MSDC hires CEO to put diabetes drug on big pharma's radar
“What they’ve invented is, frankly, one of the more exciting all-around drug opportunities I’ve seen in the 25 years I’ve been in the industry. It’s amazing,” said Beardsley, MSDC’s new CEO.
Beardsley arrives in West Michigan after a stint as CEO at Kereos Inc. in St. Louis, Mo., which works in the cancer sector. He’s held positions at a variety of biotechnology and life sciences firms in the Midwest. He holds a bachelor of science in chemical engineering, a Ph.D. in biochemical engineering from the University of Iowa and an MBA from the University of Chicago.
Former Pfizer Inc. scientists Jerry Colca and Rolf Kletzien formed Metabolic Solutions in 2006 to work on their ideas for the drug, which would compete with medicines Actos and Avandia by targeting a different molecule to make cells more sensitive to insulin.
Avandia, made by GlaxoSmithKline, saw its market share slip from 13.2 million prescriptions in 2006 to 3.1 million in 2008 after studies linked it to increased risks of heart attack. Actos, made by Takeda Pharmaceuticals of Japan, is associated with the side effects of edema and weight gain.
In clinical trials so far, the MSD drug has been shown to avoid those pitfalls while lowering blood glucose, he said. The next study, beginning next year, will look at longer term treatment in more people and determine what doses will be used in the Phase III trials, which is the last study before filing for federal Food and Drug Administration approval.
“Somewhere … between where we are right now and that point is where we’ll probably be looking at partnering with a large pharmaceutical company,” Beardsley said. “Those Stage 3 studies for a disease like diabetes are large studies. You’re talking many hundreds, if not thousands, of patients, and they’re very expensive.”
Beardsley said he thinks impending patent expirations and a dry drug pipeline will fuel big pharma’s interest in the MSDC-0160 compound.
“If you look at big pharma right now, they’re facing a challenge because so many of their big drugs are going off-patent. I think that what MSD is doing is the kind of thing that there’s no way they can’t be more than interested,” he said.
He expects the next study to be completed in early 2011, and an agreement may come after those results are known.
“We have been and are talking to large pharma companies and getting a sense of what they think we did in Phase IIa,” Beardsley said.
He said the early studies show that the compound’s benefits may extend to cardiovascular disease, as well.
“We’re confident we’ll be able to do not only the Phase IIb study … but also bring another follow-on candidate in to Phase 1 and Phase IIa testing in the next several months. Knowing what the big pharmaceutical company is like, that becomes even more attractive.”
“You’re talking about a base where you know you could very likely be the next big blockbuster in a multi-billion dollar class, but there is strong data from the human studies and from the preclinical studies that says it could be bigger than that,” Beardsley said.
Earlier this year, the company received $9.25 million from investors and $1.36 million from the National Institutes of Health.