pharmaceutical-technologyNovember 28, 2017
Canadian firm Acerus Pharmaceuticals has signed a licence, development and supply agreement to grant Apsen Farmacêutica exclusive marketing rights for Natesto in Brazil.
Natesto is a testosterone nasal gel available in a ‘no-touch’ dispenser with a metered dose pump for reduced transference risk.
Natesto is currently approved and available in Canada and the US for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism).
Acerus chief operating officer Tricia Symmes said: "We are pleased to be partnering with Apsen, a leading Brazilian pharmaceutical company, for the commercialisation of Natesto in this important market.
"Apsen has a proven commercial expertise in the field of urology and boasts of strong relationships with specialists and primary care physicians."
"Apsen has a proven commercial expertise in the field of urology and boasts of strong relationships with specialists and primary care physicians."
Apsen Farmacêutica president Renato Spallicci added: "Its unique nasal administration, safety and efficacy represent a clear opportunity to improve patient quality of life in this country."
Under the deal, Acerus will receive a non-refundable upfront fee, with a first instalment paid at the signing of the agreement while the remaining amount will be payable following the receipt of regulatory approval.
The Canadian pharmaceutical company will be responsible for overseeing the production of the therapy and will receive a supply price for the product.
If approved, Natesto will be the first and only testosterone nasal gel available for the indication in Brazil.
The drug is awaiting marketing approval in South Korea and the company expects to file for regulatory approvals in other jurisdictions in the coming years.
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