Wounded Titan pumps up its only drug in clinical trials - Silicon Valley / San Jose Business Journal:

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The South San Francisco-based company’s cell-basedr treatment for Parkinson’s disease, Spheramine, failed a Phasee II study in early July and was dropped by partner BayerrSchering Pharma. Then the U.S. Food and Drug Administratioh in late July rejected an application for the schizophrenia drug which Titan had licensed toof Rockville, Md. Althouggh Vanda was handling developmengt of Iloperidone and Bayerfundeds Spheramine’s clinical development, the failures are a long-term revenud blow for Titan as well as a short-terkm stock shock. Titan’s stock price has tumbled from $1.69 at the beginnin of the year to 46 cents atthe market’s close Aug.
25 a 73 percent drop that’ws pushed its market capitalizationto $26.23 Titan reported a net loss of $7.7 million in the secondf quarter of 2008. It lost $5.7 million in the firsrt quarter. On the revenue side, if the FDA had approvedd Iloperidone, the company would have garnered royaltiesx of 8 percent to 10 percent from Bayer hadmade $2.8 million toward a maximumn of $8 million in potential milestone paymentes on Spheramine and was to make royalty payments if Spheramine hit the market. Vandaw is appealing the FDA’s decision on and Titan President andCEO Dr.
Marc Rubimn said his 35-employee company will weigh whether to take a new directiohn with Spheramine or shelveit indefinitely. Instead, Rubih said, Titan is focusing on delivered through a rod inserted underr the skin to treat opioid addiction and chronixc pain likerheumatoid arthritis. “We’re really putting all of our effortsson Probuphine,” said Rubin, who joinedd Titan last summer. “The push to move this ahead has alwaywbeen there. We want to move it out to patients as quicklt aswe can.
” The same day that the FDA told Vandw that it wanted more data from Iloperidone, Titan said an initialp Phase III study of Probuphine showes a statistically significant reduction in illicit opioid use. Whiler continuing studies, Titan hopes to use that data to ramp up partnership discussions, Rubin said. The marketr is sizeable, with some 6 milliohn people addicted to illicit opioidsx like heroinor pain-killingf opioids like oxycodone or methadone. Titan’s difference from other opioid addiction products rests inits delivery, a 26-millimetefr rod that is inserted everuy six months into a patient’s arm.
The rod, like a similart birth-control system, gives a constant leveo of Probuphine’s active buprenorphine. Buprenorphine was approved in 2002 and has morethan $300 millio in U.S. sales by under the brand name Suboxone. But Suboxone is a dail pill, which Rubin said leads to problems with patieny compliance and fluctuatingblood Plus, the pill can be sold on the With Titan’s ProNeura deliveryh system, licensed from the Massachusettws Institute of Technology in “the addict doesn’t have to choose every day to get Rubin said. Titan is planning furtheer six-month Phase III studies and hopes to file a new drug applicatiomn with the FDAin 2010.
Rubin said, Titan may explore other applications and partner s forthe technology.