Midatech receives Orphan Drug Designation for MTD119 from the European Medicines Agency
February 28 2018 - 7:00AM
28 February 2018Midatech Pharma PLC("Midatech" or the
"Company")
Midatech receives Orphan Drug Designation for
MTD119 from the European Medicines Agency
Midatech (AIM: MTPH, Nasdaq: MTP), the
international specialty pharmaceutical company focused on
developing and commercialising products in oncology, today
announces that the European Medicines Agency (EMA) has granted
Orphan Drug Designation (ODD) for its advanced liver cancer drug
candidate MTD119.
MTD119 (previously MTR104) is a treatment for
hepatocellular carcinoma (HCC), a rare, aggressive cancer that
affects the liver. There are very few treatments for HCC,
particularly for patients with an advanced form of the disease, and
fewer than ten per cent of patients with HCC currently survive
beyond five years of diagnosis. MTD119 is a combination of
Midatech's gold nanoparticle (GNP) technology with the potent
anti-tubulin chemotherapeutic maytansine, in which the GNP is
designed to improve the biodistribution and targeted delivery of
the maytansine agent to the tumour site.
The ODD programme provides orphan status to
drugs intended for the safe and effective treatment, diagnosis or
prevention of rare diseases or disorders that affect fewer than 5
in 10,000 people in the EU. Sponsors who obtain ODD benefit from
development assistance and are eligible for 10 years of market
exclusivity once the medicine is on the market.
A recent pre-clinical study comparing the
efficacy of MTD119 with sorafenib, the current standard of
care, shows a greater response rate and suggests the potential
for an improved efficacy profile for MTD119.
The global HCC market is estimated to be worth
around $1bn by 2024 however, due to the limited efficacy and high
toxicity of existing treatments, we believe there is scope to
significantly expand this market.
This programme is currently being prepared for
clinical trials MTD119 has commenced formal investigational new
drug (IND) application enabling toxicology studies, with completion
of the pilot studies expected in H1 2018. This will be
followed by assessment and full toxicology with an expected IND
submission to the US Food and Drug Administration for first in
human studies in H2 2018 - H1 2019.
Commenting on the news, Dr Jim Phillips,
Chief Executive Officer of Midatech Pharma, said: "We are
pleased that the EMA has granted MTD119 Orphan Drug Designation to
treat patients with liver cancer. Not only does this represent an
important regulatory milestone for Midatech, but the decision means
Midatech will receive financial and developmental support, as well
as marketing exclusivity following approval of the drug. Our focus
now is on advancing the development of MTD119 as fast as possible
while also continuing to work on our exciting pipeline of oncology
and immunotherapy assets, which contains several potentially
significant and value-driving inflection points in 2018."
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 /
Ryan McCarthyBrokingTom 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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