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Amgen Wins Court Battle for Cholesterol Drug

Amgen Inc. has successfully blocked competitors Regeneron Pharmaceuticals Inc. and Sanofi from selling a rival medication to its cholesterol drug Repatha. On Jan. 5, the U.S. District Court in Delaware granted Amgen a permanent injunction, prohibiting the collaborating companies from domestically manufacturing and selling their cholesterol drug Praluent, which was found to infringe on two Repatha patents. The injunction will not take effect immediately as Regeneron and Sanofi have been given 45 days to appeal the decision. The companies announced they will file a motion to suspend proceedings, which would postpone the ban until the appeal is heard. However, if denied, U.S. sales of Praluent could cease for up to 12 years as the patents are set to expire in 2028. “Amgen respects the court’s thoughtful deliberations in a situation where a competitor made the choice to launch at risk during the pendency of a patent lawsuit within months of an expedited trial date,” the Thousand Oaks biotech said in a released statement. “The company remains confident in the validity of its patents.” At the J.P. Morgan Healthcare Conference in San Francisco, just days after the judge’s decision, Regeneron Chief Executive Len Schleifer commented on the issue. “If they (Amgen) really cared about patients, they wouldn’t rip this drug (Praluent) from patients,” Schleifer said during the conference, according to a story by Thomson Reuters. Praluent was approved by the U.S. Food and Drug Administration in July 2015, and Repatha was greenlighted the following month. Amgen brought suit against New York-based Regeneron and French pharma giant Sanofi in October 2014 for the patents, which cover antibodies that inhibit the PCSK9 gene, resulting in lower cholesterol levels. The litigation is fueled by the fact that this is a new class of drugs that is significantly more expensive than traditional statin cholesterol pharmaceuticals such as Pfizer Inc.’s Lipitor. Just one year of treatment for Repatha or Praluent can cost a patient more than $14,000. Eric Schmidt, an analyst at New York-based Cowen and Co., a subsidiary of Cowen Group Inc., wrote in a Jan. 8 note to investors that if Praluent is pulled from the U.S. market that would imply “an $8-plus per share increase in Amgen’s stock.” The stock closed Jan. 18 at $155.77. During the third quarter, Repatha posted $40 million in sales worldwide, according to Amgen’s latest financial report. Nevertheless, three quarters of Repatha prescriptions are being denied payment by insurers, according to Amgen, as the drug has not been proven to prevent heart attacks at this time. Steve Chesney, an Amgen analyst for U.K.-based Atlantic Equities, estimated that the current U.S. market for this class of drugs is worth $1 billion based on written prescriptions but said the company should release data supporting heart attack prevention by March, which could increase market value. “Following the cardiovascular outcomes trial data due to report this quarter, the PCSK9 market in the United States could be $4 billion by 2020,” Chesney said. “Repatha is probably worth $34 per share. If the data is positive, you would see a significant upside.”

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