CSL

CSL Biotherapies manufactures and markets vaccines and pharmaceutical products in Australia and New Zealand and is responsible for global sales of our influenza vaccines. In-licensed pharmaceutical products include vaccines and a range of neurological, cardio-thoracic, dermatological, analgesic, urological, allergy and emergency products.

Our sales revenue reached $502 million this year (up 5%) with a strong contribution from GARDASIL* vaccine, continuing expansion of our global influenza vaccine business, and a solid performance by in-licensed pharmaceuticals.

The success of the human papillomavirus (HPV) national immunisation program has continued with more than five million doses of GARDASIL* distributed and more than 70% of females aged 12 to 26 now vaccinated. The Australian Government has announced an extension of the program until December 2009 to enable females who have commenced the three-dose vaccination schedule to complete their courses. During the year, the Therapeutic Goods Administration (TGA) approved extending the indications for use of GARDASIL* to include all females aged 9 to 45 years. In New Zealand, an HPV national immunisation program with GARDASIL* has commenced with the launch of a two-year catch-up program offering free vaccination to females up to 18 years of age.

Merck & Co. Inc. is our exclusive licensee for the GARDASIL* vaccine with global marketing rights. CSL has distribution rights for Australia and New Zealand and receives royalties from global sales.

Following the successful rollout of the HPV program in Australia by the Commonwealth Government, sales of GARDASIL* are expected to substantially decline as the catch-up immunisation programs draw to a close.

International markets for CSL’s Afluria® and Enzira® brands of seasonal influenza vaccine continue to expand with a 60% increase in global sales achieved this year. The recently completed dispensing and packaging facilities at our Kankakee site will further enhance our influenza vaccine manufacturing capabilities and assist in meeting anticipated growth in US demand. CSL has submitted a Biologics License Application (BLA) supplement for this new plant to the US FDA.

The new Q-Vax® manufacturing facility at CSL’s Broadmeadows site in Melbourne was officially opened on 1 July 2009, following approval by the TGA. CSL manufactures the Q-Vax® vaccine against Q-Fever as part of an ongoing commitment to products of national significance. Q-Fever is primarily an occupational disease of people working in Australia’s meat and livestock industry.

_{*GARDASIL is a trademark of Merck & Co. Inc.}