Biogen drop Aduhelm drug

"Jan 31 (Reuters) - Biogen will end a post-approval study of Alzheimer's treatment Aduhelm and return the licensing rights on the drug after failing to find a partner to mitigate costs of obtaining standard regulatory approval....

....Biogen said it would now be working on the launch of Alzheimer's medicine Leqembi, with Japanese partner Eisai, and focusing on two experimental treatments that target tau, a protein associated with Alzheimer's disease.

Last year, Leqembi became the first treatment to receive standard approval for its ability to slow cognitive decline in early Alzheimer's patients.

"We see the re-prioritization of Aduhelm resources to the Leqembi launch as a positive that reflects the true priorities of the company going forward," "

https://www.reuters.com/business/healthcare-pharmaceuticals/biogen-discontinue-development-older-alzheimers-drug-aduhelm-2024-01-31

Substantial shareholder notice: 25/9/23

Anacacia capital 5%, they were already holders at 4.8%

 I’m drawing a long bow here, but it is interesting given they are launching a new fund, and CGS could potentially fit their mandate. Also, Cogstates low liquidity around 200K value per day, the current buyback, and the reported offer earlier in the year, makes it worth noting.

There have been several articles, with Anacacia talking their book about opportunities in the current market, hence the new fund. 

https://www.afr.com/street-talk/anacacia-capital-launches-fund-iv-first-close-in-october-20230901-p5e1bk

Sep 1, 2023

“The 10-year fund will target mid-market buyouts and is slated for a September 28 launch.”

“Otherwise, the playbook is the same as previous funds – profitable companies usually with $20 million to more than $500 million revenue, often via family succession planning needs.”

“We have identified and partnered with great business owners particularly during tougher capital-constrained times to increase value,” Samuel said when contacted by Street Talk. “We look for outstanding management in great businesses at a fair entry price. We have never had a better pipeline of opportunities.”

held

The efficacy and risk of the current Alzheimer drugs are not understood, ARIA is a risk to be managed for patients with limited research.

This comment sums it up, “The research is just getting started, but the drug is already in clinical use,” Chou says. “What happens now?”

https://www.science.org/content/article/will-unpredictable-side-effects-dim-promise-new-alzheimer-s-drugs?utm_source=sfmc&utm_medium=email&utm_campaign=ScienceAdviser&utm_content=quotable&et_rid=988766428&et_cid=4847916

Esiai consumer cognitive test “NouKnow”, expanding usage into 2023

https://www.scoop.co.nz/stories/WO2306/S00162/eisais-nouknow-will-continue-to-be-utilized-for-brain-health-assessment-as-part-of-fy2023-dementia-examination-project.htm

“TOKYO, June 22, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that brain health checks utilizing "NouKNOW" (pronounced "NOH-NOH"), Eisai's digital tool for self-assessment of cognitive function, will continue to be promoted as part of the FY2023 dementia examination project, conducted by Bunkyo City, Tokyo.”

“Eisai has concluded regional cooperation agreements with local governments, medical associations, and other organizations throughout Japan, and is promoting efforts to realize a Dementia-Inclusive Society (167 locations in 45 prefectures as of March 31, 2023). In addition, Eisai is collaborating with 46 other local governments including Bunkyo City (in FY2022) on dementia-related projects, providing opportunities for brain health assessments tailored to local issues and promoting initiatives to establish a pathway to subsequent medical care and support.”

https://endpts.com/smooth-and-very-much-on-track-eisai-reports-first-shipments-of-leqembi/

“Eisai and Biogen began shipping out doses of their newly approved Alzheimer’s drug Leqembi ahead of schedule last month, according to Eisai’s US chairman and CEO Ivan Cheung.

If all goes according to plan, the chief executive hopes to achieve full approval and expand access to Leqembi later this year, he said on the company’s recent quarterly call with investors.

Leqembi won an accelerated approval back in January for use in patients with mild cognitive impairment from Alzheimer’s who have confirmed presence of amyloid beta pathology prior to treatment. It’s a second chance in Alzheimer’s for Eisai and Biogen, whose controversial predecessor Aduhelm suffered a commercial flop following its accelerated approval in 2021.”

A couple of quick notes from the CGS earnings call this morning

Tailwinds

1.     Decentralised/home based trials

A trend for decentralised testing existed pre-pandemic but has been accelerated with covid. Current trial designs are considering patient access as a key component. This is an opportunity for CGS with digital remote testing, as well as benefits for pharma companies and patients.

2.     The approval of first Alzheimer drug, has management expecting a growth in R&D and trials for Alzheimer drugs. This potentially feeds into the demand for the CGS testing product.

Financials

• increased revenue
• improved margin
• cash on hand

Competition

Management consider the standard cognition tests, person to person as their major competition.  There are other companies working on tests/applications in the space.