Valeant said Thursday that it expects to close the deal in the third quarter of this year, pending customary closing conditions and regulatory approval.
This week, Sprout announced that it received Food and Drug Administration approval for Addyi (flibanserin, 100 mg), which the company called the first FDA-approved medication for hypoactive sexual desire disorder (HSDD) in women. Sprout said Addyi is slated to be released in the United States by Oct. 17. Sprout also has global rights for flibanserin, and Valeant said it will leverage its global scale to register flibanserin internationally.
“Delivering a first-ever treatment for a commonly reported form of female sexual dysfunction gives us the perfect opportunity to establish a new portfolio of important medications that uniquely impact women. We applaud the efforts of the Sprout team to address this important area of unmet need and look forward to working with them to bring the benefits of Addyi to additional markets around the world,” stated J. Michael Pearson, Valeant’s chairman and chief executive officer.
Plans call for Sprout to keep its headquarters in Raleigh, N.C. and become a division of Valeant. Cindy Whitehead, CEO and co-founder of Sprout, will join Valeant to lead this division dedicated to the introduction and global commercialization of Addyi. She will report to Anne Whitaker, executive vice president and company group chairman at Valeant.
“I am extremely proud of the commitment and passion of our 34 employees who have been mission-driven to get to this breakthrough first for women,” Whitehead commented. “This partnership with Valeant allows us the capacity to now ensure broader, more affordable access to all the women who have been waiting for this treatment. Beyond building this in the United States, Valeant also offers us a global footprint that could eventually bring Addyi to women across the globe.”
Valeant said it expects Addyi to be available in the United States in the fourth quarter through prescribers and pharmacies that have been certified under the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program to ensure safe use. After the closing of the Sprout acquisition, Valeant, under the REMS, will offer physicians and pharmacists the required certification programs for prescribing and dispensing Addyi.
“The Valeant team is excited to be a part of the launch of this critically important treatment for women, and I am personally delighted to welcome Cindy and her colleagues at Sprout to Valeant,” added Whitaker. “The Sprout team, along with the healthcare providers involved in the Addyi pivotal clinical trials, has delivered on its promise to provide access to a safe and effective treatment for a condition that affects millions of women.”