FDA Calendar Updates: Still Waiting on BDSI Print
Tuesday, 14 July 2009 10:05

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 258 entries as of 7/14/09. 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, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

On 7/14/09, Watson Pharma (NYSE:WPI) announced that it received a Complete Response Letter (CRL) from the FDA on its New Drug Application (NDA) for TRELSTAR 22.5 mg (triptorelin pamoate for injectable suspension), a 24-week formulation of TRELSTAR for the palliative treatment of advanced prostate cancer. According to the CRL, the FDA has requested clarifications related to the clinical testing of the product, additional information regarding the chemistry, manufacturing and controls (CMC) of the product and other components, and information related to third party manufacturing.

Watson is working to ensure the requested information is provided to the FDA expeditiously. The new, longer-acting formulation of TRELSTAR is designed to be conveniently administered and to continuously suppress the production of testosterone in men with advanced prostate cancer for 24 weeks. TRELSTAR is an already proven therapy with established efficacy and safety in two formulations (a 4-week depot and a 12-week LA product).

On 7/14/09, Maxygen (NASDAQ:MAXY) announced the completion of a Phase 2a clinical study in breast cancer patients in which MAXY-G34 was safe and effective in reducing chemotherapy-induced neutropenia (CIN), a major side effect of myelosuppressive anti-cancer agents.

The Company stated that it is encouraged by the results and FDA feedback for the proposed development of MAXY-G34 and confirmed plans to seek a partnership for the timely and cost effective development to a BLA filing in 2013 for MAXY-G34, which has a product profile similar to Neulasta that would represent the second product in the multi-billion dollar, long-acting G-CSF market. n May 2009, Maxygen announced a licensing arrangement with Cangene (TSE:CNJ) for MAXY-G34 for acute radiation syndrome (ARS), while retaining rights to MAXY-G34 for all other indications. Maxygen continues partnering discussions regarding the out-license or sale of MAXY-G34 for chemotherapy-induced neutropenia.

On 6/15/09, BioDelivery Sciences (NASDAQ:BDSI) announced that the Company has reached agreement with the FDA on all aspects of its pending NDA for Onsolis (fentanyl buccal soluble film), including the REMS. Although the FDA did not meet its original PDUFA action date (big surprise, a delay by the FDA in meeting a decision deadline!) of 6/12/09, the FDA will not be issuing a review extension letter (which would have extended the decision deadline by three months) as their action on the NDA is forthcoming.

BDSI received a CRL from FDA on the NDA for ONSOLIS last August with the only deficiency being the new requirement for a REMS (which was NOT required at the time the NDA was originally submitted to FDA in October 2007). The REMS was formally submitted to the FDA on 12/12/08 and the submission was placed under a six-month (Class 2) review period. BDSI provided the following guidance and commentary, "Although we cannot pinpoint the exact timing of when the FDA's action might occur, we have previously indicated that we expect a 1H09 approval of the NDA for ONSOLIS. Based on our discussion with FDA last Friday, we should be within a few weeks of that target."

BDSI has adequate liquidity to fund normal operations and continue its clinical pipeline development through 4Q09 thanks to additional funding associated with the exercise of warrants. Earlier this year, BDSI raised $6 million in cash from partner Meda AB (STO:MEDAA) from a $3 million expanded marketing agreement and a $3 million advance of the milestone payment triggered by FDA approval and the U.S. launch of Onsolis.

The remaining $26.9 million cash milestone payment is due upon FDA approval and the expected 4Q09 U.S. commercial launch of Onsolis, which represents about 25% of the Company's current market cap. In addition to double-digit royalties that BDSI will receive on the sale of Onsolis, the Company is eligible for an additional $30 million in sales-related milestone payments and a $5 million milestone payment that is due upon European approval (expected 1Q10) and launch.

I am not concerned by the consistent selling by Elliott Associates/CDC over the past month as this hedge fund has a rocky relationship with the management team, which it tried to oust around three years ago. Also, shares of BDSI have increased by about 150% over the past year (even with the recent decline to the mid-$5 area) and the average trading volume is up even more - providing the chance for Elliott/CDC to take profits and liquidate most of their large position.

The rise in short interest to just over 1 million shares at the end of June for BDSI is also not concerning given the run-up in shares and trading volume as part of the Company's inclusion in the Russell 2000 Small-Cap Index on 6/26/09, the known delay in a final decision by the FDA to mid-July at the earliest, and the rise in average daily trading volume which equates to less than three days to cover the short interest.

During the 6/15/09 conference call, BDSI stated that Onsolis would already be on the market if not for the REMS requirement. Now that BDSI has reached agreement with the review team on the REMS; the Company is simply waiting for the FDA to issue its final decision on the NDA - which represents the first REMS submitted to the FDA for an opiate compound as part of the Agency's new requirements for this class of drugs.

Now that over a month has passed from the original PDUFA action date, the likelihood of final FDA approval becomes more likely after each passing day since the Agency did not issue a formal extension letter in June, which would have postponed a final decision by at least three months to 9/12/09.

Disclosure: Long BDSI

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