FDA Accepts Actavis NDA - Analyst Blog


The US Food and Drug Administration (FDA) recently accepted Actavis, Inc.'s ( ACT ) new drug application for its oral contraceptive candidate. The company is looking to get its progestin-only transdermal contraceptive patch (norethindrone transdermal delivery system) approved for the prevention of pregnancy.

With the FDA granting standard review to the NDA, a response should be out by Dec 27, 2013. The NDA was submitted on Feb 26, 2013 and includes data from a 12-month, multicenter, open-label study.

The once-weekly dosing regimen of the patch could help improve compliance and convenience in progestin-only contraceptive users.

Actavis is working on strengthening its women's health business. Earlier this year, the company acquired Belgium-based Uteron Pharma. With this acquisition, Actavis gained a portfolio of two late-stage, one mid-stage and several early-stage pipeline candidates.

Uteron's two-late stage candidates are Levosert, an intrauterine device (IUD) for long-term contraception and the treatment of heavy bleeding and Diafert, a non-invasive immunoassay kit for the determination of the quality of oocyte (egg) during in-vitro fertilization (IVF).

While Levosert is currently under review in several EU countries, Diafert could obtain EU approval later this year. As far as the US is concerned, Levoset is currently in phase III development. Diafert is slated to enter into phase III development this year in the US.

Estelle, Uteron's mid-stage pipeline candidate, is a contraceptive that could be launched in 2018.

Actavis currently carries a Zacks Rank #3 (Hold). With fewer major patent expiries slated to occur in the next few years, we are encouraged by Actavis' focus on building its branded and biosimilars pipeline.

In the pharma/biopharma space, companies that currently look well-positioned include Salix Pharmaceuticals, Ltd. ( SLXP ), Santarus, Inc. ( SNTS ) and Jazz Pharmaceuticals ( JAZZ ). All three are Zacks Rank #1 (Strong Buy) stocks.

ACTAVIS INC (ACT): Free Stock Analysis Report

JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report

SALIX PHARM-LTD (SLXP): Free Stock Analysis Report

SANTARUS INC (SNTS): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.

This article appears in: Investing , Business , Stocks

Referenced Stocks: ACT , JAZZ , SLXP , SNTS



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