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teriparatide (Forteo), another anabolic drug delivered via a self-administered injection. That product generated around $1.2 billion in 2012. So Radius’ plan, in the past, has been trying to do two things: first, prove that an injection of BA058 just under the skin is better than teriparatide in head-to-head studies. The drug showed signs that it might be in a Phase II study, and Radius is trying to reproduce those results in a big 2,400-patient, 18-month Phase III program that completed enrollment in March and is expected to produce data next year.
Radius, however, has also been developing BA058-TD, a skin patch that would alleviate the inconvenience of an injection—a clear differentiator among current therapies. When I spoke with former CEO Michael Wyzga in May, he mentioned the skin patch more than anything else in Radius’ portfolio, moreso than Radius’ more advanced, injectable drug: “We think BA058 subcutaneous is great, but you take all that and you put it on an easy to use 5-minute wear time patch and it is spectacular,” he said at the time.
Things have changed since. In the same quarterly SEC filing where it disclosed the clinical results, Radius reported that Wyzga and chief business officer Michael Franken resigned. Wyzga was replaced by Fromkin, who resigned less than two weeks after he was hired, and was then succeeded by Richard Lyttle, one of the company’s founders, the chairman of its scientific advisory board, and the CEO until Wyzga was hired in 2011.
Then, on Tuesday, Radius reported in a press release that Robert Ward, 56, most recently an AstraZeneca executive, has taken over for Lyttle.
Neither Ward nor Harvey would explain why Wyzga resigned, or give any details behind the reason for all of the leadership upheaval of the past several weeks.
Instead, Ward sought to emphasize the fact that Radius has a Phase III injectable osteoporosis drug that will produce data in 2014. “That’s the transformational event,” he said, referring to the skin patch trial as an “early-stage development.” He also emphasized that Radius has another drug candidate called RAD1901 that was originally being developed for menopausal hot flashes but is now being tested pre-clinically as a cancer drug.
“We think that as we look over the next 12 months you’ll see a remarkably different Radius than perhaps you might be thinking about,” he said. “The portfolio story is the real story.”
That’s not the story Wyzga told about Radius in May, when asked about the company’s portfolio: “We also have some other drugs in the pipeline—we’re focusing 99.9 percent of our time on BA058 both the subcutaneous which is in Phase III, and the patch which is in Phase II. Anything beyond that—I’ve been around the block on this a couple of times—is almost like the death knell of a lot of small companies. You start focusing on other drugs, we can’t. It’s bearing down on BA058 and doing what we’re doing.”
So what gives? Radius did say that patients on the skin patch, at each dose, had increased bone mineral density in their lumbar spine when compared to a placebo. The difference was statistically significant—meaning it was unlikely to be due to chance, according to the footnote in the Radius quarterly filing. But Ward wouldn’t discuss whether the increases in bone mineral density were clinically meaningful for patients. The highest dose of the skin patch produced a 2.9 percent increase in bone mineral density in the lumbar spine after six months, and a 1.5 percent increase in the hip. Patients on the placebo basically saw no improvement, according to the Radius filing.
When asked if the results fell short of Radius’s expectations, Ward didn’t answer directly. He did say the drug … Next Page »