DexTech Medical AB announced today that the European Patent Office (EPO) has approved its patent application for the Good Manufacturing Practice (GMP) production of OsteoDex, the company's lead drug candidate for treating castration-resistant prostate cancer.
The patent application (No. 23203437.1), filed in October 2023, has now been granted, providing market exclusivity until 2045. This approval comes at a strategic time for DexTech, which has already completed Phase 2 clinical trials for OsteoDex.
"This is gratifying news as OsteoDex's patent protection is a key factor in our partnership discussions," said Anders R Holmberg, CEO of DexTech Medical. "Licensees have a requirement for a longer period of market exclusivity after registration, which we meet with the patent by far."
Strategic Importance for Clinical Development
The newly secured patent protection is considered crucial for the continued clinical development of OsteoDex. With patent validity extending over two decades, DexTech has positioned itself favorably for potential partnerships and licensing agreements.
The GMP manufacturing process is essential for ensuring consistent quality and regulatory compliance in pharmaceutical production. For a drug candidate like OsteoDex, which targets the challenging indication of castration-resistant prostate cancer, manufacturing consistency is particularly critical for both clinical trials and eventual commercial production.
Strengthening Position in Licensing Discussions
Industry analysts note that robust patent protection is often a decisive factor in pharmaceutical licensing negotiations. The extended exclusivity period granted by this patent significantly enhances DexTech's bargaining position with potential partners.
Castration-resistant prostate cancer represents a significant unmet medical need, with limited effective treatment options available for patients who progress after initial hormone therapy. OsteoDex's development pathway addresses this gap in the treatment landscape.
Next Steps for OsteoDex
Having completed Phase 2 clinical trials, OsteoDex is positioned to move toward more advanced development stages. The patent approval provides the necessary intellectual property protection to support this progression, whether through internal development or external partnerships.
The company has not disclosed specific timelines for Phase 3 trials but has indicated that partnership discussions are ongoing. The extended patent protection may accelerate these discussions by addressing a key concern of potential licensees regarding post-approval market exclusivity.
