VPRIV (formerly know as Velaglucerase Alpha)

Shire Announces FDA Approval of VPRIV™ (velaglucerase alfa for injection) for the Treatment of Type 1 Gaucher Disease
Company Announces New Enhancements to Patient Assistance Programs in the United States

Cambridge, MA, US – February 26, 2010 – Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for VPRIV, a human cell line derived enzyme replacement therapy (ERT) for the long-term treatment of Type 1 Gaucher disease in pediatric and adult patients. The FDA designated VPRIV for Priority Review and granted marketing approval in just 6 months. VPRIV offers patients and their physicians a new treatment option at a critical time, as the supply of the previously approved ERT for Gaucher disease is uncertain and remains disrupted.

“We have had the opportunity to use VPRIV in clinical trials and actively participated in the expanded access program. We appreciate the support Shire’s management team has provided during the last few months to ensure continuity of care for nearly 50 of our patients with Gaucher disease. We are confident the team Shire has put into place will ensure a seamless transition into the post-regulatory period,” said Gregory M. Pastores MD, Associate Professor of Neurology and Pediatrics at the NYU School of Medicine in New York. “VPRIV offers patients a therapeutic option that is safe and effective, and our experience with VPRIV has helped build confidence in its use, bolstered by data on low frequency of antibody formation.”

Excerpts from Feb. 26, 2010 press release
More about VPRIV
The VPRIV application has also been granted accelerated assessment by the European Medicines Agency (EMA) in the European Union (EU). Shire expects to launch VPRIV in the EU by the end of 2010 and in other countries beginning in 2011.

Full prescribing information for VPRIV can be found at www.VPRIV.com. For information on Shire’s OnePathSM services visit www.onepath.com or call 1 (866) 888-0660. For more information about Gaucher disease, please visit www.GaucherPatients.com.

Indications and Usage
VPRIV™ (velaglucerase alfa for injection) is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy for pediatric and adult patients with Type 1 Gaucher disease

Dosing and Administration

• 60 Units/kg administered every other week as a 60-minute intravenous infusion.
• Patients currently being treated with imiglucerase for Type 1 Gaucher disease may be switched to VPRIV. Patients previously treated on a stable dose of imiglucerase are recommended to begin treatment with VPRIV at that same dose when they switch from imiglucerase to VPRIV.
• Physicians can make dosage adjustments on an individual patient basis based on achievement and maintenance of therapeutic goals. Clinical trials have evaluated doses ranging from 15 Units/kg to 60 Units/kg every other week.

Clinical Trial Results
Shire’s VPRIV clinical trial program included the largest and most comprehensive set of Phase III trials conducted to date for Gaucher disease.

The efficacy of VPRIV was assessed in three clinical studies in a total of 99 patients with type 1 Gaucher disease. Eighty-two patients age 4 years and older received VPRIV and 17 patients age 3 years and older received imiglucerase. Studies I and II were conducted in patients who were not currently receiving Gaucher disease-specific therapy. Study III was conducted in patients who were receiving imiglucerase treatment immediately before starting VPRIV. In these studies, VPRIV was administered intravenously over 60 minutes at doses ranging from 15 Units/kg to 60 Units/kg every other week. Each study met its primary endpoint.

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, hypotension, hypertension, nausea, fatigue/asthenia, and pyrexia. 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.

Adverse reactions more commonly seen in pediatric patients compared to those observed in adult patients (>10% difference) include rash, upper respiratory tract infection, prolonged activated partial thromboplastin time, and pyrexia.

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Visit Shire’s website at www.gaucherpatients.com for more information about Shire, its programs and its newly approved treatment for Gaucher disease.

For information on obtaining VPRIVTM for treatment of Gaucher disease, Please contact OnePathSM services at 1-866-888-0660. To sign up for more information, please register here www.gaucherpatients.com/pgs/more-information.aspx