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 106 entries through 3/25/09. The FDA Calendar includes the following information: company name, ticker, decision date, and description.
The Clinical Trial Calendar includes 137 entries through 3/25/09 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.
Dyax Corp. (DYAX) secured a narrow approval from a FDA Advisory Panel in early February (with a 6-5-2 vote) for its Kalbitor (ecallantide or DX-88) BLA with a PDUFA date of 3/23/09, which is designated for priority review in the treatment of acute attacks of hereditary angioedema (HAE is a rare disorder marked by severe swelling which can be fatal if the throat area is involved).
The panel debated the need for an effective treatment for this rare, potentially dangerous condition against the 3% higher incidence of allergic reactions (13% versus 10%) in patients taking the drug along with questions about the data generated in the clinical trials. The FDA could rule on the BLA any day now or delay its decision and issue a new PDUFA date since the original date was this past Monday.
New Drug Filings
1.) SkyePharma [UK: SKP.L] (US: SKYEF.PK) submitted a NDA for its new asthma drug, Flutiform, which is the Company's most important pipeline product with potential sales of $500M a year, according to Piper Jaffray analyst Richard Parkes. If approved, Flutiform will be the third fixed-dose asthma combination drug on sale in the U.S., after GlaxoSmithKline's (GSK) top-selling Advair and AstraZeneca's (AZN) Symbicort.
SkyePharma is set to receive a $2M milestone payment from partner Abbott Labs (ABT) once the filing for Flutiform is officially accepted by the FDA, in addition to $25M if the drug is approved by the agency. The NDA was filed on 3/23/09; so the PDUFA date for a standard 10-month review is 1/23/10 and the FDA is expected to formally accept the filing within 60 days of the submission.
2..) Allos Therapeutics (ALTH): ALTH filed a NDA on 3/25/09 for pralatrexate in the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). ALTH requested priority (six-month) review for the application, with an expected 60-day period for the FDA to accept the filing and rule on priority review status.
The priority review PDUFA date would be 9/25/09 (versus 1/25/10 for standard, 10-month review). PTCL comprises a biologically diverse group of blood-based cancers that typically have a worse prognosis than other types of lymphoma and are less responsive to traditional chemotherapy regimens. There are currently no agents approved by the FDA for the treatment of patients with PTCL.
Clinical Trials and Pending New Drug Filings
1.) Biodel (BIOD): BIOD plans to submit a NDA in 2H09 for approval to market VIAject for the treatment of diabetes. The Company noted that the NDA would be based upon results from multiple pharmacokinetic and pharmacodynamic studies as well as two completed Phase 3 studies of VIAject in patients with Type 1 and Type 2 diabetes.
VIAject is Biodel's investigational ultra-rapid-acting injectable human insulin intended for mealtime use by people with Type 1 and Type 2 diabetes. Biodel intends to seek approval for the 100 IU/cc liquid formulation of VIAject, which is bioequivalent to the two-part 25 IU/cc lyophilized powder formulation of VIAject that was used in the company's pivotal Phase 3 clinical trials.
2.) Celsion (CLSN): CLSN announced on 3/24/09 that the FDA granted orphan drug designation for its lead compound, ThermoDox, a proprietary heat-activated liposomal encapsulation of doxorubicin, for the treatment of hepatocellular carcinoma (HCC), commonly referred to as primary liver cancer.
ThermoDox is currently being evaluated under a Special Protocol Assessment (SPA) with the FDA in a 600 patient, global Phase 3 trial in patients with non-resectable primary liver cancer. Celsion expects to complete patient enrollment for this trial in the first quarter of 2010.