BTG Regulatory News (BTG)

BTG Acquires US Marketing Rights to Wellstat's Investigational Antidote for 5-FU Overexposure

London, UK, 6th July 2011: BTG plc (LSE: BGC), the specialist healthcare company, today announces that it has acquired US commercial rights to Wellstat Therapeutics Corporation's product candidate uridine triacetate for use as a treatment for accidental overexposure to the chemotherapeutic 5-fluorouracil (5-FU).

Under the terms of the agreement, BTG will have exclusive rights to market, sell and distribute uridine triacetate for this indication in the US for up to 10 years from marketing approval. Wellstat will be responsible for completing development and regulatory filings and for product manufacture. BTG will pay Wellstat an upfront fee of $7.5 million as well as milestone payments upon NDA acceptance and approval and transfer pricing payments based on manufacturing costs and a significant percentage of net sales.

5-FU is a commonly used first-line or adjunctive treatment for colorectal, breast, head and neck tumours. According to the National Institutes of Health Federal Register, some 275,000 US patients receive 5-FU therapy annually of whom around 8,000 will experience a dangerous toxic reaction, which causes the death of around 1300 patients each year. Systemic overexposure of 5-FU can result from impaired clearance, usually caused by a genetic deficiency of an enzyme called DPD, or from medication errors. Uridine triacetate reduces the incorporation of toxic 5-FU metabolites into non-cancerous cells.

While uridine triacetate has not yet received marketing approval, it will continue to be available to patients in the US under emergency use INDs and an expanded access protocol. It is anticipated that the New Drug Application will be submitted during the first half of 2013. The compound has been granted orphan drug designation both in the United States and outside the US. Until approval, any enquiries or requests for uridine triacetate should be directed to Wellstat.

Louise Makin, BTG's Chief Executive Officer, commented: "There is currently no available antidote for accidental 5-FU overexposure, so uridine triacetate will meet a real need if approved. As an oncology antidote, it is an excellent fit with our existing US acute care business and will enable us to leverage the sales team and back office support infrastructure which we have already put in place."

David M. Wohlstadter, Vice President of Licensing and Business Development for Wellstat, commented, "We are delighted to be working with BTG to address this important unmet medical need. BTG are dedicated to marketing and commercializing antidote therapies such as CroFab® and DigiFab® and they have shown impressive growth and focus in implementing their strategic goals. We believe our investigational antidote has potential to be a safe and highly effective therapy in overexposure to 5-FU, and that our agreement with BTG further validates the strength and depth of Wellstat's drug discovery, research and development capabilities."

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About BTG

BTG is an international specialist healthcare company that is developing and commercialising products targeting critical care, cancer and other disorders. The company is seeking to acquire new products to develop and market to specialist physicians, and is building a sustainable business financed by revenues from sales of its own marketed products and from royalties and milestone payments on partnered products. For further information about BTG please visit our website at www.btgplc.com

About Wellstat

Wellstat Therapeutics Corporation is a privately-held biopharmaceutical company located in Gaithersburg, Maryland. Wellstat Therapeutics is committed to discovering, developing and commercializing products that will provide new and improved treatments for patients in the fields of oncology and metabolic, neurometabolic and neurodegenerative diseases. Wellstat Therapeutics is part of the Wellstat group of companies. For more information, please visit the website at www.wellstat.com