Date: 17 May 2004
Lawrence plc
EMEA - Further Information on Aivlosin Approval
The European Agency for the Evaluation of Medicinal Products (EMEA) has, as
anticipated in Lawrence's announcement of earlier today, now given further
details regarding its recommendation to grant a marketing authorisation for
Aivlosin. Aivlosin is a medication from ECO Animal Health Limited ("ECO"), a
subsidiary of Lawrence plc. The full text of the statement released today by
the EMEA on its website (www.emea.eu.int) is set out below:
"COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS
SUMMARY OF OPINION*
AIVLOSIN
Active substance: Acetylisovaleryltylosin
On 12 May 2004, the Committee for Veterinary Medicinal Products (CVMP) adopted a
positive opinion,** recommending to grant a marketing authorisation for the
veterinary medicinal product Aivlosin 42.5 mg/g premix for medicated feeding
stuff for pigs, intended for treatment and prevention of Swine Enzootic
Pneumonia caused by susceptible strains of Mycoplasma hyopneumaniae. The
Applicant for this veterinary medicinal product is ECO Animal Health.
The active substance of Aivlosin is acetylisovaleryltylosin, a macrolide
antibiotic that has antibacterial activity against Gram-positive and some Gram-
negative organisms and against mycoplasma. It acts by inhibiting protein
synthesis in the bacteria cell.
The benefits of Aivlosin are its efficacy in the treatment and prevention of
Swine Enzootic Pneumonia via the oral route. Although infection with Mycoplasma
hyopneumaniae is not eliminated, lung lesions and weight loss are reduced. No
side effects have been reported in pigs in the clinical trials. However, due to
its skin sensitising potential in laboratory animals the SPC includes a user
warning for people with known hypersensitivity to acetylisovaleryltylosin
tartrate.
The approved indication is "Treatment and prevention of Swine Enzootic Pneumonia
caused by susceptible strains of Mycoplasma hyopneumonia in pigs. At the
recommended dose, lung lesions and weight loss are reduced but infection with
Mycoplasma hyopneumonia is not eliminated".
Detailed conditions for the use of this product will be described in the Summary
of Product Characteristics (SPC) which will be published in the European Public
Assessment Report (EPAR) and will be available in all official European Union
languages after the marketing authorisation has been granted by the European
Commission.
The CVMP, on the basis of quality, safety and efficacy data submitted, considers
that there is a favourable benefit to risk balance for Aivlosin and therefore
recommends by majority the granting of the marketing authorisation.
* Summaries of opinion are published without prejudice to the Commission
Decision which will normally be issued within 90 days from adoption of the
Opinion.
** Applicants may appeal any CVMP opinion, provided they notify the EMEA in
writing of their intention to appeal within 15 days of receipt of the opinion.
------------------------------
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Commenting on the announcement by the EMEA, Peter Lawrence, Chairman of Lawrence
plc, said:
"This excellent, long awaited news confirms our confidence in Aivlosin. The
marketing recommendation has taken some years and reflects the very thorough and
detailed testing process carried out by the registration authorities. Further
recommendations and approvals will follow over the coming months and will
complement our extensive range of important animal health medications.
"Following the sale of Interpet in April, Lawrence is now much more
strategically focused on its animal health businesses. The global potential for
Aivlosin is substantial and we are confident that it will be a significant
driver of sales and profit growth for many years to come."
It is expected that the marketing authorisation will be tabled for granting at a
meeting of the European Commission towards the end of June. Following that
meeting, each of the 25 EU member countries is then required to issue its own
marketing authorisation within three months. The approval process is in line
with expectations as set out in Lawrence's statement of 1 April 2004.
Agreements for the sales and distribution of Aivlosin are under final
negotiation with multinational animal health companies operating throughout
Europe. Lawrence is confident these agreements will be in place in good time for
a coordinated product launch in the second half of the current financial year.
Having overcome this critical and major hurdle in the Aivlosin marketing
authorisation process, ECO is continuing to register Aivlosin for different
disease indications and animal species within Europe and other countries around
the world. This includes the USA, where the procedure through the Food and Drug
Administration is well under way.
ECO owns the Aivlosin patents and is the exclusive supplier of this
exceptionally effective and thoroughly tested veterinary medicine. We estimate
that the global market for drugs that treat respiratory and digestive diseases
in pigs and poultry exceeds $1.5 billion and is split fairly equally between
Europe, North America and the rest of the world.
Contacts:
Peter Lawrence
Chairman, Lawrence plc
020 8336 2900
Anthony Spiro
Spiro Financial
020 8949 0428
Emma Kane
RedLeaf Communications Ltd
020 7955 1410
Philip Davies
Charles Stanley & Co. Limited
020 7953 2000
Notes to Editors:
õ Lawrence plc is a leader in the development, manufacture and distribution
of principally specialist chemical and pharmaceutical products for the animal
health and farming markets worldwide. Our products for these growth markets
incorporate natural ingredients to promote well being and sustainability. We
achieve our financial goals through the careful and responsible application of
science to generate value for our shareholders.
õ Our corporate web site www.lawrenceplc.com includes our press releases
together with general information about the company and its subsidiaries. Each
subsidiary also has a web site, which gives further information about that
business and its products.
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