SHPGY » Topics » ADHD franchise

This excerpt taken from the SHPGY 10-K filed Mar 15, 2005.

ADHD franchise

Competition in the US ADHD market continues to increase. Whilst no new products were launched in 2004 several have been launched in recent years. In 2003 Eli Lilly launched STRATTERA, a non-stimulant, non-scheduled treatment for ADHD. In 2002 Novartis (in conjunction with Elan) launched RITALIN LA, an extended release formulation of methylphenidate and FOCALIN (in conjunction with Celgene), a short-acting formulation of dexmethylphenidate, the active isomer of traditional methylphenidate preparations.

With regard to the current stimulant class medications, Shire is aware of efforts by Celgene and Celltech to develop a single isomer version of methylphenidate.

The Company is also aware of clinical development efforts by Cephalon, GSK, Gliatech, Cortex, Boehringer Ingelheim, Eisai, Bristol-Myers Squibb (in collaboration with Elan) and Abbott to develop additional indications and new non-stimulant treatment options for ADHD. In December 2004 Cephalon filed a NDA with the FDA for ATTENANCE, a non-amphetamine product, for the treatment of ADHD in patients 6-17 years of age.

Generic and other possible competition to the Company’s ADHD franchise is separately discussed above in “Intellectual Property” and below in “Risk Factors” and in ITEM 3: Legal proceedings.

3TC

The HIV market experienced continued growth in 2004. Competition accelerates as new products within the current classes of agents (nucleosides, non-nucleosides, protease inhibitors and entry inhibitors) reach the market. The nucleosides segment saw further market share growth for VIREAD (tenofovir) and EMTRIVA (emtricitabine-FTC), both marketed by Gilead Sciences Inc. (Gilead), in the US and European markets in 2004. Gilead also received approval from the FDA for a co-formulation of these two agents, TRUVADA, a one-pill a day combination therapy, in the third quarter of 2004. Final approval in Europe is pending.

GSK received approvals in the US in the third quarter of 2004 and in Europe in December 2004 for a new one-pill a day product , EPZICOM/KIVEXA based on a combination of EPIVIR (lamivudine-3TC) and ZIAGEN (abacavir-ABC).

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