FDA Calendar, Extreme Trade Updates: BioElectronics, Shire, Spherix Print E-mail
Monday, 03 August 2009 12:26

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 298 entries as of 8/3/09. 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, 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 8/3/09, BioElectronics (BIEL.PK) announced Alquemie Partners, a strategic research and advisory boutique, has issued a new research report on the Company. The analyst, Carrie Snyder, places a target price on the shares of between $0.30 and $0.50, should expected FDA clearances be granted.

"We are very excited about BioElectronics's drug-free pain relief and healing technologies and products. With the recent FDA panel recommendation to restrict certain dosages of Tylenol(r) and acetaminophen, we believe the timing of the Company's clinical study completions and FDA filings is optimal," commented Ms. Snyder. "BioElectronics is clearly addressing a significantly sized market with its patented drug-free technologies. Should FDA clearances be given, as we expect, we believe the price of these shares could rise significantly."

On 8/3/09, Shire (LON:SHP) (NASDAQ:SHPGY) reported positive results from the first of three Phase 3 studies of velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease. The Company also announced that the FDA has accepted its treatment protocol for velaglucerase alfa and that Shire has begun its rolling submission of the New Drug Application (NDA) on 7/30/09 for velaglucerase alfa allowed under the Fast Track process with expected completion of the submission by the end of 3Q09. Velaglucerase alfa was found to be generally well tolerated with no drug-related serious adverse events reported in the trial. The acceptance of the treatment protocol by the FDA will enable physicians to treat Gaucher patients with velaglucerase alfa prior to commercialization.

On 6/24/09, Spherix (NASDAQ:SPEX) announced positive preliminary results from a Phase 2 dose-ranging, single-blinded clinical trial of its novel compound, Naturlose (D-tagatose), in the treatment and management of Type 2 diabetes. The Phase 2 trial is expected to be completed in early 2010. The primary endpoint for the study is reduction in HbA1c after 6 months on the drug. After 6 months on drug, the patients in the 7.5 g group experienced an average reduction of 0.3% in HbA1c from the HbA1c of the 2.5 g group. At that same 6-month point, the 5.0 g group averaged a reduction in HbA1c of 0.05% from the 2.5 g group. Naturlose appears to begin showing an effect on HbA1c within the range of doses selected for this minimum-dose study.

The ongoing Phase 3 double-blinded study of efficacy is being conducted at a 15 g dose (TID), and is powered to detect a 0.5% reduction in HbA1c with interim results expected during 3Q09 and trial completion anticipated during mid to late 2010. Over the course of the Phase 2 trial, Naturlose also decreased the average serum triglycerides of the patients by -59 mg/dl by the end of the first month on therapy, a decrease from baseline that remained at -41 mg/dl by the end of the 6 months of the trial. Naturlose also decreased serum LDL (bad cholesterol) by an average -13 mg/dl by the end of the first month on therapy, while serum HDL (good cholesterol) was essentially unchanged (+0.9 mg/dl).

Disclosure: No positions




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