Shire LLC, a subsidiary of
) recently announced that it has entered into a settlement
agreement with Anchen Pharmaceuticals, Inc., Anchen, Inc. and TWi
Pharmaceuticals, Inc. Shire has resolved all pending litigation
related to TWi's abbreviated new drug application (ANDA) for a
generic version of Shire's Intuniv (guanfacine hydrochloride) for
the treatment of attention deficit hyperactivity disorder. Anchen
is TWi's filing agent in the US and authorized distributor.
Under the terms of the settlement agreement, Anchen can launch
TWi's generic versions of Intuniv in the US on July 1, 2016 or
earlier under certain circumstances. Shire will receive royalties
on the sales of TWi's generic versions of Intuniv.
However, under certain conditions, Shire can permit Anchen to
market an authorized generic version of Intuniv. Shire will receive
significant royalties on the sale of the authorized generic version
However, Shire's Intuniv worries do not end here. The company is
fighting patent infringement lawsuits with several other companies
) and Actavis Inc., who have filed ANDAs for their generic versions
A trial is expected to commence on September 17, 2012.
Impax Laboratories, Inc.
Mylan Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc.
) and Sandoz, the generic pharmaceuticals division of
), have also filed ANDAs seeking to market their generic versions
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We currently have a Neutral recommendation on Shire. The stock
carries a Zacks #3 Rank (Neutral rating) in the short run.
The threat of generic competition, which several of Shire's
products are already facing or are likely to face, puts immense
pressure on the company's pipeline.
Shire is seeking to boost its pipeline through acquisitions and
collaborations. Even though encouraged by Shire's efforts to
develop its pipeline, we prefer to remain on the sidelines until we
gain more visibility on its progress with the pipeline.