• Actavis Inc., of Parsippany, N.J., and Mallinckrodt Inc., of Dublin, Ireland, reached a settlement on patent litigation related to Actavis' generic version of the 32-mg dosage of Mallinckrodt's Exalgo (hydromorphone hydrochloride) tablets. Mallinckrodt granted Actavis a royalty-free license to U.S. patents relating to Exalgo to sell Actavis' 32-mg product beginning May 15, 2014. Other details were not disclosed. Based on available information, Actavis said it may be a "first applicant" to file an abbreviated new drug application (ANDA) for generic Exalgo in the 32-mg dosage strength and may be entitled to 180 days of generic market exclusivity if the ANDA is approved. The companies previously settled litigation involving other product dosage strengths.

• Eisai Inc., of Woodcliff Lake, N.J., said the FDA granted orphan drug designation to its investigational drug lenvatinib (E7080) for follicular, medullary, anaplastic and metastatic or locally advanced papillary thyroid cancer. The small-molecule tyrosine kinase inhibitor is in global studies as an oral agent in radioiodine-refractory differentiated thyroid cancer.

• Merck & Co. Inc., of Whitehouse Station, N.J., reached an agreement with plaintiffs to settle two federal securities class-action lawsuits related to the statin drug Vytorin and its ENHANCE clinical trial. The suits were filed in the U.S. District Court for the District of New Jersey against Merck, Schering-Plough Corp. – which merged with Merck in November 2009 – and certain current and former officers and directors. With the trial slated to begin March 4, Merck agreed to pay $215 million to a group of investors – including lead plaintiffs Stichting Pensioenfonds ABP, International Fund Management SA, the Jacksonville Police and Fire Retirement System and the General Retirement System of the City of Detroit – to resolve the securities class action against Merck and $473 million to the second group – including lead plaintiffs the Massachusetts Pension Reserves Investment Management Board, the Arkansas Teacher Retirement System, the Public Employees' Retirement System of Mississippi and the Louisiana Municipal Police Employees' Retirement System – to resolve the securities class action against Schering-Plough. The recovery was the largest securities class action settlement against a pharmaceutical company, according to co-counsel Labaton Sucharow LLP. The plaintiffs, who purchased securities issued by Merck and Schering-Plough between December 2006 and March 2008, claimed the companies delayed publication of the ENHANCE data for two years, causing them to lose money when results published in 2008 suggested Vytorin had no statistical advantage in treating atherosclerosis compared to generic statin drug Zocor (simvastatin). Merck admitted no liability or wrongdoing in connection with the agreement, which remains subject to court approval. Merck recorded a pre-tax and after-tax charge of $493 million, reflecting anticipated insurance recoveries, but said the settlement would not affect its 2013 operating guidance. The charge reduced the company's previously reported fourth quarter 2012 GAAP earnings per share results from 46 cents to 30 cents per share and full-year 2012 GAAP results from $2. 16 to $2 per share but did not change previously reported non-GAAP results. (See BioWorld Today, Aug. 22, 2008, and March 10, 2009.)

• Teva Pharmaceutical Industries Ltd., of Jerusalem, said the FDA approved its abbreviated new drug application for the generic version of Dublin, Ireland-based Shire plc's Adderall XR in 5-mg, 10-mg, 15-mg, 20-mg, 25-mg and 30-mg dosage strengths to treat attention deficit hyperactivity disorder. Adderall XR had annual sales, including brand and generic sales, of approximately $2 billion in the U.S. in 2012. Teva sells a generic version of Adderall XR capsules under a 2006 license and distribution agreement with Shire as part of a patent litigation settlement between the companies. Under terms of that agreement, Teva has the right to be supplied product by Shire through April 1, 2014.