Quintiles is investing money and providing Phase 3 clinical services for Intarcia, a California drug development firm that is pursuing a potential once-a-year treatment for Type 2 diabetes.

Financial terms were not disclosed.

Quintiles’ Capital Solutions group will provide “a combination of equity, product, and operational investments” related to the product called ITCA 650, the companies said in a joint statement.

Called DUROS, it is actually a device described as a subcutaneous “osmotic mini-pump.”

“Quintiles is taking a small equity position in Intarcia as they prepare to conduct an extremely comprehensive global Phase 3 development plan for ITCA 650,” Phil Bridges, director of corporate communications, told WRAL Tech Wire. “The product investment component to the deal is a non-dilutive investment tied to the success of ITCA 650 that does not include any royalty of product rights. Quintiles is not acquiring separate licensing rights in the ITCA 650 intellectual property.”

Quintiles has made a number of investments in drug developments as part of its global service offerings. By providing financial and clinical related services, the RTP-based firm touts itself as the world’s largest total life sciences service company.

A Game Changing Deal?

The treatment could affect diabetes treatment globally and also could have a broader affect on the contract research organization industry, according to Bridges.

“The clinical results could provide a strong clinical rationale to reconsider the treatment protocol for Type 2 diabetes, eventually displacing current leading drugs in the category,” he said. “:he deal itself could be a game-changing approach to CRO/Biotech partnerships with promising drugs and/or devices.

“Lastly, it puts a premium on compliance in chronic illnesses by shifting away from reliance on human behavior to a drug/device combination that virtually guarantees adherence and compliance.”

In a statement, Quintiles Chairman Dennis Gillings said the deal reflects Quintiles’ strengths.

“This alliance illustrates Quintiles’ ability to bring financial, human and intellectual capital together to address a customer’s complex strategic challenges, and accelerate development of a potential therapy that could make very positive difference for those suffering from Type 2 diabetes,” he explained.

Bridges also noted that Quintiles can provide Intarcia with extensive experience in diabetes drug trials. The company “has experience with more than 130 Type 2 diabetes trials involving more than 147,000 patients in more than 56 countries since 2000,” he said.

Intarcia says its ITCA 650 treatment called Duros will be matched for effectiveness against standard oral treatments for Type 2 diabetes. ITCA 650 also does not require an injection, the company says.

Another Partner Being Pursued

Intarcia still expects to sign a global pharmaceutical partner “with significant diabetes expertise” before the actual trials being.

“Quintiles’ commitment and intellectual contributions in crafting this development alliance, plus their strategic investments in Intarcia, reflect our vision for ITCA 650 to reshape the way Type 2 diabetes is treated and to deliver significant treatment outcome advantages to patients, payors and providers,” said Kurt Graves, executive chairman of Intarcia.

“In addition, with once-yearly administration, ITCA 650 virtually ensures the adherence and compliance that payors, providers and patients really need,” he added.

Quintiles expects to enroll the first patients in the trials in the first quarter of next year.

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