Updated FDA, Clinical Trial Calendars: Myriad Pharma Announces Phase 1 Trial
Below is a summary of updates to the BioMedReports.com database of 240 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 deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 113 entries through 4/8/09. The FDA Calendar includes the following information: company name, ticker, decision date, and description.
The Clinical Trial Calendar includes 127 entries through 4/8/09 and 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.
1.) pSivida Corp. (PSDV): On 4/8/09, the data safety monitoring board (DSMB) recommended continuation of two pivotal Phase 3 clinical trials for the use of Iluvien in the treatment of diabetic macular edema (DME) under the current protocol, without change. The DSMB completed its final review of the currently available safety and efficacy data prior to the 24 month readout scheduled in October 2009, with topline results from these trials expected by year-end.
These clinical trials, known collectively as the FAME Study (Fluocinolone Acetonide in Diabetic Macular Edema), consist of two 36-month, double-blinded, randomized, multi-center trials in the U.S., Canada, Europe, and India to support a planned global registration filing, including a NDA filing Iluvien to the FDA expected in early 2010.
2.) Novartis (NVS): The FDA granted NVS approval today for Coartem tablets to treat cases of acute, uncomplicated malaria, but declined to grant approval for either the treatment of severe malaria or the prevention of malaria. The FDA awarded NVS a one-time priority review voucher for a future new drug application (NDA), as part of a program at the agency to encourage the development of drugs to treat tropical diseases. The full press release is available on the FDA's website.
3.) AstraZeneca (AZN): The Seroquel (quetiapine) XR sNDA is a pending application by AZN to expand the drug's label to treat adults with major depressive disorder and generalized anxiety disorder. The FDA issued a complete response letter (CRL) on 2/27/09 and a FDA advisory panel meeting was conducted on 4/8/9 to address concerns about potentially exposing a greatly expanded patient population (an estimated 20 million people in U.S. alone with anxiety and depression) to a drug with known metabolic side effects (e.g. high blood sugar/diabetes), a possible risk of tardive dyskinesia (which causes involuntary, repetitive movements which can become permanent), and the potential for heart problems.
Seroquel is AZN's 2nd best-selling drug, with $4.5B in 2008 sales. Seroquel XR is an extended-release version of the medicine with a longer patent life than the original formulation. Seroquel is already sold for treatment of schizophrenia and bipolar disorder, which were not a part of the FDA advisory committee review. The FDA Adviosry Panel concluded the following: (1) Seroquel XR is safe as an add-on therapy for depression; (2) Serqoquel XR was rejected as a stand-alone treatment for depression; and (3) Seroquel XR was rejected as a treatment for anxiety.
4.) Myriad Genetics (MYGN): Announced that its wholly-owned subsidiary Myriad Pharma received FDA approval to begin Phase 1 clinical trials of an experimental cancer treatment (MPC-3100), which is classified as an Hsp90 inhibitor.
MPC-3100 is a novel, fully-synthetic, orally-bioavailable, small-molecule inhibitor of Heat shock protein 90 (Hsp90). Hsp90 regulates the activity of proteins and oncogenes which are known to control cell division, apoptosis, angiogenesis, metastasis and resistance to other cancer drugs. Inhibition of Hsp90 promotes the degradation of these cellular mediators of cancer and, thereby, inhibits tumor growth.
The clinical development plan for MPC-3100 is designed to expedite the drug candidate through the clinical development path. The Phase 1 trial will assess the safety and pharmacokinetics profile of MPC-3100. In preclinical testing, MPC-3100 has demonstrated potent anti-cancer activity in xenograft models of Her2+ breast cancer, myeloid leukemia, lung cancer, prostate cancer, colon cancer, melanoma and gastric cancer.
Myriad Pharma owns and controls all rights to MPC-3100 and is currently seeking a strategic partnership to maximize the value associated with the world-wide oncology market, and MYGN plans to spin-off Myriad Pharmaceuticals as an independent, public company by the end of 2Q09.
April 20, 2009