Titan Pharmaceuticals and Braeburn Pharmaceuticals sign license agreement worth up to $305 million
SOUTH SAN FRANCISCO, Calif.—Titan Pharmaceuticals Inc. has signed a license agreement with Braeburn Pharmaceuticals Sprl that grants Braeburn exclusive commercialization rights in the United States and Canada to the investigational product Probuphine, a novel, subdermal implant and the first long-acting product designed to deliver six months of the drug buprenorphine hydrochloride following a single treatment.
Braeburn is wholly owned by Apple Tree Partners IV L.P., a partnership affiliated with Apple Tree Partners, which was founded in 1999 to create life-science companies. Through two predecessor partnerships, Apple Tree founded and built Aileron Therapeutics, Gloucester Pharmaceuticals (acquired by Celgene), HeartWare International and Tokai Pharmaceuticals. The firm intends to use the entirety of its recently closed partnership, Apple Tree Partners IV, to build Apple Tree Consolidated Sprl, a holding company that will create and own complementary life sciences businesses, such as pharmaceuticals, medical devices and technology-enabled healthcare services. Braeburn Pharmaceuticals will become a division of Apple Tree Consolidated.
Titan has received a non-refundable $15.75 million upfront payment and will receive as much as $50 million upon the approval of Probuphine by the U.S. Food and Drug Administration (FDA) for the treatment of opioid dependence. Additionally, Titan will be eligible to receive as much as $130 million upon achievement of sales milestones and potentially another $35 million in regulatory milestones for additional contemplated indications, including chronic pain.
Furthermore, Titan will receive tiered, double-digit percentage royalties on net sales of Probuphine which is, it notes, “within a range that is customary for products at this stage.” In addition to the potential milestone payments, Apple Tree Partners IV has allocated more than $75 million to launch, commercialize and continue the development of Probuphine.
On Oct. 29, 2012, Titan had announced the submission of a New Drug Application (NDA) to the FDA for Probuphine for the maintenance treatment of opioid dependence in adult patients.
"We believe this agreement with Braeburn Pharmaceuticals offers a tremendous opportunity to accelerate the commercialization of Probuphine and provides Titan with the financial resources to further advance our technology and pipeline," said Sunil Bhonsle, president of Titan. "While a broad range of pharmaceutical companies expressed interest in Probuphine, we found that the innovative model of the new company established by Apple Tree not only provides us with a value-driven transaction for Titan shareholders, but also brings to the process a seasoned team of industry veterans with proven track records of launching and commercializing important therapies, including controlled substances. The North American Probuphine franchise will be launched and developed by a top-notch commercialization team, maximizing the potential for its rapid acceptance in the medical and patient community and a successful commercial launch for both companies."
"The Board of Titan is extremely pleased with this strategic partnering outcome and the path forward for Probuphine," added Dr. Marc Rubin, executive chairman of Titan. "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 United States and Canada.
The Titan team is said to be “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.
Some 2.3 million opioid addicts are estimated to exist in the United States, some 20 percent of whom are addicted to illicit opioids, such as heroin, while the other 80 percent are addicted to prescription drugs, such as oxycontin, methadone and codeine. Probuphine is an investigational subcutaneous implant that is “capable of delivering continuous and persistent, around-the-clock blood levels of buprenorphine for six months following a single treatment, enhancing patient compliance and retention,” according to Titan. Buprenorphine, an approved agent for the treatment of opioid dependence, is currently available in the form of daily dosed sublingual tablets and film formulations, with reported 2011 sales of $1.3 billion in the United States.