2014年11月15日讯 /生物谷BIOON/ --随着世界各国生活水平的提高和老龄化比例的增大，糖尿病这种"富贵病"也已经成为各国政府健康部门的心头大患。而各大生物医药厂商也纷纷各显神通，试图进入这一领域分一杯羹。其中不仅包括诺和诺德等老牌胰岛素生产巨头，一些医疗器械生产商也正在磨刀霍霍。
不久前波士顿的生物技术公司Intarcia公司开发的用于体内注射降血糖药物的医疗器械ITCA 650临床三期研究获得圆满成功，这也引来法国的Servier公司的关注。最近Servier公司表示将支付10亿美元的资金以支持Intarcia公司这一产品的发展。而作为回报，公司将获得这种产品在美国海外市场和日本市场的销售权。
而Intarcia公司开发的这款产品是一种可移植设备，其上有一个微型泵，能够智能控制，定时向患者血液中泵入固定剂量的降血糖药物艾塞那肽。而最令人兴奋的一点是，这一体内移植器械的工作周期可长达一年之久。这大大减轻了糖尿病患者的负担。Intarcia公司透露，公司开发的这种药物/器械疗法开辟了糖尿病治疗的新思路，此前一些制药巨头如赛诺菲等都纷纷对此表示出浓厚的兴趣。
不过，Intarcia公司如果想将ITCA 650成功上市，其挑战或许才刚刚开始。下一步公司将进行与默沙东DPP-4糖尿病药物Januvia的对比试验。而此前的两项临床研究显示，ITCA 650成功将25％的患者血糖浓度由治疗前的10％降至7％以下。而对于此次Servier与Intarcia关于ITCA 650的合作，Intarcia公司也表现出强烈的信心。
详细英文报道：
Just a few weeks after claiming success with a pair of late-stage studies of its prolonged dosing approach to diabetes, Boston-based Intarcia has followed up with a billion dollar-plus sized commercialization deal for ex-U.S. and Japan commercial rights with France's Servier.
Drawn by Intarcia's potentially disruptive approach--implanting a miniature pump to provide even dosing of a newly formulated version of exenatide to control blood sugar levels for up to a year--Servier is handing over a hefty $171 million upfront payment while promising three "early stage" regulatory milestones worth $230 million and up to $650 million in accumulated development and sales milestones.
Back with a whopping $200 million in fresh investor backing last spring, Intarcia has been able to go it alone until now in a field dominated by giants with very deep pockets. The cost of late-stage development in a field where regulators demand big patient populations and detailed safety data for any therapy targeted at a patient population counted in the millions has made this a tough area for small biotechs to play in.
Intarcia execs told FierceBiotech earlier that a range of diabetes companies have been interested in licensing this technology, but notably none of the dominant companies like Sanofi ($SNY), Novo Nordisk ($NVO), Merck ($MRK) or Eli Lilly ($LLY) bought in to Intarcia's technology. And this is a very competitive field when it comes to new approaches to treating diabetes.
The biotech has been betting that a new drug/device combo like this could provide something a large number of diabetics can't provide for themselves: a consistently lower blood sugar level without any threatening gyrations. Consistent self-dosing has remained an elusive goal for many, potentially offering a GLP-1 device/drug like this a major opportunity.
Intarcia's biggest challenge lies ahead. The company is engaged in a head-to-head study with Merck's DPP-4 drug Januvia. In two other Phase III trials investigators said ITCA 650 beat out a placebo in lowering blood sugar levels and also pushed 25% of patients with blood glucose levels over 10% under the all-important 7% threshold.
Intarcia, meanwhile, says it couldn't be happier with its partner. And it insists that in this case, smaller is better.
"We are already the highest valued private biotech company in history with world-class investors, and now we are firmly set up to retain full control of the U.S. operations as we continue on our path to build a fully capable and disruptively innovative biotech company with a pipeline of game changing, once-yearly medicines," boasted Intarcia CEO Kurt Graves in a statement. "We are very pleased to partner with Servier, who shares our passion and vision for ITCA 650, and the goal of leveraging our technologies to open up a totally new way of delivering important GLP-1 therapy to patients with type 2 diabetes. Truly disruptive technologies and products tend to come from smaller, faster, more flexible, and more innovative companies not tied to the business models of the largest pharmaceutical firms. Servier brings a unique combination of financial strength, deep diabetes expertise with no competitive conflicts, and a track record of innovation and excellent performance in the EU and emerging markets. We placed high value on those factors and their partnering mindset when we made our final decision to select Servier over other major diabetes firms competing for months to be our partner."