|FDA Calendar Updates: Genzyme FDA Woes Benefit Protalix, Shire|
|Friday, 31 July 2009 13:05|
Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 293 entries as of 7/31/09. 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, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.
On 7/30/09, Achillion Pharma (NASDAQ:ACHN) stated that it expects shortly to conclude the Company's opt-in discussions with Gilead (NASDAQ:GILD) regarding its ability to advance ACH-1095 into the clinic on its own, and assuming the positive outcome of those discussions, ACHN is actively preparing for a pre-IND consultation with the FDA regarding ACH-1095 (a NS4A antagonist for the treatment of hepatitis C virus or HCV). ACHN plans to report the results of its consultation with GILD in the coming months.
On 7/30/09, ACHN announced that late in 2Q09 the Company initiated Phase 1 studies with its hepatitis C virus (HCV) protease inhibitor (ACH-1625) and continues to receive data regarding the drug's safety and tolerability profile that is expected to be announced late this summer. As ACHN continues this study in patients with HCV, the Company expects to have efficacy data during the winter.
On 7/31/09, Roche (VTX:ROG) (RHHBY.PK) announced that the FDA accepted the Company's resubmission for approval of rheumatoid arthritis treatment Actemra (tocilizumab) with a Class II (six-month) review designation for an expected FDA decision in early 2010. In December 2008, the FDA requested additional non-clinical data on Actemra, including a proposed risk evaluation and mitigation strategy (REMS) and non-clinical studies evaluating the effect of Actemra on peri- and post-natal development and fertility. In July 2008, the FDA Arthritis Advisory Committee recommended approval of the drug by a 10-1 vote.
On 7/31/09, Genzyme (NASDAQ:GENZ) announced that the FDA will re-inspect the company's Allston Landing manufacturing facility. The re-inspection is a follow-up to an inspection the agency conducted in May 2009 and is intended to verify that all corrective and preventative actions identified in a February warning letter have been implemented. In its letter to GENZ yesterday, the agency indicated that all promised actions had not been either fully or adequately implemented at the time of the May inspection. GENZ will work with the FDA to schedule the re-inspection as soon as possible. The sanitization of the facility is complete and production of Fabrazyme (agalsidase beta) and Cerezyme (imiglucerase for injection) has resumed.
On 7/6/09, Protalix BioTherapeutics (AMEX:PLX) announced that it was approached by the FDA and asked to consider submitting a treatment protocol for the use of prGCD in patients with Gaucher disease in order to address an expected shortage of the drug Cerezyme, a mammalian cell expressed version of glucocerebrosidase (GCD) and the only enzyme replacement therapy currently approved for Gaucher disease. Gaucher disease is a rare and serious lysosomal storage disorder in humans with severe and debilitating symptoms. prGCD, the Company's lead product candidate, is a proprietary plant-cell expressed recombinant form of glucocerebrosidase and is currently the subject of a Phase 3 clinical trial for the treatment of Gaucher disease.
The FDA indicated to the Company that it believes the Company's development program for prGCD satisfies the regulatory criteria required to supply prGCD for expanded access to patients under a treatment protocol. PLX expects to submit a treatment protocol to the FDA for its review as a supplement to its current Investigational New Drug (IND) application for prGCD. PLX expects to report results of the Phase 3 trial during 2H09 and expects to submit a NDA for prGCD to the FDA and other global regulatory agencies during 4Q09.
On 7/6/09, Shire (LON:SHP) (NASDAQ:SHPGY) announced that, at the request of the FDA, in view of a potential restriction on the availability of the current approved and marketed treatment for Gaucher Disease patients, it has filed a treatment protocol for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Gaucher Disease. If approved by the FDA, the treatment protocol would allow physicians to treat Gaucher Disease patients with velaglucerase alfa ahead of commercial availability in the U.S. Under the conditions of the treatment protocol, Shire would provide velaglucerase alfa free of charge initially, in order to provide access to patients as quickly as possible. Velaglucerase alfa is made with Shire's proprietary technology, in a human cell line. The enzyme produced has the exact human amino acid sequence and carries a human glycosylation pattern. Shire is working with the FDA to file a NDA for velaglucerase alfa as soon as possible.
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