FDA Calendar Updates: BDSI is Worth the Wait, Zicam Warning Print
Tuesday, 16 June 2009 14:05

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.

On 6/16/09, shares of Matrixx Initiatives (NASDAQ:MTXX) were plunging after the FDA ordered the Company to stop selling zinc-containing, intranasal versions of its Zicam cold remedy after more than 130 reports of people losing their sense of smell. The FDA also urged consumers to stop taking the over-the-counter products, according to Agency officials on a conference call with reporters. MTXX must seek FDA approval if it wants to continue selling the zinc-containing versions of Zicam that are administered through the nose, agency officials said.

On 6/16/09, ARYx Therapeutics (NASDAQ:ARYX) announced that the database for the EmbraceAC study has been locked and the study remains on schedule, with the efficacy and safety results to be available during the week of 7/6/09. The study was designed to compare its oral anticoagulation therapy, tecarfarin (previously ATI-5923), against the leading anticoagulant agent, warfarin. The purpose of the trial is to evaluate whether tecarfarin is superior to warfarin in its ability to maintain patients within a target therapeutic range of the level of anticoagulation as measured by INR (International Normalized Ratio). Based upon recent interactions with the FDA, ARYX believes this trial could be positioned as one of the required registration studies for tecarfarin.

The trial of approximately 600 patients is a randomized, double blind, parallel group, active control study comparing tecarfarin with warfarin in patients who require chronic, oral anticoagulation. All patients in the study were treated for a minimum of six months and required anticoagulation therapy to avoid serious blood clotting resulting from their underlying condition. Tecarfarin (previously ATI-5923) is modeled on the drug warfarin as an oral blood thinner, which works in the same way (as a selective inhibitor of VKOR or the vitamin K epoxide reductase enzyme). Unlike warfarin, which is dependent upon cytochrome P450 enzymes for metabolism, tecarfarin was designed to avoid drug-drug interactions through its alternative metabolic pathway. ARYX believes this alternate metabolic pathway for tecarfarin may result in more predictable dosing and anti-coagulant response compared to warfarin.

On 6/16/09, GlaxoSmithKline (NYSE:GSK) and Genmab (CPH:GEN) (PINK:GNMSF) announced that the FDA informed the companies that the agency has extended the action date for the Arzerra (ofatumumab) BLA application by three months. The three month extension will allow the agency to review additional chemistry and manufacturing data submitted on 6/5/09. The BLA was submitted 1/30/09 and the FDA accepted the filing in April with priority review (six-month) status. On 5/29/09, the FDA Oncologic Drugs Advisory Committee (ODAC) voted 10-3 that the Arzerra data are reasonably likely to predict clinical benefit for patients with chronic lymphocytic leukemia (CLL) whose disease is refractory to fludarabine and alemtuzumab. The new PDUFA action date for an expected FDA decision on the pending BLA is anticipated to occur during 4Q09.

On 6/16/09, a FDA Advisory Panel ruled that Savient Pharma’s (NASDAQ:SVNT) experimental gout drug is safe and

effective for certain patients with the disorder. SVNT is seeking FDA approval for the infused drug (Krystexxa) for those who have the painful type of arthritis, but fail to improve with first-line treatments or cannot tolerate other treatments. The FDA's panel of outside experts (in a 14-1 vote) ruled that the dramatic results in nearly half of the patients studied were encouraging, despite risks that could include serious heart problems and

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allergic reactions. 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 decision date by three months to 8/1/09.

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, BEMA fentanyl), including the lone outstanding requirement for a Risk Evaluation and Mitigation Strategy (REMS). Although the FDA did not meet its PDUFA action date of 6/12/09, the FDA will not be issuing a review extension letter as their action on the NDA is forthcoming. BDSI received a Complete Response Letter (CRL) from FDA on the NDA for Onsolis on 8/28/08 with the only deficiency being the new requirement for a REMS. The REMS 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 first half 2009 approval of the NDA for ONSOLIS. Based on our discussion with FDA last Friday, we should be within a few weeks of that target. We view this as positive news, together with the fact that we have reached agreement with the reviewing division and the review team on all aspects of our NDA, including our REMS. Our dialog and working relationship with the reviewing division have been outstanding and have been fundamental to the progress we have made in working with them in this significant undertaking, to complete the first 'opioid' REMS and the first REMS for this Division."

In conjunction with the update on the pending Onsolis NDA, BDSI stated that over the past several weeks the Company received funding associated with the exercise of outstanding warrants. With the additional funding, BDSI has adequate liquidity to fund normal operations and continue its clinical pipeline development through 4Q09. 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 over 20% 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.

While many momentum and biotech binary event traders may have exited BDSI recently with the stock price pulling back about 2 bucks from its high in the mid-$8 range; the final FDA approval for Onsolis could come at any time. Recent FDA approvals for Entereg, Cimzia, and Nplate provide examples of missed PDUFA action dates for drugs which also required REMS. In these cases, final FDA decisions occurred in a range of 10-30 days after the original PDUFA date, which translates into a possible Onsolis approval announcement sometime during late June to mid-July.

During the 6/15/09 conference call, BDSI clearly 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. In addition, the Onsolis NDA represents the first REMS submitted to the FDA associated with an opiate drug compound; so a minor delay in the final approval is not surprising.

If you think BDSI will trade above its current level in the mid-$6 range upon FDA approval of Onsolis; the recent pullback provides an excellent entry point given the near certainty of attaining FDA approval based on the Company's dialogue with the Agency outlined above and in the conference call earlier this week.

Disclosure: Long BDSI.




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