EVE Health Targets $30B Markets With Four Reformulated Drugs Ready to License

EVE Health expands reformulated drug pipeline targeting US$30 billion global markets

EVE Health Group (ASX: EVE) has completed research and development on several reformulated pharmaceutical candidates targeting sexual health and cardiovascular therapies, with the EVE Health Reformulated Drug Pipeline now positioned to address combined addressable markets estimated to exceed US$30 billion. The announcement marks a material expansion of the company’s commercialisation pipeline, with intellectual property filings in preparation to protect the novel formulations and delivery methods developed using EVE’s proprietary drug delivery and solubilisation technologies.

The programmes utilise EVE’s established reformulation platform to improve the delivery and usability of well-known pharmaceutical compounds with established safety profiles. The company’s approach focuses on targeting drugs approaching or entering patent expiry, developing differentiated formulations that can be commercialised through licensing partnerships with established pharmaceutical distribution networks. Patent applications for spray-based formulations are currently being prepared, whilst a provisional patent application relating to an apixaban reformulation has already been lodged.

Targeting the pharmaceutical patent cliff

EVE’s research and development strategy focuses on reformulating established pharmaceutical compounds that suffer from limitations such as poor solubility, slow onset of action, or suboptimal administration formats. By targeting drugs approaching or entering patent expiry, the company aims to develop differentiated formulations that can be commercialised through licensing or supply partnerships with established pharmaceutical distribution networks.

This approach offers meaningful advantages over traditional drug discovery:

1. Known safety profiles reduce clinical development risk
2. Large, established markets with predictable demand
3. Shorter development timelines compared to novel drug development
4. Potential for improved delivery formats that address unmet patient needs

Initial validation of EVE’s delivery technologies has been demonstrated through the company’s lead product programmes Dyspro®, a cannabinoid-based pastille targeting dysmenorrhoea, and Libbo™, an oral dissolving film formulation targeting erectile dysfunction. The completion of these reformulation programmes significantly expands EVE’s commercial pipeline across multiple high-value therapeutic areas.

Three men’s sexual health spray formulations now complete

EVE has successfully completed research and development on three proprietary oral spray formulations targeting major conditions in the global men’s sexual health market, which is estimated to exceed US$7 billion annually. The development of these spray-based delivery systems leverages EVE’s proprietary solubilisation and reformulation technologies, with all three formulations now being prepared for patent lodgement ahead of progression through commercialisation pathways.

Vardenafil erectile dysfunction spray

The company has developed a rapid-delivery alcohol-free spray formulation of vardenafil designed to provide faster onset and improved patient convenience and efficacy, whilst avoiding alcohol-based delivery systems used in some spray formulations. Vardenafil, the active ingredient in Levitra®, is a well-established PDE5 inhibitor with a proven safety and efficacy record. A spray formulation has the potential to improve bioavailability, effectiveness and reduce time to onset, addressing a key limitation of tablet formulations.

The global erectile dysfunction treatment market is estimated at approximately US$5 billion annually. The reformulated spray targets faster absorption and improved convenience compared to existing tablet formulations, potentially addressing unmet patient needs in a large established market.

Dapoxetine premature ejaculation spray

EVE has completed development of a reformulated spray formulation of dapoxetine targeting premature ejaculation through improved delivery characteristics and ease of administration. Dapoxetine (sold under the name Priligy) is the only short-acting selective serotonin reuptake inhibitor specifically approved for premature ejaculation in multiple markets, however requires administration three hours prior to sexual intercourse to be effective. A spray format may overcome the limitations of Priligy, enabling faster absorption and more predictable dosing.

The global premature ejaculation treatment market is estimated at approximately US$3 billion. The spray-based delivery system potentially addresses the significant timing limitations of existing tablet formulations, offering improved patient compliance.

Combination dual-molecule spray

The company has also developed a novel dual-active spray formulation combining vardenafil and dapoxetine in a single delivery system, targeting patients experiencing both erectile dysfunction and premature ejaculation, conditions that frequently co-occur. This formulation represents a differentiated approach to combination therapy, offering potential for improved compliance and patient experience compared to administering two separate products.

These conditions represent a combined global market opportunity estimated to exceed US$8 billion. The combination spray addresses both conditions simultaneously, potentially offering improved convenience and compliance versus existing therapeutic options requiring separate administration.

What is drug reformulation and why does it matter for investors?

Drug reformulation involves improving how an existing approved medicine is delivered, rather than discovering new pharmaceutical compounds from scratch. This can include developing alternative delivery formats such as sprays, films, or pastilles to replace conventional tablets or capsules. The approach focuses on enhancing existing medicines through improved bioavailability, faster onset of action, or enhanced patient usability.

Reformulating existing approved drugs differs materially from developing novel compounds. Established medicines already possess known safety profiles, validated efficacy data, and regulatory precedent. This reduces clinical development risk compared to novel drug discovery, where safety and efficacy must be established from the ground up. The regulatory pathway for reformulated products is typically shorter and more predictable than for new chemical entities.

For investors, this strategy offers several advantages. Development costs are lower, timelines are compressed, and target markets are established with predictable demand. EVE has demonstrated this approach with Dyspro® (cannabinoid pastille) and Libbo™ (oral dissolving film for erectile dysfunction), both leveraging the company’s proprietary formulation and delivery technologies to enhance bioavailability and clinical outcomes. The EVE Health Reformulated Drug Pipeline extends this proven platform across additional therapeutic areas, creating multiple potential licensing opportunities.

Apixaban anticoagulant reformulation targets US$19 billion blockbuster

EVE has developed a reformulated version of apixaban, a widely prescribed anticoagulant used to reduce stroke risk in patients with atrial fibrillation and other blood clotting conditions. Apixaban, the active ingredient in Eliquis®, is one of the world’s best-selling pharmaceutical products, generating over US$19 billion in global sales in 2022, with primary patents expiring between 2026 and 2028.

Improving apixaban’s solubility and delivery characteristics may enable development of alternative dosage forms, such as liquid or orally dissolvable formats, that address limitations of conventional tablets. This is particularly relevant for the estimated 590 million people globally affected by dysphagia (difficulty swallowing), a population that includes many patients requiring anticoagulation therapy. A provisional patent application relating to the apixaban reformulation has already been lodged.

The apixaban reformulation represents a significant opportunity as one of the world’s top-selling pharmaceuticals enters patent expiry. According to industry data, several major pharmaceuticals approaching patent expiry, including apixaban, rivaroxaban, and enzalutamide, represent a combined annual global market value exceeding US$48 billion. EVE’s reformulation platform is designed to identify and develop improved delivery formats for selected compounds within these large and established therapeutic markets.

Commercialisation pathway and next steps

EVE’s strategy is to develop and protect novel reformulations of established pharmaceutical compounds, partnering with pharmaceutical companies that possess existing regulatory capabilities, manufacturing infrastructure and established distribution networks. Rather than building its own commercial infrastructure, the company intends to license each product to organisations that already possess the regulatory relationships, sales networks, and market access required to commercialise at scale.

The company is actively pursuing licensing deals with relevant target partners for each drug or molecule in its pipeline. This asset-light model enables EVE to focus on formulation development and intellectual property protection, whilst partnering with established players to handle regulatory approval, manufacturing scale-up, and commercial distribution. The approach is designed to create multiple potential licensing opportunities across large established pharmaceutical markets.

Ben Rohr, Chief Operating Officer

“The completion of these research programs marks another significant step in expanding EVE’s reformulation pipeline. Our strategy is focused on identifying high-value pharmaceutical compounds approaching patent expiry and developing improved delivery systems that enhance patient usability and clinical outcomes.”

Following completion of formulation development, EVE intends to advance these programmes through further development activities:

• Formulation optimisation
• Intellectual property protection (patent applications in preparation/lodged)
• Regulatory pathway assessment in relevant jurisdictions
• Continued pursuit of licensing discussions with target partners

The company intends to prioritise further development and commercialisation pathways based on technical feasibility, regulatory requirements, and potential licensing or distribution opportunities. The EVE Health Reformulated Drug Pipeline positions the company to pursue multiple licensing partnerships simultaneously across validated therapeutic markets with established demand.

What’s next for EVE Health shareholders

The expanded EVE Health Reformulated Drug Pipeline creates multiple near-term catalysts across large established pharmaceutical markets. Patent filings for the three spray-based sexual health formulations are in preparation, whilst the provisional patent application for the apixaban reformulation has been lodged. Each represents a potential licensing opportunity with pharmaceutical companies seeking to maintain market position as existing patents expire.

The company’s approach of targeting established medicines approaching patent expiry offers investors multiple shots on goal across validated therapeutic markets with predictable demand. The sexual health spray formulations address a combined market estimated to exceed US$8 billion, whilst the apixaban reformulation targets one of the world’s best-selling pharmaceuticals with US$19 billion in annual sales. Combined addressable markets across the pipeline exceed US$30 billion.

Near-term catalysts include completion of patent applications, ongoing licensing discussions, and prioritisation of development pathways based on partnership opportunities. The licensing-focused model targets capital-efficient commercialisation, enabling EVE to pursue multiple high-value partnerships simultaneously without building commercial infrastructure.

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