May 03, 2018

Mundipharma licenses Starpharma’s VivaGel® BV

Mundipharma licenses Starpharma’s VivaGel® BV
  • Mundipharma licenses Starpharma’s VivaGel® BV for Asia, Middle East, Africa and the majority of Latin America, to be marketed as part of the popular BETADINE® Feminine Care portfolio
  • Mundipharma is a leading global pharmaceutical company and owns the successful international brand - BETADINE®
  • BETADINE® has a market leading position in Feminine Care, trusted by women globally
  • Mundipharma will commence regulatory activities in their licensed territory immediately to secure expedited launch of VivaGel® BV
  • Deal terms include milestones of ~A$12.2 million and a revenue share  


Melbourne, Australia:
Starpharma (ASX: SPL, OTCQX: SPHRY) and Mundipharma today announced they 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.

Commenting on the licence, Dr Jackie Fairley, CEO of Starpharma said: “We are delighted to have licensed VivaGel® BV to Mundipharma, a global leader in healthcare. Mundipharma’s market leading position and extensive sales, marketing and regulatory network make them the ideal partner for VivaGel® BV in this expansive territory. The licence represents a financially attractive deal for Starpharma. Over the coming months, we’ll be working closely with Mundipharma to secure market access for VivaGel® BV as quickly as possible throughout their territory.”  

Raman Singh, Mundipharma CEO, commented: “The VivaGel® BV product represents a true innovation in the management of bacterial vaginosis (BV). It sits well under the BETADINE® brand, which has emerged as a powerful brand platform for consumer healthcare products, trusted by women globally.” 

For more information about the BETADINE® Feminine Care portfolio please visit:

http://my.betadine.com/en/my/feminine-care

About VivaGel® BV 

VivaGel® BV is a patented, water-based vaginal gel for the treatment of bacterial vaginosis (BV) and prevention of recurrent BV. VivaGel® BV is a breakthrough product which specifically targets the organisms that cause BV, rapidly relieves symptoms and has a novel mechanism of action affecting biofilm. VivaGel® BV is a non-antibiotic therapy and is not absorbed into the bloodstream.

About Bacterial Vaginosis (BV)

Bacterial vaginosis is the most common cause of vaginal infection for women of childbearing age and affects around 30% of women in the US. It is a highly recurrent condition with 50‑60% of sufferers having it recurrently. BV is caused by an imbalance of naturally occurring bacterial flora (the usual bacteria found in a woman's vagina). Smoking, the use of some hygiene products and several other risk factors are linked to a higher risk of developing BV. Current therapies for BV are inadequate and have many unpleasant side-effects, there are also no approved products in the US for rBV making VivaGel® BV a first-in-class therapy supported by large, randomised clinical studies.

About Mundipharma

Mundipharma’s independent associated companies are privately owned entities covering the world's pharmaceutical markets. Mundipharma is a prime example of a company that consistently delivers high quality products while standing by the values that represent the company. Our mission is to alleviate the suffering of patients with cancer and non-cancer pain and to substantially improve their quality of life. Mundipharma is dedicated to bringing to patients with severe and debilitating diseases the benefit of novel treatment options in fields such as pain, oncology, ophthalmology, respiratory disease, rheumatoid arthritis and antiseptics.  In efforts to combat infectious diseases around the world, Mundipharma has and continues to donate BETADINE® products.

For more information please visit: www.mundipharma.com

Download ASX Announcement: Mundipharma licenses Starpharma’s VivaGel® BV (pdf file, 154kb)