2014年11月14日讯 /生物谷BIOON/ --俗话说"酒香不怕巷子深"，这句话用在当今的生物医药产业可以说是再合适不过了。
在Geron公司开发的抗癌新药伊美司他获得FDA批准进行进一步的临床研究后，制药巨头强生公司就宣布斥资约9亿3千5百万美元"入伙"这种新药开发进程。根据协议，强生公司将首先支付3千5百万美元的先期投资，并根据双方协议规定，视情况追加最高可达9亿美元的里程碑资金。这一消息也促涨了Geron公司的股价。伊美司他主要被用来治疗白血病，而强生公司强势加盟后，Geron公司计划进一步开展关于这种药物治疗骨髓纤维化和骨髓增生异常综合征的临床二期研究。预计这一工作将于2015年开始。
近年来，强生公司不再将目光局限于自己的研发部门，而与众多的中小型生物医药公司达成了众多的合作协议。除了Geron公司的伊美司他之外，公司还参与了Pharmacyclics公司治疗白血病新药ibrutinib的开发和Genmab 公司新药daratumumab的开发。这些协议也使得公司的开发实力得到进一步的发展。
对于Geron公司来说，强生公司此次对自己伸出橄榄枝也可谓是雪中送炭。在公司成立的20多年里，Geron公司始终没有找到自己的合适定位。直到2011年公司才最终决定将自身定位为干细胞技术公司并专注于癌症疗法的研究。然而在伊美司他之前，公司的一些研究频频受挫。此次与强生公司的合作，无疑在极大程度上增强了投资者的信心。
详细英文报道：
Days after finally getting the FDA's go-ahead to resume the stop-and-start development of its lead candidate, Geron ($GERN) has signed a deal to cut Johnson & Johnson ($JNJ) in on the process, putting the biotech in line for as much as $935 million if all goes according to plan.
The back-loaded agreement focuses on imetelstat, Geron's treatment for blood cancers, and J&J's Janssen unit is paying just $35 million up front to collaborate on the project and promising up to $900 million more if it comes through on undisclosed development, regulatory and commercial goals.
The news sent Geron's shares, battered by months of uncertainty surrounding imetelstat, up nearly 40% on Thursday evening.
With the two companies aligned, the plan now is to map out Phase II studies in myelofibrosis and myelodysplastic syndrome--imetelstat's principal indications--and begin enrollment in 2015, thereafter rolling into Phase III if the drug proves itself worthy. Separately, J&J and Geron are planning to launch an exploratory Phase II trial in acute myelogenous leukemia, pursuing late-stage studies in that indication if they can demonstrate a strong signal.
For Geron, the deal is hardly a golden ticket, and, with the companies agreeing to split R&D costs 50-50, the biotech will be using a fair bit of that new cash just to keep imetelstat moving. But, in J&J, the company has found a partner with a pedigree for making the best of such collaborations. J&J's external R&D team is responsible for wooing Pharmacyclics ($PCYC) and getting its blood cancer treatment ibrutinib all the way to FDA approval. And analysts have hailed similar promise for daratumumab, a multiple myeloma treatment J&J licensed fromGenmab for up to $1.1 billion, and ARN-509, the prostate cancer-fighting star of the company's $1 billion deal for Aragon Pharmaceuticals.
"By leveraging Janssen's ability to fully integrate and strategically align global oncology development and commercialization, we expect this collaboration to expand the development of imetelstat across a range of hematologic malignancies and potentially increase the speed with which imetelstat can be made available to patients with these serious, life-threatening diseases," Geron CEO John Scarlett said in a statement.
The deal is a welcome turn for Geron and its shareholders, who have endured an up-and-down year on Wall Street as imetelstat has been plagued by safety issues that spurred FDA holds on two midstage trials. The agency backed off of a Mayo Clinic-sponsored study in June and finally cleared Geron's in-house trial last week.
After more than 20 years in drug development, Geron has never found its way to the finish line in R&D. The company backed away from its ambitions in stem cells in 2011 and rebranded itself as a cancer-focused outfit, but a slew of clinical setbacks has reduced its pipeline to imetelstat alone and pared down that drug's potential indications in the process.