Navigation Links
Positive Kuvan(TM) Pivotal Phase 3 Trial Results Published in The Lancet
Date:8/19/2007

NOVATO, Calif., Aug. 13 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (Nasdaq and SWX: BMRN) announced today that final results from the Kuvan(TM) (sapropterin dihydrochloride) pivotal Phase 3 clinical trial were published in the August 11, 2007, issue of The Lancet. The study suggests that treatment with Kuvan results in significant reductions in blood Phe levels in some phenylketonuria (PKU) patients. Kuvan, an investigational oral small molecule for the treatment of PKU, is being developed in partnership with Merck Serono, a division of Merck KGaA, Darmstadt, Germany.

"This marks the first published Kuvan clinical study, and we expect additional publications in the coming months to build on the collection of data related to Kuvan," said Emil Kakkis, M.D., Ph.D., Chief Medical Officer of BioMarin. "We recently received priority review from the FDA and hope to receive FDA approval by late November. In the interim, we are pleased to be able to provide Kuvan to PKU patients prior to commercial availability through our expanded access program."

The Phase 3 clinical study enrolled 89 patients with elevated blood Phe levels aged eight years and above at 29 sites in the United States, Europe and Canada. All patients enrolled had demonstrated a reduction in blood Phe levels following treatment with Kuvan in a Phase 2 screening study.

The patients were randomly assigned to receive placebo or 10 mg/kg of Kuvan daily for six weeks. Patients were evaluated every two weeks for changes in blood Phe levels and adverse events. The primary objective was to assess the efficacy of Kuvan compared with placebo for reduction of blood phenylalanine in patients with PKU. The secondary objective was to assess the safety of Kuvan compared with placebo. A total of 87 patients completed six weeks of treatment.

Highlights from the Phase 3 double-blind study are summarized below:

* Patients treated with Kuvan for six weeks had a mean decrease
'/>"/>

SOURCE BioMarin Pharmaceutical Inc.

Copyright©2007 PR Newswire.

Page: 1 2 3 4 5

Related medicine technology :

1. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
2. Positive Aggrastat Results Featured in the Journal of the American College of Cardiology
3. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
4. Protox Announces Positive Clinical Data from Prostate Cancer Study
5. AM-Pharma Announces Positive Results of Phase IIa Clinical Trial with Alkaline Phosphatase For Ulcerative Colitis
6. Cougar Biotechnology Announces Presentation of Positive CB7630 Clinical Data at ESMO Conference
7. TransPharma Medical Announces Positive Results of Phase I Clinical Trials for Transdermal Delivery of hPTH (1-34) for Osteoporosis Treatment
8. Positive ZIO-201 Interim Phase II Sarcoma Data Presented at European Society for Medical Oncology
9. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
10. Portola Pharmaceuticals Announces Positive Phase II EXPERT Results and Additional Oral and Poster Presentations at the XXI Congress of the International Society on Thrombosis and Haemostasis (ISTH)
11. Chi-Med Announces Positive Phase II Proof-of-Concept Data for HMPL-004 in Ulcerative Colitis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/14/2014)... 14, 2014 /PRNewswire-iReach/ -- Acumed,s new SLIC Screw System ... accompanying instrumentation to place and insert the screw accurately ... tissue (e.g. ligament) repair or reconstruction as it holds ... (Photo: http://photos.prnewswire.com/prnh/20140114/MN45636 ) The ...
(Date:1/14/2014)... NuAire , a manufacturer of ergonomically designed laboratory equipment ... of Japan to sell and service the ... NuAire will utilize its network of sales professionals throughout ... to offer assistance in application use, product benefits and features, options ...
(Date:1/14/2014)...   Oligomerix, Inc. , a privately held company pioneering ... (AD) and related neurodegenerative disorders, announced today the relocation ... as of January 15, 2014 and expanded ... Medical College. Oligomerix, which is focused on ...
Breaking Medicine Technology:Acumed introduces the Scapho-Lunate Inter Carpal (SLIC) Screw System 2Acumed introduces the Scapho-Lunate Inter Carpal (SLIC) Screw System 3NuAire announces sales and service of Hitachi Koki centrifuges in North America 2Oligomerix Relocates Corporate Headquarters and Secures Additional Laboratory Space from New York Medical College 2
... , WAYNE, Pa., Nov. 20 Escalon Medical Corp. ... quarter ended September 30, 2009. , For the ... or 2.7%, to $8,435,000 during the three-month period ended September ... year. The Company reported the decreased net revenue of ...
... 20 Unilens Vision Inc. (OTC Bulletin Board: UVICF; ... and markets specialty contact lenses, today reported its operating ... (FY2010). , Net sales excluding royalty income, were $1,683,673 ... reported in the previous year first quarter (FY2009). ...
Cached Medicine Technology:Escalon(R) Reports First Quarter Fiscal 2010 Results 2Escalon(R) Reports First Quarter Fiscal 2010 Results 3Escalon(R) Reports First Quarter Fiscal 2010 Results 4Escalon(R) Reports First Quarter Fiscal 2010 Results 5Escalon(R) Reports First Quarter Fiscal 2010 Results 6Escalon(R) Reports First Quarter Fiscal 2010 Results 7Unilens Vision Reports Record First Quarter Earnings and Royalty Income 2Unilens Vision Reports Record First Quarter Earnings and Royalty Income 3Unilens Vision Reports Record First Quarter Earnings and Royalty Income 4
(Date:4/23/2014)... benefits of probiotics, antioxidants and other nutritional compounds, more ... industry is getting in on the action. But legitimate ... the industry is responding with clinical research to shore ... Chemical & Engineering News (C&EN), the weekly ... M. Bomgardner, a senior editor at C&EN, writes that ...
(Date:4/23/2014)... Five for-profit and non-profit organizations in Washington ... Proof of Concept grants to accelerate maturation of ... the Life Sciences Discovery Fund (LSDF) announced today. ... grant to the Washington Biotechnology & Biomedical Association ... train the next generation of entrepreneurs and help ...
(Date:4/23/2014)... of Midlife Occupational and Leisure Time Physical Activity on ... activity in midlife increases the risk of mobility limitation ... risk. This is found in a study which followed ... study was conducted at the Gerontology Research Center in ... Heavy physical labor is often repetitive, wears the body ...
(Date:4/23/2014)... that proliferation of endogenous neural precursor cells cannot ... axons. From the perspective of neural plasticity, Dr. ... in China observed the effects of functional electrical ... and expression of basic fibroblast growth factor and ... the infarct side. The researchers found that functional ...
(Date:4/22/2014)... industry leaders visited the New Jersey Institute of ... S. Bloom for the launch of the New ... provides a new model for business innovation through ... assets and investment. U.S. Senator Cory Booker, Panasonic ... Taylor, New Jersey Lieutenant Governor Kim Guadagno, New ...
Breaking Medicine News(10 mins):Health News:LSDF announces commercialization grants and Entrepreneur Mentoring Program 2Health News:Midlife occupational and leisure-time physical activity limits mobility in old age 2Health News:Government and industry leaders herald launch of NJIT's New Jersey Innovation Institute 2
... cultural changes that promote patient safety.ENGLEWOOD, Colo., March ... technology for the safe handling, packaging and administration ... targeted campaign recognizing patient safety. The year-long ... the need for a true cultural change in ...
... Air Methods Corporation (Nasdaq: AIRM ), the ... and net income for the year and fourth quarter ended ... $498.8 million compared to $396.3 million in the prior year. ... per diluted share, in the prior year to $19.3 million, ...
... release is available in French . ... manufacturing sector specifically those working in metallurgy and ... governmental norms. , According to a new study from ... Institut national de sant publique du Qubec, extra workplace ...
... the first time that maintenance therapy with the ... (CVP) therapy improves progression-free survival in patients with stage ... of NYU Langone Medical Center, lead author of a ... Journal of Clinical Oncology . , In a ...
... No serious side effects are found in latest ... News) -- A third-generation tissue-cultured smallpox vaccine shows ... smallpox bioterrorism has prompted reconsideration of the need ... associated with first-generation vaccines #133; have raised obstacles ...
... BenefitsWATSONVILLE, Calif., March 10 For millions of Americans ... that improve health and longevity, the latest research results ... published in the scientific journal, Metabolism, found ... cholesterol.The study, conducted by David J.A. Jenkins, MD, PhD, ...
Cached Medicine News:Health News:Baxa Corporation Launches 'Culture of Safety' Campaign to Recognize National Patient Safety Awareness Week 2Health News:Baxa Corporation Launches 'Culture of Safety' Campaign to Recognize National Patient Safety Awareness Week 3Health News:Air Methods Announces Year 2008 Financial Results and Provides First Quarter 2009 Update 2Health News:Air Methods Announces Year 2008 Financial Results and Provides First Quarter 2009 Update 3Health News:Air Methods Announces Year 2008 Financial Results and Provides First Quarter 2009 Update 4Health News:Air Methods Announces Year 2008 Financial Results and Provides First Quarter 2009 Update 5Health News:Air Methods Announces Year 2008 Financial Results and Provides First Quarter 2009 Update 6Health News:Noisy workplaces can make workers deaf 2Health News:Study shows that maintenance rituximab is useful for advanced indolent lymphoma 2Health News:Japanese Researchers Develop New Smallpox Vaccine 2Health News:Spoonfuls of Strawberries Help the Cholesterol Go Down 2Health News:Spoonfuls of Strawberries Help the Cholesterol Go Down 3
... operation in the cath lab has ... daily clinical routine as cardiologists balance ... and lower costs. With AXIOM Sensis, ... system that helps to master both ...
... Artis dTC is a versatile solution designed ... department from preparation to diagnosis and ... With AXIOM Artis dTC, your cath lab ... department that leaves you free to concentrate ...
... BC is a biplane cardiovascular ... ideal for cardiological diagnostics and ... architecture enables you to optimally ... focus on:, Interventional cardiology, ...
MAGNETOM Symphony, an imaging system that offers 1.5T performance and top image quality in a short bore design....
Medicine Products: