Indian bulk drug manufacturers drawn to Japan

Manufacturers upbeat about prospects in the Japanese markets

Japan has emerged as a focus market for Indian bulk drug makers. Active pharmaceutical ingredient (API) makers such as Dishman Pharmaceuticals, Suven Lifesciences and Ind-Swift Labs are all optimistic about the Japanese market.

Dishman Pharmaceuticals supplies to 11 companies in Japan and has seven APIs approved by Japan's drug regulator. The Indian company is eyeing a five-fold growth in revenue from Japan during the current fiscal year (2012-13). Suven Lifesciences, which is supplying to generic drug makers in Japan, is looking to sign API supply deals with at least three more companies this year.

Ind-Swift Labs, on the other hand, which has around six to seven approvals in place in Japan, is looking to tap the antidiabetic and anticholesterol market in Japan.

A free trade agreement with Japan that makes it easier to form business alliances with local firms has also encouraged Indian bulk drug makers to seek to gain a stronger foothold in the Japanese market.

Elder Pharmaceuticals is setting up a joint venture company, Kose Elder (India), with Japan’s Kose Corporation to make and sell cosmetics in India. The Mumbai-based drug maker will own a 40% stake in the venture.

Elder Pharmaceuticals is looking at getting its joint venture project on stream in the next three months by making use of its existing plant in Himachal Pradesh in North India.

Meanwhile, Takeda Pharmaceutical has submitted a New Drug Application (NDA) for cell culture-based H5N1 and prototype pandemic influenza vaccines to the Ministry of Health, Labour and Welfare in Japan. The company is using its Hikari Plant as the manufacturing facility.

In December 2010, Takeda and Illinois-based Baxter International entered into a development, license and technology transfer agreement in which Baxter licensed exclusive rights to its proprietary cell culture-based pandemic influenza vaccines technology for the Japanese market to Takeda. Based on the agreement, Takeda has been conducting development activities jointly with Baxter and constructing the manufacturing facility for the cell culture-based influenza vaccines.

Takeda and Baxter jointly submitted NDAs in September 2012, with Baxter’s plant in Europe as the manufacturing site. The NDAs submitted this round cover vaccine product made at Takeda’s Hikari plant.

Privately held Edison Pharmaceuticals' has entered into a licensing agreement with Dainippon Sumitomo Pharma for the development and commercialisation rights in Japan for two mid-stage compounds for the treatment of orphan paediatric mitochondrial disease and adult central nervous system diseases.

That deal is worth $50m in upfront and research payments to Edison, up to an additional $495m in milestones, and royalties on commercialised products of the collaboration.

One of the compounds is an orally bioavailable small molecule in development for inherited mitochondrial diseases. A member of the para-benzoquinone class of drugs, the compound targets an ultra rare indication. The initial scope of the transaction includes both paediatric orphan inherited mitochondrial and adult central nervous system diseases.

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