AG200-15 or Twirla®, Agile’s lead product candidate, is an once-a-week hormonal contraceptive patch. It contains the hormones levonorgestrel and ethinyl estradiol. These ingredients have a well-understood efficacy and safety profile in oral contraceptives. Twirla is designed to deliver both hormones over a seven-day period. The patch is applied once weekly for three weeks, followed by a week without a patch. This once-weekly application makes it very convenient for women, daily options like contraceptive pill tend to be forgotten with the known consequences as a result. The contraceptive patch keeps the target levels of active ingredients flow steadily through the skin. The proprietary patch design consists of 5 unique layers and is less than 1 mm thin.
The innermost layer of the patch contains the active ingredients, adhesives, and inactive ingredients that improve delivery of the active ingredients. This is called the Active Matrix. Two outer layers cover the Active Matrix and contain additional adhesives, but no other active or inactive ingredients. These layers, called the Peripheral Adhesive System, create a ring of adhesive around the edge of the patch. The outer adhesive ring is designed to prevent accumulation of dirt from coming under the patch. A barrier layer separates the Active Matrix from the Peripheral Adhesive System, preventing migration of ingredients. The outermost layer of the patch is a soft, flexible fabric designed to provide maximum comfort.¹
The Golden Investor thinks this product will be a really good alternative to other more radical contraceptives. If Agile Therapeutics will get Twirla approval it will be able to grow the company and start producing in Q4 of 2020. FDA approval is very likely since the Advisory Committee voted 14-1 for approval of the drug. Main concerns were reduced effectiveness in overweight women. So the FDA could put a side note on the approval which would mean a smaller potential client base. And while most approvals with an extended approval date get this approval, there’s still a potentially disastrous possibility of denial. This would slash the stock down to penny range again. However since the BRUDAC agreed that that the benefits of Twirla in the prevention of pregnancy outweigh the risks to support approval, The Golden Investor is bullish on this stock, approval could come as soon as the 14th of February so make sure to outweigh the risks and get on the Agile train or stay behind.
Disclaimer: The writer of this article holds Agile Therapeutics (AGRX) stock, this article should not be interpreted as investment advice or anything like that.