EXCELLENT ARTICLE/SUMMARY ON WHAT TO EXPECT!
Will the third time be a charm for Agile Therapeutics' Twirla?
Posted on October 15, 2019 by Medtech[y] Staff
Agile Therapeutics (NASDAQ: AGRX) is a women's healthcare company in the process of getting their lead product candidate, Twirla, cleared through the FDA, which could happen before the end of 2019.
Twirla is a once-weekly prescription contraceptive patch that is at the end of Phase 3 clinical development. After resubmitting a new drug application (NDA) to the FDA in May of this year, an AdCom meeting is scheduled for October 30, with an PDUFA date on November 16.
Twirla Opt
Agile Therapeutics
The road to potential approval has not been a smooth one for Agile as they have had a couple of setbacks, in the form of a CRL, with one in 2013 and the other in the 2017.
On December 21, 2017, Agile received their most recent complete response letter ("CRL") from the FDA citing deficiencies related to the manufacturing process for Twirla and raising questions on the in vivo adhesion properties of Twirla and their potential relationship to their Phase 3 clinical trial results. Due to the setback, Agile had to significantly scale back their commercialization plans for Twirla, including manufacturing validation and commercial planning, in order to address the 2017 CRL.
The FDA and Agile met in early 2018 in a Type A meeting to discuss the deficiencies in the Twirla NDA and to discuss the required regulatory path for Twirla's approval. In June of 2018, Agile announced the submission of a formal dispute resolution request ("FDRR") with the FDA, as the FDA’s reviewing Division of Bone, Reproductive and Urologic Products (“DBRUP”) shared concerns surrounding the in vivo adhesion properties of Twirla. The initial FDRR was submitted in June 2018 and was reviewed by the Office of Drug Evaluation III, which denied Agile's appeal, forcing Agile to escalate their appeal to the Office of New Drugs (OND).
Agile Investor Pres Sept 2019 P011
Agile Therapeutics Investor Presentation
In October 2018, Agile's appeal was formally denied by the OND in which they suggested that Agile conduct a wear study to evaluate whether Twirla demonstrates a generally similar adhesion performance to Xulane, the generic version of the previously marketed Ortho Evra contraceptive patch, a product the FDA considers to have acceptable adhesion.
Agile completed the recommended comparative wear study and announced top-line results, which demonstrated that Twirla was statistically non-inferior to Xulane. The study met the non-inferiority criterion set forth by the FDA by demonstrating an upper 95% confidence limit of -0.16. Primary endpoint: mean adhesion scores for Twirla,
Are you an investor or employee of Agile Therapeutics? If so, stop by our Agile Therapeutics Company Forum and join the conversation!
The FDA notified Agile of a planned Advisory Committee meeting scheduled for October 30, 2019, to discuss the Twirla NDA. As shown in the SECURE Trial, Twirla’s safety and efficacy, including the Pearl Index that FDA noted is substantially higher than other previously approved combined hormonal contraceptives.
While the wear study and data have been consistent, and improved through the long process, the FDA ultimately has the final say, which will be on November 16, the PDUFA date with the FDA.
Agile Investor Pres Sept 2019 P010
Agile Therapeutics Investor Presentation
While Agile believes they have done what the FDA has asked, their contract manufacturer, Corium, will need to provide the FDA with responses to each of the observations made during the FDA’s 2017 facility inspection, which puts the pressure on Corium as the FDA will likely re-inspect Corium’s facility during its review of the Twirla NDA before approval can be granted.
Many of the items necessary for Twirla's approval fall on Corium and their ability to complete the work and data required by the FDA.
Agile Investor Pres Sept 2019 P012
Agile Therapeutics Investor Presentation
While there should be obvious concerns with Agile's ability to meet these requirements set by the FDA as they have already received two CRL's, Agile's management has taken the necessary steps towards approval for Twirla. The excellent safety profile and giving women another option beyond a daily pill, should be enough for Agile to get the nod in November.
Additionally, while Agile has other projects in the pike, their primary source of future revenue at this moment is Twirla. Assuming FDA approval, they instantly become a target, or at least on the radar as an acquisition target. The first company that comes to mind is Boston Scientific in the Women's Health portfolio.
Agile has a plan of hiring 70-100 sales reps at launch which is a decent sized team for a start-up. They will focus by calling on Ob/Gyns and women's health NP/PAs.
Agile is projecting a 6-9% peak marketshare of the $3.8 billion addressable market, which includes CHC Pills, Ring, Patch.
The author of this article is long $AGRX with the intent to hold their position through AdCom and Twirla's PDUFA data on November 16, 2019.
Are you an investor or employee of Agile Therapeutics? If so, stop by our Agile Therapeutics Company Forum and join the conversation!
