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Shire Delivers Record Quarterly Revenues and Non GAAP Diluted Earnings per ADS up 42%
Date:7/18/2014

regarding VASCUGEL.

Legal Proceedings 

VYVANSE patent litigation

  • On June 25, 2014 Shire announced that Judge Stanley R. Chesler of the US District Court for the District of New Jersey granted Shire's summary judgment motion in a patent infringement lawsuit, holding that certain claims of the patents protecting VYVANSE were both infringed and valid.

    The ruling prevents the five pharmaceutical manufacturers (the ANDA-defendants) who have filed Abbreviated New Drug Applications ("ANDA"s) from launching generic versions of VYVANSE until the earlier of either a successful appeal to the US Court of Appeals for the Federal Circuit, or the expiration of these patents in 2023. To appeal successfully, the ANDA-defendants must overturn the Court's rulings for each of the 18 patent claims.

    The Court's summary judgment ruling concerning Shire's motion included 18 patent claims from four of the FDA Orange Book-listed patents for VYVANSE, which cover VYVANSE's active ingredient, the lisdexamfetamine dimesylate compound, and a method of using lisdexamfetamine dimesylate for the treatment of ADHD.

OTHER DEVELOPMENTS 

Completion of Lumena acquisition 

  • On June 11, 2014 Shire completed its acquisition of Lumena, a biopharmaceutical company with late stage rare disease pipeline assets. Lumena brings to Shire two new novel, once-daily, orally administered therapeutic compounds: SHP625 (formerly LUM001), in Phase 2 clinical development with four potential orphan indications; and SHP626 (formerly LUM002), ready to enter Phase 2 clinical development later in 2014. SHP625 and SHP626 are both inhibitors of the apical sodium-dependent bile acid transporter ("ASBT"), which is primarily responsible for recycling bile acids from the intestine to the liver. SHP625 works by preventing recycling of bile acids back t
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3. Shire Extends Tender Offer for ViroPharma
4. Shire Reports Top-Line Results on OPUS-2, a Phase 3 Study Investigating the Use of Lifitegrast (5.0% Ophthalmic Solution) in Adults With Dry Eye Disease
5. MinuteClinic Opens First Clinic Locations in New Hampshire
6. Block & Leviton LLP Investigates ViroPharma Inc. for Possible Breaches of Fiduciary Duty in Connection with Its Acquisition by Shire PLC.
7. Shire to Present at the Bank of America Merrill Lynch Global Health Care Conference
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9. Shire Reports 7% Product Sales Growth: Anticipating Double Digit Non GAAP Earnings Growth in 2013
10. Shire Announces Award Recipients for 2013 US ADHD Scholarship Program
11. Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting
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