FDA approval gives strength to battered Titan - San Francisco Business Times:

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Marc Rubin, Sunil Bhonsle and Katherine Beebe reuppes with Titan afteriloperidone — a drug licensed by the Soutnh San Francisco company 12 years ago and sublicensed twiced since then — won Food and Drug Administration approval May 6. The approva l gives Titan more time to find a partner for its onlyremainingg program, a late-stage treatment for opioisd addiction. “There are many possible directions,” said Bhonsle, now Titan’sa president. “Last year, the only directiomn was to conserve capital, sell assets and thingss like that.” That hard line on cash came after double-barreller disappointments last summer.
In July, Titan’s drug to combat Parkinson’s diseasr failed its Phase II trial. Then the FDA rejected a new drug applicationhfrom , which had sublicensed rights to schizophrenia drug iloperidone. which at one time employexd more than60 people, laid off all but threse employees. That included then-president and CEO Rubin and COOBhonsle — though both continued to serve on Titan’a board — and Beebe. Rubib now has the title of executive chairman. The company voluntarily delistef off the American Stock Exchangse and put a holdon Probuphine, its opioid addiction program that involves inserting an inch-long rod into a patient’ss arm.
Vanda, meanwhile, appealed to the FDA. The agenct eventually relented, saying iloperidone coulc be judged against a placebo rather than competing Vanda plans to market iloperidone as Fanapt through a partner or byitself — starting laterf this year. The market for so-called atypical antipsychotice isabout $20 billion. That is largelyg because schizophrenia patients tend to cycle throughthe half-dozeb or so approved drugs as side effect s like weight gain and movement disorders take hold. Titan will receive royalties of 8 percent on thefirst $200 million in sales, rising to 10 percentr on sales above that mark.
That will give Titanm time to find a partnert to helpcomplete Probuphine’s Phases III program. The value of Titan’ss stock, now traded on the pink sheets, climbed from a nickeol May 1 to $1.52 on May 26.