This post may be technical for some, but I feel that it is important for patients, carepartners and physicians to have an idea where the MS market
At 8:30 AM EST this morning, the Biogen team: Eric Hoffman, Jim Mullen (CEO), Alfred Sandrock, MD, PhD, Bob Hamm, Paul Clancy, and Evan Beckman presented Biogen's Q2 performance.
The analysts were very hopeful about the good Q2 performance -- revenues were up 10%, product revenues were up even higher at 16%. -- these were fueled mostly by Tysabri (natalizumab), Avonex (intramuscular IFNB-1a) and, to a lesser degree, Rituxan (rituximab).
Biogen's (Nasdaq BIIB) rich research & development (R&D) was emphasized and is obviously laudable.
Fampridine-SR and the new relationship with Acorda (ACO) was discussed, but even in the Q&A session, noone brought up the elephant in the room, nerispirdine (Sanofi-Aventis;SNY) and the potential reduced risk of epilepsy (seizures).
Analysts brought up potential screening for PML (progressive multifocal leukoencephalopathy) and Biogen made clear that they are looking at ways of ensuring that patients with PML are detected early.
The other elephant in the room was the potential risk of PCNSL (primary CNS lymphoma) -- rumors continue about another case in Germany and even one in the United States.
So, what does all this mean?
There are two possibilities:
1. If the rumors about PCNSL are true, then there will definitely be some action taken (hopefully by Biogen Idec and Elan (ELN), but maybe by regulatory authorities, such as the FDA and MAA).
2. If the rumors are false, then Biogen will continue to plug along (overall worldwide post-marketing exposure. of 56,500).
So, what does this mean?
We'll wait and see.
[For more on PCNSL, go to www.neurologique.org, navigate to the "Links" area and you will be directed right there.]
- Daniel Kantor, MD BSE
Medical Director
Neurologique
info@neurologique.org
www.neurologique.org
Thursday, July 16, 2009
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