(26) 3,4-DAP in USA - Zulassungswettlauf zweier Firmen
Comment on article in “Neurology Today on November 21, 2013:
”Free Myasthenic Syndrome Drug Program Threatened in Race for FDA Approval”. By Kurt Samson
http://journals.lww.com/neurotodayonline/blog/breakingnews/pages/post.aspx?PostID=268
Freya Matthiessen on March 30, 2014
Doesn’t Catalyst know ...? - In Germany we can do without Firdapse!
Catalyst Press release:
“Patrick J. McEnany, Catalyst's Chief Executive Officer, stated: we are gaining access to a late-stage U.S. orphan drug targeting LEMS, a disease of the central nervous system....Catalyst Pharmaceutical Partners, Inc. is a ... pharmaceutical company focused on the development and commercialization of prescription drugs targeting diseases and disorders of the central nervous system....”
Doesn’t Catalyst know ...?
LEMS is a peripheral disease! To find out about the error of LEMS wrongly being classified as “central”, I sent the following EMail to Patrick J McEnany, Catalyt Chief Executive Officer on March 24, 2013:
“Dear Sir, Wondering whether you are correctly cited, I would appreciate your comment on that".
"Patrick J. McEnany, Catalyst's Chief Executive Officer, stated:....’we are gaining access to a late-stage U.S. orphan drug targeting LEMS, a disease of the central nervous system for which there is not currently an effective treatment approved in the United States...’"
Mr. McEnany’s answer: on March 24, 2013, at 6:16 PM:
”Yes the citation is correct. LEMS is Lambert Eaton Myasthenic Syndrome”.
March 25, 2013, I confronted Mr. McEnany, Catalyst Chief officer, with his error:
“Iwas hoping that you had not stated, LEMS to be 'a disease of the central nervous system' Lambert-Eaton Myasthenic Syndrome is NOT a disease of the central nervous system. LEMS is a neuromuscular transmission disorder caused by autoantibodies at the motor nerve ending - presynapticly - of the neuromuscular junction. Fortunately the disaster occurs ‘pretty far away’ from the "central nervous system". LEMS is a peripheral disorder. Please be so kind to let me know, when you will have published your ERRATUM.”
Reaction: Quite a few mails from unindentified senders saying: “not read”.
In Germany you still can legally order the inexpensive capsules with 3,4-DAP (individual dosage!) from pharmacies. After quite a few visits to laboratories of pharmacies, discussing the safety needs and general problems of patients with LEMS, very satisfying terms could finally be arranged by the owner of the homepages below with a competent pharmacist in Göttingen, by now being able to fill 300 capsules at the same time and by that securing the same optimal content in each single capsule. The ordered capsules are sent within the next two days or even the same day.
More about this please see:
http://www.lems-mg.de/amifampridin-3-4-dap-preise-weitere-informationen-aktuell-2012-jan/
http://lems-mg.de/das-gesch-ft-mit-seltenen-erkrankungen-am-beispiel-m-duchenne-und-lems/
http://www.lambert-eaton-myasthenisches-syndrom.de
Freya Matthiessen, Germany