Algorae Pharmaceuticals locks in Cadila deal to bring cardiovascular and metabolic medicines to ANZ
Algorae Pharmaceuticals (ASX: 1AI) has finalised the Algorae Cadila License Agreement, executing a definitive Licence & Supply Agreement with Cadila Pharmaceuticals Limited to commercialise two generic medicines targeting cardiovascular and metabolic disorders across Australia and New Zealand. The agreement follows a binding term sheet announced on 20 October 2025 and establishes a clear division of responsibilities: Cadila handles product development and manufacturing, while Algorae’s wholly owned subsidiary AlgoraeRx Pty Ltd manages TGA sponsorship, regulatory submissions and commercialisation activities.
The partnership represents a strategic expansion beyond oncology into high-volume therapeutic areas, diversifying revenue streams while maintaining an asset-light operational model. By leveraging Cadila’s established manufacturing capabilities and AlgoraeRx’s regulatory and market access expertise, Algorae positions itself to capture opportunities in cardiovascular and metabolic disease markets without the capital intensity of in-house manufacturing infrastructure.
How the partnership works
Under the Algorae Cadila License Agreement, Cadila Pharmaceuticals assumes responsibility for all product development and manufacturing activities. The company operates state-of-the-art GMP-compliant manufacturing facilities from its Ahmedabad, Gujarat headquarters, supported by a global workforce of more than 9,000 professionals. Its research and development division comprises over 350 scientists working across respiratory, cardiometabolic, gastrointestinal, oncology, anti-infective and pain management therapeutic areas.
Cadila’s products are currently marketed in over 100 countries across Asia, Africa, Europe and the Americas, reflecting established quality standards and regulatory track record. AlgoraeRx retains control of all Australia and New Zealand market activities, including TGA sponsorship, regulatory submissions, market access negotiations and direct commercialisation through established distribution channels targeting hospitals, pharmacies and institutional customers.
| Partner | Responsibility | Geography |
|---|---|---|
| Cadila Pharmaceuticals | Product development, GMP manufacturing, supply | India-based facilities |
| AlgoraeRx (Algorae subsidiary) | TGA sponsorship, regulatory submissions, market access, commercialisation | Australia and New Zealand |
What is a licence and supply agreement?
A Licence & Supply Agreement grants Algorae exclusive rights to market and distribute specific products within defined territories without bearing manufacturing costs or infrastructure investment. Under this model, the manufacturing partner retains responsibility for production quality, supply continuity and regulatory compliance at the manufacturing site, while the licensee focuses capital and operational resources on market entry, regulatory approval and commercial execution.
This structure contrasts with full product acquisition or in-house development, both of which require substantial upfront capital expenditure, lengthy development timelines and ongoing manufacturing overhead. The LSA model enables faster market entry by leveraging products already developed and manufactured by established pharmaceutical companies with proven regulatory track records.
Key benefits of the LSA model for Algorae:
- Reduced capital intensity: No requirement for manufacturing facilities, equipment or production workforce
- Faster commercialisation: Products arrive market-ready, requiring only local regulatory approval
- Risk mitigation: Manufacturing partner assumes production risk, quality control and supply chain management
- Scalability: Multiple LSAs can be executed simultaneously without proportional infrastructure investment
The asset-light approach preserves cash reserves while building recurring revenue streams, allowing Algorae to scale commercial operations through strategic partnerships rather than fixed asset expansion.
Building a multi-therapy commercial platform
The Algorae Cadila License Agreement represents the latest addition to a growing commercial portfolio spanning multiple therapeutic areas and manufacturing partnerships. Algorae previously secured an exclusive commercial licensing agreement with Sakar Healthcare Limited to launch five generic oncology medicines across Australia and New Zealand, complementing the company’s oncology R&D program at Peter MacCallum Cancer Centre.
In January 2026, Algorae received its first shipment under a distribution agreement with Dr. Reddy’s Laboratories Ltd to supply Capecitabine 500 mg tablets, a chemotherapy medicine, into the Australian market. Collectively, these partnerships establish a multi-partner, multi-therapy platform providing diversified therapeutic coverage across oncology, cardiovascular and metabolic diseases.
Current commercial partnerships:
- Cadila Pharmaceuticals: Two generic medicines for cardiovascular and metabolic disorders (Australia and New Zealand)
- Sakar Healthcare Limited: Five generic oncology medicines (Australia and New Zealand)
- Dr. Reddy’s Laboratories: Capecitabine 500 mg chemotherapy tablets (Australia, first shipment received January 2026)
The diversified product base reduces single-product revenue dependency while spreading regulatory and commercial risk across multiple therapeutic areas. Multiple manufacturing partners mitigate supply chain concentration risk, ensuring continued product availability if any single partner experiences production delays or quality issues. The portfolio targets hospitals, pharmacies and institutional customers, providing multiple revenue channels within the Australian and New Zealand healthcare systems.
Next steps and what to watch
Algorae will commence TGA registration planning and documentation for the two cardiovascular and metabolic medicines covered under the Algorae Cadila License Agreement. The company has stated it will provide updates on submission timing, anticipated launch windows and expected revenue contribution as the registration program advances through TGA requirements.
AlgoraeRx continues progressing additional commercial opportunities beyond the three announced partnerships, with further updates expected as these initiatives mature. Near-term investor focus areas include TGA submission milestones, which will establish the regulatory pathway timeline, and revenue guidance updates, which will clarify the commercial contribution expected from the Cadila products once launched.
Regulatory and Commercial Outlook
The company plans to update shareholders on TGA submission timing and anticipated launch windows as registration planning progresses. Additional AlgoraeRx commercial opportunities under evaluation could further expand the therapeutic footprint and manufacturing partner network across Australia and New Zealand markets.
The execution of definitive agreements for cardiovascular and metabolic medicines positions Algorae to diversify beyond oncology-focused revenues while maintaining its asset-light commercial model. Investors should monitor TGA submission announcements and subsequent approval timelines, as these will determine the pace of market entry for the two new products. Any additional LSA announcements would signal continued expansion of the AlgoraeRx platform and further therapeutic diversification.
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