mayne pharma and pliva finalise agreement

ASX and Media release
28 July 2006
Mayne Pharma and PLIVA Finalise Agreement to Continue Development of Biosimilar G-CSF
Mayne Pharma (ASX: MYP) today announces that it has finalised an agreement with PLIVA (LSE: PLVD), a leading international generic and specialty pharmaceutical company, for the continued development of biosimilar granulocyte-colony stimulating factor (G-CSF) for the European, South East Asian, Middle Eastern and Asia Pacific markets. G-CSF is an haematopoietic growth factor used for the treatment of the side-effects associated with chemotherapy.
This agreement is an amendment of a collaboration originally signed with PLIVA in February 2005 involving G-CSF and Erythropoietin (EPO). Following the previously announced termination of the EPO part of the collaboration, this agreement secures the continuing development of G-CSF and reflects the significant progress of the product through development. G-CSF continues to meet the product development milestones for comparability to Neupogen® set by Mayne Pharma and PLIVA. In addition, the pharmaceutical industry is increasingly moving in favour of the use of biosimilar products. The European Medicines Agency (EMEA) has finalised the guidelines for demonstrating biosimilarity to reference products and has approved Europe’s first two biosimilar products, both of which are human growth hormones.
Mayne Pharma is conducting and funding all clinical development of the product and will be responsible for regulatory filings in the territories in which it will market the product. PLIVA is completing compound development and will be responsible for manufacturing the commercial product. G-CSF builds upon Mayne Pharma’s strategy to expand into the specialty pharmaceuticals arena by developing products with high barriers to entry and it also expands its clinical trials capabilities.
Contact Details:
Media Contact Investor Contact
Dr Jihad Manai Andrew Rowe
Executive Senior Vice President Vice President Investor Relations
Corporate Communications & Public Affairs
Ph: +44 (0) 207 7420 8408 Ph: +44 (0) 20 7420 8426
Mobile: +44 (0) 7920 454 228 Mobile: +44 (0) 7920 598 353
About G-CSF
G-CSF (granulocyte-colony stimulating factor) is the active ingredient in Amgen’s Neupogen® (filgrastim) primarily indicated for the regulation of white blood cell production in the treatment of cancer patients with chemotherapy induced neutropenia. According to IMS, 2005 sales of G-CSF reached €500M in the EU and €48M in Australia and New Zealand.
About Mayne Pharma
Mayne Pharma Limited is a specialty pharmaceutical company focused on developing, manufacturing and selling a comprehensive range of products to oncology customers in more than 65 countries around the world. The company seeks to augment its growth by accessing additional marketed or development-stage products either through acquisition or partnership. Mayne Pharma generated sales of more than $US 500 million in its financial year ended 30 June 2005 and is listed on the Australian Stock Exchange under the symbol 'MYP'. For more information about Mayne Pharma, please visit www.maynepharma.com.