Emerging Drug Developer: Regado

Regado capitalizes on good relationships

In biotechnology, good relationships are crucial to a long and fruitful career. And David Mazzo, PhD, knows that first hand.

After Mazzo and the board at AEterna Zentaris, where he was CEO, agreed to part ways a couple of years ago, he had some talks with Dennis Podlesak. The two had served together on the Avanir Pharmaceuticals' board for years and Podlesak--an experienced biotech exec who had led, and sold, Cerexa and Peninsula--had joined Domain as a venture partner. After Podlesak heard that Mazzo was leaving AEterna, he dropped Mazzo a line about a start-up named Regado Biosciences, one of several fledgling biotechs under his wing in need of an experienced hand at the helm.

The developer's lab was in North Carolina, a legacy of its scientific roots at Duke University. But Mazzo wanted to be closer to the Big Pharma world, and he set up shop at a new headquarters in Basking Ridge, NJ.

"The long-term strategy involved interaction and partnering with Big Pharma, raising more money," says Mazzo. "And it made sense to be closer to Wall Street and get into the pharma corridor."

Mazzo was drawn to Regado's potential. The developer is working on antithrombotics that use an RNA aptamer which can be adjusted quickly by a control agent. 

"It's a pretty simple approach," says Mazzo. An aptamer works to spur anticoagulation while another agent can be used to calibrate the level of anticoagulation. The second agent gives physicians control, allowing them to quickly - "within a minute or two"--dial down the effect if needed.

A Phase IIb clinical trial of REG1, its lead program, will be launched soon for patients with acute coronary syndrome, with full data on the IV formulation available in the fall of 2010. That should leave REG1 ready for a late-stage trial in Phase III, says the CEO. And REG2, a subcutaneous formulation, is in Phase I. That program should be Phase II-ready later in 2010. A preclinical program should be ready for the clinic in 2010 as well.

"We're actively pursuing partnerships for REG1," says Mazzo. Phase III will need a partner, "and there's been a fair amount of interest shown in the program."

A Phase III trial for a compound like this would require anywhere from 10,000 to 14,000 patients and a budget of $90 million to $100 million. But while the stakes are big, the potential payoff could be huge. Mazzo estimates that an approved therapy would earn blockbuster money, with peak sales of a billion dollars--$1.5 billion to $2 billion with European and worldwide sales included.

And Regado has the money to complete its next stage of development. Last week the developer announced a $40 million Series D. Edmond de Rothschild Investment Partners took the lead in the round, which was also backed by Domain Associates, Quaker Bioventures, Aurora Funds, Caxton Advantage Life Sciences Fund and other individual investors.

"I didn't predict how bad the financing market was going to be in the early part of the year," says Mazzo, who had planned to wrap the Series D in the first half of the year. "But we managed the burn well, and we had commitments from existing investors, so there was no big rush." Mazzo could wait, and then Rothschild came through as the lead.

"I was in Paris for almost seven years in the mid- to late-90s, and I have a network of colleagues and contacts in Europe," says Mazzo. That's how he got in touch with Rothschild. "They were looking to identify an extremely promising company to allow it to be their U.S. lead. They have a portion of their fund reserved for ex-Europe investments."

The new financing has provided Regado with a runway that will extend well into 2011, at a minimum. The developer has applied for grants from the NIH and other sources, looking for the kind of non-dilutive financing that could significantly lengthen the runway without a new fundraising.

Since arriving at Regado in August of 2008, Mazzo has added about 10 new staffers, bringing the total workforce to 30. Staffed up and with money in the bank, Mazzo has some extra time now to focus on partnerships as well as the long-term development of the company.

"It's hard to know right now," he says about the future. "We clearly are keeping our options open, looking at the IPO market. As a private, VC-backed company, it also makes sense to be in positioning for a licensing deal or M&A with a pharma company."

Emerging Drug Developer: Regado
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