爱美津制药和Biophore 合作开发青霉胺的仿制药

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2017年10月24日

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美国新泽西州林德赫斯特，2017年10月24日，消息 – 爱美津制药有限公司(爱美津)和Biophore印度制药私人有限责任公司(Biophore)今天宣布，他们将合作开发瓦兰特的青霉胺仿制药和其他青霉胺类仿制产品并在美国市场上市，原料药由Biophore公司从印度提供。 爱美津已经向美国食品和药品管理局(FDA)提交了青霉胺的简略新药申请(ANDA)，这可能会成为青霉胺产品的首仿药，该申请已经被美国FDA接收并且正在审核中。 爱美津公司总裁兼首席执行官John Lowry先生表示：“青霉胺的价格在过去的几年中不断上涨，爱美津希望此次简略新药申请能够获得FDA的批准，从而能够向美国的患者以较低的价格提供该款药物。”

LYNDHURST, N.J., Oct. 24, 2017 — Amerigen Pharmaceuticals Limited (“Amerigen”) and Biophore India Pharmaceuticals Pvt Ltd. (“Biophore”) today announced that they are collaborating to bring a generic version of Valeant’s Cuprimine and other penicillamine based generic products to the U.S. market using active pharmaceutical ingredient supplied by Biophore from India. Amerigen has already filed an Abbreviated New Drug Application (“ANDA”) with the U.S.  Food & Drug Administration (“FDA”) for potentially the first generic equivalent of Cuprimine, which has been accepted for filing and is now under FDA review. Mr. John Lowry, Amerigen’s President & CEO, stated that “After the well publicized price increases for Cuprimine over the last several years, Amerigen looks forward to securing FDA approval for its pending ANDA and bringing a lower cost version of this important medication to U.S. patients.”

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。