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 pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

Before reviewing the latest updates, below are two companies from the FDA Calendar with pending catalysts expected within the next week.

Savient Phama [SVNT: 12.06, -0.40 (-3.21%)] announced on 5/7/09 that its pending BLA for Krystexxa (pegloticase), a novel biological drug for treatment failure gout patients, will be reviewed by an Arthritis Advisory Committee appointed by the FDA on 6/16/09. In December, the FDA accepted the Company’s BLA and granted priority review status, but SVNT submitted several key amendments for the BLA earlier this year in January. The FDA accepted the amendments and determined that the additional information constituted a major amendment and extended the original PDUFA action date by three months to 8/1/09.

BioDelivery Sciences [BDSI: 6.64, +0.25 (+3.91%)] has a pending Onsolis (BEMA fentanyl) NDA resubmission for the proposed treatment of breakthrough cancer pain through a small, dissolving polymer delivery system for the opiate painkiller fentanyl designed for quick absorption through the cheek. On 12/15/08, BDSI announced in a press release that the FDA requested conversion of the originally submitted risk minimization action plan (RiskMAP) to a Risk Evaluation and Mitigation Strategy (REMS) and informed the Company that all other aspects of the NDA review were complete.

Given this information, the prospects for Onsolis approval appear excellent, with an approval decision possible as early as Friday 6/12/09 or the following Monday based on a Class II (six-month) review by the agency on the resubmission of the required REMS by BDSI. In the same press release, BDSI provided guidance for expected approval of the Onsolis approval during the first half of 2009.

Earlier this year, BDSI raised $6M in cash from partner Meda AB (STO:MEDAA) ($2.3B U.S. Dollar market cap) from a $3M expanded marketing agreement (which includes all countries except Taiwan and South Korea) and a $3M advance of the $30M milestone payment triggered by FDA approval. The remaining $27M cash milestone payment on FDA approval for Onsolis represents about 22% of the Company’s current market cap of $123M, in addition to double-digit royalties that will be received on product sales, an additional $30M possible in sales-related milestone payments, and a $5M milestone payment that is due upon EU approval/launch.

While I do not typically hold small and micro-cap bio-med stocks through binary events such as FDA decisions and clinical trial results, BDSI is an exception for me and the Company expects to generate positive operating cash flow this year if Onsolis is approved. Also, the Company is debt free with a promising mid-stage pipeline based on its drug delivery technology platform that can be funded through milestone payments and royalties from Meda AB (which expects peak sales exceeding $200M for Onsolis).

Osteotech [OSTE: 4.34, +0.35 (+8.77%)]: On 6/10/09, OSTE announced that it has completed enrollment for the clinical trial of its DuraTech BioRegeneration Matrix. Based upon Osteotech’s proprietary HCT (human collagen technology) platform, DuraTech is used to repair dura mater (the tough, outermost membrane surrounding the brain and spinal cord) during cranial surgical procedures.

A total of 60 patients were enrolled in the clinical study and the trial will evaluate the patients at 30 and 90 days post-operatively to assess the safety of DuraTech compared to historical surgical procedure outcomes. Osteotech plans to utilize the results from this trial to support its 510(k) filing for marketing clearance with the FDA during 3Q09 with expected marketing clearance before year-end.

Human Genome Sciences [HGSI: 2.71, +0.05 (+1.88%)]: On 6/11/09, HGSI announced Phase 2 continuation data which demonstrated sustained improvement in disease activity and patient response rate through four years of BENLYSTA therapy in combination with standard of care in patients with serologically active systemic lupus erythematosus (SLE). The frequency of disease flares as measured by the SELENA SLEDAI flare index and by BILAG A or B organ domain scores decreased over four years of BENLYSTA therapy and there was no increase in overall adverse events, serious adverse events, malignancies or serious infections over time.

HGSI and GlaxoSmithKline [GSK: 36.51, +0.14 (+0.38%)] have selected BENLYSTA as the brand name for belimumab (formerly known as LymphoStat-B). HGS and GSK expect to report the first Phase 3 data for BENLYSTA in July 2009 from the BLISS-52 trial, with results from BLISS-76 anticipated in November 2009. BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in lupus patients. BENLYSTA is being developed by HGSI and GSK under a co-development and commercialization agreement entered into in August 2006.

Transcept Pharma [TSPT: 4.87, +0.07 (+1.46%)]: On 6/11/09, TSPT announced that the FDA has informed the Company that it should expect to receive formal notice of a three month extension of the review period for the new drug application (NDA) for Intermezzo (zolpidem tartrate sublingual tablet). The Intermezzo NDA had been assigned a PDUFA action date of 7/30/09.

Under this revised timeline, TSPT now anticipates action from the FDA on the NDA on or before 10/31/09. In the normal course of the Intermezzo NDA review, the FDA previously requested additional information regarding middle of the night dosing instructions. As both the request and the TSPT response occurred late in the review cycle, the FDA has informed the company that it will extend the NDA review cycle by three months to consider the new information.

- Mike Havrilla

Disclosure: Long BDSI. This article is taken from the website BioMedReports with the permission of the original author.  All questions regarding disclosure should be referred to the original author.

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