Boston, MA 05/02/2014 (wallstreetpr) – On April 24, Actavis plc (NYSE: ACT) announced that it has formed an agreement with Pfizer, Inc. in order to settle all pending patent litigation related to Actavis’ generic version of its drug, Celebrex(R) (celecoxib) – related to the 50 mg, 100 mg, 200 mg and 400 mg capsules. Celebrex is recommended for the alleviation of the symptoms and signs of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis, as well as for dealing with acute pain in adults.
A Bright OutlookFor Celebrex
Under the terms of thissettlement, Actavis will be acquiring a license from Pfizer to sell its generic Celebrex from December 2014 or before, depending upon certain circumstances. Other details of the agreement were not disclosed.
The launch of Actavis’ drug is dependent upon Actavis acquiring a final approval on its Abbreviated New Drug Application (ANDA)from the U.S. Food and Drug Administration (FDA), for generic Celebrex. Based on available information, Actavis believes that it may be the first applicant to file an ANDA for the generic version of Celebrex and that should its ANDA be given approval. The company might be entitled to 180 days of exclusivity or shared exclusivity in the market, subject to determination by the FDA, that the drug is eligible for receiving exclusivity under the mandates of the Hatch-Waxman Act.
For the twelve month period ending on December 31, 2013, Celebrex had a cumulative U.S. sales figure of approximately $2.2 billion.
A Shift In Top Management
On April 21, Actavis announced that its President of Global R&D, G. Frederick Wilkinson, will be leaving the company effective on April 25. Actavis plc (NYSE: ACT) mentioned that Wilkinson had accepted the position of President and CEO at Impax Laboratories, Inc. (NASDAQ: IPXL).
Paul M.Bisaro, the Chairman and CEO of Actavis stated that, over the last five years, Wilkinson had played a key role in their evolution from a generics company to a specialty pharmaceutical company. He had been instrumental in the successful launches of the drugs – Rapaflo(R) and Gelnique(R), revitalizing the brand’s oral contraceptive category with the launch of Generess(R) Fe, and that he had broadened the brand development pipeline that he’d taken over in 2009, both organically and through acquisitions. He had also been a key figure in the establishment of their biosimilar strategy, which presently includes five products in development, four of which come under the Amgen/Actavis collaboration.
Actavis plc (NYSE: ACT)’ Global Research and Development arm will now report to Robert Stewart, the President of Actavis’ Global Operations.
