Forest Laboratories, Inc.
) 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) 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).
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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
) 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
) 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
) carrying a Zacks Rank #1 (Strong Buy).