Talking about sex with potential investors? For EvoFem Biosciences CEO Saundra Pelletier, it’s the first item on the docket.
Her company recently submitted Amphora, a non-hormonal contraceptive gel, to the FDA for review. EvoFem (NASDAQ: EVFM)—and the rest of the women’s health sector—will know by midyear whether the product will be approved, making the San Diego companies one of the few biotechs to commercialize a novel prescription women’s health product in recent years.
Pelletier was among a handful of executives at the JP Morgan Healthcare Conference in San Francisco last week pushing ahead in a sector of life sciences in which innovation has lagged. Getting women’s health companies funded involves hurdles that CEOs in other areas of biotech rarely face, such as delving into healthcare concerns with which the investor community, mostly men, are unfamiliar, and talking about topics such as sexual health and menstruation.
Amphora was designed for women looking for a birth control option that doesn’t use hormones to prevent pregnancy. EvoFem’s product comes prefilled in a tube the size and shape of a tampon, and is inserted up to an hour before intercourse. In addition to preventing pregnancy by keeping the vaginal pH within a specific range, Amphora is also being studied to determine whether it can prevent women from contracting two sexually transmitted infections, chlamydia and gonorrhea. Pelletier, in an interview during the conference, said the company is hiring 125 sales representatives and 14 area sales managers to call on obstetrician-gynecologists (OB-GYNs) when Amphora, if approved, launches in June.
“It’s such a foreign conversation, in a foreign language,” she said of her talks with potential investors about the product. “I’ve had some investors say to me, are women really going to insert something in their vagina? Hello, they’ve had their periods since they were 12; they’ve been using tampons.”
Another San Diego biotech, Daré Bioscience (NASDAQ: DARE), is also advancing an investigational non-hormonal contraceptive. On Monday, the company announced a licensing deal with Bayer.
Advancement of new treatments for issues that affect women have been stymied by the lack of understanding of those healthcare concerns among investors as well as a perception of the sector as one of primarily low-value, generic drugs, such as oral contraceptives, said members of a panel at Biotech Showcase, an investor conference that takes place during JPM. [Editor’s note: EBD Group, a Biotech Showcase organizer, is part of Informa, Xconomy’s parent company.]
About 30 people showed up for the morning discussion, which was the first on the topic hosted at Biotech Showcase in its 12-year history. Moderated by Jennifer Friel Goldstein, who heads business development for technology and healthcare at Silicon Valley Bank, the panel included an equity analyst, two entrepreneurs, and two pharmaceutical executives from companies with women’s health units—Bayer and Johnson & Johnson (NYSE: JNJ).
“This is an area which is underappreciated,” said Ami Fadia, an SVB Leerink analyst whose coverage includes women’s health companies. “I don’t think people acknowledge the variety of conditions that women suffer from, and I think there is an increasing understanding of that.”
For women’s health companies to find the money they need to get new treatments to market, the sector needs a big, commercial win, Fadia says. Given that few venture capitalists have been willing to back such companies, it may take standalone biotechs launching successful products on their own to boost funding sector wide, she said.
That’s what EvoFem plans to do.
Pelletier said that after Amphora reported positive data out of its Phase 3 study, financiers began to take the product—and potential $1 billion market opportunity—more seriously.
“It’s so much different talking to investors now that we’ve had success, we’ve hit milestones,” she said.
EvoFem says its market research determined that 17 million US women are interested in using a new kind of contraceptive without hormones, which for some women can cause side effects including mood changes, headache, and weight gain. If 5 percent of those women use Amphora, getting seven refills annually (a box will have 12 doses), the product would be a blockbuster.
Of course, commercializing a drug is expensive. That’s why the role of pharmaceutical companies, a natural partner for biotechs developing such products, is so essential when it comes to getting financial support, said Mary Kerr, president and CEO of UK-based Kandy Therapeutics, which is developing a non-hormonal treatment for the symptoms of menopause, NT-814.
“One of the first questions [investors] ask is, if I give you money and you’re successful, where will I get my exit?” Kerr said. “When I started raising money in 2016 … they couldn’t see an exit. We really struggled to raise any money.”
The startup raised €25 million (about $32 million) in August 2018.
“I hope that [NT-814] is going to be one those big wins that attracts pharma back into the sector and illustrates the fact that there is potential for true novelty and it is worth investing in some of these young startup biotech companies with good ideas,” Kerr said. “When the floodgates open,” she says, the entire sector will benefit.
First, however, the company is looking for funding for a Phase 3 study.
“Women’s health has really been ignored, and Big Pharma has largely abandoned it and moved on—they still have some old products hanging on, but they’re just not investing in R&D anymore,” said Lynn Seely, Myovant Sciences president and CEO, during an interview at JPM. “There are millions of women suffering with diseases who are in need of better therapies, so we thought that this was an amazing place for us to really take a leadership position.”
This year Brisbane, CA-based Myovant (NASDAQ: MYOV) plans to ask the FDA to review a combination drug including its lead candidate, relogolix, as a treatment for symptoms of uterine fibroids, non-cancerous tumors that develop in the muscular wall of the uterus that can cause heavy and prolonged menstrual bleeding, anemia, and pelvic pain.
The company this year also anticipates reporting results from a late-stage trial of relogolix in patients with symptoms of endometriosis, a painful disorder that can lead to infertility.
Gail Maderis, president and CEO of South San Francisco-based Antiva Biosciences—which is developing a drug to treat a precancerous condition nearly always caused by the human papilloma virus (HPV)—drew a parallel between the rise of the rare disease industry and the potential in women’s health during the Biotech Showcase panel.
“I remember pharma just kind of laughing us out of the room when we [at Genzyme] said we’re developing [a drug] for Gaucher disease,” a rare genetic disorder, she said, speaking on the showcase panel. “Like rare diseases, if we get some successes with some high-value products in the areas of uterine fibroids, and menopause, and beating hot flashes, and endometriosis, and HPV therapeutics, these kinds of higher-value products will create interest and will feed, then, the development cycle of more companies and investors being interested in the sector.”