Daiichi, Forest Labs (AGN) Reach $300M Settlement in Benicar

August 1, 2017 11:49 AM EDT

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(Updated - August 1, 2017 11:53 AM EDT)

Daiichi Sankyo Company, Limited and Daiichi Sankyo, Inc. announced that they have agreed to enter into a program to settle, on behalf of all defendants, pending product liability litigation against various Daiichi Sankyo and Forest entities. These cases are related to olmesartan products (Benicar, Benicar HCT, Azor and Tribenzor) and allegations that such products caused sprue-like enteropathy and other severe gastro-intestinal symptoms. The lawsuits were filed beginning in January 2014.

The settlement requires, among other thresholds, that at least 95 percent of all eligible litigants and claimants decide to opt-in to the settlement under certain conditions. Claimants eligible to opt-in to the settlement program, under certain conditions, include those with claims already filed in court (currently almost 2300 cases) and those with certain unfiled claims. Once the agreed-upon thresholds are met, and following a review of claims by a Claims Administrator, claimants who meet specified criteria will receive payouts from the settlement fund, which is capped at $300 million. A portion of the capped amount will also be used for plaintiffs' counsel fees and expenses and the cost of the Claims Administrator as per the settlement agreement.

The impact to the financial position of the company is not considered material because, upon presentation of proper claim documentation, the settlement fund is expected to be comprised primarily of proceeds from several of Daiichi Sankyo Group's insurance companies supplemented with company funds.

Daiichi Sankyo believes that the claims made in this litigation are without merit, and does not admit liability.

"Daiichi Sankyo is committed to the health and safety of all patients taking our medications," said Glenn Gormley, MD, PhD, Executive Chairman and President, Daiichi Sankyo, Inc. "We believe a settlement is in the best interest of all, and will allow us to continue our focus on bringing to market innovative medicines that help people live healthy and meaningful lives."

Daiichi Sankyo takes all matters of patient safety seriously and continuously monitors data from clinical trials and post-marketing case reports to identify potential safety signals. Daiichi Sankyo remains committed to our medications that contain olmesartan medoxomil, which remain widely used and available to patients with hypertension in the U.S. Olmesartan medoxomil is an angiotensin II receptor blocker (ARB) approved for the treatment of high blood pressure, alone or with other antihypertensive agents, and is one of eight marketed ARB drugs. The olmesartan medoxomil family of products used for the treatment of hypertension has a well-established safety profile with more than 53 million patient-years of use worldwide since 2002.

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