Melbourne, Australia; 22 January 2024: Starpharma (ASX: SPL, OTCQX: SPHRY) today announces it has signed a sales and distribution agreement for its VivaGel^® BV product with ITROM Pharmaceutical Group, covering 13 countries across the Middle East and North Africa (MENA) region. In this region, the prevalence of bacterial vaginosis among a female population of 238 million is 25%, indicating a high need for new effective therapeutic approaches and a significant opportunity for VivaGel^® BV[1]^,[2].

ITROM Pharmaceutical Group is a Middle Eastern company that specialises in bringing new and breakthrough pharmaceutical products to the MENA region. Established in 1998 with its headquarters based in Dubai, ITROM has a strong presence throughout the region’s public and private health sector, maintaining strong relationships with the region’s key opinion leaders, specialist physicians, hospital chains and retail outlets. ITROM has a proven track record of launching and developing the market share of new pharmaceutical products in multiple therapeutic areas within its region, with an expected doubling of its turnover over the next two years through its planned registration and launch of its vast pipeline of licensed products.

VivaGel^® BV is a novel, non-antibiotic vaginal gel developed by Starpharma for bacterial vaginosis, the most common vaginal condition affecting women aged 15 to 44[3]. Starpharma has registered VivaGel^® BV in more than 55 countries, including the UK, Europe, Asia, MENA, Australia and New Zealand, for the treatment of bacterial vaginosis (BV) and prevention of recurrent BV.

This new partnership with ITROM follows the recent reversion of VivaGel^® BV rights to Starpharma under a settlement agreement with Mundipharma, announced in August 2023[4].

ITROM Pharmaceutical Group Chief Executive Officer Dr Ismail Soboh commented:

“Starpharma's novel VivaGel^® BV is an excellent product that offers women a unique, non-antibiotic solution for the treatment and prevention of recurrent bacterial vaginosis, particularly those seeking a safe and effective alternative to antibiotics. We are excited to add this product to our portfolio and look forward to launching it across the MENA region. We believe that VivaGel^® BV has the potential to make a real difference in the lives of women struggling with bacterial vaginosis, and we are excited to be part of this journey.”

Starpharma Chief Executive Officer Ms Cheryl Maley commented:

"The ITROM Pharmaceutical Group specialises in commercialising new products in the Middle East and North Africa markets. In this region, the relatively high prevalence of BV among the female population represents a high unmet need. We are pleased to have signed a sales and distribution agreement with ITROM, who have shown great enthusiasm for bringing the product to market quickly and with strong support."

This exclusive sales and distribution agreement with ITROM has an initial 7-year term. It covers the United Arab Emirates, Saudi Arabia, Kuwait, Qatar, Oman, Bahrain, Jordan, Lebanon, Egypt, Libya, Morocco, Tunisia, and Algeria.

Under the agreement, Starpharma will manufacture and supply VivaGel^® BV, with ITROM responsible for sales, distribution, and marketing in the MENA region. The agreement includes performance obligations and customary termination provisions for sales and distribution agreements.

ITROM will market the product under the VivaGel^® BV trademark. Starpharma will now commence the transferral processes for the existing VivaGel^® BV registrations. Starpharma expects a phased launch plan across the region to follow soon after this process has been completed and expects sales to commence in FY25.

View/download the ASX Announcement: VivaGel® BV sales and distribution agreement – MENA region.

[1] https://data.worldbank.org/indicator/SP.POP.TOTL.FE.IN?locations=ZQ

[2] https://pubmed.ncbi.nlm.nih.gov/30624309/

[3] https://www.cdc.gov/std/bv/stdfact-bacterial-vaginosis.htm

[4] ASX Announcement dated 14 August 2023: Starpharma to receive A$6.5M from Mundipharma and rights to VivaGel^® BV