| | | |   | Hello, everyone. Damian here with the latest twist in the amyloid saga, a CRISPR milestone, and the cooling of merger rumors. | | | Biogen and Eisai succeed in Alzheimer's do-over The latest Alzheimer's disease treatment from Biogen and Eisai met its primary goal in a clinical trial, the companies said yesterday, slowing the rate of cognitive decline by 27% over 18 months.
The drug, lecanemab, outperformed placebo in a study enrolling about 1,800 patients in the early stages of the disease. It also succeeded on secondary endpoints of reducing amyloid plaques in patients' brains and slowing decline on three other measures of cognition and function.
The positive result is a big win for Eisai and Biogen, giving the companies a potential blockbuster product. For Biogen, which presided over the disastrous rollout of the Alzheimer’s treatment Aduhelm, the potential approval of lecanemab presents a rare second chance at a multibillion-dollar market.
Read more. | CRISPR heads to the FDA Partners Vertex Pharmaceuticals and CRISPR Therapeutics will soon submit a pioneering application to the FDA that could result in the first approved medicine made with genome-editing technology.
The companies said yesterday that their one-time treatment for sickle cell disease and beta thalessemia will begin a rolling FDA review in November that would conclude in the first quarter of 2023. That timeline was roughly in line with Wall Street’s expectations, and if everything goes smoothly, the companies could win approval for the first CRISPR-medicine medicine in 2024.
What remains to be seen is whether the FDA will take a cautious approach to the review. The treatment, called exa-cel, is made by extracting a patient’s own stem cells, editing them with CRISPR, and then reinfusing them. Last month, the FDA approved a Bluebird Bio treatment for beta thalessemia that takes a similar approach with an older technology. But it’s unclear whether the novelty of CRISPR will lead the agency to ask for more data before allowing exa-cel onto the market. | Content Collaboration for Life Sciences: 15-Day Free Trial Delivering innovative therapies and devices to market is hard enough; don’t make it harder with poor collaboration. Egnyte for Life Sciences is the easiest and most cost-effective way to share files securely with external partners and CROs. The platform integrates seamlessly with Microsoft 365, Google Docs, AWS, ELNs, and more. Track all document changes from creation to archiving in a fully validated environment. Sign up for a 15-day trial today. | Aduhelm provides a (pre-)October surprise President Biden hosted an event at the Rose Garden yesterday to claim a political victory: Premiums for Medicare beneficiaries are poised to drop for the first time in a decade.
But the details, Reuters reports, make clear that the decline is due entirely to Aduhelm.
After Biogen’s Alzheimer’s disease won approval in 2021, Medicare increased 2022 premiums by nearly 15% to account for its list price of about $56,000 per year. When the agency that governs Medicare refused to cover Aduhelm outside of clinical trials earlier this year, the drug became a commercial nonentity. That’s bad for Biogen, but it gives Biden and the Democrats a nice headline ahead of the midterm elections. | Seagen isn’t acting like a company on the brink Seagen, star of a summer-long saga involving Merck and about $40 billion, has spent the last two days selling overseas rights to one of its drugs and buying into another, moves that don’t quite befit a company on the verge of a merger.
Yesterday, Seagen signed a deal with the Chinese firm Zai Lab in which it will receive $30 million up front in exchange for rights to market the cancer treatment Tivdak in mainland China, Hong Kong, Macau, and Taiwan, with future payments tied to development milestones and sales. That news came one day after Seagen signed a $50 million licensing deal with Lava Therapeutics, which includes $650 million more if the cancer drug in question becomes a success.
Meanwhile, Seagen’s share price has fallen nearly 25% since last month as Merck’s reported interest in acquiring the company for more than $200 a share never manifested an actual offer. The company’s value dipped two weeks ago when interim CEO Roger Dansey made a vague statement about its interest in business development, and it has fallen further now that Seagen is actually doing some. | More reads - On the Texas-Mexico border, a bold plan to diversify Alzheimer’s research takes shape, STAT
- Europe's generic drugmakers may cut output due to surging energy bills, Reuters
| Thanks for reading! Until tomorrow,  | | | |
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