| | | |   | Meghana today. Regeneron's Eylea gets a shot in the arm (eye?), we see how much more effective and economical clinical trials can be if they can be conducted, in part, remotely, and more. | | | New data reinvigorates Regeneron’s Eylea franchise Years ago, Regeneron CEO Len Schleifer boggled the minds of skeptical investors by showing them the first sales numbers of the company’s eye drug, Eylea. Profits were stunning and continue to be: Eylea’s is one of the world’s most profitable drugs, accounting for about $9.2 billion in sales in 2021 alone. However, Eylea’s patent is set to expire in mid-2024, and a cadre of biosimilars are queued up to take its place. A new Roche drug, Vabysmo, has also eaten up some of the market share. But thanks to some sparkling new trial data, Regeneron should be able to protect Eylea from encroaching competitors. A new, higher dosage of the medicine, aflibercept, helped patients maintain their vision over the course of both 12- and 16-week dosing regimens in diabetic macular edema and wet age-related macular degeneration, two new trials show. Eylea currently needs to be given every 8 weeks. The trial’s intention was to convert existing Eylea customers to the higher dose, so it would need to be administered less frequently. The results “are game changing, providing not just an answer to the Vabysmo threat, but putting the Eylea franchise back on the offensive,” per the analysts at Piper Sandler. Regeneron’s stock shot up 19% on the news. | Oxford’s malaria vaccine very promising, new data show A new malaria vaccine developed by Oxford University may be more effective than GSK’s Mosquirix, the only approved inoculation for the devastating mosquito-borne disease. The Oxford vaccine, called R21/Matrix-M, was tested on 400 young children in Burkina Faso — and the highest dose of the vaccine was still 80% effective a year after the last shot was given. The lower dose was 70% effective 12 months later. A larger Phase 3 trial is still underway, testing the Oxford shot on 4,800 participants. Meanwhile, data last year showed Mosquirix was nearly 63% effective against malaria. It’s still too early to truly compare Mosquirix, which was first conceived in the 1980s, with the newer Oxford vaccine, Reuters writes, as they haven’t been compared head-to-head in a trial. But Oxford does have some advantages: It has a deal in place with the Serum Institute of India to produce 200 million doses annually, beginning next year. GSK, in comparison, plans to produce 15 million doses of Mosquirix each year through 2028 — appealing for funding from international donors to increase vaccine production. The WHO, which has endorsed Mosquirix, says at least 100 million doses a year of the four-dose vaccine would be needed to prevent malaria in the 25 million children who would need it. | mRNA became mainstream with Covid vaccines. But the technology’s therapeutic potential is huge. mRNA has proven itself in Covid-19 vaccines. But that’s just the beginning. How can we use mRNA to take health care to the next level — to potentially cure neurological disorders and the deadliest of cancers? While scientists explore those questions, biopharma must make some adjustments to pave the road to success. Read the article here. | Remote trials save time and money Drug makers could save a ton of money if they conduct clinical trials virtually or remotely, a new pilot study shows. The use of tools like telemedicine and mobile devices yielded a five-fold return on investment of $8.6 million for Phase 2 trials, research from the Tufts Center for the Study of Drug Development shows. And for Phase 3 trials involving experimental drugs, there was a 13-fold return on investment of $41 million per medicine. A number of factors helped trials perform more efficiently. Most impactful was how virtual tools reduced the overall length of the trials: Phase 2 trials ran for 27 months instead of 30 months, and Phase 3 trials ran for 28 months instead of 31 months. The analysis, notably, examined trials before the Covid-19 pandemic began — assessing data on 160 Phase 2 and 3 trials from 20 companies and CROs between 2013 and 2018. The pandemic has prompted many sponsors since then to rely more heavily on remote and virtual techniques. Read more. | Is Illumina a victim of its own success? What makes the FDA change its mind? And how will petrodollars change biotech? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Our colleague Matthew Herper joins us to discuss how Illumina, the biggest company in genomic sequencing, got into an $8 billion predicament. We also discuss a dramatic development for a new ALS treatment, the latest in cancer research, and a well-funded new player in biotech venture capital. Listen here. | More reads - Silence sees fast-track tag as proof of FDA confidence in blood cancer drug that faced trial troubles, FierceBiotech
- Merck’s Keytruda-Lenvima flop hands Novartis-BeiGene, Hengrui a brighter liver cancer future, FiercePharma
| Thanks for reading! Until next week,  | | | |
No comments