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Posted: Tue Jan 29, 2008 2:54 pm Post subject: MBP 8298
The following article includes some possible dates when MBP 8298 will be launched.
Eli Lilly has been cleared to license BioMS Medical's multiple sclerosis drug MBP8298.
The US Federal Trade Commission has cleared the global licensing and development agreement that grants Eli Lilly exclusive worldwide rights to BioMS Medical's lead multiple sclerosis compound, MBP8298. This represents a major step forward for Lilly, as the company looks to diversify its traditionally psychiatry-focused CNS offerings by expanding into neurology.
In December 2007, Lilly and BioMS entered into a global licensing and development agreement granting Lilly exclusive worldwide rights to the company's lead multiple sclerosis (MS) compound, MBP8298. The synthetic peptide compound consists of 17 amino acids linked in a sequence identical to that of a portion of human myelin basic protein (MBP).
MBP8298 is currently being evaluated in two pivotal Phase III clinical trials in secondary progressive MS (SPMS) and one Phase II trial in relapsing-remitting MS (RRMS). BioMS will continue to oversee all current clinical trials, while Lilly will be responsible for all future R&D, manufacturing and marketing activities.
MBP8298 offers Lilly an ideal entry point into neurology. Estimated to be worth $5.2 billion across the seven major markets (7MM) - US, Japan, France, Germany, Italy, Spain and the UK - in 2007, the MS market has shown consistently strong annual growth, and is estimated to be the largest neurology indication by value. Additionally, with only Bayer Schering's Betaseron (interferon-beta 1b) and Merck Serono's Novantrone (mitoxantrone) approved for SPMS, this segment of the MS market represents an underserved and yet potentially high-value niche.
Lilly's psychiatry portfolio is coming to the end of its lifecycle, and the acquisition of MBP8298 represents its focus on investing in its future CNS offering ahead of the patent expiry of its antidepressant Cymbalta (duloxetine) in 2013. Lilly will be able to utilize its well-established expertise in the psychiatry sector, to help MBP8298 realize its full potential within the neurology arena.
Datamonitor anticipates the launch of MBP8298 for SPMS in the EU in H1 2011 and H1 2012 in the US. With the additional approval for RRMS expected by the end of 2013, Datamonitor expects the dosing of once every six months to be highly favorable among a significant number of patients, and by 2016 7MM sales are forecast to be in excess of $450 million.
Interesting find. This brings up a question that keeps coming up for me these days: do you need more than one phase 3 trial to get approval? If you only need one, the more advanced trial of MBP8298 completed enrollment in January 2007. I believe it is a 2 year trial, so that means it will wrap up in January 2009. Give them a few months to get data together for submission and a few months for the regulator(s) to review said data, and I think that means it's entirely possible that it could be approved by the end of 2009...unless they require a second phase 3 trial, which is recruiting in the US right now, but won't be finished until some time in 2010 at the earliest. From those dates I mentioned, it seems that Datamonitor's timeline assumes that the second phase 3 trial results will be necessary for approval. That sucks.
I don't know. As this is a drug to treat progressive MS, then it needs to be longer to assess whether it has any effect. With drugs for RRMS, the usual measures are relapse rates and enhancing lesions etc e.g. at 6 months, 12 months etc. For SPMS, it is about time to increases in EDSS score.
These trials are still 2 years. I think they need more than one phase 3 for approval. I'm just hoping that since Rituxan is being tested in PPMS, for which there are no approved therapies, it will be approved with only one trial.
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