LEXINGTON, Massachusetts, February 14, 2014 /PRNewswire/ --
Shire plc , the global specialty biopharmaceutical company, announced today that the US Food & Drug Administration (FDA) has approved the production of VPRIV(R) drug substance (velaglucerase alfa for injection) in Shire's manufacturing facility at 400 Shire Way, Lexington, Massachusetts, US. The facility was previously approved by the European Medicines Agency (EMA) for production of VPRIV drug substance.
"FDA approval of Shire's manufacturing facility in Lexington provides greater assurance that Gaucher patients will receive consistent and uninterrupted access to enzyme replacement therapy for the treatment of type 1 Gaucher disease," said Rhonda Buyers, CEO and Executive Director, National Gaucher Foundation.
Shire has invested over $200M in manufacturing infrastructure and technology to establish a consistent drug supply chain to patients that use this treatment. The 400 Shire Way facility is the first commercially licensed facility in the world to utilize single-use bioreactor and disposable technology throughout cell culture processing designed to reduce manufacturing risk.
"Shire has always been committed to providing uninterrupted treatment for all VPRIV patients at the dose and frequency prescribed by their physicians. We continue to deliver on this commitment," said Bill Ciambrone, Executive Vice President, Technical Operations, Shire.
Shire now has two FDA and EMA approved facilities in which to manufacture VPRIV drug substance - the Alewife and the Lexington facilities, both in Massachusetts, US.
About the 400 Shire Way Manufacturing Facility
In keeping with Shire's corporate sustainability commitments, the 400 Shire Way manufacturing plant has met the requirements for Leadership in Energy and Environmental Design (LEED) Certification and received formal recognition from the United States Green Building Council in Q1 2012. In addition to increasing capacity and reducing manufacturing risk, utilization of single-use technology at 400 Shire Way requires approximately 80% less water and 50% less energy than a conventional manufacturing plant.
About VPRIV (velaglucerase alfa)
VPRIV is made in a human cell line using Shire's gene activation technology. The enzyme produced has the exact human amino acid sequence as that found in the naturally occurring human enzyme.
VPRIV is used for the long-term treatment of patients with type 1 Gaucher disease.
VPRIV is approved in over 40 countries globally, including the US, the European Union member states, and Israel, and is for patients previously treated for type 1 Gaucher disease or those who are treatment-naive.
VPRIV Important Safety Information
The most serious adverse reactions seen with VPRIV were hypersensitivity reactions. Infusion-related reactions were the most commonly observed adverse reactions in patients treated with VPRIV in clinical studies. The most commonly observed symptoms of infusion-related reactions were: headache, dizziness, low or high blood pressure, nausea, tiredness and weakness, and fever. Generally the infusion-related reactions were mild and, in treatment-naive patients, onset occurred mostly during the first 6 months of treatment and tended to occur less frequently with time.
All adult side effects of VPRIV are considered relevant to children (ages 4 to 17 years). Side effects more commonly seen in children compared with adult patients included: upper respiratory tract infection, rash, aPTT prolonged, and fever. The safety of VPRIV has not been established in patients younger than 4 years of age.
VPRIV is not available in all countries and prescribing information may differ between countries. Please consult your local prescribing information. Full prescribing information for VPRIV in the U.S. can be found at http://www.VPRIV.com.
Notes to editors
Shire enables people with life-altering conditions to lead better lives.
Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs.
We provide treatments in Neuroscience, Rare Diseases, Gastrointestinal and Internal Medicine and we are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas.
http://www.shire.com
FORWARD - LOOKING STATEMENTS - "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included in this announcement that are not historical facts are forward-looking statements. 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, Shire's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, that:
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