Naglazyme Approved by Japanese Ministry... ( NOVATO Calif. March 31 /- BioMari...)

Naglazyme Approved by Japanese Ministry of Health

Date:3/31/2008

NOVATO, Calif., March 31 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (Nasdaq and SWX: BMRN) announced today that AnGes MG, Inc. (AnGes), BioMarin's marketing and distribution partner in Japan, has received approval for its Marketing Application for Naglazyme(R) (galsulfase) from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with Mucopolysaccharidosis VI ( MPS VI).

"We are proud to work with AnGes in bringing the first drug treatment option to MPS VI patients in Japan," said Stephen Aselage, Senior Vice President of Global Commercial Development at BioMarin. "We are dedicated to providing life-altering therapies to patients around the world and continue to expand our geographic footprint through our patient identification and commercialization efforts."

BioMarin established a marketing and distribution agreement with AnGes in December 2006, through which AnGes obtained exclusive rights to market Naglazyme in the Japanese market. AnGes submitted a marketing application to the MHLW in August 2007. Naglazyme was approved by the U.S. Food and Drug Administration (FDA) in May 2005 and by the European Commission (EC) in January 2006. As the first drug approved for MPS VI, the FDA and EC have both designated Naglazyme as an orphan drug, conferring seven years of market exclusivity in the United States and 10 years of market exclusivity in the European Union. In addition, Naglazyme obtained orphan designation in June 2007 from the MHLW in Japan.

About MPS VI

MPS VI (also known as Maroteaux-Lamy syndrome) is a debilitating, life- threatening genetic disease caused by a deficiency of the enzyme N- acetylgalactosamine 4-sulfatase. This enzyme deficiency leads to the accumulation of certain complex carbohydrates, glycosaminoglycans (GAGs), in the lysosomes, giving rise to progressive cellular, tissue and organ system dysfunction. The majority of individuals with MPS VI die from disease-relat
'/>"/>

0

GOOD

Page: 1 2 3 4
Related biology technology :

1. Kuvan, Naglazyme and Aldurazyme Data to Be Presented at the 57th Annual Meeting of the American Society of Human Genetics
2. Lucids VivaScope(R) Reflective Confocal Microscope Approved for Sale in China
3. Center for Molecular Medicine Among First to Offer New FDA-Approved Test to Aid in Treatment of Prostate Cancer
4. Shires ELAPRASE(R) (idursulfase) Approved in Mexico for Treatment of Hunter Syndrome
5. Clexane(R)/Lovenox(R) Approved in Japan
6. EVICEL(TM) Fibrin Sealant (Human) Approved for General Hemostasis in Surgery
7. Avastin Approved in Europe for First-Line Treatment of Patients With Advanced Kidney Cancer
8. Bystolic(TM), a Novel Beta Blocker, is Now Approved by the FDA for the Treatment of Hypertension
9. Healthcare Announced That an Overwhelming Majority of its Shareholders Approved the NexGen Biofuels Transaction
10. Anesiva Outlines Comprehensive Commercialization Plan for FDA Approved Product Zingo(TM)
11. Shires ELAPRASE(R) (idursulfase) Approved in Japan for the Treatment of Hunter Syndrome

Post Your Comments:

Naglazyme Approved by Japanese Ministry...( NOVATO Calif. March 31 /- BioMari...)