June 22, 2023

The need-to-know this morning

Roivant Sciences reported maintenance data of its ulcerative colitis drug, RVT-3101, that showed a slight increase in efficacy over earlier results. The rate of clinical remission improved to 36% at week 56 from 29% at week 14. On June 16, Merck closed the $11 billion acquisition of Prometheus Biosciences, which is developing a competing compound.

Biotech

Intercept might just give up on NASH

Later today, the FDA will hand down a final decision on Intercept Pharmaceuticals' treatment for the liver disease NASH, a drug whose promise once quadrupled in a single day. And that decision is almost certainly going to be negative.

Last month, a panel of agency advisers voted 15-1 in favor of rejecting Intercept's application for accelerated approval, meaning the company would have to spend the next three years collecting enough data to apply for a traditional approval. And that might not be worth the wait, according to CEO Jerome Durso, who told analysts the company is "prepared to pivot to profitability" if things don't work out.

Back in 2014, Intercept became the hottest company in the industry on news that its NASH drug had worked so well that a mid-stage clinical trial was stopped early, setting off a pharmaceutical gold rush to find what would be the first treatment for the increasingly prevalent disease. Nine years and a 98% stock price decline later, Intercept, the company that put NASH on the biotech map, might stop investing in the disease altogether.

Drug pricing

PhRMA's suing, too

Days after two drugmakers filed lawsuits to block the U.S. government from negotiating drug prices, the trade group PhRMA filed one of its own yesterday, taking a slightly different legal tack.

As STAT's Rachel Cohrs reports, PhRMA's lawsuit argues that the Inflation Reduction Act, which empowers Medicare to negotiate the prices of certain drugs, violates the Eighth Amendment by levying an "excessive fine" against manufacturers. The amendment prohibits cruel and unusual punishment, including excessive bail and fines.

By contrast, earlier suits from Merck and Bristol Myers Squibb argue the law violates their Fifth Amendment rights by forcing companies to sell products without "just compensation" and then violates their freedom of speech by compelling them to call that deal a fair one.

Read more.

Regulatory

A speed bump for RSV vaccines

Advisers to the CDC stopped short of recommending all seniors get a vaccine to prevent RSV, a decision that could limit the uptake of pioneering products from GSK and Pfizer.

As STAT's Helen Branswell reports, the influential Advisory Committee on Immunization Practices recommended that anyone over 60 be able to get one of the vaccines if they and their physicians think it would be beneficial.

That distinction, while subtle, could have sizable implications for demand. Both vaccines are FDA approved for anyone over 60, but CDC advisers have expressed doubts that they will be cost effective for people at lower risk of RSV.

Read more.

Washington

PBM reforms could come this year

At least if Republican Sen. Chuck Grassley has enough sway over his caucus.

Speaking at a STAT event Wednesday, Grassley said he's pushing Senate Republicans to move forward on legislation that would rein in the power of pharmacy benefits managers, the firms that negotiate drug prices on behalf of payers. And there's some urgency: The Senate leaves this weekend for a July recess and will have just over two weeks of working days in the Capitol before a monthlong August break.

"We've got to pass legislation," Grassley said. "We can't put up any more with … middle people, between the companies and the consumer, without knowing what they're doing, particularly when they're raking in a lot of taxpayer money."

Read more.

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