【讨论】真的豪赌！！！施维雅十亿美元豪赌一年仅给药一次的降糖新药ITCA 650

这是一款刚刚发布完III期临床结果的降糖产品，名称为ITCA 650。您听到这儿已经有点不以为然了：三期的降糖药有啥稀奇的，光诺和诺德一家就有一大把，有啥好大惊小怪的？
但是该药物的最大特点是一年给药一次！只要是行业人士就会知道，这对于降糖药来说，卖点是足够足够大的！它使用了植入型微型给药泵技术，装载的药物属于GLP-1受体激动剂。
开发它的公司叫做Intarcia，总部位于美国。出售商业权益的条件很苛刻：除去美国市场和日本市场的销售许可授权，开价10亿美元。有人接手了！抛出10亿美元赌资的公司叫做Servier（施维雅），总部在法国。
据悉，施维雅将为三项里程碑结果的达成支付2.3亿美金的预付款，此外，持续开发以及销售里程碑的费用为6.5亿美金。
先说说施维雅，成立与1954年，至今尚未上市，是法国第二大制药公司，在140个国家拥有17000名员工。公司的核心治疗领域为心血管、代谢、中枢神经系统，2014年9月推出了第四大核心治疗领域——肿瘤。2013年销售额为42亿欧元。
2013年春，Intarcia获得了2亿美金的投资，这笔钱让这家公司有能力在糖尿病这个制药巨头林立的病种中拥有一些的底气，特别是在后期临床研究阶段，为了评价安全性，为了入组足够数量的患者，小生物技术公司通常难以承受数以百万计的研发投入。
在竞争激烈的糖尿病领域，押宝这样一款药物/器械组合产品必须要有难以被撼动的逻辑：Intarcia看上了那群生活不能自理的人，它希望能为他们提供持续稳定的血糖控制。
据公司高管介绍，此前赛诺菲、诺和诺德、默沙东或者礼来都曾考虑过引入这项糖尿病新型给药技术，不过，没人行动。
Intarcia并非没有竞争对手。目前，该公司开发的产品与默沙东的DPP-4药物Januvia针锋相对。三期临床试验显示：相较安慰剂组，ITCA 650具有显著的降血糖效果；此外，该药物可以使四分之一血糖水平高于10%的患者获得益处，即将其血糖水平降低到7%这一关键阈值之下。
“在世界级投资者的支持下，我们将使小型私营生物技术公司的价值发挥到最大，用不一样的给药方式赋予GLP-1药物新的竞争力，这将改变游戏规则！”Intarcia CEO Kurt Graves在声明中表示：“我们将充分掌握该产品在美国市场的命运，而财力充沛的Servier公司将在其擅长的欧洲市场和新型市场有所作为。
这些特质正是我们选择Servier而非其他糖尿病巨头的主要原因。”
“没有什么能比和施维雅合作更高兴的事情了，这就是‘小就是美’的魅力”。
Intarcia And Servier Sign Ex-U.S. Partnership For ITCA 650 In Diabetes; Intarcia Retains Independence & Full Control Of The U.S. & Japan
BOSTON, Nov. 11, 2014 /NEWS.GNOM.ES/ — Intarcia Therapeutics, Inc. today announced the successful start of a strategic partnership with Servier outside the United States and Japan, to develop and commercialize ITCA 650, Intarcia’s phase 3 investigational therapy for the treatment of type 2 diabetes. If successful in its remaining phase 3 trials, ITCA 650 would become the world’s first and only injection-free GLP-1 agonist given just once or twice yearly in a small, matchstick sized mini-pump placed sub-dermally. A qualified physician, nurse or physician’s assistant can place ITCA 650 in a simple five-minute procedure in a doctor’s office. Under the agreement, Intarcia is to receive an upfront payment and total potential development, regulatory and sales milestone payments totaling more than $1 billion. Intarcia will also receive ex-U.S./Japan tiered sales-related payments. The parties will also share future global development-related investments for the life cycle management of ITCA 650, including new head-to-head superiority studies against leading diabetes medications, as well as planned novel combination regimens. Intarcia will continue to lead the global ITCA 650 phase 3 pivotal trials, which are on track to support global filings in the first half of 2016. Intarcia also will continue its lead role in the potential registration of ITCA 650 in the U.S., while Servier will seek regulatory approvals outside the U.S. and Japan, with the support of Intarcia.
“As one of the largest ex-U.S. partnering deals ever in the biotechnology industry, our collaboration with Servier is yet another major milestone in a series of significant achievements over the last few years that are truly transformational for Intarcia and our stakeholders,” stated Kurt Graves, Chairman, President and CEO of Intarcia Therapeutics. “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 compan with a pipeline of game changing, once-yearly medicines. 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 selec Servier over other major diabetes firms competing for months to be our partner.”
Intarcia recently announced top-line results showing positive primary endpoints from two of its four phase 3 clinical trials. “With continued success in the remaining phase 3 trials, and additional outcomes studies planned to start next year, ITCA 650 represents the promise of a very important and totally novel therapeutic approach for patients with type 2 diabetes. ITCA 650 phase 3 data show the potential to provide robust glucose reductions and weight loss together with potentially game-changing compliance and adherence that comes with just once- or twice-yearly dosing. Thus, ITCA 650 holds the potential to deliver the intended GLP-1 benefits earlier in therapy wher injections don’t typically get used, while also addressing the poor compliance and adherence rates that all too often lead to poor control and treatment outcomes over time,” said Robert Henry, M.D., Professor of Medicine, in Residence, UC San Diego and Chief, Diabetes & metabolism VA San Diego Healthcare System.
Dr. Isabelle Tupinon-Mathieu, Head of the metabolism Innovative Center at Servier, stressed: “This disruptive injection-free GLP1 could reshape the treatment of type 2 diabetes in the very near future and corresponds to our objectives for patient care in metabolic diseases.” Pascal Touchon, Vice President Business Development and Scientific Collaboration at Servier added: “This strategic partnership shows our commitment to bring innovative therapies to people with type 2 diabetes in most countries around the world wher Servier has a strong presence and wher we demonstrate our extensive know-how and experience in this field. We will collaborate closely with Intarcia, with whom we share a common vision and urgency to bring such benefits to patients with diabetes.”
about ITCA 650
ITCA 650 (a once or twice-yearly continuous subcutaneous delivery of exenatide) is being developed for the treatment of type 2 diabetes. The investigational therapy employs Intarcia’s proprietary technology platform involving a matchstick-size, miniature osmotic pump that is placed sub-dermally to provide continuous and consistent drug therapy, and the company’s proprietary formulation technology, which maintains stability of therapeutic proteins and peptides at human body temperatures for extended periods of time. Exenatide, the active agent in ITCA 650, is a glucagon-like peptide-1 (GLP-1) receptor agonist currently marketed globally as twice-daily and once-weekly self-injection therapies for type 2 diabetes. Upon approval, ITCA 650 would represent the first injection-free GLP-1 therapy that can deliver up to a full year of treatment from a single placement. ITCA 650 is currently in a global phase 3 clinical trial program called FREEDOM.
about Intarcia Therapeutics, Inc.
Intarcia Therapeutics, Inc. is a biopharmaceutical company developing therapies to enhance treatment outcomes by optimizing and improving the efficacy, continuous administration and tolerability of drug therapies. In addition, delivering medicines just once or twice yearly has the potential to ensure improved patient adherence and compliance, which is very poor in most chronic diseases. Intarcia’s drug development expertise and competitive edge are demonstrated by its abilities to stabilize proteins and peptides at above-body temperature and to deliver them in a constant and consistent manner via Intarcia’s proprietary technology platform. Intarcia is conducting a phase 3-stage development program for type 2 diabetes that consists of four separate clinical trials, two of which have been completed. Intarcia continues to conduct research and development, utilizing its platform technology, to treat other chronic serious disorders in the field of diabetes and obesity. For more information on the Company, please visit www.intarcia.com.
about Servier
Founded in 1954, Servier is an independent French pharmaceutical research company. Its development is based on the continuous pursuit of innovation in the therapeutic areas of cardiovascular, metabolic, neurologic, psychiatric, bone and joint diseases as well as cancer. In 2013, the company recorded a turnover of 4.2 billion euros. Ninety-one percent (91%) of Servier drugs are consumed outside France. Twenty-seven percent (27%) of turnover from Servier drugs were reinvested in Research and Development in 2013. With a strong international presence in 140 countries, Servier employs more than 21,000 people worldwide. More information is available at: www.servier.com
Intarcia and its logo are registered trademarks of Intarcia Therapeutics, Inc.