Back to top

Analyst Blog

This page is temporarily not available.  Please check later as it should be available shortly. If you have any questions, please email customer support at support@zacks.com or call 800-767-3771 ext.  9339.

Actavis, Inc. (ACT - Analyst Report) recently confirmed that it is looking to get its generic version of Horizon Pharma, Inc.’s (HZNP - Snapshot Report) Rayos (prednisone delayed-release tablets, 1 mg, 2 mg and 5 mg) approved in the U.S. The company has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for its generic version of the drug which is approved as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases/conditions and organ transplantation; the treatment of certain endocrine conditions; and palliation of specific neoplastic conditions.

In response to Actavis’ Paragraph IV filing, Horizon Pharma and Jagotec AG have filed a patent infringement lawsuit against Actavis in the U.S. District Court for the District of New Jersey. The filing of the lawsuit within the stipulated time period under the Hatch-Waxman Act ensures that the FDA cannot grant final approval to Actavis’ generic for up to 30 months or the court’s decision, whichever is earlier.

Actavis believes it may be the first-to-file an ANDA for a generic version of Rayos – if this is the case, Actavis would be entitled to 180 days of exclusivity on gaining FDA approval for its candidate. Rayos was launched in the U.S. in Dec 2012. Net sales of Rayos in the first half of 2013 were $0.9 million.

Actavis currently carries a Zacks Rank #2 (Buy). We note that Actavis is working on strengthening its branded product portfolio. Earlier this year, Actavis had announced its intention to acquire Warner Chilcott . We are positive on this deal which makes strategic and financial sense. The deal is expected to be immediately accretive. Moreover, it will provide strong operating cash flow and allow Actavis to de-lever its balance sheet. The tax rate will also be significantly below current levels.

Other companies that currently look well-positioned include Supernus Pharmaceuticals, Inc. (SUPN - Snapshot Report), which is a Zacks Rank #1 (Strong Buy) stock.

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

Learn more

Start for as little as $4.50 per trade.

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
RAMBUS INC RMBS 12.36 +4.83%
BOFL HOLDING BOFI 85.10 +4.73%
DIXIE GROUP DXYN 15.33 +4.43%
DAIMLER AG DDAIF 92.96 +2.88%
ALLIANCE FIB AFOP 17.21 +2.75%