Announcement PDF JULY 2017 ›› Starpharma sells Agrochemicals business to Agrium for $35M cash Starpharma recently announced the sale of its agrochemicals and Priostar® business (Starpharma Agrochemicals) to Agrium, one of the largest agribusinesses in the world, for A$35M cash consideration. Agrium is listed on the NYSE and TSE and has a market capitalisation of ~US$13 billion and 1,500 ag-retail outlets globally. Starpharma Agrochemicals comprised key patents and technical know-how, and a small number of Starpharma staff dedicated solely to Priostar® dendrimers and agrochemicals operations. The sale was part of a planned strategy to maximise the value of, and monetise, Priostar® technology and does not impact on VivaGel® or DEP® IP or product opportunities. Starpharma had developed a range of value-added formulations utilising Priostar® to a stage where those products had high attraction value as differentiated products for Analyst view “We believe the company is in a much stronger position to generate value from its assets as a result of this transaction.” Canaccord Genuity Analyst, Matthijs Smith “This acquisition represents an exciting strategic technology platform for Loveland Products that will serve to further differentiate our proprietary product line and open new product development partnership opportunities”. Chuck Magro, President & CEO of Agrium “This one is special. It’s hard to find good technology that works… This is fairly unique because it will help us make considerable gains with product formulation and give farmers noticeably better results in the paddock.” Brent Smith, President of Loveland Products & Vice President of Proprietary Technology & Innovation of Agrium a market-facing third party such as Agrium. With the net proceeds from the transaction, Starpharma’s cash balance was greater than $60 million at 30 June 2017. This sale enables Starpharma to focus resources and activities on its core pharmaceutical development programs, and places the company in an excellent financial position to expand and accelerate the development of its internal DEP® programs. Key transaction details • A$35M cash consideration • Sale amount is >4x book value of A$7.5M • No conditions precedent • No income tax payable • No impact on VivaGel® or DEP® IP • Advised by Macquarie Capital Left to right: Matthew Marshall, Agrium Corporate Development & Strategy Manager, Brent Smith, President Loveland Products & Agrium VP of Proprietary Technology & Innovation, Dr Jackie Fairley, Starpharma CEO, Nigel Baade, Starpharma CFO. ›› DEP® irinotecan outperforms irinotecan in multiple cancer models Starpharma’s proprietary DEP® irinotecan has demonstrated significantly improved anti-tumour activity and increased survival compared with irinotecan in a variety of human colon cancer models. DEP® irinotecan is Starpharma’s dendrimer enhanced version of the already marketed major cancer drug, irinotecan (marketed by Pfizer under the brand name Camptosar®). Irinotecan is primarily used to treat colorectal cancer, which is a significant unmet need and attractive market. Camptosar® achieved peak sales of US$1.1 billion prior to losing patent exclusivity despite having a US FDA “Black Box” warning for severe diarrhoea and myelosuppression (including neutropenia). In Starpharma’s studies, a single treatment cycle of DEP® irinotecan administered on days 1, 8 and 15 significantly improved anti-tumour activity and enhanced survival compared to irinotecan (Camptosar®) in all cancer models tested. In the SW-620 colon cancer model, DEP® irinotecan resulted in complete tumour regression and 100% survival in animals treated. APPOINTMENT PARTNERED DRUG DELIVERY INTERNAL DRUG DELIVERY ›› DEP® irinotecan (continued) Figures 1 and 2 show the efficacy (anti-tumour effect – mean tumour volume) and survival curves comparing DEP® irinotecan to irinotecan and vehicle control. DEP® irinotecan demonstrated markedly enhanced efficacy and survival rates compared to irinotecan and the differences were highly statistically significant (P<0.0001 and P<0.0045, respectively). DEP® irinotecan was also shown to be very effective in another model – a colon cancer (HT-29) tumour model, which typically responds poorly to irinotecan (and did so in this study). In this model DEP® irinotecan treatment resulted in an 11.8-fold improvement in survival compared with irinotecan. In this model, irinotecan did not achieve appreciable anti-cancer activity compared to vehicle (saline), whereas DEP® irinotecan exhibited a significant anti-cancer effect. DEP® irinotecan was significantly more effective than irinotecan (P<0.0001) for both enhanced efficacy and survival. DEP® irinotecan was also well tolerated in the HT-29 model. Figures 3 and 4 show efficacy (anti-tumour effect – mean tumour volume) and survival curves comparing DEP® irinotecan to irinotecan and vehicle control. DEP® irinotecan demonstrated enhanced efficacy and survival rates compared with irinotecan and the differences were highly statistically significant (P<0.0001 and P<0.0001, respectively). These impressive results for DEP® irinotecan are very promising and entirely consistent with the performance of other DEP® candidates from Starpharma’s internal and partnered programs. How does the DEP® technology work? Starpharma uses its dendrimer technology to improve the performance of drugs through delivery. DEP® technology enables the drug to ‘get to right place’ and a formulation that is more ‘patient friendly’. Starpharma’s DEP® versions of anti-cancer drugs have been shown to reduce the toxicity and side effects of existing drugs such as neutropenia, and hair loss – which has been reported by chemotherapy patients as the most feared side effect of their treatment. SW-620 Xenograft Figure 1 Figure 2 HT-29 Xenograft Figure 3 Analyst view “Preclinical data from [the] DEP irinotecan study impresses us… In our view, this data provides further validation of SPL’s DEP platform. What is remarkable for us is that we have now seen similar results (preclinical improved efficacy outcomes) across various drugs and across different animal models.” Bell Potter Analyst, Tanu Jain Figure 4 ›› DEP® docetaxel, DEP® cabazitaxel and scale-up facilities Starpharma is developing several anti-cancer DEP® products internally (in addition to DEP® irinotecan). These products include DEP® docetaxel, Starpharma’s most advanced internal DEP® program, which is currently in the late stages of a phase 1 clinical trial and will soon enter phase 2, and DEP® cabazitaxel, which is due to enter a clinical trial later this year. DEP® docetaxel is a dendrimerenhanced version of docetaxel (Taxotere®). DEP® docetaxel continues to show promising efficacy signals, with no neutropenia among patients in the final expansion phase of the phase 1 clinical trial. Starpharma plans to utilise an adaptive trial design to facilitate rapid transition into phase 2 following completion of the final few patients in the phase 1 cohort. Key preparations, such as product manufacture, and CRO selection, are already complete for a seamless transition to the DEP® docetaxel phase 2 trial. Major progress has also been made in the DEP® cabazitaxel program with product manufacture, site and CRO selection now in the final stages ahead of phase 1 trial start later this year. DEP® Scale-up facilities Starpharma has recently invested in in-house DEP® scale-up capabilities and facilities to accelerate the development of its internal candidates, such as DEP® cabazitaxel and DEP® irinotecan, as well as its partnered DEP® programs. The expansion of these facilities enables the rapid manufacture of preclinical and clinical grade materials, and greater flexibility in managing the costs and faster turnaround than with third-party manufacture. The new facilities have already been used to manufacture DEP® cabazitaxel for upcoming trials and further campaigns are underway. APPOINTMENT PARTNERED DRUG DELIVERY INTERNAL DRUG DELIVERY ›› AstraZeneca pays US$2M DEP® milestone to Starpharma In April, Starpharma announced the achievement of a key development milestone for its DEP® drug delivery technology in combination with an exciting proprietary oncology molecule from AstraZeneca, triggering a milestone payment of US$2 million. This important milestone provides further validation of the utility and consistent performance of the DEP® platform and was achieved under the company’s multiproduct DEP® license with CONFERENCES AstraZeneca. Starpharma received the payment in June. This is the final preclinical milestone prior to advancing the first AstraZeneca DEP® candidate to clinical trials and follows the NEWS testing completionPARTNER of extensive and scale up activities. ›› VivaGel® BV phase TECHNOLOGY 3 results timing and commercialisation Starpharma has completed its international, multicentre, Phase 3 clinical trials evaluating VivaGel® BV for the prevention of recurrent bacterial APPOINTMENT vaginosis (rBV). The two double-blind, randomised, placebo-controlled pivotal trials were PARTNERED DRUG DELIVERY conducted at sites across the US, Europe, Canada, Mexico and Asia. The completion of these pivotal phase 3 INTERNAL DRUG DELIVERY trials is a significant milestone for Starpharma given the market for prevention of rBV is estimated at more than US$1 billion, there are currently no approved products and the company secured both Fast Track and Qualified Infection Disease Product (QIDP) designation for the product. The phase 3 trial results are now expected to be available in late July/early August 2017. This timing has allowed for additional confirmation from the US FDA DEP® license • First defined family of targets est. US$450M (US$126M + royalties) • Subsequent products US$93M + royalties • Tiered royalties on net sales on the resultant AstraZeneca DEP® products • AstraZeneca funds all development and commercialisation costs. Additionally, this Starpharma collaboration has been featured in AstraZeneca’s Innovation Medicine & Early Development (IMED) Unit 2016 Year in Review report. The report highlights this as a key collaboration that aims to: “...explore the benefits of Starpharma’s dendrimer technology to improve the therapeutic index of drugs in AstraZeneca’s Oncology portfolio and pipeline”… “A number of targets in our Oncology portfolio are currently being evaluated with this technology.” AstraZeneca IMED Unit 2016 Year in Review “…This important development milestone is indicative of the success we have seen in our DEP® program in partnership with Starpharma. ...DEP® technology has enabled us to advance a very exciting novel oncology agent towards the clinic. We’re continuing to investigate the potential of DEP® more broadly across molecules within our oncology portfolio.’’ Dr Susan Galbraith, SVP, Head of the Oncology Innovative Medicines Unit at AstraZeneca on the statistical analysis plan to ensure consistency of the trial data analyses with Starpharma’s Special Protocol Agreement (SPA), prior to un-blinding and analysis of the data. The SPA granted by the FDA provides binding FDA agreement on the phase 3 trial design including the primary endpoint. Following completion of the trials, data collation and routine blinded quality control review were undertaken and are now complete. The statistical analysis plan and bio-statistical programming are now being finalised, prior to the unblinding of the data. Starpharma is also leveraging the FDA’s recently granted QIDP designation and Fast Track status throughout this process. These designations carry significant benefits for regulatory approval and commercialisation, including increased dialogue with the FDA, priority regulatory review and an additional five years of market exclusivity. In parallel, Starpharma is welladvanced in its preparation of the New Drug Application (NDA) submission for VivaGel® for the treatment and symptomatic relief of BV. This NDA is planned for as early as possible in the second half of 2017, with final presubmission discussions with the FDA to be held in July 2017. Healthcare Investment Bank appointed for VivaGel® BV Starpharma is also actively engaged in both global and regional negotiations for commercial rights to VivaGel® BV, with a number of term sheets under discussion. Negotiations have been positively impacted by the FDA recently granting Starpharma QIDP and Fast Track designations for both indications which has attracted further significant commercial interest in VivaGel® BV. As part of this process, the Company has appointed a leading global healthcare investment bank to support the competitive process for negotiating commercial terms with potential partners for VivaGel® BV. PARTNER NEWS ® condom ›› VivaGel TECHNOLOGY launched in Canada The VivaGel® condom was launched in April in Canada by Ansell under the LifeStyles® Dual Protect™ brand. This launch marks a major commercial milestone for the product given it is APPOINTMENT the first commercial launch in North America. The condoms carry the VivaGel® brand and Starpharma will PARTNERED DRUG DELIVERY receive royalties based on sales. The VivaGel® condom is a world-first product based on innovative Australian INTERNAL DRUG DELIVERY technology and is the only condom of its type, providing barrier protection and incorporating Starpharma’s proprietary antiviral compound, VivaGel®, in the condom lubricant. VivaGel® has been “…a great example of a new and ground-breaking sexual-health product developed and commercialised by two Australian companies.” Jeyan Heper, Ansell’s President & GM, Sexual Wellness Global Business Unit The launch of LifeStyles® Dual Protect™ condom in Canada follows regulatory and marketing approval in Australia and New Zealand. Further approvals and launch are expected in the coming months, in other regions where licensing deals are in place. proven in laboratory studies to inactivate HIV (human immunodeficiency virus), HSV (herpes simplex virus) and HPV (human papillomavirus). ›› Sale of Ansell’s Sexual Wellness division In May, Ansell announced it will sell its Sexual Wellness division (condoms, lubricants, devices, manufacturing sites) to a buyer consortium: Humanwell Healthcare, a multi-billion dollar listed Chinese pharmaceutical and healthcare company with diversified global operations (market cap approx. US$4B) and Citic, a well-known global venture capital firm. Ansell has confirmed Humanwell has the ability to invest aggressively in the condom business and provide greater focus in this area. The strong Asian market presence of Humanwell will also add additional strategic opportunities for the continued market penetration of the VivaGel® condom in this fast-growing region and will complement Starpharma’s existing deal with Shenyang Sky & Land Co for the Chinese Government sector. ›› Starpharma News & Events ›› Agrium fast-tracks new ag-chem super polymer to boost herbicide firepower ›› Sky Business CONFERENCES News’ James Daggar-Nickson interviewed Dr Jackie Fairley regarding Starpharma’s recent sale of its Agrochemicals business. Watch the full interview here: http://www.starpharma. com/starpharma_tv PARTNER NEWS ›› CommSec’s Tom Piotrowski interviewed Dr Jackie Fairley on the Company’s recent highlights and upcoming milestones. Watch the interview here: http://www.starpharma. com/starpharma_tv Starpharma Holdings Limited (ASX:SPL; OTCQX:SPHRY) ABN 20 078 532 180 4-6 Southampton Crescent Abbotsford Vic 3067 +61 3 8532 2700 www.starpharma.com TECHNOLOGY APPOINTMENT Company Nigel Baade CFO/Company Secretary +61 3 8532 2704 investor.relations@ starpharma.com Media Relations Rebecca Wilson WEBuchan Mob: +61 417 382 397 rwilson@buchanwe.com.au ›› Sky Business News’ Ticky Fullerton interviewed Dr Jackie Fairley who highlighted the Company's VivaGel® portfolio and the DEP® drug delivery technology. Watch the full interview here: http://www.starpharma.com/ starpharma_tv 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 health authorities’ requirements regarding PARTNERED DRUG DELIVERY any one or more product candidates nor can there be any assurance that such product candidates will be approved by any health 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 clinical trial results, including additional analysis of existing clinical data, and new clinical 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 INTERNAL DRUG DELIVERY 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.