Regulatory Approval

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. ------------------------------ - 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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