Shire Presents Positive Efficacy and Safety Data for velaglucerase alfa in Treatment of Naive Patients With Type 1 Gaucher Disease

CAMBRIDGE, Massachusetts, February 11 - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, today presented positive results from its first
Phase III study (TKT 032) evaluating safety and efficacy of velaglucerase
alfa, its investigational enzyme replacement therapy for the treatment of
Type 1 Gaucher disease. The data were presented in an oral presentation at
the Lysosomal Disease Network (LDN) World Symposium in Miami, Florida. Data
from a pediatric subgroup of this study and five year follow-up results from
a long-term Phase I/II extension study (TKT025 EXT) conducted in adults were
also reported and add to the available data on the long-term safety and
efficacy of velaglucerase alfa in patients with Type 1 Gaucher disease.

Both studies (TKT032 and TKT025 EXT) met their primary end-points.

Additionally, Shire reported important findings from a study that
compared patient antibody response to velaglucerase alfa and imiglucerase.
All patients enrolled in the velaglucerase alfa Phase III clinical studies
underwent a comprehensive panel of tests that were developed and validated to
assess antibody response. In each study, samples were first screened using an
electrochemiluminescence (ECL) assay. Positive samples were confirmed using a
quantitative radioimmunoprecipitation (RIP) assay. Positive cut-points were
established for the ECL assay as 5 ng/mL as well as in terms of fixed raw
counts, and for the RIP assay as 4 ng/mL. The results suggest significant
antigenic differences between velaglucerase alfa and imiglucerase, with only
1% seroconversion rates against velaglucerase alfa.

"The combined data presented today provides additional and compelling
support for the long-term clinical efficacy and safety of velaglucerase
alfa," said Pramod Mistry, MD, PhD, FRCP, Professor of Pediatrics & Internal
Medicine at Yale University School of Medicine. "The Gaucher community is
very fortunate to have velaglucerase alfa as an option for patients."

Results from Study TKT032 in Adults and Children

TKT032 was a 12-month, randomized, double-blind, parallel-group global
study in 25 treatment-naive patients aged two years and older that evaluated
velaglucerase alfa at 45 U/kg and velaglucerase alfa at 60 U/kg. Patients
were eligible to participate in the study if they presented with
disease-related anemia and had at least one of the following clinical
manifestations of Gaucher disease: thrombocytopenia, moderate splenomegaly or
a readily palpable enlarged liver.

The primary endpoint was change in hemoglobin concentrations from
baseline at 60 U/kg. Secondary endpoints for both doses were changes in
platelet counts, changes in organ volumes, changes in surrogate markers of
Gaucher disease, and for the 45 U/kg dose only, change in hemoglobin
concentrations from baseline.

At 12 months, in the 60 U/kg group, statistically significant changes in
mean hemoglobin concentration increased 23.3%, +2.43 +/- 0.32 g/dL,
P<0.0001; mean platelet count increased 65.9%, +50.9 +/- 12.2×10(9)/L,
P=0.0016; and mean spleen volume decreased 50%, -1.92 +/- 0.51% body weight,
P=0.0032, from 14.0 multiples of normal [MN] at baseline to 5.75 MN. Mean
liver volume decreased 17%, -0.84 +/- 0.33% body weight, P=0.0282, from
1.46 to 1.22 MN.

Results for 45 U/kg were consistent with those observed with 60 U/kg;
however a dose-related effect in favor of velaglucerase alfa at 60 U/kg was
observed by platelet count increase and liver volume reduction between the 2
dose groups.

Adverse events reported by at least 20% of all patients included
headache, nasopharyngitis, injury, arthralgia, cough, pyrexia, dizziness,
influenza, nasal congestion, vomiting, bone pain, and activated partial
thromboplastin time (aPTT) prolonged. No drug-related serious adverse events
were reported. No patient withdrew from the study due to an adverse event.
One patient developed antibodies to velaglucerase alfa.

A subpopulation analysis of study TKT032 was conducted to assess the
efficacy and safety of velaglucerase alfa among children aged 2-17. Of 25
patients in the trial, 7 pediatric patients (28%) were enrolled and
randomized to receive velaglucerase alfa at 60 U/kg (n=4) or 45 U/kg (n=3) as
a 1-hour infusion, every other week for 12 months. In this analysis the two
dose groups were pooled and results are shown as a percent change from
baseline.

Following 12 months treatment with with velaglucerase alfa the mean
hemoglobin concentration increased 20%, mean platelet counts increased 54%,
mean spleen volume, normalized by body weight, decreased 47% (median value
5.0 multiples of normal (MN) decreased from 13.5 MN). Mean liver volume
normalized by body weight decreased 13% (median value 1.04 MN decreased from
1.40 MN). Outcomes reported in children were consistent with those seen in
the overall population. Due to the small sample sizes, the results did not
achieve statistical significance.

Most frequently reported adverse events in the pediatric subpopulation
were headache, nasopharyngitis, pyrexia, nasal congestion, productive cough,
vomiting, and injury. No pediatric participants experienced severe or serious
treatment-emergent events. No pediatric patients developed antibodies to
velaglucerase alfa.

"We are very pleased with the opportunity to present the findings
from the first of three Phase III studies for velaglucerase alfa," said
Whaijen Soo, MD, PhD, Senior Vice President, Research and Development, Shire
Human Genetic Therapies (HGT). "Our program is the largest and most
comprehensive set of Phase III clinical trials conducted to date for Gaucher
disease, and we look forward to presenting the results from the remaining
trials at future scientific meetings."

Results from Five-Year Study

Ten of 11 adult patients who completed the Phase I/II study of
velaglucerase alfa administered at 60 U/kg every other week, enrolled in a
long-term extension study. After month-12, all patients were eligible to
receive a step-wise dose reduction from 60 U/kg to 45 U/kg (13 weeks) and
then to a 30 U/kg maintenance dose upon the achievement of specific
therapeutic goals. All patients met therapeutic goals and their dose was
subsequently titrated down to the 30 U/kg dose. Seven of 10 patients received
home infusions during the extension period. Eight patients (4 male, 4 female)
have now received velaglucerase alfa treatment for 60 months.

After 5 years, velaglucerase alfa continued to be generally well
tolerated and demonstrated substantial and prolonged increases in hemoglobin
concentration and platelet count, and substantial and prolonged decreases in
liver and spleen volumes in these patients with Type 1 Gaucher disease.

At 60 months, the mean increase in hemoglobin concentration from baseline
was +2.4 g/dL (95% CI: 1.6, 3.2; 21.3% change) and the mean increase in
platelet count from baseline was +85.1 x10(9)/L (95% CI: 59.8,110.4; 157%
change). At 57 months, mean percent reduction in normalized liver volume from
baseline was 39% (95% CI: -49.1%,-28.5%) and mean percent reduction in
normalized spleen volume from baseline was 74% (95% CI: -89.3%,-58.6%).

Velaglucerase alfa was found to be generally well tolerated in these 10
patients with no drug-related serious adverse events reported.
Treatment-emergent adverse events reported by at least 50% of patients
included arthralgia, back pain, pyrexia, upper abdominal pain,
pharyngolaryngeal pain and headache. Most adverse events were of mild to
moderate severity. No patients withdrew from the trial due to an adverse
event. No patients in the 5 year extension study developed antibodies.

About velaglucerase alfa

Velaglucerase alfa is an investigational enzyme replacement therapy for
Type 1 Gaucher disease. Velaglucerase alfa is made using Shire's
gene-activation technology, in a human cell line. The enzyme produced has the
exact human amino acid sequence and has a human glycosylation pattern.

The United States Food and Drug Administration (FDA) has granted Priority
Review for the New Drug Application (NDA) for velaglucerase alfa and has
issued an action date for the NDA for velaglucerase alfa of February 28, 2010
under the Prescription Drug User Fee Act (PDUFA).

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, skeleton, and lungs. The
accumulation of glucocerebrosidase in the liver and spleen leads to
organomegaly. Bone involvement results in skeletal abnormalities and
deformities as well as bone pain crises. Deposits in the bone marrow and
splenic sequestration lead to clinically significant anemia and
thrombocytopenia.

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

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.

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    For further information please contact:

    Investor Relations  Cléa 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, Cléa 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