Shire Announces FDA Approval of VPRIV(TM) (velaglucerase alfa for injection) for the Treatment of Type 1 Gaucher Disease

By Shire Pharmaceutical, PRNE
Thursday, February 25, 2010

Company Announces New Enhancements to Patient Assistance Programs in the United States

CAMBRIDGE, Massachusetts, 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."

Shire recognizes that the treatments it develops for life-altering
diseases and conditions require specialized service and support offerings.
With today's FDA approval of VPRIV, the company has implemented enhancements
to its existing OnePathSM Access Program with the introduction of a new
Co-Pay Assistance Program. The new program was developed based on feedback
from the rare disease community. It is designed to simplify the process and
paperwork associated with initiation of therapy, and to reduce the financial
burden for patients who are treated with Shire HGT therapies in the United
States
, including VPRIV. The Company has also announced that it will price
VPRIV at a 15% savings over the other commercially available ERT for Gaucher
disease.

New Co-Pay Assistance Program for Eligible U.S. Patients

The new co-pay program provides assistance for eligible patients in the
U.S. who have commercial prescription insurance, and helps these patients pay
for out-of-pocket medication costs for Shire HGT products, regardless of
income level. Through this program, Shire HGT intends to cover these
patients' insurance co-pay for the first 3 months of their therapy in 2010.
In 2011, the Company intends to cap eligible patients' out of pocket
prescription expenses at $500.

The new Co-Pay Assistance Program will take effect immediately, and will
apply to eligible ELAPRASE(R) (idursulfase) patients and VPRIV(TM) patients
in the U.S.

"The last 6 months have been very challenging for the entire Gaucher
community, and the approval of VPRIV brings an important new treatment option
to patients suffering from Type 1 Gaucher disease," said Rhonda Buyers, CEO /
Executive Director, National Gaucher Foundation (NGF). "We at the NGF are
excited about this approval, and by the steps that Shire has taken to improve
access to treatments for patients with life-altering conditions. This co-pay
program will greatly assist the Gaucher patient population, and we appreciate
the fact that Shire has taken the time to listen to us and to act on the
needs of patients."

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(TM) (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-naive
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.

About Gaucher Disease

Gaucher disease is an autosomal recessive disorder caused by mutations in
the GBA gene which results in a deficiency of the lysosomal enzyme
beta-glucocerebrosidase. This enzymatic deficiency causes an accumulation of
glucocerebroside, primarily in macrophages. In this lysosomal storage
disorder (LSD), clinical features are reflective of the distribution of
Gaucher cells in the liver, spleen, bone marrow, and other organs. The
accumulation of glucocerebrosidase in the liver and spleen leads to
organomegaly. Presence of Gaucher cells in the bone marrow and spleen lead to
clinically significant anemia and thrombocytopenia.

Gaucher disease is the most prevalent of the lysosomal storage disorders
diseases. Gaucher disease has classically been categorized into 3 clinical
types. Type 1 Gaucher disease is characterized by variability in signs,
symptoms, severity, and progression. Type 1 is the most common and is
distinguished from Type 2 and Type 3 by the lack of early neurological
symptoms.

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:
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 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

    Clea Rosenfeld (Rest of the World)
    +44-1256-894-160

    Eric Rojas (North America)
    +1-617-551-9715

    Media

    Jessica Mann (Rest of the World)
    +44-1256-894-280

    Jessica Cotrone (North America, HGT)
    +1-781-482-9538

For further information please contact: Investor Relations: Clea Rosenfeld (Rest of the World), +44-1256-894-160; Eric Rojas (North America), +1-617-551-9715: Media: Jessica Mann (Rest of the World), +44-1256-894-280; Jessica Cotrone (North America, HGT), +1-781-482-9538

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