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

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:7/24/2014)... led by group leader Yung-Eun Sung has announced ... sulfur-doped and nitrogen-doped graphenes which can be applied ... fuel cells. Yung-Eun Sung is both a group ... Institute for Basic Science* (IBS) and a professor ... has great significance with regards to the development ...
(Date:7/24/2014)... Distinguished Professor of Engineering at the University of ... solve problems in energy engineering, environmental sustainability and ... zeolites, porous rock with a well-defined, crystalline structure. ... so precisely decided that zeolites can separate molecules ... an angstrom (one-tenth of a nanometer), making them ...
(Date:7/24/2014)... , July 24, 2014 Research and ... "Global Cell Culture Market 2014-2018" report to their ... Cell culture is the in vitro growth of ... research, cell studies, and biopharmaceutical production. Cell culture is ... Cell culture instruments and cell culture consumables are necessary ...
(Date:7/24/2014)... Your cell phone may stay charged ... storage capacity. , New research indicates that lithium-ion ... at Lawrence Livermore National Laboratory and ... components will perform as electrodes. , The growing ... for higher-performance batteries. Several key characteristics of lithium-ion ...
Breaking Biology Technology:University of Delaware researcher describes new approach for creating organic zeolites 2Global Cell Culture Market 2014-2018: Key Vendors are Becton, Dickinson and Co, EMD, GE Healthcare, Lonza Group, Sigma Aldrich and Thermo Fisher Scientific 2Getting More Life out of Lithium-ion Batteries 2
... July 1 William T. Talman , ... Societies for Experimental Biology (FASEB) on July 1, 2010 . Talman ... Iowa and is a practicing physician at the University Hospital and ... Chief of the Neurology Service. He will serve for one year as ...
... ... , ... 2010 -- Los Alamos , New Mexico, has the highest number of people with PhD’s ... logical to host the 3rd annual " Next Big Idea ” festival - a festival of ...
... June 30 THE PLANNING SHOP i nternational (TPS ... Unit (OBU) which will be fully dedicated to the oncology therapeutic area. This ... was held June 22-24, 2010 , in Berlin, Germany . , ... Oncology is a complex, fast moving therapeutic ...
Cached Biology Technology:FASEB Welcomes New President, William T. Talman, M.D. 2‘Next Big Idea' Fest Aims to Spark Interest Among NM Youth in Science, Technology as Future Career Path 2‘Next Big Idea' Fest Aims to Spark Interest Among NM Youth in Science, Technology as Future Career Path 3‘Next Big Idea' Fest Aims to Spark Interest Among NM Youth in Science, Technology as Future Career Path 4THE PLANNING SHOP international Announces Oncology Business Unit 2
(Date:7/24/2014)... sobering examples of how wildlife loss leads to conflict ... by Wildlife Conservation Society (WCS) Health & Ecosystems: ... calls for an interdisciplinary approach to tackle global biodiversity ... about 15% of the world,s people and provides protein ... It should come as no surprise that today,s unprecedented ...
(Date:7/24/2014)... of native animal species for food or commercial food ... factor in the decline of many species of primates ... that more than half of the species being consumed ... "By surveying not only the meat made available for ... the forest by hunters and brought to villages for ...
(Date:7/24/2014)... Angeles, where electric cars ply silent freeways, solar panels ... beneath the earth, from howling winds and from the ... that it is technically and economically feasible to convert ... renewable energy. Published in Energy , the plan ... energy supply in California that could create tens of ...
Breaking Biology News(10 mins):New study draws links between wildlife loss and social conflicts 2Stanford study shows how to power California with wind, water and sun 2Stanford study shows how to power California with wind, water and sun 3Stanford study shows how to power California with wind, water and sun 4
... Scientists from the Universit de Montral and McGill University ... chemical reactions within the human body, to become highly ... a new study published in The Journal of ... an enzyme structure," says Joelle Pelletier, a professor at ...
... nearly 50 years, a population of a nearly extinct ... Forest,s San Jacinto Wilderness. Biologists from the U.S. Geological ... and scientists from the San Diego Natural History Museum ... rare mountain yellow-legged frog in the San Jacinto Wilderness ...
... University of British Columbia researchers are part of an ... land plants, a step they hope will lead to ... ultimately boost conservation efforts. Barcodes based on portions ... on products have already emerged as a viable ...
Cached Biology News:Biologists rediscover endangered frog population 2Biologists rediscover endangered frog population 3Biologists rediscover endangered frog population 4UBC researchers help push for standard DNA barcodes for plants 2
Thermo Labsystems offers a basic reader for 96-well microplates that is especially adapted for ELISA and other colorimetric assays....
Features , Designed to assist users in applying domed caps to tube strips and plates , Minimises the pressure required to seal the caps effectively , Enables multiple tubes to be sealed simultaneousl...
Lysozyme C (W-20)...
... B4i ventilated and BR4i refrigerated multifunction centrifuges are ... operation at a low sound level with a ... biocontainment. Their AUTO-LOCK rotor exchange system without tools ... use within seconds. Instant rotor exchange ...
Biology Products: