Wednesday, 1 December 2010
Vifor Pharma, the pharma business sector of the Galenica Group, and Fresenius Medical Care (FMC) will intensify their current partnership through the creation of a specialty pharma company. The new nephrology company will develop and commercialise innovative and high quality products to improve the life of patients suffering from Chronic Kidney Disease (CKD) worldwide.
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 PA21. 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.
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).
_Fresenius Medical Care is the world's largest integrated provider of products and services for individuals undergoing dialysis because of chronic kidney failure, a condition that affects more than 1.89 million individuals worldwide. Through its network of 2,716 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 210,191 patients around the globe. Fresenius Medical Care also is the world's leading provider of dialysis products such as hemodialysis machines, dialyzers and related disposable products. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME, FME3) and the New York Stock Exchange (FMS, FMS/P). For more information about Fresenius Medical Care, visit the company’s website at www.fmc-ag.com.
Tuesday, 28 September 2010
Friday, 17 September 2010
Tuesday, 17 August 2010
Tuesday, 29 June 2010
Thursday, 3 June 2010
Head of Corporate Communications