BTG Regulatory News (BTG)

Health Canada approves Varithena® (polidocanol injectable foam) for patients with varicose veins

London, UK, 6 August 2015: BTG plc (LSE: BTG), the specialist healthcare company, today announces that Health Canada has issued a Notice of Compliance approving Varithena® (polidocanol injectable foam) for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein (GSV) system, above and below the knee.1

An estimated 3.7 million Canadians have varicose veins, with women twice as likely as men to develop varicosities.2

Louise Makin, CEO of BTG plc, said: "We are pleased to receive approval in Canada for Varithena® and look forward to the commercial launch during the first half of 2016. The controlled launch continues in the US reimbursed sector, where we consistently receive excellent feedback from physicians in relation to clinical performance and patient acceptability. We are also progressing development of related products for other venous disorders."

About Varithena®

Varithena® (polidocanol injectable foam) is a uniform, low-nitrogen, polidocanol microfoam, dispensed from a proprietary canister device. Treatment is minimally invasive, non-surgical (no incision) and requires neither tumescent anesthesia nor sedation.

Indications

Varithena® is intended for use in adults with clinically significant venous reflux as diagnosed by duplex ultrasound and is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the GSV system, above and below the knee.

Important safety information

For intravenous use only. Varithena® is intended for intravenous injection using ultrasound guidance, administered via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into varicosities. Physicians administering Varithena® must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease and be trained in the administration of Varithena®.

Contraindications

The use of Varithena® is contraindicated in patients with known allergy to polidocanol and those with acute thromboembolic disease.

Warnings and Precautions

Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately.

Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene. Patients with underlying arterial disease, such as marked peripheral arteriosclerosis or thromboangiitis obliterans (Buerger's Disease) may be at increased risk for tissue ischemia. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately.

Varithena® can cause venous thrombosis. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk for developing thrombosis.

Adverse Reactions

In clinical trials, the most common related adverse events (occurring in ≥3% of patients treated with Varithena®) were pain/discomfort in extremity, infusion site thrombosis (retained coagulum), injection site hematoma or pain, thrombophlebitis superficial, and extravasation.

Use in Specific Populations

Pregnancy Category C. Do not use Varithena® in pregnant women.

Please consult the full Prescribing Information or Product Monograph for more information about Varithena.

For further information contact:

About BTG

BTG is a growing international specialist healthcare company bringing to market innovative products in specialist areas of medicine to better serve doctors and their patients. We have a portfolio of Interventional Medicine products to advance the treatment of liver tumours, severe blood clots, varicose veins and advanced emphysema, and Specialty Pharmaceuticals that help patients overexposed to certain medications or toxins. Inspired by patient and physician needs, BTG is investing to expand its portfolio to address some of today's most complex healthcare challenges. To learn more about BTG, please visit: www.btgplc.com

References:

1. Varithena® prescribing information. BTG International Canada Inc. July 2015.

2. Extrapolated to Canadian population from prevalence data in Gloviczki P, Comerota AJ, Dalsing MC, et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011;53(5 suppl):2S-48S.