Regeneron & Sanofi to Appeal U.S. District Court Rulings in Ongoing Patent Litigation Regard Praluent® (ALIROCUMAB) Injection
TARRYTOWN, N.Y. and PARIS, Jan. 5, 2017 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced that they will appeal the injunction granted today by the U.S. District Court for the District of Delaware preventing the marketing, selling or manufacturing of Praluent® in the U.S. during the term of two Amgen patents. The companies believe Amgen’s asserted patent claims are invalid and will also appeal a prior jury verdict upholding the validity of those patents. The court has delayed imposition of the injunction for 30 days to allow Sanofi and Regeneron to file a motion for a suspension (stay) of this injunction during the appeal process. Praluent continues to be available to patients at this time.
“We will immediately appeal today’s ruling, along with the jury’s earlier finding upholding the validity of Amgen’s patents,” said Karen Linehan, Executive Vice President and General Counsel, Sanofi. “It is our longstanding position that Amgen’s patent claims are invalid and that the best interests of patients will be greatly disserved by an injunction preventing access to Praluent.”
“We will continue to vigorously defend our case through the appeal process as we believe the facts and controlling law support our position,” said Joseph LaRosa, Senior Vice President, General Counsel and Secretary, Regeneron.
Praluent was the first PCSK9 inhibitor to be approved for use in the U.S. It is indicated for use as adjunct to diet and maximally-tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of “bad” (LDL) cholesterol. Praluent is the only PCSK9 inhibitor that offers two doses with two levels of efficacy, allowing healthcare providers the flexibility to adjust the therapeutic dose based on their patient’s LDL cholesterol-lowering needs. The effect of Praluent on cardiovascular morbidity and mortality has not yet been determined.
Important Safety Information for U.S.
Do not use PRALUENT if you are allergic to alirocumab or to any of the ingredients in PRALUENT. Before you start using PRALUENT, tell your healthcare provider about all your medical conditions, including allergies, and if you are pregnant or plan to become pregnant or if you are breastfeeding or plan to breastfeed.
Tell your healthcare provider or pharmacist about any prescription and over-the-counter medicines you are taking or plan to take, including natural or herbal remedies.
PRALUENT can cause serious side effects, including allergic reactions that can be severe and require treatment in a hospital. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any symptoms of an allergic reaction including a severe rash, redness, severe itching, a swollen face, or trouble breathing.
The most common side effects of PRALUENT include: redness, itching, swelling, or pain/tenderness at the injection site, symptoms of the common cold, and flu or flu-like symptoms. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Talk to your doctor about the right way to prepare and give yourself a PRALUENT injection and follow the “Instructions for Use” that comes with Praluent.
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for high LDL cholesterol, eye diseases, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.