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FDA Calendar Updates: Orexo, Novo Nordisk, King, Isis, Facet. by: Mike Havrilla August 07, 2009

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 294 entries as of 8/6/09. 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, ANDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

On 8/6/09 , Orexo AB [STO:ORX] announced that its partner, UK-based international specialty pharma ProStrakan Group plc [LSE:PSK] (PKNGF.PK), submitted a New Drug Application (NDA) for Abstral to the FDA. The filing of Abstral will generate a milestone payment to Orexo as part of the agreement with ProStrakan for North America that in total can give US$27 million in certain regulatory and sales milestone payments In addition to royalties on product sales.

Abstral is a fast-dissolving tablet for sublingual administration of fentanyl, intended for the management of breakthrough cancer pain in patients who are already receiving opioid analgesics. It is based on Orexo's unique and patented sublingual tablet technology in which a rapidly dissolving tablet is placed under the tongue and the active substance is absorbed by the mucous membrane. Currently Abstral is sold in Sweden, UK, Germany and France.

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 Victoza 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 6-6, on whether the drug should be approved in the face of evidence it caused cancerous thyroid tumors in rats and mice. The panel voted 8-5 in favor of the drug's cardiovascular safety profile. On 8/6/09, NVO provided guidance that the FDA informed the Company to expect a decision either in August or September.

King has a pending NDA for Embeda (morphine + naltrexone), which is a pain drug that is designed to deter abuse and diversion. During 1Q09, KG received feedback from the FDA regarding a Risk Evaluation and Mitigation Strategy (REMS) for Embeda and stated the Company was in discussions with the Agency. On 8/6/09, King's CEO stated (in the PR for 2Q09 results) that, "we believe we are moving closer to an Embeda approval."

On 8/4/09, Facet announced that, along with its partner Biogen (NASDAQ:BIIB), both companies continue planning for the Phase 3 trial of daclizumab high-yield process (DAC HYP) in multiple sclerosis (MS) and expect to initiate the trial during 1H10. Upon enrollment of the first patient into the phase 3 study, Facet would receive a $30 million milestone payment from BIIB. Daclizumab is a humanized monoclonal antibody that binds to the alpha chain (CD25) of the interleukin-2 (IL-2) receptor on activated T cells, which are white blood cells that play a role in immune-mediated processes in the body. Facet plans to request a Special Protocol Assessment (SPA) from the FDA prior to the initiation of this study.

The companies continue to enroll patients in the SELECT phase 2b mono-therapy study of DAC HYP in MS as they plan for the Phase 3 study. The independent Safety Monitoring Committee (SMC) for the SELECT study conducted a planned interim futility analysis of a subset of the data and, based on that analysis, the SMC recommended the continuation of the SELECT trial, which remains a blinded study and is considered to be the first of two registration-enabling trials required by regulatory authorities.

On 8/6/09 , ISIS announced that its partner Genzyme (NASDAQ:GENZ) plans to file the first NDA for mipomersen in the U.S. for homozygous FH during 2H10, with a similar filing in Europe shortly afterwards. Data from the Company's Phase 3 study in severe hypercholesterolemia patients is expected to be available at the time of these U.S. submissions and may provide the basis for a broader indication.

ISIS has now completed enrollment in the mipomersen Phase 3 study in heterozygous FH patients, which is the second of four Phase 3 studies and expects to report the data from this study during 1H10. In May 2009, ISIS reported positive top-line results (with final results still pending) from a Phase 3 study of mipomersen in the largest, placebo-controlled Phase 3 study in homozygous FH patients which met its primary endpoint with a 25% reduction in LDL-C after 26 weeks of treatment with mipomersen versus 3% for placebo and all of its secondary endpoints in a highly statistically significant manner.

Disclosure: Long GENZ

http://seekingalpha.com/article/154653-fda-calendar-updates-orexo-novo-nordisk-king-isis-facet?