The US Food and Drug Administration (FDA) has approved SCM Pharma to manufacture BTG’s varicose vein treatment from its Northumberland, UK facility.
In May 2013 , BTG’s candidate drug Varithena (previously known as Varisolve) was accepted for review in the US and as part of the new drug application (NDA) UK-based contract development and manufacturing organisation (CDMO) SCM Pharma was named as the commercial supplier.
Now the manufacturer’s headquarters at Prudhoe, Northumberland has received the necessary approval from the FDA to support BTG in its commercial launch of Varithena following an inspection last month.
“BTG was one of our very fist clients back in 2005 and it is great to see the work done by everyone involved in the project coming to such a successful conclusion,” SCM’s Managing Director Dianne Sharp told Outsourcing-Pharma.com.
“This project underlines our ability to support clients from early stages all the way through to licencing and beyond.”
Varithena (polidocanol endovenous microfoam - PEM) is seen as an alternative therapy to surgical removal of varicose veins, using an injectable, pharmaceutical-grade foam to dissolve the veins and according to a European Phase III clinical trial, 90% of patients treated with PEM showed no reflux in the veins after three months.
Commercial Manufacturing & New Facility
We asked Sharp if the firm was prepped to manufacture on a commercial scale. “We already offer commercial,” she said, from SCM’s new nearby Newburn facility which was “the reason that came about.”
She continued: “Prudhoe can also offer commercial supply but Newburn gives us bigger scale-up, capacity, and flexibility.”
The Newburn site received the regulatory thumbs-up from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), allowing operations to commence from the site, earlier this year .
Newburn also offers SCM’s ‘blank canvas’ approach to manufacturing, allowing drug firms the chance to design clinical and contract manufacturing projects in empty cleanroom space, a concept Sharp said started the BTG project, albeit “at Prudhoe many years ago.”