Navigation Links
Shire's ELAPRASE(R) (idursulfase) Approved in Japan for the Treatment of Hunter Syndrome
Date:10/4/2007

BASINGSTOKE, England and CAMBRIDGE, Massachusetts, October 4 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that Japan's Ministry of Health, Labour and Welfare has approved ELAPRASE, a human enzyme replacement therapy for the treatment of Hunter syndrome, for sale and marketing in Japan. Since its U.S. approval in July 2006, ELAPRASE is now approved for marketing and commercial distribution in 34 countries worldwide.

Hunter syndrome, also known as Mucopolysaccharidosis II (MPS II), is a rare, life-threatening genetic condition mainly affecting males that results from a deficiency in the lysosomal enzyme iduronate-2-sulfatase. Without this enzyme, cellular waste products accumulate in tissues and organs, which then begin to malfunction, leading to severe clinical complications and early mortality.

ELAPRASE, developed by Shire Human Genetic Therapies, Inc. (HGT) is the first and only enzyme replacement therapy approved for people suffering from Hunter syndrome. This medicine is given as a weekly infusion and is designed to replace the deficient iduronate-2-sulfatase enzyme.

As part of an agreement with Genzyme Corporation, Genzyme will manage sales and distribution of ELAPRASE in Japan.

"The approval of ELAPRASE in Japan is another important step in bringing this much-needed treatment to Hunter syndrome patients around the world," said Sylvie Gregoire, president of Shire HGT, the Shire business focused on genetic diseases. "We greatly appreciate the commitment and determination invested by the Japanese patients and their families who temporarily moved to the United States to participate in the ELAPRASE pivotal trial. Their participation in the trial facilitated a rapid approval of ELAPRASE, allowing it to now be available to Hunter syndrome patients in Japan."

Notes to editors

About ELAPRASE

ELAPRASE is a purified form of the lysosomal enzyme iduronate-2-sulfatase and is produced
'/>"/>

SOURCE Shire PLC
Copyright©2007 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4

Related biology technology :

1. Genzyme acquistion of Bone Care approved, significant impact forecast
2. Japan on the rebound: Implications for Midwest
3. Japanese delegates highlight Wisconsin at BIO Chicago
4. Japanese telecom opens liason office at UW-Platteville
5. Promega, Japanese lab announce partnership
6. Japanese institute installs Imago system
7. Wisconsin biotechs plan Japan trade mission
8. Sonic Foundry makes Japanese version of lead product
9. OpGen forges agreement with Japanese importer
10. Japanese biotech is booming and linked with Midwest
11. Japans pharma mergers will trickle to the Midwest
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/18/2013)... This webinar will examine the ... promotion, and review the basic FDA regulations and ... apply these principles through real world case studies ... fundamentals on FDA regulations and guidance related to ...     Assessing traditional and newer forms of promotional materials ...
(Date:6/18/2013)... THE WOODLANDS, Texas , June 18, 2013 ... LXRX ), a biopharmaceutical company focused on ... that John Northcott has joined the ... strategy, and operations. Mr. Northcott brings extensive commercial ... on-market commercialization across a variety of therapeutic areas. ...
(Date:6/18/2013)... Though health care jobs continued to be added ... Labor Statistics -- the increase was far below the calendar ... care jobs were added in home health care and outpatient ... jobs. Overall, the U.S. unemployment rate stayed flat at 7.6 ... that a total of just over 36,000 job cuts were ...
(Date:6/18/2013)... 18, 2013 PathoGenetix, Inc. ... for rapid bacterial strain typing, announced today that ... company as Vice President of Engineering. Dr. Luckey ... company’s RESOLUTION™ Microbial Genotyping System . The ... instrument, pathogen-specific assay kits, database and software, will ...
Breaking Biology Technology:Drug Advertising and Promotion Labeling: FDA Regulations, New Webinar Hosted by Xtalks 2John Northcott Joins Lexicon as Vice President of Marketing, Commercial Strategy and Operations 2John Northcott Joins Lexicon as Vice President of Marketing, Commercial Strategy and Operations 3MedZilla Employment Report for June 2013 -- Jobs in Health Care Grow, But at Slower Pace 2MedZilla Employment Report for June 2013 -- Jobs in Health Care Grow, But at Slower Pace 3PathoGenetix Hires Technology Development VP for Resolution Microbial Genotyping System 2PathoGenetix Hires Technology Development VP for Resolution Microbial Genotyping System 3
... March 21, 2011 ICAP Ocean Tomo ... medicinal nebulizer on March 31st at the ICAP Ocean ... The technology of this patent portfolio provides improvements to ... Recent technological advancements have triggered the use ...
... 2011 Reportlinker.com announces that a new market ... Global Nanobiotechnology Industry ... the worldwide markets for Nanobiotechnology in US$ Million ... Inorganic Nanoparticles, Nanocomposites, Nanostructured Materials & Membranes, Nanotubes ...
... VentiRx Pharmaceuticals, Inc., a biopharmaceutical company focused ... (TLR8) agonists and antagonists for the treatment of ... presentation of positive clinical results from its randomized, ... of allergic rhinitis. The results demonstrated statistically significant ...
Cached Biology Technology:ICAP Ocean Tomo Announces the Auction of an Improved Compact, Portable Nebulizer Developed and Patented by Tidal Air 2ICAP Ocean Tomo Announces the Auction of an Improved Compact, Portable Nebulizer Developed and Patented by Tidal Air 3ICAP Ocean Tomo Announces the Auction of an Improved Compact, Portable Nebulizer Developed and Patented by Tidal Air 4Reportlinker Adds Global Nanobiotechnology Industry 2Reportlinker Adds Global Nanobiotechnology Industry 3Reportlinker Adds Global Nanobiotechnology Industry 4Reportlinker Adds Global Nanobiotechnology Industry 5Reportlinker Adds Global Nanobiotechnology Industry 6Reportlinker Adds Global Nanobiotechnology Industry 7Reportlinker Adds Global Nanobiotechnology Industry 8Reportlinker Adds Global Nanobiotechnology Industry 9Reportlinker Adds Global Nanobiotechnology Industry 10Reportlinker Adds Global Nanobiotechnology Industry 11Reportlinker Adds Global Nanobiotechnology Industry 12Reportlinker Adds Global Nanobiotechnology Industry 13Reportlinker Adds Global Nanobiotechnology Industry 14Reportlinker Adds Global Nanobiotechnology Industry 15Reportlinker Adds Global Nanobiotechnology Industry 16Reportlinker Adds Global Nanobiotechnology Industry 17VentiRx Pharmaceuticals Presents Positive Clinical and Pre-Clinical Data at American Academy of Allergy Asthma & Immunology Annual Meeting 2
(Date:6/17/2013)... 17, 2013How kids eat their food may turn out to ... a new study out of St. Michael,s Hospital. , ... found a significant association between poor eating habits in ... or "bad" cholesterol, putting them at risk for ... in the Canadian Medical Association Journal today. ...
(Date:6/17/2013)... foundations with more modern elements. Using this same approachbut ... Dietrich School of Arts and Sciences have designed a ... storage, and gas transport more efficient and at a ... issue of the Journal of the American Chemical ... builds upon Pitt Associate Professor of Chemistry Nathaniel Rosi,s ...
(Date:6/17/2013)... bacteria, and algae, is a common component of sugar-free ... the medical field it,s approved by the FDA ... used during surgery as a substance that opens the ... , Now Profs. Ehud Gazit and Daniel Segal of ... and the Sagol School of Neuroscience, along with their ...
Breaking Biology News(10 mins):Poor eating behaviors may put preschoolers at risk for later health problems 2'Chemical architects' build materials with potential applications in drug delivery and gas storage 2Artificial sweetener a potential treatment for Parkinson's disease 2
... of antibiotics that followed it, streptococcus bacteria have remained ... reason: the superb evolutionary skills of this pathogen to ... published this week in Science , scientists from ... genome sequencing to identify the precise steps in the ...
... for its immunosuppressive functions could also point the way ... the Indiana University School of Medicine have reported. ... enzyme called SHP2, which plays an important role in ... mutations are also known to cause several types of ...
... This release is available in German . ... mammals. As defense against these herbivores they developed complex defense ... and a number of toxic chemical substances. For decades it ... incurs costs to the plants. Now, using a new method ...
Cached Biology News:New research traces evolutionary path of multidrug-resistant strep bacteria 2New research traces evolutionary path of multidrug-resistant strep bacteria 3
Glycerol-based mounting medium for immunofluorescence microscopy. Formulated to retard photobleaching of fluorochromes such as fluorescein and rhodamine. Product can also be used as a diluent for fl...
... an aqueous-based mounting medium designed for ... Gel/Mount is especially recommended when using ... FluoroBlue. It can also be used ... fluorescein (FITC), Rhodamine (TMRITC) and Texas ...
... Reagent A - Fixation medium Reagent B ... intended for fixing cells in suspension with ... with Reagent B. This procedure gives antibodies ... morphological scatter characteristics of the cells intact. ...
...
Biology Products: