22 MARKET NEWS 'Adderall' for ADHD and hypersomnia in the US

The combination amphetamine/dexamphetaimne product ['Adderall'; Richwood] has gained a supplemental approval by the US FDA for the treatment of attention deficit hyperactivity disorder (ADHD), hypersomnia and exogenous obesity, reports the Pink Sheet. Richwood will launch the drug in March this year for all indications, except obesity.

'Adderall' was withdrawn from the US market in October 1994, following a warning letter by the FDA that cited Richwood for marketing an unapproved new drug.

Cost advantage over current leader 'Adderall' was previously marketed by Rexar

Pharmaceuticals as 'Obetrol', but withdrawn from sale in 1973. According to the FDA, Rexar reformulated 'Obetrol' and continued to market the drug even though a supplemental NDA for the new formulation had not gained regulatory approval. Richwood obtained the amphetaminel dexamphetamine product through its acquisition of Rexar in 1994.

'Adderall' appears to have a slight cost advantage over methylphenidate ['Ritalin'; Geneva]; $US.25 vs $USO.32 per day, respectively (average wholesale prices). Methylphenidate is the current leader in the market for ADHD therapies. 'Adderall' has the lowest age threshold for use in ADHD - it is indicated for children aged ~ 3-5 years. Richwood Addc:rall return to market in March to follow sNDA approval. FOe Reports - Pink sbcel - Prescription Pharmaceuticals and Biotechnology: T &G 4, 26 Feb 1996 _,...,

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