Medicines360, to put it as simply as they do on their website, is “a different kind of pharmaceutical company.” The not-for-profit pharmaceutical organization is dedicated not to making money, but improving access to medication, specifically in the area of women’s health.
The company recently launched their first product Liletta, a hormonal intrauterine device (IUD), with the help of an anonymous donor and a partnership with Actavis (now Allergan). PM360 spoke with Medicines360’s Chief Executive Officer Jessica Grossman about the company’s unique not-for-profit model, what they look for in a partner, what happens to the money they make and how they hope to impact the industry.
PM360: Can you start by providing a general understanding of who Medicines360 is and what makes you so different from traditional pharma companies?
Jessica Grossman: Medicines360 was formed in 2009, and after six years our first product, Liletta, gained FDA approval on February 26 and launched on April 13 of this year. Now, what makes us very different is that we are a not-for-profit pharmaceutical company, and dedicated with a mission to expand access to quality women’s health products.
Regardless of whether a woman is in a certain economic class, whether she lives in the United States, whether she has insurance—we want to make sure we expand access and remove the barriers so that women can receive our products. Liletta is our first one, and our goal is to ensure that any woman who wants a hormonal IUD has access to one in the United States and beyond. We plan to expand globally as well next year.
With Liletta, you have a partnership with Actavis in which they’re handling the commercial end of it for the private market. Can you explain in more detail how your model works? Does it rely on you to have a larger partner that can handle the commercial aspects? Or would you be able to eventually handle that yourselves?
The plan with Liletta was to form this very unique, groundbreaking partnership with Actavis in which Actavis works with the private and public sector, but we further support the public sector. Both companies have the same commitment to increasing access.
Now, of course, that’s our mission. They’re obviously a for-profit. It’s not their mission, but they’ve made a commitment on Liletta to expand access. Actavis has the largest women’s health salesforce in the industry and it is top caliber. They’re very dedicated to researching and expanding their women’s health portfolio. While they were selected as a partner, they’re very committed and have a great sales and marketing infrastructure.
How did you go about selecting a partner for this product?
In 2013, Medicines360 began looking for partners, and we received a lot of interest in the industry from those who wanted to expand or get into women’s health. It was a very competitive situation among a number of companies, but Actavis was selected as a partner because they really understood Medicines360. They were completely committed and supportive of our access mission.
They have a long-term health support, so they weren’t looking at it as a small part of their overall portfolio. Even today, with the many mergers that Actavis has been through—Forest and now Allergan—women’s health is still very much front and center and important to them. For us, it was just the right mix, and we’re working with them in a true partnership every day.
As part of the partnership, they’re mostly handling the commercial aspects and distribution to the private market? Do they have any other role in the deal you made?
Absolutely, they commercialize and also distribute to the public sector. They work in both sectors, but Medicines360 is part of the overall strategy with Actavis (now Allergan)—private and public. But what Medicines360 brings to the table is essential: The largest hormonal IUD study ever conducted. The 29 investigators were the top key opinion leaders in the United States. We brought all of that support for the launch. Plus, Medicines360 also works very closely with the advocacy groups in the public sector.
We are able to help support communication and advocacy work through our relationships and commitment because we hold a shared mission with the not-for-profit public sector groups committed to women’s health. Access is not only about cost and price, but education as well.
As part of your not-for-profit model, how do you redistribute any money that you do make?
We fund it into three areas. First, into R&D or business development, meaning we could either expand a portfolio by purchasing an existing product or develop a new one. Second is expansion outside of the United States. We plan to go into Africa next year and then beyond. Third, we can potentially create other innovative partnerships—and expand our education and advocacy efforts.
In this hybrid model, does that allow you to rely less on deals with either a pharma company or a foundation such as the Gates Foundation? Can you be more self-sufficient than typical non-profits?
Exactly, Medicines360 actually received its first funding for the Liletta trial from an anonymous donor. That paid for the full development of Liletta thus far. Ultimately, the goal is for Medicines360 to become self-sufficient through this unique model. But at the same time, we keep the door open for potential foundational funding.
Now that Liletta is available, can you share anything about what is next? Are you focusing on any new therapeutic area or are you still focusing on the contraceptive area?
Our lead is contraception, but we’re opening ourselves fully to all women’s health. So what are the unmet needs in women’s health? It could be a medical unmet need. Or it could be an access unmet need, which was the case with Liletta. A hormonal IUD was already available on the market, but many women could not access it due to cost. In some parts of the world, the use of hormonal IUDs was up to 20% of contraceptive use. In the United States, it was 1% to 2% percent at that time. Now, it’s 7%, which still significantly lags behind other developed countries.
In fact, when you look at the CHOICE study that surveyed 9,000 women, if you remove the access and cost barriers, 58% of women would choose an IUD over any other contraception. Why is it that only 7% get it in the U.S.? The data does not make sense. We know that price is a major barrier, so we’ve now removed that hurdle. We’re hoping to see a significant expansion in the IUD usage in the U.S.
You talked about acquiring products that are currently on the shelf. Is that something you are looking into?
It could be something on the shelf. It could be something that is already on the market. It could be something that started with us. But what makes Liletta so unique, and what we believe we can emulate and do in other models here, is not just offer a lower cost, and actually be commercially competitive.
Even though Liletta costs less than Mirena and Skyla, it’s still very competitive. Consider the three tiers. You’ve got the commercial pricing. You’ve got Medicaid, and then you’ve got what we have expanded and have made our mission—a very affordable 340B price available at clinics, certified as 340B.
You mentioned why you choose Actavis for this specific product. Can you talk more generally about what you look for in a potential pharma partner?
It depends on the type of partner and the stage of the product, but someone who is committed to not only commercial success. Yes, we want to help build commercial success, but we also want a commitment to expand in the public sector. That kind of dual purpose and dual objective is what we’re looking for in a company.
In fact, what we’d like to demonstrate with Liletta is that success in the public sector actually will help drive and further support success in the private sector. To prove our theory, we’re actually studying it. We’re going to be measuring our results with the IMPACT study and the results will be released early next year.
That’s interesting. What kind of impact do you think those results could have on your company considering this is your first product?
As you know, for-profits measure results in pharma very much by prescription uptake, market share taken from competition, sales, etc. But in not-for-profits, it’s very important to measure whether or not you’ve achieved your mission. Part of measuring the mission to have an impact in expanding access is determining how many women we have reached that weren’t reached before.
Then, as a secondary benefit, it could demonstrate to other potential partners that, “Hey, they have reached a lot of women, and it is good for business because look how successful Liletta is doing in the commercial sector—in addition to reaching and achieving the mission and expanding access in the public sector.”
