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Lipoxen PLC (XEN)

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Monday 16 November, 2009

Lipoxen PLC

New Research Collaboration wi

RNS Number : 5321C
Lipoxen PLC
16 November 2009

For immediate release

16 November 2009

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:

Lipoxen plc

+44 (0)20 7389 5015 

M. Scott Maguire, Chief Executive Officer

Singer Capital Markets (nominated adviser)

+44 (0)20 3205 7500

Jeff Keating / Claes Spång 

Noble & Company

+44 (0) 20 7763 2200 

John Llewellyn-Lloyd / Sam Reynolds  

Buchanan Communications

+44 (0)20 7466 5000

Lisa Baderoon, Catherine Breen

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 £2.9 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:

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:

This information is provided by RNS
The company news service from the London Stock Exchange