Lexington, MA -- February 7, 2017 – 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.
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.
|Ian Karp||[email protected]||+1 781 482 9018|
|Robert Coates||[email protected]||+44 1256 894874|
|Lisa Adler||[email protected]||+1 617 588 8607|
|Debbi Ford||[email protected]||+1 617 949 9083|
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.
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:
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.
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