Shares of Shire Plc (SHP.L, SHPGY) declined around 13 percent on the London Stock Exchange after the U.S. drug regulators approved a generic version of its best selling hyperactivity drug Adderall XR. Shire was expecting a generic competitor for Adderall only after a couple of years.
The Irish specialty biopharmaceutical company on Saturday said that the US Food and Drug Administration approved the abbreviated new drug application or ANDA for generic Adderall XR filed by Iceland-based generic drug maker Actavis Group Hf. The FDA has not approved any other Adderall XR ANDAs. Adderall XR is Shire's second-biggest selling drug that contributed $111.4 million revenue in the first quarter.
The FDA also responded to Shire's Adderall XR citizen petition on Friday, in consistent with its recent decisions on other long acting ADHD products. FDA's response requires that all ANDAs have to establish bio-equivalence using partial area under the curve measurements at 5 hours and beyond 5 hours, for both d- and l- amphetamine.
Shire said it believes that it will remain competitive in the Adderall XR marketplace through the distribution of branded Adderall XR and through its two authorized generic partners, Pharmaceutical Industries Ltd. (TEVA: Quote) and Impax Laboratories Inc.
Shire expects full year 2012 earnings growth to be good, however projects multiple dynamics affecting the overall market following the approval of the Actavis generic.
Earlier in April, Actavis has agreed to be acquired by Watson Pharmaceuticals Inc. (WPI) for 4.25 billion euros or $5.3 billion that will result in a major global generics company with operations in 40 countries.
Shire shares are currently trading at 1,715 pence, down 251 pence or 12.77 percent in London.
In pre-market activity in the U.S., Watson shares are currently trading at $72.31, up $1.29 or 1.82 percent.
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by RTT Staff Writer
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