The accompanying table (click to enlarge) includes a weekly update of 71 expected FDA decision dates as part of the ETF Innovators (ETFI) New Drug Regulatory Decision Catalyst Index. Since my article last week, the following action has taken place at FDA:
1.) Pain Therapeutics (PTIE) & King Pharma (KG) lost 21% and 7%, respectively, today after receiving a complete response letter from the FDA for their abuse-resistant form of controlled-release oxycodone, which is designed to deter the abuse and diversion of the blockbuster pain drug OxyContin sold by privately-held Purdue Pharma.
While details are scant on the decision, no additional clinical trials will be required to attain approval for Remoxy, which means non-clinical data is likely required to back up the abuse-resistant claims of the drug. Since Remoxy is not abuse-proof, the gray area is determining what constitutes abuse-resistant, which is an area that was debated in the advisory panel meeting for the drug.
King Pharma still has another shot at approval of an abuse-resistant opiate pain drug before year-end since it is set to acquire Alpharma (ALO), which has a pending decision for Embeda (morphine). An advisory panel also 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.
2.) Acusphere (OTCPK:ACUS) cratered yesterday by 73% on a 16-1 FDA advisory panel vote which recommended against approval for Imagify, which is a contrast imaging agent to detect heart disease. The panel believed that Imagify's risks (such as causing low blood pressure) did not justify approval because it offers no significant advantages to existing products.
3.) Eli Lilly (LLY) filed a sBLA for Erbitux to be used in first-line, combination treatment for non-small cell lung cancer. Also, Lilly and Amylin Pharma (AMLN) expect the FDA to miss their decision deadline for Byetta as a first-line treatment of Type 2 diabetes. However, the major news for Amylin & Alkermes (ALKS) which sent shares soaring by over 10% today was the expectation by Lilly to apply for FDA approval of a once-weekly version of diabetes treatment Byetta (exenatide LAR) during 1H09 with investors hoping the less frequent dosing will improve anemic sales of the current twice-daily formulation.
4.) Targanta Therapeutics (TARG) received an anti-climactic complete response for its antibiotic drug oritavancin today. The shares previously tanked on a FDA advisory panel recommendation against approval for the drug.
5.) Cypress Bioscience (CYPB) and Forest Labs (FRX) announced positive Phase 3 results earlier this week for milnacipran in the treatment of fibromyalgia, which was statistically significant compared to placebo. More detailed results are expected next year as the data is analyzed is further. Both companies are still awaiting a missed FDA decision deadline from mid-October, when the agency said it expected to resolve the issue in "a matter of weeks."
I bought more shares of CYPB today around $5.50 as the Company has about 4 bucks in cash, zero debt, over 10 years of patient data for milnacipran outside the U.S., and a large database of milnacipran trial data confirming its benefit in the treatment of fibromyalgia.
At current levels, the risk/reward ratio strongly favors the upside on milnacipran approval (10 bucks or more) compared to the downside risk of more delays by the FDA – as an outright rejection appears highly unlikely given the statement by the agency at the time of the PDUFA date.
Disclosure: Author owns positions in CYPB.