FDA Calendar Updates: Novo Nordisk, Eisai, Acura, King and Myriad Pharma

 |  Includes: ACUR, ESALY, KG, MYGN, NEPH, NVO
by: Mike Havrilla

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 clinical trial results.

On 7/3/09, Novo Nordisk (NYSE:NVO) announced European Commission marketing authorization for Victoza (liraglutide) in the treatment of type 2 diabetes in adults. NVO will launch Victoz in Britain, Germany, and Denmark this summer and in other European markets during the remainder of 2009 and in 2010. Victoza is regarded as the most important compound in Novo's pipeline and a key FDA decision is still pending.

The original PDUFA action date for the Company's pending Victoza NDA for type 2 diabetes was 3/23/09, but a FDA decision is still pending. Victoza is used once-daily via subcutaneous injection, and the drug is a synthetic glucagon-like peptide-1 (GLP-1) that works by stimulating insulin release when glucose levels become high. On 4/2/09, an FDA Advisory Panel stated liraglutide does not appear to carry heart risks, though serious questions remain about its possible links to tumors. Panelists were split, voting 6 to 6, on whether the drug should be approved in the face of evidence it caused cancerous thyroid tumors in rats and mice. The panel voted 8 to 5 in favor of the drug's cardiovascular safety profile.

On 7/2/09, Eisai (OTCPK:ESALY) [TYO:4523] announced that it plans to submit a new drug application (NDA) with the FDA on a new (sustained-release or SR) form of its Alzheimer's disease drug Aricept (donepezil) in August or September as Aricept faces U.S. patent expiration in 2010 and will face generic competition for the standard formulation. Eisai has completed a Phase 3 study of Aricept 23 mg SR in patients with moderate to severe Alzheimer's disease.

Aricept 23 mg SR is being developed to increase clinical benefits while maintaining a favorable safety profile compared to currently marketed Aricept 10 mg immediate release. Clinical trials of a once-a-week transdermal patch formulation of donepezil, which include a bioequivalence study compared to the currently marketed formulation of donepezil, are currently being conducted by Teikoku Pharma in the U.S.

On 7/2/09, Acura Pharma (NASDAQ:ACUR) and King Pharma (NYSE:KG) announced that the FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for Acurox (oxycodone and niacin) Tablets CII, an immediate release product intended for the relief of moderate-to-severe pain. The CRL raises issues regarding the potential abuse deterrent benefits of Acurox. Acura and King are currently evaluating the CRL and at this stage believe they can respond to the issues raised without conducting any additional studies and plan to meet with the Agency after submitting their response to the CRL.

On 7/1/09, Myriad Pharma (NASDAQ:MYRX) announced that it has completed its previously announced spin-off from Myriad Genetics (NASDAQ:MYGN).MYRX is focused on discovering, developing and commercializing novel, small molecule drugs that address severe medical conditions, including cancer and HIV infection. MYRX expects to report data from Azixa efficacy trials by the end of 2009 and begin a Phase 2b trial for its HIV maturation inhibitor later in 2009.

As of 7/1/09, MYRX has $188 million in cash and equivalents. Azixa is the Company's most advanced cancer drug candidate which is currently in three Phase 2 clinical trials. MPC-3100 is a novel, fully-synthetic and orally-bioavailable heat shock protein 90 (Hsp90) inhibitor and the Company's second clinical oncology drug candidate that is currently in Phase 1 clinical testing. MPC-4326 (bevirimat dimeglumine) is a small molecule, novel mechanism of action drug candidate for the treatment of HIV that is expected to begin a Phase 2b clinical trial in the second half of 2009.

On 11/14/08, Nephros (OTCQB:NEPH) submitted a 510(k) application to the FDA for approval of its HDF products for ESRD in the U.S. market. Following its review of the application, the FDA requested additional information, and Nephros replied to the Agency on 3/13/09. Per FDA guidelines, the FDA has 90 days to review the additional information provided by the Company, but a response from the Agency is still pending for the OLpur H2H Hemodiafiltration (HDF) Module and OLpur MD 220 Hemodiafilter.

On 10/7/08, Nephros filed a 510(k) application for approval to market its Dual Stage Ultra-filter (DSU filters) to dialysis clinics for in-line purification of dialysate water. On 7/1/09, Nephros received approval of the DSU to be used to filter biological contaminants from water and bicarbonate concentrate used in hemodialysis procedures.

Disclosure: No positions.