Navigation Links
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
'/>"/>

SOURCE BioMarin Pharmaceutical Inc.
Copyright©2008 PR Newswire.
All rights reserved

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:
*Name:
*Comment:
*Email:
(Date:7/24/2014)... 24, 2014 -- A novel combination of microscopy and ... Energy,s Oak Ridge National Laboratory an unprecedented look at ... physical and electrochemical properties. , The research team ... the surface of a perovskite manganite, a complex material ... avenue to understand surface behavior could benefit researchers who ...
(Date:7/24/2014)... 24, 2014  Now available is a stem cell ... Regenerative Therapies , located in Guadalajara, Mexico ... people a new health option: stem cell therapies ... countless patients suffer from joint and muscle injuries due ... tears, torn rotator cuff, tennis elbow, and knee injuries. ...
(Date:7/24/2014)... Calif. , July 24, 2014  ECC West ... Denver, Colorado with University College Hospital (UCH) ... a development project to finance, design, construct, and operate ... Nigeria . Under the first of ... prepare scoping documents and funding applications. UCH Ibadan intends ...
(Date:7/24/2014)... A research team led by group leader Yung-Eun ... technology to synthesize sulfur-doped and nitrogen-doped graphenes which ... secondary batteries and fuel cells. Yung-Eun Sung is ... Nanoparticle Research at Institute for Basic Science* (IBS) ... , This achievement has great significance with regards ...
Breaking Biology Technology:ORNL study reveals new characteristics of complex oxide surfaces 2Stem Cells In Sports Injuries, Joints And Muscular Pain 2Stem Cells In Sports Injuries, Joints And Muscular Pain 3ECC Signs a Contract for the Finance, Design, and Construction of a Premier Cancer Institute in Ibadan, Nigeria 2
... present the 2011 "ALBERT EINSTEIN" World Award of Science ... Distinguished University Professor University of Toronto, Canada. ... Ozin as the winner of the 2011 "ALBERT EINSTEIN" ... the field of nanochemistry that have helped to define ...
... Pharmaceuticals, Inc. (Nasdaq: ANDS ) is updating the ... Nicolaus Healthcare Conference to Thursday, September 8, 2011 at 4:25 ... at the Four Seasons Hotel in Boston.  Steve Worland, Ph.D., ... overview of Anadys and its clinical development programs, setrobuvir and ...
... ALCLS), the French genome engineering specialist, will present at the UBS ... 2011, and at the MidCap Event in Paris on September 22 ... the activities and the development strategy of the Cellectis group at ... York hotel on Tuesday, September 20, 2011 at 11:30 am ET. ...
Cached Biology Technology:2011 Awards of World Cultural Council 22011 Awards of World Cultural Council 32011 Awards of World Cultural Council 42011 Awards of World Cultural Council 5Anadys Pharmaceuticals Updates Its Presentation Date at the Stifel Nicolaus Healthcare Conference 2
(Date:7/25/2014)... Canadian wildfires have been raging this summer and some of ... U.S. In this image collected by the Moderate Resolution ... 2014 a swath of smoke has descended over the Great ... interesting is the fire image from July 23, 2014 (first ... smoke as it drifts off southeastward. In the image, ...
(Date:7/25/2014)... Birla, associate professor of biomedical engineering at the ... on tissue engineering and artificial organ development., "Introduction ... comprehensive guide to entering into the field of ... professor of biomedical engineering at UH, served as ... that while there are other published books on ...
(Date:7/25/2014)... Spina bifda (SB) is a complex congenital central ... incomplete closing of the neural tubes during the ... spasticity, urinary and fecal incontinence and neurocognitive retardation. ... their quality of life. Researchers at Ankara Physical ... investigate the functional performance in children with SB, ...
Breaking Biology News(10 mins):University of Houston researcher publishes textbook on tissue engineering 2
... scientific studies of the effects on wildlife of large-scale ... assess their impact, especially in the desert Southwest, according ... Geological Survey and published in the journal BioScience ... the paper, USGS scientist Jeffrey Lovich and Maryville College ...
... oil spill in the Gulf of Mexico, the U.S. ... Engineering and National Research Council to convene a committee ... disaster and identify measures for preventing similar harm in ... IMPROVING OFFSHORE DRILLING SAFETY, the committee,s final report, analyzes ...
... believe decision making mechanisms in the human brain could mirror ... similarities have been found in decision making systems between humans ... bees could teach us about how our brains work. ... an often paralysing thought process in humans, with scouts who ...
Cached Biology News:Literature review on solar energy and wildlife impacts research 2Swarms of bees could unlock secrets to human brains 2
Can be used for the quantitative recovery of small amounts of nucleic acids within dilute solutions. 5mg/ml...
APOPTAG® Plastic Coverslips are designed to be custom fitted to the specific APOPTAG® kit application. Each coverslip has 2.5 x 1 dimensions....
Human VEGF-D Biotinylated MAb (Clone 78923)...
Recombinant Mouse TGF-beta RII/(human) Fc Chimera, CF...
Biology Products: