| | | |   | Hello, all. Damian here with news on the next big Alzheimer's disease study, a cautionary biotech tale, and a reminder that the Theranos saga is not quite over yet. | | | Aurinia could go the way of Amarin Aurinia Pharmaceuticals became a biotech darling in early 2021 when Lupkynis, its lead drug, won FDA approval as a treatment for lupus, leading to waves of speculation that it would soon be bought for a lucrative premium. But thanks to an emerging legal issue, the odds of such an acquisition are starting to look long.
As STAT’s Adam Feuerstein reports, Aurinia is now facing a patent challenge from the generics firm Sun Pharma, which is seeking to invalidate some key intellectual property tied to Lupkynis. The drug’s main patent, which expires in 2027, is safe, but a secondary one, which extends to 2037, is now under attack. If Sun prevails, Lupkynis could face generic competition a decade sooner than expected.
The same thing happened to the drugmaker Amarin and its heart pill Vascepa. Despite a strong commercial launch, Amarin was never able to find a pharma company willing to acquire it, mostly because of uncertainty surrounding ongoing legal challenges to Vascepa patents. And in Amarin’s case, those concerns proved to be correct.
Read more. | Roche and Genentech take a big swing in Alzheimer’s Partners Roche and Genentech have started an ambitious, four-year study of their treatment for Alzheimer’s disease, enrolling patients before learning the results of key trials that read out later this year.
The two companies will test whether their treatment, gantenerumab, can prevent the development of Alzheimer’s for patients who have disease-related plaques called amyloid in their brains but no evidence of cognitive or functional decline. They plan to enroll about 1,200 people, testing whether gantenerumab can meaningfully delay the onset of symptoms as measured by cognitive tests.
Meanwhile, Roche and Genentech are awaiting results from a pair of two-year studies measuring gantenerumab’s effects on patients who are already in the early stages of Alzheimer’s, data that will likely shake up the field when they arrive later this year. Those studies, if positive, will set in motion gantenerumab’s application for Food and Drug Administration approval.
Read more. | Advanced clinical solutions powered by healthcare intelligence — delivered seamlessly ICON is the world’s largest and most comprehensive clinical research organization, powered by Healthcare Intelligence. Leveraging their human expertise, robust clinical capabilities, and insightful data resources, ICON is expanding the possibilities of clinical research without sacrificing the vital, day-to-day functions of today’s CROs. Learn more. | The next Theranos trial is a week away As Elizabeth Holmes prepares for a sentencing hearing, her former second-in-command will stand trial on identical charges starting next week.
Jury selection starts next Wednesday for Ramesh “Sunny” Balwani, who served as chief operating officer at Theranos, with opening arguments scheduled for March 15. He faces two counts of conspiracy to commit wire fraud and nine counts of defrauding investors and patients.
Balwani’s trial will surely be quieter than Holmes’, but its implications could be similarly weighty. The entire Theranos saga has been an examination of just how culpable entrepreneurs can be when hype turns out to be hyperbole. Holmes was convicted of lying to investors but beat the charges related to defrauding patients. Balwani, often described as the more hands-on among the two, might fare differently. | Intercept’s NASH data still isn’t ready Intercept Pharmaceuticals, once at the vanguard of companies developing treatments for NASH (a liver disease once at the vanguard of lucrative ideas in biotech), is asking for patience.
Phase 3 data on Intercept’s NASH drug were expected by the end of 2021. Then, in December, that promise drifted into the first quarter of 2022. Now the results will take until the third quarter of this year, Intercept said during its earnings presentation yesterday, pointing to the complexity of analyzing patients’ liver biopsies.
Intercept’s stock price, which fell 10% yesterday, peaked at more than $450 a share in March of 2014, when NASH, a prevalent disease with no approved treatments, emerged as a future pharmaceutical gold mine. The ensuing years brought scores of medicines into the clinic, but not one has lived up to expectations. And Intercept, long the favorite to reach the market first, has lost more than 95% of its value since. | More reads - Formally ending the pandemic is going to be a huge headache for the entire health care system. STAT
- Founders are turning to tech VCs to fund the riskiest stage of starting a drug company. It's testing the divide between the biotech and tech worlds. Business Insider
- Biotech leaders look to halt business deals in Russia. Wall Street Journal
- Inappropriate march-in actions would jeopardize public-private partnerships that make lifesaving medicines possible. STAT
| Thanks for reading! Until tomorrow,  | | | |
No comments