Friday, 17 September 2010
Based on very promising results from the Phase II study and a clear unmet clinical need, Kissei Pharmaceutical will become the partner of Vifor Pharma for development and commercialisation of PA21 for Japan.
_Vifor Pharma, the Pharma business sector of the Galenica Group, has entered into an agreement with Kissei Pharmaceutical Co., Ltd. to develop and commercialise its novel iron-based phosphate binder – PA21 – in Japan. This collaboration is a further step in the strategy of developing and commercialising PA21 with strong regional partners. In June 2010, a first partnership was announced with Fresenius Medical Care (FMC). FMC will support the phase III study in the US and will become the commercial partner for Vifor Pharma in North America.
_PA21 covers an unmet clinical need in the phosphate binder market. Dialysis patients suffer from hyperphosphatemia and nephrologists agree that this is a key risk factor for cardiovascular mortality. Despite the fact that almost all dialysis patients are treated with phosphate binders less than 50% reach their target phosphate levels. Therefore, the market needs new products. PA21 has an ideal target product profile to serve these needs. The compound has potential applications for the estimated 1.5 million dialysis patients worldwide of whom around 290,000 are estimated to live in Japan, as well as a potential indication in pre-dialysis patients. PA21 is currently poised to enter phase III clinical development in North America and Europe.
_The collaboration builds on the global success of Vifor Pharma in iron-based pharmaceuticals, and the considerable market and development expertise of Kissei Pharmaceutical in Japan. Under the agreement, Kissei Pharmaceutical will be responsible for all future development and commercialisation activities in Japan.
_“The phosphate binder market is currently estimated at CHF 230 million in Japan and is growing fast. This country represents both an extremely attractive yet highly complex commercial environment. We are extremely pleased to have secured this agreement with one of Japan’s leading specialty pharmaceutical companies. Kissei’s combination of development capabilities and strong market presence is the perfect combination to ensure the success of PA21 in Japan.” said Dr. David Ebsworth, CEO Vifor Pharma.
_Mutsuo Kanzawa, President and CEO of Kissei Pharmaceutical Company commented: “We expect that the excellent product profile of PA21 will give a benefit to dialysis patients for their treatment of hyperphosphatemia. Therefore, our aim is to make this innovative compound available for the patients in Japan in the near future, by advancing the development. We look forward to working together with Vifor Pharma to continue this project.”
Galenica is a diversified Group active throughout the healthcare market which, among other activities, develops, manufactures and markets pharmaceutical products, runs pharmacies, provides logistical and database services and sets up networks. With its two Business units Vifor Pharma and Galenica Santé, the Galenica Group enjoys a leading position in all its core business activities. A large part of the Group’s income is generated by international operations. Galenica is listed on the Swiss Stock Exchange (SIX Swiss Exchange, GALN, security number 1,553,646).
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Head of Corporate Communications