Press release

Injectafer® NDA submitted to the US Food and Drug Administration

Thursday, 13 October 2011

Galenica is very pleased that its US partner Luitpold Pharmaceuticals, Inc. has submitted a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for Injectafer® (US brand name of Ferinject®, ferric carboxymaltose) for the treatment of iron deficiency anaemia. The NDA includes data and information from two new large randomized controlled clinical trials investigating the cardiovascular risk profile of Injectafer®.

_The submission reflects the conclusion of a clinical study program designed to assess the risk profile of Injectafer® following FDA’s issuance of a non-approvable letter in 2008 with respect to the original NDA submission.

_As part of the submission, Luitpold Pharmaceuticals provided the FDA with additional safety and efficacy data from two large scale, multi-center, randomized clinical trials. One trial compares Injectafer® to Venofer® (iron sucrose injection) in patients with iron deficiency anaemia and chronic kidney disease. The second study compares Injectafer® to either oral or intravenous (i.v.) iron (standard of care therapy) in patients with iron deficiency anaemia of various etiologies.

_Galenica is very pleased that its North American partner has submitted the NDA to the FDA. Luitpold Pharmaceuticals and the study investigators are to be commended for the dedication and commitment they have demonstrated in the conduct of these studies. Galenica is encouraged by the completion of these studies and looks forward to working closely with Luitpold Pharmaceuticals to address any further questions or issues that the FDA may present in connection with the NDA.

_Injectafer®, the novel i.v. iron replacement therapy, is a non-dextran iron. In 2007, registration of Ferinject® (brand name outside the US) was approved by the Swiss regulatory agency Swissmedic and by the UK Medicines & Healthcare products Regulatory Agency (MHRA). Thereby the MHRA, acting as a Reference country, has supported the subsequent approval of Ferinject® throughout the European Union. Ferinject® is currently registered for use in 35 countries worldwide.

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).

_Galenica is listed on the Swiss Stock Exchange (SIX Swiss Exchange, GALN).

_Iron Deficiency Anemia (IDA) is defined as a state in which iron stores are inadequate for normal blood formation, as the iron requirements exceed the supply. Iron deficiency anaemia results from low or depleted stores of iron. In severe cases red cells in a patient with IDA are both microcytic (small) and hypochromic (pale), and values for mean corpuscular volume (MCV) and mean corpuscular Hb concentration (MCHC) are characteristically changed. According to the World Health Organization (WHO) it is estimated that about 700 million people have iron deficiency anaemia (IDA). [Source: World Health Organization. Preventing and controlling Iron Deficiency Anaemia through primary health care. 

_Injectafer® is an innovative non-dextran intravenous iron (i.v.) replacement therapy discovered and developed by Vifor Pharma, a company of the Galenica Group. Ferric carboxymaltose is the active pharmaceutical ingredient of Injectafer®. To date, Ferinject® (brand name of Injectafer® outside the US) has gained marketing authorisation in 30 countries in Europe as well as in South Korea, Argentina, Russia, Australia and Lebanon, for the treatment of iron deficiency where oral iron is ineffective or cannot be used. In many countries, intravenous iron replacement products are primarily used to treat dialysis patients. However, iron deficiency is also a complication of many other illnesses. Vifor Pharma is evaluating new opportunities in the treatment of iron deficiency with Ferinject® in different therapeutic areas. Further trials with Ferinject® in chronic kidney disease (CKD), oncology (anaemia in cancer patients), cardiology (chronic heart failure), patient blood management and gynaecology are ongoing.



Christina Hertig

Christina Hertig

Head of Corporate Communications

Galenica Ltd.

Corp. Communications
Untermattweg 8
CH-3027 Bern

+41 58 852 85 17
+41 58 852 85 58

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