Sanofi and Regeneron strongly disagree with verdict upholding three of five Amgen U.S. patent claims relating to PCSK9 antibodies
Praluent® (alirocumab) continues to be available in the U.S.
PARIS and TARRYTOWN, NY - February 25, 2019 - Sanofi and Regeneron Pharmaceuticals Inc. announced they strongly disagree with certain aspects of today's jury verdict from the U.S. District Court for the District of Delaware. The jury upheld the validity of three of the five asserted claims of two Amgen U.S. patents covering antibodies targeting PCSK9 (proprotein convertase subtilisin/kexin type 9). The jury agreed with Sanofi and Regeneron for two of the five asserted claims, finding they were invalid based on lack of written description. The verdict does not impact U.S. physicians' and patients' access to Praluent® (alirocumab).
"We are disappointed in today's verdict," said Karen Linehan, Executive Vice President and General Counsel, Sanofi. "It is our longstanding belief that all of Amgen's asserted U.S. patent claims are invalid and we believe the law and the facts support our positions."
Sanofi and Regeneron intend to file post-trial motions with the District Court over the next few months, seeking to overturn the jury verdict and also requesting a new trial. In addition, if necessary, the companies plan to appeal to the Court of Appeals for the Federal Circuit. On February 8, 2019, the District Court dismissed Amgen's claim for willful infringement.
"We will continue to vigorously defend our positions against Amgen's overly broad patent claims," said Joseph LaRosa, Executive Vice President, General Counsel and Secretary, Regeneron. "We are considering our next steps in this important case and continue to believe in the differentiated clinical profile of Praluent."
Praluent® (alirocumab) inhibits the binding of PCSK9 to the low-density lipoprotein (LDL) receptor and thereby increases the number of available LDL receptors on the surface of liver cells to clear LDL, which lowers LDL-C levels in the blood. Praluent was developed by Regeneron and Sanofi under a global collaboration agreement.
Praluent is approved in more than 60 countries worldwide, including the EU, U.S., Japan, Canada, Switzerland, Mexico and Brazil. In the U.S., Praluent is approved for use as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL-C.
In the EU, Praluent has been initially approved for the treatment of adult patients with primary hypercholesterolemia (HeFH and non-familial) or mixed dyslipidemia as an adjunct to diet: a) in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL-C goals with the maximally-tolerated statin or b) alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. The effect of Praluent on cardiovascular morbidity and mortality has not been determined.
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neuromuscular diseases, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life
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