STOCKHOLM, SWEDEN - January 13, 2025 - OncoZenge AB (publ) ("OncoZenge" or the "Company"), announces that the Company has entered into a non-binding agreement with the intention to partner with pharmaceutical leader Molteni Farmaceutici ("Molteni") regarding exclusive rights to commercialization of BupiZenge in Europe.
The Company has signed a non-binding offer from Molteni for a commercial partnership to introduce BupiZenge in Europe with the goal to sign the definitive licensing agreement no later than April 30th, 2025. During a period of exclusivity, the parties will complete planning, due diligence and evaluate manufacturing capabilities. The intended agreement will include royalties of 15% to OncoZenge on BupiZenge sales in the territory. The agreement will also include milestone payments of EUR 250.000 upon execution of the definitive agreement, EUR 250.000 at the successful completion of the phase III study, EUR 300.000 at the first commercial sale, as well as milestone payments of EUR 500.000 upon reaching EUR 10 million of cumulative net sales and EUR 1.000.000 upon reaching EUR 20 million of cumulative net sales. Molteni, during the exclusive period of negotiation, is open to negotiate further milestone payments reaching cumulative net sales of EUR 30 million and EUR 40 million.
Molteni is an Italian pharmaceutical company, a specialty pharma leader in therapeutics solutions for pain management and drug addiction. Founded in 1892 and headquartered in Florence, Italy. With its own Manufacturing, R&D, Regulatory, Supply Chain and Commercial capabilities it is able to serve a broad distribution reach in Europe and across the globe.
Stian Kildal, CEO of OncoZenge, comments: "This partnership marks an important step forward in bringing BupiZenge to market. We are thrilled with the opportunity to collaborate with Molteni 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. Molteni'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 of BupiZenge across Europe."
Gianluca Corbinelli, CEO of Molteni, adds: "This partnership represents a key milestone for the Molteni Group's strategic expansion program. We are excited to start building 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 a better pain relief along their cancer treatment therapeutic schedule. We are really looking forward to making this happen and have a positive impact on those patients lives."
OncoZenge, with Molteni's support, will now move to finalize the Phase III study protocol and confirm the CDMO and CRO agreements necessary for the execution of the Phase III study. OncoZenge and Molteni will also work together to finalize the appropriate regulatory path and the development of an effective commercial strategy for the launch of BupiZenge in Europe.
The Company will provide timely updates to the market as developments occur.
BupiZenge - Potential to be the leading treatment for oral pain.
For additional information, please contact:
Stian Kildal, CEO, mobile: +46 76 115 3797, e-mail: stian.kildal@oncozenge.se
Michael Owens, CFO, mobile: +46 73 324 4988, e-mail: michael.owens@oncozenge.se
Certified Adviser
OncoZenge's Certified Adviser is Redeye AB.
OncoZenge AB
Gustavslundsvägen 34, 167 51 Stockholm, Sweden
About OncoZenge
OncoZenge is dedicated to developing an innovative, effective, and well-tolerated treatment for oral pain in conditions where current options fall short, often due to insufficient pain relief or significant side effects. BupiZenge is a novel oral lozenge formulation of bupivacaine, a local anesthetic with decades of clinical experience. The lead indication for BupiZenge is oral pain caused by oral mucositis, an inflammatory condition affecting millions of cancer patients. Oral mucositis leads to severe physical and psychological distress, representing a significant unmet medical need for an effective, opioid-sparing treatment. In Phase 2 trials, BupiZenge demonstrated substantially better pain relief compared to the standard of care.
OncoZenge is headquartered in Stockholm, Sweden, and is publicly traded on Nasdaq First North Growth Market under the ticker ONCOZ.
This information is such that OncoZenge AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (MAR). The information was submitted for publication, through the agency of the contact persons set out below, at 17:30 CEST on January 13, 2025.
