New Research Collaboration with Pharmsynthez
November 16 2009 - 2:00AM
UK Regulatory
TIDMLPX
RNS Number : 5321C
Lipoxen PLC
16 November 2009
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| For immediate release | 16 November 2009 |
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Lipoxen plc
('Lipoxen' or 'the Company')
New Research Collaboration with Pharmsynthez
Six candidates to be clinically validated utilising ImuXen or PolyXen
Lipoxen plc (AIM: LPX), a bio-pharmaceutical company specialising in the
development of high-value differentiated biologicals, vaccines and siRNA
delivery, is pleased to announce that it has signed a collaboration agreement
(the "Agreement") with Pharmasynthez ZAO ("Pharmsynthez"), a leading Russian
private research-based pharmaceutical company, to apply Lipoxen's ImuXen and
PolyXen proprietary technologies to a broad range of six drug and vaccine
candidates in collaboration with Pharmsynthez. Lipoxen will provide scientific
supervision to Pharmsynthez for candidate optimisation and clinical proof of
concept trials will be funded by Pharmsynthez. Lipoxen will have access to all
relevant clinical data arising from the subsequent clinical trials.
Highlights of the Agreement
* Lipoxen's ImuXen and PolyXen platform technologies to be validated across a
broad spectrum of six vaccine and drug candidates
* Limited resources required from Lipoxen to achieve human clinical proof of
principle, with Pharmsynthez funding subsequent full clinical trial programmes
in the Russian Federation.
* Lipoxen will have the right to use all relevant clinical trial data to conduct
further trials and seek marketing authorisation in other world territories
* Four product candidates targeting the rare disease indications which could
potentially lead to abbreviated clinical pathway and market exclusivity periods
under EU and US Orphan Drug legislation.
Under the Agreement, Pharmsynthez will apply Lipoxen's ImuXen technology to
create three enhanced vaccine candidates for secondary progressive multiple
sclerosis, HIV and non-Hodgkin's lymphoma. Similarly, Lipoxen's PolyXen
technology will be applied to active compounds to create three pharmaceutical
candidates for treatment of cystic fibrosis, acute myeloid leukaemia,
non-Hodgkin's lymphoma and type 2 diabetes.
Scientists from Pharmsynthez will optimise the candidates with guidance from
Lipoxen and will complete testing to achieve clinical proof of principle the end
of 2010. Candidates that show promise, as determined by a Programme Committee,
will then progress to full-scale clinical development in Europe and the United
States.
Secondary progressive multiple sclerosis, cystic fibrosis ,non-Hodgkin's
lymphoma and acute myeloid leukaemia are all rare diseases and candidates that
are progressed for these indications could be eligible for an abbreviated
clinical pathway under EMEA and FDA regulations and market exclusivity for ten
years and seven years respectively. Lipoxen will have the right to use all
relevant data from the clinical trials to conduct further trials and seek
marketing authorisation in other world territories.
As a result of the Agreement, Lipoxen will receive royalties of 10% of all net
sales from Pharmsynthez should the products progress through clinical
development and be approved for marketing in the Russian Federation. A Programme
Committee, to be chaired by Lipoxen, will be formed to progress the Agreement
which will comprise representatives from both Lipoxen and Pharmsynthez. Any
arising intellectual property will be jointly owned by the two parties, unless
it relates solely to Lipoxen's platform technologies.
ImuXen is an advanced platform vaccine delivery technology that employs novel
liposome constructs to boost the effectiveness of DNA, protein and
polysaccharide vaccines. PolyXen is a multifaceted platform technology that
employs polysialic acid to prolong the active life of the drug in the body and
improve the effectiveness of the drugs.
Commenting on the Agreement, M. Scott Maguire, CEO of Lipoxen, said:
"We are very pleased to be working with Pharmsynthez to apply our ImuXen and
PolyXen platform technologies to Pharmsynthez's compounds in multiple sclerosis,
HIV and non-Hodgkin lymphoma as well as cystic fibrosis, acute myeloid leukemia
and type 2 diabetes. Given that the commitment of upfront resources is limited
to sharing our scientific knowledge of our propriety platform technologies,
Lipoxen is particularly pleased to have access to the clinical data from these
trials which will put it in a strong position to decide whether to run EMEA and
FDA trials on the candidates to achieve marketing approval in other world
territories.
"In addition, achieving human clinical proof of concept for these products
further validates our ImuXen and PolyXen platform technologies and the clinical
data produced will support the utility of these broadly applicable technologies
to enhance existing propriety compounds, which forms an important part of our
business model."
- Ends -
For further information please contact:
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| Lipoxen plc | +44 (0)20 7389 5015 |
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| M. Scott Maguire, Chief Executive Officer | |
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| | |
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| Singer Capital Markets (nominated adviser) | +44 (0)20 3205 7500 |
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| Jeff Keating / Claes Spång | |
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| | |
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| Noble & Company | +44 (0) 20 7763 2200 |
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| John Llewellyn-Lloyd / Sam Reynolds | |
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| | |
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| Buchanan Communications | +44 (0)20 7466 5000 |
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| Lisa Baderoon, Catherine Breen | |
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Notes for Editors
About Lipoxen
Lipoxen plc is a biopharmaceutical company focused on the development of new and
improved biologic drugs and vaccines. Lipoxen has three proprietary patented
technology platforms:
1) PolyXen - for extending the efficacy and half life of biologic drugs
2) ImuXen - for creating new vaccines and improving existing vaccines
3) SiRNAblate - for the delivery of siRNA
Lipoxen's technology is designed to improve the efficacy, safety, stability,
biological half-life and immunologic characteristics of its products.
Lipoxen has multiple drug and vaccine programmes in development. Two products
are in clinical development, SuliXen, a long acting insulin and ErepoXen, a
long-acting erythropoietin (EPO). Lipoxen's preclinical pipeline includes
vaccines against HIV, influenza and malaria. Also Lipoxen has an exclusive
license with Baxter International, a leading global healthcare company, for
utilizing PolyXen with Factor VIII. Total milestone payments could reach $75M
plus royalties on sales.
The Company has a low-risk business model and out-licenses its proprietary
technologies to biopharmaceutical companies that have strong manufacturing and
marketing capabilities. Lipoxen currently has commercial agreements with some of
the world's leading biotechnology and pharmaceutical companies including Baxter,
Schering-Plough, Sanofi-Aventis, the Serum Institute of India Limited,
Genentech, Amgen and Genzyme. Furthermore, Baxter led the GBP2.9 million
fundraising that the Company announced in May 2009, with a US$1 million
investment. Serum Institute of India and Baxter are currently the second and
third largest shareholders in Lipoxen.
Lipoxen, which was founded in 1997, now trades on the AIM Market of the London
Stock Exchange under the ticker symbol LPX. More information can be found at the
Company's website: www.lipoxen.com.
About Pharmsynthez
Pharmsynthez ZAO is a leading Russian private pharmaceutical research-based
company and offer high quality chemical and analytical development of
investigational medicinal products. It is one of the major companies operating
in this segment of the Russian market. Currently the company manufactures and
markets drugs for the treatment of cancer, tuberculosis, and infection diseases.
For more information, please visit the company's website: www.pharmsynthez.com.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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