Regulatory Update from Forest Labs

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Forest Laboratories, Inc. (FRX) and partner Almirall, S.A. announced that the U.S. Food and Drug Administration (:FDA) has provided a feedback on their new drug application (:NDA) for the fixed dose combination (FDC.V) of Tudorza (aclidinium) and formoterol. Forest Labs and Almirall are looking to get the FDC approved for the treatment of chronic obstructive pulmonary disease (:COPD).

Forest Labs and its partner said that the FDA notified them regarding the need to discuss matters related to chemistry, manufacturing and control (CMC). Importantly, the FDA has not raised any new issues.

We remind investors that Forest Labs and Almirall delayed the submission of an NDA for the FDC based on the FDA’s feedback at a pre-NDA meeting last year. The companies expect to conduct a type C meeting with the FDA during the third quarter of calendar 2014.

Meanwhile, Forest Labs is working towards strengthening its pipeline. The company recently filed an NDA for its FDC of Bystolic and Diovan for the treatment of hypertension.

Forest Labs and partner AstraZeneca’s (AZN) antibiotic combination comprising Fortaz and avibactam is in phase III studies for complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI). Results should be out by mid-2014. With a qualified infectious disease product (:QIDP) designation in the U.S. for both indications, Fortaz/avibactam might be eligible for the FDA’s fast track program and accepted for priority review. Forest Labs and AstraZeneca intend to file an NDA for the candidate for both indications in mid-2014.

We remind investors that Actavis plc (ACT) announced its intention to acquire Forest Labs for a cash and equity transaction valued at about $25 billion. The deal is expected to close in mid-2014.

Forest Labs carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is ImmunoGen, Inc. (IMGN) carrying a Zacks Rank #1 (Strong Buy).

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