Royalty Pharma's $93 million man

Pablo Legorreta, founder and CEO of Royalty Pharma, doesn't get paid like other drug industry executives. In 2022, he drew no salary, received no bonus, and was awarded no stock. Instead, he was entitled to a percentage of profits from the firm's investments in other companies' drugs. Last year went pretty well, so he made $93 million, paid out in cash.

That's just one eyebrow-raising datapoint from STAT's analysis of how more than 300 publicly traded health care companies paid their CEOs in 2022. The group made a combined $4 billion in total compensation, an 11% decline from 2021.

None did better than Moderna's Stéphane Bancel, who brought in nearly $400 million, equal to the take-home pay of the next six highest-paid CEOs in biotech and pharma. The vast majority of Bancel's compensation came from the pre-planned sales of stock options set to expire this year, and he has promised to donate the vast majority of that income to charity.

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Regulatory

Ipsen wins a pioneering FDA approval

The FDA approved the first treatment for an ultra-rare disease that causes people to grow bone where it otherwise shouldn't be, allowing Ipsen to market a drug whose supporting data has divided global regulators.

The treatment, an oral medication that will be marketed as Sohonos, is meant to slow the damaging bone growth caused by fibrodysplasia ossificans progressiva, or FOP, a disease that affects about 1,000 people worldwide.

Sohonos — its scientific name is palovarotene — initially failed to meet its goal of reducing bone formation in its pivotal trial, but subsequent analyses using different statistical methods showed the drug cut bone growth by 54% in patients given the drug versus untreated patients, according to Ipsen. Relying on such post-hoc analyses is typically frowned upon by regulators, but in this case, the FDA indicated the trial originally relied on a type of analysis that couldn't have detected any benefit.

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Chart of the day

Biotech's summer surge is over

D3 vis exported to PNG (67)

The closely watched XBI biotech index fell more than 2% yesterday, part of a gradual decline that has now erased all of the sector's gains over the last four months.

The XBI reached its 2023 zenith in February, buoyed by news of a few high-dollar acquisitions, before bottoming out in March amid a protracted drought for biotech IPOs. The index climbed more than 20% over the next three months, reaching another peak in June before collapsing in the late summer. As of yesterday, the XBI is down more than 4% on the year.

Regulatory

FDA takes the rare step of enforcing the law

For just the fifth time, the FDA threatened to punish a drug company for failing to post study results on a federal government database, following escalating calls to take enforcement more seriously.

As STAT's Ed Silverman reports, the agency sent a letter to Light Sciences Oncology on July 19 about its failure to post study results about a prostate treatment to ClinicalTrials.gov, which the company later did. Under a 2007 law, trial sponsors are required to register studies on ClinicalTrials.gov within 21 days of the first patient enrollment and submit summary results information to the database within 12 months after the trial's primary completion date.

The agency has been loath to exercise its enforcement authority, which advocates say has been deleterious to science and medicine. "Congress clearly intended for this law to end the scandal of hidden clinical trial results," aid Till Bruckner, who heads TranspariMED, an advocacy group that researches clinical trial transparency issues. "FDA's persistent foot-dragging on this issue is not only a slap in the face for American patients, but also a slap in the face for Americans' elected representatives."

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