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Despite the popularity of hormonal contraceptives, they are associated with some potential severe side effects. The risk of venous thromboembolism, the formation of a blood clot in a deep vein, increases three to six times and the risk of a heart attack or stroke goes up two to three times.3 Also, certain women are contraindicated from receiving hormonal therapy, such as smokers over the age of 35 and women with a history of breast or pelvic cancers.Hence, a safe and effective hormonal alternative is expected to attract a market of women who will switch from hormone-based therapies and those not using any contraception
Evofem is developing its first product candidate, Amphora, from their proprietary Multipurpose Vaginal pH Regulator platform. Amphora is a bioadhesive vaginal gel that is a mix of L-lactic acid, citric acid, and potassium bitartrate that are all compounds generally regarded as safe by the FDA and frequently found in food. A normal vaginal pH is acidic at 3.54.5 and the gel works by maintaining acidity in the presence of semen, keeping the environment inhospitable to sperm motility. Unlike much of the competition, Amphora is non-hormonal and accordingly does not appear to have the same long-term safety concerns compared to hormone-based contraceptives.
Evofem is also looking to expand the Amphora label to include the prevention of infection of Chlamydia trachomatis (chlamydia) and Neisseria gonorrhea (gonorrhea) in women. In December 2019, the company reported positive and statistically significant data from its AMPREVENCE study. The Phase IIb trial assessed 860 patients over a four-month period and found that the use of Amphora led to a 50% relative risk reduction in chlamydia infection and a 78% reduction in gonorrhea (see Exhibit 7). Evofem will discuss the data with the FDA at an end-of-Phase II meeting and expects to initiate the Phase III program in Q121 with approval in 2022
According to the CDC, there were 1.8m new cases of chlamydia in 2018, up 19% over 2014, and over 583,000 new cases of gonorrhea in that same year, up 63% over 2014. While the addressable market is quite large and both infections can lead to serious complications if left untreated, we believe Amphora will most likely be used to prevent both pregnancy and infection versus infection alone. As such, our forecasts factor in that infection prevention will make Amphora incrementally more attractive as a contraceptive since neither hormonal contraceptives, spermicides and intrauterine devices have been shown to decrease infection rates.
Zulassungswahrscheinlichkeit sehr hoch mMn, es wird was aufm Markt kommen, was es so noch nicht gegeben hat, FDA wird wohl unter Zugzwang sein
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