美格鲁特的首仿产品在美国获批

2018年4月23日

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2018年4月23日,新泽西州林德赫斯特和瑞士基亚索消息 – 爱美津制药有限公司(爱美津)和Dipharma S.A.(Dipharma)今天宣布美国食品和药物管理局批准了其美格鲁特胶囊100mg的简略新药申请。这是和Actelion制药公司的Zavesca等效的首个获得批准的仿制药产品。该产品的申报是爱美津和Dipharma独家合作开发和在全球范围内商业化美格鲁特胶囊100mg的结果。美格鲁特的原料药由Dipharma向爱美津提供。Dipharma拥有US9079856B2和US8802155B1这两个获批的美国专利,其中一个专利是关于美格鲁特合成方法的专利,另一个是美格鲁特的晶型专利。爱美津有权在美国使用这些专利,爱美津的附属公司将进行该产品的生产且在其已上市的美国市场上实现该产品的商业化。

美格鲁特是一种葡萄糖神经酰胺合酶抑制剂,作为用于治疗轻度至中度1型戈谢病的成人患者的单一疗法,对于这些患者酶替代疗法并不是一种治疗选择。

爱美津公司总裁兼首席执行官John Lowry先生表示:“我们很高兴在与Dipharma公司进行卓有成效的合作之后上市这个产品。 这是爱美津第五个在美国上市的产品,也是第三个首仿产品,它将为美国医疗保健系统节省大量资金。”

Dipharma首席执行官Marc-Olivier Geinoz对与爱美津的合作表示满意。 “这标志着我们集团与爱美津针对不同市场合作开发的一系列产品首次获得批准。”他说:“得益于这一批准,长期患病的美国患者和付费人将能够获得高质量、更经济实惠的替代治疗方案。 对于我们这个年轻的公司来说,这是一个伟大的成就,它标志着我们发展战略的一个重要里程碑。”

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.”


关于爱美津 About Amerigen

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. The group has products on the market currently in both the US and China plus an active portfolio of products under development, filed, or intended for filing, as ANDA's with the US FDA and the Chinese CFDA. Amerigen's focus is orally delivered products that are potential first generics, challenging to develop, require specialized technologies or high containment to manufacture, and present complex regulatory and intellectual property obstacles to bring to market. All Amerigen's products are developed and manufactured by the company or its partners around the world to meet the highest quality standards, including the US FDA.

爱美津制药致力于仿制药所涉及到的全部阶段的业务,是一家包括美国和中国多成员企业的集团公司。集团由爱美津制药控股。美国市场的注册和商业活动由位于新泽西州,林赫斯特的美国爱美津负责;集团的中国分公司,苏州爱美津制药有限公司,位于中国江苏省苏州市。爱美津制药集团目前在美国以及中国均有药品上市和销售,同时,我们拥有活跃的在研产品组,面向美国食品药品监督管理局(FDA)注册和已申报若干个仿制药品种(ANDA),并且计划开展向中国食品药品监督管理局(CFDA)注册和申报产品的工作。爱美津从事开发的口服制剂产品,是开发难度高,需要专门的技术,或生产要求高度严格管理控制,以及法规复杂,需要规避或挑战专利的仿制药。爱美津集团旗下公司或合作方开发和生产的所有产品,都满足高质量标准,包括美国FDA。