New Jersey-based company seeks to provide women with contraception options beyond the birth-control pill
Lead product is Twirla, a low-dose prescription contraceptive delivered through the skin via a patch
Company seeking FDA clearance of Twirla in 4Q of 2019
As of March 31, Agile had nearly $12 million in cash and cash equivalents
The Princeton, New Jersey-based company has five products in its pipeline but the main focus now is on lead product candidate Twirla, also known as AG200-15.
The product is a low-dose prescription contraceptive delivered through the skin via the company’s proprietary patch technology called Skinfusion. Its active ingredients are ethinyl estradiol, a synthetic estrogen, and levonorgestrel, a type of progestin.
Twirla is designed to be applied once weekly for three weeks, followed by a week without the patch. The company has eight patents covering Twirla, which is as effective as taking the birth-control pill.
Currently there’s only one US government-approved contraceptive available to women -- Xulane, which is produced by Mylan Pharmaceuticals Inc (NASDAQ:MYL).
But Agile contends its product is superior for two reasons: Twirla is safer given its low dosage and offers better skin adhesion.
“We believe there is an unmet market need for a low-dose contraceptive patch that is designed to address the limitations of the existing patch, while increasing patient convenience and compliance in a non-invasive fashion,” Agile says.
Agile has completed its Phase 3 clinical trials of Twirla and is pursuing regulatory approval by US Food and Drug Administration. This month Agile resubmitted a new drug application with the FDA, which is a follow-up to its oirginal application filed in 2017.
The company said the new application is intended to satisfy a complete response letter the regulator sent Agile, questioning the manufacturing process at a third-party facility and the adhesion properties of its proprietary patch, among other issues.
Agile’s resubmission dossier includes the comprehensive results from a comparative wear study (Twirla vs. Xulane) that the FDA had requested, information on the company’s manufacturing process with partner Corium Inc, and other analyses.
The company also anticipates the FDA will hold an Advisory Committee meeting to review Twirla’s safety and efficacy. It hopes to get FDA clearance in the fourth quarter of 2019, despite what the company acknowledges has been a “long and complicated history seeking regulatory approval for Twirla in the US.”
In addition to Twirla, Agile has a pipeline of four other transdermal contraceptive products:
- AG200-ER, a regimen that allows a woman to extend the length of her cycle.
- AG200-SP, a regimen designed to provide shorter and lighter periods.
- AG200-ER (SmP), a regimen to allow a woman to extend the length of her cycle while experiencing shorter and lighter periods.
- AG890, a progestin-only contraceptive patch intended for use by women who are unable or unwilling to take estrogen.
However, Agile has placed a hold on the development of those products as the company focuses its energies and resources on Twirla and winning FDA approval.
If the FDA certifies Twirla, Agile intends to commercialize the product in the US through a direct sales force of 70 to 100 representatives that will target obstetricians and gynecologists, nurse practitioners, physician assistants and primary-care providers. The company also will market directly to patients. Lastly, Agile says it will need additional capital to fully implement Twirla’s commercialization.
Agile ended the first quarter of 2019 with $11.6 million in cash and cash equivalents, which includes the sale of about 8.4 million shares at $0.93 per share to an institutional accredited investor through a private placement, resulting in net proceeds of $7.8 million. The company says it has enough cash to meet projected operating requirements into the fourth quarter of 2019.
For the first quarter, which ended on March 31, Agile reported a narrowing loss of $4.7 million, or $0.13 per share, compared to a loss of $6.8 million, or $0.20 per share, for the same quarter a year ago.
Going forward, the company also says it could finance its cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements.
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