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 115 entries through 4/9/09. The FDA Calendar includes the following information: company name, ticker, decision date, and description.
The Clinical Trial Calendar includes 127 entries through 4/9/09 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.) Cardiome (CRME): On 4/8/09, Merck (MRK) licensed an experimental heart drug (vernakalant) for the treatment of a type of irregular heart beat (atrial fibrillation or a-fib) from CRME for $60M upfront and up to $200M in additional development/approval milestone payments. MRK also granted CRME a secured, interest-bearing credit facility of up to $100M that CRME may access in tranches over several years commencing in 2010.
MRK receives the global rights to oral vernakalant for maintenance of normal heart rhythm in patients with a-fib, while an affiliate company gains the rights outside of the U.S., Canada, and Mexico to the intravenous (IV) formulation of the drug for rapid treatment of acute cases of a-fib. Astellas Pharma (Japan: 4503) (US ADR: ALPMY.PK) holds the North American rights to IV vernakalant.
In December 2006, Astellas submitted a NDA to the FDA for Kynapid (IV vernakalant) that included results from two pivotal Phase 3 clinical trials. An FDA advisory panel recommended approval for Kyanpid, but the FDA requested additional information before proceeding with the review and this data has not been submitted to the agency yet.
2.) Eli Lilly (LLY): Results from a third Phase 3 Clinical Trial are expected in late 2009 for arzoxifene to increase bone mineral density in post-menopausal women. Arzoxifene has been shown to reduce bone turnover/breakdown and is also being studied to reduce the risk of breast cancer. The drug significantly increased lumbar spine and total hip bone mineral density (BMD) in postmenopausal women with normal or low bone mass, versus placebo.
Newly published data announced on 4/8/09 are from the FOUNDATION Study, which is one of three Phase 3 trials evaluation arzoxifene. In March, data from the second Phase 3 trial called NEXT were presented at a medical conference. The third Phase 3 trial, GENERATIONS, is a five-year, randomized, double-blind, placebo-controlled study assessing the effects of arzoxifene on vertebral fracture incidence and on invasive breast cancer incidence in postmenopausal women with osteoporosis or with low bone density, with results expected in late 2009.
3.) Par Pharma (PRX) (Strativa Pharma is the proprietary products division of PRX):
On 4/7/09, Strativa submitted a NDA for its new orally dissolving film strips (ODFS) formulation of ondansetron to the FDA. The NDA is seeking approval of ondansetron ODFS in 8 mg and 4 mg strengths for the prevention of chemotherapy and radiation-induced nausea and vomiting, and prevention of post-operative nausea and vomiting.
A program consisting of three separate pivotal studies comparing the bioequivalence of ondansetron ODFS 8mg to Zofran ODT 8mg was completed in December 2008 and supports the NDA filing of ondansetron ODFS. The pharmacokinetic results of each study demonstrate that a single dose of ondansetron ODFS, taken with or without water, is bioequivalent to Zofran ODT, taken under similar conditions.
In June 2008, Strativa acquired the commercialization rights to ondansetron ODFS from MonoSol Rx, and has paid MonoSol Rx a total of $3.5M for the completion of certain milestones to date.
Loramyc (miconazole) NDA for the treatment of oropharyngeal candidiasis (OPC). After preliminary review, the FDA has informed BioAlliance Pharma (France: BIO.PA), Strativa's development partner, that the agency did not accept its NDA for Loramyc mucoadhesive buccal tablet (MBT) based on the lack of an imprint code on the tablet. Loramyc was approved in the European Union in 2007 and is currently marketed in several EU territories.
The E.U. does not require an imprint code while the U.S. requires an imprint code for drug identification purposes. Prior to the initial filing, BioAlliance initiated the development of a debossed tablet to fulfill this requirement. BioAlliance will work closely with the FDA on the introduction of a debossed tablet and will soon after resubmit the Loramyc application.
$4.1 (04/10/09)
