➤ Radius Health Inc.'s Tymlos, or abaloparatide, injection for the treatment of postmenopausal women with osteoporosis was approved by the U.S. Food and Drug Administration in April 2017, but rejected by the European Medicines Agency in July.
➤ Radius is additionally developing a patch treatment and metastatic breast cancer therapies.
➤ Over the past year, Radius' stock fell by nearly 50%, and the company saw personnel changes in its chief scientific officer, chief medical officer and chief commercial officer.
Jesper Høiland joined Radius Health, based in Waltham, Mass., as president and CEO on July 17, 2017. In an interview conducted Oct. 2, Høiland said Tymlos is 44% covered under Medicare Part D. On Oct. 3, the coverage was increased to 64% through a partnership with CVS, effective Jan. 1, 2019.
This interview has been condensed for clarity.
Radius Health President and CEO Jesper Høiland
S&P Global Market Intelligence: How was your first year with Radius Health, and what challenges did you experience?
Jesper Høiland: Tymlos has been 15 months on the market. Coming up with a price point, we have taken a very responsible pricing in comparison with the product that was on the market, and came in less than half the price as that. We've gotten very good market access particularly in the commercial space, and we have better chance of negotiating that, ending up with a commercial access of 95%. What I am less pleased with was the market access in the Part D segment; in Medicare, we ended up with a 44% market access.
One of the challenges in the area of osteoporosis is there hasn't been a big switch in the marketplace, because when patients have already been approved to one treatment, they will not change to another treatment. However, Express Scripts gave us a very favorable status. They gave us, as of Jan. 1, a very strong foothold by even switching the patients that were on competitor's product to our product during the first six months of 2018.
What I had not anticipated was we did not receive the European approval. The day I joined, we got feedback from the EMA Committee for Medicinal Products for Human Use that they wanted to postpone the decision. We don't feel we are getting any further with this, and therefore we are putting that behind us and looking forward to deals we need for the rest of the world. We have had more than 40 inbound interests into Tymlos from global operations or from global companies.
Are there additional insights on Radius' financials in terms of expenses and performance?
We have had a burn rate of about $50 million, so that's what we're aiming for in growth. So we're set with the light at the end of the tunnel in terms of where we will be ending, and breaking even on Tymlos. We haven't given the exact date but of course we're doing this very aggressively with the approach we're taking in the marketplace. And from a cash point of view, shortly after I joined, we went up to the marketplace and raised $300 million. That's of course the money we have been burning from, but the steep uptick in the area of Tymlos is going to offset the burning. We're seeing a double-digit growth in the osteoporosis anabolics market.
Radius has also seen a number of personnel changes recently. How does that figure into company outlook and vision?
When you're moving from the research part into the development part, it is critical that you have the right competencies around that. Human resources is such an important part of a company when you're going forward, so we have lifted the HR function into becoming a part of the executive leadership team. So yes, many changes; all in all, not unexpected, the way I look at it. We have a very strong idea of what this company will be by 2025. One thing this company is not is a global company. We will always be solely focusing on the U.S. markets. For the rest, we will find partners. I'd also say you could consider us a women's health company — we focus on postmenopausal women with osteoporosis and now are looking into breast cancer.
Radius is developing a patch for osteoporosis. Is there an unmet need for this product?
Numerous companies have tried to enter into this field and have not been successful. Many patients suffer from needle-phobia, and this patch, which feels like a little sandpaper, you put it on your skin for 10 to 15 minutes, and by doing that, you get your "injection" of Tymlos. We see huge opportunity in terms of expanding the market for osteoporosis in this segment, and right now, there are more than 800,000 women in the U.S. that should be diagnosed with osteoporosis, and therefore should get treatment. The active number is only about 45,000 who have been getting treatment.
And you're also conducting a bone histomorphometry study for Tymlos?
One of the things we have said to ourselves is, for us to be the front-runner we need to demonstrate everything we know about our compound. We're going to enter into a male trial, because the males count for 10% to 12% of the market. Secondly, we want to learn more about the bone and how Tymlos works on the bones — and Europe represents about 10% to 12% of the market, so therefore getting the male indication would basically provide us with the same opportunity.
How about the oncology portion of Radius' pipeline?
We have elacestrant which we've been working on since 2006. We are in phase 1b, so we have developed what we need to do and we feel comfortable enough in our situation to move straight to a phase 3 clinical trial, which we are going to start year-end fourth quarter.