MEDIA RELEASE

Galenica and Luitpold Pharmaceuticals, Inc. are pleased with the recommendation for approval. The recommendation establishes a path forward with the FDA. Galenica and Luitpold are committed to working closely with the FDA to see the product through approval. The mentioned second line treatment recommendation, when oral iron is ineffective, is clearly in-line with the current labelling in Europe and in Switzerland: all countries have included a similar restriction, particularly due to the fact that all intravenous iron products are in the same situation.

The FDA is expected to make a decision on the New Drug Application (NDA) requesting approval for the use of Injectafer^® in these patient populations by mid-March, 2008. The agency is not bound by the Committee’s recommendation but takes its advice into consideration when reviewing products for approval. 

The development program for Injectafer^® represents the largest prospectively enrolled program of any intravenous iron product ever submitted to the Agency for approval. Data were derived from 12 studies involving more than 2,000 patients.

Iron deficiency anemia represents a significant health issue in women. More than half of the 4 million women in the United States who give birth each year develop iron deficiency and approximately 1 million of these women progress to iron deficiency anemia. In addition, as many as one in five women suffers from heavy uterine bleeding, defined as excessive or prolonged blood loss.

The innovative injectable iron replacement product Ferinject^® was registered by the public health authorities in 18 EU countries in September 2007 and in Switzerland in November 2007. It has been used to treat iron deficiency diseases in Germany since November 2007 and will be on sale in Switzerland from mid-February 2008.