CSL, Merck strengthen bid to be first to market with HPV vaccine

By Renate Krelle
Thursday, 03 February, 2005

Australia's CSL (ASX:CSL) and California's Medimmune both won a milestone and royalty bonus today when their collaborators, developers of two competing vaccines for HPV (human papillomavirus) vaccines, announced they would cross-licence patents on which both vaccines were based.

There are more than 100 types of HPV virus, which are sexually transmitted. HPV 16 and 18 are linked to the majority of cervical cancers. CSL has been developing the HPV vaccine since 1991, when it licensed technology from Prof Ian Frazer at the University of Queensland which identified the virus' L-1 coat protein of HPV as a prospective target for a vaccine. The main claim granted to CSL under the patent was to the sequence of the surface protein of the HPV 16 serotype necessary for the formation of virus-like particles.

In 1995, CSL gave Merck & Co an exclusive licence to commercialise the technology, in return for a royalty on all overseas sales, and the right to market the vaccine itself in Australia and New Zealand. The financial terms between CSL and Merck & Co apparently remain unchanged by today's settlement.

MedImmune had licensed its HPV vaccine patents to Glaxo in 1997, and the companies developed a vaccine jointly. It is currently in Phase III trials.

The Merck-CSL vaccine, to be marketed as Gardisil, is also in Phase III clinical trials, and Merck & Co expects to apply for US regulatory approval for the vaccine to prevent HPV and cervical cancer in the second half of 2005.

Further details of settlement remain confidential. CSL is to receive both a one-off milestone payment and royalties when the product goes on sale. The royalties from Merck & Co, are subject to the outcome of US patent proceedings.

The settlement does, however, clear the way for both companies to go ahead with the launches of their vaccines, and CSL is confident that it will be first to market.

A spokeswoman for CSL also said that the resolution of the dispute would mean an additional period of patent protection, extending beyond the current patent life of 2012.

When it is launched, the vaccine will be marketed to women in the US and Europe aged between 9 and 24. Merck & Co will also be conducting ongoing studies with a view to extending vaccination to women aged between 25 and 50.

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