Amerigen Pharmaceuticals Limited (Amerigen), a group of companies engaged in all phases of the generic pharmaceutical business, and Dipharma S.A. (Dipharma), a Swiss specialty pharmaceutical company, announced that Amerigen’s Abbreviated New Drug Application (ANDA) for Miglustat 100 mg capsules has received final approval from the US Food and Drug Administration. This is the first ANDA to be approved as a generic equivalent to Actelion Pharmaceuticals’ Zavesca.
The ANDA filing was the result of an exclusive collaboration between Amerigen and Dipharma in developing and commercializing Miglustat 100 mg capsules worldwide. Miglustat active ingredient is supplied to Amerigen by Dipharma who holds two granted US patents, US9079856B2 and US8802155B1, one pertaining to a method of synthesis of miglustat and the other to a crystalline form of the same. Amerigen has the right to enforce these patents in the US whilst Amerigen’s affiliates will manufacture the finished product and commercialize it in the US, where it has already been launched.
Miglustat is a glucosylceramide synthase inhibitor indicated as monotherapy for the treatment of adult patients with mild to moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option.
John Lowry, Amerigen’s president and CEO, commented “We are delighted to launch this product following a fruitful collaboration with Dipharma. This is Amerigen’s fifth US product launch and the third time we have brought a first generic to market, with important savings for the American healthcare system.”
Marc-Olivier Geinoz, chief executive officer of Dipharma, expressed his satisfaction regarding the collaboration with Amerigen. “This marks the first approval of a series of products our group has been developing in collaboration with Amerigen for various markets.” he said. “Thanks to this approval, chronically ill US patients and payers will have available a high quality, more affordable alternative to current treatment. For our young company it is a great achievement and it marks a significant milestone in our growth strategy”.
Amerigen Pharmaceuticals is a group of companies engaged in all phases of the generic pharmaceutical business, with operations in the US and China. The group is controlled by Amerigen Pharmaceuticals Limited. The US regulatory and commercial activities within the group are conducted by Amerigen Pharmaceuticals Inc., based in Lyndhurst, NJ, USA. The group's Chinese subsidiary, Suzhou Amerigen Pharmaceutical Company Limited, is located in Suzhou, Jiangsu Province.
Dipharma S.A. is a Swiss specialty pharmaceutical company, developing high quality, improved, medicines for rare diseases. Dipharma S.A. is part of a third generation group of family-owned companies that have grown to a global presence.