'Unicorn' Intarcia files U.S. approval for diabetes implant

[November 22, 2016]  (Reuters) - Intarcia Therapeutics Inc said on Monday it submitted a marketing application for its matchstick-size implantable drug-delivery pump for diabetes to the U.S. Food and Drug Administration.

Privately held Intarcia, which clinched a royalty-based financing deal last year valuing the company at about $5.5 billion, is developing ITCA 650 in partnership with French pharmaceutical company Servier.

Intarcia's ITCA 650, which is designed as a once or twice-yearly therapy for type 2 diabetes, has been proven to be more effective than Merck & Co Inc's blockbuster diabetes drug, Januvia, in controlling blood sugar levels.

ITCA 650 could pose a challenge to large drugmakers such as Novo Nordisk A/S, AstraZeneca Plc, Sanofi SA and Eli Lilly & Co that sell similar so-called GLP-1 drugs as daily or weekly injections.

GLP-1 drugs are analogues that stimulate insulin production.

The company said, if approved, ITCA 650 would be the first and only injection-free GLP-1 therapy.

Intarcia said last year that it had plenty of funds for a potential launch of the device around mid-2017.

(Reporting by Divya Grover; Editing by Martina D'Couto)

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