Agile Therapeutics(US:AGRX)2019-09-10 15:22Twirla's Market Opportunity and Strategy - Agile's corporate strategy is to become a leader in women's health, starting with Twirla in the prescription contraceptive market [10] - The U S contraceptive market is a significant opportunity, estimated at $5 56 billion in 2017, with combined hormonal contraception (CHC) accounting for $3 8 billion [24, 25, 30] - Twirla has the potential for significant market share, with peak TRx share estimates based on market research and analogs suggesting 14% to 23% [31] Twirla's Clinical Trial Data and Regulatory Status - The SECURE trial, a Phase 3 study with approximately 2000 subjects, showed a low rate of hormone-related adverse events and a bleeding profile similar to low-dose oral CHCs [36, 37, 69, 72] - The overall serious adverse events (SAEs) were observed in 1 97% of the SECURE trial study population [70] - A life table analysis showed a failure rate of 4 2% at Cycle 13, inclusive of all subjects regardless of BMI [64] - A comparative wear study demonstrated non-inferior adhesion of Twirla to Xulane, with Twirla having a mean adhesion score of 0 14 compared to Xulane's 0 39 [85, 86, 87] Agile's Commercialization Plan - Agile is reactivating its plan for commercialization of Twirla, focusing on manufacturing, market access, launch network, and a targeted sales force of 70-100 representatives [47, 48] - The company completed a comparative wear study in February 2019 and resubmitted the Twirla NDA to the FDA in June 2019 [40, 57] - Agile expects to launch into a $3 8 billion addressable market [57]