Paris, France and Tarrytown, New York – February 8, 2017 – Regeneron Pharmaceuticals, Inc (NASDAQ: REGN) and Sanofi announced today that the United States Court of Appeals for the Federal Circuit has stayed (suspended) the permanent injunction for Praluent® (alirocumab) Injection pending the companies’ appeal. This ruling (available here) means that Sanofi and Regeneron will continue marketing, selling and manufacturing Praluent in the U.S. during the appeal process. Sanofi and Regeneron remain committed to ensuring patients who can benefit from Praluent continue to have access to this innovative therapy.
“This decision is important for patients in the U.S. who will continue to have access to Praluent during the appeal process giving them a choice in PCSK9 inhibitor treatments to best meet their individual needs,” said Karen Linehan, Executive Vice President and General Counsel, Sanofi. “It is our longstanding position that Amgen’s asserted patent claims are invalid and we look forward to moving forward with the appeal process.”
The companies are challenging both the injunction ruling and validity judgment during the appeal process. The companies believe Amgen’s asserted patent claims for antibodies targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) are invalid in the ongoing U.S. patent infringement lawsuit.
“We continue to believe the facts and controlling law support our position in this case,” said Joseph J. LaRosa, Senior Vice President, General Counsel and Secretary, Regeneron. “We will continue to vigorously defend our case through the appeal process.”
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 (75 mg and 150 mg) 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.
The injunction (which has been suspended as noted above) is not applicable outside the U.S. or to clinical trials which are continuing as planned. Outside the U.S., Praluent is marketed and sold in 15 countries with anticipated launches in 15 additional countries in 2017.
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.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here for the full Prescribing Information