15th April 2016
Investment to help meet growing demand for rare disease treatments
Expected to create 400 jobs in Ireland at new state-of-the-art facility in Co. Meath
Shire plc (LSE: SHP, NASDAQ: SHPG) announces that it plans to expand its global biotechnology manufacturing capacity over the next four years by investing US$400 million in Ireland to meet the rapidly growing demand for its highly innovative products and robust pipeline.
Shire will create a new, state of the art biologics manufacturing campus, which it expects will lead to the creation of approximately 400 permanent jobs on a 120 acre site at Piercetown, County Meath. Construction of the new site will begin in mid-2016 with the site expected to be operational by mid-2019.
Shire’s Chief Executive Officer, Flemming Ornskov, MD, MPH, commented: “Increasing our biologics manufacturing capability is fundamental to achieving our ambition of becoming the world’s leading Biotechnology Company focused on rare diseases and other speciality conditions. The expansion will enable us to meet increasing product demands, support our pipeline and, ultimately, help more patients. We are delighted to be expanding our operations in Ireland, where we have strong, existing relationships. The new campus in County Meath will provide necessary geographic diversification and will help us serve our growing international business.”
Employing the latest bioprocessing techniques, the facility will employ flexible production strategies enabling it to supply both clinical and commercial scale products. The roles at Shire’s new campus in County Meath will consist of highly skilled, full time jobs in the areas of R&D, operations, technical staff, engineering and construction.
Shire’s Senior Vice President of Technical Operations, Tim Kelly, commented: “The expansion supports our manufacturing strategy to develop and provide innovative specialty medicines for patients. Ireland is a strategically important location for Shire, providing both excellence in life science R&D and manufacturing. We already have a strong team on the ground in Ireland and believe that it is the right location for us to build a new state of the art facility which will complement our existing manufacturing operations in the US.”
Mr. Richard Bruton TD, Irish Minister for Jobs, Enterprise and Innovation, said: “Today’s announcement is a huge boost for the Irish economy and for County Meath. The scale of the global investment being made by Shire and the creation of 400 full-time positions in Ireland, as well as over 700 additional jobs during construction, will have a major impact, and further validates Ireland’s position as a leading global location for biotechnology manufacturing and R&D. Biotechnology is a key sector which we have targeted as part of our jobs plans, and Shire's decision to build on its very capable team already in Ireland with a $400million investment is a very welcome step-up in its presence here.”
Mr. Martin Shanahan, CEO, IDA Ireland, said: “Ireland is an attractive location for many industries, but for the life sciences and biotechnology sectors in particular. These are sectors in which we excel and we are very pleased that Shire is building on its existing presence here with the development of a new campus at Piercetown, County Meath. This investment by Shire demonstrates not only IDA’s strategy of attracting biotechnology investment to Ireland but also our focus on supporting balanced regional economic development. It is also worth noting that this is the second significant investment for Meath in the past six months. The scale of this investment will have a substantial economic impact on Co Meath and the wider Mid-East Region.”
ENDS
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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 focus on providing treatments in Rare Diseases, Neuroscience, Gastrointestinal and Internal Medicine and we are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas, such as Ophthalmics. www.shire.com
Forward-Looking Statements
Statements included herein that are not historical facts, including without limitation statements concerning our announced business combination with Baxalta and the timing and financial and strategic benefits thereof, our 20x20 ambition that targets $20 billion in combined product sales by 2020, as well as other targets for future financial results, capital structure, performance and sustainability of the combined company, the combined company’s future strategy, plans, objectives, expectations and intentions, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products 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, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, the following:
- the proposed combination with Baxalta may not be completed due to a failure to satisfy certain closing conditions, including any shareholder or regulatory approvals or the receipt of applicable tax opinions;
- disruption from the proposed transaction with Baxalta may make it more difficult to conduct business as usual or maintain relationships with patients, physicians, employees or suppliers;
- the combined company may not achieve some or all of the anticipated benefits of Baxalta’s spin-off from Baxter International, Inc. (“Baxter”) and the proposed transaction may have an adverse impact on Baxalta’s existing arrangements with Baxter, including those related to transition, manufacturing and supply services and tax matters;
- the failure to achieve the strategic objectives with respect to the proposed combination with Baxalta may adversely affect the combined company’s financial condition and results of operations;
- products and product candidates may not achieve commercial success;
- product sales from ADDERALL XR and INTUNIV are subject to generic competition;
- the failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payers in a timely manner for the combined company’s products may affect future revenues, financial condition and results of operations, particularly if there is pressure on pricing of products to treat rare diseases;
- supply chain or manufacturing disruptions may result in declines in revenue for affected products and commercial traction from competitors; regulatory actions associated with product approvals or changes to manufacturing sites, ingredients or manufacturing processes could lead to significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
- the successful development of products in various stages of research and development is highly uncertain and requires significant expenditures and time, and there is no guarantee that these products will receive regulatory approval;
- the actions of certain customers could affect the combined company’s ability to sell or market products profitably, and fluctuations in buying or distribution patterns by such customers can adversely affect the combined company’s revenues, financial condition or results of operations;
- investigations or enforcement action by regulatory authorities or law enforcement agencies relating to the combined company’s activities in the highly regulated markets in which it operates may result in significant legal costs and the payment of substantial compensation or fines;
- adverse outcomes in legal matters and other disputes, including the combined company’s ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on the combined company’s revenues, financial condition or results of operations;
- Shire is undergoing a corporate reorganization and was the subject of an unsuccessful acquisition proposal and the consequent uncertainty could adversely affect the combined company’s ability to attract and/or retain the highly skilled personnel needed to meet its strategic objectives;
- failure to achieve the strategic objectives with respect to Shire’s acquisition of NPS Pharmaceuticals Inc. or Dyax may adversely affect the combined company’s financial condition and results of operations;
- the combined company will be dependent on information technology and its systems and infrastructure face certain risks, including from service disruptions, the loss of sensitive or confidential information, cyber-attacks and other security breaches or data leakages that could have a material adverse effect on the combined company’s revenues, financial condition or results of operations;
- the combined company may be unable to retain and hire key personnel and/or maintain its relationships with customers, suppliers and other business partners;
- difficulties in integrating Dyax or Baxalta into Shire may lead to the combined company not being able to realize the expected operating efficiencies, cost savings, revenue enhancements, synergies or other benefits at the time anticipated or at all; and
other risks and uncertainties detailed from time to time in Shire’s, Dyax’s or Baxalta’s filings with the Securities and Exchange Commission (“SEC”), including those risks outlined in Baxalta’s current Registration Statement on Form S-1, as amended, and in “ITEM 1A: Risk Factors” in Shire’s Annual Report on Form 10-K for the year ended December 31, 2015.
All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Except to the extent otherwise required by applicable law, we do not undertake any obligation to republish revised forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
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