lications. With respect to Naglazyme, the company has 52 issued patents, including 3 U.S. patents. Claims cover its ultrapure N -acetylgalactosamine-4-sulfatase compositions of Naglazyme, methods of treating deficiencies of N -acetylgalactosamine-4-sulfatase, including mucopolysaccharidosis VI, methods of producing and purifying such ultrapure N -acetylgalactosamine-4-sulfatase compositions and methods of detecting. These patents would expire between 2021 and 2028. With respect to Kuvan, the company owns, co-owns or has licensed various patents and pending patent applications that relate generally to formulations and forms of its drug substance, methods of use for various indications under development and dosing regimens. The company has rights to 107 issued patents including 14 issued U.S. patents with claims to a tablet and oral solution formulation of 6R-BH4, methods of treating PKU using a once daily dosing regimen, methods of administration of Kuvan with food, crystalline forms of 6R-BH4, and methods of producing 6R-BH4. These patents would expire between 2024 and 2032. The company has rights to 33 issued patents, including 6 U.S. patents, related to Aldurazyme. These patents cover its ultra-pure alpha-L-iduronidase composition of Aldurazyme, methods of treating deficiencies of alpha-L-iduronidase by administering pharmaceutical compositions comprising such ultra-pure alpha-L-iduronidase, a method of purifying such ultra-pure alpha-L-iduronidase and the use of compositions of ultra-pure biologically active fragments of alpha-L-iduronidase. These patents would expire in 2019 and 2020. There are U.S. patents on alpha-L-iduronidase owned and controlled by a third-party. The company has examined such issued U.S. patents, the related U.S. and foreign applications and their file histories, the prior art and other information. Corresponding foreign applications were filed in Canada, Europe and Japan. The company has patent protection in the European Patent Organization countries for Firdapse for the treatment of LEMS. It has no issued patents in the U.S. for Firdapse for the treatment of LEMS. These patents would expire in 2022. With respect to Vimizim, the company owns or has licensed a number of patents and pending patent applications that relate generally to compositions of matter, methods of use and methods of production. The company has rights to 39 issued patents including 14 issued U.S. patents with claims to compositions of purified recombinant N-acetylgalactosamine-6-sulfate sulfatase (Vimizim) methods of treating Morquio Syndrome and sulfatase-modifying factor I (SUMF1) polypeptides and nucleic acids used in the manufacture of Vimizim. Issued U.S. patents cover SUMF1 compositions (set to expire in 2019), purified recombinant Vimizim compositions (set to expire in 2029) and methods of treating Morquio Syndrome (set to expire in 2029). The company also has issued U.S. and European patents that cover methods of production (set to expire in 2024) and formulations (set to expire in 2031). Competition The company’s competitors include Sarepta Therapeutics, Inc. and Spark Therapeutics, Inc. Government Regulation The company’s products require approval from the Food and Drug Administration, the European Medicines Agency, and corresponding agencies in other countries before they could be marketed. History BioMarin Pharmaceutical Inc. was founded in 1996. The company was incorporated in Delaware in 1996 and began its operations in 1997.
biomarin pharmaceutical inc
770 Lindaro Street
San Rafael, CA 94901
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