Healthcare Industry News: S.A.
News Release - April 23, 2018
Amerigen and Dipharma Announce U.S. FDA Approval for Generic Miglustat 100 mg Capsules
The first generic version of MigluS.A. is now approved in the U.S.LYNDHURST, N.J. and CHIASSO, Switzerland, April 23rd, 2018 -- (Healthcare Sales & Marketing Network) -- Amerigen Pharmaceuticals Limited ("Amerigen") and Dipharma S.A. ("Dipharma") today announced that Amerigen'S.A.breviated New Drug Application ("ANDA") for MigluS.A. 100 mg capsules has received final approval from the U.S. Food and Drug Administration. This is the first such ANDA to be approved aS.A.generic equivalent to Actelion Pharmaceuticals' ZaveS.A.. The ANDA filing was the result of an exclusive collaboration between Amerigen and Dipharma in developing and commercializing MigluS.A. 100 mg capsules worldwide. MigluS.A. active ingredient is supplied to Amerigen by Dipharma who holds two granted U.S. patents, US9079856B2 and US8802155B1, one pertaining to a method of synthesis for migluS.A. and the other for a cryS.A.line form of the same. Amerigen has the right to enforce these patents in the U.S. whilst Amerigen'S.A.filiates will manufacture the finished product and commercialize it in the U.S., where it haS.A.ready been launched.
MigluS.A. iS.A.glucosylceramide synthase inhibitor indicated as monotherapy for the treatment of adult patients with mild to moderate type 1 Gaucher diS.A.e 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.A.erigen's fifth U.S. 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 satiS.A.tion 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.A.proval, chronically ill U.S. patientS.A.d 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."
About Amerigen
Amerigen Pharmaceuticals iS.A.group of companies engaged in all phases of the generic pharmaceutical business, with operations in the U.S. and China. The group is controlled by Amerigen Pharmaceuticals Limited. The U.S. regulatory and commercial activities within the group are conducted by Amerigen Pharmaceuticals Inc., based in Lyndhurst, NJ. The group's Chinese subsidiary, Suzhou Amerigen Pharmaceutical Company Limited, is located in Suzhou, Jiangsu Province.
The group has products on the market currently in both the U.S. and China pluS.A. active portfolio of products under development, filed, or intended for filing, aS.A.DA's with the U.S. FDA and the Chinese CFDA. Amerigen's focus is orally delivered products that are challenging to develop, require specialized technologies or high containment to manufacture, and present complex regulatory and intellectual property obS.A.les to bring to market. All Amerigen's productS.A.e developed and manufactured by the company or its partnerS.A.ound the world to meet the highest quality S.A.dards, including the U.S. FDA.
About Dipharma
Dipharma S.A. iS.A.Swiss specialty pharmaceutical company, developing high quality, improved, medicines for rare diS.A.es. Dipharma S.A. is part of a third generation group of family-owned companies that have grown in to a global presence.
With a portfolio of generic orphan products for the treatment of Phenylketonuria, Gaucher DiS.A.e, Niemann Pick Type C, Hereditary Tyrosinemia Type 1, Urea Cycle DisorderS.A.d others, Dipharma SA works every day to provide improved solutions for people affected by inborn metabolic diS.A.eS.A. an affordable cost and with a global reach.
ZaveS.A. iS.A.registered trademark of Actelion Pharmaceuticals. The U.S. FDA approved ZaveS.A. in July 2003.
Source: Amerigen Pharmaceuticals
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