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Galenica promising launch for Ferinject® in Europe
- Market launch of Ferinject® in the UK; clinical trials with Ferinject® in new therapeutic areas such as cardiology and gastroenterology are ongoing or planned to start this year.
- The implementation of an expanded patient clinical program for Injectafer®, by Luitpold in collaboration with Vifor Pharma, to provide the additional safety data necessary to obtain FDA approval.
Promising launch for Ferinject® in Europe
After reaching registration in 18 EU countries and in Switzerland, Ferinject® was launched in Germany in November 2007 and in Switzerland in February 2008 with extremely positive feedback in both countries and rapidly growing sales. In May Ferinject® was launched in UK. Further launches are planned this year for Spain and in Scandinavia.
On Galenica's domestic market, Switzerland, Vifor Pharma has sucessfully established the usage of i.v. iron in many different therapeutic areas outside the field of dialysis. Indeed, these new therapeutic areas account today for over 85% of the sales of Vifor Pharma's i.v. iron products in Switzerland. Sales of Ferinject® and Venofer® together are growing by over 100% and will reach more than CHF 12 million after 6 months. Per capita in Switzerland, this development is very impressive and represents already a turnover of CHF 4 million each million inhabitants, with strong potential of improvement.
European sales of Venofer® and Ferinject® are expected to show double digit growth in 2008.The overall patient potential for i.v. iron in the therapeutic fields of Nephrology, Oncology and Gastroenterology in Europe is estimated up to nearly 3 million patients, representing a large market with unmet medical needs.
There are more ongoing and planned trials for Ferinject® run by Vifor Pharma in Cardiology (Chronic Heart Failure) and in Gastroenterology (Inflammatory Bowel Disease) which are planned for this year, as well as in Nephrology (Non Dialysis Chronic Kidney Disease) next year. Further trials in Oncology, Hemodialysis, Obstetrics/Gynaecology and Iron Deficiency without anaemia are under evaluation for 2009.
Injectafer®: trials expanded, new studies initiated
In February 2008, an FDA Advisory Committee recommended approval for Injectafer® (US brand name for Ferinject® ) for the treatment in case of an unsatisfactory response to oral iron or an intolerance to oral iron in women due to heavy uterine bleeding and postpartum iron deficient anaemia. However, in March 2008, the FDA issued a non-approvable letter requesting more safety data to confirm the benefit/risk ratio. The US partner of Vifor Pharma, Luitpold Pharmaceuticals, Inc.,working closely with Vifor Pharma has expanded ongoing trials and is initiating three further clinical trials to provide additional clinical data addressing the concerns expressed by the FDA, with the intention of successfully registering Infectafer® in the US. The currently planned clinical trial programme on Injectafer® will provide patient experience involving over 4000 patients of which 2000 patients will be treated with Injectafer®. These trials will take two years to be completed to be followed by regulatory filing in the US.
Publication of half year results
The Galenica Group will publish its half year results on 19 August 2009
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