The terms of the global licensing agreement stipulate thatdevelopment costs for Volitinib in China will be shared between HMP andAstraZeneca, with HMP continuing to lead the development in China. AstraZenecawill then lead and pay for the development of Volitinib in the rest of theworld.
HMP will also receive up to $120 million contingent upon thesuccessful achievement of clinical development and first sale milestones. Theagreement also contains possible significant future commercial sale milestonesand up to double-digit percentage royalties on net sales.
Volitinib is a potent and highly selective c-Met inhibitorthat inhibits the growth of tumors in a series of preclinical disease models,especially for those tumors with aberrant c-Met signaling such as geneamplification or c-Met overexpression. In addition, these biomarkers providethe potential to explore patient selection strategies in late-stage clinicaltrials.
"Volitinib represents a highly attractive global opportunityfor AstraZeneca as we seek to develop and commercialize novel, targeted cancertherapies," Susan Galbraith, head of Oncology Innovative Medicines atAstraZeneca, stated in a Dec. 22 news release. "This collaboration with HMPrepresents our commitment to China and brings together two groups with highlycomplementary capabilities."
Volitinib is primed to enter Phase I testing for specificcancers, says AstraZeneca. If successful, worldwide sales of this landmark dealare expected to be huge.
"We intend to initially focus development on diseases withhigh prevalence in Asia, including gastric cancer and non-small cell lungcancer," Laura Woodin, an AstraZeneca spokesperson, tells ddn. "There is potential to explore patient selection strategy inlater-stage clinical trials."
Woodin says the global deal "represents the first time amajor pharmaceutical company directly licensed a clinical-stage compound from abiotech company in China, with plans to develop and commercialize it in therest of the world."
The agreement came about following initial informaldiscussions between Xiaolin Zhang, head of AstraZeneca's Innovation CenterChina (ICC) in Shanghai, and his contacts at Hutchison MediPharma, which islocated close to the ICC on the Zhangjiang Hi-Tech Park campus, Woodin says.
The c-Met signaling pathway is an important target forcancer research, she adds.
"Although there are a number of c-Met inhibitors indevelopment, Volitinib appears to be among the most potent and selective,"Woodin says. "We intend to explore whether this will translate into truedifferentiation in the clinic, though it is too early to say how it will beused in a patient's cancer regimen."
Christian Hogg, CEO of Chi-Med, says, "We are very muchlooking forward to collaborating with AstraZeneca around Volitinib. Ourcollaboration will support the development and commercialization of this noveloncology innovation, discovered in China, to the global market on anaccelerated 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 progressAstraZeneca's investigational compound olaparib into Phase III development forthe maintenance treatment of serous ovarian cancer. That decision followed areview of an interim analysis of a Phase II study that indicated the previouslyreported progression-free survival benefit is unlikely to translate into anoverall survival benefit.
The company also canceled the second RENAISSANCE Phase IIIstudy of TC-5214 for patients with major depressive disorder because it did notmeet its primary endpoint. AstraZeneca, however, will continue with the developmentof the two remaining fixed-dose Phase III RENAISSANCE efficacy and tolerabilitystudies and one long-term safety study.
AstraZeneca is the largest multinational pharmaceuticalcompany in the prescription market in China. The company employs approximately5,000 staff working in manufacturing, sales and marketing, clinical researchand new product development at the company's headquarters in Shanghai andacross sites in mainland China and Hong Kong.
AstraZeneca acquiresChinese generics company
CONGHUA CITY, China—AstraZeneca PLC also recently announcedits acquisition of Guangdong BeiKang Pharmaceutical Co. Ltd., a privately ownedgenerics manufacturing company based here.
AstraZeneca says the deal will give the pharma access to aportfolio of injectable medicines used to treat infections, which it will makeavailable to patients in China. Following completion of the acquisition,AstraZeneca will be responsible for the manufacture and commercialization of thesemedicines.
The acquisition is contingent on the approval of certainregulatory authorities, including the approval of the Ministry of Commerce inChina. 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 theleading biopharmaceutical companies in the country, with a turnover of morethan $1 billion in 2010.