Announcement PDF VivaGel® BV sales and distribution agreement – MENA region 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® BV1,2. 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 443. 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 20234. 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. https://data.worldbank.org/indicator/SP.POP.TOTL.FE.IN?locations=ZQ 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 1 2 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. About Starpharma Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY) is a world leader in dendrimer technology for medical applications. As an innovative Australian biopharmaceutical company, Starpharma is focused on developing and commercialising novel therapeutic products that address significant global healthcare needs. Starpharma boasts a strong portfolio of products, partnerships, and intellectual property. Starpharma’s innovative technology is based on proprietary polymers called dendrimers, which are precise, synthetically manufactured, nanoscale molecules. The unique properties of dendrimers – including their size, structure, high degree of branching, polyvalency, and water solubility – are advantageous in medical and pharmaceutical applications. Starpharma uses its dendrimer technology to develop novel therapeutics and to improve the performance of existing pharmaceuticals. Starpharma’s portfolio includes multiple clinical-stage oncology products, which utilise its Dendrimer Enhanced Product (‘DEP®’) drug delivery technology, and marketed products, including VIRALEZE™ and VivaGel® BV, which utilise SPL7013, a proprietary dendrimer with antimicrobial properties. Starpharma’s DEP® drug delivery platform is being used to enhance the effectiveness of existing and novel therapies and to reduce drug-related toxicities through controlled and specified drug delivery. In addition to Starpharma’s internal DEP® programs, Starpharma has multiple DEP® partnerships with international biopharmaceutical companies, including AstraZeneca (oncology), MSD (Antibody-Drug Conjugates), Chase Sun (anti-infectives), and other world-leading pharmaceutical companies. Due to the broad applicability and optionality of Starpharma’s DEP® platform, partnered DEP® programs have the potential to generate significant future milestones and royalties. Starpharma’s topical antiviral nasal spray, VIRALEZE™, is now registered in more than 35 countries*, including Europe, the UK, and Asia. Starpharma’s novel non-antibiotic vaginal gel, VivaGel® BV, for the treatment of bacterial vaginosis (BV) and prevention of recurrent BV, is registered in more than 50 countries, including in the UK, Europe, Southeast Asia, South Africa, Australia and New Zealand. For more information about Starpharma, visit www.starpharma.com or connect with Starpharma on LinkedIn. WE Communications Hannah Howlett WE-AUStarPharma@weworldwide.com Starpharma Holdings Limited Cheryl Maley, Chief Executive Officer Justin Cahill, CFO and Company Secretary +61 3 8532 2700 investor.relations@starpharma.com 4-6 Southampton Crescent Abbotsford Vic 3067 Disclosure This ASX Announcement was authorised for release by NonExecutive Director Dr Jeff Davies. 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”, “outlook”, or similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such forwardlooking 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. Clinical case studies and other clinical information given in this document are given for illustrative purposes only and are not necessarily a guide to product performance and no representation or warranty is made by any person as to the likelihood of achievement or reasonableness of future results. Nothing contained in this document nor any information made available to you is, or shall be relied upon as, a promise, representation, warranty or guarantee as to the past, present or the future performance of any Starpharma product. 2