A researcher's journey
The licensing route
In some cases, it may make the most sense to license IP to a commercial partner to develop and take to market. This is often the case when the innovation itself is not a complete product and needs to be integrated with other technology, or when the IP would need major, long term, high-risk investment. An example is Professor David Currow, who licensed a treatment for breathlessness to Mayne Pharma.
Professor David Currow, research leader in the Discipline of Palliative and Supportive Services has spent his entire career as a researcher, clinician, educator and policymaker, focused on patients at the end of life and with life-limiting illness. As part of his commitment, David’s research group has demonstrated the benefit of slow-release morphine in Phase II clinical trials of patients with chronic breathlessness. Three hundred thousand (300,000) Australians have breathlessness, at rest or on minimal exertion, 70,000 of whom are so breathless they cannot leave their home.
David approached Mayne Pharma, an Australian pharmaceutical manufacturer and global distributor of Kapanol, a slow-release morphine product. He proposed the idea of partnering to expand the approval of Kapanol as a treatment for chronic pain, to include low-doses as a treatment for breathlessness.
Mayne conducted some initial due diligence on the market, the regulatory pathway and the manufacturing challenges of producing a capsule with a lower dose of Kapanol. Following its successful completion they expressed their interest in negotiating a licence for the IP.
Negotiations between the parties took several months. A key consideration for Flinders Partners was making sure that David’s interests were identified and protected in the Licence Agreement. In addition to the common concern of researchers, that of balancing the rights to publish quickly versus patenting, David’s main goal in partnering with Mayne was that he, as a clinician, would be able to write a prescription for Kapanol, in Australia, for a patient suffering from chronic breathlessness.
Mayne’s key concerns revolved around being able to have input into the clinical trials to ensure the outcomes of the trials met the standards of key regulatory bodies such as the TGA, FDA and EMEA. They also wanted to ensure that we maximized the development of patentable IP, which we knew was key to maximizing the global value of the project.
The Licence Agreement took around 10 months to negotiate. Flinders Partners started the process with a Term Sheet, which allowed us to agree the key terms prior to getting down to the nitty gritty of clauses in the full agreement. During this time Flinders Partners built great working relationships with Mayne which we knew would be fundamental in moving the project forward after execution of the Agreement.
In November 2014, Flinders Partners granted Mayne an exclusive worldwide licence to past, present and key, future clinical studies, conducted by Flinders University on the treatment of breathlessness. In consideration for the licence, Flinders Partners is entitled to a combination of milestone payments and royalties on sale of the product.
Flinders University and Mayne are now working collaboratively on Phase III clinical studies. These studies will support regulatory filings in key global markets.
Once the drug is approved for use, Flinders Partners hope that it will be life changing for many people, significantly increasing their quality of life.