Shire: Impax Laboratories Files For Intuniv Generic Drug Application

Shire PLC (SHP.LN), a global biopharmaceutical company, said Monday it has received a Paragraph IV Notice Letter from Impax Laboratories, Inc. (IPXL) advising of the filing of an Abbreviated New Drug Application, or ANDA, for a generic version of Shire's 4 mg guanfacine hydrochloride extended release tablet, INTUNIV.

MAIN FACTS:

-INTUNIV is protected by three FDA Orange Book listed patents:

* U.S. Patent No. 5,854,290, or the '290 patent, titled Use of Guanfacine in the Treatment of Behavioral Disorders;

* U.S. Patent No. 6,287,599, or the '599 patent, and

* U.S. Patent No. 6,811,794, or the '794 patent, both titled Sustained Release Pharmaceutical Dosage Forms with Minimized pH Dependent Dissolution Profiles.

-The three patents expire in 2015, 2020 and 2022, respectfully.

-Shire is reviewing the details of Impax's Paragraph IV Notice Letter which was directed to the '290, '599 and '794 patents.

-The Hatch-Waxman exclusivity period for INTUNIV runs until Sep. 2, 2012 therefore, ANDA for generic versions of INTUNIV cannot be approved prior to the end of that exclusivity period.

-Shire shares at 1110 GMT up 13.0 pence, or 0.9%, at 1484.0 pence.

By Iain Packham, Dow Jones Newswires; 44-20-7842-9269; iain.packham@dowjones.com

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