MELBOURNE, Australia—Cytopia Ltd. recently announced the signing of a global license and research and development collaboration with Novartis to develop orally active, small-molecule therapeutics targeting the JAK3 kinase for the prevention of transplant rejection and the treatment of autoimmune diseases such as rheumatoid arthritis.
According to Dr. Kevin Healey, Cytopia's managing director and CEO, this is the first time Novartis has entered into a collaboration with an Australian biotechnology company. And with approximately $9.5 million over three years including an up-front payment and research funding—and development, regulatory and sales milestones that could total approximately $205 million—it is also reportedly the largest licensing agreement ever secured by any Australian biotech. Cytopia also stands to share in royalties on product sales.
"This deal is an important recognition of Cytopia's internationally leading position in the development of kinase inhibitors, particularly for the JAK family of kinases that are the immune system," Healey says.
The companies will jointly provide expertise and intellectual property related to JAK3 inhibitors in order to bring potential compounds through preclinical testing and into clinical trials. Novartis will assume responsibility for product development and commercialization, and Cytopia has retained co-promotion rights for Australia and New Zealand.
Current therapies for transplant rejection and for autoimmune diseases like rheumatoid arthritis often affect cells outside of the immune system and thus can cause severe side effects, notes Cytopia, which has focused its work on the discovery and development of new drugs to treat cancer, immune disorders and cardiovascular diseases. JAK3 only occurs in cells of the immune system, so Cytopia and Novartis are banking on the hypothesis that JAK3-specific drugs will offer a novel approach to treating these disorders while also reducing potential side effects.
The current market for drugs to prevent transplant rejection is approximately $3 billion, Healy notes, and the transplant market is expected to grow from a current level of 440,000 per year to 700,000 per year by 2010, making this line of drug discovery a very timely and potentially profitable one. As for the autoimmune applications for JAK3 inhibitors, Healy notes that the market for rheumatoid arthritis alone is forecast to grow to $15 billion by 2009. Current drugs for rheumatoid arthritis, he notes, focus on treating pain, slowing the disease's progression or "mopping up" immune stimulators. Healy says JAK3 inhibitors may provide a means to intervene earlier and provide more effective treatment.
JAK3 inhibitors also could be useful for other autoimmune disorders, such as inflammatory bowel disease, psoriasis, atopic diseases and multiple sclerosis, Cytopia notes.