AstraZeneca (NYSE: AZN) and Hutchison China MediTech Limited (NASDAQ: HCM), also known as Chi-Med, have announced the amending of a 2011 global licensing and commercialization agreement regarding savolitinib in order to increase its global development. In addition to increasing the global development, Chi-Med will be able to have more involvement in the project. With this in mind, savolitinib’s worldwide expansion will help with a number of Met-driven tumors, such as specific types of lung cancer, colorectal, gastric and kidney cancers. With the phase II open-label global PRCC results from savolitinib recently finished and being presented at a scientific meeting, Chi-Med and AstraZeneca have decided to go forward with phase III clinical testing.
Phase III of savolitinib is the first key research done in c-Met-driven PRCC, a unique subtype of renal cell carcinoma (RCC) that coincides with changes in the c-Met gene. Currently available RCC treatments have only shown small benefits in PRCC, and there are currently no solutions specifically tailored to the treatment of c-Met-driven PRCC. Phase III trials have not yet been designed in full. Plans will be determined after prolonged conversations with the health authorities. The trial will start once the diagnostic for c-Met-driven PRCC is available.
Christian Hogg, chief executive officer of Chi-Med, had this to say: “Bringing savolitinib to a global launch in multiple areas of unmet medical need is our very clear focus. We believe that savolitinib has the potential to become the first approved therapy for kidney cancer in a molecularly selected patient population, as well as in multiple c-Met-driven lung and gastrointestinal tract cancers. As we enter a period where pivotal trials in multiple indications are close at hand, we are now happy to take on a small minority of the investment in order to help accelerate development while increasing our share in the long-term economic value of savolitinib.”
As part of Chi-Med’s increased participation in the program, the company will contribute up to $50 million to the joint development costs over the space of three years. This will line up with the development costs of the phase III research for c-Met-driven PRCC. Consequently, Chi-Med will benefit from a five percent increase in the tiered royalty rate of savolitinib on a global scale, not including China. Other factors of the 2011 agreement have not yet been determined and have therefore not been changed.
In addition to the above, AstraZeneca is developing a phase II expansion of the TATTON trial. This will allow the company to expand the development of savolitinib in other cancers.
Susan Galbraith, Senior Vice President, Head of Oncology, Innovative Medicines and Early Development at AstraZeneca, commented: “The accelerated development of savolitinib in RCC and NSCLC reflects our ongoing commitment to deliver world-class medicines to patients with limited treatment options. We are pleased to be building on our established collaboration with Chi-Med, as this reinforces our enterprise leadership approach to drug development.”
About NetworkNewsWire
NetworkNewsWire (NNW) provides news aggregation and syndication, enhanced press release services and a full array of social communication solutions. As a multifaceted financial news and distribution company with an extensive team of journalists and writers, NNW is uniquely positioned to best serve private and public companies who need to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing network of more than 5,000 key distribution outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge. For more information, visit www.networknewswire.com.
Please see full disclaimers on the NetworkNewsWire website: http://nnw.fm/Disclaimer
