Shire Announces FDA Approval of Manufacturing Facility for VPRIV® (Velaglucerase Alfa for Injection) Drug Substance

Lexington, Massachusetts (ots/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:

- Shire's products may not be a commercial success;
- revenues from ADDERALL XR are subject to generic erosion and revenues from
INTUNIV will become subject to generic competition starting in December 2014;
- the failure to obtain and maintain reimbursement, or an adequate level of
reimbursement, by third-party payors in a timely manner for Shire's products may
impact future revenues, financial condition and results of operations;
- Shire conducts its own manufacturing operations for certain of its Rare
Diseases products and is reliant on third party contractors to manufacture other
products and to provide goods and services. Some of Shire's products or ingredients
are only available from a single approved source for manufacture. Any disruption to
the supply chain for any of Shire's products may result in the Shire being unable to
continue marketing or developing a product or may result in Shire being unable to do
so on a commercially viable basis for some period of time.
- the development, approval and manufacturing of Shire's products is subject to
extensive oversight by various regulatory agencies and regulatory approvals or
interventions associated with changes to manufacturing sites, ingredients or
manufacturing processes could lead to significant delays, increase in operating costs,
lost product sales, an interruption of research activities or the delay of new product
launches;
- the actions of certain customers could affect Shire's ability to sell or
market products profitably. Fluctuations in buying or distribution patterns by such
customers can adversely impact Shire's revenues, financial conditions or results of
operations;
- investigations or enforcement action by regulatory authorities or law
enforcement agencies relating to Shire's activities in the highly regulated markets in
which it operates may result in the distraction of senior management, significant
legal costs and the payment of substantial compensation or fines;
- adverse outcomes in legal matters and other disputes, including Shire's
ability to enforce and defend patents and other intellectual property rights required
for its business, could have a material adverse effect on Shire's revenues, financial
condition or results of operations;
- Shire faces intense competition for highly qualified personnel from other
companies, academic institutions, government entities and other organizations. Shire
is undergoing a corporate reorganization and the consequent uncertainty could
adversely impact Shire's ability to attract and/or retain the highly skilled personnel
needed for Shire to meet its strategic objectives;
- failure to achieve Shire's strategic objectives with respect to the
acquisition of ViroPharma Incorporated may adversely affect Shire's financial
condition and results of operations;

and other risks and uncertainties detailed from time to time in
Shire's filings with the U.S. Securities and Exchange Commission,
including its most recent Annual Report on Form 10-K.

ots Originaltext: Shire Pharmaceuticals Group Plc
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For further information please contact: Investor Relations: Eric
Rojas, erojas@shire.com, +1-781-482-0999; Sarah Elton-Farr,
seltonfarr@shire.com, +44-1256-894157; Media: Jessica Mann,
jmann@shire.com, +44-1256-894-280; Gwen Fisher, gfisher@shire.com,
+1-484-595-9836; Jessica Cotrone, jcotrone@shire.com, +1-781-482-9538