Titan Pharmaceuticals Inc. (TTNP) plunged the most in 17 years after the company failed to win U.S. regulatory approval for an implant to treat addiction to heroin and prescription painkillers.
Titan fell 74 percent to 43 cents at 4 p.m. New York time, the biggest drop since January 1996 when the company began offering public shares. The Food and Drug Administration asked for more information to prove the matchstick-size implant called Probuphine for opioid dependence works, the company said in a statement yesterday. The FDA wants additional data on the effect of higher doses of Probuphine and training for doctors on insertion and removal of the implant.
Probuphine may generate $360 million in sales in 2018, Michael Higgins, an analyst for Brinson Patrick Securities Corp., said in an e-mail before the rejection. Titan, based in South San Francisco, California, licensed the U.S. and Canadian rights to Apple Tree Partners’ Braeburn Pharmaceuticals. Titan is eligible for a $50 million milestone payment on approval.
“Titan and our partner, Braeburn Pharmaceuticals, are extremely surprised and disappointed with the FDA’s response,” Marc Rubin, executive chairman of Titan, said in the statement.
Titan believes Probuphine demonstrated both safety and efficacy and meets a “critical need for new safe and effective treatments that reduce the likelihood of abuse, diversion and accidental pediatric exposure,” Rubin said.
Titan plans to discuss the rejection with the FDA to obtain clarification and determine next steps.
More than 12 million people reported using prescription painkillers recreationally or without a prescription, according to the Centers for Disease Control and Prevention. The drugs were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined, the Atlanta-based CDC said.
A panel of FDA advisers that gave Probuphine a positive recommendation in March raised concern that the dose of the active ingredient, buprenorphine, may have been too low and questioned the adequacy of the physician training program.
Addicts now can use Slough, England-based Reckitt Benckiser Group Plc (RB/)’s Suboxone dissolvable film that combines buprenorphine with the drug naloxone, which is used to reverse the effects of overdose. Orexo AB (ORX), a Swedish biotechnology company, is awaiting an FDA decision in July on its experimental tablet Zubsolv that dissolves under the tongue for opioid dependence.
Titan’s Probuphine implant deliver’s six months of buprenorphine.
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