September 28, 2023
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Amgen lawsuit over cholesterol drug will get new trial


An Amgen lawsuit against a competing cholesterol drug will get a new trial but sales of the drug will be allowed in the U.S. until a decision is rendered.

A federal court of appeals judge threw out a ban on the sale of Praluent, manufactured by New York-based Regeneron Pharmaceuticals and French biotech company Sanofi SA. A jury trial had previously resulted in a sales ban when Thousand Oaks-based Amgen sued, claiming that Praluent violated its patents for Repatha.

The judge in the appeal said that jurors were given improper instructions related to the broad range of antibodies Amgen had patented.

“We continue to believe that the law and facts support our position, and we look forward to presenting our complete evidence at trial to a new jury,” Joseph LaRosa, senior vice president and general counsel at Regeneron, said in a joint statement with Sanofi Oct. 5. “Praluent represents an important medical advancement for patients, and we remain confident in the meaningful value that Praluent provides not only to patients, but to the overall health care system.”

The two companies said the schedule for the trial had not been determined but that they did not expect it to begin before the end of the year.

“Our ability to discover and deliver new medicines that benefit patients depends on meaningful patent protection and enforcement that enable significant investments in drug development and clinical trials,” Amgen said in an email statement to the Business Times. “We are disappointed by the court’s action in reversing and remanding the district court’s decision with respect to validity of our patents based on select pre-trial rulings. The court, however, also rejected a main argument brought by defendants in seeking to overturn the injunction. We firmly believe in the validity of our patents and we look forward to reasserting our rights in court.”

Sales of Repatha have already brought in $132 million for Amgen in the first half of 2017, after totaling $141 million in fiscal year 2016.

Shares for Amgen fell nearly 2 percent to $186.69 after the announcement.

In other Amgen news, the company partnered up with Bay Area-based CytomX Therapeutics to develop an anti-cancer drug, purchasing $20 million of its common stock.

CytomX will lead the early development of the therapy and Amgen will head up later development and commercialization. Amgen also made a $40 million upfront payment to CytomX, and agreed to pay another $455 million with the achievement of certain milestones in development, regulatory approval and commercialization. CytomX will have the option for a share of U.S. profits as well as double-digit royalties on international net sales.

Preclinical studies of the treatment, which uses antibodies called T-cell engaging bispecifics that help fight tumors, showed that it reduced tumor regressions and increased the window for patients to receive therapies.

“Our collaboration with CytomX leverages Amgen’s development leadership in bispecifics and expands our immuno-oncology capabilities with an additional and complementary bispecific technology,” Sean Harper, executive vice president of research and development at Amgen, said in a news release, calling the area of study “a particularly compelling target” due to its potential for limiting toxicity for patients.

Amgen also gained access to exclusive rights for three other potential therapies. If it decides to develop and commercialize them, CytomX would receive upfront and milestone payments up to $950 million, plus royalty payments.

The Bay Area company also received rights to a preclinical T-Cell engaging bispecific program, from which Amgen is eligible to receive milestone and royalty payments on products, but specific financial terms of that deal were not disclosed.

• Contact Marissa Nall at