Agile Therapeutics Adds to Leadership Team Prior to Expected Twirla FDA Approval

Posted on January 02, 2020 by Medtech[y] Staff

Shares of Agile Therapeutics (Nasdaq: AGRX) were higher by almost 20% in early trading after the company announced new additions to the company's management team in preparation for the potential commercialization of Twirla, which is the company's lead product candidate.

Kimberly Whelan was appointed as Vice President of Market Access and will be responsible for overseeing the development and execution of Agile’s market access strategy.

The other positions filed were Charles S Grass, CMA as the company's Senior Director of Finance and Matthew Riley as Product Manager.

“We remain focused on seeking FDA approval of Twirla and building a robust women’s health company. We continue to make strategic investments and build our team to achieve those goals,” said Al Altomari, Chairman and Chief Executive Officer of Agile.

Twirla, also known as AG200-15 is an investigational, once-weekly combined hormonal contraceptive (CHC) patch that contains the active ingredients ethinyl estradiol (EE), a type of estrogen, and levonorgestrel (LNG), a type of progestin.

Twirla is designed to be applied once weekly for three weeks, followed by a week without a patch. Agile has completed its Phase 3 clinical trials of Twirla and is pursuing regulatory approval in the U.S. after resubmitting a New Drug Application (NDA) for Twirla on May 16, 2019.

After a positive AdCom, with the BRUDAC voting 14 to 1 in favor of Twirla, the FDA assigned a PDUFA (Prescription Drug User Fee Act) goal date of November 16, 2019, but then extended the PDUFA date to February 16, 2020.

The next month or so leading up to the PDUFA date will be exciting for Agile Therapeutics shareholders and the addition of the company's leadership team, especially those filling market access and product manager needs, are a great sign of the company's confidence for an upcoming approval of Twirla.

The next question is, do they hire and develop a sales team or go the acquisition route?