• Starpharma licenses VivaGel®BV to Mundipharma for Europe, Russia, CIS[1] and the balance of Latin America to be marketed as part of the popular BETADINE® Feminine Care portfolio
• Deal terms include a financially attractive revenue share; in addition to an upfront fee and eligible milestones which total up to A$20.9M (US$15.5M)
• This deal brings the total eligible milestones payable to Starpharma for all Mundipharma territories up to A$33.3M (US$24.7M), plus revenue share 
• Mundipharma plans to launch VivaGel®BV in Europe as soon as practicable  

Melbourne, Australia; 27 June 2018: Starpharma (ASX: SPL, OTCQX: SPHRY) and Mundipharma today announced they have signed a licence agreement for the sales and marketing rights to VivaGel®BV for 43 countries in Europe, Russia, the Commonwealth of Independent States (CIS) and the balance of countries in Latin America. This deal builds on the VivaGel® BV licence signed with Mundipharma in May 2018 for Asia, the Middle East, Africa and parts of Latin America. 

Mundipharma is a leading global pharmaceutical company and owns the successful international brand - BETADINE®. It is one of the largest privately-owned pharmaceutical companies in the world employing over 8,600 people. 

The European region is an important addition to the territories already under licence with Mundipharma.Europe represents a large commercial opportunity for VivaGel® BV, enabling access to more than 260 million women. Coupled with the European Union (EU) regulatory approval already in place, this licence is expected to provide a rapid timeline for product launch. Mundipharma will proceed to launch the product under its BETADINE® brand as soon as practicable with first launches targeted for early 2019.

Consistent with the previous Mundipharma deal, Starpharma will receive returns via a revenue share on VivaGel® BV sales and is also eligible to receive signing, launch and other commercial milestones. Under the European deal, eligible milestones total up to A$20.9 million (US$15.5 million), including a A$2.0 million (US$1.5 million) upfront payment. The combination of territories now under licence with Mundipharma means Starpharma is eligible to receive total signing, regulatory and commercial milestones of up to A$33.3 million (US$24.7 million), in addition to receiving revenue share.

The term of this licence is 15 years and contains commercial performance obligations, including minimum annual purchases by Mundipharma. Mundipharma is responsible for marketing, promotion and sales of the product in its licensed territories. Starpharma retains ownership of the VivaGel® BV trademark and will supply Mundipharma with VivaGel® BV. Other commercial terms of the agreement remain confidential.

Commenting on the licence, Dr Jackie Fairley, CEO of Starpharma said: “We are delighted to expand our commercial relationship with Mundipharma, owners of the rapidly growing feminine care brand, BETADINE®. In particular, Europe represents a very important market for VivaGel® BV and with this licence in place, VivaGel® BV will soon be available to millions of European women who suffer from BV. We’re impressed by Mundipharma’s commitment to the feminine care category and their plans to expedite the product launch through their extensive marketing network in Europe”. 

Raman Singh, Mundipharma CEO, commented: “We’re excited to be working with Starpharma in an area of significant unmet need and to be adding this highly innovative product, VivaGel® BV, to our BETADINE® feminine care range throughout additional regions, including Europe.”

The signing of this licence for Europe is the culmination of a competitive process undertaken by Starpharma involving multiple leading pharmaceutical and women’s health companies. Significant weighting was applied to commercial terms, each company’s marketing and sales capabilities, as well as their planned time to market.

Starpharma is also in advanced commercial negotiations for marketing rights to VivaGel® BV in North America and expects to announce further licensing arrangements in the near future. Starpharma lodged its New Drug Application (NDA) with the US FDA under a Fast Track designation in April 2018. 

Raman Singh, Mundipharma CEO, commented: “We’re excited to be working with Starpharma in an area of significant unmet need and to be adding this highly innovative product, VivaGel® BV, to our BETADINE® feminine care range throughout additional regions, including Europe.”

The signing of this licence for Europe is the culmination of a competitive process undertaken by Starpharma involving multiple leading pharmaceutical and women’s health companies. Significant weighting was applied to commercial terms, each company’s marketing and sales capabilities, as well as their planned time to market.

Starpharma is also in advanced commercial negotiations for marketing rights to VivaGel® BV in North America and expects to announce further licensing arrangements in the near future. Starpharma lodged its New Drug Application (NDA) with the US FDA under a Fast Track designation in April 2018. 

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). Current therapies for BV are inadequate and have many unpleasant side-effects, there are also no approved products in the US for recurrent BV making VivaGel® BV a first-in-class therapy supported by large, randomised clinical studies. 

About Mundipharma 

Mundipharma is a network of independent associated companies which are privately owned entities covering pharmaceutical markets in Asia-Pacific, Latin America, the Middle East and Africa. The headquarters for these territories is in Singapore. Mundipharma is a prime example of an organization that consistently delivers high-quality medicines while standing by the values it represents. Its mission is to alleviate the suffering of patients and to substantially improve their quality of life. Mundipharma is dedicated to bringing to patients the benefit of novel treatment options in fields such as pain, oncology, oncology supportive care, ophthalmology, respiratory disease and consumer healthcare. For more information please visit: www.mundipharma.com

Download ASX Announcement: Starpharma licenses VivaGel® BV to Mundipharma for Europe (PDF, 142kb)

[1] CIS: Commonwealth of Independent States is a political and economic confederation of nine-member states and one associate member, all of which are former Soviet Republics located in Eurasia (primarily in Central to North Asia), formed following the dissolution of the Soviet Union.

• Starpharma licenses VivaGel®BV to Mundipharma for Europe, Russia, CIS[1]and the balance of Latin America to be marketed as part of the popular BETADINE®Feminine Care portfolio
• Deal terms include a financially attractive revenue share; in addition to an upfront fee and eligible milestones which total up to A$20.9M (US$15.5M)
• This deal brings the total eligible milestones payable to Starpharma for all Mundipharma territories up to A$33.3M (US$24.7M), plus revenue share 
• Mundipharma plans to launch VivaGel®BV in Europe as soon as practicable 

Melbourne, Australia; 27 June 2018:Starpharma (ASX: SPL, OTCQX: SPHRY) and Mundipharma today announced they have signed a licence agreement for the sales and marketing rights to VivaGel®BV for 43countries in Europe, Russia, the Commonwealth of Independent States (CIS) and the balance of countries in Latin America. This deal builds on the VivaGel®BV licence signed with Mundipharma in May 2018 forAsia, the Middle East, Africa and parts of Latin America. 

Mundipharma is a leading global pharmaceutical company and owns the successful international brand - BETADINE®. It is one of the largest privately-owned pharmaceutical companies in the world employing over 8,600 people. 

The European region is an important addition to the territories already under licence with Mundipharma.Europe represents a large commercial opportunity for VivaGel®BV, enabling access to more than 260 million women. Coupled with the European Union (EU) regulatory approval already in place, this licence is expected to provide a rapid timeline for product launch. Mundipharma will proceed to launch the product under its BETADINE®brand as soon as practicable with first launches targeted for early 2019.

Consistent with the previous Mundipharma deal, Starpharma will receive returns via a revenue share on VivaGel®BV sales and is also eligible to receive signing, launch and other commercial milestones. Under the European deal, eligible milestones total up to A$20.9 million (US$15.5 million), including a A$2.0 million (US$1.5 million) upfront payment. The combination of territories now under licence with Mundipharma means Starpharma is eligible to receive total signing, regulatory and commercial milestones of up to A$33.3 million (US$24.7 million), in addition to receiving revenue share.

The term of this licence is 15 years and contains commercial performance obligations, including minimum annual purchases by Mundipharma. Mundipharma is responsible for marketing, promotion and sales of the product in its licensed territories. Starpharma retains ownership of the VivaGel®BV trademark and will supply Mundipharma with VivaGel®BV. Other commercial terms of the agreement remain confidential.

Commenting on the licence, Dr Jackie Fairley, CEO of Starpharma said: “We are delighted to expand our commercial relationship with Mundipharma, owners of the rapidly growing feminine care brand, BETADINE®. In particular, Europe represents a very important market for VivaGel®BV and with this licence in place, VivaGel®BV will soon be available to millions of European women who suffer from BV. We’re impressed by Mundipharma’s commitment to the feminine care category and their plans to expedite the product launch through their extensive marketing network in Europe”. 

Raman Singh, Mundipharma CEO, commented: “We’re excited to be working with Starpharma in an area of significant unmet need and to be adding this highly innovative product, VivaGel®BV, to our BETADINE®feminine care rangethroughout additional regions, including Europe.”

The signing of this licence for Europe is the culmination of a competitive process undertaken by Starpharma involving multiple leading pharmaceutical and women’s health companies. Significant weighting was applied to commercial terms, each company’s marketing and sales capabilities, as well as their planned time to market.

Starpharma is also in advanced commercial negotiations for marketing rights to VivaGel®BV in North America and expects to announce further licensing arrangements in the near future. Starpharma lodged its New Drug Application (NDA) with the US FDA under a Fast Track designation in April 2018. 

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). Current therapies for BV are inadequate and have many unpleasant side-effects, there are also no approved products in the US for recurrent BV making VivaGel® BV a first-in-class therapy supported by large, randomised clinical studies. 

About Mundipharma 

Mundipharma is a network of independent associated companies which are privately owned entities covering pharmaceutical markets in Asia-Pacific, Latin America, the Middle East and Africa. The headquarters for these territories is in Singapore. Mundipharma is a prime example of an organization that consistently delivers high-quality medicines while standing by the values it represents. Its mission is to alleviate the suffering of patients and to substantially improve their quality of life. Mundipharma is dedicated to bringing to patients the benefit of novel treatment options in fields such as pain, oncology, oncology supportive care, ophthalmology, respiratory disease and consumer healthcare.For more information please visit: www.mundipharma.com

[1]CIS: Commonwealth of Independent States is a political and economic confederation of nine-member states and one associate member, all of which are former Soviet Republics located in Eurasia (primarily in Central to North Asia), formed following the dissolution of the Soviet Union.

• Starpharma licenses VivaGel®BV to Mundipharma for Europe, Russia, CIS[1]and the balance of Latin America to be marketed as part of the popular BETADINE®Feminine Care portfolio
• Deal terms include a financially attractive revenue share; in addition to an upfront fee and eligible milestones which total up to A$20.9M (US$15.5M)

About Starpharma

This document contains Forward Looking Statements

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