OncoZenge Partners with Meribel Pharma for BupiZenge Phase 3 Manufacturing
核心洞察
OncoZenge (搜索) has appointed Meribel Pharma Solutions (搜索) as its Contract Development and Manufacturing Organization (CDMO) for the BupiZenge (搜索) Phase 3 project.
The partnership will support OncoZenge (搜索)'s multi-country Phase 3 study aimed at securing European approval for BupiZenge (搜索), a novel bupivacaine lozenge for oral pain (搜索).
BupiZenge (搜索) targets oral mucositis (搜索) in cancer patients, representing a significant unmet medical need affecting millions of patients worldwide.
OncoZenge (搜索) AB announced it has engaged Meribel Pharma Solutions (搜索) (formerly Recipharm) as its Contract Development and Manufacturing Organization (CDMO) for the BupiZenge (搜索) Phase 3 project. The Swedish biotechnology company is preparing a multi-country Phase 3 study to secure European approval for its novel oral pain (搜索) treatment.
Strategic Partnership for Phase 3 Development
The project scope has been refined in close collaboration with OncoZenge (搜索)'s pan-European licensing partner, Molteni Farmaceutici (搜索). The decision to partner with Meribel Pharma Solutions (搜索) in Sweden was made to leverage their expertise in development and manufacturing for BupiZenge (搜索) clinical trial material. Both companies will work together to complete the necessary activities and documentation for a successful Clinical Trial Application (CTA) and project delivery.
"I am confident in Meribel's capabilities and look forward to our collaboration on this Phase 3 project," said Tuulikki Lindmark, Head of CMC at OncoZenge (搜索). "Together, we now have the resources to progress through this next, important development phase, ensuring we secure the lozenges needed for our trial and critical inputs to our regulatory efforts."
Bruce Vielle, CEO of Meribel Pharma Solutions (搜索), commented, "We are delighted to partner with OncoZenge (搜索) as their CDMO for the BupiZenge (搜索) Phase 3 project. This award highlights our proven expertise in developing and manufacturing complex oral solid dose forms like lozenges. We are fully committed to collaborating closely with OncoZenge to ensure a seamless and efficient process, from project management to Clinical Trial Application to successful product delivery, ultimately contributing to addressing an important unmet need."
Manufacturing Expertise and Scale-Up Capabilities
Meribel's extensive experience in pharmaceutical development, including their prior work with BupiZenge (搜索) formulations, was a decisive factor in OncoZenge (搜索)'s selection. According to Stian Kildal, CEO of OncoZenge, "Their local team will ensure efficient collaboration at this critical stage of our mission to bring BupiZenge to patients. Furthermore, Meribel's regional capabilities will help assure quality in processes and manufacturing, which is essential for future scale-up to high-volume production upon trial completion."
Addressing Unmet Medical Need in Cancer Care
BupiZenge (搜索) is a novel oral lozenge formulation of bupivacaine, a local anesthetic with decades of clinical experience. The lead indication for BupiZenge is oral pain (搜索) caused by oral mucositis (搜索), 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 (搜索) demonstrated substantially better pain relief compared to the standard of care. OncoZenge (搜索) is dedicated to developing an innovative, effective, and well-tolerated treatment for oral pain (搜索) in conditions where current options fall short, often due to insufficient pain relief or significant side effects.
The company positions BupiZenge (搜索) as having the potential to be the leading treatment for oral pain (搜索), addressing a critical gap in cancer supportive care where millions of patients experience severe oral complications during treatment.