Warner Chilcott plc
) recently received encouraging news from the US Food and Drug
Administration (FDA) when the regulatory agency approved the
company's acne drug Doryx at 200 mg strength (delayed release
tablets). The company intends to launch the 200 mg version of the
drug in Jul 2013.
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We are positive on the approval of Doryx (200 mg) as it has
extended the life cycle of the drug at Warner Chilcott, following
the genericization of the 150 mg dosage of Doryx last year. We
note that Doryx, the sole dermatological offering at Warner
Chilcott, has been facing declining sales following its
On Apr 30, 2012, a US district court issued a verdict regarding
) applications to the FDA to sell their generic versions of 150
mg of Doryx. The court ruled the generic versions of neither of
the companies infringed the patent of Doryx. Following the
verdict, Mylan entered the US market with its generic version of
Doryx 150 mg in May 2012.
Doryx sales declined 58.7% to $19 million in the final quarter of
2012 due to competition from generics. Sales in 2012 declined
46.8% to $92 million. The approval of the 200 mg dosage of the
drug should go a long way in arresting the declining trend.
We note that in Feb 2013, Warner Chilcott gained another FDA
approval when the US regulatory body cleared the company's
ulcerative colitis drug Delzicol (mesalamine).
Warner Chilcott currently carries a Zacks Rank #3 (Hold).
) is a favorably placed company, in the pharma space, carrying a
Zacks Rank #1 (Strong Buy).