Watson Pharmaceuticals (NYSE:WPI) faces a delay in the approval of a vaginal gel that addresses high-risk pregnancies because it received a complete response letter from U.S. regulators.
The letter from the U.S. Food and Drug Administration said the results of phase 3 clinical trial for progesterone vaginal gel 8% did not meet the level of statistical significance expected to support the approval of the product in the U.S. market from a single trial, according to a statement from the Parsippany, New Jersey pharmaceutical company.
Watson will have to do additional clinical work to support approval of the drug, the pharmaceutical company said, citing the letter.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Paul M. Bisaro, the CEO of Watson, said in a statement: “We believe that there is a significant unmet medical need for a safe and effective treatment of patients at risk for preterm birth, which affects approximately one in eight live-born infants in the U.S.”
Columbia Laboratories (NASDAQ:CBRX), a drug developer focused on women’s reproductive health in Livingston, New Jersey, developed the drug with Watson, but transferred its new drug application (NDA) for the preterm birth gel to Watson earlier this month. The move gives Watson full rights and regulatory responsibility for the NDA and helps negotiate the regulatory hurdles to get the drug approved.
Watson, a generic drugmaker, has made branded drugs a priority. In an interview with Bloomberg earlier this month, Bisaro said the company was allocating $6 billion to build its branded business through acquisitions.
