Midatech Pharma PLC: Midatech Announces Successful Initial Scale-Up of Its Sustained Release Manufacturing Facility
March 10 2017 - 7:52AM
Midatech Announces Successful Initial Scale-Up of
Its Sustained Release Manufacturing Facility
~ 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).
- Ends –
Notes for Editors
About Midatech Pharma PLC Midatech is an international
specialty pharmaceutical company focused on oncology and other
therapeutic areas with a US commercial operation marketing four
cancer care supportive products, and co-promoting two others.
Midatech's strategy is to internally develop oncology products and
collaborate with partners in other therapy areas, and to drive
growth both organically and through strategic acquisitions. The
Company's R&D activities are supported by two breakthrough drug
delivery technologies: Q-Sphera for sustained release and our
proprietary gold nanoparticles. The Group, listed on AIM: MTPH and
Nasdaq: MTP, employs c.110 staff in four countries. For further
company information see: www.midatechpharma.com
Forward-Looking Statements Certain statements in this press
release may constitute "forward-looking statements" within the
meaning of legislation in the United Kingdom and/or United States,
including (without limitation) those regarding potential offering
of securities, the Group's financial position, business strategy,
products, plans and objectives of management for future operations,
and any statement preceded or followed by, or including, words such
as "target", "believe", "expect", "aim", "intend", "will", "may",
"anticipate", "would" or "could", or negatives of such words. 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.
For more information, please contact:
Midatech Pharma PLC
Jim Phillips, CEO
Tel: +44 (0)1235 841575
www.midatechpharma.com
Panmure Gordon (UK) Limited (Nominated Adviser and Broker)
Corporate Finance
Freddy Crossley / Duncan Monteith
Broking
Tom Salvesen
Tel: +44 (0)20 7886 2500
Consilium Strategic Communications (Financial PR)
Mary Jane Elliott / Ivar Milligan / Cameron Standage
Tel: +44 (0)20 3709 5700
Email: midatech@consilium-comms.com
Westwicke Partners (US Investor Relations)
Chris Brinzey
Tel: +1 339 970 2843
Email: chris.brinzey@westwicke.com
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