|FDA, Clinical Trial Calendars: Nine Cash Plus Catalyst Trades|
|Sunday, 10 May 2009 03:00|
1.) BioForm Medical (NASDAQ:BFRM): Market Cap = $59.8M, Net Cash = $41.4M. In March 2009, BioForm Medical announced the results of a clinical trial evaluating the mixing of lidocaine with RADIESSE dermal filler, which demonstrated an approximate 60% reduction of pain when RADIESSE dermal filler was mixed with lidocaine, and comparable safety and effectiveness of mixed and non-mixed RADIESSE dermal filler. The results were submitted to the FDA under a PMA supplement with an estimated decision during 4Q09 since the FDA does not issue decision date deadlines for medical device filings.
2.) Spectrum Pharma (NASDAQ:SPPI): Market Cap = $119.1M, Net Cash = $70.5M. Zevalin sBLA (priority review) as consolidation therapy follicular B-cell non-Hodgkin's lymphoma if a first-line treatment response is achieved. A three-month delay in the PDUFA decision date to 7/2/09 was announced on 2/23/09 as SPPI submitted additional data to the FDA, which was classified as a major amendment to the sBLA filing. SPPI also has a pending sNDA for Fusilev (levoleucovorin) for Injection to expand use of the drug in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. The PDUFA decision date for the sNDA is 10/8/09.3.) Nanosphere (NASDAQ:NSPH): Market Cap = $81.4M, Net Cash = $58.2M. In the past week, NSPH received FDA clearance for its influenza and respiratory syncytial virus (RSV) test which leaves the Company with three pending applications for molecular diagnostic assays for cystic fibrosis and hemochromatrosis along with a second generation version of its Verigene System that incorporates automated sample processing.
4.) Vivus (NASDAQ:VVUS): Market Cap = $310M, Net Cash = $176.6M. VVUS expects to release data during 3Q09 from two phase 3 EQUIP and CONQUER clinical trials of Qnexa (phentermine + topiramate) in addition to topline REVIVE Phase 3 study data (the first of three pivtoal clinical trials) which may be released before year-end for avanafil for the treatment of erectile dysfunction as a next-generation, fast-acting, selective, investigational oral phosphodiesterase type 5 (PDE5) inhibitor. Click here for my overview article on VVUS from early March.
5.) Amicus Therapeutics (NASDAQ:FOLD): Market Cap = $174M, Net Cash = $108M. FOLD expects to release Phase 2 clinical trial results during late 3Q09 for Plicera in the treatment of Gaucher disease. The Company also plans to announce the final Phase 3 clinical trial protocol and begin Phase 3 clinical development for Amigal (migalastat) in the treatment of Fabry disease during 2Q09.
6.) Pain Therapeutics (NASDAQ:PTIE): Market Cap = $179M, Net Cash = $185.6M. PTIE has a pending complete response re-submission by King Pharma (NYSE:KG) for the Company's Remoxy (oxycodone) NDA. KG expects to meet with the FDA during mid-2009 to clarify the non-clinical information required to address the complete response letter.
7.) Biodel (NASDAQ:BIOD): Market Cap = $93M, Net Cash = $72.1M. BIOD: Plans to submit a new drug application (NDA) to the FDA 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.
8.) Avanir Pharma (NASDAQ:AVNR): Market Cap = $62.6M, Net Cash = $30.5M. Pivotal Phase 3 Results Expected during 3Q09 for Zenvia (dextromethorphan/quinidine). AVNR completed targeted enrollment on 3/16/09 of patients into the STAR trial, a confirmatory Phase 3 trial of Zenvia (dextromethorphan/quinidine) in patients exhibiting signs and symptoms of pseudobulbar affect. The randomized, multi-center, international STAR trial is designed to compare the effects of Zenvia 30/10 mg, Zenvia 20/10 mg and placebo on involuntary crying/laughing episodes rates. AVNR expects to release topline data no later than end of 3Q09 and plans to submit a complete response to the FDA approvable letter during 1H10.
9.) Orexigen Therapeutics (NASDAQ:OREX): Market Cap = $96.7M, Net Cash = $64.7M. OREX has three pending Phase 3 clinical trials for its experimental weight loss drug Contrave, with results expected during 3Q09.
Disclosure: No positions.