Midatech (AIM: MTPH, Nasdaq: MTP), the international specialty pharmaceutical company focused on developing and commercialising products in oncology, today announces it has received oral confirmation from Polish regulators that its first in-human study of its sustained release product octreotide MTD201 is approved. Formal written confirmation of the approval is expected within the next two weeks.
Q-Octreotide (MTD201) is Midatech’s treatment for carcinoid cancer and acromegaly built on its Q-SpheraTM sustained release platform technology. The somatostatin analogue treatment for carcinoid cancer and acromegaly is being developed as the first alternative version of the commercial leading product, Sandostatin® LAR (SLAR). During its pre-clinical programme, data suggested that Q-Octreotide has an equivalent profile to the Novartis SLAR and may offer some important advantages to clinicians and patients. Midatech believes that if these data are confirmed in the upcoming study Q-Octreotide could capture up to a 5% share of the market for SLAR, which is worth $2bn annually1.
This potentially pivotal study comprises an initial exploratory phase which is expected to complete by mid-2018. The final confirmatory phase is expected to complete in H2 2018.
The decision to take Q-Octreotide to commercial scale will be taken following the interim data. Assuming positive clinical data, Midatech anticipates a launch as early as 2020.
Commenting on the news, Dr Jim Phillips, Chief Executive Officer of Midatech Pharma, said: "This is a major milestone for Midatech and we are pleased to start dosing in subjects soon. We have seen compelling data for MTD201 in pre-clinical models and we are excited by the potential for this to be evidenced in patients as well. This trial will provide useful data not only for MTD201, which is one of our top three priority programmes, but also for our sustained release technology platform that is being evaluated for follow-on products.”
1 Novartis.com; Ipsen.com
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).