糖尿病领域的“独角兽公司”Intarcia取得重大进展

Intarcia Therapeutics 将在今天宣布，一种对于2型糖尿病患者具有革命性意义的新型疗法，已经扫清了最后的主要临床障碍，并且公司表示，将在下个季度末之前申请美国食品药品监督局（FDA）的批准。此外，公司完成了7,500万美元的新一回合债务融资，希望开始加快生产，以确保这种新疗法在2017年底获得批准和开始销售时，公司有充足的库存。

虽然私人投资者最近给出了55亿美元的估值，但这家位于波士顿的公司依旧拒绝上市。

多数生物科技公司均希望在临床试验初期进行首次公开募股（或被收购），主要原因是这种试验需要大量的资本支持。但Intarcia却成功筹得了风险投资家和其他私人市场投资者超过10亿美元的投资，公司认为在产品商业化之前上市，会导致公司的价值被低估。

在对超过4,000名患者为期三年的心血管安全性研究结束之后，公司旗舰产品“GLP-1”的第3阶段临床试验现已完成。“GLP-1”通过皮下植入的微型注射泵给药。门诊程序仅需几分钟即可完成，而且每年只需要进行一次或两次门诊。换言之，糖尿病患者不需要每天或每周一次注射。

Intarcia原计划在夏末申请FDA的批准，但公司董事长兼CEO科特•格拉夫斯表示，由于心脏研究是事件驱动研究，因此申请时间可能会推迟一到两个月。他表示：“你无法确定事件驱动研究的准确完成时间，因为你只能等待，比如等到发生150个事件。不过我们已经实现了需要实现的目标，现在我们可以计算所有第3阶段的试验数据，用于向FDA申请。”

FDA的审批流程通常需要12个月左右，格拉夫斯相信，公司的产品面临的监管风险很低。他解释说：“我们研究的是在正常情况下已经获得批准的注射药物，我们只是在尽量提高这些药物的疗效，开发更好的给药方式。其他糖尿病药物申请通常是FDA之前从未见过的新药。”

在等待审批的过程中，Intarcia将于今年利用最近从MidCap Financial Trust 和硅谷银行（Silicon Valley Bank）获得的7,500万美元信贷融通，通过位于加州海沃德的现有设施，开始储存产品库存。Intarcia声称，其产品在体温条件（更不用说室温）下可保持稳定性长达三年之久，所以早期生产应该不会产生废品。

不过有一个明显的问题是，如果Intarcia在向FDA申请批准的同时，开始生产程序，这是否意味着公司准备上市？毕竟，公司的计划就是在产品商业化之后上市。这不仅是因为Intarcia将拥有市场普及数据，也是因为一种新型糖尿病药物的上市成本通常在2.25亿美元到3亿美元之间。

对这个问题，格拉夫斯非常小心谨慎。

他说道：“我们已经做好了上市的准备，但我们依旧有大量获得私人资本的途径。上市固然是好事，但我们还没有到必须做出最终决定的时候。”（财富中文网）

译者：刘进龙/汪皓

Intarcia Therapeutics today will announce that it has cleared the last major clinical hurdle for what could become a revolutionary new treatment for patients suffering from Type 2 diabetes, and that it will file for FDA approval by the end of next quarter. It also has raised $75 million in new debt financing to begin ramping up manufacturing, so that it will have adequate inventory if and when it is allowed by begin selling its product in late 2017.

But what the Boston-based company, most recently valued at $5.5 billion by private investors, still refuses to do is become publicly traded.

Most biotech startups attempt to IPO (or be acquired) early in the life of their clinical trials, primarily because such testing is capital-intensive. Intarcia, however, has managed to raise more than $1 billion from venture capitalists and other private-market investors, arguing that a pre-commercialization IPO would leave too much value on the table.

And with the conclusion of its three-year cardiovascular safety study of more than 4,000 patients, the company has now completed Phase 3 clinical trials on its flagship product, a “GLP-1” that is administered via a tiny injectable pump inserted below the skin. The outpatient procedure takes just a few minutes and only needs to be done once or twice a year. In other words, no daily or weekly injections.

Intarcia originally had planned to file for FDA approval in late summer, but company chairman and CEO Kurt Graves says there will be a month or two delay because the cardio study was events-based. “You can never quite pinpoint when an events-driven study is going to finish, because you’re just waiting, for example, for the 150th event to occur,” he says. “But we achieved what we needed to achieve, and now we’re free to compute all of the Phase 3 data for the FDA application.”

The FDA approval process typically takes around 12 months, and Graves believes that the regulatory risk should be fairly low. “We’re working with that is normally an already-approved injectable medicine that we’ve tried to make better and with a better delivery form,” he explains. “Other diabetes applications are usually for brand new drugs that the FDA has never seen before.”

As Intarcia waits, it will use its new $75 million credit facility ― from MidCap Financial Trust and Silicon Valley Bank ― to begin stockpiling product inventory this year via its existing facility in Hayward, California. Intarcia claims its drug is stable at body temperature (let alone room temperature) for over three years, so the early manufacturing should not create spoiled goods.

One obvious question, of course, is that if Intarcia is running a manufacturing process parallel to its FDA application, is it preparing for an IPO? After all, the plan was to go public post-commercialization. Not only because Intarcia will have market adoption data, but also because a new diabetes drug launch typically costs somewhere between $225 million and $300 million.

This is where Graves gets a big cagey.

“We are a company that is IPO ready, but we also still have plenty of access to private capital, Graves says. “It’s a great spot to be in, but we’re not at the point yet where we need to make a final decision either way.”