Full Press Release Details
("Midatech", "Company"
Midatech receives FDA feedback on clinical
Midatech Pharma (AIM: MTPH, Nasdaq: MTP),
the R&D company focused on delivering innovative oncology and rare disease products to patients, is pleased to announce that
further to its announcement on 20 December 2018 (the "Update Announcement") it has received feedback from the FDA on
the regulatory study for its lead product MTD201 Q-Octreotide.
The scenarios outlined for MTD201 in the
Update Announcement included:
The FDA feedback received indicates that
Scenario 1 a single dose pharmacodynamic study in healthy volunteers would not support a new drug application. With this regulatory
guidance the Company will now focus on Scenario 2. and 3. to determine the optimal study design for this final phase of the development
of MTD201 to either establish equivalence of MTD201 versus Novartis' Sandostatin LAR ("SLAR"), or, the development
of a differentiated product with an improved clinical profile. This could therefore include a multi dose study in healthy volunteers
(Scenario 2), or a study in patients (Scenario 3). The final study protocol will be subject to the customary regulatory approvals.
The MTD201 exploratory study conducted
in 2018 has shown MTD201 to have a number of competitive advantages over SLAR, including smaller needle size, simpler and more
reliable reconstitution and injection, reduced wastage and significantly lower manufacturing costs. The Q-Sphera technology used
in MTD201 has patent protection through into the 2030s.
Regulatory marketing authorisation submissions
are currently planned for 2021 based on the Company's commercial manufacturing plan, and the Company expects to generate
the required clinical data within this timeframe.
With regards to the Company's cash
position and further to the Update Announcement, the Company has very limited cash to enable it to continue as a going concern.
Following this announcement, the Company will urgently look to conclude its discussions with the potential strategic investor described
in the Update Announcement. There is no guarantee that the Company will be able to conclude these funding discussions on terms
or quantum similar to those outlined in the Update Announcement or at all. Further announcements will be made as appropriate.
Commenting on the announcement, Dr Craig
Cook, Chief Executive Office of Midatech Pharma, said: "We are pleased to receive clarity from the regulator on the
development path for our lead product MTD201 and we are excited by the prospects of the MTD201 program, as well as the Q-Sphera
platform. With the feedback from the FDA now in hand, we are in a position to finalise the advancement plan for the program as
we look to capture a share of the multibillion dollar sustained-release treatment opportunities. We look forward to updating the
market on our funding and our development plans."
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION
FOR THE PURPOSES OF THE MARKET ABUSE REGULATION (EU) NO. 596/2014.
For more information, please contact:
Panmure Gordon (UK) Limited (Nominated Adviser and Broker)
Corporate finance: Freddy Crossley / Emma Earl
Corporate broking: James Stearns
Consilium Strategic Communications (Financial PR)
Mary Jane Elliott / Angela Gray / Nicholas Brown
Westwicke Partners (US Investor Relations)
Midatech Pharma (LSE AIM: MTPH; NASDAQ:
MTP) is an R&D company focused on delivering innovative oncology and rare disease products to patients. The Company is developing
a range of improved chemotherapeutics or new immunotherapeutics, using its three proprietary platform drug delivery technologies,
all of which are in the clinic, specifically:
Each of our three technologies are thus
focussed on improved bio-delivery and bio-distribution of medicines or agents to areas of the body where they are needed and can
exert their actions in an effective, safe and precise manner.
Midatech is headquartered in Oxfordshire, with an R&D facility in Cardiff and a manufacturing operation
in Bilbao, Spain. For more information please visit www.midatechpharma.com.