Navigation Links
European Authorities Approve New Manufacturing Facility for Shire's REPLAGAL® (agalsidase alfa)
Date:6/24/2011

DUBLIN and LEXINGTON, Massachusetts, June 24, 2011 /PRNewswire/ --


 

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that the European Medicines Agency has approved the purification of REPLAGAL® (agalsidase alfa) drug substance at its new manufacturing facility in Lexington, MA, US.  REPLAGAL, Shire's enzyme replacement therapy for the treatment of Fabry disease is the first product that will be made available to patients from the new facility.

With this approval, the company now has two approved facilities - Alewife, which is located in Cambridge, MA, as well as the new Lexington facility - in which to purify REPLAGAL, thus providing increased manufacturing flexibility. The cell culture portion of the REPLAGAL manufacturing process will continue to be conducted at Alewife.

 "We are pleased that we were able to accelerate the construction and approval of our new manufacturing facility in order to provide rapid access to important therapies for patients in need," said Bill Ciambrone, Senior Vice President of Technical Operations, Shire HGT. "This new facility allows greater flexibility to meet global demand for our products, including REPLAGAL."

Shire reiterated that it has sufficient product inventory to continue to meet the needs of Fabry patients worldwide currently receiving REPLAGAL and that it can meet anticipated additional demand.  The Company is committed to continuing to provide uninterrupted long-term access to the product at the licensed dose.  

In addition to REPLAGAL, Shire anticipates regulatory agency submission of the VPRIV (velaglucerase alfa) manufacturing process at the new Lexington manufacturing facility by the end of 2011.

Notes to editors

SHIRE PLC

Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

For further information on Shire, please visit the Company's website: http://www.shire.com.

"SAFEHARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company's Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company's products; the Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the Company's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company's ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission.

For further information please contact:



    Investor Relations 

    Eric Rojas (erojas@shire.com)          +1-781-482-0999
    Sarah Elton-Farr                       +44-1256-894-157
    (seltonfarr@shire.com)

    Media              

    Jessica Mann (jmann@shire.com)         +44-1256-894-280
    Jessica Cotrone (jcotrone@shire.com)   +1-781-482-9538

 


'/>"/>
SOURCE Shire plc
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. CV Therapeutics Announces Eight Abstracts Accepted for Presentation at the European Society of Cardiology Congress 2007
2. Boston Scientific Announces Schedule for European Society of Cardiology Congress 2007
3. European Experts Recommend Pregnant and Nursing Women Take More DHA - Every Day
4. Genasense(R) Data in Melanoma to be Presented in Opening Session at First Worldwide Melanoma Center Meeting of the European Association of Dermato-Oncology
5. Terumo Heart to Announce Results of European Clinical Trial of DuraHeart(TM) LVAS at European Association of Cardiothoracic Surgeons Meeting in September
6. Threshold Pharmaceuticals Announces Two Presentations on Glufosfamide at the 2007 European Cancer Conference (ECCO)
7. Study Results for Aclidinium Bromide, a Novel Anticholinergic, Presented at European Respiratory Society Annual Congress
8. Life Recovery Systems Receives European CE Mark Approval for Its ThermoSuit(R) System
9. Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer
10. European Unions CHMP Issues Positive Opinion on PEGINTRON(TM) Combination Therapy for Retreating Hepatitis C Patients Who Failed Previous Therapy
11. Positive Xeloda(R) Five-Year Overall Survival Study Data in the Adjuvant Treatment of Colon Cancer Presented at Leading European Cancer Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/4/2017)... 4, 2017  DarioHealth Corp. (NASDAQ: DRIO), a leading ... data solutions, today announced that it is teaming up ... Technologies Limited to lower diabetes healthcare costs in ... card, which is available throughout all provinces and territories ... be eligible for additional savings when shopping for Dario ...
(Date:5/3/2017)... COUNTY, Calif. , May 3, 2017 /PRNewswire/ ... aspect of any hospital or healthcare facility. Commonly ... examination room is equipped with diagnostic imaging technology ... arteries of the heart. In these spaces, a ... angiography, catheterization, balloon angioplasty, percutaneous coronary intervention, congenital ...
(Date:5/3/2017)... Pa. , May 3, 2017  West ... in innovative solutions for injectable drug administration, announced ... Scientific Affairs and Technical Services, and Diane ... workshops and offering presentations focused on West,s expertise ... injectable products, as well as providing commentary on ...
Breaking Medicine Technology:
(Date:5/19/2017)... ... May 19, 2017 , ... As a groundbreaking surgeon on ... importance of prostate cancer screenings. Early detection of the disease, he says, can make ... at Georgia Urology , stands alongside the Georgia Comprehensive Cancer Control’s (GC3) Prostate ...
(Date:5/19/2017)... ... , ... CloSYS products which are marketed as the gentle giants of the ... gum health, which is linked to one’s overall health. Since 1991 when the CloSYS ... ways in which CloSYS products immediately helped eliminate bad breath as well as help ...
(Date:5/19/2017)... Santa Clara, CA (PRWEB) , ... May 18, 2017 , ... ... feature that allows sleep labs and physicians to independently dispense CPAP devices and supplies, ... DME orders, and sleep labs can dispense the devices. Device registration for daily usage ...
(Date:5/18/2017)... ... May 18, 2017 , ... Originally launched to market as the EPIK ... Due to the rapid expansion of their product line, the company believed it was ... Now, the HighQ brand will be any tablet product sold by EPIK Learning. ...
(Date:5/18/2017)... (PRWEB) , ... May 18, 2017 , ... ... Alliance, a Dulles, VA based educational and charitable organization which sponsors numerous programs ... for their third MURPH Challenge event over Memorial Day Weekend. , The ...
Breaking Medicine News(10 mins):