Midatech and MonoSol Rx Announce Positive Phase 1 Clinical Results for Their Novel Transbuccal Oral Insulin Film Product
MonoSol Rx
03.05.2012 14:00
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OXFORD, England and WARREN, N.J., 2012-05-03 14:00 CEST (GLOBE NEWSWIRE) --
Midatech Ltd., a global leader in the design, synthesis and manufacture of
nanomedicines based on its passivated gold-nanoparticle technology, and MonoSol
Rx LLC, the developer of PharmFilm(r) drug delivery technology, today announced
positive bioavailability and pharmacokinetic results from a first-in-human
Phase 1 clinical study of their Midaform(tm) Insulin PharmFilm product in 27
healthy volunteers. The companies have licensed to their joint venture company,
MidaSol Therapeutics LLC, a proprietary nanoformulated transbuccal insulin film
product, which delivers monomeric insulin through the use of a rapidly
dissolving mucoadhesive film that is placed onto the inside of the cheek.
Insulin, stabilized on a nanoparticle and delivered transbuccally, has the
potential to offer diabetic patients a viable oral alternative to injectable
insulin. The Phase 1 study established Midaform Insulin PharmFilm as a safe,
novel, non-injectable insulin delivery system, which closely mimicked the
delivery characteristics of monomeric insulin from the pancreas. Importantly,
MidaSol's product showed a faster onset of action compared to subcutaneous
insulin. Top-line results, including PK and bioavailability elements, from the
study will be presented at the European Summit for Clinical Nanomedicine
(CLINAM) in Basel, Switzerland by Prof.Dr. med. Fritz R. Buhler, Chief Medical
Officer and member of the Board of Midatech Ltd.
A. Mark Schobel, Co-President and CEO of MonoSol Rx, said 'These results are as
good as we could have hoped for in terms of insulin bioavailability and
pharmacokinetics following administration of Midaform Insulin Pharmfilm. The
rapid onset of action surpassed our expectations and we look forward to further
clinical development of this exciting and new groundbreaking product. Based on
the success of this in-man study, which unequivocally validates the utility of
our diverse pre-clinical animal models, we look forward to accelerating the
entire product development program.'
Professor Thomas Rademacher, CEO and Chairman of Midatech, remarked: 'The
success of Midaform Insulin PharmFilm demonstrates its safety, tolerability and
potential use in treating diabetes, particularly meal-dependent hyperglycemia.
This study is a significant step forward for the commercialization of this
novel, non-injectable insulin formulation. This trial shows the success of the
MidaSol Therapeutics LLC joint venture between Midatech and MonoSol, and brings
us closer to using nanomedicines in clinical practice.'
About Diabetes
Diabetes is a disease associated with high levels of blood glucose resulting
from defects in insulin production, insulin action, or both. It is the seventh
leading cause of death in the United States and can cause serious health
complications including heart disease, blindness, kidney failure, and
lower-extremity amputations. According to the Centers for Disease Control,
nearly 24 million people in the United States are currently living with
diabetes. Globally, more than 230 million people are living with the disease
and this number is expected to rise to 350 million within 20 years.
About MidaSol Therapeutics LLC.
MidaSol Therapeutics LLC. is a joint venture formed by Midatech Ltd. of Oxford,
England and MonoSol Rx LLC of Warren, New Jersey. The JV company is dedicated
to the development of new products for the treatment of diabetes, including
existing therapeutics such as insulin and GLP-1, as well as new molecules. The
JV utilizes proprietary technology of the parents in the fields of
nanoparticles sourced from Midatech (Midaform(tm) ) and film technology from
MonoSol Rx (PharmFilm(r) ) . All partnering for development and commercialization
in the field of diabetes will be through MidaSol Therapeutics LLC, which is
being advised by Ferghana Partners, a specialist investment bank in the biotech
field.
About Midatech Ltd.
Midatech Ltd., UK, is a world leader in the design, synthesis and manufacture
of glycan-coated biocompatible gold-nanoparticles. These nanoparticles can be
used to create a wide variety of products with novel characteristics, functions
and applications for a number of industry segments including life sciences,
electronics and fine chemicals.
Founded in 2000, Midatech Ltd. is a private company headquartered in Abingdon,
Oxford, UK. In 2005 it registered its manufacturing facility - Midatech Biogune
S.L. - in Bilbao, Spain, which became fully operational for cGMP standard
design and manufacturing of API nanoparticles In March 2007. In 2008 Midatech
Ltd. further expanded with the opening of PharMida AG in Basel, Switzerland,
which is responsible for clinical development of Midatech's products.
Midatech's biocompatible nanoparticles possess a number of unique properties
that make them ideal for diagnostic and therapeutic applications.
The nanoparticles are water soluble and can be designed to either diffuse
freely in vivo, or to target specific cells. With a diameter of less than 5nm,
unbound nanoparticles are freely excreted from the kidneys, reducing the
likelihood of non-specific in vivo accumulation. Their size potentially enables
drug delivery via different routes of administration, such as parental,
transdermal, mucosal, intradermal transbuccal, sublingual or
intranasal/inhalation. Their stability to enzymatic digestion may also permit
oral therapy. Nanoparticles can be designed to be invisible to the host immune
system with multiple ligands attached to a single nanoparticle allowing
multivalent drug or multi-drug delivery on a single particle. In addition, as
the nanoparticles self-assemble in a single step chemical process manufacturing
is simple, safe, scalable and low cost.
Midatech Ltd. has exclusive world-wide IP for the technology covering design,
manufacture and application/use of nanoparticles in both diagnostic and
therapeutic pharmaceutical areas as well as in other industries. It also has
exclusive world-wide rights for technology relating to the synthesis and
applications of self-assembling nanoparticles.
For further company information see www.midatechgroup.com
About MonoSol Rx LLC
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary
PharmFilm(r) technology to deliver drugs in films. PharmFilm(r) is designed to
benefit patients by improving the convenience, efficacy, and compliance of new
and currently marketed drugs. The Company's leadership in film drug delivery is
supported by strong intellectual property, a portfolio of commercialized
prescription drug products, a pipeline of prescription formulations based on
PharmFilm(r) technology, and two recent FDA approvals - Zuplenz(r), the first
approved prescription oral soluble film for the prevention of
chemotherapy-induced, radiotherapy-induced, and postoperative nausea and
vomiting, and Suboxone(r) sublingual film, the first combination sublingual film
product for the treatment of opioid dependence.
For press releases and other company information visit www.monosolrx.com
CONTACT: Midatech Ltd.
Thomas Rademacher, Chief Executive Officer and Chairman
Storme Moore-Thornicroft, Vice President, Corporate Management
Tel: +44 (0)1235 528022
info@midatechgroup.com
MonoSol Rx
Mark Schobel, Co-President, CEO and CTO
Keith Kendall, Co-President, CFO and COO
Tel: +1 (908) 941-1906
Ferghana Partners
William J. Kridel, Jr., Managing Partner
Tel: +1 (917) 531-5851
College Hill Life Sciences (on behalf of Midatech Ltd.)
Anastasios Koutsos, Nicole Yost
Tel: +44 (0)20 7866 7856
midatech@collegehill.com
The Ruth Group (on behalf of MonoSol Rx)
Victoria Aguiar (media)
Tel: +1 (646) 536-7013
vaguiar@theruthgroup.com
Joshua Drumm, PhD (investors)
Tel: +1 (646) 536-7006
jdrumm@theruthgroup.com
News Source: NASDAQ OMX
03.05.2012 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: MonoSol Rx
United States
Phone:
Fax:
E-mail:
Internet:
WKN:
End of Announcement DGAP News-Service
---------------------------------------------------------------------------
MonoSol Rx
03.05.2012 14:00
---------------------------------------------------------------------------
OXFORD, England and WARREN, N.J., 2012-05-03 14:00 CEST (GLOBE NEWSWIRE) --
Midatech Ltd., a global leader in the design, synthesis and manufacture of
nanomedicines based on its passivated gold-nanoparticle technology, and MonoSol
Rx LLC, the developer of PharmFilm(r) drug delivery technology, today announced
positive bioavailability and pharmacokinetic results from a first-in-human
Phase 1 clinical study of their Midaform(tm) Insulin PharmFilm product in 27
healthy volunteers. The companies have licensed to their joint venture company,
MidaSol Therapeutics LLC, a proprietary nanoformulated transbuccal insulin film
product, which delivers monomeric insulin through the use of a rapidly
dissolving mucoadhesive film that is placed onto the inside of the cheek.
Insulin, stabilized on a nanoparticle and delivered transbuccally, has the
potential to offer diabetic patients a viable oral alternative to injectable
insulin. The Phase 1 study established Midaform Insulin PharmFilm as a safe,
novel, non-injectable insulin delivery system, which closely mimicked the
delivery characteristics of monomeric insulin from the pancreas. Importantly,
MidaSol's product showed a faster onset of action compared to subcutaneous
insulin. Top-line results, including PK and bioavailability elements, from the
study will be presented at the European Summit for Clinical Nanomedicine
(CLINAM) in Basel, Switzerland by Prof.Dr. med. Fritz R. Buhler, Chief Medical
Officer and member of the Board of Midatech Ltd.
A. Mark Schobel, Co-President and CEO of MonoSol Rx, said 'These results are as
good as we could have hoped for in terms of insulin bioavailability and
pharmacokinetics following administration of Midaform Insulin Pharmfilm. The
rapid onset of action surpassed our expectations and we look forward to further
clinical development of this exciting and new groundbreaking product. Based on
the success of this in-man study, which unequivocally validates the utility of
our diverse pre-clinical animal models, we look forward to accelerating the
entire product development program.'
Professor Thomas Rademacher, CEO and Chairman of Midatech, remarked: 'The
success of Midaform Insulin PharmFilm demonstrates its safety, tolerability and
potential use in treating diabetes, particularly meal-dependent hyperglycemia.
This study is a significant step forward for the commercialization of this
novel, non-injectable insulin formulation. This trial shows the success of the
MidaSol Therapeutics LLC joint venture between Midatech and MonoSol, and brings
us closer to using nanomedicines in clinical practice.'
About Diabetes
Diabetes is a disease associated with high levels of blood glucose resulting
from defects in insulin production, insulin action, or both. It is the seventh
leading cause of death in the United States and can cause serious health
complications including heart disease, blindness, kidney failure, and
lower-extremity amputations. According to the Centers for Disease Control,
nearly 24 million people in the United States are currently living with
diabetes. Globally, more than 230 million people are living with the disease
and this number is expected to rise to 350 million within 20 years.
About MidaSol Therapeutics LLC.
MidaSol Therapeutics LLC. is a joint venture formed by Midatech Ltd. of Oxford,
England and MonoSol Rx LLC of Warren, New Jersey. The JV company is dedicated
to the development of new products for the treatment of diabetes, including
existing therapeutics such as insulin and GLP-1, as well as new molecules. The
JV utilizes proprietary technology of the parents in the fields of
nanoparticles sourced from Midatech (Midaform(tm) ) and film technology from
MonoSol Rx (PharmFilm(r) ) . All partnering for development and commercialization
in the field of diabetes will be through MidaSol Therapeutics LLC, which is
being advised by Ferghana Partners, a specialist investment bank in the biotech
field.
About Midatech Ltd.
Midatech Ltd., UK, is a world leader in the design, synthesis and manufacture
of glycan-coated biocompatible gold-nanoparticles. These nanoparticles can be
used to create a wide variety of products with novel characteristics, functions
and applications for a number of industry segments including life sciences,
electronics and fine chemicals.
Founded in 2000, Midatech Ltd. is a private company headquartered in Abingdon,
Oxford, UK. In 2005 it registered its manufacturing facility - Midatech Biogune
S.L. - in Bilbao, Spain, which became fully operational for cGMP standard
design and manufacturing of API nanoparticles In March 2007. In 2008 Midatech
Ltd. further expanded with the opening of PharMida AG in Basel, Switzerland,
which is responsible for clinical development of Midatech's products.
Midatech's biocompatible nanoparticles possess a number of unique properties
that make them ideal for diagnostic and therapeutic applications.
The nanoparticles are water soluble and can be designed to either diffuse
freely in vivo, or to target specific cells. With a diameter of less than 5nm,
unbound nanoparticles are freely excreted from the kidneys, reducing the
likelihood of non-specific in vivo accumulation. Their size potentially enables
drug delivery via different routes of administration, such as parental,
transdermal, mucosal, intradermal transbuccal, sublingual or
intranasal/inhalation. Their stability to enzymatic digestion may also permit
oral therapy. Nanoparticles can be designed to be invisible to the host immune
system with multiple ligands attached to a single nanoparticle allowing
multivalent drug or multi-drug delivery on a single particle. In addition, as
the nanoparticles self-assemble in a single step chemical process manufacturing
is simple, safe, scalable and low cost.
Midatech Ltd. has exclusive world-wide IP for the technology covering design,
manufacture and application/use of nanoparticles in both diagnostic and
therapeutic pharmaceutical areas as well as in other industries. It also has
exclusive world-wide rights for technology relating to the synthesis and
applications of self-assembling nanoparticles.
For further company information see www.midatechgroup.com
About MonoSol Rx LLC
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary
PharmFilm(r) technology to deliver drugs in films. PharmFilm(r) is designed to
benefit patients by improving the convenience, efficacy, and compliance of new
and currently marketed drugs. The Company's leadership in film drug delivery is
supported by strong intellectual property, a portfolio of commercialized
prescription drug products, a pipeline of prescription formulations based on
PharmFilm(r) technology, and two recent FDA approvals - Zuplenz(r), the first
approved prescription oral soluble film for the prevention of
chemotherapy-induced, radiotherapy-induced, and postoperative nausea and
vomiting, and Suboxone(r) sublingual film, the first combination sublingual film
product for the treatment of opioid dependence.
For press releases and other company information visit www.monosolrx.com
CONTACT: Midatech Ltd.
Thomas Rademacher, Chief Executive Officer and Chairman
Storme Moore-Thornicroft, Vice President, Corporate Management
Tel: +44 (0)1235 528022
info@midatechgroup.com
MonoSol Rx
Mark Schobel, Co-President, CEO and CTO
Keith Kendall, Co-President, CFO and COO
Tel: +1 (908) 941-1906
Ferghana Partners
William J. Kridel, Jr., Managing Partner
Tel: +1 (917) 531-5851
College Hill Life Sciences (on behalf of Midatech Ltd.)
Anastasios Koutsos, Nicole Yost
Tel: +44 (0)20 7866 7856
midatech@collegehill.com
The Ruth Group (on behalf of MonoSol Rx)
Victoria Aguiar (media)
Tel: +1 (646) 536-7013
vaguiar@theruthgroup.com
Joshua Drumm, PhD (investors)
Tel: +1 (646) 536-7006
jdrumm@theruthgroup.com
News Source: NASDAQ OMX
03.05.2012 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: MonoSol Rx
United States
Phone:
Fax:
E-mail:
Internet:
WKN:
End of Announcement DGAP News-Service
---------------------------------------------------------------------------