The contract – which saw SCM named in the new drug application (NDA) accepted for review in the US last month – builds on a relationship that dates back to 2005 which has seen the CMO provide process development services and manufacture trial supplies.
The US Food and Drug Administration (FDA) is expected to complete its review in 2014 at which point – if approval is granted – BTG and SCM will be the only firms supplying a non-surgical treatment option for the country’s estimated 40 million varicose vein sufferers.
Varisolve – or polidocanol endovenous microfoam (PEM) – is an injectable treatment designed to reduce the swelling associated with varicose veins, specifically for incompetent great saphenous veins (GSV) and associated varicosities, above and below the knee.
A recently completed 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 one year.
Dianne Sharp, managing director at SCM Pharma, said: “We are very proud to be supporting BTG with its NDA for Varisolve, as it is a product that we have helped them develop for many years.
“The complexities involved in developing, processing and producing this product illustrates the type of work we do here at SCM Pharma. Working with novel products, difficult processes and applications and often dangerous substances and APIs at relatively smaller scale is very much our sweet spot.”