CDMO has previously been providing clinical development consultancy for varicose vein treatment
SCM Pharma is to assist specialist healthcare company BTG in preparation for the commercial launch of Varisolve (polidocanol endovenous microfoam (PEM)), after providing clinical development consultancy for the product for several years.
The UK-based contract development and manufacturing organisation (CDMO) has worked with BTG since 2005, assisting with clinical studies through to the recent Phase III clinical trial supply.
BTG is developing PEM as a treatment for the appearance and symptoms of varicose veins. In the US alone more than 40 million people suffer from varicose veins.
To date, SCM Pharma has supported BTG with process development, sterile manufacturing, packaging and distribution to trial sites in the US. The CDMO will now be named on the New Drug Application (NDA) for PEM as a commercial supplier and is prepared to further support BTG throughout the NDA review process.
Dianne Sharp, Managing Director at SCM Pharma, said: ‘The complexities involved in developing, processing and producing this product illustrate 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.’