Feuerstein's Biotech-Stock Mailbag: Titan

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Thanks for returning to the weekly Biotech Mailbag. Our first question comes from Anh N., who asks:

"Could you comment on the future of Titan Pharmaceuticals (TTP Quote) with respect to Probuphine. Looks like it is the last hope for Titan."

The last hope for Titan sounds about right, after the programs for spheramine (Parkinson's disease) and iloperidone (schizophrenia) went bust. Probuphine is a long-acting form of the painkiller buprenorphine, which is used in the U.S. primarily as a treatment for opiate addiction. (Buprenorphine, taken daily as a sublingual tablet, is surpassing methadone as the treatment of choice for heroin addicts, for instance.)

Probuphine takes buprenorphine and reformulates the drug into a rod that is placed just under the skin, releasing a controlled amount of the drug into the body for six months. By eliminating the need to take a pill every day, Titan believes that Probuphine will increase compliance and cut down problems with abuse or diversion.

Initial results from the first phase III study of Probuphine in patients addicted to heroin or other opioids were released on July 28 and were positive.

For Probuphine, so far, so good. That doesn't mean there aren't issues. Titan has a lot more clinical work to do before it can seek regulatory approval for the drug. Another phase III study needs to get done, which will likely require Titan to test Probuphine head to head against sublingual buprenorphine. (Current data pit Probuphine against placebo.)

Given that Probuphine is an implant, safety will be a big concern for regulators. To address the issue, Titan will have to study and collect safety data on Probuphine use for an extended period of time, probably 12 months or more, before seeking approval.

Titan isn't likely to have all its Probuphine clinical studies completed until the latter part of 2010. That's a long time to wait for a drug that really doesn't have a huge commercial potential. (U.S. sale of sublingual buprenorphine were about $350 million, according to Titan, which means Probuphine would be competing for some smaller slice of that amount.)

In the more near term, the best way for Titan to bump up its stock price will come from signing a Probuphine development partner. That's a task management says it's working on. A deep-pocketed partner, if Titan can find one, will also be the way to move Probuphine into more lucrative indications, like chronic pain.