Evofem's birth control gel meets main study goal; shares rise
Evofem's birth control gel meets main study goal; shares rise
(Reuters) - Evofem Biosciences Inc said on Monday its birth control gel showed effectiveness in a late-stage study, bringing the first hormone-free contraceptive close to approval and sending its shares up 27 percent before the bell.
Male condoms and oral pills dominate the $5.5 billion contraceptive market in the United States. However, oral pills cause side effects such as bleeding between periods, mood swings and nausea in women.
“These results pave the way for Amphora’s disruption of the contraception market as a novel, highly effective, non-hormonal and woman-controlled method that finally answers women’s long-awaited desire to avoid hormones,” Roth Capital Partners analyst Yasmeen Rahimi said.
The gel works by regulating vaginal pH within the normal range of 3.5 to 4.5, creating a hostile environment for sperm and certain viral and bacterial pathogens that can cause sexually transmitted diseases.
Amphora was found to have a 86 percent efficacy rate in avoiding pregnancies and no serious side-effects were observed in the study, which evaluated about 1,400 healthy women belonging to the age group 18-35 years, Evofem said.
Oppenheimer analyst Leland Gershell said he expects Amphora, the company’s lead product, to bring in peak sales of $415 million by 2032.
The company plans to resubmit the marketing application for Amphora in the second quarter next year and if approved, plans to launch the product in January 2020.
Evofem is also testing Amphora as a preventive treatment for chlamydia and gonorrhea - two of the world’s most common sexually transmitted infections.
Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Maju Samuel
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