Intarcia Bets It Will Shake Up Diabetes Treatment With Implantable Device

11/29/10Follow @xconomy

[Corrected: 11:15 pm Pacific, 11/29/10] Diabetes is supposed to be one of the biggest public health threats facing the U.S. over the next decade, yet if you talk to anybody developing drugs for this chronic disease, times have never been tougher. So how can Kurt Graves, the executive chairman at Hayward, CA-based Intarcia Therapeutics, sound so relentlessly upbeat?

“We have an opportunity to reshape treatment of diabetes,” Graves says.

Intarcia is still a long way from showing it can really do that, but the company clearly has an intriguing strategy tailored for the tough new era of regulatory and insurance scrutiny for diabetes meds.

There’s certainly a big potential opportunity for any clever new approach. More than 24 million Americans are said to be diabetic today with the vast majority of them having Type 2 diabetes. By the end of the decade, something like half of all people in the U.S. are expected to be either diabetic, or prediabetic. That means diabetes—a condition in which inadequate blood sugar control can lead to a slew of complications like blindness, heart attack, stroke, and limb amputations—could account for about $500 billion annually, or about one one-tenth of the nation’s healthcare bills, by the end of the decade, according to a new report by UnitedHealth Group.

But despite the growing scale of this costly epidemic, the FDA has taken an ever-tougher stance toward new therapies for diabetes. In September, the FDA placed tight new restrictions on use of GlaxoSmithKline’s rosiglitazone (Avandia), after studies suggested it may increase heart risks—years after it was approved for the market and reached billion-dollar blockbuster sales status. The next month, the FDA slapped down a new drug application from Amylin Pharmaceuticals and Eli Lilly for a once-weekly version of the drug exenatide, asking the companies to do further study about cardiovascular risks. One startup company that had raised more than $100 million, San Diego-based Phenomix, went out of business, saying it would take too long and cost too much to run the necessary clinical trials.

Kurt Graves

Kurt Graves

None of that deters Graves. “I’m still every bit as excited as I ever was,” he says.

One of the reasons is that Intarcia is attempting to tackle diabetes in an unorthodox drug/device combination strategy. The company started on this track about five years ago when it obtained a license to technology from Alza (now part of Johnson & Johnson), Graves says. By March 2007, it had raised $50 million from New Leaf Venture Partners, Quilvest Ventures, New Enterprise Associates, Venrock Associates, Alta Partners, Omega Fund, and Granite Global Ventures. The plan was to further develop an intriguing platform to deliver drugs in an efficient new way.

Intarcia’s key technology, called Duros, is a matchstick-sized implantable mini pump that is supposed to slowly, steadily secrete a precise amount of any drug in the body. One of the main … Next Page »

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  • WACG

    I am extremely surprised at the author’s claim that “[Exenatide]had recently lost its patent protection.” Where exactly did you get this notion? I am willing to wager it is WRONG.

  • http://www.xconomy.com/author/ltimmerman/ Luke Timmerman

    WACG—that point came up during the interview with Graves. As an aside, I wondered why generics haven’t come in and copied exenatide. It’s only speculation, but Graves suggested that generic Byetta wouldn’t be worth much since Bydureon has been widely expected to replace it with a more convenient once-weekly branded form. Another thought is that exenatide is a peptide that would have to follow the still-unresolved regulatory pathway of follow-on biologics or biosimilars, which isn’t as clear cut as conventional small molecules.

  • http://www.xconomy.com/author/ltimmerman/ Luke Timmerman

    WACG–you are right, and I stand corrected. Amylin spokeswoman Anne Erickson wrote later today to say that Byetta does still have patent protection. I’ve updated the story above. Sorry for the error. Here’s what Erickson said.

    “Byetta is protected by seven FDA Orange Book listed patents that have expiration dates ranging from December 1, 2016 to January 14, 2020. Amylin and Lilly have a high degree of confidence in the strength and depth of Amylin’s intellectual property rights in Byetta.”

  • http://www.corengi.com Ryan Luce

    This seems like a very promising strategy. Did they say when they phase 3 study was going to open?

    Also, there’s a copy of the presentation they gave on the results in Stockholm here: http://www.intarcia.com/documents/ITCA650_EASD_2010_000.pdf

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  • http://www.xconomy.com/author/ltimmerman/ Luke Timmerman

    Ryan—Phase 3 is scheduled to begin in early 2011. Thanks for the link to the Stockholm presentation.

  • John Miller

    The Amylin comment on Byetta patents is irrelevant to Intarcia! I just read their SEC report and there is no composition of matter patent to block Intarcia.

  • http://www.xconomy.com/author/ltimmerman/ Luke Timmerman

    John—I’m not an IP expert, but as I understand the situation, there are important distinctions to be made here on composition of matter vs. method of use patents. I don’t intend to dive into these weeds unless it becomes a story. But from checking back with Intarcia, they obviously have studied the Amylin IP situation closely, and insist that nothing stands in the way of Intarcia’s attempt to commercialize ITCA 650.

  • Pingback: Intarcia Snags $210M to Push Implantable Device for Diabetes | Xconomy