Eisai + Biogen, Amylyx, Sanofi + Regeneron

Major Alzheimer’s news, an ALS approval, and expanded therapies for skin conditions

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Story References
Eisai + Biogen
Amylyx
Sanofi + Regeneron

About the Show
Life Science Today is your source for stories, insights, and trends across the life science industry. Expect weekly highlights about new technologies, pharmaceutical mergers and acquisitions, news about the moves of venture capital and private equity, and how the stock market responds to biotech IPOs. Life Science Today also explores trends around clinical research, including the evolving patterns that determine how drugs and therapies are developed and approved. It’s news, with a dash of perspective, focused on the life science industry. 

Transcript

Introduction

Welcome to Life Science Today, your source for stories, insights, and trends across the life science industry. I’m your host, Dr. Noah Goodson. This week, major Alzheimer’s news, an ALS approval, and expanded therapies for skin conditions. 

Disclaimer

The views expressed on Life Science Today are those of the host and guests. They do not necessarily reflect the opinions of any organizations with which they are affiliated. 

Hope for Biogen with Big Topline Alzheimer's News

Japanese Pharmaceutical Eisai and Biogen have released positive topline results from their phase 3 study of Lecanamab to treat early Alzheimer’s. According to the preliminary data readout within the press release all primary and secondary endpoints were achieved in the global study with 1795 participants. Preliminary analysis suggest that the anti-amyloid beta antibody works on both Mild Cognitive Impairment (MCI)  driven by Alzheimer’s and mild Alzheimer’s. Together these stages are classified as early Alzheimer's. During the 18-month study time period participants on Lecanamab saw a 27% reduction in loss of function compared to the placebo group when assed by the CDR-SB scale of dementia symptoms. Basically, the decline caused by Alzheimer’s was slowed. This is massive news for the Alzheimer’s community marking the best late phase data to emerge in years. Biogen plans to submit to the FDA in Q1 2023. Before then, Eisai will present more detailed findings at the end of November. Many, like myself are hoping to see a more thorough data readout including a deeper dive into adverse events and consistency across the study population.

For Biogen, who lead the charge to new Alzheimer’s therapies with Aduhelm this is a massive boon. Aduhelm showed activity again Aß buildup in theory, but never had convincing changes in clinical outcomes for participants. The new therapy, Lecanamab in contrast has the most promising data for Alzheimer’s in decades. Stocks for Eisai and Biogen shot through the roof on the news. That’s not to say the journey is over. A more complete readout of the data will be required, and regulatory agencies will likely expect continued long-term analysis to continue for a therapy that could be taken for years. Standing in contrast to regulatory concern will be advocacy groups who remain eagerly on the lookout for any therapy that can slow the progression of the chronic degenerative condition early. 

It's worth noting that as Biogen sales have fallen across their backbone therapeutics they are pushing hard for new solutions. Earlier this year they pushed their ALS therapy Tofersen for a priority review with the FDA, with a response expected January 2023, despite the fact that the readout showed a failure to meet the primary endpoint. When compared to the Aduhelm flop and a  questionable Tofersen readout, Lecanamab looks all the more promising. 

Amylyx Earns ALS FDA Approval

In a second round of major news for neurodegenerative diseases, Amylyx Pharmaceuticals has been granted FDA approval to treat ALS with their combination therapy of sodium phenylbutyrate and taurursodiol sold as Relyvrio. The therapy showed a reduction in decline and is predicted to increase ALS patient lifespan by a 10.6 month median increase in survival. The data are positive for a still deadly condition and provides ALS patients the opportunity to extend their life and quality of life. 

The drugs is set to be priced at $158,000 per a year, a not insignificant number. This raises one of the challenges that is likely to plague producers of novel complex therapeutics in the coming decade – who is going to pay for this? Part of the challenges with the commercialization of Aduhelm was the price tag of $56,000. Even when that was cut in half, payers balked. And sure, in that instance clinical efficacy and a lot of other concerns also impacted the commercialization, but price is certainly one of the factors. The cost-burden whether through private insurance or public support for neurodegenerative conditions remains high globally. One publication from 2015 showed that between 2001-2010 the total cost for a single US-based ALS patient’s care was >$1.4M, a number that is likely more than double today even without Relyvrio costs. 

ALS is a rare disease, and perhaps for that reason will see less balking at annual costs than something like Alzheimer’s. Nevertheless, for pharmaceutical companies effective pricing may become an increasing challenge in their drug development pipelines in the coming decade. For smaller organizations like Amylyx or larger pharmaceutical companies like Biogen effective commercialization may become just as important as clinical development in driving success. For those suffering from the diseases they may find themselves stuck in the middle in the meantime with new potentially life changing therapies that they just can’t afford and national or corporate payers reticent to open their wallets.

Sanofi and Regeneron Earn Another Dupixent Approval

Sanofi and Regeneron have been granted FDA approval to treat the chronic skin condition pruruigo nodularis with Dupixent. This represents the 5th condition Dupixent is approved to treat, and the first and only medicine approved to treat pruruigo nodularis in the US. The skin condition impacts about 75,000 individuals within the united states and causes persistent itch with thick skin lesions known as nodules over most of the body. In two phase 3 clinical studies participants experienced reduction in itch and far more achieved clear or almost clear skin. The safety profile of Dupixent was commiserate with other conditions the antibody is approved to treat, and are generally better than the currently prescribed high-potency topical steroids. The therapy can be administered at home every two weeks utilized pre-loaded syringes. With continued expanded sales across all conditions and new conditions added Dupixent sales are set to continue to rise across 2023 and beyond. Sanofi has high hopes that with numerous targeted conditions Dupixent will remain a bread winner for years to come. 

Closing Credits

Thanks for joining me for Life Science Today, your source for stories, insights, and trends across the life science industry. Learn more at LifeScienceTodayPodcast.com. If you like what you hear, please tell a friend. Once again, I’m Dr. Noah Goodson, I’ll see you next week.