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Mike Havrilla is an index developer, pharmacist, writer, and Co-Founder of BioMedReports.com with experience that includes online investing since August 1997 and writing for investors since April 2007 with a focus on the healthcare sector and small / micro-cap stocks. Mike holds Doctor of... More
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  • FDA Calendar Updates: ACUR, BSX, GSK, JAV, KG, SNTS 0 comments
    Jun 23, 2009 09:52 AM | about stocks: ACUR, KG, BSX, JAV, SNTS, GSK

    Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

     
    Acura Pharma (NASDAQ:ACUR): On 6/23/09, ACUR announced the receipt from the FDA of a review letter related to its pending New Drug Application (NDA) for Acurox (oxycodone + niacin) tablets. On 2/22/09, Acurox was granted a priority review classification by the FDA with a PDUFA action date of 6/30/09. FDA stated in the review letter that their comments are preliminary, subject to change, and do not reflect a final decision on the information reviewed or a review of the entire NDA.
     
    Based on the review letter, ACUR does not believe Acurox will receive NDA approval on the PDUFA date. ACUR has an exclusive licensing agreement with King Pharma (NYSE:KG) for the development and commercialization of certain opioid analgesic products utilizing the Company's Aversion Technology, which includes an exclusive license for Acurox.
     

    On 6/23/09, GlaxoSmithKline (NYSE:GSK) announced the receipt of a complete response letter (CRL) from the FDA related to the Company’s pending NDA (which was originally filed with the FDA in late May 2008) for Rezonic/Zunrisa (casopitant) for the prevention of chemotherapy-induced nausea and vomiting (CINV) and post-operative nausea and vomiting (PONV). GSK plans to review the CRL and discuss the next steps for the NDA with the Agency.

     
    Javelin Pharma (AMEX:JAV): On 6/23/09, JAV reported that it has completed its open-label multi-dose, multi-day, observational safety study of Dyloject in the U.S. and that the study successfully met its objective. The objective of the study was to evaluate the safety of Dyloject following IV bolus administration of multiple doses over multiple days in patients aged 18 to 85 with acute post-operative pain. 856 patients successfully completed the study, receiving at least 8 doses of Dyloject over a 48 hour period.
     
    The successful completion of this study satisfies the Company’s goal of having well in excess of a 1000-patient safety data base for its Dyloject NDA filing with the FDA, which is planned for the fall of 2009 at the same 37.5 mg dose used in the study. Dyloject is an injectable formulation of diclofenac in Phase 3 clinical development in the U.S. and already marketed in the U.K. In December 2008, JAV released top-line results from its second of two Dyloject pivotal Phase 3 clinical trials, which demonstrated effectiveness across all five primary study endpoints.
     
    Boston Scientific (NYSE:BSX): On 6/23/09, BSX announced that the landmark MADIT-CRT trial has met its primary endpoint. Preliminary results show the Company's cardiac resynchronization therapy defibrillators (CRT-Ds) to be associated with a significant 29% reduction (p=0.003) in death or heart failure interventions when compared to traditional implantable cardioverter defibrillators (ICDs).
     
    MADIT-CRT demonstrates that early intervention with cardiac resynchronization therapy can slow the progression of heart failure. It is the world's largest randomized NYHA Class I/II CRT-D trial, with more than 1,800 patients enrolled at 110 centers in 14 countries. The trial is being conducted under the leadership of Principal Investigator Arthur J. Moss, M.D., Professor of Medicine at the University of Rochester Medical Center.
     

    On 6/9/09, Santarus (NASDAQ:SNTS) announced that Schering-Plough HealthCare Products, Inc. has submitted its response to the FDA complete response letter (CRL) for an over-the-counter (OTC) Zegerid branded omeprazole + sodium bicarbonate product with the dosage strength of 20 mg of omeprazole. Schering-Plough received the complete response letter in January 2009 for its New Drug Application (NDA) seeking approval to sell Zegerid in the U.S. OTC heartburn market.

     

    The NDA for OTC Zegerid was submitted by Schering-Plough in March 2008 under the terms of a license agreement signed in October 2006 for OTC proton pump inhibitor products using Santarus’ proprietary technology. If Schering-Plough receives FDA approval of its NDA for an OTC Zegerid product, SNTS will earn a $20 million regulatory milestone upon approval, a low double-digit royalty on net sales of OTC Zegerid, and may receive up to an additional $37.5 million in sales milestones. On 6/23/09, SNTS announced the NDA resubmission will receive a Class 2 (six-month) review by the Agency with an estimated PDUFA action date of 12/9/09 for a possible FDA decision.

     
    Disclosure: No positions.
    Stocks: ACUR, KG, BSX, JAV, SNTS, GSK
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