Mr. Bienaime continued, "As of October 24, 208 patients have been referred through the Kuvan free drug program, including patients in the pilot program. We are supporting a number of investigator-sponsored trials to generate additional data to support the use of Kuvan, as well as various patient communication and online efforts. Also, our partner Merck Serono received a positive CHMP opinion for Kuvan in late September which bodes well for potential approval by the end of the year. We are well on our way to achieving our first fully profitable year with a strong cash position and a full development pipeline. Going forward, we remain focused on the Kuvan launch, the continued geographic expansion of Naglazyme, and the timely development of the PEG-PAL, GALNS for MPS IVA and other promising pipeline programs."
Net Product Revenue
Net product revenue from Naglazyme (galsulfase), an enzyme replacement therapy for mucopolysaccharidosis VI (MPS VI), was $33.3 million for the third quarter of 2008, an increase of 56.3 percent compared to Naglazyme net product revenue of $21.3 million for the third quarter of 2007. Net product revenue from Naglazyme for the nine months ended September 30, 2008 was $96.2 million, an increase of 58.7 percent from Naglazyme net product revenue of $60.6 million for the nine months ended September 30, 2007. BioMarin is directly commercializing Naglazyme in the United States, Western Europe, Brazil, and Turkey and through distributors in other international markets.
Net sales of Aldurazyme (laronidase), an enzyme replacement therapy for
mucopolysaccharidosis I (MPS I) recorded by Genzyme, were $38.2 million for
the third quarter of 2008, an increase of 18.3 percent compared to net
sales by Genzyme of $32.3 million for the third quarter of 2007. Net sales
of Aldurazyme recorded by Genzyme for the nine months ended September 30,
2008 were $113.7 million
|SOURCE BioMarin Pharmaceutical Inc.|
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