Lead Program for Contraceptive Patch Candidate AG200-15 Recently Announced Early Completion of Patient Enrollment in Pivotal, Phase 3 NEW CHOICE Study
PRINCETON, N.J.--(BUSINESS WIRE)-- Agile Therapeutics, Inc., a pharmaceutical development company specializing in women’s healthcare products, today announced that Al Altomari, a former senior manager at Johnson & Johnson who has been serving as Agile’s Executive Chairman, will succeed Dr. Thomas Rossi as President and Chief Executive Officer, effective immediately. Dr. Rossi, who joined Agile as President and CEO in 2004, will serve as Scientific Advisor to the Company.
Agile recently announced that the Company’s pivotal, Phase 3 NEW CHOICE Study of AG200-15, Agile’s lead contraceptive patch candidate, completed patient enrollment two months ahead of schedule. This will enable Agile to plan for an earlier submission of the New Drug Application (NDA) for AG200-15 to the U.S. Food and Drug Administration (FDA).
“We are proud of the record of accomplishment and progress at Agile and believe that, with the lead product development program proceeding ahead of schedule, this is the right time for Agile to develop a more commercial orientation,” Dr. Rossi stated. “Al’s extensive industry experience in product launch activities and commercial operations, as well as his history with Agile, make him the ideal choice to lead the company through this next stage of growth. I am very pleased to see him move into this role.”
Mr. Altomari has more than 25 years of experience in the pharmaceutical industry, with more than 18 of those years focused on the development and marketing of specialty pharmaceutical products. Most recently, he was the CEO of Barrier Therapeutics. During his tenure, Mr. Altomari spearheaded commercialization of Barrier’s product portfolio and completed the sale of Barrier to GSK/Stiefel Laboratories. Previously, he served for more than two decades at Johnson & Johnson, where he held executive roles in general management, commercial operations, business development, product launch preparation and finance. Mr. Altomari completed his tenure with Johnson & Johnson as General Manager of Ortho Neutrogena. He also served as Vice President/Franchise Head of Ortho-McNeil Pharmaceutical’s Women’s Health Care Franchise, where he introduced several life cycle and new product development initiatives, including the market preparation for ORTHO EVRA®, the contraceptive patch.
Mr. Altomari serves on the Boards of Auxilium Pharmaceuticals Inc., DUSA Pharmaceuticals Inc., and Nitric Bio Therapeutics. He also served as Executive Chairman of Agile from April 2009 until his current appointment as President and CEO.
Mr. Altomari commented, “It has been a pleasure working with Thom throughout his tenure. His leadership of Agile has set a high bar for innovating in the area of women’s health, and I am grateful for the opportunity to take this successful and thriving organization to the next level. I look forward to helping Agile prepare for commercialization of our two clinical programs.”
During Dr. Rossi’s tenure, Agile secured additional intellectual property rights and the granting of several key U.S. and European patents for the Company’s novel Skinfusion™ technology for the transdermal drug delivery of contraceptive hormones. Dr. Rossi and his team advanced into the clinic two contraceptive patch candidates incorporating this proprietary technology:
- AG200-15, designed to effectively deliver a low dose of estrogen (ethinyl estradiol (EE)) in combination with levonorgestrel (LNG). AG200-15 is applied once weekly for three weeks followed by a patch-free week.
- AG900, a low-dose, LNG-only contraceptive patch designed to provide a new option for women for whom estrogen-containing contraceptives are contraindicated, inappropriate or unwanted.
Agile announced earlier this year the completion of a $45 million round of venture financing and the expansion of its investor syndicate. The funding is expected to 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, AG900, into Phase 2 clinical development.
About Agile Therapeutics, Inc.
Agile Therapeutics is a pharmaceutical development company specializing in women’s healthcare products, with an initial focus on developing safer, more convenient methods of hormonal contraception. Agile has two clinical-stage contraceptive patch candidates: AG200-15, currently in pivotal, Phase 3 studies, which is designed to deliver a low dose of estrogen (ethinyl estradiol (EE)) in combination with levonorgestrel (LNG); and AG900, a low-dose, progestin-only contraceptive patch. Both AG200-15 and AG900 incorporate Agile’s proprietary SKINFUSION™ technology, consisting of an active and peripheral adhesive system that allows stable drug delivery and dependable adhesion over seven days. For more information, please visit http://www.agiletherapeutics.com.
Burns McClellan on behalf of Agile Therapeutics
Justin Jackson, 212-213-0006
KEYWORDS: United States North America New Jersey
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Hospitals Pharmaceutical Other Health General Health