BioMarin Initiates Phase 3b Study to Evaluate the Effects of Kuvan on Neurophychiatric Symptoms in Subject... ( NOVATO Calif. Aug. 17 /- BioMarin Pha...)

BioMarin Initiates Phase 3b Study to Evaluate the Effects of Kuvan on Neurophychiatric Symptoms in Subjects with PKU

Date:8/17/2010

NOVATO, Calif., Aug. 17 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that the first subject has initiated treatment in a Phase 3b study (PKU-016) to evaluate the effects of Kuvan (sapropterin dihydrochloride) on neuropsychiatric symptoms in subjects with phenylketonuria (PKU). BioMarin expects to report results in the first half of 2012.

"We hope that this trial will provide quantitative data regarding the neuropsychiatric effects of Kuvan for PKU patients, and if successful, will continue to build its value proposition and to drive the continued expansion of the market," said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. "Although we have heard anecdotal accounts from patients and physicians regarding Kuvan's impact beyond blood Phe level reduction, BioMarin has never formally evaluated these endpoints in a company trial due to the extremely short development time for Kuvan. We are excited to have this important study underway, and if the results are positive, we plan to file for a label amendment. We also look forward to upcoming data from several investigator-sponsored studies on the neurocognitive effects of Kuvan at the SSIEM meeting in Istanbul in late August."

The Phase 3b study is a double-blind, placebo-controlled, randomized 28-week study (2-week screening period, 13-week randomized treatment period, 13-week open-label treatment period) to evaluate the safety and therapeutic effects of sapropterin dihydrochloride on neuropsychiatric symptoms in subjects with PKU. The study will enroll approximately 200 subjects ages twelve and above at approximately 40 sites in the U.S. and Canada.

The primary efficacy variable for symptoms of attention deficit hyperactivity disorder (ADHD) will be evaluated using the Attention-Deficit Hyperactivity Disorder Rating Scale (ASRS) in sub
'/>"/>

SOURCE BioMarin Pharmaceutical Inc.
Copyright©2010 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3
Related medicine technology :

1. BioMarin Partner AnGes MG, Inc. Submits BLA to Japanese Ministry of Health
2. BioMarin Announces FDA Approval for Kuvan
3. BioMarin Initiates Phase 1 Clinical Study of PEG-PAL in PKU
4. BioMarin Announces Positive Results From Phase 2A Clinical Study of 6R-BH4 in Sickle Cell Disease
5. BioMarin Initiates Phase 1/2 Clinical Trial for GALNS for Morquio A Syndrome
6. BioMarin Initiates Phase 2 Clinical Study of PEG-PAL in PKU
7. BioMarin Acquires Huxley Pharmaceuticals, Inc.
8. BioMarin to Present at the Oppenheimer Healthcare Conference
9. BioMarin Announces Third Quarter 2009 Financial Results
10. BioMarin to Acquire LEAD Therapeutics
11. BioMarin to Present at the Credit Suisse Healthcare Conference

Post Your Comments:

(Date:5/16/2013)... N.C. , May 16, 2013 Today, the ... North Carolina House of Representatives recently approved ... for chemotherapy from charging patients higher out-of-pocket fees for ... formularies, many of which have more severe side-effects. However, ... limit of $300, which will continue to be a ...

(Date:5/16/2013)... -- Alere Inc. (NYSE: ALR ), a global leader ... home through the merger of rapid diagnostics and health management, ... its Series B Convertible Perpetual Preferred Stock (NYSE: ALR.PR.B). The ... record of Series B stock at the close of business ... the amount of all dividends accrued from April 1, 2013 ...

(Date:5/16/2013)... Calif. , May 16, 2013 AcelRx Pharmaceuticals, ... focused on the development and commercialization of innovative therapies for ... Richard King , President and CEO, will ... at the Sheraton New York Hotel in New ... May 22, 2013 at 9:30 a.m. ET/6:30 a.m. PT. ...

Breaking Medicine Technology:National Patient Advocate Foundation Responds to N.C. State House Approval of Flawed Cancer Treatment Fairness Bill 2 National Patient Advocate Foundation Responds to N.C. State House Approval of Flawed Cancer Treatment Fairness Bill 3 AcelRx Pharmaceuticals to Present at the UBS Global Healthcare Conference 2 AcelRx Pharmaceuticals to Present at the UBS Global Healthcare Conference 3

[0] National Patient Advocate Foundation Responds to N.C. State House Approval of Flawed Cancer Treatment Fairness Bill [0] Alere Inc. Declares Cash Dividend on its Series B Convertible Perpetual Preferred Stock [0] AcelRx Pharmaceuticals to Present at the UBS Global Healthcare Conference

... genomics, SAN DIEGO, April 14 Systems ... Inc. (CTI) (Nasdaq,and MTAX: CTIC), presented data from ... more likely to respond to treatment with the,experimental ... Research (AACR) annual meeting. These findings will be ...

... During Wednesday,s Satellite Symposium,3: The Challenges of ... the,International Society of Heart and Lung Transplantation ... researchers discussed some of,the unique challenges in ... CF., A highlight of the session ...

Cached Medicine Technology:New Gene Discovery Suggests Which Patients CTI's Brostallicin May Benefit 2 New Gene Discovery Suggests Which Patients CTI's Brostallicin May Benefit 3 New Gene Discovery Suggests Which Patients CTI's Brostallicin May Benefit 4 New Gene Discovery Suggests Which Patients CTI's Brostallicin May Benefit 5 Lung Transplants in Cystic Fibrosis Patients With Life-Threatening Bacteria Sparks Debate at ISHLT Meeting 2 Lung Transplants in Cystic Fibrosis Patients With Life-Threatening Bacteria Sparks Debate at ISHLT Meeting 3

New Gene Discovery Suggests Which Patients CTI's Brostallicin May Benefit Lung Transplants in Cystic Fibrosis Patients With Life-Threatening Bacteria Sparks Debate at ISHLT Meeting

(Date:5/19/2013)... IL (PRWEB) May 19, 2013 In partnership ... LLC, E-dentist.com has announced the launch of an SEO website ... dentists get high rankings in Google. , http://www.e-dentists.com/ ... not pay for the service until they see results. Dentists ... The lead generation websites run by JD Media Surge, LLC ...

(Date:5/19/2013)... (PRWEB) May 19, 2013 Grinding your ... just losing sleep, or annoying your spouse. At the ... by CNY Central (“Snoring and Teeth Grinding Could Be ... of teeth grinding can be hard to prevent. Apparently, ... Americans, and one of its symptoms is a habit ...

(Date:5/19/2013)... The report “Feed Additives Market by Types, Livestock ... 2017” published by MarketsandMarkets, defines and segments the global ... the global volume and revenue for the animal feed ... for the global market with analysis of trends, opportunities, ... segmented and revenue is forecasted on the basis of ...

(Date:5/19/2013)... May 19, 2013 Farming methods have ... in the ground 10,000 years ago. Most recently, the ... productivity by using genetically engineered seeds and by applying ... a backlash to these techniques due to the adverse ... and a corresponding surge in interest in organic, sustainable ...

(Date:5/19/2013)... Yeast infections are common in both men and women. ... human body. A new yeast infection treatment product has been ... method of application to help eliminate over growth of the ... men and women searching for a natural process of yeast ... food and is stored in the intestines. In small consumable ...

Breaking Medicine News(10 mins):Health News:Effective New Dental SEO Solution Launched by E-dentists.com in Partnership with JD Media Surge, LLC 2 Health News:Dr. Kanani, Woodland Hills Dentist: Dangers of Tooth Damage and Obstructive Sleep Disorder 2 Health News:Dr. Kanani, Woodland Hills Dentist: Dangers of Tooth Damage and Obstructive Sleep Disorder 3 Health News:Feed Additives Market to Reach $19.5 Billion by 2017 at a CAGR of 3.8% - New Report by MarketandMarkets 2 Health News:Feed Additives Market to Reach $19.5 Billion by 2017 at a CAGR of 3.8% - New Report by MarketandMarkets 3 Health News:Green Acre Aquaponics Introduces a Revolutionary Approach to Farm Education and Commercial Aquaponics 2 Health News:Green Acre Aquaponics Introduces a Revolutionary Approach to Farm Education and Commercial Aquaponics 3 Health News:A Safe & Homeopathic Yeast Infection Relief by Yeastrol Now Available at HealthCareSupplementz.com with Massive Discount 2

[0] Effective New Dental SEO Solution Launched by E-dentists.com in Partnership with JD Media Surge, LLC [0] Dr. Kanani, Woodland Hills Dentist: Dangers of Tooth Damage and Obstructive Sleep Disorder [0] Feed Additives Market to Reach $19.5 Billion by 2017 at a CAGR of 3.8% - New Report by MarketandMarkets [0] Green Acre Aquaponics Introduces a Revolutionary Approach to Farm Education and Commercial Aquaponics [0] A Safe & Homeopathic Yeast Infection Relief by Yeastrol Now Available at HealthCareSupplementz.com with Massive Discount

... ... enrollment grew by 708,000 members during 2007, - Selling, general and administrative expense ratio continued to improve, ... Operating cash flow exceeded $4.3 billion for the year, or 1.3 times net ... income, - Company reiterates diluted earnings per share target of $6.41 for ...

... Mentally Fit Years Longer, KIRKLAND, Wash., Jan. 23 ... people need long term care today," says Cameron,Truesdell, CEO ... care insurance agency. "That shouldn,t be, so we,re going ... To that end, the,company is offering a free guidebook ...

... Approval for Gestiva(TM) Anticipated in Calendar 2008, Gestiva(TM), is ... the Prevention ... Birth in Singleton Pregnancies, ST. LOUIS, Jan. 22 ... pharmaceutical company that,develops, manufactures, acquires and markets technology-differentiated,branded and ...

... Group of Lawmakers Vow to Fight Premature Birth in Ohio, ... and Ohio,s rate of premature birth is up once again ... 19,321 preterm births were recorded for,2005 and over 20 lawmakers ... of Ohio,s babies. "We were happy to receive the news ...

... cleaners with the hospital laundry, FORT WORTH, Texas, Jan. ... Huguley Memorial Medical Center after,the hospital staff sent their newborn ... July 8, 2007, Kourtney McGee gave birth to her son, ... was taken to the,hospital morgue., As Ms. McGee and ...

... Sargent of Success Design International, to offer a new course in ... ... The business of,life coaching takes another step forward with the Hemispheric,Integration(TM) ... science of personal achievement. It is an art,because the way each person ...

WellPoint Reports Fourth Quarter and Full Year 2007 Results Long Term Care Insurance Leader Offers Advice on Preventing Dementia, the Leading Cause of Care Claims KV Pharmaceutical Company Announces Acquisition of Rights to Gestiva(TM)Ohio Prematurity Caucus Forming to Meet Challenge A Fort Worth Couple Sues Huguley Memorial Medical Center Spencer Institute Offers a Home-Training Course for Hemispheric Integration & Neuro-linguistics Coach Certification

GP8R is a powerful 3-liter large capacity centrifuge which is flexible and easy to use with refrigeration facility. Performs separations 50-100% faster than the rest, powerful, accommodating and conv...

... Rotanta 460 family of ... line that meets a ... They feature high capacity, ... state-of-the-art technology and high ...

... 15 centrifuge provides all the ... for today's full-service clinical lab ... a speed up to 15,300 ... spin tubes, plates and rotors ...

BD Dynac III is a general purpose centrifuge. Digitally precise variable speeds, microprocessor controlled, versatile rotor choices, user programmable: speed, RCF and time, 10 program (memory) settin...

Medicine Products:

Centra-GP8R Rotanta 460R Spinchron 15 Refrigerated Centrifuge Dynac III