Midatech receives confirmation that its Q-Octreotide (MTD201) first in-human EU study is approved
January 09 2018 - 6:00AM
9 January 2018Midatech Pharma PLC("Midatech" or the
"Company")
Midatech receives confirmation that its
Q-Octreotide (MTD201) first in-human EU study is
approved
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).
- Ends -
For more information, please contact:
Midatech Pharma PLCJim Phillips, CEOTel:
+44 (0)1235 841575www.midatechpharma.com
Panmure Gordon (UK) Limited (Nominated
Adviser and Broker)Corporate FinanceFreddy Crossley /
Atholl TweedieBrokingTom SalvesenTel: +44 (0)20 7886
2500
Consilium Strategic Communications (Financial
PR)Mary Jane Elliott / Ivar Milligan / Nick BrownTel: +44 (0)20
3709 5700Email: midatech@consilium-comms.com
Westwicke Partners (US Investor
Relations)Chris BrinzeyTel: +1 339 970 2843Email:
chris.brinzey@westwicke.com
Notes for Editors
About Midatech Pharma PLC Midatech is an international
specialty pharmaceutical company focused on the research and
development of a pipeline of medicines for oncology and other
therapeutic areas, and marketing these through its established US
commercial operation which includes four cancer care supportive
products and two further co-promoted products. Midatech's
strategy is to internally develop oncology products, and to drive
growth both organically and through strategic acquisitions.
The Company's R&D activities are focused on three innovative
platform technologies to deliver drugs at the "right time, right
place": gold nanoparticles ("GNPs") to enable targeted delivery;
Q-Sphera polymer microspheres to enable sustained release ("SR")
delivery; and Nano Inclusion ("NI") to provide local delivery of
therapeutics, initially to the brain. The Group, listed on AIM:
MTPH and Nasdaq: MTP, employs c.100 staff in four countries. For
further company information see: www.midatechpharma.com
Forward-Looking StatementsCertain
statements in this press release may constitute "forward-looking
statements" within the meaning of legislation in the United Kingdom
and/or United States. Such forward-looking statements include, but
are not limited to, statements regarding the ability of Midatech to
successfully test, manufacture, produce or commercialize products
for conditions using the nanoparticle and sustained release drug
delivery platforms, and the ability for products in development to
achieve positive clinical results, and the ability to meet or
achieve timelines associated with pre-clinical studies, clinical
trials or regulatory submissions. Any forward-looking statements
are based on currently available competitive, financial and
economic data together with management's views and assumptions
regarding future events and business performance as of the time the
statements are made and are subject to risks and uncertainties. We
wish to caution you that there are some known and unknown factors
that could cause actual results to differ materially from any
future results, performance or achievements expressed or implied by
such forward-looking statements.
Reference should be made to those documents that
Midatech shall file from time to time or announcements that may be
made by Midatech in accordance with the London Stock Exchange AIM
Rules for Companies ("AIM Rules"), the Disclosure and Transparency
Rules ("DTRs") and the rules and regulations promulgated by the US
Securities and Exchange Commission, which contains and identifies
other important factors that could cause actual results to differ
materially from those contained in any projections or
forward-looking statements. These forward-looking statements speak
only as of the date of this announcement. All subsequent written
and oral forward-looking statements by or concerning Midatech are
expressly qualified in their entirety by the cautionary statements
above. Except as may be required under the AIM Rules or the DTRs or
by relevant law in the United Kingdom or the United States,
Midatech does not undertake any obligation to publicly update or
revise any forward-looking statements because of new information,
future events or otherwise arising.
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