Warner Chilcott plc
) received encouraging news when the US Food and Drug
Administration (FDA) approved its ulcerative colitis drug
Delzicol (mesalamine). The company intends to launch the drug in
Mar this year.
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The approval will enable Warner Chilcott to market the drug in
dosage of 400mg for treating patients suffering from mildly to
moderately active ulcerative colitis and for the maintenance of
remission of the disease.
We note that another distinguished ulcerative colitis drug in the
company's product portfolio is Asacol. This drug is marketed in 2
doses - 400 mg and 800 mg.
We are positive on the addition of a new product to Warner
Chilcott's product portfolio since many of its key drugs are
facing declining sales due to generic competition. The generic
competition that the company is currently facing or expects to
face for its various drugs has put significant pressure on it.
Osteoporosis drug, Actonel lost exclusivity in Western Europe in
late 2010. Actonel accounted for 70% of Warner Chilcott's 2010
revenues from the region. Moreover, the company suffered a huge
setback in 2012 when a US district court ruled that the generic
versions of neither
Impax Laboratories Inc.
) infringed the patent of Warner Chilcott's 150 mg dosage of acne
Following the verdict, Mylan has entered into the US market with
its generic version of Doryx 150 mg. Also, drugs such as Loestrin
and Enablex are expected to go off patent in the US in 2014 and
2015, respectively. The genericization of key products will make
it challenging for Warner Chilcott to drive the top line.
Warner Chilcott, a specialty pharmaceutical company, currently
carries a Zacks Rank #3 (Hold).
Valeant Pharmaceuticals International, Inc.
) is well placed in the specialty pharmaceutical space with a
Zacks Rank #1 (Strong Buy).