Amarin (AMRN -3.7%) is not yet admitting defeat in its patent infringement litigation against would-be generic Vascepa competitors Dr. Reddy’s Laboratories (RDY -0.2%) and Hikma Pharmaceuticals.
Within 30 days, it plans to file a petition for an en banc review of the U.S. Court of Appeals for the Federal Circuit panel decision upholding a Nevada court ruling in favor of the above two generic drug firms. An en banc review allows the full circuit court of 12 judges to potentially overturn a decision from the three-judge panel.
CEO John Thero says, “We are extremely disappointed with today’s ruling and plan to vigorously pursue available remedies. Importantly, we and our partners are continuing to pursue additional regulatory approvals for VASCEPA in China, Europe and the additional countries in the Middle East, and remain confident in the global market potential of VASCEPA. We are particularly excited about the anticipated commercialization opportunities for VASCEPA in Europe as we prepare for expected approval and launch in early 2021. At the same time, we will continue to meet the strong demand for VASCEPA here in the United States through our proven manufacturing capabilities.”
In a statement, Hikma says it received the FDA (conditional) nod in May and is now preparing for commercial launch.
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