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A new checkpoint inhibitor, a crowded vaccine market, & should pharma boycott Russia?

  

 

The Readout

Meghana today. Today, we talk about the newest checkpoint inhibitor on the block, and contemplate whether pharma could help end the Ukraine conflict. Have a good week.

The Covid-19 vaccine market is drying up

As the world becomes increasingly vaccinated against Covid-19 — and, in some factions, increasingly resistant to receiving vaccines — demand for the products is beginning to wane. That's a challenge for the myriad vaccines still in development, as STAT's Helen Branswell explains.

There will be a need for boosters, no doubt, but demand there is limited as well. And, according to the WHO’s Covid vaccine tracker, there are still 149 candidate vaccines in clinical development and another 195 in earlier stages of testing. 

“We think there’s likely going to be long-term ongoing demand for Covid vaccines, for boosters at least,” said one health analytics expert who tracks the Covid-19 market. “But it will be a lot smaller than it is. We believe it’s kind of peaked.”

Read more.

A brand-new checkpoint inhibitor gets approved

An entirely new type of checkpoint inhibitor drug just got the FDA green light — the first such approval since Merck’s Keytruda, Biospace points out. Bristol Myers Squibb’s drug Opdualag, which is a combination of monoclonal antibody drugs relatlimab and nivolumab, was approved to treat non-resectable or metastatic melanoma. It works by blocking LAG-3 — an inhibitory immune checkpoint that limits T-cell activity. The relatlimab allows T-cells to rev back up and attack tumor cells.

Opdualag is Bristol's third checkpoint inhibitor drug, after Opdivo and Yervoy. The data backing up its approval are pretty compelling. Two monoclonal antibodies combined more than doubled the media progression-free survival compared to just Opdivo — 10.1 months to 4.6 months. Relatlimab is also being tested alone in both solid and hematologic tumors.

Should pharma stop selling life-saving drugs to Russia?

In response to the invasion of Ukraine, should drugmakers stop sending important medications to Russia? Many industry players have already begun winding down clinical trials, ending investment, and withholding non-essential medicines. But when it comes to medicines for diabetes, cancer, or infections — should companies continue sending them to Russian civilians, when their government is killing civilians and threatening nuclear war?

Such a bold move might help convince the Kremlin to change its behavior, STAT’s Ed Silverman writes — but it could exact a brutal toll on innocent Russians. Some experts believe that collateral damage is worth it.

“People are caught up in this notion that the pharmaceutical companies have a duty to sell medicines come hell or high water. But I’m not persuaded we have much choice," one bioethics professor told STAT. "Putin is committing war crimes and now is threatening nuclear war. The rules about boycotts have to include pharma.”

Read more.

Drug for rare genetic epilepsy approved

The FDA on Friday approved an oral drug from Marinus Pharmaceuticals that treats CDKL-5 deficiency disorder, a rare genetic condition that triggers seizures that are difficult to control.

The drug, called Ztalmy, works on the GABAA receptor to tamp down on both anxiety and seizure activity. A late-stage study showed a 30.7% median reduction in seizure activity when patients were given the drug, compared to a 6.9% reduction with placebo.

The thrice-daily pill has been priced at $133,000 per year wholesale, but after discounts will cost $105,000, Reuters writes. One Cowen analyst projects the drug will generate peak sales of $71 million in the U.S. Marinus shares jumped 36% on news of the approval.

More reads

  • Leen Kawas, Alzheimer’s CEO who resigned in data manipulation scandal, returns to launch investment firm with billionaire. (Endpoints)
  • Canadian Pfizer partner sues to head off patent lawsuit over Covid-19 vaccine. (Reuters)

Thanks for reading! Until tomorrow,

@megkesh
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Monday, March 21, 2022

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