SCM to Support BTG NDA
News Apr 26, 2013
SCM Pharma will assist 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 organization (CDMO) has worked with specialist healthcare company BTG since 2005, assisting with clinical studies through to the recent pivotal Phase III clinical trial supply.
PEM is being developed by BTG as a comprehensive treatment for the appearance and symptoms of varicose veins. In the US alone over 40 million patients 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: “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.”
SCM Pharma is an award-wining manufacturer specializing in the sterile production of products for clinical trials along with the supply of licensed drugs in niche commercial markets.
It is currently gearing up for the opening of its new commercial contract manufacturing facility that will reinforce its expertise in vial, ampoule and syringe filling, particularly when dealing with highly potent and toxic products that require aseptic filling.