Starpharma Holdings Limited products

Starpharma’s technology is based on a type of polymer, a highly branched, roughly spherical polymer – called a dendrimer. Dendrimers are precise, synthetically manufactured, nanoscale molecules with unique properties that make them useful to the health and pharmaceutical industry to enhance existing products and as entirely new products. Starpharma`s dendrimer technology allows the creation of specifically defined nanoparticles that are applicable to a wide range of medical uses. Starpharma uses its proprietary dendrimers in two different ways: as therapeutics themselves (e.g. SPL7013/VivaGel®) or by using the dendrimer scaffold (DEP®) with covalently attached drug molecules (DEP® conjugate) to improve the performance of those existing drugs.

VIRALEZE™ is an antiviral nasal spray that contains astodrimer sodium (SPL7013), which has been shown in laboratory studies to inactivate a broad spectrum of respiratory viruses, including >99.9% of coronavirus SARS-CoV-2, the virus that causes COVID-19.^

VivaGel® (SPL7013, or astodrimer sodium) is an innovative agent applied to a range of marketed women’s health and sexual wellness products. The safety and efficacy of VivaGel® has been successfully tested in several clinical studies.  VivaGel® is a proprietary dendrimer that is antiviral and blocks bacteria. When formulated as a mucoadhesive gel and delivered vaginally, VivaGel® has been shown to relieve the signs and symptoms of bacterial vaginosis (BV), and to reduce risk of recurrence of BV, in clinical studies. Further, VivaGel® has been shown, in laboratory studies, to have broad-spectrum and potent antiviral activity against a wide range of viruses, including HIV, herpes simplex, hepatitis B, HPV, Zika, adenovirus, RSV and SARS-CoV-2 (the coronavirus that causes COVID-19). 

VivaGel® BV is available for sale under the brand names Betafem® BV Gel (UK), Betadine BVTM (Europe), BetadineTM BV Gel (Asia) and Fleurstat BVgel (Australia & New Zealand). VivaGel® has been developed for the treatment of BV and prevention of recurrent bacterial vaginosis (BV).  BV is caused by an imbalance of the normal vaginal bacterial microflora, with healthy bacteria (e.g. Lactobacillus species) being depleted and harmful bacteria (e.g. Gardnerella vaginalis) overly abundant. VivaGel® formulated as a mucoadhesive gel (VivaGel® BV) has been approved for marketing in the European Union as a 7-day therapy for treatment and prevention of BV including its symptoms.  VivaGel® BV has been shown to have efficacy for treatment of BV in a Phase 2 clinical study and was shown to achieve statistically significant cure of the signs and symptoms of BV at the end of treatment in two Phase 3 studies. 

Starpharma’s VivaGel® condom is the world’s first and only antiviral condom. The physical barrier of the condom provides primary protection against sexually transmitted infections (STIs). The condom is lubricated with VivaGel® lubricant.  VivaGel® (SPL7013, or astodrimer sodium) is an antiviral agent proven, in laboratory studies only, to inactivate HIV, herpes simplex virus (HSV) and human papillomavirus (HPV), which are viruses that cause STIs.

DEP® cabazitaxel is an enhanced version of leading prostate cancer drug cabazitaxel (Jevtana®). Cabazitaxel (Jevtana®) had global sales of €536M in 2020 despite having multiple US FDA “Black Box” warnings.

DEP® irinotecan is an improved version of irinotecan (Camptosar®), predominantly used for colorectal cancer. DEP® irinotecan is a novel, patented nanoparticle formulation of SN-38, the active metabolite of irinotecan, delivered using Starpharma’s proprietary DEP® technology. Irinotecan (Camptosar®) is a major cancer drug used to treat colorectal cancer with peak global sales of >US$1.1 billion despite having multiple US FDA “Black Box” warnings. Irinotecan is a pro-drug that requires conversion to its active metabolite, SN38. The need for this conversion may lead to variable clinical effect/efficacy and toxicity among patients. DEP® solubilises SN38 and allows direct dosing, avoiding the need for liver conversion. DEP® irinotecan has been shown to demonstrate improved efficacy in multiple animal models and has patent filings to 2039 (plus up to an additional ~5 years).

Starpharma’s DEP® technology provides enhanced therapeutic benefits to Antibody Drug Conjugates (ADCs) including greater homogeneity, site specific attachment, and higher drug antibody ratio (DAR), than conventional ADC approaches. The use of ADCs is an innovative and cutting-edge area in cancer therapy that continues to grow, and Starpharma has a number of partner programs in the area. Starpharma’s novel DEP® HER-2 Targeted ADC binds to the same target (HER-2) as the leading monoclonal antibody and ADC cancer therapies, Herceptin® and Kadcyla®, which had sales in excess of US$5 billion in 2021.

DEP® radiotheranostic conjugates have the potential to minimise off-target toxicity, optimise pharmacokinetics and enhance efficacy when used alone or in combination with other therapeutic approaches. The versatility of Starpharma’s DEP® platform means it can be used with a wide range of therapies and types of molecules (e.g., small molecule drugs, peptides, antibodies, radioisotopes). This flexibility has allowed Starpharma to develop a range of DEP® radiotheranostics as well as its other DEP® programs. Radiotheranostics is a rapidly developing area of cancer treatment and diagnosis, and sales in this category are estimated to grow to $12–15 billion by 2030 (source: Nuclear medicine world market report & directory, MEDraysintell, 2016). The area has also seen several significant commercial acquisitions in recent years.