Galenica and Fresenius Medical Care form a new renal pharmaceutical company

The products of the new company will include Venofer® and Ferinject® (Injectafer®, the brand name for Ferinject® in the USA) within the field of dialysis and pre-dialysis (CKD stage III – V) as well as PA21, a novel iron-based phosphate binder.

The creation of the new company is an extension of the current agreements between Vifor Pharma and FMC. Vifor Pharma will contribute its expertise in phosphate binding and its global leadership in iron replacement therapy. FMC, the world leader in dialysis products and services, will provide access to its network of dialysis centres, which is the most extensive in the world.

The new company Vifor Fresenius Medical Care Renal Pharma Ltd. will hold the global nephrology commercialisation rights to Venofer® and Ferinject®. Venofer® is the leading intravenous iron product for the treatment of iron deficiency anaemia in renal patients and Ferinject® is a new high-dosed intravenous iron product currently being introduced in Europe. The intellectual property of these iron products will remain with Vifor Pharma.

This partnership enables Vifor Pharma to further focus its activities on the development and commercialization of Ferinject® (Injectafer®) outside nephrology. Today, in many countries, intravenous iron replacement products are primarily used to treat patients suffering from chronic kidney disease. However, iron deficiency is a complication of a number of other illnesses and intravenous iron is also used in other areas such as in cardiology to treat chronic heart failure, in oncology to treat anaemia in cancer patients, in gastroenterology for the treatment of inflammatory bowel diseases and in gynaecology to treat pregnancy-related anaemia. It is also used in the treatment of pre- operative anaemia. Vifor Pharma will continue to promote Ferinject® and to provide additional scientific evidence in order to further develop the significant market potential in these conditions.

The new company will also hold all rights to the novel iron-based phosphate binder A21. In the first half of 2010 successful meetings were held with several regulatory agencies including the FDA and selected European regulators to review the results of phase II studies. Preparations for phase III studies are well advanced and will be conducted in Europe and the USA in close cooperation with FMC. Filing is expected in 2012.

The new company pools the assets and skills of Galenica and FMC
In addition to commercialising the above mentioned products, Vifor Fresenius Medical Care Renal Pharma Ltd. can in-license and develop other drugs for use in dialysis and pre-dialysis (CKD, stage III - V). FMC will market the products through its subsidiaries in the USA, in Europe, and in certain countries in Middle East, Africa, Asia Pacific and Latin America. In other countries, Vifor Pharma and its current licensees and agents will continue to act as partners of the new company. In Japan, the collaboration on PA21 with Kissei Pharmaceutical Co. Ltd. announced in September 2010 will continue.

Closing and financial conditions
Vifor Fresenius Medical Care Renal Pharma Ltd.will be 55 percent owned by Galenica and 45 percent owned by FMC. Fresenius Medical Care will make an initial down payment in 2010 for its participation and the Galenica Group’s ongoing development efforts and obligations in this field. Subsequent payments will be made in the following years.

In a first step, Vifor Pharma will transfer to Vifor Fresenius Medical Care Renal Pharma Ltd. the nephrology sales rights to Ferinject® (Injectafer®) and Venofer® as well as the sales rights to PA21 for North America. Once approved by the responsible antitrust Commissions, Vifor Pharma will also transfer the nephrology marketing and sales rights to Ferinject® and Venofer® as well as all rights to PA21 for Europe and the rest of the world.

Financial terms of the agreement are not disclosed.

As earnings growth will be fully invested in activities intended to exploit existing potential, the Galenica Group expects its consolidated earnings for 2010 to be at the previous year’s level.

For further information, please contact:
Investor Relations: Fritz Hirsbrunner, Deputy CEO and CFO Tel. +41 58 852 85 29 E-mail: investors@galenica.com

Media Relations: Christina Hertig, Head of Corporate Communications Tel. +41 58 852 85 17 E-mail: media@galenica.com