Proteon Therapeutics - 2009 Fierce 15

Based: Waltham, MA
Founded: 2001
Web site: www.proteontherapeutics.com [1]
CEO: Tim Noyes (photo [2])

The Scoop: 

Dilating blood vessels can offer relief from a range of ailments, big and small. Proteon Therapeutics has gone right after the market with a lead program in early testing that has demonstrated some remarkable qualities. Investors have responded with a big new injection of cash and Novartis has won the right to buy the company for $550 million - provided the Phase II data falls on the positive end of the spectrum.

What Makes it Fierce:

How do you judge the value of a therapeutic long before you hit mid-stage studies? That was the challenge Proteon faced when it recently began to work through negotiations for an option to sell the company.

Proteon CEO Tim Noyes approached the question in the belief that the developer had already identified a golden opportunity. And in a period of three months, he put together a deal that gives Novartis an option to buy the company for $550 million, provided Phase II data comes in positive.

In the three years since Proteon raised its Series A, the developer has moved into the clinic with PRT-201- a recombinant human elastase now in a Phase I/II trial. Researchers working with company founder and CSO Nick Franano are testing its safety and looking for some hints of its ability to dilate blood vessels in patients. It can be applied topically during surgery, the simplest and most straightforward approach, or perhaps infused through a catheter. And the therapy may act very quickly - within five minutes - with limited side effects.

"I think if we can get a couple of indications for vascular access, this is a billion-dollar opportunity," says Noyes.

Proteon now has all the cash that it will need to put that belief to a proof-of-concept test. A group of investors came together recently to provide $50 million in Series B money. Proteon also snared non-dilutive cash from Novartis as it completed the buyout option.

The FDA has extended orphan drug status to PRT-201 for prevention of arteriovenous fistula maturation failure and arteriovenous graft failure in patients with end-stage renal disease who are on or preparing for hemodialysis. Proteon gained fast-track status from the FDA last fall.

If PRT-201 performs as expected in upcoming trials, the therapy could eventually go on to play a big part in controlling ailments like peripheral arterial disease. And that hasn't escaped the notice of venture investors or big pharma. Or Tim Noyes.

What to Look For: Proteon has bet the farm that it can gain the right kind of proof-of-concept data needed to demonstrate that PRT-201 can work in humans the way it has performed in animals. "We hope to start that (Phase II) trial toward the end of next year and complete it in 2012," says Noyes. And given the nature of therapeutic delivery and the targeted effect, researchers have good reason to hope for the best.

Venture backers: Bessemer Venture Partners joined Devon Park Bioventures to top up the Series B, which also included new investors MPM Bio IV NVS Strategic Fund L.P. and Vectis Healthcare & Life Sciences Fund. Existing investors TVM Capital, Skyline Ventures, Prism VentureWorks, Intersouth Partners and several of Proteon's original angel investors.