focusing on the short-term use of cangrelor in settings where oral drugs cannot be used or when a short half-life is highly desirable.
The Company had previously begun studying cangrelor in such a setting – known as the BRIDGE study which aims to establish the dosage of cangrelor that achieves greater than or equal to 60% inhibition of platelet aggregation for five days. The Company plans to enroll approximately 200 patients who discontinue Plavix (clopidogrel) in preparation for cardiac surgery. The aim is to show safe "bridging" of patients during the pre- and post-surgical period of risk. If successful, this approach may form the basis for subsequent regulatory filings, and MDCO also noted that discontinuation of the two CHAMPION trials will result in cost savings of $5M for 2009.
Questcor Pharma (NASDAQ:QCOR) : On 5/12/09, QCOR received notice from the FDA that in order for its supplemental New Drug Application (sNDA) seeking approval to market H.P. Acthar Gel (repository corticotropin injection) for the treatment of infantile spasms to be considered a Complete Response, Questcor must perform additional statistical analyses relating to data from one study within the filing and submit this data to the agency.
The following is the previous entry for QCOR from the BioMedReports.com FDA Calendar: H.P. Acthar Gel (repository corticotrophin injection) sNDA for treatment of infantile spasms - previously submitted application, but on 2/24/09 QCOR announced that the FDA asked them to re-format the sNDA and re-submit before accepting for review to expand use - Acthar is currently approved to treat multiple sclerosis flare-ups - the SNDA is to expand the label to treat infantile spasms (usually begin in first year of life). QCOR most recently re-submitted the sNDA on 3/17/09, which is the basis for the FDA's response for additional data.
Pozen (NASDAQ:POZN), AstraZeneca (NYSE:AZN): On 5/13/09, POZN announced that a decision was made by AZN to have Pozen file the New Drug Application (NDA) for FDA approval of PN 400. Pozen expects to file the NDA by mid-2009 and will receive a $10M milestone payment from AZN once the NDA is formally accepted for review by the FDA. PN 400 combines NSAID pain reliever naproxen with the stomach medicine (proton pump inhibitor) esomeprazole (aka Nexium) with a proposed indication of treating the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in patients who are at risk of developing gastric ulcers.
Emergent BioSolutions (NYSE:EBS): On 5/13/09, EBS announced that it has submitted a Development Plan for the company’s Recombinant Protective Antigen (rPA) anthrax vaccine candidate to the FDA ahead of the 6/15/09 deadline in response to the Department of Health and Human Services (HHS) amendment to its request for proposal to develop and deliver up to 25 million doses of an rPA vaccine for the Strategic National Stockpile. The amendment requested that all bidders deemed to be in the competitive range submit to FDA a comprehensive plan outlining the regulatory strategy for their rPA vaccine ahead of receiving any award granted by HHS for the development and procurement of the vaccine. This process has no impact on the Company’s existing contracts with HHS to supply BioThrax, which is currently the only FDA licensed anthrax vaccine for the Strategic National Stockpile.
Insmed (NASDAQ:INSM) : On 5/13/09, INSM reported its quarterly operating results, including an update on the clinical development of IPLEX, for which the Company continues to expect preliminary Phase 2 results in the treatment of Myotonic Muscular Dystrophy (MMD) during 2Q09. The FDA will also allow Insmed to provide access to IPLEX for investigational use in patients with Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's disease), and the Company will conduct a controlled clinical trial under an Investigational New Drug (IND) application after finalizing the study protocol with the FDA. Insmed also announced that it will received net proceeds of about $125M from the sale of its follow-on biologics (FOB) assets to Merck (NYSE:MRK).
Jazz Pharma (NASDAQ:JAZZ) : On 5/7/09, JAZZ reported its quarterly operating results and provided a clinical development update on JZP-6, which is the Company's sodium oxybate product currently in Phase 3 development for the treatment of fibromyalgia. JAZZ has completed its second Phase 3 pivotal trial for JZP-6 and expects to announce the results in mid-2009. JAZZ also provided guidance on submitting a NDA for JZP-6 by the end of 2009 seeking FDA approval in the treatment of fibromyalgia.
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