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

AsiaNet 55819

LEXINGTON, Massachusetts, Feb. 15/PRN=KYODO JBN/ --

    Shire plc (LSE: SHP, NASDAQ: SHPG), 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.

    SOURCE: Shire plc