SHIRE PLC LEXINGTON, Massachusetts, February 7, 2017 /PRNewswire/ --
Shire plc (Shire) (LSE: SHP, NASDAQ: SHPG) acknowledges the decision announced today by the U.S. Federal Trade Commission ("FTC") to file a civil action against one of its subsidiaries, Shire ViroPharma (ViroPharma) related to citizen petition submissions ViroPharma filed regarding one of its products, Vancocin, an antibiotic for the treatment of severe bacterial infections.
Shire acquired ViroPharma in January 2014, and divested Vancocin in August 2014. The Company played no role in ViroPharma's challenged petitioning, which took place between 2006 and 2012. Shire believes the FTC's challenge to ViroPharma is wholly without merit, and will vigorously defend these claims. ViroPharma's actions were in furtherance of its fundamental right to petition the government, which is guaranteed and protected by the First Amendment, and raised legitimate issues with the U.S. Food and Drug Administration ("FDA") involving complex scientific questions that had significant public health implications.
ADDITIONAL BACKGROUND
ViroPharma filed an initial citizen's petition challenging a change in a FDA policy in 2006. At the time, no generic forms of Vancocin had been approved under the FDA's longstanding bioequivalence standard, which required in vivo testing. In 2006, the FDA disclosed that it had changed its policy to permit in vitro testing to establish bioequivalence instead of in vivo testing.
In its original petition and in multiple supplements to the petition over the course of six years, ViroPharma challenged on scientific grounds the FDA's adoption of a lower in vitro threshold for approving generic versions of Vancocin. Although the FDA ultimately modified its policy to require in vivo testing for bioequivalence in some instances, it declined to return to a policy that did not allow any in vitro testing as ViroPharma had advocated. In 2012, the FTC initiated an investigation of ViroPharma's conduct relating to the citizen petition and subsequent filings.
NOTES TO EDITORS
About Shire
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
http://www.shire.com
Forward-Looking Statements
Statements included herein that are not historical facts, including without limitation statements concerning 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:
- Shire's products may not be a commercial success;
- increased pricing pressures and limits on patient access as a result of governmental
regulations and market developments may affect Shire's future revenues, financial
condition and results of operations;
- Shire conducts its own manufacturing operations for certain of its products and is
reliant on third party contract manufacturers 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 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 manufacture of Shire's products is subject to extensive oversight by various
regulatory agencies. Regulatory approvals or interventions associated with 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;
- certain of Shire's therapies involve lengthy and complex processes, which may prevent
Shire from timely responding to market forces and effectively managing its production
capacity;
- Shire has a portfolio of products in various stages of research and development. The
successful development of these products 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 Shire's ability to sell or market
products profitably. Fluctuations in buying or distribution patterns by such customers
can adversely affect Shire's revenues, financial conditions or results of operations;
- Shire's products and product candidates face substantial competition in the product
markets in which it operates, including competition from generics;
- adverse outcomes in legal matters, tax audits 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 the combined company's
revenues, financial condition or results of operations;
- inability to successfully compete for highly qualified personnel from other companies
and organizations;
- failure to achieve the strategic objectives with respect to Shire's acquisition of NPS
Pharmaceuticals, Inc., Dyax Corp. ("Dyax") or Baxalta Inc. ("Baxalta")may adversely
affect Shire's financial condition and results of operations;
- Shire's growth strategy depends in part upon its ability to expand its product
portfolio through external collaborations, which, if unsuccessful, may adversely
affect the development and sale of its products;
- a slowdown of global economic growth, or economic instability of countries in which
Shire does business, as well as changes in foreign currency exchange rates and
interest rates, that adversely impact the availability and cost of credit and customer
purchasing and payment patterns, including the collectability of customer accounts
receivable;
- failure of a marketed product to work effectively or if such a product is the cause of
adverse side effects could result in damage to Shire's reputation, the withdrawal of
the product and legal action against Shire;
- 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 significant legal costs and the payment of substantial
compensation or fines;
- Shire is 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 Shire's revenues, financial condition or
results of operations;
- Shire incurred substantial additional indebtedness to finance the Baxalta acquisition,
which may decrease its business flexibility and increase borrowing costs;
- 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 filings with the Securities and Exchange Commission, including those risks outlined in "ITEM 1A: Risk Factors" in Shire's Quarterly Report on Form 10-Q for the quarter ended June 30, 2016.
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 update or revise forward-looking statements, whether as a result of new information, future events or otherwise.
For further information please contact:
Investor Relations
Ian Karp, ikarp@shire.com, +1-781-482-9018
Robert Coates, rcoates@shire.com, +44-1256-894874
Media
Lisa Adler, lisa.adler@shire.com, +1-617-588-8607
Debbi Ford, debbi.ford@shire.com, +1-617-949-9083
SOURCE Shire plc
