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Agile Therapeutics preps for commercialization of contraceptive skin patch Twirla

Snapshot

Twirla, which earned FDA approval in early 2020, is worn weekly and delivers daily doses of estrogen and progestin

patch

Quick facts: Agile Therapeutics

Price: 2.05 USD

NASDAQ:AGRX
Market: NASDAQ
Market Cap: $178.47 m
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  • New Jersey-based company seeks to provide women with contraception options beyond the birth-control pill
  • Flagship product Twirla is an FDA-approved low-dose prescription skin patch contraceptive
  • Sufficiently capitalized for Twirla's commercial rollout in 2020 

What Agile Therapeutics does:

Agile Therapeutics Inc (NASDAQ:AGRX) is a women’s health-care company dedicated to providing women with contraception options that offer them freedom from taking the pill daily.

The Princeton, New Jersey-based company has five products in its pipeline but the main focus now is on lead product Twirla, also known as AG200-15 — which won US Food and Drug Administration approval in February 2020.

The low-dose prescription contraceptive is delivered through the skin via the company’s proprietary patch technology called Skinfusion.

Twirla is designed for weekly application to deliver a 30 mcg daily dose of ethinyl estradiol, a type of estrogen, along with a 120 mcg daily dose of levonorgestrel, a well-known progestin. The patch can be worn on the abdomen, buttock, or upper torso (excluding the breasts).

Agile notes that Twirla is contraindicated for women who have body mass indices greater than 30 kg/m2. It's also contraindicated for women over 35 who smoke.

In addition to Twirla, Agile has a pipeline of four other transdermal contraceptive products in various stages of development and testing:

  • 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.

How is it doing:

Agile has said it plans to begin the pre-validation and validation of the commercial manufacturing process for Twirla in the first half of 2020. It will manufacture three batches of Twirla and complete the validation process in the second half of 2020.  

At the same time, the company will prepare to make Twirla available for commercial supply in a market estimated to be worth $3.7 billion and in which Agile could generate up to $300 million in sales, by some estimates.

In the first quarter of 2020, Agile plans to target managed care and patient payors to gain market access for Twirla. In the second quarter, the company plans to begin hiring and training an initial sales team of 70 to 100 persons who will reach out to obstetricians and gynaecologists, nurse practitioners, physician assistants and primary-care providers.

In the fourth quarter of 2020, Agile intends to ship the product to wholesalers.  

Many on Wall Street foresee the promise of Twirla, which means the company has been able to arrange sufficient capital in hand or in the pipeline to expand operations and fund Twirl’s manufacturing and roll-out. 

The company closed 2019 with $34.5 million in cash and cash equivalents. Since then it has launched financing plans to raise some $80 million, including a three-tier deal with Perceptive Advisors of New York to provide Agile up to $35 million and interest-only payments until February 2023. 

Inflection points:

  • Ship Twirla to wholesalers in 4Q 2020
  • Expects to generate revenue soon after with expanded sales staff
  • Broaden company's women’s health portfolio to address unmet needs

What the boss says:

“The FDA’s approval of Twirla will enable us to deliver on our short-term goal of establishing Agile in the contraceptive prescription market and working towards our longer-term mission to broaden our women’s health portfolio, including in areas of unmet need," according to Agile CEO Al Altomari.

"We are grateful to the clinical trial patients, researchers, healthcare providers, and advocates, whose contributions helped us secure the approval of a new transdermal contraceptive option that may serve the contraceptive needs and preferences of many women. We are proud to offer this new option and look forward to bringing Twirla to women and their healthcare providers.”

Contact the author: [email protected]

Follow him on Twitter @PatrickMGraham

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Watch

Agile Therapeutics looks forward to Feb 16 PDUFA date

Agile Therapeutics (NASDAQ:AGRX) CEO Al Altomari sat down with Proactive’s Christine Corrado at the Biotech Showcase 2020 in San Francisco. New Jersey-based Agile is focused on seeking FDA approval of its lead drug Twirla, and is looking forward to its Feb 16 PDUFA date

on 01/14/2020

4 min read