Blog Coverage Amgen’s Legal Victory Blocks Rivals Sanofi and Regeneron from Selling their Cholesterol Drug in the US

LONDON, UK / ACCESSWIRE / January 9, 2017 / Active Wall St. blog coverage looks at the headline from Amgen Inc. (NASDAQ: AMGN), Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi SA (NYSE: SNY). In a major legal victory for Amgen Inc. (NASDAQ: AMGN), the US District Court Judge at Delaware, Sue Robinson, ruled that the Company’s rivals Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi SA (NYSE: SNY) will not be able to market, sell, or manufacture their Cholesterol drug Praluent in US for 12 years as the drug infringes on Amgen’s two patents for Repatha. Register with us now for your free membership and blog access at:

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Following the Federal Judge’s ruling, Sanofi and Regeneron will be banned from selling Praluent in US markets, which will leave Amgen’s Repatha in an unchallenged position. Sanofi and Regeneron have a 30-day time frame to evaluate the ruling and appeal against it.

Commenting on the legal victory Chairman and CEO of Amgen, Robert A. Bradway said:

“We are pleased with today’s decision that recognizes Amgen is entitled to an injunction against further infringement of our patent rights. Sanofi and Regeneron admitted that they had infringed our patents, and the jury upheld our patents as valid. Protecting intellectual property is essential to our industry as it reinforces the incentives for the large and risky investments we make in innovation to bring forward new medicines to treat serious diseases.”

Amgen has assured patients using Praluent who want to switch over to Repatha, that their Repatha drug is available in enough quantity to be able to meet the additional demand.

Amgen’s patent Infringement case so far

Amgen had filed the lawsuit against Sanofi and Regeneron in October 2014. Praluent uses PCSK9 inhibitors to block PCSK9 proteins to reduce LDL Cholesterol levels. Amgen claimed that this infringed on its patents related to PCSK9 proteins.

In March 2016, the trial jury in the Federal Court in Delaware issued a verdict in favor of Amgen, stating that Amgen’ two patents on the PCSK9 proteins were valid and Sanofi and Regeneron were infringing on these patents. Before the start of the trial, Sanofi and Regeneron had acknowledged infringement claims.

Following the jury’s verdict, Sanofi and Regeneron announced that they disagreed with the jury’s verdict and would appeal against the decision. Sanofi and Regeneron feel that Amgen patent claims are invalid and that they exceed the scope of its original discovery. Judge Sue Robinson had suggested the three companies to work out a royalties’ payment agreement to amicably sort the patent-infringement claim and even threatened to ban the sale of Praluent, if they did not agree. Under the agreement, Sanofi and Regeneron could decide on a royalty payment to Amgen based on sales of Praluent.

However, Sanofi and Regeneron had rejected the Judge’s suggestion and asked for a fresh trial after overturning the trial jury’s verdict. The Judge had denied the motion on January 04, 2017.

Repatha and its contender, Praluent

Repatha (evolocumab) Injection was approved in August 2015 by the US Food and Drug Administration (FDA) for the treatment of two rare genetic diseases known for high LDL-C, as well as patients who have atherosclerotic cardiovascular disease (The build-up of fats, cholesterol, and other substances in and on the artery walls). Sanofi and Regeneron had received the FDA’s approval for Praluent in July 2015, before Amgen’s Repatha’s FDA approval. Repatha and Praluent are a new class of drug called proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. PCSK9 inhibitors work by blocking PCSK9, which affects the liver’s ability to remove cholesterol from the blood.

Sanofi and Regeneron’s response

Sanofi and Regeneron have announced that they would file a motion for a suspension (stay) on the injunction granted by the US District Court of Delaware which banned both companies from marketing, selling or manufacturing of Praluent in US. During the 30-day period, Praluent will continue to be available commercially.

Karen Linehan, Executive Vice President and General Counsel at Sanofi, said:

“We will immediately appeal today’s ruling, along with the jury’s earlier finding upholding the validity of Amgen’s patents. 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”

Joseph LaRosa, Senior Vice President, General Counsel, and Secretary at Regeneron, added:

“We will continue to vigorously defend our case through the appeal process as we believe the facts and controlling law support our position.”

Stock Performance

At the close of trading session on January 06, 2017, Amgen’s stock price rose 2.48% to end the day at $156.78. A total volume of 9.89 million shares were exchanged during the session, which was above the 3-month average volume of 3.91 million shares. The Company’s share price has gained 8.04% in the past one month and 7.23% on YTD basis. The stock currently has a market cap of $117.88 billion and has a dividend yield of 2.93%.

Regeneron Pharma’s shares were the hardest hit as it fell 5.84%, finishing last Friday’ trading session at $358.68 with volume of 3.25 million shares exchanging hands by the close of the trading session. Shares of the company have a PE ratio of 52.25. The stock has a market capital of $38.52 billion.

Sanofi’s shares, on the other hand, saw a decline of 2.84% and closed at $40.32 on January 06, 2017. A total of 2.60 million shares exchanged hands on the day’s trade. The stock has advanced 4.70% in the last quarter and 1.81% in the last twelve months. The stock is trading at a PE ratio of 23.83 and has a dividend yield of 4.12%. At the close of Friday’s session, the stock has a market cap of $102.08 billion.

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