BTG Regulatory News (BTG)

TheraSphere® Recommended by the National Institute for Health and Care Excellence (NICE) for the Treatment of Primary and Secondary Liver Cancer

London, UK, 30 July 2013: BTG plc (LSE: BTG), the specialist healthcare company, today announces that the National Institute for Health and Care Excellence (NICE) has issued guidance recommending the use of Selective Internal Radiation Therapy (SIRT) (1), which includes TheraSphere®, for patients with liver cancer across the NHS. The guidance supports the use of this innovative treatment for patients with primary hepatocellular carcinoma as well as for those with intrahepatic cholangiocarcinoma (2) and follows the previous recommendation for its use in patients with colorectal cancer liver metastases (3).

The NHS in England is currently preparing guidelines on how SIRT should be used as a treatment option for patients with liver cancer, including those with colorectal cancer liver metastases and cholangiocarcinoma, after recently issuing an interim policy on how this therapy should be funded (4). It is anticipated that this latest NICE guidance will result in a similar evaluation for patients with primary liver cancer. "NICE's guidance further highlights the growing acceptance and understanding of radioembolization in the treatment of liver cancer," said Peter Pattison, General Manager TheraSphere®. "With over 4,000 new liver cancer cases diagnosed annually in the UK (5), this new guidance will potentially provide patients with access to a broader range of treatment options."

Pattison added: "With many countries looking to the UK for direction on their own reimbursement decisions and processes, this guidance should lead to greater awareness amongst physicians and patients and may also prompt similar guidance in other geographies. In addition to increasing liver cancer treatment options for physicians and patients in the UK, this guidance will assist BTG as we continue to explore other reimbursement opportunities in various regions across the world."

About TheraSphere®

TheraSphere is a form of radioembolization therapy that consists of millions of small glass beads (20 to 30 micrometers in diameter) containing radioactive yttrium-90 (Y-90). The product is injected by physicians into the artery of the patient's liver through a catheter, which allows for a high dose of radiation to be delivered directly to the tumour via blood flow thereby limiting the damage to surrounding healthy tissue and side effects to the patients.

TheraSphere is used in the European Union and in Canada for the treatment of hepatic neoplasia in patients who have appropriately positioned arterial catheters. Since its introduction in Europe, more than 1,000 patients have been treated with TheraSphere.

Common side effects include mild to moderate fatigue, pain and nausea for about a week. Physicians describe these symptoms as similar to those of the flu. Some patients experience some loss of appetite and temporary changes in several blood tests. For details on rare or more severe side effects, please refer to the TheraSphere package insert/instructions for use at www.nordion.com/therasphere.

1. National Institute of Care Excellence. IPG460 Selective internal radiation therapy for primary hepatocellular carcinoma: guidance. London. 24 July 2013.

2. National Institute of Care Excellence. IPG459. Selective internal radiation therapy for primary cholangiocarcinoma. London. 24 July 2013.

3. National Institute of Care Excellence. IPG401. Selective internal radiation therapy for non-resectable colorectal metastases of the liver: guidance. London. July 2012 (updates May 2013).

4. NHS England. Interim Clinical Commissioning Policy Statement: Selective Internal Radiotherapy (SIRT). June 2013.

5. http://www.cancerresearchuk.org/cancer-info/cancerstats/types/liver/

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About BTG

BTG is an international specialist healthcare company that is developing and commercialising products targeting critical care, cancer and varicose veins. 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 at www.btgplc.com.