Agile Therapeutics, Inc. Secures $45M in Series B Funding to Progress Lead Contraceptive Patch, AG200-15, Through NDA Filing
The funding will allow Agile to complete Phase 3 clinical development and file for marketing approval for its lead contraceptive patch, AG200-15, and to advance Agile’s second contraceptive patch, AG1000, into Phase 2 clinical development. Further, the financing provides for development of additional pipeline products based upon the company’s SKINFUSION™ technology.
Agile’s lead product, AG200-15, is an innovative, low-dose weekly contraceptive patch entering U.S. pivotal Phase 3 clinical trials. If approved, AG200-15 will be the first contraceptive patch based on a low dose of estrogen (ethinyl estradiol (EE)) in combination with levonorgestrel. AG1000 is a levonorgestrel-only patch intended for women who are breastfeeding or cannot use estrogen-based contraceptives. Agile’s patches are being developed to provide women with a convenient and easy-to-use alternative to their current means of contraception.
Thomas M. Rossi, Ph.D., Agile’s President and Chief Executive Officer, commented, “This round of financing allows us to achieve NDA approval on our lead asset AG200-15, and to advance AG1000 into late stage development. We are very pleased to welcome representatives from prominent new investors to our board of directors and appreciate the continued strong support from our earlier investors. Their industry knowledge and experience will greatly benefit Agile as we transition into a company with marketed products.”
Dr. Rossi continued, “Agile is the only company advancing contraceptive patches based on the well-established hormone, levonorgestrel, which has a 25 year safety history in the U.S. and internationally. The convenience and compliance of a weekly contraceptive patch are attractive features to both patients and their doctors, especially when based upon hormones with proven safety profiles. AG200-15 and AG1000 have the potential to tap into a significant unmet need for a weekly contraceptive, and become leading products in the $6 billion global hormonal contraceptive market.”
Abhijeet J. Lele, Managing Director of Investor Growth Capital, added, “Agile is making important progress in its clinical development programs, with not only AG200-15, but also in its pipeline products such as the levonorgestrel-only patch, AG1000, for women who are breastfeeding or cannot use estrogen-based contraceptives. We look forward to supporting the company’s growth, and bringing innovative products to the women’s health market to fill a compelling unmet need.”
According to market research conducted on behalf of Agile with 105 OB/GYN physicians who are significant prescribers of contraception, 89 percent said they would be likely to prescribe AG200-15. Almost half said they would prescribe it immediately upon approval, demonstrating that physicians perceive a large need among their patients for the comfort and convenience of Agile’s low-dose, weekly contraceptive patch. This physician data supports the findings of Agile market research with 1,500 women, where nearly two-thirds of the participants said they would ask their doctor about AG200-15 if it were available to them.
About Agile Therapeutics, Inc.
Agile Therapeutics is a high-growth, late-stage pharmaceutical company specializing in women’s healthcare products prescribed by OB/GYNs with an initial focus on developing safer, more convenient methods of hormonal contraception. In late 2009, Frost & Sullivan recognized Agile Therapeutics with the 2009 North American Pharmaceuticals & Biotechnology Healthcare Innovation of the Year Award for its outstanding achievements in drug development based on AG200-15 with SKINFUSION™ technology. The company is led by an experienced team of pharmaceutical executives and has the support of a distinguished board of scientific advisors. For more information, please visit http://www.agiletherapeutics.com.
Contact:
Media: LaVoie Group Lisa Rivero, 978-745-4200 x106 lrivero@lavoiegroup.com http://www.lavoiegroup.com or Business Development: Agile Therapeutics, Inc. Thomas Rossi, Ph.D. President and Chief Executive Officer trossi@agiletherapeutics.com http://www.agiletherapeutics.com