26 May 2011
SPECIALITY European Pharma (SEP) has initiated the transfer of the commercial supply of its oncology product Plenaxis® to contract manufacturing organisation (CMO) SCM Pharma.
The initial Manufacturing Development Agreement between the two firms covers the development and validation of the manufacturing and product testing processes at the CMO’s UK-based facility.
On completion of this development stage, the sterile manufacturing specialist is expected to be appointed the exclusive production partner for the vial filling of SEP’s hormonal product, which is used to treat advanced and metastatic prostate cancer. The specialist CMO will then supply the licensed product into Germany with a pan-European roll-out scheduled for late-2011 and beyond.
Plenaxis® is a gonadotrophin-releasing hormone receptor (GnRH) blocker and it works by direct blockade of the GnRH receptors, resulting in a rapid and sustained reduction in testosterone levels and rapid and sustained disease control.
In keeping with SCM Pharma’s expertise in sterile services, the product is a highly potent substance in the form of a dry powder that will be filled in a highly contained environment and presented in terminally sterilised vial.
Tim Record, vice president of operations at Speciality European Pharma, said: “SCM Pharma have an excellent reputation in the industry and high quality standards, which makes them an ideal partner for a specialist pharma company such as SEP.
“Our decision to select them as our contract filling partner comes after a lengthy process to identify a European-based CMO that could handle this type of product and also offer the flexibility to meet increased future demand from across Europe.
“We feel SCM Pharma have the right facilities, expertise and approach to meet our current and forecasted product supply needs and we look forward to building a long-term relationship with them.”
The SEP deal is hot-on-the-heels of SCM Pharma picking-up a sterile filling project with Italian firm Molteni Therapeutics. The diabetes-related work involves the supply of an aseptically manufactured novel drug substance being developed for the topical treatment of infected skin lesions for a Phase II clinical trial.
Dianne Sharp, managing director at SCM Pharma, said: “The project with SEP is a real milestone for our business in that it should lead to the securing of another long-term commercial contract and also further reinforces our position of assisting pharmaceutical companies developing or requiring supply of cancer products.
Whether for clinical trials or commercial markets, our established track record of sterile manufacturing potent liquid, gel and powder products into vials and ampoules gives clients such as SEP the assurance needed to subsequently select us as a CMO partner to meet their product supply requirements.”
The proposed production process at SCM Pharma will also include full in-house analytical, microbiological and sterility testing of the product from the award-winning CMO’s MHRA-licensed facility.
Aside from its ability to produce potent drugs such as cytotoxic and cytostatic compounds, SCM Pharma is also licensed to handle and sterile fill finish C14 radiolabeled products to GMP standards.
SCM Pharma now works with several speciality pharmaceutical companies alongside a third of top ten big pharma on various product indications across a number of therapeutic areas including cancer, diabetes, arthritis, epilepsy, dermatitis, needle-free injection technology and sexual health.
SEP is a privately owned urology-focused specialty pharmaceutical company with commercial operations in the UK, Germany, France and Italy. The business is growing rapidly through the acquisition and licensing of approved pharmaceutical products.
Follow SCM Pharma…www.twitter.com/scmpharma
ENDS
Picture caption: SEP DEAL: SCM’s MD Dianne Sharp
Media contact: Raman Sehgal at SCM Pharma
01661 838 186 / ramans@scm-pharma.com
