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QuickView: Endo launches Natesto
US partner Endo has launched Trimel’s Natesto in the c US$2bn US testosterone replacement therapy (TRT) market. Natesto is being positioned as the first and only nasal gel for hypogonadism, and is highlighted for its lower associated risk of testosterone transference.
QuickView: Endo to partner Natesto
Trimel is partnering its Natesto intranasal gel testosterone replacement therapy (TRT) product in the US and Mexico with Endo Pharmaceuticals, receiving US$25m upfront and a tiered supply price for manufacturing. Endo’s marketed portfolio of TRT products makes it an ideal partner, and Trimel expects to be ready for commercial manufacturing in Q115.
QuickView: TRT under FDA spotlight
A joint panel of two FDA advisory committees voted in September to modify the labelling of TRT products to curtail usage when clinical benefit may not be definitive. While it is unclear how the FDA will respond, we believe that end-user demand for TRT will largely persist and that Natesto’s novel delivery should generate interest when launched in H115.
QuickView: Seeking positive EBITDA with Estrace
Trimel has acquired Canadian rights to Estrace (oral 17-beta estradiol) for C$44.5m from Shire. This profitable asset, with US$9-10m in annual sales, complements Trimel’s existing hormone replacement pipeline. The transaction fits with the goal to become EBITDA positive within 12-18 months, although future Natesto-related revenue (upon completion of a partnership transaction) will be the key driver towards this objective.
QuickView: A closer look at Tefina Phase II FOD results
While Trimel continues to work on securing a commercial licensing transaction for its recently approved Natesto testosterone nasal gel, the firm recently provided further encouraging data on its 253-patient Phase II study for Tefina in female orgasmic disorder (FOD). Trimel continues to analyse the data and plans to meet with the FDA in H214, ahead of the next clinical study.
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