Updated FDA Decision Calendar: Five Decisions Before Year-End

by: Mike Havrilla

The accompanying table (click to enlarge) includes an updated FDA calendar of 65 expected decision dates included in the ETF Innovators (ETFI) New Drug Regulatory Catalyst Index, with six companies listed in red with overdue decisions and the possibility for five decisions during the coming week. Click here for my previous FDA calendar articles. Below is a review of recent decisions + a preview of the coming week's activity:

1.) Allergan (NYSE:AGN) received FDA approval on Friday for Latisse (bimatoprost solution 0.03%) as a cosmetic medicine treatment which represents the first and only FDA-approved product to enhance eyelashes (making them darker, longer, and thicker). Allergan estimates peak sales for Latisse of $500M, compared to trailing 12-month sales of $4.4B, and the stock rose by 2% during trading on Friday.

2.) EPIX Pharma (NASDAQ:EPIX) is up over 213% in the past five days since receiving FDA approval for a blood vessel imaging agent, Vasovist (gadofosveset trisodium), to evaluate peripheral vascular disease in adults.

3.) Genzyme (GENZ) is still waiting on a FDA decision for its Synvisc-One PMA, with the reformulated product designed to provide pain relief for osteoarthritis of the knee for up to six months from a single dose 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.

4.) King Pharma (KG) and Alpharma (NYSE:ALO) – King Pharma still has another shot at approval of an abuse-resistant opiate pain drug (since receiving a complete response for Remoxy) before year-end since it is in the process of acquiring Alpharma, which has a pending decision for Embeda. An advisory panel endorsed Embeda as an improvement to existing opiate pain drugs which can easily be abused to circumvent their controlled-release formulations, but the panel conceded the drug is not abuse-proof.

5.) Northfield Labs (NFLD) should hear back from the FDA on whether the agency will accept its BLA filing for its blood substitute PolyHeme by 12/29 and if a priority review of six months will be granted. If the depressed share prices and low market caps for NFLD and another blood substitute company, Biopure (BPUR), are not enough to scare you away from investing – a meta-analysis published in JAMA concluded the following:

. . . the authors found a 30% increase in the risk of death and nearly a 3-fold increase in risk of myocardial infarction when all hemoglobin-based oxygen carrier (HBOC) trials were pooled. . .

I would be very surprised if the FDA even accepts the BLA for review given the available data for blood substitutes summarized in the JAMA study – for those speculators and traders looking for the next EPIX, I would look elsewhere.

6.) Savient Pharma (OTC:SVNT) should hear back from the FDA on whether the agency will accept its BLA filing for gout drug Puricase by 12/31 and if a priority review of six months will be granted. SVNT has lost about three-quarters of its market value in the past year on cardiovascular concerns for Puricase and the CEO resigned in late November.

7.) Labopharm (DDSS) has an expected PDUFA date of Friday 1/2 for its once-daily formulation of the widely used pain drug tramadol. DDSS is up by nearly 150% in the past month and is up by about 8% in the past year. The company's once-daily tramadol is already marketed outside of the U.S. and the drug is typically dosed about four times daily for the standard products.