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through a combination of hourly fees or equity. Through leaning on consultants and vendors to keep expenses low, Resolve hopes to achieve a venture-style return. The exit strategy is to sign a conventional licensing transaction with a Big Pharma company that will provide some upfront cash and milestone payments. Resolve went this route because the founders knew the odds of getting returns via an IPO or whole-company acquisition were pretty slim, and the chances were better of enticing a pharma company to in-license a single compound for the next stages of clinical development.
A few things have happened in lupus since Resolve was getting started. Human Genome Sciences and GlaxoSmithKline made big news in the lupus world in March 2011, when they won FDA approval of an antibody drug called belimumab (Benlysta): it marked the first new treatment for the disease in 56 years. So far, the drug has gotten off to a slow start in the marketplace, and has done nothing to deter other contenders, Posada says. “There’s still quite a bit of unmet medical need in the space,” he says.
The next couple years will be a critical time for Resolve to show its strategy has merit. The company hopes to start its key study of 50-60 lupus patients in late 2013 or early 2014, then have positive results to show prospective Big Pharma partners one year later. Even though Resolve doesn’t need to do any long-term follow-up of patients and their symptoms in this study, the trial will probably take about a year because lupus patients are notoriously difficult to enroll in trials, Posada says.