Vifor Pharma, which has just posted healthy revenue growth for 2012, has signed a distribution deal with China Medical System Holdings to sell its iron deficiency drug Maltofer and a urinary infection treatment.
Under the agreement, CMS will have rights to register and distribute the products in the People's Republic of China (ie excluding Hong Kong, Macao and Taiwan). The pact is for 10 years from the date of the first commercialisation in China, and will be automatically extended for a further five years if certain sales targets are met.
The first product covered by the deal is Maltofer, an oral iron supplement which is currently available in more than 80 countries. Switzerland-headquartered Vifor cited IMS data which shows that sales of iron supplements in the Chinese market reached 504.4 million renminbi (about $81 million) in 2011, with a compound annual growth rate of 27.1%; currently there are at least 200 million people suffering from iron deficiency in China.
The second treatment is Uro-Vaxom, an extract of the bacterium Escherichia coli for recurrent urinary tract infections. The latter affects just over 2% of the country's female population and the market size of UTI drugs in China is 5-5.50 billion renminbi.
Ferinject sales soar
Meantime, Vifor, which is the pharmaceutical unit of Galenica, has posted an 8.4% increase in sales for 2012 up to 633.3 million Swiss francs (about $678.9 million). Growth was driven by the intravenous iron drug Ferinject (ferric carboxymaltose) which saw revenues soar 48.4% to 127.1 million francs.
Ferinject performed particularly well in France, the UK, Ireland, the Netherlands and Germany. Vifor noted that the growth has been helped by "advancing into therapeutic areas outside of dialysis", and guidelines in Europe now recommend treatment with Ferinject in anaemic patients with acute and chronic heart failure, inflammatory bowel disease and ulcerative colitis. Also results from the PREFER study presented in April last year showed that a single 1,000 mg dose of Ferinject rapidly improves fatigue symptoms in iron deficient, non-anaemic women.
As for the USA, due to deficiencies in a manufacturing facility near New York, the Food and Drug Administration notified Vifor's partner Luitpold Pharmaceuticals in July 2012 that it would be withholding approval for Injectafer (the brand name of Ferinject across the Atlantic) until the problem is rectified. No additional clinical data were requested and Luitpold has since been working closely with the FDA to resolve these deficiencies and is also preparing for the US launch.
First filings for PA21
Vifor is now concentrating on advancing its phosphate binder PA21 (iron(III)-oxyhydroxide) for treating hyperphosphatemia in patients with chronic kidney disease. Late-stage trials confirmed that PA21 is well tolerated and as effective as Sanofi's Renvela (sevelamer carbonate) and an approval dossier was submitted to the European Medicines Agency at the end of 2012.
The dossier for Singapore was submitted earlier this month and filings are being finalised for the USA and Switzerland. In 2011, all rights to PA21 were transferred to a new venture, Vifor Fresenius Medical Care Renal Pharma, and hopes are high for the product, not least because of its advantage over Renvela in terms of a lower pill burden (three-four per day versus eight-nine).