"The Board of Titan is extremely pleased with this strategic partnering outcome and the path forward for Probuphine," said Marc Rubin, M.D., executive chairman of Titan Pharmaceuticals. "It is our ultimate goal to rapidly and efficiently advance Probuphine to the market and the patients and clinicians who can benefit from safe and effective treatments for opioid addiction. Braeburn Pharmaceuticals has been formed with that same goal and we look forward to working with their team to achieve it."
Under the terms of the agreement, Titan will remain responsible for any expenses associated with the support of the current NDA review process. Upon completion of the FDA review process, Braeburn Pharmaceuticals will assume all responsibility for commercialization and further clinical development of Probuphine in the U.S. and Canada. The Titan team is already interacting routinely with the Braeburn team and will continue to assist through product launch as needed. Titan and Braeburn Pharmaceuticals will also have a joint development committee to oversee the overall strategic objectives and plans relating to the development of Probuphine, including regulatory strategy with respect to any Phase IV clinical trials, communications with regulatory authorities and clinical programs for chronic pain and any other potential indications.
"The leadership team of Braeburn Pharmaceuticals combines the entrepreneurial success of Apple Tree Partners with a proven track record in pharmaceutical development and commercialization," said Ms. Crane, partner at Apple Tree Partners and head of pharmaceutical commercialization at Apple Tree Consolidated. "We are excited by the Probuphine opportunity and look forward to working with the Titan team to drive the successful commercial launch following FDA approval."
"Probuphine is an exciting new product with the potential to change the lives of patients suffering from opiate dependence," said Dr. Neil, partner at Apple Tree Partners and head of pharmaceutical research and development at Apple Tree Consolidated.
Titan Conference Call
Members of the Titan and Braeburn Pharmaceuticals management teams will host a conference call to discuss the deal today at 4:05 pm ET. Participating on the call will be Mr. Bhonsle, Dr. Rubin, Katherine Beebe, Ph.D., executive vice president and chief development officer of Titan, Ms. Crane and Dr. Neil. The live webcast of the call may be accessed by visiting the Titan website at www.titanpharm.com. The call can also be accessed by dialing 888-221-3887, Participant Code: 7422088 five minutes prior to the start time. A replay of the call will be available on the Titan website approximately two hours after completion of the call and will be archived for two weeks.
About Opioid Addiction
It is estimated that there are 2.3 million opioid addicts in the U.S. Approximately 20 percent of this potential patient population is addicted to illicit opioids, such as heroin, and the other 80 percent to prescription drugs, such as oxycontin, methadone, and codeine. Until recently, medication-assisted therapies for opioid addiction had been sanctioned to a limited number of facilities in the U.S. Today, physicians can be certified to prescribe certain opioid addiction medications in an office setting, which has greatly expanded patient access to opioid addiction pharmaceutical therapies. As a result, it is estimated that there are approximately 750,000 people in the U.S. receiving medicinal treatment for opioid addiction.
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