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The road to the commercial contraceptive market is a “constant battle,” admits Dr. Michael Orlando.
For nearly a decade, Orlando’s company, Epin Pharma, has been on a long and expensive path to developing male contraceptives, a drug that has the potential to completely change family planning.
“It takes hundreds of millions of dollars to bring a drug to market,” Orlando said. “As you go down the rabbit hole of contraceptive development, it gets darker and darker. The only thing that brings light is money.”
But with compelling scientific results, a record of successful grant funding, and the promise of an easy-to-take drug that can alleviate the social, economic, and personal hardships caused by unplanned pregnancies, Orlando I set a goal. Bright possibilities for the future: Pill-sized innovations with the potential to have a profound impact on humanity and the economy.
“The high prevalence of unintended pregnancies is an important problem to solve, and one way to do that is to make family planning a more egalitarian landscape in which both men and women can participate.” said Orlando, a former professor at the university. UNC School of Medicine, he launched Eppin Pharma in 2014 based on research conducted in the university’s lab. The problem described by Orlando, now president and CEO of Epin Pharma, is widespread.
According to the Centers for Disease Control and Prevention’s National Center for Health Statistics, more than 5.5 million unplanned pregnancies occur in the United States each year. And although that number has declined since 2010, unplanned pregnancies still account for more than a third of all pregnancies in the U.S., and nearly half of all pregnancies worldwide, according to a United Nations report. Of these, 121 million pregnancies are unplanned. These unplanned pregnancies lead to increased medical costs, creating a burden on the health care system and taxpayers.
Federal and state expenditures in the United States for unintended pregnancies are estimated in the tens of billions of dollars annually. Beyond the broader economic aspects, unwanted pregnancies can also strain personal and family relationships and disrupt educational and career plans. Research studies also show that children born from unwanted pregnancies and their mothers may be at higher risk for adverse health outcomes.
Male version of the pill without hormones and side effects
Because there is no comparable contraceptive for men to the pill, women now have a greater responsibility for avoiding unplanned pregnancies, Orlando explained. But Eppin Pharma’s lead drug candidate, a safe, non-hormonal oral male contraceptive, has the potential to bring greater balance, choice and flexibility to everyone.
The company’s technology is a small compound that binds to EPPIN, a male-specific secreted protein on the surface of human sperm, resulting in a loss of sperm motility. “We’ve been studying sperm motility for quite some time, and the drugs we’re developing block the forward swimming of sperm,” Orlando said. “When you look at sperm, instead of seeing it swimming forward, as you might imagine, it’s just treading water, just staying in place. They’re not going anywhere.”
The drug’s non-hormonal composition offers significant advantages over other hormone-based male contraceptive technologies, such as topical gels and creams, which are also in development. “Giving men too much testosterone and progestin combinations can have long-term health effects,” says Dr. Orlando.
“When you use hormonal contraceptives for men, you have to stop producing sperm, and it takes several months to stop that process. And if you change your mind and want to start again, the engine starts running again. You have to wait another month or more for it to start and function, that is, for spermatogenesis to turn on again. Therefore, in addition to the possible hormonal side effects, stopping spermatogenesis There are also drawbacks that may not be appealing to people.”
Unlike hormonal options, Eppin Pharma’s drug candidates are designed to work quickly, with little to no side effects, and for quick recovery because they act on mature sperm. Orlando said data from early primate studies show that the drug takes effect within six hours and lasts only one to two days, making it suitable for short-term and long-term use. He said it could provide significant flexibility. “This could become an on-demand contraceptive pill where one day you choose to take the pill or not,” he says. “But we think the market is going to be men who find it easier to take a pill every day, whether they need it or not. Just like women have a pill wheel, men can have the same option of taking the pill as part of their daily routine.”
Breakthrough research kickstarts market development plan
Orlando, a pioneer in reproductive biology who founded an in vitro fertilization lab at UNC Hospitals and led efforts on the first “test tube” babies conceived in North Carolina, said the School of Medicine’s lab was interested in researching in vitro fertilization. Epin Pharma was established when the company started holding Effects of drugs on male fertility.
“As a faculty member in the School of Medicine, research in our lab was funded by NIH grants. For example, how drugs affect fertilization or activate specific pathways. I wanted to start exploring the problem,” Professor Orlando said. “These were not basic science problems like the NIH had in mind, but rather more practical problems. We had good ideas about contraception, but we needed to fund the lab.” So we started a company that could apply for NIH SBIR and STTR grants. Funding research was what led us to start the company.”
A lab in Orlando has identified certain compounds that could act as potential contraceptives. The company worked with his UNC Office of Technology Commercialization to apply for patents on its compounds using the Carolina Express licensing agreement. This licensing agreement is intended to make the licensing process more efficient for faculty and employee-founded startups by shortening negotiation timelines and minimizing litigation costs for young ventures. Masu.
Professor Orlando said, “An important part of our dealings with UNC was the Carolina Express License Agreement,” which states that the university owns the intellectual property patents, which are licensed to Epin Pharma. He said that “We entered into a special agreement with the Express License Agreement because Carolina’s Express License would save the company a lot of money,” Orlando said. He said he was protected. Patent protection in China could be next, he said.
By 2018, Eppin Pharma had enough support in grants to conduct research in collaboration with the Oregon National Primate Research Center using one of the STTR grants and funding from the North Carolina Biotechnology Center .
“We gave the monkeys the drug, collected the sperm and observed it. Sure enough, we noticed a change in motility,” Orlando said. “That research was the main impetus for developing this drug, because if we could see that it had this effect in primates, we could pave the way to market.”
The Path to Impact: Lessons from Eppin Pharma’s Entrepreneurial Journey
Part of Eppin Pharma’s initial funding came from the KickStart Commercialization Grant-Award Program, a fund issued by Innovate Carolina’s KickStart Venture Services team. The award, presented by Innovate Carolina, the Innovation, Entrepreneurship, and Economic Development core team at UNC-Chapel Hill, and its KickStart team, is an initiative to help early-stage companies achieve early commercial milestones. Helpful. Following the KickStart grant, Eppin Pharma focused on the federal SBIR/STTR grant program, which provides funding to small businesses focused on science and technology innovation.
Eppin received SBIR Phase 1 and 2 grants and STTR Phase 1 and 2 grants. SBIR grants are for small businesses to engage in federal research and development, while STTR grants require collaboration between small businesses and research institutions. The company also participated in the One North Carolina Small Business Program, which provides matching funds to North Carolina businesses that receive federal SBIR or STTR grants. In 2019, Eppin Pharma also received a $75,000 small business research loan from NCBiotech.
In 2023, Eppin Pharma received an investment of up to $800,000 from the Male Contraceptive Initiative (MCI) to fund proof-of-concept studies of drug candidates. The startup previously received a $300,000 grant from MCI at the end of 2019. “The grant system is great, but at the end of the day we need more funding than we can get from grants. That’s where MCI comes in. They were willing to invest more than they could,” Orlando said. “MCI is a critical tool in the development of male contraceptives, and their investment has allowed us to make further progress toward that goal.”
Like many university spin-out companies, Eppin Pharma took root on campus. Originally housed in a lab in Orlando under a facility use agreement, the startup moved off-campus in 2018. The company currently operates out of North Carolina BioLab in downtown Durham. Orlando said BioLab met the company’s needs in a way that many locations around the Research Triangle could not.
“There are several other locations available in the Triangle, but they don’t always have wet lab space or the necessary supplies and equipment. For example, one of the things we need is liquid nitrogen, so I Our location had to be a wet lab that was well-supplied with those types of resources,” he said. “The Biolab is a very nice, well-run place with all the equipment and amenities you need.”
When the company was founded, Orlando said about six people worked in a lab on campus. Molecular biologist and biochemist Katherine Hamill was one of them. Hamill immediately began working for the company, and today he continues to serve as Eppin Pharma’s senior director of operations. She has worked closely with Orlando from the beginning to develop the company.
In addition to continued collaboration with Hamill, Orlando said the startup’s approach to staffing has evolved with scientific and business advances. “Initially, we needed to synthesize a drug, so we started by hiring experts in organic chemistry and product development,” he said. “We currently have several consultants who are experts in areas such as CMC, toxicology and regulatory issues, and we pay them to work as part of Eppin Pharma.”
Orlando also points to the value of having executive-level expertise to support decision-making. “When you start a business, you need a scientific advisory board and a business board, and these people provide a lot of input into how we do things,” he says. said. “He also has two partners in the business who provide input on the development of the business and what to do next.”
Entrepreneurial education opportunities
Orlando, whose distinguished career has been built on expertise in fields such as biochemistry, immunology and molecular biology, said he considers himself “a scientist, not a businessman.” This self-awareness led him to find ways to learn about go-to-market business strategies and regulatory issues. “You definitely need help because it’s a steep learning curve to figure out how to run a business and understand all the things the FDA requires of drug development,” he said. .
An early form of entrepreneurship education came from the Carolinas’ KickStart Venture Services program. “One of the most important things when I was on his faculty at UNC was the KickStart Entrepreneurship Program, because it encouraged students to take short courses in college on how to become entrepreneurs and how to start a business. Because they encouraged me,” Orlando said. “The people at KickStart encouraged me to consider starting a company.”
Orlando said he was introduced to NCBiotech by the KickStart team and attended several seminars in Eppin Pharma’s early days.
“The NCBiotech seminar was very helpful in terms of hearing what other CEOs were doing and how they developed their companies,” he said. Eppin Pharma also received guidance from the North Carolina Small Business Technology Development Center, which helped him think through and deliver one of the company’s first grant applications from a business perspective. We also worked with Innovate Carolina’s patent landscaping and market research services, which help entrepreneurs evaluate their technology and market.
Note: This story is from UNC’s Innovate Carolina publication.
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