Case closed on patents, Alzheimer’s data, generic approvals, and expanded approvals.
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Alexion + Chugai
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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.
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, case closed on patents, Alzheimer’s data, generic approvals, and expanded approvals.
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.
Alexion and Chugai resolve $775M Lawsuit
A major patient lawsuit has been settled between Alexion, the rare disease arm of AstaZeneca, and Chugai Pharmaceuticals. Under the terms of the agreement, AZ will pay a single payment of $775M to settle the dispute of patient infringement of the approved drug Ultomiris. This case involves suits going back to 2018 in both Japan and then the US over alleged patent infringement across multiple patents. The terms of agreement see all suits fully resolved, but at $3/4B price-tag. Ultiomiris itself brought in more than $1B in revenue in 2020 and was north of $1.5B for 2021. While this is a setback in the net profitability of the therapy, it is still being studied for additional indications and may continue to expand the accessible population.
Biogen Data Published
Biogen has published some long-term data from their Alzheimer’s therapy Aduhelm. The major controversy around the approval was that, while the therapy showed a decrease in the build up of amyloid plaques, they did not necessarily show a shift in disease symptoms. This newly published clinical study data show that Aduhelm does act against key Alzheimer’s markers, and there was one clinically relevant datapoint at 78 weeks of showing decreased cognitive decline. One data point across 128 week study is far from a roaring success. Biogen will continue to move forward with long-term trials, but at this point it seems unlikely the pricy treatment with questionable clinical outcomes will take off. That leaves an open market for the next round of potential therapies, notably Eli Lilly’s donanemab.
Viatris Generic Approval
Mylan Pharmaceuticals, a Viatris subsidiary, has received FDA approval for Breyna. The drug-device combination is a genetic version of AstraZeneca’s asthmas and COPD therapy Symbicort. This is a fairly standard looking inhaler. AZs version has an actuation counter on top, it’s not clear if the generic will share this feature. But For those living with COPD or asthma this will open new routes to more affordable medications. Viatris owns a wide range of recognized brands and is likely to be successful in commercialization and competition in this space. This all bodes well for the future of Breyna, but may mark the beginning of a slow decline in the $2.5B+ AZ sees in revenue from Symbicort.
Rinvoq Gains Additional FDA Approval
To say that AbbVie has been successful in immune-related therapies would be … well it’s just a massive understatement. Not only do they have Humira, the most successful medication of all time financially, they are seeing growth across a wide portfolio, resulting in a 22.7% increase in revenue in 2021. Last year, one of their up-and-coming medications, Rinvoq saw a 100% increase in sales to $1.65B for the treatment of rheumatoid arthritis. In January it saw approval to treat moderate to severe atopic dermatitis. Last week, the potential expanded when the FDA granted approval to treat ulcerative colitis. Based on these approvals, AbbVie is predicting $7.5B a year from the therapy by 2025. That’s no Humira, but then, nothing is.
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.