Pharmaceutical Business review

Mapi Pharma granted US patent covering process for preparation of fingolimod for multiple sclerosis

Novartis reported sales of Fingolimod of $1,934m in 2013, representing a 62% increase from 2012. With the issuance of this patent, Mapi intends to develop a generic version of Fingolimod for sale once Novartis loses its marketing exclusivity, commencing as early as 2017 in certain markets.

The US patent application no. 13/881,961 is titled Intermediate Compounds and Processes for the Preparation of Fingolimod. Fingolimod is an immunomodulating drug, approved for treating multiple sclerosis. Fingolimod is a sphingosine 1-phosphate receptor modulator, which sequesters lymphocytes in lymph nodes, preventing them from contributing to an autoimmune reaction.

Mapi chairman and CEO Ehud Marom Fingolimod is another key product in its MS portfolio that includes Glatiramer Acetate Depot (US Patent number 8,377,885 B2) to be administered once-a-month, rather than daily or thrice weekly as is currently available, and a new chemical entity (‘NCE’), a novel pentapolymer.

"Today’s news strengthens Mapi’s patent position, supports its business plan and advances the company one step closer to building a complete medicinal portfolio for MS," Fingolimod added.