Agile Therapeutics, Inc. Provides Corporate Update and Revised Cash Guidance
GlobeNewswire•June 7, 2018
Cash Expected to Enable Company to Fund Operations into Second Quarter 2019
PRINCETON, N.J., June 07, 2018 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc., (AGRX), a women’s healthcare company, today announced several key corporate updates:
Formal dispute resolution request has been submitted to the FDA regarding Twirla® (levonorgestrel/ethinyl estradiol transdermal system), its lead product candidate
Reducing workforce by approximately 30% and reducing other planned expenses
Reductions in workforce and expenses expected to allow existing cash to fund operations into the second quarter of 2019
Agile has submitted a formal dispute resolution request (FDRR) with the FDA for Twirla (AG200-15), the Company’s investigational low-dose, non-daily, combination hormonal contraceptive patch. The dispute pertains to the determination from the FDA’s reviewing Division of Bone, Reproductive and Urologic Products (DBRUP), that concerns surrounding the in vivo adhesion properties of Twirla prevent its approval and cannot be addressed through the Company’s proposed patient compliance programs.
The Company anticipates that its FDRR will be reviewed by the Office of Drug Evaluation III (ODEIII) and has requested a meeting with the Office Director, which, according to FDA’s guidance, should occur within thirty days of the request. After the meeting, the Director should provide a decision within thirty days.
The formal dispute resolution process exists to encourage open, prompt discussion of scientific and procedural disputes that arise during drug development, new drug review, and post-marketing oversight processes of the FDA. By submitting its FDRR, the Company is availing itself of the FDA’s established appeal process whereby disagreements with conclusions reached by a reviewing Division within the FDA are reviewed above the Division level. Through this process the Company has the ability to escalate its appeal to additional levels of FDA management, if necessary.
“Twirla’s adhesion profile was assessed in the context of a large Phase 3 trial, the objective of which was to demonstrate safety and efficacy as the basis for approval of the product. We continue to believe the objectives of this trial were met, and that there is no evidence that in vivo adhesion impacted the clinical outcomes of the trial. On this basis, we believe the in vivo adhesion data are adequate to support approval without the need for product reformulation or additional work. We have also developed multiple innovative approaches to patient compliance that we believe can further support or enhance the appropriate use of Twirla if it is approved,” said Al Altomari, Chairman and Chief Executive Officer, Agile Therapeutics. “We disagree with the FDA’s conclusions on the adhesion of Twirla and look forward to having the opportunity to engage with the Office of Drug Evaluation III on these issues.”
The Company also announced a reduction in its workforce, which will result in the elimination of the positions of several employees primarily from the Company’s commercial and clinical teams, representing approximately thirty percent of its employees. This workforce reduction, along with other reductions in its planned operating expenses, is designed to reduce operating expenses and preserve cash while the Company pursues formal dispute resolution. The Company now expects that its cash and cash equivalents as of March 31, 2018, will be sufficient to meet its operating requirements into the second quarter of 2019.
Mr. Altomari continued, “Due to the ongoing regulatory process with Twirla and our need to fund the formal dispute resolution process, we made the difficult decision to reduce our workforce. I would like to personally express my appreciation to each of the employees impacted by this decision for their commitment and contributions to Agile. We are also grateful to those members of our team that will continue to seek the approval of Twirla.”
About Twirla® (AG200-15)
Twirla (levonorgestrel/ethinyl estradiol transdermal system) or AG200-15 is an investigational low-dose, once-weekly contraceptive patch. AG200-15 is a 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 received a complete response letter (CRL) from the FDA on December 21, 2017 relating to the New Drug Application (NDA) for Twirla. In the CRL, the FDA informed the Company that the product could not be approved in its present form due to deficiencies related to quality adhesion test methods, observations identified during the pre-approval inspection of the manufacturing facility for Twirla, and because of questions the FDA had on the in vivo adhesion properties of Twirla and their potential relationship to the Company’s Phase 3 clinical trial results. As announced on May 18, 2018, Agile met with the FDA during a Type A meeting on April 16, 2018 to discuss the CRL and received the official end of review (EOR) minutes on May 15, 2018.
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