FDA Calendar Updates: Transcept Pharma Surges on Deal

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Includes: AEZS, ICGN, KERX, PRTK, RPRX, SVNTQ
by: Mike Havrilla

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 297 entries as of 8/3/09.. I originally created this calendar 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, ANDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

On 8/2/09, Savient Pharma (NASDAQ:SVNT) announced it received a complete response letter (CRL) from the FDA for the company's Biologics License Application (BLA) seeking approval of Krystexxa (pegloticase) as a treatment for chronic gout patients who do not respond to conventional therapy. The CRL cites deficiencies with the chemistry, manufacturing and controls (CMC) section of the BLA and also provided the current draft of the proposed labeling and further guidance regarding a Risk Evaluation and Mitigation Strategy (REMS).

The company intends to immediately request a meeting with the FDA to discuss and clarify the issues raised in the complete response letter. Under FDA regulations, the company believes that this meeting is deemed a "Type A" meeting, meaning that the FDA would meet with the company within 30 days of its receipt of the meeting request. SVNT stated that it is currently targeting a resubmission for early 2010 and expects to provide more details after meeting with the FDA to discuss the CRL. Resubmissions to the Agency are designated as either Class I (60-day) or Class II (six-month) reviews.

On 8/3/09, Repros Therapeutics (NASDAQ:RPRX) announced that, in the interest of patient safety (elevation of liver enzymes), it is voluntarily suspending dosing of all patients in its clinical trials of Proellex. This decision is based on available information regarding the occurrence of clinically significant increases in liver enzymes with 50 mg and 25 mg doses of Proellex, coupled with recent input from a consulting panel of liver experts.

The company submitted a meeting request to the FDA on 7/30/09 and, in response, the Agency has proposed to change the topic of the previously scheduled End of Phase II meeting for endometriosis in late September into a discussion about the safety of Proellex and overall direction and scope of the program.The suspension of dosing will involve all ongoing clinical trials with Proellex for the treatment of chronic symptomatic uterine fibroids, anemia associated with this condition, and endometriosis.

On 8/2/09, Transcept Pharma (NASDAQ:TSPT) and privately-held Purdue Pharma announced an exclusive deal to commercialize Intermezzo (zolpidem tartrate sublingual tablet) in the U.S. Pending FDA approval, Intermezzo has the potential to be the first prescription sleep aid specifically approved for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. The PDUFA action date for the Intermezzo NDA is 10/30/09 for an expected FDA decision.

Purdue will pay TSPT near-term milestones that include an upfront cash payment of $25 million and an additional payment of up to $30 million based upon the timing of an FDA approval of Intermezzo, which approval and payment are subject to review and acceptance by Purdue. In addition, TSPT is eligible to receive up to an additional $90 million upon reaching future milestones related to achievement of intellectual property and U.S. net sales targets along with double-digit royalties ranging up to the mid-20% level on U.S. net sales.

Shares of TSPT have more than doubled since the stock was featured as an FDA Calendar Extreme Trade on 7/20/09 as one of 20 stocks below $5 with pending FDA decisions or clinical trial results.

On 8/3/09, BVX announced a 510(k) submission to the FDA seeking pre-market clearance for the company's ICON VS electrosurgical generator. The generator has been designed to work with Bovie's Seal-N-Cut line of vessel sealing instruments providing both monopolar and bipolar energy options to the surgeon. The fully digital ICON VS generator has a user friendly interface allowing the surgeon flexibility to choose the type of effect desired. The monopolar and bipolar functions satisfy a wide variety of surgical demands needed during surgeries including vessel sealing.

On 8/3/09, Keryx Biopharma (NASDAQ:KERX) announced an agreement with the FDA for a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its KRX-0401 (perifosine), in relapsed or relapsed / refractory multiple myeloma patients previously treated with bortezomib (Velcade). The SPA provides agreement that the Phase 3 study design adequately addresses objectives in support of a regulatory submission.

The study is a double-blinded, placebo-controlled trial comparing the efficacy and safety of KRX-0401 vs. placebo when combined with bortezomib and dexamethasone and will enroll about 400 patients with relapsed or relapsed / refractory multiple myeloma. The primary endpoint is progression-free survival and secondary endpoints include overall response rate, overall survival and safety. Perifosine is in-licensed by Keryx from Aeterna Zentaris (NASDAQ:AEZS) in the U.S., Canada and Mexico.

On 8/3/09, Icagen (NASDAQ:ICGN) announced that the FDA has lifted the partial clinical hold related to the development of ICA-105665, the company's novel orally available small molecule KCNQ potassium channel agonist, for the treatment of epilepsy. Accordingly, the company is planning to initiate a proof-of-concept study in patients with photosensitive epilepsy. The study measures the ability of ICA-105665 to reduce the photic-induced epileptiform EEG responses. The duration of an observed effect will also be measured over time.

A range of doses of ICA-105665 will be studied in successive cohorts, and the response observed in each cohort will determine the subsequent dose for the next cohort. The objective of the study is to determine a potential dose range to study in subsequent, more advanced clinical trials. The study is anticipated to be completed by mid-2010 but interim results may be available earlier. In addition, the company continues preparations for a proof-of-concept pain study, which is also expected to be initiated during 3Q09 with initial results expected by early 2010.

Disclosure: No positions

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