|3 Disastrous Outcomes This Week for Titan, AVEO, and Delcath|
|By Brian Wilson, Lead Contributor|
|Friday, 03 May 2013 01:02|
As mentioned on Wednesday’s post, Titan Pharmaceuticals finally reached the PDUFA goal date for the NDA that had been submitted for opioid addiction drug probuphine. Contrary to the expectations of the market, the FDA issued a CRL that outlined cases against approval that may prove to be impossible for Titan to address going forward. For instance, concerns that patients could actually tear the probuphine implants out of their bodies to reach the multi-month dosage of buprenorphine were considered by the FDA, and lots of issues arose when the FDA tried to gauge how probuphine’s dosing could be matched with standard buprenorphine prescriptions.
Titan Pharmaceuticals is down 77% in the last five trading sessions in light of this news.
2.) AVEO Pharmaceuticals (AVEO)
Yesterday was the long-awaited FDA Oncology Drugs Advisory Committee (ODAC) meeting for AVEO Pharmaceuticals’ drug tivozanib – a VEGF inhibitor that exhibited mixed results in its efficacy when compared to another common cancer drug that works through the same mechanism of action. More specifically, the 13-1 vote against the drug’s demonstration of efficacy versus its implied risks was focused around the notion that the drug could actually shorten patients’ lifespans if doctors were to switch patients from other VEGF inhibitors to AVEO’s tivozanib based on the overall survival data that was taken from the most recent phase III trial.
As a result of this, AVEO is down 64% in the last five trading sessions.
3.) Delcath Systems (DCTH)
Trading was halted yesterday for shares of DCTH in the early afternoon as the FDA Oncology Drugs Advisory Committee (ODAC) meeting was held for Delcath System’s Melblez Kit – a therapy that is designed to deliver a chemotherapeutic regimen (specifically with the chemotherapeutic agent Mephalan) directly to the liver through a proprietary system tweaked and presumably perfected by Delcath over the years. The advisory committee was clearly spooked by the adverse events that were seen in the product’s phase I testing, and ended with a 16-0 vote against the Melblez kit’s benefit versus risk vote (or the “overall” vote if you will. DCTH resumed trading just before after-hours trading closed (after 6:35 PM EST) and closed at $.40/share or at a market capitalization of $36.4 M
While the Delcath vote wasn’t as surprising due to the adverse events from the old clinical trials (and due to a filter that was changed for the Melblez kit too), I think a good number of shareholders were surprised that the FDA rejected Titan’s probuphine due to the enormous unmet need for opioid addiction products that can curb the rise in addiction rates that we’ve seen in the United States in recent years. It also seems that there is some surprise that AVEO’s tivozanib was taken down so harshly by the ODAC on the lackluster overall survival data that we saw in the recent Phase III trial. Based on the votes from today, it’s also likely that tivozanib and the Melblez Kit will also see rejections on their respective PDUFA goal dates of July 28, 2013 and September 13, 2013.