Intarcia Therapeutics 將在今天宣布，一種對(duì)于2型糖尿病患者具有革命性意義的新型療法，已經(jīng)掃清了最后的主要臨床障礙，并且公司表示，將在下個(gè)季度末之前申請(qǐng)美國食品藥品監(jiān)督局（FDA）的批準(zhǔn)。此外，公司完成了7,500萬美元的新一回合債務(wù)融資，希望開始加快生產(chǎn)，以確保這種新療法在2017年底獲得批準(zhǔn)和開始銷售時(shí)，公司有充足的庫存。

雖然私人投資者最近給出了55億美元的估值，但這家位于波士頓的公司依舊拒絕上市。

多數(shù)生物科技公司均希望在臨床試驗(yàn)初期進(jìn)行首次公開募股（或被收購），主要原因是這種試驗(yàn)需要大量的資本支持。但I(xiàn)ntarcia卻成功籌得了風(fēng)險(xiǎn)投資家和其他私人市場(chǎng)投資者超過10億美元的投資，公司認(rèn)為在產(chǎn)品商業(yè)化之前上市，會(huì)導(dǎo)致公司的價(jià)值被低估。

在對(duì)超過4,000名患者為期三年的心血管安全性研究結(jié)束之后，公司旗艦產(chǎn)品“GLP-1”的第3階段臨床試驗(yàn)現(xiàn)已完成?！癎LP-1”通過皮下植入的微型注射泵給藥。門診程序僅需幾分鐘即可完成，而且每年只需要進(jìn)行一次或兩次門診。換言之，糖尿病患者不需要每天或每周一次注射。

Intarcia原計(jì)劃在夏末申請(qǐng)F(tuán)DA的批準(zhǔn)，但公司董事長兼CEO科特?格拉夫斯表示，由于心臟研究是事件驅(qū)動(dòng)研究，因此申請(qǐng)時(shí)間可能會(huì)推遲一到兩個(gè)月。他表示：“你無法確定事件驅(qū)動(dòng)研究的準(zhǔn)確完成時(shí)間，因?yàn)槟阒荒艿却?，比如等到發(fā)生150個(gè)事件。不過我們已經(jīng)實(shí)現(xiàn)了需要實(shí)現(xiàn)的目標(biāo)，現(xiàn)在我們可以計(jì)算所有第3階段的試驗(yàn)數(shù)據(jù)，用于向FDA申請(qǐng)?！?/p>

FDA的審批流程通常需要12個(gè)月左右，格拉夫斯相信，公司的產(chǎn)品面臨的監(jiān)管風(fēng)險(xiǎn)很低。他解釋說：“我們研究的是在正常情況下已經(jīng)獲得批準(zhǔn)的注射藥物，我們只是在盡量提高這些藥物的療效，開發(fā)更好的給藥方式。其他糖尿病藥物申請(qǐng)通常是FDA之前從未見過的新藥。”

在等待審批的過程中，Intarcia將于今年利用最近從MidCap Financial Trust 和硅谷銀行（Silicon Valley Bank）獲得的7,500萬美元信貸融通，通過位于加州海沃德的現(xiàn)有設(shè)施，開始儲(chǔ)存產(chǎn)品庫存。Intarcia聲稱，其產(chǎn)品在體溫條件（更不用說室溫）下可保持穩(wěn)定性長達(dá)三年之久，所以早期生產(chǎn)應(yīng)該不會(huì)產(chǎn)生廢品。

不過有一個(gè)明顯的問題是，如果Intarcia在向FDA申請(qǐng)批準(zhǔn)的同時(shí)，開始生產(chǎn)程序，這是否意味著公司準(zhǔn)備上市？畢竟，公司的計(jì)劃就是在產(chǎn)品商業(yè)化之后上市。這不僅是因?yàn)镮ntarcia將擁有市場(chǎng)普及數(shù)據(jù)，也是因?yàn)橐环N新型糖尿病藥物的上市成本通常在2.25億美元到3億美元之間。

對(duì)這個(gè)問題，格拉夫斯非常小心謹(jǐn)慎。

他說道：“我們已經(jīng)做好了上市的準(zhǔn)備，但我們依舊有大量獲得私人資本的途徑。上市固然是好事，但我們還沒有到必須做出最終決定的時(shí)候?！保ㄘ?cái)富中文網(wǎng)）

譯者：劉進(jìn)龍/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.”