Weekly FDA Calendar Update

by: Mike Havrilla

The accompanying table (click to enlarge) presents an updated calendar of 74 expected FDA decision dates as part of the ETF Innovators [ETFI] New Drug Regulatory Catalyst Index. Below is a summary of the FDA action over the past week.

1.) ViroPharma (VPHM) – Filed a sBLA on 12/1/08 to expand use of Cinryze C1 Inhibitor (human) as a treatment for acute attacks of hereditary angioedema (HAE), which is already FDA approved for regular use in the prevention of angioedema attacks in adolescent and adult patients with HAE. Standard 10-month review target decision date = 10/1/09.

2.) Questcor Pharma (QCOR) – Re-submitted a sNDA on 12/2/08 to expand the use of H.P. Acthar Gel (repository corticotrophin injection) for the treatment of infantile spasms. Standard 10-month review target decision date = 10/2/09.

3.) Advanced Life Sciences (OTC:ADLS) – The FDA accepted the Company's NDA for a new once-daily antibiotic, cethromycin, for the treatment of mild-to-moderate community acquired pneumonia with a standard 10-month review period and target action date of 7/31/09. Given the FDA's tough stance on antibiotics recently and many other existing antibiotics for this condition, I would be very cautious on this outcome. However, cethromycin also has an orphan drug designation for the prophylactic treatment of inhalation anthrax so the drug could play a role in the defense of bio-terrorism.

4.) Eli Lilly (NYSE:LLY) – Withdrew its sNDA to expand the label of Cymbalta to include the treatment of chronic pain with plans to re-submit the application during 1H09, adding positive clinical trial data from a recently concluded study in patients with chronic osteoarthritis knee pain.

5.) Roche (OTCQX:RHHBY) – Plans to submit a complete response to the FDA during 3Q09 for Actemra (tocilizumab), which is the first interleukin-6 ((IL-6)) receptor-inhibiting monoclonal antibody studied for the treatment of adult patients with moderate to severe rheumatoid arthritis. Roche must submit a Risk Evaluation and Mitigation Strategy (REMS) and provide animal study data to confirm published literature which shows that Actemra does not affect fetal development and fertility.

6.) AstraZeneca (NYSE:AZN) – A complete response was issued by the FDA for motavizumab, which is a monoclonal antibody ((MAb)) for the prevention of serious respiratory syncytial virus (RSV) disease. No additional clinical trials are required and AZN expects to re-submit during 1H09.

7.) Genzyme (GENZ) – The FDA posted briefing documents today ahead of a Tuesday advisory panel meeting for Genzyme's Synvisc-One single-dose reformulation PMA, which is designed to provide pain relief for osteoarthritis of the knee for up to six months in patients who do not respond to conventional treatments. While the FDA questioned the small sample size and short 26-week follow-up period of the European study, the agency noted that Synvisc-One appears equivalent to the existing product, Synvisc, in terms of safety and component materials.

Key dates for the Synvisc-One PMA include 12/9/08 for the advisory panel meeting and 12/23/08 for the target action date. Based on the documents filed on Friday, I think Synvisc-One will be approved with the possibility of a post-approval study to follow-up with patients for at least one year since the FDA notes the treatment effects of similar joint injections can persist for this long.

8.) Allergan (NYSE:AGN) Wants To Improve Your Eyelashes – AGN received an approval recommendation today from a FDA advisory panel for Latisse (bimatoprost solution 0.03%) as a cosmetic medicine treatment which would represent the first and only FDA-approved product to enhance eyelashes (making them darker, longer, and thicker). Latisse would be packaged with a special applicator to apply the drops on the edge of the eyelid as compared to the current use of bimatoprost as Lumigan, which is already on the market as a treatment for glaucoma to lower eye pressure.

Allergan estimates peak sales for Latisse of $500M, compared to trailing 12-month sales of $4.4B, with an expected FDA action date by mid-2009 on the pending NDA. Allergan is also a component in the ETFI Cosmetic & Reconstructive Medicine Index and could be a takeover target for big pharma after Johnson & Johnson (NYSE:JNJ) agreed to pay $1.1B for breast implant maker Mentor (MNT) – although the market cap of Allergan is much larger at $11.7B with a wider range of businesses such as specialty pharma, medical devices, and cosmetic medicine.

Click here for a web link to my previous FDA calendar articles.