NATURE OF ACTION
This is an action against Shire Human Genetic Therapies, Inc. (“Shire HGT”)and Shire plc (“Shire”) for injunctive and monetary relief for false advertising in violation of the Lanham Act (15 U.S.C. § 1125,
. On June 28, 2012, Shire HGT and/or Shirepublished a press release (the “Shire Press Release”) entitled “Shire’s VPRIV® (velaglucerasealfa for injection) Shows Significant Improvement in Gaucher-Related Bone Disease.” TheShire Press Release purported to describe “new data” presented from a “head to head trial” of two competing drugs used to replace a deficient enzyme in patients suffering from a raregenetic disorder, Gaucher disease. However, the Shire Press Release contained false andmisleading statements regarding the nature of the analysis conducted by Shire HGT and/orShire and the capabilities of Shire’s drug, VPRIV®, as compared to the market leading drug,Cerezyme® (imiglucerase for injection), manufactured and sold by Genzyme Corporation(“Genzyme”).
Shire placed the Shire Press Release on its public corporate website under theheadline “Latest News.” The Shire website is accessible by people throughout the United States,including healthcare providers and patients. Upon information and belief, Shire HGT and/orShire also provided a copy of the Shire Press Release to PR Newswire, which distributes pressreleases to media outlets throughout the country, and they caused their public relations firm todistribute the Shire Press Release to certain Gaucher patient organizations.
The Shire Press Release has been picked up by at least 33 media outlets,including but not limited to the Wall Street Journal online (online.wsj.com), Indiana NBCaffiliate WTHR (wthr.com), Delaware Fox affiliate WBOC 16 (wboc.com), Eastern Texas ABCaffiliate KTRE 9 (ktre.com), and pharmaceutical newsletter Fierce Pharma (fiercepharma.com).
Case 1:12-cv-11386-RGS Document 1 Filed 07/30/12 Page 3 of 25