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赛诺菲糖尿病实验新药Toujeo接替来得时 发布日期：2014-06-22 来源：新药汇
根据6月14日美国糖尿病协会（ADA）2014学术会议上公布的大型临床试验结果，糖尿病患者有望从两只实验性胰岛素药物中受益，这两只药物最终可能会取代赛诺菲生产的在全球领先的胰岛素来得时（Lantus）。来得时是世界上最常用的处方胰岛素。
全天控制血糖水平
赛诺菲开发的实验性新药Toujeo被定位于接替来得时，后者的年销售额接近80亿美元，该药将在明年年初失去专利保护。礼来则在加快步伐，欲销售来得时仿制药，行业分析人士表示，到2020年，这只仿制药可能会创造高达6亿美元的年销售额。
这两只治疗药物都是基础胰岛素，它们可帮助糖尿病患者在两餐之间和全天控制血糖水平。
针对Toujeo所做的后期研究表明，与使用来得时相比，2型糖尿病患者使用该药之后，在夜间血糖水平下降到潜在危险性地步的可能性要降低31%。
低血糖会让患者晕倒或失去知觉。这种不良事件是胰岛素所引起的最可怕的副作用。
帮助领导其中一项研究的意大利佩鲁贾大学教授格雷米亚・波利（Geremia Bolli）表示，低血糖事件（尤其是在夜间发生）是一个大问题，因为它们让人恐惧，是使用胰岛素的一个障碍。波利在美国糖尿病协会于旧金山举行的会议上介绍了他的研究结果。
等待欧洲获批
波利表示，Toujeo与被称为甘精胰岛素的来得时具有相同的活性成分，但它的活性成分含量要高出3倍多。它的活动水平不会在夜间跃升，这与来得时的情况是一样的。
有关低血糖的数据来自于对赛诺菲发起的3项Ⅲ期研究所做的一项联合评审。研究还显示，在控制总体血糖方面，Toujeo和来得时同样有效，这是赛诺菲最近向美国监管机构提交Toujeo上市申请的基础。
这只新药也在欧洲等待批准。
在第4项涉及1型糖尿病患者的后期研究中，低血糖的发生率和总体血糖控制水平对Toujeo和来得时来说都是相似的。1型糖尿病是一种较为少见的遗传性疾病。
虽然赛诺菲针对其摇钱树来得时开发出了接替产品，但是，礼来开发的一只潜在性竞争产品在治疗1型和2型糖尿病患者方面与来得时一样有效和安全，这其中包括低血糖的发生率也是相似的。
礼来这只药物与来得时具有相同的分子式，针对该药所获得的研究结果基于礼来及其合作伙伴勃林格殷格翰所发起的6项研究。
礼来开发基础胰岛素
帮助领导这项研究的德克萨斯奥斯汀大学糖尿病与内分泌学的汤姆・布莱文斯（Tom Blevins）表示，针对这只甘精胰岛素新产品所开展的完整的临床试验显示，它在患者体内以类似的方式发挥治疗作用，并且产生了与来得时相类似的临床结果。
华尔街预测，这只名为LY2963016的仿制药价格将大大低于来得时，目的是为了在来得时失去专利保护之后，吸引糖尿病患者。
虽然这只仿制药正在美国、欧洲和日本等待审批，但由于礼来与赛诺菲之间发生的专利纠纷悬而未决，该仿制药在美国市场推出的时间可能会被推迟到2016年中期。
礼来表示，该药在美国将不会被认定为生物类似药，美国还没有通过立法，对此类药物的仿制产品进行监管。相反，礼来的这只产品将作为品牌药进行销售。
礼来还在开发它自己的新的基础胰岛素peglispro。在今年年初公布的临床试验结果中，该药在让2型糖尿病患者降低血糖水平方面要比来得时更加有效。它引发的夜间低血糖事件也要少得多。
礼来预计将在明年年初寻求该药在美国和欧洲获得批准。但是，使用peglispro的患者肝酶会严重升高，这是潜在性肝中毒的一个迹象，而这可能会让Toujeo具有一定的优势。
New rivals to top diabetes drug Lantus show promise in studies
By Ransdell Pierson June 14 (Reuters) - Diabetes patients stand to benefit from two experimental insulin therapies that could eventually replac Sanofi's global leader Lantus, according to results from large clinical trials released on Saturday. Sanofi's experimental new drug Toujeo is being positioned to succeed Lantus, whose annual sales approach $8 billion, when it loses patent protection early next year. Eli Lilly and Co is gearing up to sell a copycat version of Lantus, which industry analysts say could bring in up to $600 million a year by 2020. Both treatments are basal insulins, which help diabetics keep blood sugar levels under control between meals and throughout the day. Late-stage studies of Toujeo showed that patients with type 2 diabetes were 31 percent less likely at nighttime to have potentially dangerous declines in blood sugar than those taking Lantus, the world's most prescribed insulin, researchers said on Saturday. Such episodes of hypoglycemia, in which patients can faint or lose consciousness, are the most feared side effect of insulins. "Low blood sugar events, especially at night, are a big deal because they are frightening and are a barrier to use of insulin," Dr. Geremia Bolli, a professor at the University of Perugia, Italy, who helped lead one of the studies, said in a telephone interview. He presented his findings at the American Diabetes Association meeting in San Francisco. More than 370 million people worldwide have diabetes, with up to 95 percent of them having type 2, a condition often triggered by obesity, according to the International Diabetes Federation. The disease raises the risk of numerous serious health problems. Toujeo has the same active ingredient as Lantus, called insulin glargine, but in a three-fold higher concentration, Bolli said. Its activity level does not jump overnight, as is the case with Lantus. The hypoglycemia data came from a combined review of three Phase III studies sponsored by Sanofi. The studies also showed that Toujeo and Lantus were similarly effective in controlling overall blood sugar and are the basis for Sanofi's recently filed U.S. marketing application for Toujeo. The new drug is also awaiting approval in Europe. In a fourth late-stage study involving patients with type 1 diabetes - the less common, inherited form of the disease - rates of hypoglycemia and overall blood sugar control were similar for Toujeo and Lantus. LILLY'S LANTUS COPYCAT While France's Sanofi develops the successor to its cash cow, a potential rival from U.S. drugmaker Eli Lilly proved just as effective and safe as Lantus for patients with type 1 and type 2 diabetes, including similar incidence of hypoglycemia. Results for the Lilly drug, which has the same molecular formula as Lantus, were based on six studies sponsored by Lilly and its partner Boehringer Ingelheim. "Completed clinical trials for this new insulin glargine product show that it works similarly in the body and produces clinical results similar to Lantus," said Dr. Tom Blevins of Texas Diabetes & Endocrinology in Austin, Texas, who helped lead the research. Wall Street is expecting the copycat, called LY2963016, to be priced significantly lower than Lantus, in order to attract patients once Lantus loses patent protection. Although awaiting approval in the United States, Europe and Japan, its U.S. launch could be delayed until mid-2016 by an ongoing patent dispute with Sanofi. Lilly said the drug will not be designated a biosimilar, or biotech generic, in the United States, which does not yet have legislation regulating copycats of such drugs. Instead, it will be marketed as a branded medicine. Lilly is also developing its own new basal insulin, called peglispro, which in clinical trial results released earlier this year, proved more effective than Lantus in reducing blood sugar levels for patients with type 2 diabetes. It also caused significantly fewer episodes of overnight hypoglycemia. Lilly expects to seek U.S. and European approvals early next year for the drug. But patients taking peglispro had seriously elevated liver enzymes, a sign of potential liver toxicity, which could give Toujeo an advantage. (Aadditional reporting by Bill Berkrot in New York and Natalie Huet in Paris; Editing by Michele Gershberg, Bernard Orr)
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