) recently confirmed that it is looking to get its generic
Horizon Pharma, Inc.'s
) 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
). 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.
), which is a Zacks Rank #1 (Strong Buy) stock.
ACTAVIS INC (ACT): Free Stock Analysis Report
HORIZON PHARMA (HZNP): Free Stock Analysis
SUPERNUS PHARMA (SUPN): Free Stock Analysis
WARNER CHIL PLC (WCRX): Free Stock Analysis
To read this article on Zacks.com click here.