Novavax Inc and King Pharmaceuticals Inc announced that the U.S. Food and Drug Administration (FDA) has approved Estrasorb (estradiol topical emulsion), the first prescription topical emulsion for estrogen therapy. Estrasorb, which utilizes a topical formulation developed by Novavax, is approved for short-term use to reduce moderate to severe vasomotor symptoms - commonly known as "hot flashes" – in menopausal women.

"The approval of Estrasorb marks the culmination of over nine years of work on our proprietary micellar nanoparticle (MNP) drug delivery platform," commented Nelson M. Sims, President and Chief Executive Officer of Novavax. "As a result, we have the opportunity to create a unique position within the $1.6 billion domestic estrogen therapy market. We are also optimistic about the potential of our proprietary MNP technology for use in a wide variety of other drug classes such as analgesics, central nervous system drugs and anti-inflammatory agents. With FDA approval of Estrasorb, Novavax joins an elite group of biopharmaceutical companies that have transitioned from a discovery-based start-up to a fully integrated, operating company."

Novavax and King will co-promote Estrasorb in the United States and Puerto Rico. The companies will share equally gross profits from net sales of Estrasorb within these territories and associated costs of promotion. King also has an exclusive license from Novavax to promote, market, distribute and sell Estrasorb worldwide, except in the United States and Puerto Rico. Novavax will receive a royalty on net sales of Estrasorb outside of the United States and Puerto Rico. Novavax and King expect to launch Estrasorb in the United States and Puerto Rico in early 2004 utilizing a combined sales force of over 120 individuals.