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Male contraceptive developers seek reproductive equity amid limited options

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IFRS 9 Impairment How It Impacts Your Corporation And How We Can Help

The Market Intelligence Platform


Male contraceptive developers seek reproductive equity amid limited options

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Female birth control options make up the bulk of the contraception market, as males are limited to condoms and vasectomies.
Source: AP Images

The cruel joke in the male contraceptives field is that a viable product has been "five years away" from market since the 1970s — and while medical device developers say they may now truly be five years away from commercializing a new male contraceptive, pharmaceutical product candidates face at least another 10 years before hitting the market.

Currently, condoms and vasectomies are the only male contraceptive options.

Many individuals do not like single-use condoms, and surgical vasectomy procedures are irreversible, according to the CEO of Contraline Inc., a company that is developing an intrauterine-like device for men. The Mayo Clinic notes that vasectomies can be reversed in some instances, but the reversal procedure is much more difficult than the original one.

Though existing options are limited, the field of innovators is "scrappy," small and underfunded, according to executives at Male Contraceptive Initiative, or MCI, which facilitates research and development of nonhormonal products to prevent pregnancy.

But MCI director of operations and programs Logan Nickels said that every day, he comes across "someone new."

"Real developments are showing real promise making their way through the pipeline," Nickels said in an interview with S&P Global Market Intelligence. "And among the general public, these are things people want and will use — which was a case people had trouble making before."

Hormonal candidates

Hormonal contraceptives are furthest along among the drug candidates.

One of these is NES/T, comprised of progestin compound Nestorone and testosterone, now being tested by the National Institutes of Health and the National Institute of Child Health and Human Development in a phase 2 trial involving 420 couples.

The combination gel is applied to the back and shoulders every day, forming a reservoir on the skin, contraceptive development program chief Diana Blithe said.

The reservoir releases the product continuously to the blood, shutting down testosterone in the testes but simultaneously maintaining testosterone in the blood to "keep everything else functioning," such as ejaculation, according to Blithe.

"You're using a high amount of one hormone to shut down production of the other and then you're replacing that other, but at a level not sufficiently high enough to start sperm production again," Blithe summarized.

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NES/T can take between eight and 12 weeks to lower sperm levels to less than one million sperm per milliliter.

Men make 1,000 sperm per heartbeat, Blithe said, and an ejaculation contains approximately 100 million sperm.

"The woman only needs to make one egg per cycle, and you only have to inhibit one egg per cycle, but a man needs to make many millions of sperm to be able to fertilize the egg," she pointed out.

Blithe compared NES/T's regimen to that of the female birth control pill, which, when adhered to completely, has a perfect use failure rate of less than 1%.

"But in the typical world, women forget to take it, so the typical failure rate ... is about 7%," Blithe said. "We're hoping that if men were using the gel every day, they'll come close to the perfect use rate, but being a user-controlled method, it may be closer to the typical rate."

The phase 2 trial will take about four years to complete, and then move on to phase 3.

The same groups are also developing a male birth control pill, now in the "very early phase 1 stage" of testing for safety and efficacy, Blithe said.

Nonhormonal development

Male Contraceptive Initiative, meanwhile, specifically finds and funds nonhormonal developers.

MCI's focus is in part due to the public sector's dedicated resources for hormonal contraceptives, according to Nickels and executive director Heather Vahdat.

"[We're] directing dollars to one that's comparatively overlooked despite having greater overall opportunities," Nickels said.

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Like the female contraceptives space, some men would prefer nonhormonal contraceptives or are unable to tolerate hormonal options.

MCI contributed $200,000 in funding to Charlottesville, Va.-based Contraline, which has a vas occlusion device that mimics the mechanism of a vasectomy without the permanence.

The device, Echo-VR, injects a hydrogel that blocks sperm from traveling through the vas deferens in a minimally invasive procedure, CEO Kevin Eisenfrats said in an interview with S&P Global Market Intelligence.

"Our goal is to develop the IUD for men," Eisenfrats said. "The sweet spot for a first product in our pipeline is somewhere between one and two years."

Eisenfrats said IUDs, intrauterine contraceptive devices rated for different yearslong lifespans, are the fastest-growing category of female contraceptive on the market.

Echo-VR is slated to begin clinical trials by 2021.

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Contraline CEO Kevin Eisenfrats holds up the Echo-VR gel.
Source: AP Images

On the drug front, Durham, N.C.-based startup Eppin Pharma is leveraging a compound that binds to its titular male-specific protein, EPPIN, found on the surface of human sperm, to reduce sperm motility.

The oral drug would be taken while the sperm are still stored in the epididymis, thus inhibiting sperm movement before ejaculation.

According to Eppin Pharma CEO Michael O'Rand, the compound, when injected in monkeys, demonstrated effect within about six hours and lasted approximately three days.

The company is planning for investigational new drug acceptance from the FDA in 2020, O'Rand said.

Going where no pharma company has gone before

Most male contraceptive developers are academics, nonprofits or startups spun out of universities. The pharma industry has not engaged with male contraception research.

Eisenfrats hypothesized that the pharma industry has "a certain amount of money to spend, and ... they're not thinking about male contraceptives."

He added that, since insurance coverage of female contraceptives is "well-defined ... we already know what the market is willing to pay, which is not a huge amount." However, MCI's Nickels is unsure how male contraceptives would fare, as men do not bear risk of pregnancy.

Pharma companies that already have female contraceptives under their belt, such as Merck & Co. Inc., may not want to delve into a space that could compete with their existing products, O'Rand and Eisenfrats both said in separate conversations.

But the NIH's Blithe said she does not "see it as a zero-sum game, where if [a male contraceptive is available], women will stop using their methods."

"It's likely there will be an increase in overall usage of both methods," she said.

O'Rand also said women are "very much in favor" of male contraceptives. Common rumors that Vahdat and Nickels hear are that women will not trust men to use contraceptives, or that men will not use them.

"There's a lot of big moving parts that I think represent a broader cultural shift," Nickels said. "We're dealing with a construct of what contraceptives always have been."

Eisenfrats emphasized a movement toward greater reproductive equity, especially among millennials, as well as men's desire to gain more control over their own bodies and health.

"It's about time guys played a larger role," Eisenfrats said.

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