Titan Pharmaceuticals Inc. (TTNP) rose the most in almost four years after U.S. regulatory advisers recommended approval for the company’s experimental implant to treat addiction to heroin and prescription painkillers.
Titan increased 36 percent to $1.67 at the close in New York, its biggest single-day gain since May 7, 2009. The Food and Drug Administration is scheduled to decide by April 30 whether to approve the treatment.
Titan’s clinical trial data on the matchstick-size implant, called Probuphine, supports approval, the FDA advisory panel said yesterday in a 10-4 vote with one abstention. Probuphine may generate $360 million in sales in 2018, Michael Higgins, a Brinson Patrick Securities Corp. analyst in New York, estimates.
“Opioid dependence is a rapidly growing public health concern and we remain committed to expanding the treatment options available to physicians and patients to manage this chronic condition,” South San Francisco, California-based Titan said in a statement.
Titan, which licensed the U.S. and Canadian rights to Apple Tree Partners’ Braeburn Pharmaceuticals, has the potential to receive a $50 million milestone payment if the drug is approved.
The FDA panel voted that the drug is safe and effective, while questioning whether the dose of the active ingredient, buprenorphine, was appropriate to help addicts. The advisers supported a risk-mitigation plan though some questioned the adequacy of the company’s training and distribution programs.
“This is at least an incremental step forward in a disease that can have very tragic consequences,” said Christopher Kratochvil, a panel member and associate vice chancellor for clinical research at the University of Nebraska Medical Center. “More data is needed on the safety, but at least it’s a step.”
Addicts now can use Slough, England-based Reckitt Benckiser Group Plc (RB/)’s Suboxone tablets and dissolvable film that combine buprenorphine with the drug naloxone, which is used to reverse the effects of overdose. Orexo AB (ORX), a Swedish biotechnology company, said in November it’s awaiting an FDA decision in July on its experimental film Zubsolv for opioid dependence.
At the meeting, the FDA advisers voted 5-4 with six abstentions that a plan to mitigate the risk of Titan’s drug that using a physician training program and a restricted distribution program is adequate.
Titan’s original risk mitigation proposal is inadequate, and the agency said it’s reviewing a new plan that conforms to federal standards for controlled substances.
“We still have time,” Bob Rappaport, director of the FDA’s Division of Anesthesia, Analgesia, and Addiction Products, said, referring to the agency’s April 30 decision date. “It’s going to be difficult.”
The panel voted 10-5 that Probuphine is effective. FDA staff had questioned whether the dose was high enough to have an adequate effect on drug abuse even though the implant met preset clinical trial goals on effectiveness. Panel members agreed more work is needed to determine the proper dose.
“Overall, the need for a product such as this exceeded those deficiencies,” said Edward Covington, chairman of the panel and director of the Neurological Center for Pain at the Cleveland Clinic in Ohio who voted against approval, summing up the final vote.
The panel also voted 12-2 with one abstention that Titan had shown the implant is safe. FDA staff questioned whether a one-time training program for physicians would be adequate to avoid potential complications from the procedure to put the implant in place.
“One of our jobs is to be as conservative as possible and to look for all the potential problems of a drug,” Rappaport told the panel. “This is a deadly disease. This is a seriously life-threatening disorder.”
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