Sales of Celgene’s marquee cancer drug surge as Trump's price-crackdown looms

Sales of Celgene’s marquee cancer drug are growing despite questions about how the Trump administration's plan to address rising drug costs will affect pharmacy companies.

[Trump speech on drug prices set for May 11, sources say]

U.S. sales of Revlimid increased nearly 21 percent to $1.4 billion for the quarter that ended on March 31, the company said Friday. The drug drove $8.2 billion in global sales in 2017, 63 percent of Celgene's product sales for the year.

Generic competitors have long accused Celgene of abusing a safety program at the Food and Drug Administration for riskier drugs – known as the Risk Evaluation and Mitigation Strategy, or REMS – to restrict access to the medications, which generic rivals need to create lower-cost versions. The company has faced related antitrust lawsuits from rivals like Mylan Pharmaceuticals.

Celgene itself filed a lawsuit earlier this year to block Dr. Reddy's Laboratories from selling a generic version of Revlimid, but doesn't expect to make it to court in the near future.

"We don't see a trial at all this year, and it's very, very difficult to know if something would be scheduled for 2019," Chief Executive Officer Mark Alles told investors.

The pharmaceutical industry is bracing for President Trump to unveil a drug-pricing plan, details of which are largely unknown but have been hinted at by FDA Commissioner Scott Gottlieb. Changes to the risk program might be among them, based on Gottlieb's urging of brand-name manufacturers to “end the shenanigans” with it.

Lawmakers, who have tried for years to push forward legislation that would address concerns with the REMS program, have encountered resistance from both the pharmaceutical lobby and companies like Celgene, according to drug lobbyists and congressional aides.

The Summit, N.J.-based company's first quarter revenue rose 19 percent to $3.5 billion. Net income dropped 9.2 percent to $846 million, or $1.10 a share, as research costs spiked.

https:// www.washingtonexaminer.com/business/sales-of-celgenes-marquee-cancer-drug-surge-as-trumps-price-crackdown-looms