Trading and Programme Update
February 05 2010 - 2:00AM
UK Regulatory
TIDMLPX
RNS Number : 7252G
Lipoxen PLC
05 February 2010
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| FOR IMMEDIATE RELEASE | 5 February 2010 |
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Lipoxen plc
('Lipoxen' or 'the Company')
Trading and Programme Update
Lipoxen plc (AIM: LPX), a bio-pharmaceutical company specialising in the
development of high-value differentiated biologicals, vaccines and siRNA
delivery, provides a trading update for the period ended 31 December 2009, prior
to announcing its final results in April 2010.
Lipoxen reports that, due to a delay in the Phase II clinical trials for
long-acting EPO and Insulin, the potential licensing revenues accompanying these
candidates did not materialize in H2 2009 as originally expected; as a
consequence the Company did not meet its revenue expectations for the second
half of 2009.
While operating costs remained tightly controlled, the quantum of cost reduction
was not enough to offset the level of revenue shortfall. As a result, the
Company's net cash position of GBP1.02 million at 31 December 2009 was below
management expectations. To this end Lipoxen will continue to review its cash
requirements whilst pursuing revenue from licensing deals and other funding
options.
Importantly Lipoxen has implemented a laboratory restructuring to move the
Company's focus from a scientific research-driven and intellectual property
company to one focused on maximising near term commercial opportunities in
FY2010 for its platform technologies and lead projects. This has involved some
staff changes, including the departure of Dr Peter Laing (former Chief Operating
Officer of the Company's operating subsidiary, Lipoxen Technologies Limited). As
announced in September 2009, the Company appointed Dr David Moss as Director of
Projects to deliver on the Company's commercial objectives.
Lead Projects Update
ErepoXen
The Serum Institute of India ("Serum Institute"), Lipoxen's partner responsible
for conducting its Phase II trial ErepoXen in India, has agreed to accelerate
the product candidate towards marketability by expanding the planned trial into
a fully integrated Phase II US FDA compliant trial. This has necessitated the
engagement of a specialised Contract Research Organisation to carry out the
multi-centre trial and new regulatory permissions. Although the project
experienced an interim delay as a result, the required documentation has now
been submitted to the Indian Regulatory Authority (DCGI) and Lipoxen expects to
announce formal dosing of the first patient in Q1 of 2010.
The additional cost of the expanded Indian ErepoXen Phase II trial will be met
by the Serum Institute. This however has culminated in the Serum Institute
taking the decision that it is no longer in a position to fund the earlier stage
ErepoXen Phase I trial in Canada, as previously agreed. As a result, the
Canadian trial is on hold until Lipoxen concludes an alternative funding route.
SuliXen
FDS Pharma ("FDS"), Lipoxen's Russian counterparty responsible for the Company's
Phase II Insulin trial of SuliXen in Russia, was unable to commence the trial at
the end of 2009. In consultation with FDS, the Company is resetting the
timelines for this trial with a view to initiating it in the first half of 2010.
Initial results from the Barbara Davis Institute study of SuliXen for Type 1
diabetes have indicated that this study will be extended through Q1 of 2010.
While the Company initially expected to report on this study in Q4 of 2009,
following the extension of the study, Lipoxen now anticipates being in a
position to report in Q2 this year.
H1N1 Influenza Vaccine
As announced at the end of September 2009, Lipoxen has been appointed the lead
member of the grant consortium to develop a novel H1N1 influenza vaccine. This
programme is being funded by the UK Technology Strategy Board. While still at an
early preclinical stage, this programme is progressing well and, when the latter
stages of the programme have been successfully attained, Lipoxen expects to
apply for further funding to move the vaccine candidate into the clinic within
the next 12 months.
Baxter Healthcare
Lipoxen's Factor VIII project, which is partnered with Baxter, is progressing
well and, as expected, the Company anticipates lead Product Candidate
declaration in the first half of this year. Baxter is now the Company's third
largest shareholder and sees the potential for broadening the collaboration this
year.
HIV and Malaria Vaccine
The Company's HIV project, partnered with the world's leading HIV vaccine
organization, International AIDS Vaccine Initiative, remains on track to report
in Q1 of 2010 and Lipoxen's novel malaria project partnered with PATH Malaria
Vaccine Initiative and the US NIH, is expected to report in the same time frame.
siRNA Delivery Project
Lipoxen's agreement, announced in June 2009, for its siRNAblate technology to
evaluate the effectiveness of combining its partner's (currently undisclosed)
proprietary siRNA with Lipoxen's platform technology, is progressing well and
the Company will provide a further update in the near future.
Other Projects
The Company's collaboration with Pharmasynthez ZAO, announced in November 2009,
to apply Lipoxen's ImuXen and PolyXen proprietary technologies to a broad range
of six drug and vaccine candidates, is progressing well. This project will
provide human proof of concept data on Lipoxen's vaccine platform technology as
early as the end of this year.
Commenting on the trading update, M. Scott Maguire, CEO of Lipoxen, said: "We
are delighted that the Serum Institute has decided to extend the Phase II
ErepoXen trial in India to a fully compliant FDA trial. While incurring an
initial delay, we are very pleased that the product will be accelerated to
market.
"Following the recent restructuring, Lipoxen is better able to focus on
delivering the near term commercial opportunities for its promising platform
technologies. We therefore are confident of delivering value enhancing newsflow
over the course of the next few months."
- 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 | +44 (0)20 3205 |
| adviser) | 7500 |
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| Jeff Keating, Claes Spång | |
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| | |
+------------------------------------------+--------------------+
| Noble & Company | +44 (0)20 7763 |
| | 2200 |
+------------------------------------------+--------------------+
| James Bromhead, Sam Reynolds | |
+------------------------------------------+--------------------+
| | |
+------------------------------------------+--------------------+
| Buchanan Communications | +44 (0)20 7466 |
| | 5000 |
+------------------------------------------+--------------------+
| 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 and an exclusive license deal with
Baxter Healthcare for Factor VIII
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, the Serum Institute of India Limited, Genentech, Amgen
and Genzyme. Furthermore, Baxter, the Company's third largest shareholder, and
management led the GBP2.9 million fundraising that the Company announced in May
2009.
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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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