FDA Calendar Updates: Botox Rival Approved

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars.The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

Medicis (NYSE:MRX) and Ipsen [EPA:IPN] announced Friday that the FDA has approved Dysport (abobotulinumtoxinA) for two separate indications, including (1) the treatment of cervical dystonia in adults to reduce the severity of abnormal head position and neck pain and (2) the temporary improvement in the appearance of moderate to severe glabellar lines (wrinkles) in adults younger than 65 years of age.

Reloxin, which was the proposed U.S. name for Ipsen’s botulinum toxin product for aesthetic use, will be marketed under the name of Dysport for the therapeutic indication (cervical dystonia) (expected market launch 2H09), while Medicis will market Dysport in the U.S. for the aesthetic indication (glabellar lines) (expected market launch within 30-60 days). Additionally, DYSPORTTM is differentiated from other marketed botulinum toxin products such as Allergan's (NYSE:AGN) Botox with the unique established name of 'abobotulinumtoxinA'.

As per the terms of a 2006 deal, Medicis will pay Ipsen approximately $75 million as a result of FDA approval and Ipsen will receive a royalty based on sales and a supply price, the total of which is equivalent to about 30% of net sales.

CSL Behring, a subsidiary of Australia-based CSL Limited [ASX:CSL] (CMXHY.PK) announced Friday that it submitted a BLA requesting FDA approval to market a 20% liquid formulation of its Immune Globulin Subcutaneous (Human) (IgSc), in the U.S. for weekly replacement therapy in patients with primary immune system deficiencies (PI). This formulation is designed for patient convenience as it can be stored at room temperature and offers the ability for self-administration by subcutaneous injection.

PIs are a group of genetic disorders in which the immune system is compromised, resulting in impaired ability for affected patients to resolve or fend off infections from daily exposure to bacteria and viruses. There are nearly 100 types of PIs identified and most cases are inherited and affect children. There is not cure for PIs and the administration of a variety of immune globulins to provide protective antibodies is used to manage the condition.

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