22 Nov 2011
Shire Announces Regulatory Filings in US and EU for New Manufacturing Facility
Approval Will Add Substantial Manufacturing Capacity for Rare Disease Products
Lexington, MA, US– November 22, 2011 – Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that it has submitted regulatory filings with both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) for the production of VPRIV® (velaglucerase alfa) in its state-of-the-art manufacturing facility at 400 Shire Way in Lexington, Massachusetts. Subject to regulatory approval, which is anticipated in early 2012, Shire expects the new plant to significantly increase manufacturing capacity and allow for increased global supply of VPRIV. These approvals will also make available further capacity for the manufacture of Replagal® (agalsidase alfa) at Shire’s Alewife facility, where both VPRIV and Replagal are currently manufactured.
“Shire remains committed to meeting the unique needs of patients living with rare diseases,” said Bill Ciambrone, Senior Vice President, Technical Operations, Shire HGT. “Accelerating the completion of our new manufacturing facility in Lexington will enable us to provide substantial additional capacity for VPRIV less than two years after launch. Once approved, this new facility will give us greater flexibility to meet the global demand for VPRIV as well as some of our other products for rare diseases.”
Currently there are approximately 1,200 patients receiving VPRIV and over 2,800 patients receiving Replagal worldwide. Shire is committed to provide current patients with uninterrupted long-term access to treatment at the dose and frequency prescribed by their physician.
About VPRIV (velaglucerase alfa)
On February 26, 2010, VPRIV was approved by the FDA as a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy for adult and pediatric patients with type 1 Gaucher disease. On August 26, 2010, the European Commission granted marketing authorization for VPRIV for the long-term treatment of type 1 Gaucher disease, making it available in 30 countries across Europe. VPRIV is currently approved in 38 countries world wide.
VPRIV is for patients who are treatment-naïve as well as patients who have previously been treated with imiglucerase.
About REPLAGAL (agalsidase alfa)
Replagal is a form of the human enzyme alfa-galactosidase A (α-Gal A) manufactured in a human cell line by gene activation. 2011 marks the 15th year of clinical experience with Replagal, which is now approved in 46 countries worldwide. Replagal is not currently approved for commercial sale in the U.S.
Replagal is the only human-cell-line-derived form of enzyme replacement therapy that is indicated for the long-term treatment of patients with a confirmed diagnosis of Fabry disease (α-Gal A deficiency).
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-naïve 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.
Replagal Important Safety Information
The most serious adverse reactions seen with Replagal were hypersensitivity reactions. Infusion-related reactions were the most commonly observed adverse reactions in patients treated with Replagal in clinical studies. Most side effects are mild to moderate and include headache, tingling, numbness, tremors, fatigue, change in temperature sensation, increased blood pressure, upset stomach, diarrhea, coughing, sore throat, prolonged sleeping, change in the taste of food, change in smell, difficulty speaking, acne, rash and itching and eye problems. About 1 out of 10 patients may have a reaction during or shortly after infusion of Replagal. These effects include chills and facial flushing (warmth and redness).
Replagal is not available in all countries and prescribing information may differ between countries. Please consult your local prescribing information.
For further information please contact:
Eric Rojas (firstname.lastname@example.org) +1 781 482 0999
Sarah Elton Farr (email@example.com) +44 1256 894 157
Jessica Mann (firstname.lastname@example.org) +44 1256 894 280
Jessica Cotrone (email@example.com) +1 781 482 9538
Notes to editors
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, human genetic therapies, gastrointestinal diseases and regenerative medicine 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.
"SAFE HARBOR" 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 Pharmaceuticals, Human Genetic Therapies and Regenerative Medicine products, as well as the ability to secure 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.