AZ pursues targeted cancer therapy
LONDON—Turning toward the new land of the rising sun for a novel cancer drug discovered and developed in China, AstraZeneca PLC has agreed to pay $20 million in cash to Hutchison MediPharma Ltd. (HMP), an R&D company owned by Chi-Med, for the co-development and commercialization of Volitinib (HMPL-504), a highly selective inhibitor of the c-Met receptor tyrosine kinase.
The terms of the global licensing agreement stipulate that development costs for Volitinib in China will be shared between HMP and AstraZeneca, with HMP continuing to lead the development in China. AstraZeneca will then lead and pay for the development of Volitinib in the rest of the world.
HMP will also receive up to $120 million contingent upon the successful achievement of clinical development and first sale milestones. The agreement also contains possible significant future commercial sale milestones and up to double-digit percentage royalties on net sales.
Volitinib is a potent and highly selective c-Met inhibitor that inhibits the growth of tumors in a series of preclinical disease models, especially for those tumors with aberrant c-Met signaling such as gene amplification or c-Met overexpression. In addition, these biomarkers provide the potential to explore patient selection strategies in late-stage clinical trials.
"Volitinib represents a highly attractive global opportunity for AstraZeneca as we seek to develop and commercialize novel, targeted cancer therapies," Susan Galbraith, head of Oncology Innovative Medicines at AstraZeneca, stated in a Dec. 22 news release. "This collaboration with HMP represents our commitment to China and brings together two groups with highly complementary capabilities."
Volitinib is primed to enter Phase I testing for specific cancers, says AstraZeneca. If successful, worldwide sales of this landmark deal are expected to be huge.
"We intend to initially focus development on diseases with high prevalence in Asia, including gastric cancer and non-small cell lung cancer," Laura Woodin, an AstraZeneca spokesperson, tells ddn. "There is potential to explore patient selection strategy in later-stage clinical trials."
Woodin says the global deal "represents the first time a major pharmaceutical company directly licensed a clinical-stage compound from a biotech company in China, with plans to develop and commercialize it in the rest of the world."
The agreement came about following initial informal discussions between Xiaolin Zhang, head of AstraZeneca's Innovation Center China (ICC) in Shanghai, and his contacts at Hutchison MediPharma, which is located close to the ICC on the Zhangjiang Hi-Tech Park campus, Woodin says.
The c-Met signaling pathway is an important target for cancer research, she adds.
"Although there are a number of c-Met inhibitors in development, Volitinib appears to be among the most potent and selective," Woodin says. "We intend to explore whether this will translate into true differentiation in the clinic, though it is too early to say how it will be used in a patient's cancer regimen."
Christian Hogg, CEO of Chi-Med, says, "We are very much looking forward to collaborating with AstraZeneca around Volitinib. Our collaboration will support the development and commercialization of this novel oncology innovation, discovered in China, to the global market on an accelerated basis, something we could not have done alone."
The lucrative deal seeks to bolster AstraZeneca's pipeline, which has been hit by generic drug competition and pricing pressure. In fact, this current agreement comes on the heels of decisions made not to progress AstraZeneca's investigational compound olaparib into Phase III development for the maintenance treatment of serous ovarian cancer. That decision followed a review of an interim analysis of a Phase II study that indicated the previously reported progression-free survival benefit is unlikely to translate into an overall survival benefit.
The company also canceled the second RENAISSANCE Phase III study of TC-5214 for patients with major depressive disorder because it did not meet its primary endpoint. AstraZeneca, however, will continue with the development of the two remaining fixed-dose Phase III RENAISSANCE efficacy and tolerability studies and one long-term safety study.
AstraZeneca is the largest multinational pharmaceutical company in the prescription market in China. The company employs approximately 5,000 staff working in manufacturing, sales and marketing, clinical research and new product development at the company's headquarters in Shanghai and across sites in mainland China and Hong Kong.
AstraZeneca acquires Chinese generics company
CONGHUA CITY, China—AstraZeneca PLC also recently announced its acquisition of Guangdong BeiKang Pharmaceutical Co. Ltd., a privately owned generics manufacturing company based here.
AstraZeneca says the deal will give the pharma access to a portfolio of injectable medicines used to treat infections, which it will make available to patients in China. Following completion of the acquisition, AstraZeneca will be responsible for the manufacture and commercialization of these medicines.
The acquisition is contingent on the approval of certain regulatory authorities, including the approval of the Ministry of Commerce in China. The transaction is expected to close in the first quarter of 2012. Financial terms were not disclosed.
Since first establishing a presence in China in 1993, AstraZeneca has invested around $500 million in China and has become one of the leading biopharmaceutical companies in the country, with a turnover of more than $1 billion in 2010.