Good news flowed in at Gilead Sciences Inc. (GILD - Free Report) from Europe regarding its drug Viread. The European Commission (EC) cleared the drug for a couple of additional indications.
Following the clearance by the EC, Viread (as a combination therapy) will be marketed in the EU for treating HIV infected children aged between 2 and 18 years. The EC also approved Viread for treating adolescents, aged above 12 but less than 18 years, infected with chronic hepatitis B virus.
The approval by the EC will allow Gilead to market a new oral granule version of Viread for treating HIV infected children aged between 2 and 6 years in the EU. The oral granule formulation of the drug will also be available in the EU for treating HIV infected children above 6 years of age for whom a solid dosage version is inappropriate.
Moreover, the EC also cleared Viread tablets to be marketed in the EU at three new lower dosages (123 mg, 163 mg and 204 mg) for treating HIV infected children aged between 6 and 12 years.
We note that Viread is already available in the EU as a combination therapy for treating HIV infected adults and also for chronic HBV. Approval for additional indications in the EU would further boost Viread’s sales potential. Viread competes primarily with GlaxoSmithKline’s (GSK - Free Report) Epivir.
We remind investors that in January 2012, the US Food and Drug Administration (FDA) cleared Viread as a combination therapy in children aged between 2 and 12 years for treating HIV. The US agency cleared Viread in doses of 150 mg, 200 mg and 250 mg for children in the age group of 6-12 years. Additionally, the FDA also cleared an oral powder version of Viread for children aged between 2 and 5 years.
We currently have a Neutral recommendation on Gilead. Gilead carries a Zacks #3 Rank (Hold rating) in the short run.