Biotech4cast Stock Weekly Digest March 18th
This past week was a relatively quiet week for FDA meetings and decisions.
ARIAD: On Friday the 16th of March the FDA released the briefing documents for the upcoming (March 20th) Oncologic Drugs Advisory Committee where ARIAD’s ridaforolimus for the treatment of soft tissue/bone sarcomas will be discussed. As a reminder, briefing documents provide insight to what the committee will be discussing and gives some indication if the FDA has any major concerns. These briefing documents showed that the FDA is concerned that ridaforolimus provides little benefit to patients despite having serious side effects. In clinical trials involving ridaforolimus there was a small benefit of delaying tumor growth by only 2 weeks and didn’t show treatment prolonged survival. The panel will most likely vote against approval. Furthermore, this decision will have a muted and temporary effect on the stock price because the trial results have been known for some time. In addition, most of the interest in ARIAD comes from its other drug ponatinib. Ponatinib results have been more promising and the market potential is much greater. The PDUFA date or date for an FDA approval decision regarding ridaforolimus is June 5th, 2012.
AVI BioPharma: On March 12, 2012 the AVI BioPharma announced that they will be presenting trial results at the American Academy of Neurology Emerging Science program on April 25, 2012. This week we wrote an article titled Trial Results for AVI BioPhamra’s Eteplirsen Represents a Trading Catalyst detailing the opportunity.
Upcoming this week…
Talon Therapeutics: On March 21st, 2012, Talon Therapeutics’ Marqibo® will be assessed by the Oncologic Drug Advisory Committee with a PDUFA Date of May 13, 2012. A New Drug Application for Marqibo® was submitted to the FDA to provide a standard of care in adults with Philadelphia chromosome negative acute lymphoblastic leukemia (ALL) in second or greater relapse or that has progressed following two or more prior lines of anti-leukemia therapy and was accepted for filing under Subpart H accelerated approval. However, after an initial review of the NDA the FDA did not grant the accelerated 6 month review but instead went with the standard 10 month review. This type of behavior from the FDA usually doesn’t bode well for approval. Furthermore the clinical trial used to support FDA approval was a single arm trial meaning there was no control group to compare the results to. The treatment group did see some benefit and these patients have no other options available to them. Therefore, the AdComm may deem that some type of treatment is better than nothing. The stock price has more than doubled YTD. However, the company is only valued at about $20 Million. If the market thought that approval was likely the company should be valued much higher. Therefore, we are giving the AdComm meeting 2 stars for approval. The briefing documents should be available on Monday March 19th.
