London, UK - 1 February 2010; Proximagen
Neuroscience plc, the biotechnology company
focused on diseases of the central nervous
system ("CNS"), today issues a strategic update.
Since the £50m fundraising in June 2009, the
Company has seen a period of unprecedented
corporate activity and undergone a notable
transition. During this time, the Company has
evolved from specialising mainly in Parkinson's
disease related programmes to the wider area of
the CNS in general. The purpose of this
announcement is to update shareholders on the
progress made since June 2009.
Key points
·£50m raised in June 2009 to fund the
acquisition of CNS companies and drug
development programmes;
· As the Group continues to deliver on its
acquisition and consolidation strategy, the
Group's portfolio has grown from five programmes
at the beginning of 2009 and now consists of a
broad portfolio of 14 programmes, from
discovery, through pre-clinical and clinical
stages;
· The recently announced offer for Minster
Pharmaceuticals plc would bring an additional
two clinical stage assets, tonabersat and
sabcomeline, into the Group, which have the
potential to treat epilepsy and schizophrenia
respectively;
· Dr Jackie Hunter, currently the Senior Vice
President and Head of Science Environment
Development at GlaxoSmithKline (GSK) and
formerly the Senior Vice President and Head of
the Neurology & GI Centre of Excellence for Drug
Discovery (CEDD) at GSK, has joined the Board of
directors;
· Dr Tim Sparey, formerly in Business
Development at Merck Serono and Merck & Co,
Inc., has been appointed as Proximagen's Head of
Business Development;
· Consolidation and integration of
acquisitions is expected to deliver cost savings
of an estimated £1.7m in 2010; and
· Cash resources at 30 November 2009 of over
£55.5m.
Objective and strategy
Proximagen's objective is to become one of
the world's leading companies developing
therapeutics for patients suffering from
diseases of the CNS. To achieve this, the
Company is establishing a pipeline of CNS
programmes spanning all phases of development.
We are taking a flexible approach to how far
we develop our programmes before partnering or
monetising them. In taking these decisions, we
are mindful of a number of factors, including
development risk, the progress of competitor
programmes, our financial position and our
belief that the retention of rights to certain
territories is an important long-term value
driver.
In order to achieve our objectives, we have
developed the following five strategic
priorities:
· expand our pipeline within CNS through
acquisition, in-licencing and partnering, thus
building quality and critical mass in research
and development;
· structure innovative deals and defer
consideration where possible;
· with respect to our pipeline, either
· invest in programmes where the value
inflection point is identifiable (such as
establishing clinical proof of concept) and
where such investment is justified by the
potential returns, and then out-license the
programme with the retention of rights in
certain territories; or
· out-license programmes prior to significant
investment where it is commercially viable to do
so;
· reduce duplicated costs through sector
consolidation and integration; and
· build closer relationships with 'Big
Pharma' in our specialist areas.
Proximagen's pipeline
Proximagen's pipeline now comprises
programmes derived from in-house discovery
activities, outright purchase of assets, and
purchases of assets through corporate
acquisition on success-based terms. Below are
details of six of the 14 programmes in our
pipeline:
PRX00933 (5HT2c agonist for obesity) PRX00933
(formerly BVT933) belongs to a new class of drug
candidates that effect weight loss through
selective activation of 5HT2c receptors located
in the brain. PRX00933 demonstrated significant
weight loss in a Phase II clinical trial and is
the next most advanced 5HT2c agonist in clinical
development (Source: MedTrack). PRX00933 has
been shown to be safe and well tolerated in over
400 patients. The compound is now entering
further development, including non-clinical
combination studies for obesity and diabetes.
PRX00023 (5HT1a agonist for epilepsy): 5HT1a
receptor loss has been implicated in epilepsy
and is associated with the brain atrophy that
occurs in epileptic patients with depression. It
is thought that by activating 5HT1a receptors,
seizure incidence and depressive symptoms in
epileptics may be reduced. PRX00023 was shown to
be safe and well tolerated in over 400 patients
and is now entering into further development to
determine its utility in epilepsy. If
successful, Proximagen will open discussions
with funding agencies in the US to support a
broader clinical development programme.
Compounds that activate the 5HT1a receptor
are also thought to inhibit dyskinesia by
regulating abnormal activity of certain
neurologic pathways which co-ordinate movement.
The reversal of dyskinesia has been shown using
other 5HT1a agonists, both in functional models
of the disorder and in clinical trials. We are
undertaking studies in models of Parkinson's
disease to determine PRX00023 utility in
alleviating dyskinesia. If successful, PRX00023
would advance the PRX2 programme, designed to
reduce the involuntary movements associated with
Parkinson's disease, to a Phase II ready
clinical programme.
5HT6 antagonist programme for cognition/pain:Proximagen
acquired a set of 5HT6 antagonists from
Biovitrum, the most advanced being a Phase II
ready compound for cognition. Scientists at
Proximagen determined that back-ups within this
set showed superior pharmacokinetic
characteristics, and in line with our strategy
of investing in the best drug candidates,
although not necessarily the most advanced, we
are advancing a pre-clinical backup compound.
5HT6 receptors have also been implicated in the
control of pain.
PRX1 programme for Parkinson's disease: Drug
candidates from the PRX1 programme have the
potential to become the first choice in the
treatment of Parkinson's disease, having the
efficacy benefits of L-DOPA, considered the best
symptomatic treatment available, with advantages
over L-DOPA's side-effect profile. This
programme is subject to a $232 million licensing
agreement with Upsher-Smith. As part of the
agreement, Upsher-Smith is responsible for the
worldwide development and commercialisation of
PRX1. PRX1354, the lead candidate in the PRX1
programme, has shown an improvement over L-DOPA,
with prolonged activity and a reduction in
unwanted dyskinesia in models of the disease.
Whilst PRX1354 demonstrates an improvement over
L-DOPA in these models, back-up compounds from
the same series are being identified with
superior properties, thus potentially
strengthening the programme considerably. Work
on a back-up series is nearing completion and
thereafter the best candidate will be taken into
IND-enabling studies. Evaluating back-up
compounds, in addition to the lead PRX1354, is
expensive and time consuming, but demonstrates
Upsher-Smith's commitment to develop drug
candidates that represent the best chance of
generating significant commercial value for both
themselves and Proximagen.
Vascular Adhesion Protein-1 (VAP-1) programme
for inflammation: The VAP-1 programme has the
potential to deliver a blockbuster drug that
regulates the movement of immune cells from the
blood into sites of inflammation. This novel
small molecule represents a new class of
anti-inflammatory for the treatment of several
CNS disorders including multiple sclerosis.
The drug candidate may also have utility in
the treatment and prevention of the acute and
chronic inflammation found in inflammatory bowel
disease (Crohn's disease and ulcerative
colitis), respiratory distress syndrome,
psoriasis and chronic obstructive pulmonary
disease.
TrkA programme: The TrkA programme is a
novel, small molecule programme for pain
therapy. TrkA is a target of great interest,
particularly as antibodies to NGF have
demonstrated clinical efficacy. There have been
significant licensing deals for antibodies to
NGF (e.g. Abbott-PanGenetics $190m deal of which
$170m was upfront for P110, currently in Phase I
for osteoarthritis), but given the challenges
associated with developing antibodies there is
an opportunity to develop small molecule
modulators of this pain pathway.
Other programmes
Research and development at Proximagen has
always been a streamlined process, with
programmes showing the most visible
commercialisation opportunities competing for
resource and investment. In accordance with this
strategy, a regular assessment is made of all
Proximagen programmes. This evaluation led to
the deprioritisation of our early stage PRX4
programme, wherein the neuroprotective effects
of the full-length PRX4 gene product were not
reproduced when undertaken in a large scale
study. However, we are sufficiently encouraged
by the developments of our other neuroprotection
gene product, such that it will receive
development resource in 2010. Whilst it is
disappointing when we are unable to justify
significant allocation of funds to certain
programmes, the Company has long been an
advocate of only investing shareholders' funds
where there are justifiable reasons for doing so
and then towards the most promising programmes.
Programmes not meeting our stringent investment
hurdles will be divested or closed down.
Compared with many other biotechnology
companies, Proximagen now has a rich and growing
pipeline, reflecting the Company's ability to
pursue treatments for various therapeutic
indications in later stages of development. We
expect to continue to make significant
investment in the development of our pipeline,
whilst adhering to our merit-based approach to
research and development.
Consolidation overview
Many biotechnology companies have seen their
market valuations depreciate over the past two
years and many companies appear attractively
priced. However, identifying attractively priced
companies in the sector is the easy part;
finding companies with strong technologies and
good science is more challenging. The Company
reviewed over 40 opportunities worldwide in the
second half of 2009 alone and undertook detailed
due diligence on 20, completing one company
acquisition and one asset acquisition during
2009. An offer on a third acquisition, Minster
Pharmaceuticals plc, was made in early 2010.
Proximagen believes that significant value
creation opportunities can arise by building
critical mass, reducing the cost base, and
focusing resources on a more promising pipeline
where tough decisions will be taken to
discontinue weak programmes.
Ongoing acquisition activities
On 4 January 2010, Proximagen announced a
cash offer for Minster Pharmaceuticals plc
("Minster") which has two clinical stage assets,
tonabersat and sabcomeline. Worldwide rights to
both compounds were acquired by Minster from
GlaxoSmithKline ("GSK") and these compounds
benefit from comprehensive safety tolerance data
as a result of investment by GSK.
Proximagen is interested in tonabersat for
epilepsy and if utility is demonstrated,
Proximagen would pursue the strategy stated
above and look to partner tonabersat for this
indication in 2010, whilst retaining some
territorial rights.
Management team
The Company has made a number of key
appointments in the last twelve months to help
it deliver on its growth strategy.
· Peter Allen, who was appointed Chairman in
February 2009, brings extensive sector and
transaction experience to the Group.
· Dr Jackie Hunter has recently joined
Proximagen as a Non-Executive Director. Jackie
is currently the Senior Vice President and Head
of Science Environment Development at
GlaxoSmithKline (GSK) and until March 2008, she
was the Senior Vice President and Head of the
Neurology & GI Centre of Excellence for Drug
Discovery (CEDD) at GSK.
· Our business development team has been
strengthened with the appointment of Dr Tim
Sparey as our Head of Business Development. Tim
joined Proximagen after 15 years in the
industry, first at Merck & Co. and latterly with
Merck Serono.
· We are also pleased to have appointed Dr
Maeve Duffy as Senior Clinical Project Leader.
Maeve brings a wealth of clinical development
experience to the Group.
Intellectual property
Over the past six months, Proximagen has
significantly expanded its patent portfolio. As
a result of the recent acquisitions, the Group
now owns the rights to 26 patents and patents
pending relating to our drug programmes in
pre-clinical and clinical development.
Balance sheet
Balance sheet strength remains of paramount
importance for executing our acquisition and
drug development strategy. To date, our
innovative deal structures, coupled with the
ability to take advantage of the challenging
funding environment in the biotechnology sector
have resulted in only a relatively small amount
of our capital having been used for
consideration.
As at 30 November 2009, Proximagen had cash
resources of £55.5m. We expect to invest these
funds over the next two to three years in
acquiring assets and developing our programmes.
The outlook
We have broadened our pipeline, both in terms
of therapeutic indications addressed and the
development profile, and we have a flexible,
scalable operating infrastructure that can
accommodate further programmes without
replicating overhead costs.
We look forward to updating shareholders as
we progress our acquisition and partnering
strategy. The Company is expected to announce
its preliminary results for the year ended 30
November 2009 in March 2010.
Commenting on the strategic update, Kenneth
Mulvany, CEO, said:
"Proximagen made significant strategic
progress in the second half of last year and is
well positioned to capitalise on that progress
during 2010. With a strong Board, senior
management team and balance sheet, as well as a
greatly enhanced asset portfolio, we look
forward to building on this platform to deliver
further significant improvements in the
Company's long term prospects this year."
Enquiries:
Proximagen Neuroscience plc
Kenneth Mulvany, Chief Executive Officer
James Hunter, Finance Director
Phone: +44 (0)20 7848 6938
Evolution Securities Limited (NOMAD)
Stuart Andrews, Bobbie Hilliam, Tim
Redfern
Phone: +44 (0)20 7071 4300
Pelham Bell Pottinger
Charles Cook, Dan de Belder, Zoë Pocock
Phone: +44 (0)20 7861 3800