Amgen Shares Soar After Blocking Rivals From Selling Competing Cholesterol-Lowering Drug

January 6, 2017
By Alex Keown, BioSpace.com Breaking News Staff

THOUSAND OAKS, Calif. – Shares of Amgen are still climbing this morning after the company was successful in blocking rivals Regeneron and Sanofi from selling their cholesterol drug Praluent in the United States.

The legal victory leaves Amgen’s Repatha as the sole drug of its type in the United States. Regeneron and Sanofi will not be allowed to market Praluent in the United States for 12 years because the drug infringes on Amgen’s patents for Repatha, U.S. District Court Judge Sue Robinson ruled Thursday, according to Bloomberg. The injunction will not take effect immediately as the court has delayed its imposition for 30 days to allow defendants the opportunity to seek expedited review of this decision, Amgen said in a Thursday statement.

Prior to the hearing, Sanofi and Regeneron admitted their combined research infringed on Amgen’s patents. Bloomberg noted this is a common legal tactic that drives the focus to whether or not a patent should have been issued at all. In their arguments, Sanofi and Regeneron said Amgen’s patent exceeds the scope of its original discovery, which wrongfully gave “it control over a new class of treatments.” "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," Robert A. Bradway, Amgen’s chairman and chief executive officer, said in a statement.

Following the ruling, Amgen’s shares shot up 5 percent in after-hours trading on Thursday. The stock has continued to rise nearly 3 percent this morning. Shares are currently trading at $158.14. In contrast, shares of Regeneron are down nearly 7 percent, trading at$354.42. Shares of Sanofi are down nearly 3 percent, trading at $40.38.

Repatha was approved by the U.S. Food and Drug Administration last year to treat two rare genetic diseases known for high LDL-C, as well as patients who have atherosclerotic CV disease. Repatha is a PCSK9 inhibitor. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, which lowers LDL-C levels.

Amgen said it has the ability to “supply all potential Repatha patients and will work to ensure a smooth transition for patients who wish to switch to Repatha.”

While Amgen is certainly celebrating the victory, Regeneron and Sanofi will appeal the ruling. In a statement, the two pharma companies said “the best interests of patients will be greatly disserved by an injunction preventing access to Praluent.” In their arguments, lawyers for Regeneron and Sanofi said that banning sales of Praluent “would harm patients, who are able to take lower doses of the cholesterol drug than are available through Amgen’s medication,” Bloomberg reported.

Praluent was the first PCSK9 inhibitor to be approved for use in the United States. The drug is available in two dose levels, which allows “healthcare providers the flexibility to adjust the therapeutic dose based on their patient's LDL cholesterol-lowering needs,” the companies said in a joint statement.