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Biotech / Medical : Elan Corporation, plc (ELN) -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (4285)	4/15/2003 7:19:26 AM
From: Icebrg	Read Replies (1) \| Respond to of 10345

Zonegran Looking in Dainippon's annual report for 2002 it turns out that the drug is also in phase II clinical trials for the treatment of Parkinsons. Erik From the annual report. Zonisamide is an antiepileptic agent developed by Dainippon Pharmaceutical that has been marketed in Japan under the brand name EXCEGRAN- since 1989. At the Neurology Department of the University of Tokyo Hospital, when epilepsy patients with Parkinson's symptoms were given zonisamide, their Parkinson's symptoms improved significantly. These findings attracted a great deal of attention when they were reported at the Annual Meeting of the Japanese Society of Neurology held in May 2001. Parkinson's disease is currently treated with L-dopa, which becomes less effective as the disease progresses. However, zonisamide produces a beneficial effect through a completely different mechanism of action, and there are high expectations for its clinical efficacy. Dainippon Pharmaceutical is currently conducting Phase II trials for an additional indication for zonisamide as a treatment for Parkinson's disease. dainippon-pharm.co.jp

To: Icebrg who wrote (4285)	4/16/2003 4:56:42 AM
From: Icebrg	Read Replies (1) \| Respond to of 10345

Zonegran's patent situation. Someone, who seems to have a grip on what is patented and what is not, made the following comments over at Yahoo!. I think the ingredient for Zonagran is already generic. The patent cited in the Orange Book (6,342,515) does indeed expire in late 2018. However, the claims of that patent are directed only to a method for treating neurodegenerative diseases. These are not the stronger compound or composition claims. Moreover, if there is another indication for the drug, this patent does not cover the use for another indication. While this patent is not as egregious as the cheap patent trick used to extend the Skelaxin monopoly, it is still open to a generic filing a subparagraph iv patent attack. That is both good and bad. It is bad in that generics could potentially market for the new use. It is good in that the new use is potentially patentable and allows for further market exclusivity of the new label indication (providing clinical studies are done and FDA approval is obtained). This is why it is important to actually read the patent claims. Enough of the lecture. This seems reasonable to me. If correct - it appears that the only way for Elan to protect the obesity franchise (if there will be one) is to provide enough clinical studies supporting the use of Zonegran in this indication, but to not file for an FDA-approval, hoping that off-label use will take off. Erik