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2018年4月23日，新澤西州林德赫斯特和瑞士基亞索消息 – 愛美津制藥有限公司（愛美津）和Dipharma S.A.(Dipharma)今天宣布美國食品和藥物管理局批準了其美格魯特膠囊100mg的簡略新藥申請。這是和Actelion制藥公司的Zavesca等效的首個獲得批準的仿制藥產品。該產品的申報是愛美津和Dipharma獨家合作開發和在全球范圍內商業化美格魯特膠囊100mg的結果。美格魯特的原料藥由Dipharma向愛美津提供。Dipharma擁有US9079856B2和US8802155B1這兩個獲批的美國專利，其中一個專利是關于美格魯特合成方法的專利，另一個是美格魯特的晶型專利。愛美津有權在美國使用這些專利，愛美津的附屬公司將進行該產品的生產且在其已上市的美國市場上實現該產品的商業化。

美格魯特是一種葡萄糖神經酰胺合酶抑制劑，作為用于治療輕度至中度1型戈謝病的成人患者的單一療法，對于這些患者酶替代療法并不是一種治療選擇。

愛美津公司總裁兼首席執行官John Lowry先生表示：“我們很高興在與Dipharma公司進行卓有成效的合作之后上市這個產品。 這是愛美津第五個在美國上市的產品，也是第三個首仿產品，它將為美國醫療保健系統節省大量資金。”

Dipharma首席執行官Marc-Olivier Geinoz對與愛美津的合作表示滿意。 “這標志著我們集團與愛美津針對不同市場合作開發的一系列產品首次獲得批準。”他說：“得益于這一批準，長期患病的美國患者和付費人將能夠獲得高質量、更經濟實惠的替代治療方案。 對于我們這個年輕的公司來說，這是一個偉大的成就，它標志著我們發展戰略的一個重要里程碑。”

Lyndhurst NJ, and Chiasso, Switzerland. April 23, 2018 /PRNewswire/ – Amerigen Pharmaceuticals Limited (“Amerigen”) and Dipharma S.A. (“Dipharma”) today announced that Amerigen’s Abbreviated New Drug Application (“ANDA”) for Miglustat 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’ 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 U.S. patents, US9079856B2 and US8802155B1, one pertaining to a method of synthesis for miglustat and the other for a crystalline form of the same. Amerigen has the right to enforce these patents in the U.S. whilst Amerigen’s affiliates will manufacture the finished product and commercialize it in the U.S., 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 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 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 U.S. 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.”

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