FDA Calendar Updates: AspenBio, CytRx, Cephalon, Pozen, Sanofi, AMAG

by: Mike Havrilla

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. I originally launched 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 pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

On 6/30/09, AspenBio Pharma (NASDAQ:APPY) announced a 510(k) submission to the FDA for its AppyScore Test, which represents the first blood-based test designed as an aid in the diagnosis of human appendicitis with the proposed indication of use: AppyScore is an ELISA test system that is used to quantitatively measure S100A8/A9 heterodimer complex in blood. It is an in vitro diagnostic device that is intended to be used as an adjunctive tool for the diagnosis of acute appendicitis in conjunction with additional diagnostic modalities (such as clinical exam, basic lab testing, imaging) in patients with abdominal pain that is suspicious for acute appendicitis.

This filing advances the Company's commercialization plan for AppyScore, which involves initially filing the 510(k) based on the ELISA test format. Upon receiving market clearance for this device, the company plans to use the ELISA device as a predicate for a rapid assay device that includes a reader instrument. AspenBio plans to begin initial hospital testing of the rapid assay device in late 2009. Assuming the company receives FDA clearance of the AppyScore ELISA test and development work is completed, clinical trials of the rapid assay are planned to begin in early 2010. These follow-on trials will be designed to support a 510(k) submission for this rapid assay platform using the ELISA test as a predicate. The rapid assay system represents the format that APPY plans to ultimately commercialize.

On 6/30/09, CytRx Corp. (NASDAQ:CYTR) announced that it filed a report (including results from an animal toxicology study) with the FDA in response to the Agency’s partial clinical hold on the Company’s Phase 2b efficacy clinical trial with its molecular chaperone regulator drug candidate arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease). CYTR expects that the FDA will review the report during 3Q09 and stated that the Agency’s partial clinical hold was unrelated to data generated by human studies and arimoclomol has been studied in seven Phase 1 and two Phase 2 clinical trials without any significant adverse events.

On 6/30/09, Cephalon (NASDAQ:CEPH) announced that it has submitted a supplemental New Drug Application (sNDA) to FDA requesting approval of NUVIGIL (armodafinil) Tablets [C-IV] for the indication of improved wakefulness in patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel. Jet lag disorder is an acute condition that occurs when a person's internal body clock becomes disrupted as a result of rapid travel across several time zones. Based on U.S. Bureau of Labor Statistics findings, an estimated 70 million American travelers experience jet lag annually. Currently, there are no FDA-approved medications to improve wakefulness in travelers who experience the excessive sleepiness commonly associated with long flights.

On 6/30/09, Pozen (NASDAQ:POZN) announced the submission of a NDA to the FDA for the marketing approval of VIMOVO (PN 400), the combination of enteric-coated naproxen and immediate-release esomeprazole (currently marketed as Nexium). Pozen and AstraZeneca (NYSE:AZN) entered into a global co-development agreement for VIMOVO in August 2006. Pending regulatory approval, the proposed trade name is VIMOVO and the proposed indications are for the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in patients who are at risk for developing NSAID-associated ulcers. Upon the Agency’s acceptance for filing of the NDA, a $10 million milestone payment from AZN will be payable to Pozen. The estimated PDUFA action date is 4/30/10 for a standard, 10-month review for a possible FDA decision on this NDA.

On 6/30/09, Sanofi-Aventis (NYSE:SNY) provided an update on the Company’s R&D division and stated that it is still awaiting a FDA decision for its pending NDA for heart drug Multaq (dronedarone) in the treatment of atrial fibrillation (a type of irregular heartbeat). In March, a FDA panel of cardiology experts recommended that Multaq should be approved with a 10-3 vote and the original PDUFA action date was 4/30/09. Both the Company and analysts are expected Multaq to post annual peak sales over $1 billion (U.S. dollar) despite FDA Advisory Panel recommendations that the drug (1) should not be used in patients with advanced cases of heart failure (Class III and IV) and (2) SNY cannot claim the drug lowered the risk of death.

On 6/30/09, AMAG Pharma (NASDAQ:AMAG) announced that the FDA has granted marketing approval for Feraheme (ferumoxytol) Injection for intravenous (IV) use as an iron replacement therapy for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. The recommended dose of Feraheme is an initial 510 mg IV injection followed by a second 510 mg IV injection three to eight days later. Feraheme should be administered as an undiluted IV injection delivered at a rate of up to 1 mL/sec (30 mg/sec). The recommended Feraheme dose may be re-administered to patients with persistent or recurrent iron deficiency anemia. Feraheme is expected to be commercially available in the U.S. during the second half of July 2009.

Disclosure: Long AMAG.