FDA Calendar Updates: Zogenix, Aradigm, Medtronic, BioForm, Cornerstone

by: Mike Havrilla

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 260 entries as of 7/16/09. I originally created the 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, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

On 7/16/099, privately-held Zogenix, Inc. announced that it has received approval from the FDA for its New Drug Application (NDA) for Sumavel DosePro (sumatriptan injection) needle-free delivery system to treat acute migraine, with or without aura, and cluster headache. Sumavel DosePro is a first-of-its-kind needle-free delivery system for subcutaneous sumatriptan, a treatment that provides migraine relief within 10 minutes for some patients.

Subscribers to the BioMedReports.com FDA Calendar knew in advance that shares of Aradigm Corp. (NASDAQ:ARDM) would move higher on an approval decision and ARDM.OB is currently trading up by over 20% this morning on about 2 million shares within 20 minutes of the market open. The entry for Aradigm in the FDA Calendar before today's decision is summarized below:

In August 2006, the Company sold all of its assets related to the Intraject needle-free injector technology platform and products Zogenix, which is responsible for further development and commercialization efforts of Intraject (now rebranded under the name DosePro). The Company received a $4.0 million initial payment from Zogenix, and it will be entitled to a milestone payment upon initial commercialization, and royalty payments upon commercialization of DosePro products with a PDUFA action date of 7/15/09 and planned product launch during 2H09.

On 7/16/09, Medtronic (NYSE:MDT) announced the submission of a Pre-Market Approval (PMA) application with the FDA for Medtronic Deep Brain Stimulation (DBS) Therapy for patients with medically refractory epilepsy with partial-onset seizures. These are patients who have uncontrollable seizures with little or no response to currently available anti-epileptic medications. Medtronic’s PMA submission includes data from the SANTE (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy) prospective, randomized, double-blind pivotal clinical trial sponsored by Medtronic.

The study is still ongoing with some patients having received Medtronic DBS Therapy for more than four years. Medtronic DBS Therapy is currently approved by the FDA for the treatment of the disabling symptoms of essential tremor, advanced Parkinson's disease, dystonia, and chronic, severe, treatment-resistant obsessive-compulsive disorder and has been used in more than 60,000 people worldwide for these approved indications.

Shares of BioForm Medical (NASDAQ:BFRM) were soaring by over 30% during early trading on 7/16/09 following FDA marketing clearance for the Company's PMA supplemental application for its lead product Radiesse (a dermal filler type of wrinkle treatment) which is mixed with the local anesthetic lidocaine to decrease pain upon injection of the treatment. BFRM was previously featured in several articles as an FDA Extreme Trade at BioMedReports.

On 7/15/09, Cornerstone Therapeutics (NASDAQ:CRTX) announced that it has submitted a regulatory filing FDA for an extended-release anti-tussive product (CRTX 067). CRTX believes that its cough product may improve patient compliance by providing more convenient twice-daily dosing. According to data derived from Source Pharmaceutical Audit Suite during 2008 there were over 30 million prescriptions and nearly $1 billion dollars in sales generated for oral anti-tussives; however, most oral anti-tussive products that are currently marketed are in an immediate-release formulation (over 25 million prescriptions annually) requiring dosing every four to six hours, which can be inconvenient and adversely affect patient compliance.

Disclosure: No positions.