| | | |   | Hello, everyone. Damian here with some unanswered questions about Biogen and Eisai's latest treatment for Alzheimer's disease, the view from physicians who treat it, and a step toward the so-called artificial pancreas. | | | We have some questions about lecanemab In the aftermath of this century’s first clearly positive Phase 3 study of a new treatment for Alzheimer’s disease, the field has turned its attention to everything we don’t yet know about the latest medicine from partners Biogen and Eisai.
How much is it going to cost? Can it succeed in a market where Aduhelm failed? How well did it work, exactly, and what does its success tell us about the other Alzheimer’s treatments soon to generate pivotal data?
The answer to each question will determine whether the drug, lecanemab, is a meaningful advance for patients or another false dawn in Alzheimer’s. (One question we can answer: What was Al Sandrock, Biogen's former R&D chief, doing when he heard Tuesday night's news?)
Read more. | What lecanemab means for patients While lecanemab’s Phase 3 success would appear to make FDA approval a foregone conclusion, physicians, caregivers, and millions of patients with Alzheimer’s disease are still parsing what the treatment’s demonstrated benefits might actually mean.
Biogen and Eisai declared statistical success with a 27% reduction in cognitive decline compared to placebo, beating placebo by .45 points on an 18-point scale of dementia. For doctors who treat Alzheimer’s, the challenge is translating those numerals to the real-life needs of their patients before deciding whether to eventually prescribe the medicine.
Read more. | Clinicogenomics: How new, linked data is advancing life sciences research Clinicogenomics offers life sciences researchers a powerful new tool by linking genomic data to rich, longitudinal clinical information. The life science research community is only beginning to unlock its potential to better understand disease pathways, discover novel therapeutic targets, identify variation in disease onset and progression, and evaluate drug safety and efficacy. Read this white paper to get an in-depth look into this rapidly evolving field of research. | To sell a medicine, you have to manufacture it When BioNTech first started to think about making a Covid vaccine, the company could only make 1 gram per week — about 20,000 doses per day — of the medicine, BioNTech COO Sierk Poetting said at a virtual event yesterday. Quickly, the company realized that it needed to do more, and implemented what he described as a “Hail Mary” strategy for getting there. They went from 1g in March 2020 to 10g at the beginning of the summer to 350g, when the company transferred much of its manufacturing to Pfizer. Later on, it bought a Novartis plant in Marburg, Germany, to help scale up its own manufacturing capability.
Investors tend to get much more excited about making and testing medicines than manufacturing them, but in recent years, with new technologies such as mRNA and gene therapy, manufacturing has become a key concern. And as the types of products that are developed change, so too can the concerns around manufacturing them.
C. Greg Guyer, the chief technology officer at BioMarin, described how that company years ago decided to invest in its own gene therapy manufacturing capabilities, which use insect cells to make the viral vectors that deliver the therapies. Now, as it prepares for the launch for its Roctavian therapy for hemophilia A, BioMarin is thinking hard about making sure that its manufacturing is ready. One difficulty: Unlike with many other therapies, sales will eventually peak and then decline, because there are a limited number of patients with the disease and the gene therapy will be an infrequent, if not one-time, treatment. Nobody knows how long that will take, or when the peak will happen. | One in three U.S. biotechs is trading below cash That’s according to a new analysis from the investment bank Torreya, which found that 34% of U.S. biotech companies have a negative enterprise value, meaning their market caps are smaller than the sum of their cash and debt.
That could be an ominous statistic for a sector soon to enter the second year of a painful correction, in which valuations have plummeted and raising money has grown more difficult. It also underlines a long-held concern among biotech investors about whether there were simply too many companies of varying promise vying for a finite amount of money and attention.
On the other hand, the growing number of companies trading below cash creates a windfall-in-waiting for healthier biotechs that might convince them to sell. Last week, Rocket Pharmaceuticals engineered an all-stock transaction for the flailing Renovacor, absorbing that company’s $38 million in cash on hand. And in July, Ginkgo Bioworks functionally raised $337 million in cash in exchange for $300 million in stock by merging with struggling rival Zymergen. | A step toward the ‘artificial pancreas’ Researchers have been working for years to craft a technology that would seamlessly regulate blood glucose for people with Type 1 diabetes, a so-called artificial pancreas that would eliminate the constant stream of calculations required to stay healthy.
As STAT’s Katie Palmer reports, data from a pivotal trial suggest an automated insulin delivery system from Beta Bionics represent a step toward that goal.
The device, called iLet, simplifies how patients interact with their automated insulin pumps. In results published in the New England Journal of Medicine yesterday, participants using the iLet saw improvements in blood glucose levels while participants receiving standard care saw theirs remain steady. The time iLet users spent in a target blood glucose range also increased by 11% over the control group.
Read more. | More reads - Early analysis suggests monkeypox vaccine is reducing risk of infection in U.S., STAT
- How a Japanese drugmaker got the ‘clean win’ over Alzheimer’s, Bloomberg
- Merck agrees to allow Sinopharm to sell Covid drug in China, Reuters
| Thanks for reading! Until tomorrow,  | | | |
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