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Regeneron Pharmaceuticals, Inc.

Partner : Sanofi

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PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.

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Proceedings Relating to Praluent (alirocumab) Injection

On October 17, 2014 and October 28, 2014, Amgen Inc. filed complaints against Regeneron, Sanofi, Aventisub LLC (subsequently removed and replaced with Sanofi-Aventis U.S. LLC), and Aventis Pharmaceuticals, Inc. in the United States District Court for the District of Delaware seeking an injunction to prevent us and the other defendants from manufacturing, using, offering to sell, or selling within the United States (as well as importing into the United States) Praluent, the antibody to PCSK9 for LDL cholesterol reduction we are jointly developing with Sanofi. On November 11, 2014 and November 17, 2014, Amgen filed complaints against Regeneron, Sanofi, Sanofi-Aventis U.S. LLC, and Aventis Pharmaceuticals, Inc. in the same court seeking the same relief. Amgen asserts U.S. Patent Nos. 8,563,698, 8,829,165 (the '165 Patent), and 8,859,741 (the '741 Patent) in the first complaint, U.S. Patent Nos. 8,871,913 and 8,871,914 (the '914 Patent) in the second complaint, U.S. Patent No. 8,883,983 in the third complaint, and U.S. Patent No. 8,889,834 in the fourth complaint. Amgen also seeks a judgment of patent infringement of the asserted patents, monetary damages (together with interest), costs and expenses of the lawsuits, and attorneys' fees. On December 15, 2014, all of the four proceedings were consolidated into a single case.

On September 15, 2015, Amgen filed a motion for leave to file a supplemental and second amended complaint, which was granted on January 29, 2016. As amended, the complaint alleges, among other things, willful infringement of the asserted patents, which would allow the court to increase damages up to three times the amount assessed if the court finds willful infringement. On October 20, 2015, the District Court issued its claim construction order, in which it defined the meaning of certain disputed claim terms; none of the court's rulings was dispositive of the issues in the case. On November 3, 2015, pursuant to court order, the patents asserted by Amgen were narrowed to the '165, '741, and '914 Patents. The trial is currently set to begin on March 7, 2016, and a permanent injunction hearing (which would be held if the court finds infringement of a valid patent claim by us and Sanofi) is currently scheduled to begin on March 23, 2016.
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Source: Form 10K, 2/11/16. https://www.sec.gov/Archives/edgar/data/872589/000153217616000045/regn-1...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Alirocumab (REGN727/SAR236553)CardiovascularAtherosclerosisPCSK9 inhibitorPCSK9

Mechanism of action: Alirocumab (REGN727/SAR236553) is the first fully human monoclonal antibody directed against proprotein convertase subtilisin/kexin type 9 (PCSK9). REGN727/SAR236553 is a high affinity, sub-cutaneously delivered, specific inhibitor of PCSK9. It blocks the binding of PCSK9 to the low density lipoprotein (LDL) receptor and interrupts the resultant internalization and degradation of the LDL receptor.

Phase of Development: Approved

Event Type: Legal: Patent litigation

Dates: 2016-03-07 - 2016-03-31

Results:

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March 16, 2016
Regeneron and Sanofi Strongly Disagree with U.S. Jury Verdict in Ongoing Patent Litigation Regarding Praluent® (alirocumab) Injection and Will Appeal
TARRYTOWN, N.Y. and PARIS, March 16, 2016 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the companies strongly disagree with a U.S. District Court jury verdict that the asserted claims of two Amgen patents for antibodies targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) are valid. Sanofi and Regeneron believe these Amgen patent claims are invalid in the ongoing U.S. patent infringement lawsuit and plan to appeal the judgment. This decision is the first step in this ongoing litigation and does not impact Praluent® (alirocumab) Injection or our ability to deliver it to physicians and patients at this time.

"It has always been and remains our position that Amgen's asserted patent claims in this matter are invalid," said Karen Linehan, Executive Vice President and General Counsel, Sanofi.

Next steps on damages are to be determined. The judge will hold a hearing to consider a permanent injunction in the near future.

"This is a complex area of law and science, and we believe the facts and controlling law support our position. We look forward to taking our case to the Federal Circuit Court of Appeals, the U.S. appellate court that hears all biopharmaceutical patent appeals," said Joseph LaRosa, Senior Vice President, General Counsel and Secretary, Regeneron. "Praluent was developed with Regeneron's proprietary science and technology and represents an important medical advance for patients."

In July 2015, 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 available in two starting doses that allow physicians to adjust the dose based on a patient's LDL cholesterol lowering needs. The effect of Praluent on cardiovascular morbidity and mortality has not yet been determined.
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Source: press release, 3/16/16. http://investor.regeneron.com/releaseDetail.cfm?ReleaseID=960950

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