[November 18, 2008]

Agile's Lead Product, AG200-15, Moving Into Pivotal Phase 3 Trials

(Marketwire Via Acquire Media NewsEdge) PRINCETON, NJ, November 18 / MARKET WIRE/ --

Agile Therapeutics, Inc., a late-stage
pharmaceutical company specializing in women's health products, announced
today that after a successful end-of-Phase 2 meeting with the Food and Drug
Administration (FDA), the company is moving forward with its pivotal Phase
3 program to support a NDA filing and marketing approval of AG200-15 with
SKINFUSION(TM) technology. AG200-15 is an innovative, low-dose
contraceptive patch that offers women a convenient, once-weekly form of
birth control. AG200-15 will fulfill a large unmet need for a more
convenient contraceptive alternative to the birth control pill.

New market research, conducted by Agile in 2008 with approximately 1,500
women of reproductive age, highlights that of the 80 percent of women who
would consider using the patch these women actually prefer the weekly
contraceptive to the pill by a 4-to-1 margin. More than 30 percent of
women who use birth control reported dissatisfaction with their current
contraceptive methods -- with a lack of convenience cited as a leading
reason. In addition, up to 65 percent of women who reported thinking about
using contraception said they would discuss AG200-15 with their doctors.

Thomas Rossi, Ph.D., President and Chief Executive Officer of Agile
Therapeutics, Inc., said, "We are very excited about the outcome of the
end-of-Phase 2 meeting with the FDA. We now have a clear development
pathway for AG200-15 for marketing approval. Agile's low-dose
contraceptive patch is expected to fill a sizeable need in the $6 billion
global ($2.5 billion U.S.) hormonal contraceptive market, opening the way
for AG200-15 to become a leading contraceptive product."

During the meeting, the Company obtained FDA review and feedback on
AG200-15's results in Phase 1 and 2 clinical studies, along with
non-clinical and CMC data. While citing no safety concerns over drug
components, levonorgestrel and ethinyl estradiol, the FDA is requiring the
customary birth control Phase 3 study design to assess safety and efficacy
of AG200-15 along with some additional supporting data for AG200-15's
label.

Marie Foegh, M.D., Chief Medical Officer and Vice President, Clinical
Research and Development at Agile Therapeutics, said, "We are very
comfortable with the FDA's requests and are confident in our ability to
have a successful Phase 3 program based upon our Phase 2 results."

About AG200-15, Agile's Low-Dose Contraceptive Patch

AG200-15 with SKINFUSION(TM) technology is a low-dose, weekly contraceptive
patch that is entering Phase 3 development with a clear defined regulatory
pathway. SKINFUSION(TM) technology makes it possible to use the trusted

hormone combination of levonorgestrel and ethinyl estradiol in a
contraceptive patch. AG200-15 has completed Phase 2 development and met
all target endpoints, including providing estrogen dose, ovulation
suppression, and side-effect similar to low-dose oral contraceptives. The
patch was designed for flexibility and comfort.

About the Contraceptive Patch Market

Ortho EVRA?, the only contraceptive patch available on the market today,
suffered major sales declines in 2005, when the FDA revised the product's
labeling to warn women about the risks associated with its higher than
expected estrogen dose. Prior to this labeling change, Ortho EVRA? had
been the most successful contraceptive launch in U.S. history.

About Estrogen

Estrogen is associated with certain common side effects, such as breast
tenderness, bloating/weight gain and nausea. These side effects are
believed to be related to the level of hormones delivered into the blood
stream, particularly with higher levels of estrogen. In some rare cases,
high estrogen levels are thought to be linked with serious, cardiovascular
side effects in some women. Therefore, low doses of estrogen in hormonal
contraception are desired.

About Agile Therapeutics, Inc.

Agile Therapeutics is a high-growth, late-stage pharmaceutical company
specializing in women's health products prescribed by OB/GYNs with an
initial focus on developing safer, more convenient methods of hormonal
contraception. Agile is privately financed and has raised a total of $35
million in venture funding with experienced and committed healthcare
investors, including ProQuest Investments, The Hillman Company, TL
Ventures, and Novitas Capital. For more information, please visit
www.agiletherapeutics.com.

Copyright ? 2008 Marketwire

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