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An Update on Pipeline Drug MD1003

September 28, 2015

Medical Need Europe, has appointed London, U.K. based Durbin PLC, a leading global supplier and distributor of pharmaceuticals, to manage warehousing and supply chain for a range of Medical Need products.

This collaboration will involve only a single product, Medical Need’s new multiple sclerosis management drug: MD1003. In April, Medical Need partner Med-Day Pharmaceuticals announced positive results from the pivotal randomized 2:1, double-blinded, placebo-controlled Phase III clinical trial MS-SPI. The trial was conducted in 16 MS reference centers in France, and showed evidence of the efficacy and safety of MD1003, a highly concentrated pharmaceutical-grade biotin administered at a dose of 300 mg per day for treatment of primary and secondary progressive multiple sclerosis. Treatment duration was one year.

The company reported that the MS-SPI clinical trial’s primary endpoint was met with a proportion of MS patients showing an improvement in EDSS expanded disability status scale or timed 25-foot walk at Month 9 and confirmed at Month 12. The primary endpoint was supported by evidence of a substantial decrease in the risk of disease progression.

Durbin will coordinate distribution of MD1003 through its Managed Access Program, which will enable patients with clinical need to receive the drug before it is generally commercially available.

“Initial feedback from neurologists and the MS community indicated that there will be requests for MD1003 on a Named Patient or Early Access basis,” explains Medical Need CEO Peder Walberg in a release. “We believe our collaboration with Durbin will strengthen our logistical setup and improve our ability to answer the requests for MD1003 in these markets.”