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Type 2 Diabetes Technology Licensed in $1 Billion Deal

ITCA 650 pump

ITCA 650 pump (Intarcia Therapeutics Inc.)

12 November 2014. Intarcia Therapeutics Inc., developing a drug and delivery mechanism to treat type 2 diabetes, licensed its technology to the pharmaceutical company Servier in a deal with a potential value of $1 billion. The agreement gives Servier exclusive rights to Intarcia’s diabetes treatment technology to regions outside of the U.S. and Japan.

Intarcia’s lead technology, code-named ITCA 650, consists of exenatide, a drug that acts like a hormone in the body known as incretin to help control blood sugar. Exenatide, like incretin, prompts the pancreas to release insulin, and at the same time prevents the hormone glucagon from stimulating the liver to release sugar into the blood stream. In addition, the drug helps slow the rate at which the stomach empties after a meal, keeping an individual feeling full longer, thus also keeping blood sugar from rising to quickly after eating.

The use of exenatide and other drugs acting like incretin is limited by the need for people with type 2 diabetes to self-inject the drug twice a day, with nausea a common side effect. ITCA 650 also includes a delivery method for exentatide, where a pump the size of a matchstick is inserted under the skin to provide a continuous dose of the drug through osmosis for up to one year without replacement.

The company says a continuous flow of exenatide helps overcome issues of compliance with the twice-a-day injections required for the drug and common nausea side effects. Because the pump is inserted under the skin, notes Intarcia, a qualified clinician can quickly remove it if needed.

Intarcia is testing ITCA 650 in a series of 4 late-stage clinical trials, 2 of which are still in progress. Top-line results from the 2 completed trials, reported in October, show more patients with type 2 diabetes, fitted with ITCA 650, and also taking standard diabetes drugs, were able to reduce their blood glucose levels and lose weight than patients receiving a placebo. Patients with ITCA 650 were also able to sustain their lower blood glucose levels over 39 weeks. The studies show as well few ITCA 650 recipients (“low single digits”) encountered problems with nausea causing patients to discontinue treatments.

Servier, headquartered in France, is a pharmaceutical research enterprise developing therapies addressing cardiovascular, metabolic, neurologic, psychiatric, bone, and joint diseases as well as cancer. The privately-held company employs some 21,000 people in 140 countries, 3,000 of whom work in R&D.

In the deal, Servier receives exclusive rights to ITCA 650 technology outside of the U.S. and Japan. In return Servier is paying Intarcia $171 million up front, with another $230 million expected in early-stage regulatory milestones. Further development, regulatory, and sales milestone payments could reach as high as $650 million.

Both parties are expected to fund another manufacturing center outside the U.S., and share costs for clinical trials already planned and agreed upon. Trials needed for further regulatory approvals in regions outside the U.S. and Japan will be funded by Servier.

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