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:1/15/2014)... Arizona (PRWEB) January 15, 2014 2013 ... for Scottsdale’s Brain State Technologies®. They saw continued independent ... Medical Center who were awarded a $1 million grant ... published in “Brain and Behavior” a peer reviewed journal, ...
(Date:1/14/2014)... 14, 2014 Carahsoft and CDS Federal ... 23, 2014 at 2pm EST (11am PST), “Natural Language ... focuses on how technology can turn raw, heterogeneous data ... government agencies. The online webinar will last approximately one ...
(Date:1/14/2014)... 2014 The largest international professional organization of ... therapeutic derivatives thereof has endorsed an educational program ... the challenges of adulterated herb and botanical products. ... The Society for Medicinal Plant and Natural ...
(Date:1/14/2014)... 14, 2014 Global Record Systems, ... information technology solutions for patients, physicians, the biopharmaceutical ... announced today the signing of a three-year Research ... Drug Administration (FDA). This initiative is designed ...
Breaking Biology Technology:Dynamic Innovative Technology Showcased at Scottsdale Company’s Open House 2Dynamic Innovative Technology Showcased at Scottsdale Company’s Open House 3Webcast - Natural Language Processing: Converting Raw Data into Actionable Knowledge – Hosted by Carahsoft and CDS Federal Services 2World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 2World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 3World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 4World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 5World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 6World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 7World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 8Global Record Systems Announces Research Collaboration Agreement with FDA to Create a Novel “Big Data” Paradigm for Collection of Patient Safety and Outcomes Information 2
... vision affects 3.3 million Americans age 40 and over, ... to reach 5.5 million by the year 2020, according ... of Ophthalmology . , ,Because of an aging population, ... diseases responsible for blindness such as age-related macular degeneration, ...
... in ePrairie reviewed the top 100 most wired hospitals in ... the top 100. While this is a sign of progress ... hospitals is U.S. News & World Report annual ... some very interesting results, and I have tried to cull ...
... seeking increased connectivity with their healthcare providers hope that ... and make services easier to access. Although the streamlining ... evolving piecemeal, a group of Wisconsin hospitals appears to ... ,The group, organized under Aurora Health Care , ...
Cached Biology Technology:Medical College given funds for eye research 2Midwest shines among best hospitals in U.S. 2Midwest shines among best hospitals in U.S. 3Midwest shines among best hospitals in U.S. 4Midwest shines among best hospitals in U.S. 5Midwest shines among best hospitals in U.S. 6Midwest shines among best hospitals in U.S. 7Midwest shines among best hospitals in U.S. 8Aurora ranks among most wired systems 2
(Date:4/24/2014)... A common plant puts out a welcome mat to bacteria ... mix. , The study published this week in the ... targets during the battle between microbe and host that researchers ... the humble and oft-studied plant Arabidopsis puts out ... It,s as if a hostile army were unknowingly passing by ...
(Date:4/23/2014)... German . Man ... difference between sexes depends on one single element of the genome: ... two sexual chromosomes are X and Y, whereas women have two ... morphological and physiological differences between males and females. , But this ... the X and Y were identical, until the Y started to ...
(Date:4/23/2014)... research shows that male black widow spiders prefer their ... example of mate preference by male spiders. ... and Maydianne Andrade, a professor in UTSC,s Department of ... the wild that males overwhelmingly chose to mate with ... can tell whether a potential mate is well-fed and ...
Breaking Biology News(10 mins):How a plant beckons the bacteria that will do it harm 2How a plant beckons the bacteria that will do it harm 3Male or female? 2Male or female? 3Picky male black widow spiders prefer well-fed virgins 2
... mutations in cancer patients to predict clinical outcome has ... decades, but now researchers at the Kimmel Cancer Center ... links cancer cell metabolism with poor clinical outcome. This ... of human cancer cell. The researchers demonstrate ...
... and demand for it is increasing all the time but ... more secure, thanks to research at The University of Nottingham,s ... the vanilla bean, the ,fruit, of the flowering vanilla orchid. ... ancient Central American civilisations such as the Aztecs and is ...
... is available in German . , Insects ... of odor molecules in the air are sufficient to be ... receptor proteins, expressed in these neurons recognize the odors. The ... electrical signals that are processed in the insect brain and ...
Cached Biology News:Jefferson researchers unlock key to personalized cancer medicine using tumor metabolism 2Jefferson researchers unlock key to personalized cancer medicine using tumor metabolism 3Preserving a world favorite flavour 2Molecular messages from the antennae 2
... SUPERaseIn RNase Inhibitor (patent pending) is a ... noncovalently binds and inhibits the most common ... C, 1 and T1. SUPERaseIn can be ... could be problematic. It is ideal for ...
... RNaseOUT Recombinant Ribonuclease Inhibitor ... of pancreatic-type ribonucleases such as ... inhibitors RNaseOUT Recombinant Ribonuclease Inhibitor ... a molecular weight ~52 kDa. ...
...
... Core Kit contains all the ... assays on a wide range ... to dNTPs, the Core Kit ... used BIOLASE DNA polymerase, which ...
Biology Products: