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Intarcia Bets It Will Shake Up Diabetes Treatment With Implantable Device

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2,000 people, mostly physicians, gathered to hear investigator Bob Henry of UC San Diego describe the latest Phase II results at the European Association for the Study of Diabetes in Stockholm. The study, involving 155 patients, looked a number of dosing regimens, and found that it could get a key measure of blood sugar control, hemoglobin A1C, to drop from 7.9 to 6.94 over the course of 12 weeks of therapy, with nausea rates declining from 21 percent to 2 percent from start to finish. This is what physicians want to see, since the American Diabetes Association’s guidelines are that diabetic patients should keep their hemoglobin A1C scores to 7 or less.

Besides the adequate blood sugar control, patients also typically lost 3-5 kilograms of weight (6.6 to 11 pounds) and reported improved quality of life, researchers said. This was all compelling enough for Intarcia to say it was ready to go to the third and final stage of clinical trials sometime in early 2011.

This is the sort of profile that has got the marketer in Graves thinking big. Graves, the former chief commercial officer at Vertex Pharmaceuticals, worked a lot on hepatitis C market dynamics while he was there but says he spent a lot of time studying diabetes during an earlier stint in his career at Swiss drug giant Novartis. He formally joined Intarcia in September, so this is all still relatively new to him. Besides going over the clinical trial results, he has been surveying payers on what they would be willing to shell out for a drug that gets patients to their desired hemoglobin A1C score, and has 100 percent compliance. He said that the existing branded form of exenatide currently costs about $3,200 a year, and his market research says payers have no problem paying a 20 percent premium as long as they could be certain patients stayed on their meds. “We actually didn’t find a price point where they said ‘No,’ which is the first time I’ve ever seen that,” Graves says.

The really big idea at Intarcia will be to see whether it can move its therapy up to earlier stages of disease. Most patients with diabetes initially go on metformin treatment, which is a cheap and widely available generic in oral pill form. When that drug fails, patients tend to move through other classes of what are known as DPP4 oral medications like Merck’s sitagliptin (Januvia) or Bristol-Myers Squibb’s saxagliptin (Onglyza). Doctors today try to warn patients to stay on their regular regimens with those drugs, because when they fail, then it’s time to turn to injectables like exenatide (Byetta), or ultimately, insulin replacement therapy. Intarcia’s hope is that it can take exenatide from that third-line position, and move it into the first line of therapy, where there are more patients and more money to be made.

If everything goes right in clinical trials, Intarcia could be in position to file its new drug application with the FDA by the end of 2012, and to potentially introduce its product to the market by the end of 2013 or early 2014, Graves says. Meantime, he’s talking to a number of Big Pharma partners, trying to strike a deal. He concedes that most people he talks to see this primarily as a more convenient version of exenatide, and probably not worth that much. His main task is to convince partners that the drug/device combo is actually more effective at controlling diabetes through the consistent dosing, more attractive to payers because of the 100 percent compliance rate, and likely to change the standard of care by being used in combination with metformin in front-line therapy.

If Intarcia can even get a tiny toehold in his market, it could mean big bucks. The global market for Type 2 diabetes treatment is expected to double to about $35 billion, according to Decision Resources, a market research firm. Every percentage point of market share will be worth hundreds of millions of dollars a year, Graves says. It’s lucrative enough to justify the risk that anyone assumes when they get in the business of developing new diabetes meds.

“I’ve really fallen in love with this,” Graves says. “I think this could be one of the biggest drugs in the industry.”

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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.

  • 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.

  • 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.”

  • 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

  • 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.

  • 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.