23 Jul 2015 07:00
23 July 2015
Midatech Pharma PLC
("Midatech" or the "Company")
Initiation of Phase IIa study of insulin delivery via buccal strip for type 1 diabetes
Midatech (AIM: MTPH), the international specialty pharmaceutical company with a diversified portfolio of high-value products in development, in partnership with MonoSol Rx, today announces that the first patient has been treated in a Phase IIa open label, cross-over, seven arm study of Insulin Buccal Soluble Film (MSL-001) for type 1 diabetes mellitus.
The objectives of the study are to establish the pharmacodynamic and pharmacokinetic profile, and safety and tolerability of MSL-001 (MidaForm® Insulin PharmFilm®) in comparison to subcutaneous administered human recombinant insulin (Humulin®).
The study is being conducted in Perth, Australia, with a total of 12 patients, male and female, aged 18 - 55 being treated from a screening pool of up to 35 subjects. The overall study duration is approximately five months.
MSL-001 contains recombinant human insulin which is non-covalently bound to glycan-coated gold nanoparticles and embedded in an oral, muco-adhesive, polymeric film for transbuccal delivery. The drug was invented by Midatech and MonoSol Rx and is being developed by the parties' joint venture, MidaSol Therapeutics.
Commenting on the study, Dr. Jim Philips, CEO of Midatech Pharma, said: "Diabetes incidence is forecast to hit 500m people, globally, by 2025; with our partnered transbuccal insulin strip, MSL-001 is targeting a $20 billion market, adding significant revenue potential to our growing portfolio of products."
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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 / Adam James / Atholl Tweedie / Duncan Monteith
Broking
Tom Salvesen
Tel: +44 (0)20 7886 2500
Consilium Strategic Communications (Financial PR)
Mary Jane Elliott / Ivar Milligan / Matthew Neal / Hendrik Thys
Tel: +44 (0)20 3709 5700
Email: midatech@consilium-comms.com
About Midatech Pharma PLC
Midatech is a nanomedicine company focused on the development and commercialisation of multiple, high-value, targeted therapies for major diseases with unmet medical need. These diseases include diabetes, rare cancers including brain (glioblastoma), ovarian, liver and pancreatic cancer and neurological/ophthalmologic conditions. Midatech's strategy is to develop its products in-house in rare cancers and with partners in other indications, and to accelerate growth of its business through strategic acquisition of complementary products and technologies.
Midatech's core product candidates derive from its two multi-applicable platform technologies that can be used alone or in combination to enable the targeted delivery ('right place') and controlled release ('right time') of existing drugs. These technologies are provided through its wholly-owned subsidiaries, Midatech and Q-Chip (acquired in 2014). Midatech's core platform is a drug conjugate delivery system based on a patented form of gold nanoparticles (GNP) combined with existing drugs for the safe and targeted release of therapeutic payloads at specific organs, cells or sites of disease.
The Group's second platform is a sustained release technology acquired with Q Chip that involves the consistent and precise encapsulation of active drug compounds within polymer microspheres enabling their release into the body in a highly controlled manner over a prolonged period of time.
On 4 June 2015, Midatech announced a proposed acquisition of DARA BioSciences, Inc. (NASDAQ: DARA), an oncology supportive care pharmaceutical company, based in Raleigh, NC. The acquisition brings a portfolio of marketed oncology products and a salesforce in US to Midatech and is expected to complete in H2 2015.
The Group is headquartered near Oxford, UK, with a nanoparticle manufacturing operation in Bilbao, Spain and an R&D facility in Cardiff, UK. For further company information see: www.midatechgroup.com.
About MonoSol Rx
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to develop products which address the unmet needs of patients. PharmFilm® is designed to benefit patients by improving the safety, efficacy, compliance and convenience of new and currently marketed drugs. The Company's leadership in film drug delivery is supported by strong intellectual property, a pipeline of prescription formulations based on PharmFilm® technology, and two FDA approvals - Zuplenz®, the first approved prescription oral soluble film for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting, and Suboxone® sublingual film, the first sublingual film product for the treatment of opioid dependence. For press releases and other company information visit: www.monosolrx.com.