The agreement will see SCM Pharma developing; manufacturing and product testing the gonadotrophin-releasing hormone receptor (GnRH) blocker at its Northumberland facility in the north east of England.
“The project with SEP is a real milestone for our business,” said Dianne Sharp, managing director at SCM Pharma. “It should lead to securing another long-term commercial contract and also further reinforces our position of assisting pharmaceutical companies developing or requiring supply of cancer products.”
Exclusive production partner
Once the development stage is complete, SCM Pharma expects to become SEP’s exclusive production partner for the vial filling of Plenaxis – a potent substance which comes in dry powder form and is used to treat advanced and metastatic prostate cancer.
The planned production process will include full in-house analytical, microbiological and sterility testing of Plenaxis at SCM Pharma’s 14,000 sq. ft. MHRA-licensed facility.
SCM Pharma says its Northumberland unit is capable of accommodating the production of various potent drugs such as cytotoxic and cytostatic compounds, as well as being licensed to handle and sterile fill finish C14 radiolabeled products to good manufacturing practice (GMP) standards.
Tim Record, vp of operations at Speciality European Pharma, said: “Our decision to select [SCM Pharma] 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.”
This latest deal with SEP follows SCM Pharma’s teaming with Italian firm Molteni Therapeutics in a diabetes-related sterile filling project announced earlier this month.
As part of the project, SCM Pharma is developing an aseptically manufactured novel drug substance for Molteni, which is being used to treat infected skin lesions in a Phase II clinical trial.
The CMO is currently working with several speciality pharma companies on products in various therapeutic areas including cancer, diabetes, arthritis, epilepsy, dermatitis, needle-free injection technology and sexual health.