FDA approves Clinigen’s Foscavir sNDA to treat HIV/AIDS-related CMV infections and herpes

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.

Separately, Clinigen has signed an agreement granting South Korea's BL&H Co exclusive rights to market and distribute Foscavir locally. Clinigen and BL&H are collaborating to secure Korean marketing authorizations for Foscavir, both in its primary indications and as a treatment for CMV in hematopoietic stem cell transplant (HSCT) patients (bone marrow transplants). The companies expect a decision from the Korea Food and Drug Administration (KFDA) by the end of 2012.

"We're excited about entering South Korea, not only because of the country's status as a fast-growing emerging market but, crucially, because it is a world leader in the field of stem cell research," said Jim Curtis, business development director at Clinigen. "As we establish relationships with local researchers, we will acquire valuable insights that will inform our approach in other key markets around the world."

Clinigen is in on-going discussions with key opinion leaders in the field of bone marrow transplantation and with the regulatory authorities, with the aim of adding CMV in bone marrow transplant patients to Foscavir's European label later this year. Foscavir received its first marketing authorization for use in the HSCT setting from Japan's Ministry of Health Labor and Welfare (MHLW) in July 2011.