October 10, 2014
BTG reaches settlement regarding CroFab® patent litigation

London, UK, 10 October 2014

BTG plc (LSE: BTG) today announces that it has settled its United States patent infringement complaint against Instituto Bioclon (Bioclon) of Mexico and Rare Disease Therapeutics, Inc. (RDT) of Nashville, Tennessee.  The case was filed by BTG with the International Trade Commission in October 2013 based upon the unlawful and unauthorised importation and sale into the US of certain crotalid antivenom pharmaceutical compositions that infringe one or more claims of BTG’s US Patent No. 8,048,414 (“the ‘414 patent”). 

Under the terms of the agreement, BTG would allow Bioclon to begin selling crotalid antivenom relying on BTG’s 414 patent from October 2018, subject to Bioclon receiving regulatory approval for its antivenom product. BTG will receive a single-digit royalty on sales of any Bioclon product relying on the 414 patent until the end of the exclusivity period in 2028. In addition, Bioclon will withdraw its legal challenge to the validity of the 414 patent. BTG has agreed to reimburse Bioclon USD $6 million for its legal fees and costs incurred.

Louise Makin, Chief Executive Officer at BTG, said: “Settling this litigation is good for our business as it removes uncertainty for our investors and other stakeholders. Most importantly, it allows us to concentrate on what we do best, delivering a first-class treatment and supporting our customers and their patients by continuing to invest in a product that has treated over 40,000 people.”

About BTG
BTG is a growing international specialist healthcare company that is developing and commercialising products targeting acute care, cancer and vascular diseases. The company has diversified revenues from sales of its own marketed products and from royalties on partnered products, and is seeking to acquire new programmes and products to develop and market to specialist physicians. For further information about BTG, please visit our website atwww.btgplc.com.

About CroFab®

CroFab® Crotalidae Polyvalent Immune Fab (Ovine) is an antivenin indicated for the management of patients with North American crotalid envenomation. The term crotalid is used to describe the Crotalinae subfamily (formerly known as Crotalidae) of venomous snakes that includes rattlesnakes, copperheads, and cottonmouths/water moccasins. Early use of CroFab®(within 6 hours of snakebite) is advised to prevent clinical deterioration and the occurrence of systemic coagulation abnormalities.

In the year to 31 March 2014, BTG generated revenue of £62.7 million from CroFab®.                                          

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Ben Atwell
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