Apotex and Grünenthal have finalised a licensing agreement granting Apotex exclusive Canadian rights to Nebido, a long-acting injectable testosterone undecanoate therapy for male hypogonadism.
This contract enables Apotex to seek marketing authorisation and distribute the product in the country through its branded medicine division, Searchlight Pharma, once regulatory approval is secured.
Grünenthal will receive upfront and regulatory milestone payments, as well as a margin on the product sales.
The licence builds on an existing partnership between Apotex and Grünenthal, supporting both companies’ initiative to expand patient access to therapies in Canada.
Grünenthal acquired global rights to Nebido in 2022 as part of its growth strategy. The company has invested more than €2bn ($2.3bn) in mergers and acquisitions since 2017 to diversify its portfolio and create synergies across manufacturing, supply, logistics, and commercial infrastructure.
Searchlight Pharma president Mark Nawacki said: “This marks an important step in Apotex's mission to broaden access to innovative medicines and advance our purpose as a Force for Health.
“Nebido addresses a recognised need in men's health and represents our first entry into testosterone therapy — opening a meaningful new therapeutic area for Apotex while strengthening our branded portfolio and expanding our presence in speciality care.”
Grünenthal chief commercial officer Jan Adams said: “We are delighted to expand our partnership with Apotex and further strengthen the global presence of the brand. Through this agreement, we are providing a valuable and well-established brand that can benefit people living with testosterone deficiency in Canada.”
Nebido is administered as a long-acting depot injection of testosterone undecanoate by physicians every ten to 14 weeks. It is indicated for adult men with confirmed hypogonadism due to insufficient testosterone levels.
In August 2024, Formosa Pharmaceuticals signed an exclusive licensing agreement with Apotex to commercialise clobetasol propionate ophthalmic suspension 0.05% (APP13007) for ocular surgery relief and recovery.
