Herpes simplex virus is incurable. 16% of all American adults have genital herpes. In some countries, prevalence exceeds 50% - nearly 600 million people are currently infected worldwide. The cause, primarily HSV-2, is a serious source of morbidity and mortality, and a co-factor in HIV infection. Research to develop a vaccine to prevent herpes simplex was first attempted 100 years ago, with no prevention vaccine on the horizon. Treatment vaccines are in Phase I and 2 clinical trials but may be many years before approval and appear to be effective in reducing viral shedding and recurrent outbreaks. Oral drugs are available that suppress frequency of outbreaks, but can have side effects, are contra-indicated for certain people, and are not 100% effective.
The global market for herpes simplex treatment drugs is estimated to reach $4.9 billion in 2017 (Source: Global Industry Analysts). PPCM has the potential to be the first topical drug product for genital herpes that significantly reduces the severity and duration of herpes outbreaks.
Genital herpes can be transmitted even when an infected person is asymptomatic. It is easily transmissible and a person infected with genital herpes is 5 times more likely to acquire HIV. According to the World Health Organization (WHO):
HSV-2: The incidence and prevalence of incurable genital herpes in the US is growing. The CDC estimates 63 million Americans have HSV-2. There will be an estimated 500,000 to 1,000,000 new infections annually in the US alone.
HSV-1: 79% of US population has HSV-1 and 25%-35% have recurrent outbreaks. There are an estimated 100 million "cold sore" outbreaks in the US each year.
Other Sexually Transmitted Infections (STIs)
Sexually transmitted infections (STIs) cause human suffering and can be fatal. They are a significant economic burden, especially in disadvantaged populations. There are over 330 million new sexually transmitted infections globally every year. STIs are a serious cause of morbidity and mortality in adults and infants. These diseases, including human papillomavirus (HPV), herpes simplex virus (HSV), Chlamydia trachomatis (CT), Neisseria gonorrhea (NG) and others, cause discomfort, sterility, even death to adults and newborns. The CDC reports there are 19 million new STIs in the US each year.
There is a need for a new OTC vaginal contraceptive that is non-irritating, doesn't depend on hormones and doesn't require a physician's prescription.
We believe there is a need for a simple, pleasant OTC vaginal contraceptive that women can easily procure.
The contraceptive market is estimated to be $17 billion, at retail, in 2015. Revenues are generated primarily from hormonal products and condoms. Yet, there are 84 million unplanned pregnancies globally every year. 49% of all pregnancies are unplanned depending on the country. Nearly half are terminated by abortion.
Physicians and researchers understandably focus on highly efficacious, long-acting birth control products that must be prescribed by a physician. Yet, many women still do not have access to these products because they may not have insurance or money or they may not be in a settled, committed relationship that justify the cost and side-effects of using hormonal contraceptives. Lastly, initiating contraceptive use can take some time to see a physician and require out of pocket expenses. There is also high interest in non-hormonal contraceptives because many women resent side effects and remain concerned about their long term health. OTC contraceptives are, in theory, available but are all based on nonoxynol-9, an irritating surfactant that promotes infection in women.