Agile Therapeutics,Inc. (NASDAQ:AGRX) Files An 8-K Other Events
Item 8.01.Other Events.
On January10, 2019, Agile Therapeutics,Inc. (the “Company”) issued a press release announcing that on January9, 2019, it received final meeting minutes from its December11, 2018 meeting with the U.S. Food and Drug Administration’s (“FDA”) Division of Bone, Reproductive, and Urologic Products (“DBRUP”). The Company met with DBRUP to discuss the design of a comparative wear study between Twirla®and Xulane®(“the comparative wear study”) as suggested by FDA’s Office of New Drugs (“OND”) in its decision on the Company’s previously announced formal dispute resolution request. In its meeting with DBRUP, the Company discussed the specific design and success criteria of the comparative wear study, which is intended to demonstrate adequate adhesion via non-inferiority of Twirla to Xulane, the generic version of the previously marketed Ortho Evra®contraceptive patch, a product the FDA considers to have acceptable adhesion. The Company has initiated a crossover wear study in approximately 80 healthy women with a Body Mass Index (“BMI”) of less than 35 kg/m2who will be randomized to wear either Twirla or Xulane for the first week and then switched to the patch not initially worn for the second week.
The Company confirmed that its current plan is to complete the comparative wear study in the first quarter of 2019 and to resubmit the Twirla new drug application in the first half of 2019, which provides it the opportunity to receive approval by the end of 2019. The FDA has previously informed the Company that in connection with its review of the Twirla NDA, the FDA plans to bring the safety and efficacy of Twirla to an Advisory Committee. The Company also expects that the FDA will conduct a pre-approval inspection of the Company’s third-party manufacturer’s facility, which must be successfully completed prior to approval.
The Company also confirmed that it believes that its unaudited cash and cash equivalents as of December31, 2018, will be sufficient to meet its projected operating requirements into the second quarter of 2019, which will include completion of the comparative wear study. The Company will require additional capital to fund its operating needs for the remainder of the second quarter of 2019 and beyond, including among other items, preparation for an anticipated Advisory Committee meeting to discuss safety and efficacy of Twirla, the completion of its commercial plan for Twirla, which primarily includes validation of the commercial manufacturing process and the commercial launch of Twirla, if approved, and advancing the development of its other potential product candidates.
A copy of the Company’s press release is attached hereto as Exhibit99.1 and is hereby incorporated by reference herein.
Xulane®is a registered trademark of Mylan N.V., and Ortho Evra®is a registered trademark of Johnson & Johnson.
AGILE THERAPEUTICS INC Exhibit
EX-99.1 2 a19-1052_3ex99d1.htm EX-99.1 Exhibit 99.1 Agile Therapeutics,…
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About Agile Therapeutics,Inc. (NASDAQ:AGRX)
Agile Therapeutics, Inc. is a women’s health specialty pharmaceutical company. The Company is focused in the development and commercialization of prescription contraceptive products. The Company has developed a transdermal patch technology, called Skinfusion. The Company’s lead product candidate is Twirla, also known as AG200-15, is a combined hormonal contraceptive (CHC) patch. In addition to Twirla, the Company is developing a pipeline of other new transdermal contraceptive products, including AG200-ER, which is a regimen designed to allow a woman to extend the length of her cycle; AG200-SP, which is a regimen designed to provide a shortened hormone-free interval, and AG890, which is a progestin-only contraceptive patch intended for use by women who are unable or unwilling to take estrogen. Each of its product candidates utilizes its Skinfusion technology designed to deliver contraceptive-levels of hormones to the blood stream through the skin over a seven-day period.