Endo Pharmaceuticals (NASDAQ:ENDP) has ended its developments of an octreotide implant to treat a disorder in which the body produces too much growth hormone following a review of its research and development priorities, according to a filing with the U.S. Securities and Exchange Commission.
The move was prompted in part by a request by the U.S. Food and Drug Administration earlier this year for the company to do additional preclinical studies, including a carcinogenicity study. Acronegaly is a condition in which the body produces too much growth hormone and the body tissues gradually enlarge. Other factors cited by the company in its decision were focus and available resources for current and future projects, and the commercial potential for the product.
The decision was an about-face for the company that had said in a 10-k filing last month that it would go ahead with the development of the treatment despite facing additional years before FDA approval. “Although this development causes a delay of up to four years in the timing associated with regulatory approval, the company intends to continue the development of this product and is encouraged by recent preliminary results from its phase 3 study.”
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.
Additionally, Endo discontinued development of the octreotide implant for the treatment of carcinoid syndrome because market research found it faced commercial challenges with physician acceptance and the expected rate of existing patients willing to switch therapies, the filing said.
Earlier this month, the Chadds Ford, Pennsylvania company got FDA approval for its extended-release drug Felodipine, a generic version of AstraZeneca‘s (NYSE:AZN) drug, Plendil, which has produced $196 million in sales for AstraZeneca for the first nine months of 2011.
