Navigation Links
Kuvan Receives Positive Opinion From CHMP for European Approval
Date:9/25/2008

Decision on Marketing Authorization Expected by End of 2008

NOVATO, Calif., Sept. 25 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that its partner Merck Serono, a division of Merck KGaA, Darmstadt, Germany, has received a positive opinion for Kuvan(R) (sapropterin dihydrochloride) as an oral treatment for hyperphenylalaninemia (HPA) in patients with phenylketonuria (PKU) or tetrahydrobiopterin (BH4) deficiency from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA). The CHMP recommendation will be considered by the European Commission, which will deliver its final decision on the granting of marketing authorization within 67 days.

"The positive opinion from the CHMP is encouraging and bodes well for potential approval, which is on track by the end of the year, triggering a $30 million milestone payment to BioMarin," said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. "We are excited to work with our partner Merck Serono to offer the first therapeutic option to manage PKU in the European market."

About Kuvan

Kuvan(R) (sapropterin dihydrochloride) Tablets is indicated to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Kuvan is to be used in conjunction with a Phe-restricted diet.

The active ingredient in Kuvan, sapropterin dihydrochloride, is the synthetic form of 6R-BH4 (tetrahydrobiopterin), a naturally occurring enzyme cofactor that works in conjunction with phenylalanine hydroxylase (PAH) to metabolize Phe. BioMarin and Merck Serono estimate that Kuvan could be a potent
'/>"/>

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

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. Exclusive Rights to Kuvan(TM) Data Licensed to Asubio Pharma in Japan
3. Corgenix Receives Third U.S. Patent on AtherOx(R) Technology
4. Sustainable Oils Receives Regulatory Approval for Feeding Camelina Meal in Livestock Diets
5. U.S. Genomics Inc. Receives $4.5 Million Investment from BD
6. AdvanDx Receives FDA 510(k) Clearance for Yeast Traffic Light PNA FISH(TM)
7. PLC Systems Receives Delisting Notice From American Stock Exchange
8. Nephros Receives Non-Compliance Notification from AMEX
9. China Biologic Receives SFDA Approval for Clinical Trial of Human Coagulation Factor VIII
10. Barr Receives Approval for Generic Version of Razadyne(R) ER Capsules
11. Intact Medical Corporations Intact(R) Excise XL Receives 510(K) Marketing Clearance from the FDA

Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2009).... 2 /PRNewswire-Asia/ -- Simcere Pharmaceutical Gr... leading pharmaceutical company,specializing in th...nded,generic and proprietary pharmaceuticals in Ch...en included in China,s National Drug Reimbursement...ry of Human Resources and Social,Security on Novem...
(Date:12/1/2009)...lomon announced that he has joined Carolina Eyecar...te at www.DrKerrySolomon.com , which was develope...roven LASIK, lens implant, and cataract surgery ex...s substantial contributions to improving vision co... Surgeons, which screens LASIK surgeons based upon...
(Date:12/1/2009)...RNewswire/ -- Harvest Technologies Corp. ( www.har...mpany sponsored 60-patient clinical trial conducte...dia using the company,s BMAC System to treat patie...a (CLI). Sri Ramachandra Medical Center is a Harva...sed in Chennai, India and one of the largest priva...
(Date:12/1/2009)... 1 Prairie Heart Institute of Illi...ntly awarded two statuettes at the first-ever CLIO...ty. The CLIO Healthcare Awards recognizes creative...tising industry and is an extension of the CLIO Aw...mpetitions for advertising, design and interactive...
Breaking Biology Technology:Simcere Announces 105 Drugs Included in China's National Drug Reimbursement List 2Simcere Announces 105 Drugs Included in China's National Drug Reimbursement List 3Charleston LASIK and Cataract Expert Dr. Kerry Solomon Opens New Practice and Launches DrKerrySolomon.com 2Charleston LASIK and Cataract Expert Dr. Kerry Solomon Opens New Practice and Launches DrKerrySolomon.com 3Charleston LASIK and Cataract Expert Dr. Kerry Solomon Opens New Practice and Launches DrKerrySolomon.com 4Charleston LASIK and Cataract Expert Dr. Kerry Solomon Opens New Practice and Launches DrKerrySolomon.com 5Charleston LASIK and Cataract Expert Dr. Kerry Solomon Opens New Practice and Launches DrKerrySolomon.com 6Harvest Technologies Announces Trial Results in its India Study Using BMAC to Treat Patients With Non-Reconstructable Critical Limb Ischemia 2Harvest Technologies Announces Trial Results in its India Study Using BMAC to Treat Patients With Non-Reconstructable Critical Limb Ischemia 3Prairie Heart Institute of Illinois Wins Two CLIO Healthcare Awards 2
...tions, such as this barrel spring, are old enough ...r produced. Over the past decade, the economy has...ortance of intangible assets, such as patents. A p...d business method or a killer app software tool to...ical industry can form the basis for an entire bus...
...studies stem cells in his Primate Center lab. Phot... Madison, Wis. James Thomson avoided talking...esidential election, explaining instead the scienc... a scientific celebrity on the University of Wisco...ng human embryonic stem cells, packed an auditoriu...
...vity and communications tools now ubiquitous, orga...potential to promote more effective communication ...apabilities have an important role in organization...d to modify the culture and behavior of an organiz...ure, is naive. Yet that is precisely what some exe...
Other Biology Technology:Patent essentials for business owners: from patent to profit 2Patent essentials for business owners: from patent to profit 3Patent essentials for business owners: from patent to profit 4Patent essentials for business owners: from patent to profit 5James Thomson plans to stay in Madison to study genesis of stem cells 2James Thomson plans to stay in Madison to study genesis of stem cells 3Dont rely on information technology to change corporate culture 2Dont rely on information technology to change corporate culture 3
(Date:12/2/2009)...e University of Georgia College of Veterinary Medi... could open new avenues for treating Ichthyophthir...lled protozoan parasite that commonly attacks fres...encing, researchers found that Ich harbors two app...ides, which are usually found free-living, and Ric...
(Date:12/2/2009)...fit have a higher IQ and are more likely to go on ...ut at the Sahlgrenska Academy and Sahlgrenska Univ...day in the prestigious Proceedings of the Nationa...d 1.2 million Swedish men doing military service w...roup analysed the results of both physical and IQ ...
(Date:12/2/2009)...smokeless tobacco product called moist snuff plac...esota to urge the tobacco industry to change manuf...rcinogens. Their study is published online in ACS,.... It reports that this category of tobacco product...ic and cancer-causing substances. Called polycycli...
Breaking Biology News(10 mins):UGA researchers lead team in discovery involving devastating freshwater fish parasite, 'Ich' 2UGA researchers lead team in discovery involving devastating freshwater fish parasite, 'Ich' 3Young adults who exercise get higher IQ 2DaVita Named to List of Best Places to Work in Los Angeles by the Los Angeles Business Journal 48596 1DaVita Named to List of Best Places to Work in Los Angeles by the Los Angeles Business Journal 48596 2ClearTrial Industry Expert to Lead Session at DIA Annual Meeting on Improving Accrual and Contract Management in Clinical Trials 12584 1ClearTrial Industry Expert to Lead Session at DIA Annual Meeting on Improving Accrual and Contract Management in Clinical Trials 12584 2WHO Readies to Declare Swine Flu Pandemic 48590 1WHO Readies to Declare Swine Flu Pandemic 48590 2WHO Readies to Declare Swine Flu Pandemic 48590 3WHO Readies to Declare Swine Flu Pandemic 48590 4WHO Readies to Declare Swine Flu Pandemic 48590 5WHO Readies to Declare Swine Flu Pandemic 48590 6WHO Readies to Declare Swine Flu Pandemic 48590 7WHO Readies to Declare Swine Flu Pandemic 48590 8WHO Readies to Declare Swine Flu Pandemic 48590 9WHO Readies to Declare Swine Flu Pandemic 48590 10WHO Readies to Declare Swine Flu Pandemic 48590 11
...er field in Canada,s High Arctic may help research... and provide insights for future exploration of ou...ty of Calgary,s Arctic Institute of North America ... spring on the surface of an ice field not far fro...red by Institute Executive Director Dr. Benoit Bea...
...nter, Chicago, and Ceregene Inc., San Diego, have ...unction and stop the anatomic, cellular changes th...isease (HD). This is the first study to demonstrat...might be prevented in HD mice with this treatment....ceedings of the National Academy of Sciences of th...
... effect on some of the world,s finest coral reefs ... to show the long-term impact of sea temperature r...ections of coral reefs and much of the marine life...nternational team of researchers, who surveyed 21 ... in the inner islands of the Seychelles in 1994 an...
Other Biology News:Arctic expedition will investigate alien-like glacier 2Gene therapy injected into the brains' of mice with Huntington's disease 2Gene therapy injected into the brains' of mice with Huntington's disease 3Gene therapy injected into the brains' of mice with Huntington's disease 4Global warming may have damaged coral reefs forever 2
...amer screening and binding optimization and built ...on-chip synthesis platform. These microarrays are ...amer Microarray Service. Probe Content Our Stan...han 1500 known aptamer sequences. Add up to 100 of...
...sive service for custom peptide microarray experim...nthesized on Paraflo microfluidic chips for quanti...s or serum samples. This comprehensive service inc...ng assays using sample(s) provided by you, single ...
...amer screening and binding optimization and built ...on-chip synthesis platform. Thousands of customer ... LC Sciences can provide assistance with custom se...part of our comprehensive DNA/RNA Aptamer Microarr...
...nsferase (GST) is commonly used as a fusion partne...Tag sequence has been reported to enhance the prod...ion partners. When expressed in a soluble, properl...ied with immobilized glutathione. Gentle elution i...
Biology Products: