| |   | Good morning, everyone. Damian here with news of a biotech redux, a hefty tax bill, and the challenge of finding treatments for long Covid. | | | A serial biotech founder goes back to the future Alexis Borisy, who made his name as a venture capitalist at Third Rock Ventures, is taking a page from the earliest days of his career with his latest startup, aiming to mix and match existing drugs to create something new.
As STAT’s Allison DeAngelis reports, Borisy’s IDRx has raised $122 million to combine multiple drug compounds and create precise, durable cancer treatments in the process.
The notion traces back to his first company, CombinatoRx, which launched in 2000 with a similar goal that Borisy believes was ahead of its time. Chemistry and computation have come quite a ways in the ensuing two decades, and IDRx believes it can succeed where its predecessor failed.
Read more. | Finding long Covid drugs is going to be hard Just ask Axcella Therapeutics, whose potential treatment for long Covid missed its primary endpoint in a small trial, underlining the difficulty of developing a medicine for a disease that remains confounding.
The news, disclosed this morning, is that Axcella’s treatment was no better than placebo at improving patients’ recovery from exercise as measured by levels of phosphocreatine, the study’s main goal. It also showed no statistically significant benefit on lactate levels, a measure of fatigue, or on distance traveled in six minutes of walking. However, the drug did lead to a significant improvement in patient scores on a questionnaire measuring physical and mental fatigue, and now Axcella is planning to meet with regulators about designing another trial that might support approval.
While it’s unclear how those conversations might go, Axcella’s results could be a preview of future readouts in long Covid. When the biology of a disease remains murky, how can you be sure observed benefits aren’t simply a placebo effect? | STAT Event: Creating AI That Improves Health On August 3, hear how researchers aim to create a “data economy” to ensure that artificial intelligence lives up to its promise. Register now to join. | Amgen’s tax filing came in about $11 billion light, IRS says Amgen’s escalating dispute with the Internal Revenue Service has now led to a bill of $10.7 billion in back taxes and penalties, a regulatory nuisance that is quickly rising to the level of serious business risk.
As the Wall Street Journal reports, the IRS claims that Amgen underreported its taxable income by more than $20 billion by wrongly crediting its Puerto Rico subsidiary with profits made in the U.S. Amgen, whose effective tax rate has long been the envy of other drugmakers, argues that its tax returns have always complied with federal law.
Amgen’s IRS issues are a growing concern for Wall Street. In the short term, analysts expect a negotiation that leads to a settlement well below $10.7 billion. But the IRS’s persistence suggests Amgen’s future tax bills will be higher than in the past, cutting into long-term profitability. | AstraZeneca’s CEO ends a rumor with a plural Pascal Soriot’s 10 years in charge of AstraZeneca have included a hostile takeover, an international controversy, and more than a few references to physical violence, all on the way to an impressive turnaround for a drug company that spent years flirting with disaster. And amid speculation that Soriot might hang it up after a decade in charge, the CEO used AstraZeneca’s latest earnings call to obliquely dismiss any rumors.
On the subject of Michel Demare, who will take over as the company’s chairman starting in 2023, Soriot told analysts that “Michel and I will be working together and forming an excellent team for the many years to come.”
Soriot’s continued employment is at the will of AstraZeneca’s board, but the company’s recent returns suggest the job is his as long as he wants it. Once an also-ran in oncology, AstraZeneca has successfully developed treatments that have changed the standard of care in lung and breast cancer, and the company’s stock price has more than doubled in the last five years. | More reads - Major European research funders often fail to set policies or monitor progress on clinical trial transparency. STAT
- Kirin turns to health care as beer business draws scrutiny. Bloomberg
- Clay Siegall built Seattle biotech firm Seagen into a $1.6B giant. Then the cops came calling. Seattle Times
- Otonomy cuts lead asset loose after Phase 2 failure. FierceBiotech
| Thanks for reading! Until tomorrow,  | | | |
No comments