Interim Management Statement
Phytopharm PLC
18 February 2008
Company Contact: U.K. Investor Relations
Phytopharm plc Contact: FD
Dr Daryl Rees CEO David Yates
Piers Morgan CFO Ben Atwell
+44 1480 437 697 +44 207 831 3113
www.phytopharm.com
18 February 2008
Phytopharm plc
Interim Management Statement for 3 months ended 31 December 2007
Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm' or the 'Company') is
today issuing its Interim Management Statement ('IMS') which relates to the
three month period from 1 October 2007 to 31 December 2007 and contains
information up to the date of publication of this IMS.
Portfolio Highlights
Hoodia extract
• Our weight management product partnered with Unilever, continues to
make good progress through the final development stage prior to registration
and commercial launch
Phytopica(R)
• Preparation continues for launching into additional territories
Cogane(TM)
• Successful grant of funding of $1.16 million from The Michael J. Fox
Foundation in January 2008 for Parkinson's Research (MJFF) to support the
development of Cogane(TM) as a treatment for Parkinson's disease
Myogane(TM)
• EU orphan medicinal product submission for ALS to EMEA; response
anticipated H1 2008
The Hoodia programme is fully funded by Unilever, Phytopica(R) is revenue
generating and discussions are ongoing for further financial support from
charitable organisations to develop Cogane(TM) as a treatment for Parkinson's
disease and Myogane(TM) as a treatment for motor neurone disease. There have been
no other significant changes in the financial position or performance of the
Company since the publication of the last audited Report and Accounts in respect
of the period ended 30 September 2007. Cash and cash equivalents as at 30
September 2007 was £2.24 million.
Dr Daryl Rees, Chief Executive, commented: 'Hoodia extract, our weight
management product partnered with Unilever, has continued to make good progress
through the final stage of development prior to registration and commercial
launch. Our canine skin health product, Phytopica(R), partnered with
Schering-Plough is progressing towards launch in additional territories. Our
pharmaceutical products Cogane(TM) and Myogane(TM) continue to make good progress
and we are now beginning to benefit from the strategic financial support of
charitable organisations for the further development of these products. This
non-dilutive funding will reduce our net development costs and cash burn while
increasing long term shareholder value. We look forward with confidence to
building on our achievements and reporting on our progress.'
Notes to Editors
Phytopharm plc
Phytopharm is a pharmaceutical development and functional food company. Our
products are developed from medicinal plants, thereby reducing the development
risk, cost and time to market. As a virtual company, Phytopharm's model is
centred on a lean cash burn with all laboratory, manufacturing and clinical work
out-sourced to specialists, while core competencies such as strategy and
management are maintained in-house. Close collaboration with charitable
organisations enhances our interaction with worldwide specialists and
accelerates our development programmes increasing their value.
Pharmaceutical products
Cogane(TM) is in clinical development as a treatment for Parkinson's disease.
In pre-clinical models, Cogane(TM) reverses the changes in the area of the brain
involved in Parkinson's disease by inducing the body's own production of
proteins known as neurotrophic factors. In particular, one of these factors
known as 'GDNF' has been shown to be particularly effective in re-growing
damaged nerves. Since GDNF is a protein it cannot be given orally (in tablet or
liquid form) because it is degraded in the stomach and intestine, and also does
not readily cross the blood-brain barrier. GDNF can work only when injected
into or when produced inside the brain. Direct injection of GDNF into the area
of the brain involved in Parkinson's disease has shown substantial beneficial
effects in small-scale clinical studies but requires highly complex and
difficult surgical procedures. Cogane(TM), which can be taken orally, readily
crosses the blood-brain barrier and in pre-clinical models has been shown to
stimulate the release of GDNF in the brain and therefore has the potential to
overcome many of the difficulties associated with GDNF administration.
The MJFF funding will support preclinical studies to determine the optimal
dosing requirements for Cogane(TM) and will be carried out by Dr Jonathan
Brotchie, a Senior Scientist at the Toronto Western Hospital and part of the
University Health Network (UHN) in Toronto, Canada. Dr Brotchie is a recognised
expert in the field of Parkinson's disease and, at UHN, runs one of the world's
premier research laboratories for the identification of novel treatments,
diagnostics and cures for Parkinson's disease and related disorders.
The neuroprotective, neurorestorative and neurotrophic actions of Cogane(TM)
suggest potential beneficial effects in other neurodegenerative diseases
including Alzheimer's disease. Dysregulation of neurotrophic factors has been
implicated in a number of neuropsychiatric disorders suggesting that Cogane(TM)
may have utility in schizophrenia, depression and anxiety, which together with
Alzheimer's disease have an estimated aggregate market size of $50bn.
Myogane(TM) is in clinical development as a treatment for ALS (also known as Lou
Gehrig's disease). ALS is the most prevalent motor neurone disease and results
from progressive degeneration of motor neurones. This condition has a high unmet
medical need. In pre-clinical studies, Myogane(TM) protects against neuronal
damage and when administered orally to pre-clinical models of ALS, delays the
loss of muscle strength and extends survival time. Myogane(TM) has successfully
completed a Phase Ia clinical study that evaluated the safety, tolerability and
pharmacokinetic profile of Myogane(TM). This residential clinical study was
conducted under an investigational new drug (IND) filed with the United States
Food and Drug Administration (FDA). The FDA has also granted Orphan Drug and
Fast Track designation to Myogane(TM) for the treatment of ALS. The new liquid
formulation of Myogane(TM), suitable for ALS patients, has also successfully
progressed through a Phase Ib healthy volunteer clinical trial conducted under a
clinical trial authorisation (CTA) filed with the Medicines and Healthcare
products Regulatory Agency (MHRA). An application has been submitted for EU
orphan medicinal product status for ALS to the EMEA and a response is
anticipated in H1 2008.
The neuroprotective, neurorestorative and neurotrophic actions of Myogane(TM)
suggest potential beneficial effects in other orphan neurodegenerative diseases
including Huntington's disease, Friedrich's ataxia, progressive supranuclear
palsy and multiple system atrophy. The aggregate market size for these orphan
diseases, including ALS, is estimated at in excess of $1bn.
Functional Foods
Hoodia extract is in development as a weight management functional food product
based on an extract of the succulent plant, Hoodia, which contains a novel
satiety stimulator that reduces calorie intake in overweight subjects, as
demonstrated in a double-blind, placebo-controlled clinical study. Extracts of
Hoodia and the active molecules therein are the subject of a global patenting
programme, with major patents granted in the US, UK, Europe and Japan and
pending in all other major territories.
The programme has successfully progressed into the final development stage of
the Unilever Joint Development Agreement. This stage includes supply chain
expansion and consumer studies that will evaluate reductions in calorie intake
as part of a weight management programme in the general population, and is the
final stage prior to submission for regulatory approval. As part of the
agreement, Unilever is committed to fully funding the development programme. In
addition, Phytopharm will receive an undisclosed royalty on sales of all
products containing the extract. Separately, Unilever is also managing the
agronomy programme, including scale up for launch, undertaking manufacturing and
market research activities, and supporting the international patent programme
for the products.
Phytopharm and Unilever have become aware of many companies that are selling
products over the Internet and in some stores claiming to contain Hoodia and
causing weight loss. Analysis of these products has demonstrated that the great
majority of them contain little or no Hoodia. Phytopharm and Unilever have made
contact with the relevant authorities concerning this development and are
satisfied with the progress being made to limit these activities.
Phytopica(R) is a natural, three plant product for canine skin health that
provides a novel 3 in 1 approach to help maintain a normal healthy immune
system, support normal white cell function and provide anti-oxidant benefits.
The beneficial effects and excellent safety profile of Phytopica(R) have been
proven extensively in clinical trials and the product has been found to be
suitable for all dogs whatever size or breed. Canine dermatological disorders
are well recognised by veterinarians to be a major problem, with an estimated
15% of the UK dog population (around 900,000 dogs) affected by skin conditions.
Maintenance of a healthy skin and coat and alleviation of itching are of major
importance to canine general health and quality of life.
In January 2006, Phytopharm entered into an exclusive global agreement with
Schering-Plough Animal Health ('Schering-Plough') for Phytopica(R). Under the
terms of the agreement, Phytopharm is responsible for manufacturing Phytopica(R)
whilst Schering-Plough is responsible for the global sales, marketing and
distribution. Schering-Plough launched Phytopica(R) in the UK in April 2006 and
in Italy and France in March and April 2007, respectively. The product has
enjoyed firm support from veterinary dermatologists, with sales exceeding
expectations. Preparation continues with Schering-Plough for launching into
additional territories worldwide.
Forward-looking statements
Certain information included in these statements is forward-looking and involves
risk and uncertainties that could cause results to differ materially from those
expressed or implied by the forward looking statements.
Forward-looking statements include, without limitation, projections relating to
results of operations and financial conditions, market estimates, the Company's
plans and objectives for future operations, including future revenues, financial
plans and expected expenditures and divestments. All forward-looking statements
in this report are based upon information known to the Company on the date of
this IMS. The Company undertakes no obligation to publicly update or revise any
forward-looking statement, whether as a result of new information, future events
of otherwise.
It is not reasonably possible to itemise all of the many factors and specific
events that could cause the Company's forward looking statements to be incorrect
or that could otherwise have a material adverse effect on the future operations
or results of the Company.
For further information about Phytopharm please see our website at
http://www.phytopharm.com
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