At least a slight delay...
FDA Questions on Merck's New Rebif Delay Approval
Feb. 6 (Bloomberg) -- Merck KGaA faces a delay in introducing a new formulation of Rebif, the world's second- biggest multiple sclerosis medicine, after U.S. regulators asked for more information.
``We've received questions from the FDA that require our response,'' said Benedicte Bogh, a spokeswoman at the company's Merck Serono unit in Geneva, in a telephone interview today. ``We continue to work very closely with the FDA to address these requests.''
Merck needs Rebif to beef up sales from branded pharmaceuticals, which are growing slower than at competitors, as the German company rebuilds the unit to focus on cancer, diabetes and central nervous diseases. Merck Serono plans to use the new formulation to increase its share of the $5 billion global market and surpass its larger rival, Biogen Idec Inc.'s Avonex for MS.
The company applied for approval of the treatment, which has fewer side effects than the current version, last April. The Food and Drug Administration, which usually gives its decision within 10 months, was due to rule on the application by Feb. 4. Bogh declined to comment on how long the regulator may take to complete its review.
The new version, which isn't made from human or animal-based materials although it is produced in mammalian cells, reduces reactions at the injection site and results in fewer antibodies forming compared with older versions of the medicine.
``The new formulation is intended to replace the current formulation,'' Bogh said. ``It will support our objective to reach global market leadership for Rebif.''
Elan Corp. and Biogen Idec's Tysabri is the latest treatment to enter the multiple sclerosis market as companies jostle to defend their share. Berlin-based Bayer Schering Pharma AG is widening the use of its Betaseron, the oldest multiple sclerosis therapy, to include patients with early stages of the disease to fend off the rising competition.
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