Navigation Links
Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA
Date:8/2/2009

LEXINGTON, Massachusetts, August 3 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today reported positive results from the first of three Phase III studies of velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease. The Company also announced that the U.S. Food and Drug Administration (FDA) has accepted its treatment protocol for velaglucerase alfa and that Shire has begun its rolling submission of the New Drug Application (NDA) for velaglucerase alfa allowed under the Fast Track process.

"We are very pleased with the progress of the velaglucerase alfa program from both a clinical and regulatory perspective," said Sylvie Gregoire, President of Shire Human Genetic Therapies. "This data are consistent with those previously reported from the Phase I/II and extension studies. We will continue to work diligently with the FDA and other regulatory agencies to make velaglucerase alfa available as soon as possible to help meet the needs of the Gaucher community."

Shire's velaglucerase alfa program is the largest and most comprehensive set of Phase III clinical trials conducted to date for Gaucher disease. Over 100 patients at 24 sites in 10 countries around the world have participated in the clinical studies.

Velaglucerase alfa is made using Shire's proprietary technology, in a human cell line. The enzyme produced has the exact human amino acid sequence and carries a human glycosylation pattern.

Phase III Study Overview and Results

The first trial in the Phase III program to be completed was a multicenter, randomized, double-blind, two dose study of velaglucerase alfa in patients with Type 1 Gaucher disease. The primary goal of this study was to evaluate the safe
'/>"/>

SOURCE Shire Plc
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Shire Strives to Increase Adherence Among Chronic Kidney Disease Stage 5 Patients
2. Shire Enhances its Orphan Drug Pipeline With the Acquisition of a New Clinical Candidate for Metachromatic Leukodystrophy
3. Shire to Present Additional Scientific Data on ADHD Treatment Portfolio at American Psychiatric Association Annual Meeting
4. Shires Investigational Nonstimulant ADHD Treatment INTUNIV(TM) (Guanfacine Extended Release) Demonstrated Significant Efficacy in Reducing ADHD Symptoms at All Measured Time Points Up to 24 Hours Postdose
5. Shire Announces Approval of ELAPRASE(R) (idursulfase) in Brazil
6. Shire to add New Orphan Drug to its HGT Portfolio - EU Launch Imminent
7. Shire Withdraws European Application for DAYTRANA(TM) (Methylphenidate Transdermal System)
8. Shire Announces Study Results of the Effects of INTUNIV(TM) (Guanfacine) Extended Release on Secondary Measures in Children with ADHD and Oppositional Symptoms
9. Shire Presented Results of a New Database Analysis on Lialda(R) (Mesalamine) and Other 5-ASAs for Ulcerative Colitis at Digestive Disease Week
10. Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease
11. Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/27/2014)... - New Solution That Makes ... JIN Co., Ltd. will launch JINS MEME "ACADEMIC PACK" ... yen or $5,000 (without tax /including two pairs of JINS ... a dedicated solution of "JINS MEME" to academic researchers, and ... generated by electrooculography and six-axis sensors without API. (*Physiological data ...
(Date:11/26/2014)... 2014  Thoratec Corporation (NASDAQ: THOR ), ... to save, support and restore failing hearts, said today ... On Tuesday, December 2, the company will ... Healthcare Conference.  D. Keith Grossman , President and ... company beginning at 11:30 a.m., Eastern Standard Time (8:30 ...
(Date:11/26/2014)... 2014   Royal Philips (NYSE: ... availability of its portfolio of diagnostic X-ray ... Opta[i] , ProGrade and PrimaryDiagnost[ii]. With new releases ... the U.S., and availability of all these solutions ... customers innovative solutions designed to meet the needs ...
Breaking Medicine Technology:JIN to Launch JINS MEME ACADEMIC PACK in Late April 2015 2JIN to Launch JINS MEME ACADEMIC PACK in Late April 2015 3Thoratec Announces Presentations At Investor Conferences For December 2014 2Philips expands global reach of diagnostic X-Ray solutions 2Philips expands global reach of diagnostic X-Ray solutions 3
... Greater Than 50% Response Rate and 100% Disease Control Rate Observed ... Patients with Medullary Thyroid Cancer, ... encouraging new data from an ongoing phase 1 clinical trial of,XL184, ... with advanced malignancies. The maximum tolerated dose (MTD) for,XL184 has been ...
... in Management of Transplant Recipients with Cancer, ... in post-transplant patients with cancer is challenging.,Clinicians must ... while,simultaneously monitoring the impact of chemotherapeutic agents on ... management of such patients will be,presented today at ...
Cached Medicine Technology:Exelixis Reports Encouraging Phase 1 Data for XL184 at ASCO 2Exelixis Reports Encouraging Phase 1 Data for XL184 at ASCO 3Exelixis Reports Encouraging Phase 1 Data for XL184 at ASCO 4Exelixis Reports Encouraging Phase 1 Data for XL184 at ASCO 5Exelixis Reports Encouraging Phase 1 Data for XL184 at ASCO 6Penn State Hershey Transplant Program Uses Assay to Monitor Cell-Mediated Immunity 2
(Date:11/27/2014)... "As a nurse I see patients every ... incontinence," said an inventor from Whiting, N.J. "I put ... to prevent leakage and keep them dry and comfortable." ... This prevents stains on pants, skirts and bottoms, which ... that the individual has time to get to the ...
(Date:11/27/2014)... 27, 2014 Nearly 1,100 Risperdal ... in a consolidated litigation now underway in Pennsylvania ... Documents recently updated in the Philadelphia Court of ... state proceeding, all of which involve a drug ... psychiatric conditions. Many of the cases in this ...
(Date:11/27/2014)... HealthDay Reporter , WEDNESDAY, Nov. 26, 2014 ... a second language, new research suggests. But anyone who tries ... brain boost, the small study finds. The brain ... Ping Li, co-director of the Center for Brain, Behavior and ... Li said, that "the brain networks of the more successful ...
(Date:11/27/2014)... News) -- Most babies and young children don,t need ... and Drug Administration says. Over-the-counter (OTC) cold and ... than 2 because they could cause serious and potentially ... average about three colds a year, but children get ... might want to give them pain relievers, decongestants and ...
(Date:11/27/2014)... Thompson HealthDay Reporter WEDNESDAY, ... appears to be safe and produces an immune system response ... early clinical trial results reported by the U.S. National Institutes ... trial for the vaccine paves the way for field-testing it ... Leone as early as January, said Dr. Anthony Fauci, director ...
Breaking Medicine News(10 mins):Health News:New Risperdal Lawsuits Added to Philadelphia Litigation, Bernstein Liebhard LLP Reports 2Health News:New Risperdal Lawsuits Added to Philadelphia Litigation, Bernstein Liebhard LLP Reports 3Health News:New Risperdal Lawsuits Added to Philadelphia Litigation, Bernstein Liebhard LLP Reports 4Health News:Some People May Be Pre-Wired to Be Bilingual 2Health News:Some People May Be Pre-Wired to Be Bilingual 3Health News:Steer Clear of Cold Meds for Babies, FDA Advises 2Health News:Early Trial Promising for Ebola Vaccine 2Health News:Early Trial Promising for Ebola Vaccine 3
... Roche Pharmaceuticals has granted a sub-license to Indian firm Hetero ... is the only drug known so far to have any ... virus. ,Hetero is based at Hyderabad and ... distributed across South East Asia and Africa. Commenting on the ...
... gearing up worldover, as the australian health minister ... be provided to all patients visiting queensland// hospital ... smoking following which the Australian Competition and Consumer ... sponsor anti-smoking advertising. ,Cigaretter manufacturers in ...
... and Resorts has banned smoking in the rooms, restaurants, bars ... Canada and the Caribbean from January 2006//., ,Guests will ... outdoor areas. , ,Westin said research among its customers ... room. , ,"Nobody likes to walk into a smoky ...
... has revealed that routine chest X-rays may serve to identify ... 172,000 Americans // are expected to be diagnosed with lung ... as this disease is invariably detected late. ,Earlier ... tumors, or patients were put through risky surgery as a ...
... and Finch showed the effect of childhood infections and ... diseases // . ,They collected mortality data ... and Switzerland from different years but ending with individuals ... was an important factor in treating childhood illness. ...
... Scientists in Scotland have discovered that an ordinary kitchen ... superbug, which is capable of resisting many // antibiotics. ... brand of the kitchen-scouring pad alone contains the cure ... according to reports can be grown on one particular ...
Cached Medicine News:
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: