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technical challenges was figuring out how to keep protein and peptide drugs stable over long periods of time at high temperature in the body. Once that was solved, the next step was to figure out the best potential application of such a technology, Graves says.
Diabetes seemed like a logical place to start, because the market is so big and growing. So Intarcia went to work on putting exenatide into its slow-release pump, to see what it could do. That drug made sense, Graves says, because Amylin and Eli Lilly had already spent many millions of dollars and years of effort to show it was safe and effective against diabetes. [Correction: An earlier version of this story said Byetta had also lost its patent protection. Amylin spokeswoman Anne Erickson says that’s not the case. “Byetta is protected by seven FDA Orange Book listed patents that have expiration dates ranging from December 1, 2016 to January 14, 2020,” Erickson wrote in an e-mail. “Amylin and Lilly have a high degree of confidence in the strength and depth of Amylin’s intellectual property rights in Byetta.”]
Exenatide, currently marketed as Byetta, is proven to control blood sugar, and to provide the added benefit of helping many overweight diabetics lose weight. Its main drawback, however, is that it must be injected twice a day. That’s why Amylin and Lilly have sought to build on the franchise by offering the same benefits in a more convenient once-weekly dose.
Intarcia hopes to raise the bar much higher. Its drug/device combo can be set to release exenatide continuously for three months, six months, or a full year at a time, Graves says. A patient can come in, get some topical anesthetic to numb an area under the beltline, and have the matchstick-sized device implanted just under the skin in less than 10 minutes, Graves says. Intarcia has dubbed this combination therapy ITCA 650.
From a regulatory point of view, this has advantages, Graves says. The drug itself is well understood by the FDA, and has been used by an estimated 2 million patients, so there’s less chance the agency will have unpredictable safety questions like it might have with a new chemical entity. Having an implantable device releasing a small, steady dose means that there should be fewer of sort of side effects such as nausea that typically come right after injection, when the drug reaches peak concentration in the blood.
For insurers, things get more interesting. An estimated two-thirds of diabetes patients don’t take all their medications exactly as prescribed. That leads to further complications that often end up sending patients to the hospital—to the endless annoyance of payers. So Intarcia, by implanting a device and taking patients’ behavior out of the equation, is betting that it can keep blood sugar under control on a more steady basis, and cut down on complications (although this isn’t something it can prove yet).
“If you are a payer, you know that two-thirds of the medicine you are paying for is being wasted,” Graves says. “With this device, you know you are getting 100 percent of the benefit from the drug that you are paying for.”
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