AÂ federal jury this month cast doubt on the future of the latest drug product marketed by Regeneron Pharmaceuticals Inc. and its French collaborator, Sanofi, when it found they infringed on patents held by another U.S. biotech company when developing an injectable antibody to lower bad-cholesterol levels in adults.
Regeneron”™s alirocumab, whose trade name is Praluent, was approved last July by the U.S. Food and Drug Administration for use by adults with either an inherited form of high low-density lipoprotein cholesterol ”” commonly called bad cholesterol ”” or atherosclerotic cardiovascular disease. Used as an adjunct to diet and standard cholesterol-reducing drugs called statins, Praluent was the first of a new class of drugs known as PCSK9 inhibitors to be approved by the FDA, based on the results of ongoing clinical trials on humans in the U.S. and Europe by Regeneron and Sanofi. PCSK9 is a protein that reduces the liver”™s ability to remove bad cholesterol from the blood.
Praluent last September was approved in European Union countries for use by adult patients with specific medical conditions to lower their bad-cholesterol levels.
Introduced to physicians and patients in the U.S. in late July, Praluent in its first months on the market last year notched $10.5 million in net product sales, according to Regeneron in its recent annual report. Net sales for Praluent in the fourth quarter of 2015 amounted to $7 million.
Potential revenue from Praluent sales could be much greater for Regeneron, the state”™s largest biotech employer, which reported total revenue of $4.1 billion in 2015, an approximately 45 per cent increase from 2014, and net sales in the U.S. last year of nearly $2.68 billion for its leading commercial product, Eylea, a treatment for retinal disease, a 54 percent increase from 2014. In the U.S. alone, Praluent”™s potential users include 8 million to 10 million patients with the inherited form of high bad cholesterol, heterozygous familial hypercholesterolemia, officials at Regeneron headquarters on the Landmark at Eastview campus near Tarrytown said last summer.
And more than 71 million American adults have high bad-cholesterol levels, according to Regeneron”™s opponent in the patent infringement case, Amgen Inc.
Regeneron officials in the annual report said Praluent faces potentially strong competition in the market from PCSK9 inhibitors and other bad-cholesterol therapies being developed by other companies, including Pfizer, Eli Lilly and Merck. Among those competitors, only Amgen, based in Thousand Oaks, Calif., already has received approval from the FDA and the European Commission to market its evolucumab compound, whose trade name is Repatha. The FDA”™s approval of the new drug in 2015 came one month after Regeneron’s Praluent was approved as the first PCSK9 inhibitor licensed in the country.
In October 2014, while Praluent was still being developed by Regeneron, Sanofi and Sanofi”™s U.S. subsidiaries, Amgen filed a complaint in U.S. District Court in Delaware that the companies were infringing on patents held by Amgen for its PCSK9 inhibitor. Amgen sought a judgment that its active patents had been infringed upon and a court injunction halting the manufacture, sale, use and import of Praluent in the U.S.
Amgen in its complaint claimed its competitors began developing their own fully human monoclonal antibody drug to treat bad cholesterol after Amgen had begun research on monoclonal antibodies that led to its Repatha drug. The company claimed Regeneron and Sanofi in 2014 sped up their regulatory submissions to the FDA and in Europe and used a special FDA priority review voucher they purchased for $67.5 million from another biopharmaceutical company to shorten the FDA review and approval timeline.
In January, Amgen amended its federal complaint to allege that Regeneron and its partner”™s actions amounted to willful infringement of Amgen”™s patents. If the court agrees, the defendants could pay damages up to three times higher than the assessed amount, Regeneron officials said in their annual report.
On March 16, a federal jury found the defendant companies had failed to prove that Amgen”™s patent claims were invalid. Following the verdict, Regeneron and Sanofi asked U.S. District Court Judge Sue L. Robinson to issue a judgment of no willful infringement by the defendants. Amgen has opposed that legal move.
A hearing on a permanent injunction to remove Praluent from the U.S. market had been scheduled to begin on March 23 as the Business Journal went to press. A Regeneron spokesperson did not respond to a request for comment on the status of the case and the potential impact on Regeneron”™s business.
On the day of the verdict, Regeneron and Sanofi in an announcement said they “strongly disagree” with the jury”™s findings. “It has always been and remains our position that Amgen”™s asserted patent claims in this matter are invalid,” said Karen Linehan, Sanofi”™s executive vice president and general counsel.
Attorney Joseph LaRosa, senior vice president, general counsel and secretary of Regeneron, said the losing parties will take their case to the U.S. Court of Appeals for the Federal Circuit, the court in Washington, D.C. that hears all patent and trademark appeals. “This is a complex area of law and science, and we believe the facts and controlling law support our position,” he said.
“Praluent was developed with Regeneron”™s proprietary science and technology and represents an important medical advance for patients,” LaRosa added.
Regeneron officials through a company spokesperson said they do not expect the U.S. District Court to rule on Amgen’s request for a permanent injunction for six to eight months.
The jury verdict and prospect of a permanent injunction seemed to have little immediate effect on Regeneron Pharmaceuticals stock prices. Trading closed at $368.46 per share on the day of the verdict and company announcement, up $1.24 per share from the previous day”™s closing price, and closed that week at $364.51 per share.
Regeneron stock prices, however, have tumbled through the first quarter of this year after closing out 2015 at $542.87 per share.
