Anavex Life Sciences Corp (AVXL)

[sokol]

Talon: This is a letter I wrote the WSJ a year or so ago about the Biogen drug and Biogen’s partner, Eisai. I received a response. The WSJ agreed with me. This is what I wrote back then:

“They, Biogen and Eisai, obtained a different outcome with a new measure of efficacy. Biogen’s partner Eisai, a Japanese pharmaceutical company, came up with a new standard to measure ”success”. This ”success” measured by a new internally conflicted standard should by itself raise a red flag.

Even then this ”success” may not be so great considering their drug is an infusion and the same WSJ article points out: The study in­volved 856 sub­jects in the early stage of the dis­ease. Among the side ef­fects that the com­pa­nies reported were re­ac­tions at the sites of the in­fu­sion and swelling around blood ves­sels ob­served with brain imag­ing.

Making multiple trips to a clinic or medical office for infusions as opposed to taking a pill poses difficulties in addition to the risks of adverse events, and for what: BAN240 does not stop or reverse Alzheimer’s. To sum up : IV injected, only works at highest dosage at if at all, takes 6 months to kick in, and the cognitive tests we're created in house and not standard. And, what percentage of adverse events occurred at this highest dosage? It would be of interest to know what percentage of those receiving ONLY the highest dosage, the one that reportedly works, developed adverse events.”

H. Hampel as we all know is now Vice President and Chief Medical Officer (CMO) of the Neurology Business Group at Eisai Inc. and is a member of the company’s Executive Committee for the Americas. Cite: https://www.researchgate.net/profile/Harald_Hampel

Note: Hampel was not with Eisai at the time I wrote the above letter to the WSJ. Therefore, he was not involved in obtaining a different outcome with a new measure as I pointed out in that letter.

With Hampel’s current position at Eisai , Hampel as CMO, is “... responsible for leading Eisai’s medical affairs strategy and technical expertise in neurology with the aim of advancing opportunities for innovation and continuous improvement. With more than 25 years of experience conducting clinical trials in Alzheimer’s disease (AD) and related neurodegenerative diseases, I (Hampel) am overseeing the planning and implementation of Eisai’s global neurology clinical trial programs. I am also responsible for developing the global neurology medical strategies for the company’s commercial products, pipeline assets and late-stage compounds approaching the commercialization stage...”

I like the part about Hampel being responsible for “strategy and technical expertise in neurology with the aim of advancing opportunities for innovation and continuous improvement... overseeing the planning and implementation of Eisai’s global neurology clinical trial programs...”. I also especially like the fact that he is responsible for “...pipeline assets and late stage compounds approaching the commercialization stage...”.