Intarcia’s Diabetes Implant Beats Januvia in Trial

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Intarcia Therapeutics Inc.’s matchstick-sized diabetes pump lowered blood glucose levels and reduced weight more than Januvia, a commonly used treatment for diabetics that is Merck & Co.’s best-selling drug.

Intarcia’s pump is implanted under the skin for up to a year and continuously delivers a diabetes drug known as a GLP-1 receptor agonist. The pump reduced a measure of blood glucose by 1.5 percentage points, compared with 0.8 percentage point for Januvia, in a yearlong study of 535 patients, the company said Tuesday in a statement. The device also led to an average weight loss of 4 kilograms (9 pounds), compared with a loss of 1.3 kilograms in the patients taking Januvia.

Intarcia, a closely held company backed by venture-capital firms including New Enterprise Associates Inc. and Venrock, is seeking to challenge the crowded field of type 2 diabetes treatments with its device, called ITCA 650.

ITCA 650 is “a disruptive technology that gives patients a totally new way to treat diabetes,” Chief Executive Officer Kurt Graves said in an interview. “People on injections will want to switch over. It’ll have broad appeal in the market.”

Intarcia, based in Boston, stands out in the biotech field because it hasn’t gone public or formed an alliance with a large pharmaceutical company, even though it has run four final-stage trials covering 5,000 patients.

Venture-Capital Backing

Graves has chosen instead to rely on venture-capital backing and $300 million in convertible notes. The financing assumed an equity valuation of $5.5 billion after U.S. regulatory approval of the pump. The positive trial results reported Tuesday have triggered a $100 million payment to investors, Intarcia said.

Intarcia has a partnership with closely held French drugmaker Les Laboratoires Servier SAS to develop and commercialize the product outside the U.S. and Japan.

Januvia is a commonly prescribed oral pill when generic metformin isn’t effective in reducing blood glucose. Merck generated $3.93 billion in sales from the drug last year, making it the pharmaceutical giant’s top seller.

Graves said he had picked Januvia, which isn’t a GLP-1 receptor agonist, for a head-to-head trial with ITCA 650 because injectable medicines typically are third or fourth options for patients, and he wanted to show that his company’s device could be used sooner. ITCA 650 is a new technology, and the only way to persuade doctors and patients to use it is to show its superiority over standard of care, he said.

‘Confident’ Merck

Merck is “confident that physicians will continue to choose Januvia,” spokeswoman Pamela Eisele said in an e-mail. A recent trial showing that Januvia didn’t increase patients’ heart risk compared with a placebo supports the drug’s “compelling clinical profile,” she said.

Intarcia will apply for U.S. regulatory approval in the first half of 2016, according to the company’s statement. It has one more trial under way to study the pump’s effect on heart health.

There were about 29 million Americans age 20 or older with diabetes in 2012, according to the U.S. Centers for Disease Control and Prevention, and the total has been rising quickly as obesity rates increase and the population ages.

(Company corrects measurement unit in second paragraph.)

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