| | | |   | Good morning, one and all. Damian here with word from Gilead Sciences' CEO, a preview of a massive year in Alzheimer's disease research, and an update on a long-in-the-making science project. | | | Gilead CEO: Have a little patience The last year has not been kind to Gilead Sciences, with one multibillion-dollar deal after another running aground in the face of reality. But Daniel O’Day, who took over as CEO in 2019, is defending his company’s recent spending, arguing that the tangible benefits are yet to come.
“I just think we're at the beginning now of Gilead’s next chapter,” O’Day told STAT’s Matthew Herper, “and it's going to be playing out over the course of the next several years, with lots of opportunity.”
One can understand why investors might be skeptical. The three major deals Gilead has made since O’Day became CEO in 2019 have ranged from curious to catastrophic. A $5 billion partnership with Galapagos, a Belgian biotech, basically unraveled a year ago when development of the lead drug was stopped because the medicine’s benefits didn’t outweigh its risks. Earlier this year a cancer drug developed by biotech FortySeven, which Gilead bought for $5 billion in March 2020, was put on clinical hold. And Monday’s equivocal update on a treatment for breast cancer cast doubt on Gilead’s 2020 decision to pay $21 billion for a firm called Immunomedics.
Read more. | The 12 months that could make or break the amyloid hypothesis By the middle of 2023, we will know whether investigational Alzheimer’s disease treatments from Biogen, Roche, and Eli Lilly actually benefit patients. And while each drug has its own specific virtues and its own nuanced clinical trials, their successes or failures will inevitably be judged together, creating a thorny situation for each company.
Before the summer, Biogen expects to have data from an 18-month Phase 3 trial on lecanemab, an amyloid-targeting successor to Aduhelm. By the end of the year, Roche will have the results of a two-year study on the competing gantenerumab. And some time in 2023, Eli Lilly expects Phase 3 data on the anti-amyloid treatment donanemab.
A clean sweep of success would benefit everyone, affirming the amyloid hypothesis and likely rescuing Aduhelm’s stalled commercial potential. And a trio of outright failures would close the book on at least this generation of amyloid-targeting treatments. But every outcome in between has complicated implications. In a note to clients yesterday, Stifel analyst Paul Matteis wrote that Lilly’s treatment has the best odds of success, somewhere around 50-50, followed by lecanemab at 30% and gantenerumab at roughly 25%.
That’s where timing makes things interesting. If Biogen and Roche fail in 2022 but Lilly succeeds in 2023, the scientific world’s appetite for amyloid might completely bottom out in the intervening months, making a clinical victory for donanemab hard to believe and negating the potential benefit for the whole class. | Rapidly evolving technology demands leadership that keeps pace Driven by scientific discovery, competition, and ever-increasing demand, the life sciences industry produces pioneering therapies and meets novel challenges. Success in the life sciences requires a firm grasp of intellectual property protection, regulatory compliance, and continually advancing fundamental science, as well as their complex intersections. Discover how a Master of Science in Law: Life Sciences bridges boundaries separating science, law, and business and prepares leaders for success in the dynamic biotech and pharma sectors. | Vertex’s long quest for a new painkiller nears a moment of truth The drug industry has spent the last decade or so in search of novel medicines that can relieve pain without the risk of addiction, committing more than a billion dollars to what to date has been a fruitless endeavor. Vertex Pharmaceuticals, which entered the race in 2017, is days away from data that could reinvigorate the field.
Later this month, Vertex expects to have data from two Phase 2 trials on VX-548, an analgesic meant to work as an off-switch for pain by targeting a protein that plays a role in sending signals to the brain. The studies will determine whether multiple doses of the drug can outperform placebo at relieving acute pain after surgery. If they’re positive, Vertex will be one step closer to having succeeded where so many of its peers have failed.
Similar therapies from Pfizer, Biogen, and Amgen have all been tested and sidelined, and Vertex has stopped development of two related medicines of its own. VX-548, the company believes, is both more potent and more tolerable than its predecessors. | Peace among the Covid vaccine makers might come to an end Yesterday brought the news that Moderna won’t sue anyone in low-income countries for infringing its Covid-19 patents, prompting the question: Is Moderna going to start suing people in high-income countries?
As STAT’s Ed Silverman reports, Moderna’s updated patent pledge promises the company will never enforce its intellectual property in 92 nations around the world. Everywhere else, vaccine supply is “no longer a barrier to access,” according to Moderna, and the company will invite manufacturers to license its technology on “commercially reasonable terms.”
Moderna has not said whether there are any companies currently violating its intellectual property outside those 92 countries, and the company didn’t respond to questions on the subject yesterday. The only other commercial mRNA vaccine belongs to partners Pfizer and BioNTech, and Wall Street analysts have speculated that all three companies might eventually find themselves in a legal battle.
Read more. | More reads - Mallinckrodt to pay $260 million to settle federal lawsuits over Medicaid rebates and kickbacks. STAT+
- Sherlock Bio raises $80 million to develop CRISPR-based diagnostics. Reuters
- Congress considers a longer phase-out of looser, Covid-era telehealth policies. STAT
- Theranos judge trims jury pool over race bias, abuse views. Law360
| Thanks for reading! Until tomorrow,  | | | |
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