OncoZenge AB (publ) ("OncoZenge" or "the Company") today announces that it has entered the national and regional phase of its Patent Cooperation Treaty (PCT) application for BupiZenge in 17 jurisdictions. The filings were completed within the applicable 30-month PCT deadline and mark the next step in building out global patent protection for BupiZenge in support of the Company's commercialization strategy.
Background
- February 7, 2024: OncoZenge filed a priority-establishing patent application with the Swedish Patent and Registration Office (PRV), broadening protection for BupiZenge and its second-generation formulation.
- January 16, 2025: The Company filed the corresponding PCT application, opening the pathway to patent protection with global coverage.
- March 5, 2025: OncoZenge received a positive international search report and written opinion from the PCT authority, confirming that the claims met all patentability criteria.
- July 30, 2025: In its market and strategy update, the Company confirmed that the PCT filing would be taken into national phase submissions in lockstep with the PCT process, and global licensee requirements.
With today's confirmation of national filings, the Company has acted on that strategy, submitting national and regional applications ahead of the 30-month statutory deadline. Once granted, protection is expected to extend to 2045, complementing OncoZenge's existing granted patents, which protect BupiZenge lozenges into 2032/33.
Filing jurisdictions
- Americas: USA, Canada, Brazil, Mexico, Colombia
- Europe: Regional phase entry with the European Patent Office (EPO)
- Africa: South Africa
- Asia-Pacific: China, Japan, South Korea, Thailand, Indonesia, the Philippines, Vietnam, Malaysia, Singapore, Australia (and Hong Kong with 'Request for Registration and Grant' pending EPO)
"The positive PCT opinion gave us a clear, well-founded basis for the scope of protection we could pursue. Taking that opinion into national and regional examination across these 17 markets in a single, coordinated filing round gives prospective licensees the certainty they need on the strength and duration of protection as they build their own business cases for BupiZenge," said Marie Mannerlöf, PhD, Patent Attorney, CEO of Imariel AB and Head of Intellectual Property at OncoZenge.
Strategic rationale
The filings extend patent protection across OncoZenge's priority licensing markets ahead of BupiZenge's potential launch, pending conclusion of the ongoing Phase III trial and European regulatory approval.
Secured patent protection across these 17 markets is intended to support the due diligence and business case evaluations currently underway with prospective regional licensees, positioning the Company for efficient, partner-led launches in each territory following European approval.
"Securing this filing footprint now, ahead of our Phase III readout, is a deliberate step to make sure the IP foundation is in place before we finalize partnership discussions in these regions. It removes a key open question for licensees conducting due diligence and supports an efficient, coordinated launch of BupiZenge upon approval," said Stian Kildal, CEO of OncoZenge.
BupiZenge - Potential to be the leading treatment for oral pain.
Contact
Stian Kildal CEO Mobile: +46 76 115 3797 E-mail: stian.kildal@oncozenge.se
About
OncoZenge AB (publ) is a clinical-stage pharmaceutical company developing an innovative, effective, and well-tolerated treatment for oral pain in conditions where current options are insufficient, such as oral mucositis from cancer therapy. Its lead candidate, BupiZenge, represents a novel formulation of bupivacaine in a lozenge form, aimed at providing rapid and sustained local pain relief without the risks associated with systemic opioids. The Company recently received European regulatory approval to initiate its pivotal Phase III study 'BEAM-Pain'. The first patient has been enrolled in the trial and site activations are currently ongoing. OncoZenge is headquartered in Stockholm, Sweden, and is publicly traded on Nasdaq First North Growth Market under the ticker ONCOZ. For more information, please visit www.oncozenge.se.
OncoZenge AB
Gustavslundsvägen 34, 167 51 Stockholm, Sweden
Certified Adviser
Redeye Nordic Growth AB is the company's Certified Adviser.
