Advancing reproductive choices for men

Transcript - Advancing reproductive choices for men

Alivia Kaylor: Hello and welcome back to Healthcare Strategies. I'm your host, Alivia Kaylor, Senior Editor of Pharma Life Sciences, and today, we're diving into a topic that has long been overlooked and is now gaining significant traction: male contraception. Joining me today is Darlene Walley, CEO of NEXT Life Sciences, the company developing Plan A. Plan A is a long-acting reversible male contraceptive that could change the game of reproductive health. Darlene, thank you for coming today and welcome to the pod.

Walley: Thank you, Alivia. I am so excited to be here.

Kaylor: Well, let's just go ahead and dive into the basics. Can you please tell me what Plan A is exactly and how it works? I understand it's based on a technology called Vasalgel, correct?

Walley: That's correct. So, Plan A consists of a delivery device and a polymer called Vasalgel. So, the delivery device allows the polymer to be accurately deposited into the vas deferens of the male. The polymer is very interesting. It starts out as a viscous, very thick, clear solution, like honey. And when it goes into the vas deferens, it becomes very spongy, very porous, and it will allow fluids to pass, but not sperm. And then, the really interesting part is, on-demand, that hydrogel can be reversed. It could be dissolved very easily and removed from the body.

Kaylor: We often hear this narrative that birth control is seen as a woman's responsibility, but I feel attitudes are shifting. What kind of demand are you seeing for male contraception, especially in the wake of the Dobbs decision that overturned Roe vs. Wade?

Walley: You're absolutely right. After the overturn of Roe vs. Wade, and with the new administration, there's been a spike in the request for vasectomies. So, vasectomies are pretty final. They have a very low reversal rate and a very expensive out-of-pocket fee. So, men are really looking for another option -- 85% of men in our demographic, which is 18-45, are looking for other forms of male birth control. Right now, they have condoms, which have a high failure rate and aren't as convenient to use, or the extreme of vasectomies. It turns out that one-third of the men who call to make an appointment for a vasectomy actually don't show up because it is pretty final. It's a very big decision.

Kaylor: Yeah, that's a good point there. I guess I didn't realize that stat. That's pretty staggering. Well, and they say good things take time, but when it comes to male birth control, I feel like we've all been waiting forever. The first female contraceptive pill was FDA-approved back in 1960, and here we are, 65 years later. When I reported on Plan A a few years ago, I was told Vasalgel would hit the market by 2024. Now that we're here in 2025, can you provide a more updated road map for Plan A? When will men actually have access to this option? And, if you could elaborate, please, what regulatory hurdles are still needed to be cleared at this point?

Walley: Reproductive health is ripe for innovation. As you said, the female hormonal birth controls have been around, as well as the IUDs, for over half a century with very little innovation. And now, we're learning that many women can't tolerate the hormonal birth control pills and IUDs, so it's not a great option. So, products like Plan A are very desirable by men and by the medical profession. Right now, we are in the process of scaling up our manufacturing. We're getting ready to start our clinical trials in humans, and we have met with the FDA, have very clear pathway to the market. So, we're very excited about that. I will be glad to keep you apprised of all of our progress in the future, but, right now, we're just poised to start all of our clinical trials in the US as well as around the world. We have Australia and Canada, as well.

Kaylor: Great. And, for those who may not be familiar in the audience, can you break down the approval process since it is considered more of a medical device? And, how does the regulatory path for medical devices like Plan A compare to say the traditional FDA drug approval process?

Walley: Great question. First and foremost, every product that goes on the market should be safe and effective. Plan A is very inert. There's nothing that interacts with the body. It serves as an occlusion, if you will. It excludes certain sizes like sperm at three microns, and it lets fluids and other materials that are less than one micron pass through. So, our approval process is very different. A drug has to go through phase one, two, three and four testing, which could take up to a decade. A medical device, because the elements of it, like ours, really don't have a reaction with the body, doesn't cause a change in the body, etc. So, we have a pretty straightforward pathway, but we still have to prove safety and efficacy, which everyone should want. Our pathway right now is, we're starting with early feasibility trials, then we move into feasibility trials, and then, next year, we'll be in pivotal trials, and that leads to our FDA submission.

Kaylor: Thank you for explaining that. Now, Plan A isn't the only male contraception in development, right? How does Plan A compare to other options that are currently in the pipeline, and what are those options, if you can elaborate more?

Walley: Absolutely. So, remember, Plan A is a LARC, long-acting reversible contraceptive. So, there are other products that are being developed. We already talked about the two in the market, condoms and vasectomies. And then, there are products that are in the pill form and those are in early safety testing, in development. There's another product that's similar to ours, but it's not reversible and it's not as long-lasting. So, we believe we have the only long-lasting reversible male contraceptive.

Kaylor: Awesome. And I just have a follow-up question now that you're talking about the development here. Could Plan A possibly, potentially last longer than 10 years in the future?

Walley: We believe, based on some early research done in India with the predecessor of Plan A, that the product can last over 10 years. There are men right now in India that have been implanted with the precursor to Plan A that are over 10 years. We have every reason to believe that Plan A can be effective longer than 10 years, but right now, we're using 10 years as our claim.

Kaylor: That's great news. Now, Darlene, let's switch our focus. Let's talk about affordability. Obviously, affordability is a major factor in contraceptive use and access.

Walley: Mm-hmm.

Kaylor: How much will Plan A cost and will it be covered by insurance?

Walley: So, Plan A will initially be covered by the vasectomy reimbursement code. So, everyone who has insurance should be covered by that code. And typically, right now, in the U.S., the cost of a vasectomy is somewhere under $1,000. So, our procedure would be the same price.

We also have a public access program for people who don't have insurance or can't afford our product. We have a loan system for people who may have to pay a large out-of-pocket fee because of their insurance, so it makes it more feasible for those people, as well. It's very affordable. After we get FDA approval, we will apply for our own unique reimbursement code, and then, there will be no out-of-pocket for the patient and there will be reimbursement to the physician. So, it'll be a win.

Kaylor: Well, I'm definitely no mathematician, but let's quickly do the math on that, if we can. So, let's say someone chooses to maintain Plan A for 10 years, where it's just stopping at the 10 years right now.

Walley: Mm-hmm.

Kaylor: For this example, that equates to just over $8 per month out-of-pocket on the higher end, and that's if that's the full $1,000, not even considering the payment plans or anything else that you just mentioned, that would relieve the stress of the cost.

Walley: No, you're absolutely right. It's a very affordable option, and when you think about the downside of unplanned pregnancies, 50% of pregnancies right now in the U.S., as well as around the world, are unplanned. And the cost to the insurer and consumer is tremendous with an unplanned pregnancy. So, not only is our option, Plan A, very affordable, but it's also a much better consequence for the public as well as for the insurer.

Kaylor: You just walked me up right to my next question. Beyond the U.S. -- you did mention Australia -- do you have plans to expand Plan A to international markets?

Walley: Absolutely.

Kaylor: More international markets?

Walley: Yeah, absolutely. The U.S. will be our first market. It's our largest market. We will expand quickly into Europe, Canada, Australia and Asia. We also have plans to go to places that would love Plan A, like India and Africa. Those will require contributions by foundations who have already had discussions with us to support our expansion into areas that do not have the affordability we have in the U.S. So, we're really excited. This is a global product. Definitely.

Kaylor: If you're willing to share with the audience and myself, who are you working with to make this happen? What partnerships are you making use of here?

Walley: Yeah, great question. So, Planned Parenthood is a partner. The Male Contraceptive Initiative, which has been going on for over a decade, is a very strong partner of ours. In fact, we have had grants from them to develop our product. We also have the World Vasectomy Day and the No Scalpel Vasectomy Organizations. And, if I could, I was just at a conference in Colorado of all the vasectomists that go around the world on missions training doctors to do vasectomies, which their mission is really to prevent unplanned pregnancy. So, they really want to keep population growth to a minimum, just on the planned pregnancies, and they've embraced Plan A wholeheartedly. They've all signed up to help us with our clinical trials, and it'll be a wonderful avenue to launch our product worldwide.

Kaylor: Excellent. Well, as we finish out our conversation, Darlene, is there anything else you'd like to share, whether it's about NEXT Life Science's next steps, ongoing research, or just how listeners can stay engaged with the progress of male birth control?

Walley: We're really excited. We have over 50,000 men that have signed up on our website without soliciting. So, the best place probably for information and to follow us in our newsletters is through our website. Men in general that we meet with, young men especially in our demographic (18-45), are looking for other options. They want to participate in birth control and be a partner who's taking responsibility, and they realize that, for a lot of women, there aren't good alternatives. Women are having difficulty with the current products on the market, and men really want to step up to the plate and be responsible. So, we found, as I said earlier, 85% of the men in this category, which is our demographic, really want something like Plan A to be able to do. Plan A is something you set it and forget it, and then, if you change your mind, it's a very easy procedure to reverse it. So, it's a perfect option for men who maybe are not ready for children or don't know in the future when they would want to have children. It's a perfect option.

Urologists love the product. Right now, urologists really have embraced this option. We're not competing with vasectomies. Vasectomy is a great option for men who are over 50 years old and know they don't want to have any more children. We're not competing with that. We are targeting the men who are younger, who may still want to have children somewhere in the future, and we offer them a great option of worry-free protection and very easy reversal.

Kaylor: Awesome. And, just one more question before we go: Can you clarify for the audience when exactly your timeline predicts when men can actually have access to this product once it's FDA-approved and available to the market?

Walley: Our plan right now is in 2027 to have the product commercialized in the U.S., and that really depends on all of our clinical trials and manufacturing that's in progress right now. We've raised $8 million already. We're in the middle of a series A raise, $20 million, and that'll get us two years of clinical trials. And then, we have a commercialization plan that kicks in at that point to take us not only in the U.S. but globally. So, it's a very exciting time.

Kaylor: Yes, it definitely is. I'd like to go back and talk a little bit about the men who are seeking vasectomies after the overturning of Roe vs. Wade. You did mention that it's been spiking. Do you have any more data to highlight just how actively they are seeking these treatments? I know you said they are reaching out to have the vasectomies, but if they're not showing up, then they're not having the treatments, right?

Walley: Yeah, no, that's a great question. What we've seen reported is over a 200% increase, right after Roe vs. Wade was overturned, in requests for vasectomies in one survey. And then, recently, with the new administration, one source published over a 1000% increase in requests. But you're correct, we have to see the data this year and last to see how many men actually went through with the procedure. We are seeing in our vasectomy clinics of our advisory board members that much younger men coming in for vasectomies because the fear of pregnancy is so high right now with the legislation in our country.

But we know, on the really positive side, from the work and research that was done by the Male Contraceptive Initiative in 2019, 85% of men in our demographic really want something else for birth control. So, that's 19 million men. And what men really want is something that fits their daily lifestyle. They don't really want a pill they could take every day. They don't want something that's going to have side effects or may cause feminizing attributes, which is what the hormonal options provide. So, really, we fit our demographic with what their needs are because it's a very easy, painless procedure. Set it and forget it -- 10 years later, it's still working. But if you change your mind or if you're in a new relationship or decide you want children, it's just a very easy process to reverse it. It's well under 10 minutes. We feel that Plan A is a very attractive option to meet the needs of men today.

Kaylor: And you said it's just a 10-minute procedure. Is it pain-free?

Walley: It is absolutely pain-free -- think of having your blood taken and imagine if you have a local anesthetic on your arm. So, a lot of people don't feel their blood being drawn, but even with a local topical anesthetic, you would definitely feel nothing. So, it's a very quick procedure. It's less invasive than a vasectomy because our hydrogel is inserted into the vas deferens, and then, you're done. So, in literally less than five minutes, the man can walk out and have no downtime, pain, etc.

Kaylor: And, just like you said, 85% of men, they want something else. They want to be a part of family planning. So, I think you definitely have a huge market here.

All right. Well, that is all the time we have. Darlene, thank you for setting aside the time to speak with me today. I truly appreciate it. This was so insightful. Take care.

Walley: Thank you, Alivia. Great meeting you.

Kelsey Waddill: And thank you, listener, for tuning in. If you liked what you heard, head over to Spotify or Apple and drop us a review. We'll be choosing some of our reviews to be read on the show in appreciation. So, keep listening through to the end because you might get name-dropped. See you next time.

Music by Kyle Murphy and production by me, Kelsey Waddill. This is an Informa TechTarget production.