|
| |

York Pharma (AIM:YRK) Preliminary Results for the
Year Ended 30 September 2006
Hitchin, UK, 24 November 2006 - York Pharma plc, the AIM-listed (AIM:YRK)
strategic acquirer, developer and marketer of pharmaceutical products in the
field of dermatology, is pleased to announce its preliminary results for the
year ended 30 September 2006.
Over the period, York has made significant progress towards its aim of becoming
a leading international company focusing on the development and
commercialisation of novel prescription products for dermatological use. This
strategy remains firmly on track and the Company is now poised to achieve major
scientific and commercial milestones.
Financial Highlights
• Pre and post tax loss of £5,884,490 in-line with management expectations
• Cash of £2,939,056 at the end of the period
• A further £3,000,000 of new equity was raised shortly after the period end via
an institutional placing
Product Highlights
• Response received from the UK regulator (MHRA) for a Marketing Authorisation
for its lead product Abasol™
• In the light of the MHRA response, the Company is preparing for the
commercialisation of Abasol™ in the UK in H1 2007
• Sabarep™ (YP001) entered controlled trials in human subjects in a model of
eczema
• Vampex™ (YP003) completed successfully a Phase IIa clinical trial in psoriasis
• Clinical development programmes for Vampex™ & Sabarep™ discussed with the
regulator
• €1,000,000 competitive research grant awarded to support the development of
S1P (YP005)
• Confirmed malignant melanoma as the disease target for YP004, York Pharma’s
skin cancer programme
• Other product programmes remain ‘on-track’
Operating Highlights
• Portfolio now covers over 75% of the target dermatology market by value
• Intellectual property portfolio strengthened and extended
• Board strengthened with additional non-executive director
• Company poised to achieve major scientific and commercial milestones
Terry Sadler, York Pharma’s CEO said: ‘This has been a year in which York has
made major advances in all areas of our business; scientifically, commercially
and structurally. The response from the UK regulator to our application for a
Marketing Authorisation for our lead product was a major milestone and has given
us the confidence to begin planning for the first international launch of Abasol™
in the first half of 2007. Two other products, Sabarep™ and Vampex™, have
successfully entered clinical development and show great promise as new and
novel treatments for eczema and psoriasis respectively, whilst our pre-clinical
programme is also advancing strongly.
Our prospects for the coming months look extremely strong, with the
aforementioned launch of Abasol™ and with other programmes moving through
clinical development. We believe our pipeline is among the strongest and most
attractive in our sector. This together with our sound financial position
enables us to take a considered approach to selecting our first international
partner for products within our portfolio; an event which, when concluded, will
significantly strengthen our finances and give further impetus to our
development programme.
We look forward to 2007 as a year in which our shareholders should begin to reap
the rewards of their confidence in our business as we generate revenues from
both product sales and partnerships and create substantial added value for
them’.
Chairman's statement
York Pharma is a pharmaceutical company specialising in the acquisition,
development and commercialisation of new prescription dermatological products.
Our goal is to provide patients and their carers with top quality,
cost-effective and safe medicines for the best possible treatment of skin
disease.
In 2006 we made further steady progress towards achieving our key objectives.
Our lead product, Abasol™, has advanced through several stages of its regulatory
approval and is now on course to be commercialised in the UK in the first half
of next year. Two of our other products have advanced into Phase II clinical
development. Progress with the rest of our portfolio remains both firmly within
budget and in line with our original timescale.
Terry Sadler, our Chief Executive, has once again prepared a very detailed
product and market report that accompanies this statement.
For the year ended 30 September 2006, York Pharma reported a loss of £5,884,490
and will not be paying a dividend. This result is broadly in line with
expectations and reflects our ongoing investment in the creation of a product
portfolio that will allow us to achieve our key strategic corporate objectives.
Insofar as the loss is actually less than we projected at the commencement of
the financial year, it is the result of the Board’s careful management of the
Group’s expenditure and cash resources. Throughout the year York Pharma has been
in a cash positive position. Our ability to complete the first phase of our
product commercialisation has now been strengthened further by a recent placing
of new shares to raise £3 million, before expenses. Since this took place after
our year-end, these new funds are not reflected in the September 2006 balance
sheet.
As the Group moves towards commercialisation we have taken appropriate steps to
strengthen the management team. I am delighted that Ian Harvey has become our
full time Finance Director. Ian has been with us on a part time basis since the
flotation in April 2004, and his full time commitment to our business is a major
vote of confidence in our future. I am also pleased to welcome Dr Allan Salem to
the Board as a non-executive Director. Allan has a long and distinguished career
in microbiology and in the pharmaceutical industry and his contribution is
already greatly valued.
The team have worked exceptionally hard in the last year and I am sure
shareholders will once again join me in expressing our gratitude for their
efforts. It is thanks to them that the business is now well placed to move to
its next phase of development that should, over time, yield real financial
returns for all its stakeholders. I am confident that 2007 will be a year of
significant progress for all involved in the Company.
Max Dyer Bartlett
Chairman
Chief Executive's review
Summary
Sustained progress has been made in all areas of the business in the current
financial year.
The eagerly awaited response to our first regulatory application for a marketing
authorisation for our lead product Abasol™ was received and we are now preparing
our response to the regulator whilst actively working towards its
commercialisation in H1 2007.
Two of our products continue their path through Phase II clinical development
and have given rise to a strengthening of our intellectual property portfolio.
All other programmes are ‘on-track’ and in line with budgets.
Research funding of €1,000,000 for the pre-clinical phase of development of
YP005 was awarded to York Pharma GmbH by the Federal Ministry for Education and
Research in Germany under its Nanotechnologies for Life Science and Health
programme.
During the period, the business has continued to deliver on its targets, has
maintained a positive cash position and major value creating milestones have
continued to be generated.
Corporate Objectives
York Pharma is a speciality pharmaceutical company. Our stated objective is the
acquisition, development and commercialisation of novel prescription
dermatological products.
We are committed to bringing to both patients and healthcare professionals,
effective and safe medicines of the highest quality for the superior treatment
of diseases of the skin.
Financial Information
The results for the twelve months ended 30 September 2006 are in line with
management expectations and show a pre-tax loss of £5,884,490 (2005 – loss of
£2,690,011). This reflects the Company’s investment in the development of our
portfolio of products, in implementing our regulatory strategy and in planning
for the first commercialisation of Abasol™ in the United Kingdom, other key
markets in the European Union, the USA and Japan.
Business Review
Our pipeline currently comprises seven products/projects. Products span
pre-clinical to pre-registration status, and cover many of the key therapeutic
areas within prescription dermatology.
• Abasol™(dermatomycoses) In first registration in the UK
• Sabarep™ (YP001) (anti-eczema) In controlled human studies
• YP002 (skin diagnostic) In laboratory development
• Vampex™ (YP003) (antipsoriatic) Completed Phase IIa clinical study
• YP004 (skin cancer) Pre-clinical
• YP005 (anti-acne) Pre-clinical
• YP006 (onychomycoses) New development
In addition to the antifungal market in which our lead product Abasol™ will
operate, the company has innovative dermatology products in development for the
treatment of atopic eczema/irritant dermatitis, psoriasis and acne.
Combined, these four therapeutic markets make up over 75% of the total
prescription dermatology market, valued at over US$10 billion. We have a robust
and strategically focused dermatology product portfolio consisting of innovative
products, that are well advanced, are relatively low-risk and that address
significant unmet market needs.
The conduct of clinical trials and the risk factors associated with developing
medicines applied to the skin, whilst still facing rigorous development hurdles,
pose generally fewer risks than the development of systemic medicines which pass
through most of the body’s major organs in significant quantities via the
circulatory system.
Intellectual Property
The 13 patent families which protect York Pharma’s current R&D projects are
owned and controlled wholly by the Company. Additional IP has been generated in
the period to extend further York Pharma’s leadership position in the field of
skin protease inhibition for treating eczema/dermatitis and VAMP Inhibition for
managing a wide range of skin diseases.
Trademarks are also under our own ownership; in particular the Abasol™ mark is
being registered in all territories where commercialisation is anticipated; the
Sabarep™ mark has been applied for internationally as the product is now
progressing through studies of phase II design en-route to commercialisation.
Similarly, the Vampex™ mark will be used, now that YP003 has successfully
completed its initial Phase IIa clinical study and is progressing towards the
market.
Current Operations
York Pharma plc, currently has four operational subsidiaries, York Pharma (R&D)
Limited, York Pharma (UK) Limited, York Pharma GmbH and York Pharma KK.
Products/Projects
Abasol™
Our lead product, Abasol™ (abafungin), as an arylguanidine, is the first in a
new class of antifungal agents. It is also a totally new therapeutic molecule
having a novel mode of action that offers features and benefits which will give
it a meaningful competitive advantage in the important topical antifungal
market.
The antifungal market in which Abasol™ will compete is valued at approximately
$2.65 billion or approximately 25% of the overall dermatology market therefore
illustrating the strategic importance of the product to the company.
The initial indication for Abasol™ is for the treatment of dermatomycoses
(fungal infections of the skin) and, subsequently, we hope to expand the
indications to include fungal infections of the nails. The potential for further
indications is being evaluated and may include seborrhoeic dermatitis, tinea
capitis, vaginal candidiasis, vulvovaginitis (especially where bacteria are also
implicated), dermatitis associated with various skin bacteria and possibly some
forms of acne.
During the period the Company received its first response from the UK regulator
(MHRA) to its application for a marketing authorisation for Abasol™. The
response was in the form of a request for further information, to which the
Company is in a position to respond, using either data already in its possession
or which will be available shortly.
Our first regulatory approval is now within our sights and the first
commercialisation in Europe is now planned for H1 2007. Manufacturing scale up
for commercialisation of the product has been completed and York Pharma is now
planning for and proceeding toward securing marketing authorisations in other
key European markets, the USA and Japan.
Sabarep™ (YP001)
The first therapeutic product to emerge from York Pharma’s Skin Barrier Repair
Technology platform is Sabarep™ (YP001), a product for the treatment of atopic
eczema (synonym dermatitis), a disease characterised by intense itching,
scratching, redness and dryness of the skin. Atopic eczema affects 15 to 25% of
children and 2% of adults and causes an enormous amount of suffering at a
crucial time in a child’s development.
A published medical review has revealed that approximately 66% of children with
clinically defined atopic dermatitis and who consult their primary care
physician are not immunologically atopic. This strongly supports York Pharma’s
earlier discoveries surrounding skin barrier dysfunction and its role in the
development of atopic eczema. Changes in genes that regulate the thickness and
function of the skin barrier have been identified. The physical sites
predisposed to atopic eczema are also those that have a relatively thin skin
barrier such as the face, inside flexor of the arm, behind the knees and the
eyelids thereby supporting further the relevance of the skin barrier function in
the disease.
To date, in vitro and in vivo data has confirmed Sabarep™ has substantial
anti-protease activity and exerts a significant beneficial effect on minimising
water loss from the skin.
Sabarep™ will be marketed as a topical cream and entered controlled human
studies in December 2005. In July 2006, the Company announced that, during the
course of its clinical development programme for Sabarep™, it had created the
opportunity to extend further its intellectual property position in the field of
skin protease inhibition. The Company also confirmed that details of clinical
progress achieved to date and the proposed route to commercialisation of Sabarep™
would be disclosed following the filing of a new patent and after a meeting with
the UK regulator (MHRA), to clarify and agree the requirements for the remainder
of its development programme prior to regulatory submission.
YP002
YP002, will be marketed as a point of care (POC) diagnostic test for identifying
individuals having a dysfunctional skin barrier that would benefit from using
Sabarep™. The product arises from important discoveries made by York Pharma
scientists into the genetics of eczema and the resulting abnormal composition of
proteins that are associated with the impaired skin barrier. The test will
enable those having an impaired skin barrier to take positive therapeutic steps
prior to the cascade of events which can result in overt clinical skin disease.
Importantly, it will also provide a valuable tool for clinicians and patients to
monitor the response to skin barrier therapy such as Sabarep™.
Vampex™ (YP003)
Psoriasis affects approximately 2% of the world’s population and the market for
therapeutic products is valued at approximately $630 million; independent
analysts have projected it to grow to $2.0 billion by 2008. Approximately 85% of
patients have mild to moderate disease that is not appropriate for treatment
with the newer biologics due to their profile, associated high cost and
administration by injection. York Pharma’s anti-psoriatic product, Vampex™
(YP003), is a small molecule that will be presented in a cosmetically acceptable
formulation for the topical management of psoriasis.
With Vampex™, York Pharma scientists have discovered a new therapeutic target
and mechanism of action for the treatment of psoriasis. Correspondingly, the
company has also discovered a potent inhibitor of the therapeutic target that is
an existing medicinal product on which the company has generated new patents
covering its use in dermatology which provide the necessary freedom to
commercialise exclusively.
Data generated by the company through in vitro and in vivo tests has confirmed
the ability of Vampex™ to significantly alter the abnormal hyperproliferation of
epidermal cells, characteristic of the disease. By inhibiting a particular
biochemical pathway that is over-active in psoriasis, Vampex™ triggers cells
that are abnormally proliferating to stop dividing and undergo final
differentiation, a principal therapeutic objective in psoriasis.
The present gold standard therapy for mild to moderate psoriasis consists of the
vitamin D analogues, such as calcipotriol. Vampex™ has recently completed a
Phase lla “proof of concept” clinical trial in psoriatic patients. A comparison
was made against placebo and also against calcipotriol, as a positive control.
The study was double-blind and randomised within patients. For each patient,
three medications: the test medication, Vampex™ (2% carbenoxolone gel), placebo
and 0.05% calcipotriol cream (reference product) were applied to selected
psoriasis plaques daily for four weeks. Whilst the carbenoxolone formulation was
not optimised, in terms either of dosage form or concentration, this product
showed favourable signs of clinical effect. Its activity profile demonstrated
clinical activity according to the guideline set by the European Medicines
Agency (EMEA), showing an improvement of at least a 50% reduction in redness,
scaling and thickness of plaques. Histological examination further supported
these positive results. There were no adverse reactions to carbenoxolone.
The profile of Vampex™ and the results from this study give a provisional
indication that Vampex™ will be an effective anti-psoriatic agent which is well
differentiated versus its competitors by having a lower risk of skin irritancy,
a more favourable safety profile and, potentially, efficacy that is not
diminished with ongoing administration. During the period, the Company met with
the UK Medicines Regulator (MHRA) to confirm its development plans for Vampex™.
YP004
Although YP004 is at a pre-clinical programme stage, it has a major potential in
the treatment of melanoma. York Pharma scientists have identified that the
relevant drug target is expressed preferentially in melanoma skin cancer cells –
thus making it of particular interest for evaluating that condition.
YP004 is aimed at the therapeutic inhibition of a novel receptor characterised
by York Pharma that is expressed on the surface of the cell and believed to be
over-expressed in a variety of cancers. Inhibition of the receptor has been
associated with an important and marked shift from a state of ongoing
proliferation to a state of terminal differentiation in the cells targeted by
the therapy.
Recent reports predicting a trebling in skin cancer over the next 30 years
illustrates the growing problem which YP004 may address. Malignant melanoma is
associated with 77% of the mortalities caused by skin cancers and kills 1,700
people annually in the UK; 7,300 new cases are also diagnosed each year for
which new therapeutic treatments are needed urgently.
In February 2006, York Pharma reported new data which confirmed malignant
melanoma as a target malignancy for York Pharma’s YP004 skin cancer programme.
Discovery of a receptor involved in the cellular uptake of retinol (vitamin A)
on the surface of cells that provides a novel means of treating cancer has now
been validated in two skin malignancies; malignant melanoma and basal cell
carcinoma.
The same cell-surface receptor has also been identified in renal cell carcinoma.
In view of this observation, York Pharma’s scientific team believes that the
eventual novel anti-proliferative agent may have a wider role in the treatment
of cancers extending beyond those involving the skin.
The findings present an exciting opportunity for the development of a novel
therapeutic treatment of malignant melanoma and potentially other cancers. York
Pharma has filed for patent protection internationally in relation to these
scientific findings.
This discovery marks an important step along the road to producing a therapeutic
agent against a devastating cancer that regrettably is increasing in incidence.
York Pharma has developed a unique understanding and patent exclusivity over the
novel use of a receptor involved in cellular transport of vitamin A as a
treatment for malignant melanoma. Our achievements make the Company ideally
placed both to develop and partner our scientific and intellectual property in
the field of skin and potentially other cancers.
YP005
Sphingosine-1-phosphate (S1P) is a pre-clinical product which may have potential
in hyperproliferative skin disorders such as acne.
S1P has a novel dual mechanism of action which is aimed at preventing the
overproduction of corneocytes at the entrance of sebaceous follicle ducts
believed to be a primary cause of acne, whilst also having complementary
anti-inflammatory properties. The profile of S1P has the potential to become a
breakthrough treatment for this commonly occurring skin condition.
On this programme, York Pharma is collaborating with the Freie Universität
Berlin, one of the world’s leading teams in dermatological research. In June
2006, the Company announced research funding of €1,000,000 for the pre-clinical
phase of development of YP005 had been awarded to York Pharma GmbH by the
Federal Ministry for Education and Research in Germany under its
Nanotechnologies for Life Science and Health programme.
YP006
YP006 is the development and use of Abasol™ in onychomycoses – fungal infections
of the nails and nailbed – a common and chronic condition.
Current locally applied treatments offer only low cure rates and lengthy
treatment regimens, whilst oral treatments which offer a higher degree of
efficacy give some concerns over toxicity which limit their use in what is a
non-life threatening condition.
Abasol™ has the potential to offer a treatment which is both safe and effective,
with an important competitive advantage; Abasol™ not only kills fungus when it
is in the actively growing phase, it also kills the resting spores, which may
become active after an apparent cure has been achieved, once again starting the
cycle of recurrent infection.
York is currently evaluating the most appropriate dosage form for delivering
Abasol™ into and through the nail. Once the dosage form has been selected and
validated, the product will proceed into Phase II human studies.
People
We announced in December 2005 the strengthening of the York Pharma Board with
the appointment of an additional Non-Executive Director, Dr Allan Salem.
Dr Salem gained an MA, DPhil in Biochemistry and Microbiology at Wadham College,
Oxford. Subsequently, he lectured in microbiology at the University of
Sheffield, before embarking on a long and distinguished career in the
pharmaceutical industry. Since 2002, Dr Salem has operated as a pharmaceutical
industry consultant for a number of international companies.
Dr Salem’s R&D expertise coupled with his International business development
skills is already impacting positively on the York Pharma Board’s planning and
decision making processes.
The Future
Your Company has made substantial progress over the last twelve months, having
advanced all products/projects along the development path and closer to
commercialisation; most importantly we have gained clarity on the requirements
and timeframe for the first regulatory approval for our lead product Abasol™.
Significant progress of a study programme on Sabarep™ in an eczema model in
human subjects under a controlled Phase II study design has been achieved and
awaits the filing of a new patent before release of the data. Vampex™ shows
great promise as a novel treatment for psoriasis and YP004 could herald a major
breakthrough in the treatment of one of the most aggressive skin cancers. YP005
has been the subject of a major grant award and YP006 progresses towards the
selection of a final formulation to treat fungal infections of the nails, prior
to entering clinical development.
It has taken great effort and dedication from the York Pharma team, our advisers
and supporters to make such impressive progress during the past year; we thank
them all for their efforts and look forward with great anticipation to the
commercialisation of our first product – Abasol™ – in 2007.
Terry I Sadler
Chief Executive Officer
For further information:
York Pharma plc
Tel: +44 (0) 870 067 2563
Terry Sadler, Chief Executive Officer
J M Finn
Sam Smith
Tel: +44 (0) 020 7860 6470
Collins Stewart
Navid Malik
Tel: +44 (0) 020 7523 8000
Northbank Communications
Tel: +44 (0) 203 008 7550
Frances Bornstein (financial enquiries)
Annabel Entress (media enquiries)
Notes to editors:
About York Pharma plc
York Pharma is an AIM-listed strategic acquirer, developer and marketer of
pharmaceutical products in the field of dermatology. Its portfolio now targets
skin diseases that make up approximately 75% of the global $10.4bn dermatology
market. The Company's lead product Abasol, an entirely new drug for the
treatment of fungal infections of the skin, is anticipated to be commercialised
from H1 07. For further information, please go to
www.yorkpharma.com .
| |
|