Agreement & Trading Update
Allergy Therapeutics PLC
05 January 2005
5th January 2004
Allergy Therapeutics announces Canadian collaboration and trading update
Allergy Therapeutics plc (LSE:AGY), the specialty pharmaceuticals company
focused on allergy vaccines, today announced it has granted exclusive rights to
market Allergy Therapeutics' award-winning four-shot allergy vaccine Pollinex(R)
Quattro in Canada to Allerpharma Inc, a privately-owned Canadian company
specialising in allergy. The two companies will collaborate in the development
of Pollinex(R) Quattro vaccines for allergy to Ragweed, grass and tree pollen
and to house dust mite. In anticipation of the registration of Pollinex(R)
Quattro, Allerpharma will also have the rights to sell Allergy Therapeutics'
existing registered Ragweed allergy vaccine, Pollinex(R) R, in Canada.
Under the terms of the agreement Allerpharma will make milestone payments to
Allergy Therapeutics totalling £8million during the period of development and
registration of the products. Following registration Allergy Therapeutics will
also be entitled to royalty payments and will supply Allerpharma with the
products.
Simultaneously Allergy Therapeutics has entered into a broad collaboration with
Allied Research International ('ARI'), a sister company of Allerpharma.
Toronto-based ARI is a well-respected Contract Research Organisation, owned and
managed by Dr. Piyush Patel, an internationally renowned allergist. ARI
operates an advanced and proven environmental exposure chamber for controlled
allergen exposure, making it the ideal partner for the supportive pre-phase III
trials. Under the terms of the collaboration ARI will conduct a number of
clinical trials (Phases I, II and III) with a view to achieving early
registration in the Canadian market of Pollinex(R) Quattro for the treatment of
allergy to Ragweed - the most common cause of seasonal allergic
rhino-conjunctivitis in North America.
In addition to Ragweed, vaccines for other allergens are also covered by the
agreement and Allergy Therapeutics will use the data from all the studies to
support its programme of world-wide registrations for Pollinex Quattro,
including the US and European markets.
Phase III Clinical Trials
Allergy Therapeutics has also selected PRA International Inc. (NASDAQ:PRAI) to
conduct the pivotal phase III study for grass, which will initiate globally
later this year, following approval of an Investigational New Drug (IND)
application by the US Food & Drugs Administration (FDA). PRA is one of the
world's leading clinical development organisations with more than 2,500
employees worldwide.
Trading update
Allergy Therapeutics expects to announce its maiden interim results for the six
months ended 31 December 2004 in early March. The Company will report gross
sales in line with market expectations and management projections, whilst costs
and profits will be better than expected. Sales of Pollinex(R) Quattro, Allergy
Therapeutics' award-winning four-shot allergy vaccine, show growth of nearly 40%
over the same period last year.
Owing to the seasonality of the allergy market, some 70% of Allergy
Therapeutics' sales are taken in the first half of the Company's financial year
and as a consequence the first half results give a better than normal indication
for full year performance.
German statutory sales rebate
At present, nearly 70% of Allergy Therapeutics' sales are generated in Germany,
so the increase of the compulsory rebate from 6% to 16% in January 2004 has been
costly to the company in terms of sales and profits. As from 1 January this
year the rebate has reverted to 6% and this rebate will be calculated using
current list prices, as opposed to prices as at October 2002 as was previously
the case. The impact of these measures will be an improvement in net sales and
profits of over £1million in the current financial year, to 30 June 2005, and
over £2.5million in a 12 month period at current sales levels.
Commenting on these developments Keith Carter, CEO of Allergy Therapeutics,
said:
"We are very pleased to be able to report on our progress since listing on AIM
in October. With regard to the Canadian agreement, Dr. Patel is a practicing
allergist as well as an experienced drug developer and his enthusiasm for
Pollinex(R) Quattro is further validation of our development plans. The
Canadian market is the 8th largest in the world and therefore the milestone
payments Allergy Therapeutics will receive reflect the commercial potential of
our new vaccines.
"In Germany, the reversion of the sales rebate to 6% is welcome news for all
pharmaceutical companies operating there, but particularly so for smaller
businesses such as Allergy Therapeutics with a large proportion of sales
generated in that market. We look to the future with growing confidence."
For further information:
Allergy Therapeutics 01903 844720
Keith Carter, Chief Executive
Grandfield 020 7417 4170
Samantha Robbins / Charles Cook
KBC Peel Hunt 020 7418 8900
Capel Irwin
NOTES TO EDITORS
About Allergy Therapeutics
Allergy Therapeutics is a fully integrated, specialty pharmaceuticals business
focused on the treatment and prevention of allergies. The Group was formed in
June 1998 following the MBI of the Bencard allergy vaccine business from
SmithKline Beecham (now part of GSK). The Group has a manufacturing, sales and
marketing and product development infrastructure dedicated to a portfolio of
marketed products and a pipeline of development products, focused on achieving
registrations world-wide.
The Group has a history of pioneering innovative short course allergy vaccines
by developing well-characterised modified allergens using tyrosine as a depot
adjuvant. Allergy Therapeutics' short term development objective is to create
allergy vaccines capable of use as a first line therapy for the treatment and
cure of allergic diseases including allergic rhinitis, allergic conjunctivitis
and allergic asthma. To achieve this, the Group has a pipeline of new vaccines
based on the patented innovative adjuvant MPL(R) to which the Group has licensed
certain exclusive rights.
Through its own sales force in Germany, Italy and Spain and indirectly in more
than 20 countries, including 8 countries through licensing agreements, the Group
currently sells and distributes four families of vaccine products, injected and
sub-lingual, ranging from registered general seasonal pollen allergy
vaccinations for common allergens (such as grass and trees) to patient-specific
(named patient products) . The Group also sells a range of skin-prick diagnostic
tests.
www.allergytherapeutics.com
About Allied Research International
Allied Research International Inc. (formerly known as Allied Clinical Research)
is a dynamic group of scientific and medical professionals dedicated to the
advancement of clinical research. For over ten years, Allied Research
International (ARI) has been providing services to the Pharmaceutical and
Biotechnology industries. These services range from conducting complex single
site Phase I / Bioequivalence /Bioavailability (BE/BA) studies or early Phase II
studies, to being a site in multi-center Phase II and III studies.
ARI has developed an Environmental Exposure Chamber (EEC) for studies that
require controlled allergen exposure. This is a unique solution to the need for
large Phase II type studies for anti-allergic drugs. In the EEC up to 100
subjects can be exposed to known controlled amounts of allergen thereby
simulating a heavy pollen day in the season.
www.allied-research.com
About Allerpharma
Allerpharma Inc. is a sister company of ARI, offering a complementary service
for sales and marketing of products to treat allergies. The business is run by
Bipin Kothyari, who has over 15 years experience in pharmaceutical sales in
Canada. His previous roles have included Director, Clinical Liaison at Bristol
Myers Squibb and senior positions at GlaxoSmithKline (Vaccine Business Unit) and
at Dupont Pharma.
About PRA International
PRA International is one of the world's leading clinical development
organisations, with over 2,500 employees working from offices in North America,
Europe, South America, Africa, Australia and Asia. PRA delivers services to its
clients through a unique approach called Project AssuranceSM, which represents
the Company's commitment to reliable service delivery, program-level therapeutic
expertise, easy, global access to knowledge and involved senior management.
www.prainternational.com
This information is provided by RNS
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