Clinigen Healthcare, the pharmaceutical products division of Clinigen Group, announced today that its supplemental new drug application (sNDA) for Foscavir (foscarnet sodium), a treatment for HIV/AIDS-related cytomegalovirus (CMV) infections and herpes, has been approved by the US Food and Drug Administration (FDA).
Clinigen appointed Hospira (NYSE: HSP) to distribute Foscavir to US patients on an emergency supply basis in September 2011. Now that FDA approval has been received, Hospira has the exclusive rights to market, promote and distribute Foscavir in the US pursuant to the License and Distribution Agreement executed by Hospira and Clinigen in July 2011.
Peter George, chief executive of Clinigen Group, commented: "Since we acquired global rights to Foscavir, a mature brand from AstraZeneca, in March 2010 our growth strategy for the product has included work on its price, the label and its availability in different geographical markets. We've already established good penetration across Europe, but because we didn't initially have a US license, the country's contribution to overall Foscavir sales has been relatively modest. Being granted an sNDA in the world's largest pharmaceutical market will be key to meeting our ambitious growth projections."
Global Foscavir revenues grew six-fold in 2010-2011 and Clinigen expects another doubling in sales by the end of the current financial year.