Starpharma and Mundipharma have signed a multi-region licence for the sales and marketing rights to VivaGel BV in Asia (including China, Japan and Korea), the Middle East, Africa and the majority of Latin America.

Mundipharma is one of the largest privately-owned pharmaceutical companies in the world and has a presence in over 120 countries, employing over 8,600 people. 

Mundipharma will register and launch VivaGel BV as part of the popular BETADINE range, which is sold in more than 120 countries. BETADINE has a market leading position in Feminine Care and this licence enables Mundipharma to develop the consumer market for VivaGel BV in rapidly developing markets across Asia, the Middle East, Africa and Latin America, where demand for trusted intimate health and hygiene products is growing.

Under the licence, Starpharma will receive returns via a revenue share on VivaGel BV sales. In addition, Starpharma is eligible to receive signing, regulatory and commercial milestones totaling up to A$12.2 million (US$9.2 million) including a A$1.3 million (US$1 million) upfront payment. The term of the agreement is 15 years and incorporates commercial performance obligations, including minimum annual purchases by Mundipharma. Other commercial terms of the agreement remain confidential.

Mundipharma is responsible for regulatory activities, market pricing and marketing and promotion of the product. Mundipharma will commence regulatory activities immediately with initial approvals anticipated towards the end of 2018. Under the agreement, Starpharma retains ownership of the VivaGel BV trademark and will supply Mundipharma with product.

VivaGel BV already has regulatory approval in both Europe and Australia. In addition, Starpharma has lodged its New Drug Application (NDA) with the US FDA under a Fast Track designation. The NDA submission provides a comprehensive clinical and regulatory package to support rapid approval in many of Mundipharma’s licensed countries.

Starpharma is also in advanced commercial negotiations for marketing rights to VivaGel BV in the rest of world, including North America and Europe, and expects to announce further licensing arrangements in the coming months.