Q-Octreotide will become Midatech’s first Sustained Release product candidate manufactured in house at its state-of-the-art facility in Bilbao, Spain
Midatech Pharma (AIM: MTPH, Nasdaq: MTP), the international specialty pharmaceutical company focused on developing and commercialising products in oncology, is pleased to announce the successful initial scale-up and regulatory inspection of its state-of-the-art manufacturing site in Bilbao, Spain.
The manufacturing facility currently produces all Midatech’s gold nanoparticle (GNP) products. Now in addition the Company has installed facilities, equipment and quality assurance systems for in-house manufacturing of its Sustained Release (Q-Sphera) products, at scale.
This new facility has been successfully inspected by the Spanish Agency of Medicines and Medical Devices (AEMPS), and a formal Sustained Release sterile manufacturing licence will be granted upon completion of final process validation which is currently underway.
The first sustained release product to be produced at the Bilbao facility is anticipated to be Q-Octreotide (MTD201), Midatech’s in-development programme for the treatment of acromegaly and carcinoid syndrome, which is planned to commence a Phase I study and follow-on regulatory program later in 2017, with anticipated approval and launch expected in 2018/19.
Commenting on the announcement, Dr. Jim Phillips, Chief Executive Officer of Midatech Pharma said: “We are pleased with the successful scale-up of our Bilbao facility which was completed within budget, and has had a positive inspection and debrief by the AEMPS. Manufacturing our GNP and sustained release technologies in Bilbao allows us to control the process without being reliant on an external manufacturer, and all the investment, intellectual property and expertise will therefore be retained in-house. Furthermore, there will be significant cost efficiencies rather than outsourcing the manufacturing process to a third-party. This facility will provide for our requirements through to product launch, following which further scale up is planned to cover commercial supplies.”
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).