Princeton-based Agile Therapeutics, Inc., a specialty pharmaceutical company focused on the development of innovative women’s healthcare products, opened its doors in 1997 with a couple of employees. Today, the company boasts a full-time staff of 11, with plans for further expansion in the coming years. Agile completed its initial public offering in May 2014, raising gross proceeds of $55.0 million from various investors, including Princeton-based ProQuest Investments.
Agile also turned twice to the State’s innovative Technology Business Tax Certificate Transfer (NOL) Program to support its continued growth. Administered by the EDA, the NOL Program allows emerging technology and life sciences companies to sell net operating losses and research and development tax credits to unrelated profitable corporations in order to raise cash to finance their growth and operations. Since the program was established in 1999, more than 490 different businesses have been approved for awards totaling $770 million.
Agile is led by President and CEO Alfred Altomari. He had served as the company’s executive chairman from 2004 to October 2010 prior to becoming President and CEO. The New Jersey Technology Council (NJTC) recently honored Mr. Altomari with a CEO of the Year award. During the panel discussion that preceded the awards ceremony, Mr. Altomari spoke about how the State’s assistance was crucial to the success of Agile.
What did the NOL Program mean for your company?
The NOL Program was vital to the Company’s 2014 funding strategy. The proceeds from the NOL Program in combination with a bridge loan from our existing investors allowed Agile to fund operations during its IPO process. Specifically, it allowed Agile to engage a CRO to begin the process of implementing a confirmatory Phase 3 clinical trial (Secure clinical trial) for its lead product candidate, Twirla™, a once-weekly prescription contraceptive patch, in advance of the completion of the IPO.
What is Agile’s biggest success to date?
Agile’s biggest success to date is the development of Twirla based on our proprietary transdermal patch technology. Twirla is a combined hormonal contraceptive, or CHC, patch that contains the active ingredients ethinyl estradiol and levonorgestrel both of which have an established history of efficacy and safety in currently marketed combination low-dose, oral contraceptives. Twirla is designed to consistently deliver both hormones over a seven-day period at levels comparable to currently marketed low-dose oral contraceptives. By delivering these active ingredients over seven days, in a convenient and easy-to-use weekly patch, Twirla is designed to promote enhanced patient compliance. We believe Twirla will fulfill an unmet need in contraception.
What’s on the horizon for Agile?
Agile is currently enrolling subjects for its Phase 3 clinical trial for Twirla (Secure clinical trial) and hopes to have data from this trial in 2016. If approved, Agile plans to launch Twirla in the United States through a focused specialty sales force. In addition, Agile is also in the process of determining additional contraceptive patch products for development.
For more information on the NOL Program and other support for the technology industry, visit www.njeda.com and follow us on Twitter and LinkedIn @NJEDATech.