Agile Therapeutics - Therapeutic Market

	MARKET HISTORY	MARKET POTENTIAL

MARKET HISTORY

The birth control marketplace is going through an evolution. During the first 40 years after the introduction of the birth control pill in 1960, the majority of changes to the pill involved dose reductions, new progestins and different phasing regimens of the hormones used in birth control pills. The launch of more convenient, non-daily short-term options included:

In 2002, the first weekly contraceptive patch, known as Ortho EVRA^®, was introduced by Johnson & Johnson providing all women with a more convenient contraceptive option. (Please See Product Safety Information Below)

In 2005, Organon introduced a 21 day vaginal ring known as NuvaRing^®. (Please See Product Safety Information Below)

The Ortho EVRA^® (Evra^®) patch was the first contraceptive method to challenge the hold that the birth control pill has on the marketplace. The EVRA^® patch was very successful initially, achieving net sales of over $400 million within 2 years of launch. One quarter to one-third of women using contraception have tried the patch (market research sponsorsed by Agile) and its success not only confirmed the need for a weekly contraceptive method, but also validated the belief that women would accept a patch as a birth control method.

In November 2005, the FDA and Ortho added a bolded warning to Evra’s labeling stating that Evra’s estrogen dose was approximately 60% higher than a 35 mcg EE oral contraceptive. The higher estrogen levels could increase the risk of cardiovascular events such as VTE. As a result, the usage of Evra declined dramatically as seen in the figure below. There is a major unmet market need for a low dose contraceptive patch.

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Recent market research with contraceptive users indicates that women like the weekly birth control patch and would be very receptive to the low-dose Agile patch that provides a convenient alternative to daily pills. In addition, OB/GYN are very likely to prescribe Agile's patch for a significant portion of their contraceptive patients. (Please See Market Potential Section)

SAFETY INFORMATION

ORTHO EVRA^®:
IMPORTANT SAFETY INFORMATION ABOUT ORTHO EVRA^®: Serious as well as minor side effects have been reported with the use of the Patch. Serious risks, which can be life threatening, include blood clots, stroke and heart attacks and are increased if you smoke cigarettes. Cigarette smoking increases the risk of serious cardiovascular side effects, especially if you are over 35. Women who use the Patch are strongly advised not to smoke. Some women should not use the Patch, including women who have blood clots, certain cancers, a history of heart attack, blood clots, or stroke, as well as those who are or may be pregnant. Hormones from ORTHO EVRA get into the blood stream and are processed by the body differently than hormones from birth control pills. You will be exposed to about 60% more estrogen if you use ORTHO EVRA than if you use a typical birth control pill containing 35 micrograms of estrogen. In general, increased estrogen may increase the risk of side effects. The risk of venous thromboembolic events (blood clots in the legs and/or the lungs) may be increased with ORTHO EVRA use compared with use of birth control pills. Studies examined the risk of these serious blood clots in women who used either ORTHO EVRA or birth control pills containing one of two progestins (levonorgestrel or norgestimate) and 30-35 micrograms of estrogen. Results of these studies ranged from an approximate doubling of risk of serious blood clots to no increase in risk in women using ORTHO EVRA compared to women using birth control pills. You should discuss with your healthcare professional whether ORTHO EVRA is a good method of contraception for you. The Patch does not protect against HIV or sexually transmitted diseases.

NUVARING^®:
IMPORTANT SAFETY INFORMATION ABOUT NUVARING^®: The use of combination oral contraceptives is associated with increased risks of several serious side effects, including blood clots, which may lead to stroke or heart attack. NuvaRing^® is not for women with a history of these conditions. The risk of getting blood clots may be greater with the type of progestin in NuvaRing^® than with some other progestins in certain low-dose birth control pills. It is unknown if the risk of blood clots is different with NuvaRing^® use than with the use of certain birth control pills. Cigarette smoking increases the risk of serious cardiovascular side effects, especially in women over 35; women who use combination hormonal contraceptives are strongly advised not to smoke. NuvaRing^® is not for women with certain cancers or those who may be pregnant. NuvaRing^® does not protect against HIV infection and other sexually transmitted diseases. The most common side effects reported by NuvaRing^® users are: vaginal infections and irritation, vaginal secretion, headache, weight gain, and nausea.