Pearl Therapeutics has grabbed a hefty $65 million venture round, enough to bankroll the launch of a key late-stage COPD drug program that--one way or another--will prove transformational for the biotech.
The cash haul will be spent on PT003, which has wrapped up 9 midstage studies, leaving company officials on the verge of its end-of-Phase II sit-down with the FDA. Bill Picht, Pearl's vice president of finance and administration, says that the biotech is now positioned to launch two Phase III studies on PT003 in the middle of next year, setting up a final readout on data by the end of 2014 as they position their drug against some major league rivals now pushing their own blockbuster contenders.
The Series D money--which brings Pearl's total venture haul to $167 million in the past 5 years--is not enough to fund the company through a Phase III program that will ultimately recruit some 1,500 to 2,500 patients. For that Redwood City, CA-based Pearl will be required to either raise another round, pursue an IPO, follow through on ongoing licensing negotiations, or match up a variation of those money-raising tactics, says Picht. And while the company's strategy will stay focused on marching on to a new drug application, adds the CFO, no one is ruling out a buyout if someone comes along with the right offer. Regional pacts are currently being discussed with potential partners, says Picht, though a worldwide licensing deal could also be struck.
PT003 is a combination LAMA/LABA, which Pearl says should be well positioned against Novartis ($NVS) (with the experimental QVA149, which has dosing issues in the U.S.) and GlaxoSmithKline ($GSK) (which has its own LAMA/LABA combo in Phase III with once-daily dosing). All of the developers are aiming for a chunk of Spiriva's multibillion-dollar market. And Picht says that PT003's twice-daily dosing regimen will work best for patients, putting them at an advantage over other once-daily drugs that won't have the same kind of therapeutic benefit for patients when they need it most.
"It fits the times they need the drug," says Picht, "morning and evenings."
The round was led by Vatera Healthcare Partners, with contributions from longtime backers at 5AM Ventures, Clarus Ventures and New Leaf Venture. Michael Jaharis, who founded Kos Pharmaceuticals and sold it to Abbott ($ABT) for $3.7 billion in 2006, set up Vatera.
- here's the press release