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:8/29/2014)... are based on electrons, but one of the most ... i.e. circuits based on light (photons) instead of electrons. ... a stream of single photons and control their direction. ... attempts to achieve this control, but now scientists at ... steady stream of photons emitted one at a time ...
(Date:8/29/2014)... , Aug. 29, 2014 /PRNewswire/ - iCo ... ICOTF), today reported financial results for the six ... otherwise, are expressed in Canadian dollars and presented ... Second Quarter 2014 Highlights , Announced ... acuity (VA) primary endpoint for subjects enrolled in ...
(Date:8/29/2014)... (PRWEB) August 29, 2014 A major ... the biotech start-up dense realm of Boston-Cambridge, is gaining ... able investors. James Sherley, the Director of Boston’s Adult ... the local and national visibility of his company an ... 2013. , In addition to a social media marketing ...
(Date:8/28/2014)... Best Sanitizers, Inc., the first company to ... asks food processors and food handling professionals to prepare ... currently using to Best Sanitizers’ Alpet® E3 Plus ... fighting cross-contamination and the spread of pathogens in the ... key criteria that make a hand sanitizer most effective, ...
Breaking Biology Technology:Breakthrough in light sources for new quantum technology 2iCo Therapeutics Announces Second Quarter 2014 Financial Results 2iCo Therapeutics Announces Second Quarter 2014 Financial Results 3iCo Therapeutics Announces Second Quarter 2014 Financial Results 4The Adult Stem Cell Technology Center, LLC Participates in Multiple Stem Cell and Regenerative Medicine Conferences Before Year End 2The Adult Stem Cell Technology Center, LLC Participates in Multiple Stem Cell and Regenerative Medicine Conferences Before Year End 3The Adult Stem Cell Technology Center, LLC Participates in Multiple Stem Cell and Regenerative Medicine Conferences Before Year End 4Food Processors and Food Handlers are Encouraged to Prepare for Fall Harvest by Evaluating Their Current Hand Sanitizer Using Nine Key Criteria 2Food Processors and Food Handlers are Encouraged to Prepare for Fall Harvest by Evaluating Their Current Hand Sanitizer Using Nine Key Criteria 3
... will receive state grants under the Department of ... governor's office said on Monday: , , InvivoSciences ... Developing tests to measure physiological responses of cells. ... planning and grant writing. Makes electronic systems ...
... two-part series looking at the successes of five students from a ... business. , ,Yet it is a widely held truth that biotechnology ... UW-Madisons Master of Science in Biotechnology degree program is ... the brave new world of biotech. , ,The mission of the ...
... Center shows a potential new avenue for stem cell-based ... could enable brain cells that generate dopamine, which helps ... the damage caused by disease. , ,The study involved ... called glial cell-derived neurotrophic factor, or GDNF, which has ...
Cached Biology Technology:UW biotech program launches graduates into evolving industry (part 1) 2UW biotech program launches graduates into evolving industry (part 1) 3Stem cells produce anti-disease protein in brain experiment 2
(Date:9/2/2014)... hot oven, you rapidly pull your hand away. Although ... and responding to such painful stimuli, they are still ... made a surprising discovery about the role of a ... built a structural model of the molecule. These discoveries, ... help direct new strategies to treat pain in people. ...
(Date:9/1/2014)... some modest improvement in the last decade in large ... unhealthy trans fats, but the gap in overall diet ... An unhealthy diet is closely linked to cardiovascular ... is an important part of the strategy to prevent ... is important because it can offer guidance for public ...
(Date:9/1/2014)... nucleotidethe basic building block of DNAcould initiate fragile X syndrome, the ... The Journal of Cell Biology . ... gene on the X chromosome called fragile X mental retardation ... 360 men carry a so-called premutation, in which a series of ... is slightly longer than normal. These repeats are prone to even ...
Breaking Biology News(10 mins):Surprising new role for calcium in sensing pain 2Surprising new role for calcium in sensing pain 3Quality of US diet improves, gap widens for quality between rich and poor 2Quality of US diet improves, gap widens for quality between rich and poor 3A nucleotide change could initiate fragile X syndrome 2
... (Sept. 26, 2008) -- Rice University has established a ... for preventing corrosion -- a problem that is estimated ... To develop the center, Rice is ... than 20,000 scientists, engineers and technicians around the world ...
... (September 25, 2008) A light-transmitting compound that could ... in sensors to detect biological and chemical weapons at ... structure was too difficult to examine. Luckily, scientists ... Northwestern University were able to determine the structure of ...
... enzyme called Uch37 is kept in check when it is ... were published in today,s issue of Molecular Cell . ... protein tags (called ubiquitin) from other proteins. The presence of ... it for destruction, but others serve as marks to affect ...
Cached Biology News:Rice University establishes National Corrosion Center 2Argonne scientists peer into heart of compound that may detect chemical, biological weapons 2
Mouse polyclonal antibody raised against a partial recombinant MHC2TA. NCBI Entrez Gene ID = 4261...
Mouse monoclonal antibody raised against a partial recombinant JRKL. NCBI Entrez Gene ID = JRKL...
... Polymorphic DNA Technologies also offers a DNA ... of templates including plasmids, PCR products, BACs, ... customer-provided templates such as purified plasmids or ... liquid handling robotics optimized for automated reaction ...
... a premium quality recombinant form of Thermus ... suitable for a wide range of PCR ... reproducible performance, each preparation is extensively tested ... NovaTaq DNA Polymerase possesses an integral 5′→3′ ...
Biology Products: