OncoZenge AB has entered into an exclusive commercialization agreement with Italian pharmaceutical company Molteni Farmaceutici for BupiZenge, a novel oral pain treatment, across European markets. The binding agreement, announced on March 28, 2025, follows the completion of due diligence after a non-binding agreement was initially announced in January.
The partnership grants Molteni Farmaceutici exclusive rights to commercialize BupiZenge throughout Europe, including the EU27, European Economic Area, Switzerland, and the United Kingdom. This collaboration aims to address the significant unmet need for effective pain management in cancer patients suffering from oral mucositis.
Financial Terms and Milestone Structure
The agreement includes a comprehensive financial framework with both milestone payments and royalty structures. OncoZenge will receive an immediate milestone payment of EUR 250,000 upon execution of the agreement, with additional milestone payments tied to clinical and commercial achievements:
- EUR 250,000 upon successful completion of the Phase III study
- EUR 300,000 at first commercial sale
- EUR 500,000 when cumulative net sales reach EUR 10 million
- EUR 1,000,000 when cumulative net sales reach EUR 20 million
- EUR 1,000,000 when cumulative net sales reach EUR 30 million
- EUR 1,000,000 when cumulative net sales reach EUR 40 million
The royalty structure is tiered based on annual sales performance:
- 15% royalty on annual sales up to EUR 30 million
- 18% royalty on annual sales between EUR 30-60 million
- 20% royalty on annual sales exceeding EUR 60 million
Additionally, OncoZenge will retain 50% of any upfront licensing fees should Molteni Farmaceutici sub-license commercialization rights in certain territories.
Addressing a Critical Unmet Need
BupiZenge is a novel oral lozenge formulation of bupivacaine, a well-established local anesthetic with decades of clinical use. The product is being developed primarily for oral pain caused by oral mucositis, an inflammatory condition that affects millions of cancer patients undergoing treatments such as chemotherapy and radiation therapy.
Oral mucositis represents a significant burden for cancer patients, causing severe physical and psychological distress that can impact treatment adherence and quality of life. Current treatment options often provide insufficient pain relief or come with significant side effects, particularly opioid-based therapies.
"This partnership marks an important step forward in bringing BupiZenge to market," said Stian Kildal, CEO of OncoZenge. "We are thrilled with the opportunity to collaborate with Molteni Farmaceutici whose team, capabilities and distribution reach for pain products make them a great partner for us. This partnership provides important validation of our market opportunity, and important support to our program."
Clinical Evidence and Development Status
BupiZenge has already demonstrated promising results in clinical development. In Phase 2 trials, the treatment showed substantially better pain relief compared to the standard of care for oral mucositis pain. The product is now advancing toward Phase 3 clinical trials, with the successful completion of these studies representing a key milestone in the new partnership agreement.
The novel formulation offers potential advantages over existing treatments, including targeted local anesthetic effects without the systemic side effects associated with opioid analgesics. This opioid-sparing approach aligns with current clinical priorities to reduce opioid use while still providing effective pain management.
Strategic Fit for Both Companies
For Molteni Farmaceutici, an Italian pharmaceutical company founded in 1892 and headquartered in Florence, the partnership represents a strategic expansion of their pain management portfolio. The company is already established as a specialty pharma leader in therapeutics for pain management and drug addiction, with operations in over 40 countries.
Gianluca Corbinelli, CEO of Molteni Farmaceutici, emphasized the strategic importance of the partnership: "This partnership represents a key milestone for the Molteni Farmaceutici Group's strategic expansion program. We are excited to strengthen our collaboration with OncoZenge; our joint Leadership, Knowledge and Capabilities will be instrumental to bring BupiZenge to market and make this new therapeutic option available and affordable for the patients in need of better pain relief along their cancer treatment therapeutic schedule."
Manufacturing and Future Development
Both companies will continue to evaluate manufacturing capabilities for BupiZenge, with OncoZenge committing to provide timely updates to the market as developments occur. The partnership leverages Molteni Farmaceutici's established manufacturing, R&D, regulatory, supply chain, and commercial capabilities to support the eventual launch of BupiZenge across European markets.
Kildal noted that "Molteni Farmaceutici's market reach will ensure an ambitious and cohesive launch plan for commercialization of BupiZenge across Europe. Together we will offer significant Quality of Life improvements for the millions of cancer patients who deserve better pain relief during their treatments, while realizing the full commercial potential in Europe."
Market Potential and Patient Impact
Oral mucositis affects approximately 40% of patients receiving chemotherapy and nearly 80% of patients receiving radiation therapy for head and neck cancers. The condition can lead to severe pain, difficulty eating and drinking, increased risk of infection, and in some cases, interruption of cancer treatment.
BupiZenge has the potential to become a leading treatment for oral pain associated with mucositis, addressing a significant gap in current treatment options. The partnership between OncoZenge and Molteni Farmaceutici aims to make this innovative treatment accessible to patients across Europe, potentially improving quality of life for millions of cancer patients undergoing treatment.
OncoZenge, headquartered in Stockholm, Sweden, and publicly traded on Nasdaq First North Growth Market under the ticker ONCOZ, continues to focus on developing innovative treatments for conditions with significant unmet medical needs.
