Interview by JIM STOMMEN
BB&T Contributing Editor
Al Altomari is the president and CEO of Agile Therapeutics (Princeton, New Jersey), a privately held, venture-funded company focused on developing transdermally delivered women's contraceptive products. Prior to being named to those posts last October, he served as Agile's executive chairman, in which capacity he closed a $45 million “B“ round of venture financing in May 2010. Al has more than 28 years of experience in the pharmaceutical industry, the lion's share of which were focused on the development and marketing of specialty pharmaceutical products. He now is leading Agile through the final stages of development and commercialization of its initial transdermal contraceptive products to compete in a market estimated at more than $4 billion annually.
Prior to joining Agile Therapeutics, Altomari served as CEO of Barrier Therapeutics. In 2008, he completed the successful sale of the company to GlaxoSmithKline/Stiefel Laboratories for a 73% premium.
Before joining Barrier, he functioned in numerous executive roles in general management, commercial operations, business development, product launch preparation and finance within Johnson & Johnson from 1982 to 2003, including heading up Ortho-McNeil Pharmaceutical's women's health care franchise when the Ortho Evra contraceptive patch was launched.
He discussed the company's prospects and the drug delivery space in general with BB&T contributing editor Jim Stommen.
BB&T: You have a extensive track record within the pharmaceutical sector, including leadership roles in business units of Johnson & Johnson and the CEO role at a smaller firm, Barrier Therapeutics. How does taking the helm of Agile at its present stage of development compare with some of your past experiences?
Altomari: This is a big challenge for me. My background has been more as a commercial guy, which essentially is my training. I came up through 23 years at Johnson & Johnson on the finance and commercial side of the business. Here at Agile, we're really more of a development-stage company, so for the first time in my career I'm really running all the development within an organization and a little bit of the commercial. So it's a little bit of a personal challenge for me. My job here is to transform Agile from a small, development-based company into a commercial-based company. It's a challenge, but that's why I signed up. I love the company, I like the product and I like the personal challenge here also.
BB&T: What are the biggest challenges you face in taking over a development-stage company as it is about to make the turn toward commercialization-type activities?
Altomari: The real challenge is in setting up the infrastructure. Up to this point, I would say 90% of our effort have been on the development of this drug and about 10% on commercialization. We need to start getting a better balance toward commercialization, so what that means is we need to bring in some people talent, we need to spend some money developing the initial roadmap of commercialization-related activities. It's a game plan that we need to follow as we come closer and closer to commercializing the product. One of the things that we take comfort in as we formulate our plans to take our product to the FDA is that we are working with two known molecules. They are very safe, so the FDA and our staff are very comfortable with that.
We just brought in a head of regulatory affairs, Grace Deebo, who came from Eli Lilly & Co., so she not only has a pharma background, but also has incredible relationships with the FDA, which will be very good for us going forward. Not only great relationships, but great respect within the FDA. Our chief medical officer and VP of clinical research and development, Marie Foegh, came from Bayer and has a great track record as well. It's important that the people we are really counting on have this kind of background. We feel we have a great amount of scientific acumen and a tremendous track record of working with the FDA, and getting things done.
So we have a lot of talent involved with this and we believe we have a very good proposition to bring forward to the FDA. It's something we spend a lot of time thinking about. It's time well spent. You really can't overplan this one; you've spent a lot of time developing these drugs, so planning for your filing with the FDA is something that has to have a sharp focus. We're encouraged because the division we're filing with at the FDA, the Reproductive Division, has a very good track record of working with sponsors. It's a division that has a track record of working with industry. There seems to be a sense of optimism these days about improvements in working with the FDA, where the strength of your product dossiers is what carries the day.
BB&T: You have said that “there is a significant unmet need in the women's healthcare product market for more convenient contraceptive options that are safe and easy for patients to use.“ Besides being a succinct description of market goals, is that almost a mission statement for the company?
Altomari: That's what we're here to do. I think you've said it real well. Most women are taking birth control pills, and particularly in combination with hormones. If you really study the category, I think you would be surprised to find out how many pills are missed – in all categories, really, but in the case of birth control pills, you're risking unwanted pregnancies. There are other methods, of course. For instance, IUDs. A fantastic product, but they can be difficult for some women to use, and they're difficult to be taken off of – they're not easy methods of contraception. So this idea of a weekly patch is something that women and physicians say is a sweet spot in the market. In a sense, it takes one thing off a woman's mind. This idea of a reliable, safe method just fits well with the busy schedules women keep these days.
BB&T: The initial push of your company's efforts in the women's health space is on developing what you refer to as “safer, more convenient methods of hormonal contraception.“ That includes your lead program, the contraceptive patch known as AG200-15. Could you tell me about the science involved, and how you think that will play once the product reaches commercialization?
Altomari: The simplest way to describe what we're doing is that we're taking two hormones that are some of the best and most well-known hormones. AG200-15 is a weekly contraceptive patch containing the active ingredients levonorgestrel and ethinyl estradiol. These two hormones are very well-known; they've been around for years. The FDA and physicians and women will know them. The AG200-15 patch is applied once weekly for three weeks, followed by a fourth, patch-free week. If you look at our patch, it looks pretty simple. It's a soft patch, not rigid like a Band-Aid – it's like a soft fabric. We want it to be able to be worn for seven days, so it has to hold up. You can imagine someone trying to wear a Band-Aid for seven days, how that would be affected by multiple showers, for instance. It has to hold up, so it has to be rugged enough to stay on the skin, but not so rugged that when you take it off the skin is irritated.
It has to deliver those drugs, deliver a continuing dose for seven days. That's the elegance of what we're doing. Our product is very soft, with a silky feel. The reason why we did it that way is so that when a woman wears it, it kind of breathes with her, it moves around with her. That prevents it from pulling off. We made it round for that reason, so there are no edges on it that could get caught on clothing. You have to think through a lot of elegance to make a product like this.
At the end of the day, it has to perform, so that's the way ours works. You have to conceptualize a ring within a ring: the outer ring, the largest part, is what sticks to the skin, with a little reservoir is in the middle. This is what's called a matrix patch, meaning that it is almost like a film of drug that is in there. So it's not really a reservoir like some patches where the drug can actually be dumped out of there. Ours is a matrix; it actually comes out very slowly over time. That's how our patch works. It's an elegant kind of solution – when you take it off after seven days of use, it doesn't irritate the skin in any way.
BB&T: Enrollment was completed in the phase III NEW CHOICE pivotal study of AG200-15 two months ahead of schedule early last fall, enrolling 1,500 women in all. Where does that put your expectations of a filing date for your eventual NDA submission to the FDA?
Altomari: Two things: One, it definitely moves it up, which I'll get to in a moment. And two, it was just a monument to our investigators. We had signed up more than 125 investigators to administer this trial, but we closed out before 25 of them could even recruit a patient. I've never seen anything like this; it just isn't done in record time like this. I know that as a CEO, I should be a worrier about this and say, “I wonder how that happened?“ Marie Foegh talked to the investigators and they said women just seem to be genuinely excited that there is a patch out there that works.
Closing two months early, that means we'll be filing that much quicker and commercializing quicker. That means we have to marshal a lot of resources toward preparing for that filing and then for commercialization. It's exciting to see that women are excited about being part of this trial. Once we commercialize, this will be only the second patch out there following the J&J patch. We're certainly all in and very excited here at Agile.
As for when we go to the FDA, we have said publicly that our commitment is to file by the first quarter of 2012. We're in the home stretch now, we're in the “red zone,“ as they say in football. We're not bringing the FDA any new chemicals; we're taking them two hormones they know well. We're putting them together into a patch, so we're only changing the delivery. We have a lot of safety data and a lot of patient exposure – this is a pretty big trial. Knock on wood, we hope it goes well. We have a lot of background in working with the FDA among our team, so we think that strong network and background will serve us well.
BB&T: Beyond the AG200-15 and AG900 products, what does the company's pipeline look like at present, and might there be other areas that might be considered in the future?
Altomari: If you think about this patch, it certainly is a platform that we can use for other products. Our initial labeling is for contraception, but physicians also use birth-control pills for treating acne, for treating certain kinds of mood disorders for women, so we can look at other indications as our next step. Also, you're seeing a lot in the birth-control market where women can change their regimens. Women who use our patch put on one for seven days, then replace it with a new patch for another seven days, then a third, followed by one patch-free week, essentially following their menstrual cycle. But in the birth-control space there are what we call extended regimens, where a woman could not go patch-free, say, just carry on with new patches each week and only have three or four periods a year. If you look at that, a patch is a perfect way to follow that.
Another big idea that we have spent very little time on yet is that you certainly can use a patch to deliver other things, not just hormones. We have a very elegant system, so we can look at delivering other drugs. To be sure, all of our efforts to date have been focused on getting these two products into the clinic, with a little bit of thinking about other possible indications or regimens. But we have ideas for the future and will continue to develop new products. Right now we're really focused on the first two.
One of the things that often affects young companies is that you get a little wide-eyed: you try to do too much. There's only so much that you can do. We tend to be very, very disciplined. You want to pick your next best bets, but you need to pick them wisely, otherwise you'll end up spreading your resources too thin.
BB&T: Beyond your own products under development and in the pipeline, could you discuss transdermal drug delivery in general and how you see that space developing?
Altomari: You're starting to see more and more attention being paid to transdermal delivery. I'm aware, for instance, of work being done with nanotechnology on a transdermal delivery basis. Another company is working with an ionophoresis platform to deliver antifungals to the nails via ionophoresis charge.
There's a lot of really good stuff being done out there. The idea is how can we deliver drugs other than through the mouth or through the systemic system, can we deliver it more locally, either in a patch form or via nanotechnology or even mechanically with an ionophoresis platform. It's really cutting-edge; these are advanced programs. These are not theoretical, “wonder if we can do this“ programs. The one I just mentioned, for instance, is in phase II. It makes sense to bring the drug right to the site of action, if you will, without having to go through systemic action.
I think we're going to see more and more device-like combinations. If you're working with known molecules, then it's just a matter of working on delivering the drug in a new way. I think that these young companies that are following that model have a reasonable chance of success. It's an exciting time to be operating in this space. We're looking conceptually at combining the drug with devices, of living in the device world.
BB&T: There is a lot of talk in med-tech circles about a decline in medical innovation due to the twin hurdles of tight financing and shall we say “overabundant“ regulation. Given your experience, what are your views on where we are in regard to such innovation?
Altomari: I don't agree with those who think innovation can't happen. It's a matter of getting the right amount of people in the room who are very focused on getting the job done, and figuring out ways to finance themselves. It isn't easy, but it can happen. I think the biggest thing is the funding issue, but you're seeing management teams being tremendously resourceful in finding ways to fund themselves. There are collaborations with Big Pharma, there are funds available from states – New Jersey has a couple of programs that we are able to take advantage of. You have to be scrappy, but smart people that are patient can make it work. Keep yourself lean; keep the overhead down.
These companies that are emerging from these difficult times are coming out stronger. Pharma still needs products, but if they don't want them, we'll launch them ourselves. I'm an optimist; I see so much innovation out there. I'm so impressed with what I see in this area. Between New Jersey and Pennsylvania, there is a proliferation of young companies doing fantastic work. So I'm all in, I'm excited about what's happening in these sectors.
Because of the financing issues, not everyone is going to make it, but those that do are going to be strong companies going forward. The IPO door is opening just a smidgeon; if we can kick that door open and have public funding available for these companies, then I think we're going to be in good shape.
BB&T: Is there a question I haven't asked, but you wish I had?
Altomari: I'm glad you asked about regulatory, because we get a little caught up in our euphoria of developing these drugs, and that really is only half the battle, so I'm glad we talked about the regulatory issues. That's certainly something I spend time on. The other question I get quite often is, “Can a small company handle this kind of compound commercially? Can you bring to bear the marketing effort?“ We think we can; we know what we're doing. It's a big market category, but you don't need a lot of reps to do this – the OB-GYN category is pretty limited. You don't need a ton of sales reps to reach this audience. I think we can do it. We have experienced people who have built a commercial entity from scratch, and Agile will benefit from that.
Published: May 1, 2011