– Starpharma licenses VivaGel® BV to Mundipharma for Europe, Russia, CIS1 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, plus an upfront fee and eligible milestones which total up to US$15.5M
– This deal brings the total eligible milestones payable to Starpharma for all Mundipharma territories up to US$24.7M, plus revenue share
– Mundipharma plans to launch VivaGel® BV in Europe as soon as practicable
SINGAPORE, June 27, 2018 /PRNewswire/ — 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 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 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.
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.
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.
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
Starpharma Holdings Limited (ASX: SPL, OTCQX:SPHRY), located in Melbourne Australia, is an ASX 300 company and is a world leader in the development of dendrimer products for pharmaceutical, life science and other applications.
Starpharma’s underlying technology is built around dendrimers — a type of synthetic nanoscale polymer that is highly regular in size and structure and well suited to pharmaceutical and medical uses. Starpharma has two core development programs: VivaGel® portfolio and DEP® drug delivery with the Company developing several products internally and others via commercial partnerships.
VivaGel®: Starpharma’s women’s health product – VivaGel® BV is based on SPL7013, astodrimer sodium, a proprietary dendrimer. VivaGel® BV is approved for marketing in the EU and Australia for bacterial vaginosis (BV) and a new drug application is under Fast Track review by the US FDA. Starpharma has licensed the sales and marketing of VivaGel® BV to Mundipharma for Europe, Russia, CIS, Asia, the Middle East, Africa and Latin America; and to Aspen Pharmacare for Australia and New Zealand. Starpharma also has licence agreements to market the VivaGel® condom (an antiviral condom which includes VivaGel® in the lubricant) in several regions, including Australia, Europe, Canada, China and Japan (Okamoto). The VivaGel® condom has been launched in Australia and Canada under the Lifestyles® Dual Protect™ brand.
DEP® – Dendrimer Enhanced Product®: Starpharma’s DEP® drug delivery platform has demonstrated reproducible preclinical benefits across multiple internal and partnered DEP® programs, including improved efficacy, safety and survival. Starpharma has two internal DEP® products – DEP® docetaxel and DEP® cabazitaxel – in clinical development in patients with solid tumours, and further DEP® products approaching clinical development. Starpharma’s partnered DEP® programs include a multiproduct DEP® licence with AstraZeneca, which involves the development and commercialisation of two novel oncology compounds, with potential to add more.
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Forward Looking Statements
This document contains certain forward-looking statements, relating to Starpharma’s business, which can be identified by the use of forward-looking terminology such as "promising", "plans", "anticipated", "will", "project", "believe", "forecast", "expected", "estimated", "targeting", "aiming", "set to", "potential", "seeking to", "goal", "could provide", "intends", "is being developed", "could be", "on track", or similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA’s and other authorities’ requirements regarding any one or more product candidates nor can there be any assurance that such product candidates will be approved by any authorities for sale in any market or that they will reach any particular level of sales. In particular, management’s expectations regarding the approval and commercialization of the product candidates could be affected by, among other things, unexpected trial results, including additional analysis of existing data, and new data; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Starpharma is providing this information as of the date of this document and does not assume any obligation to update any forward-looking statements contained in this document as a result of new information, future events or developments or otherwise.
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