Development

We’re developing Varisolve^® (polidocanol endovenous microfoam (PEM)) as a first line treatment for incompetent great saphenous veins (GSV) and associated varicosities, above and below the knee.

In the US alone over 40 million patients suffer from varicose veins.¹ Most sufferers opt not to have their veins treated, as current treatments require either the surgical removal of the vein or insertion of a catheter. As potentially the first approved drug, PEM could transform this underserved market by making varicose vein treatment more acceptable.

PEM has a controlled density, consistent bubble sizes, and proprietary gas mix that makes it a simple and comprehensive treatment for symptomatic and aesthetic varicose veins. A European Phase III clinical trial showed that 90% of patients treated with PEM had no reflux in the GSV at 3 months and fewer than 10% of patients had recurrence at 1 year. Patients can generally return to work or their usual activities the same day they are treated, and cosmetic results after PEM treatment are apparent at 6 weeks.¹

Results of three Phase III US trials of Varisolve^® were reported in the first half of 2012.

The two pivotal US trials, VANISH-1 and VANISH-2 had relief of symptoms as the primary endpoint and improvement in appearance as the secondary endpoint. Both trials met all primary, secondary and tertiary endpoints with a high degree of statistical significance. This is the first time patient benefit has been shown using patient-reported outcome measures in pivotal Phase III trials in patients with varicose veins. The full data from VANISH-1 and VANISH-2 were presented at the 26^th Annual Congress of the American College of Phlebology in Hollywood, Florida, USA on 16 November 2012.

A third, smaller study (VV017) separately evaluated patients treated first with heat ablation of the great saphenous vein (GSV) followed by treatment with PEM or placebo for the remaining visible varicosities. Appearance was measured by co-primary endpoints, a blinded independent panel review of photographs and a patient-reported measure of appearance. Relative to baseline, all PEM treatment groups demonstrated a greater improvement in appearance than placebo by both measures. One co-primary endpoint was met with statistical significance but not the other, hence the primary objective of the study was not achieved.

BTG's New Drug Application (NDA) was submitted to the FDA in early 2013, seeking approval of PEM as a comprehensive treatment for varicose veins. The filing has been accepted for full review by the FDA and based on standard review timelines, BTG anticipates potential US approval and launch of PEM during H1 2014.

We plan to market and sell PEM directly in the US reimbursed sector following approval.

We’re exploring options for partnering in the US aesthetic and rest-of-world markets.

References:

1. Wright et al, Phlebology 2006. Vol .21 No. 4

PARAGON Bead^® is a drug-eluting bead in development for the treatment of colorectal cancer which has metastasized to the liver (mCRC). It consists of a bead embolisation system pre-loaded with the chemotherapeutic drug irinotecan, which prevents DNA replication and transcription in rapidly growing cancer cells by inhibition of the enzyme topoisomerase I. The highly engineered beads are locally administered via the hepatic artery to physically block blood flow to the liver tumour, starving it of oxygen. In addition, irinotecan elutes from the beads, providing a local, controlled and sustained dose of drug directly to the tumour.

Up to a half of all colorectal cancer patients develop secondary hepatic metastases, giving an annual incidence of approximately 200,000 patients in the US and EU5.¹ The current global market for liver directed loco-regional therapies for mCRC is $90-100m.²

In December 2012 the US Food and Drug Administration (FDA) granted Humanitarian Use Device (HUD) designation for PARAGON Bead^®. During H1 2013, BTG plans to submit a Humanitarian Device Exemption (HDE) application for PARAGON Bead^®, seeking authority to market the product as a drug-eluting bead treatment for intrahepatic cholangiocarcinoma.

References:

1. Approximate incidence. Patients per annum based on Globocan 2002, ACS 2009 and Biocompatibles data
2. Biocompatibles data on file

PRECISION Bead^® is a drug-eluting bead in development for the treatment of primary liver cancer or hepatocellular carcinoma (HCC). It consists of a bead embolisation system pre-loaded with the chemotherapeutic drug doxorubicin, an intercalating agent which inhibits DNA replication in rapidly growing cancer cells. The highly engineered beads are locally administered via the hepatic artery to physically block blood flow to the liver tumour, starving it of oxygen. In addition, doxorubicin elutes from the beads, providing a local, controlled and sustained dose of drug directly to the tumour.

Approximately 350,000 patients per annum will develop HCC in the US, EU5 and Asia-Pacific countries, with by far the majority being in the latter because of the higher incidence of viral hepatitis in these countries.¹ The current global market for loco-regional therapies for HCC is $80-90m.²

In June 2012, the US Food and Drug Administration (FDA) granted Humanitarian Use Device (HUD) designation for PRECISION Bead^®. A Humanitarian Device Exemption (HDE), seeking authority to sell the product for the treatment of patients with uveal melanoma with hypervascularised hepatic metastases is now planned for submission in H1 2013.

References:

1. Approximate incidence. Patients per annum based on Globocan 2002, ACS 2009 and Biocompatibles data
2. Biocompatibles data on file