The partnership covers the manufacture and supply by DSM for MedDay’s 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 III clinical trial, MS-SPI in patients suffering from progressive multiple sclerosis (MS).
The phase III study demonstrated evidence of the efficacy and safety of MD1003, a highly concentrated pharmaceutical-grade biotin administered at a dose of 300mg per day in the treatment of primary and secondary progressive MS, a major area of unmet medical need.
MedDay’s 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.
Frédéric Sedel, Chief Executive Officer of MedDay, said: 'Our partnership with DSM to secure the manufacturing of large amounts of a pharmaceutical-grade D-biotin represents a significant milestone for MedDay. With more than 50 years of experience in the synthesis of biotin, we believe DSM is an excellent partner to supply us with a high-quality active pharmaceutical ingredient (API), and to support us through a regulatory filing.'
Christoph Goppelsroeder, President and CEO, DSM Nutritional Products, commented: 'As a science-based company, DSM is delighted to partner with MedDay in bringing this novel treatment to patients worldwide. We see an increasing number of vitamin applications emerging as pharmaceutical products for so-far difficult to treat illnesses. This is a very promising field in which we are proud to take the lead.'