Biotechnology Company Announces Licensing Deal

New Zealand biotechnology company Genesis Research and Development have announced that a licensing deal with a US pharmaceutical firm for distribution rights to the PVAC psoriasis treatment, which is jointly owned by Genesis and Corixa, has been completed.

Under the agreement, Medicis Pharmaceutical will pay license and additional fees to Corixa upon the completion of development and commercialisation milestones for exclusive rights to the treatment in the US and Canada. Genesis will receive its share of these payments.

Further payments will be based on PVAC's success in clinical trials and on achieving commercialisation milestones. Medicis will also pay Corixa a royalty on any future sales of PVAC. Genesis will receive its share of these payments.

Under its arrangement with Medicis, Genesis retains certain rights in its intellectual property and will derive income from future sales.

PVAC is currently undergoing Phase II trials, which are expected to be completed by the end of 2000. Sales of PVAC will be dependent on satisfactory completion of Phase III trials anticipated to begin in 2001, subsequent to US regulatory approvals.

Medicis focuses primarily on the treatment of dermatological conditions. This was a factor in selecting this marketing path for PVAC treatment, which is a psoriasis immunotherapeutic.

Psoriasis is estimated to affect 1 to 3% of the world's population. There are approximately seven million people in the US with psoriasis. Of these, an estimated 30% have a moderate to severe form of the disease.

The disease is characterised by chronic inflammatory lesions with red scaling plaques and is believed to be an autoimmune phenomenon mediated by T cells.

Genesis and Corixa have developed a potential immunotherapeutic product for psoriasis that is derivative of the bacterium Mycobacterium vaccae (M vaccae). The treatment is currently in Phase II clinical trials in the US, the Philippines and Brazil.

Approximately 20 moderate to severe psoriatic patients were treated in the initial Phase I/II clinical trial with two injections of PVAC administered three weeks apart. Of these, just over half of the patients had complete responses to the therapy for the 52-week duration of the trial, following the two injections given at day 0 and 21.

Corixa is currently conducting a 13-site trial involving 240 patients in the US. Patient enrolment into the randomised placebo-controlled trial is completed and Genesis expects the trial to be completed by the end of 2000.