#Canada #Toronto #Grünenthal #Apotex #Qutenza®

Apotex Secures Exclusive Rights to Qutenza® in Canada

Apotex Inc., known as Canada's largest pharmaceutical company, has made a significant move in the pain management sector by securing exclusive Canadian rights to Qutenza® from Grünenthal, a pioneer in pain-related therapeutics. This licensing agreement, announced on February 24, 2025, represents a strategic partnership aimed at enhancing treatment options for neuropathic pain in Canada.

Qutenza® is a topical, non-systemic, and non-opioid pain patch that is designed explicitly for managing neuropathic pain. By gaining these rights, Apotex is set to not only expand its portfolio but also provide patients with a differentiated solution that is already established in European and American markets.

Mark Nawacki, President of Apotex's specialty pharma division, Searchlight Pharma, expressed enthusiasm about the agreement, stating, "Licensing the Canadian rights to Qutenza enables us to improve the lives of Canadians by increasing options for advanced pain management. This differentiated agent will offer a new avenue for neuropathic pain treatment, aiming to meet the pressing needs of patients in Canada."

As part of this agreement, Searchlight will take the lead in seeking marketing authorization for Qutenza® and will handle its marketing and distribution contingent on regulatory permissions. In exchange, Grünenthal will receive a combination of upfront payments, milestone payments related to regulatory approvals, and ongoing royalties from sales.

Jan Adams, Chief Commercial Officer at Grünenthal, highlighted the importance of this deal, emphasizing that Apotex’s strong commercial capability positions it as the ideal partner to access the Canadian pharmaceutical market. He noted, "Grünenthal has continuously developed Qutenza to expand its footprint and reach more patients in need. We are excited to work with Apotex to deliver this innovative treatment option to Canadian patients."

Grünenthal, which acquired the global rights to Qutenza® in 2018 as part of its growth strategy, has invested over €2 billion in successful market access transactions since 2017, focusing on augmenting its product offerings and enhancing overall patient care.

In Europe, Qutenza® is approved for the treatment of peripheral neuropathic pain in adults, either alone or in combination with other medicines. It has previously been approved in the U.S. for neuropathic pain conditions such as postherpetic neuralgia and diabetic peripheral neuropathy. Its approach leverages an 8% capsaicin content, which works to provide localized pain relief.

Apotex is renowned for its commitment to making innovative medicines accessible and affordable for patients across the globe, boasting a robust portfolio of over 550 pharmaceutical products, encompassing generic, branded, and biosimilar offerings. With its headquarters located in Toronto and regional offices across key markets, it plays a crucial role in the Americas’ pharmaceutical landscape.

About Qutenza®
As a topical treatment, Qutenza® stands out in its non-opioid formulation, providing alternative therapy devoid of the risks commonly associated with opioid use. The partnership with Grünenthal marks a pivotal addition to Apotex’s offerings, particularly as pain management becomes increasingly significant in healthcare discussions.

Conclusion
This agreement not only signifies a collaborative advancement in pain management options for Canadians, but it also mirrors Apotex's broader mission along its Journey of Health growth strategy. With this collaboration, we can anticipate enhanced patient outcomes and a continuing commitment to innovative therapies from both Apotex and Grünenthal.