Media release

Thursday, 31 January 2008

Ferinject^® registred in 18 EU countries and in Switzerland
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.

Registration dossier for the US market
The registration dossier for Ferinject® for the US market, where the drug, if approved, will be registered under the name InjectaferTM, was submitted to the US Food and Drug Administration (FDA) by Luitpold Pharmaceuticals, Inc., the US licence partner of Vifor (International). 

Non approvable letter – deficiency letter versus non approval – rejection letter
Within the registration process, Luitpold had received a "non-approvable letter” from the FDA, in which the FDA raised questions focusing primarily on the mortality rate in the supporting clinical trials. During every registration process the authorities can send out a so called "non approvable letter" (deficiency letter) in the ongoing process, with further requests and/or questions about the new drug before the FDA makes a final decision on whether to approve the drug. If the requests and/or questions can be answered in on sufficient way, and no other issues are raised, the drug may be approved. If the questions and/or request of the authorities cannot be fully answered or the authorities do not agree to the answers, they will reject the drug as non approved (rejection letter).

Galenica has been informed by Luitpold that Luitpold responded promptly to the FDA letter by collecting and submitting to the FDA additional data and analyses that addressed the FDA’s questions. In general, Luitpold does not concur with the FDA concern regarding a mortality safety signal.

Advisory Committee Meeting on February 1, 2008
In order to obtain additional and independent information and guidance on the significance, if any, of the mortality rate issue, the FDA has decided to convene an Advisory Committee Meeting, which will take place on February 1, 2008. Galenica informed on this matter on December 11, 2007.

Galenica understands that Luitpold is well-prepared for the Advisory Committee Meeting. As with all products, benefit and risk must be carefully evaluated. And as with all development program in complex population groups suffering from severe diseases, death can be an unfortunate outcome. Galenica believe that the clinical and scientific safety database on InjectaferTM (Ferinject®) will help to demonstrate to FDA the overall safety of the drug and that there is no direct causal relationship between the drug and the deaths that occurred within the clinical program.

An Advisory Committee meeting is often part of the US New Drug Application (NDA) process. No conclusions can be drawn with regard to the potential approval or non-approval of InjectaferTM for the US market as a result of the decision to convene a meeting of the Advisory Committee. The Drug Safety and Risk Management Advisory Committee has no decision-making authority itself, and will make a recommendation to the FDA with regard to the points discussed. While the FDA is not bound by the committee’s recommendations, they generally follow the advice of the panel, and a final decision is expected  by mid-March 2008.