Date: 2015-06-17
Type of information: Production agreement
Compound: D-biotin
Company: Medday (France) DSM Nutritional Products (The Netherlands)
Therapeutic area: CNS diseases - Neurological diseases - Neurodegenerative diseases
Type agreement: production manufacturing supply
Action mechanism: vitamin. MD1003 is an active pharmaceutical ingredient administered at a dose of 300 mg /day has patent protection in EU and US for dose and use in multiple sclerosis. MD1003 has a mode of action which potentially influences two targets related to progressive MS: (1) it activates acetyl-CoA carboxylases (ACC1 and ACC2), the rate-limiting enzymes in the synthesis of fatty acids required for myelin synthesis, and (2) it activates the Krebs cycle in demyelinated axons to increase energy production.
MD1003’s proof of concept has been obtained in a pilot open label study involving 23 subjects with primary and secondary progressive MS. Results were positive with up to 90% of subjects exhibiting clinical improvement over time. Treatment efficacy was also assessed using electrophysiology studies and magnetic resonance spectroscopy.
Disease: multiple sclerosis
Details: * On June 17, 2015, MedDay and DSM Nutritional Products, global leader in innovative nutritional solutions for the pharmaceutical, food, feed and cosmetics industries, today announced a partnership and co-investment for the manufacturing of pharmaceutical grade D-Biotin. The partnership covers the manufacturing and exclusive supply by DSM for MedDay’s lead product MD1003, a pharmaceutical grade D-Biotin, which is currently being investigated in a series of Phase III clinical trials. This partnership follows the announcement by MedDay in April 2015 of positive results from the pivotal phase 3 clinical trial, MS-SPI in patients suffering from progressive multiple sclerosis. The Phase III study demonstrated evidence of the efficacy and safety of MD1003, a highly-concentrated pharmaceutical-grade biotin administered at a dose of 300 mg per day in the treatment of primary and secondary progressive MS, a major area of unmet medical need.
MD1003 will require a chronic administration of very high dose of biotin to treat patients with progressive MS, corresponding to 10,000 times the recommended daily intake, and therefore a pharmaceutical grade extra-pure source of biotin is required. Different sources of D-Biotin currently exist for low-dose food supplements or veterinary use. DSM is currently producing the only pharmaceutical grade biotin having a CEP (Certificate of suitability of Monographs of the European Pharmacopoeia) suitable for chronic administration of high doses in patients. The partnership will also cover the full support from DSM for regulatory filings in Europe and USA as well as an investment in a dedicated production facility at a DSM manufacturing site in Europe for the industrial scale production of pharmaceutical grade D-Biotin.
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