Emerging Drug Developer: Follica


Follica starts with a market in search of a therapy

Most biotech companies start with an interesting discovery technology or a drug development program and then go out in search of money to fund their work. But PureTech Ventures likes to put in the seed money up front, and then go in search of the right program.

"In the case of Follica, aesthetic medicine was the concept," says Daphne Zohar, the managing partner at PureTech and acting CEO of the fledgling, two-year-old biotech company. Working with a team of experts, PureTech identified several areas where there was an obvious unmet medical need and a woefully inadequate group of therapeutics approved for use. The company's scientific team concentrated on finding a non-invasive approach to fat reduction, a new approach to wrinkle removal and "everything to do with the hair follicle."

The hair follicle won. At that point the group of scientific co-founders was honed down to leading follicle experts - a group that included George Cotsarelis at the University of Pennsylvania, Rox Anderson at Harvard Medical School and Vera Price, director of the UCSF Hair Research Center.

"One day George Cotsarelis told me that he was working on something in his lab that was really interesting," recalls Zohar. "I was appropriately skeptical, but said, OK. Let's take a look at it. It's a great lab. It turned out to be extremely exciting. Potentially paradigm shifting."

Cotsarelis's epiphany had started with an experiment on wound healing when he observed hair growing in the middle of wounds.

"He tracked epithelial stem cells," says the venture capitalist. "After disruption of a certain type, the skin reverted back to a more primitive state. There's an embryonic window that opens in adult skin; pathways which are activated that are usually not activated in adult skin. By applying compounds you can push them down the direction of making hair or skin."

That insight - using an abrasive procedure on the skin and then treating it with reformulated compounds -- was enough to get Follica launched in 2006. At the beginning of this year, PureTech helped round up $5.5 million for the start-up's Series A and an $11 million round followed earlier this month. Interwest Partners was one of the original investors and Polaris Venture Partners led the second round.

Right now their money is funding a small human study which Zohar describes as "more of an investigator-sponsored trial." And the company has enough money to push the program through proof-of-concept toward an NDA - a path that's likely to take an accelerated development path that compresses the usual early and mid-stage trials into a 24- to 36-month window. An approval could conceivably be won in four to five years.

"What's nice about it," she adds, "is that even though this is based on breakthrough science, we are using existing compounds previously approved for systemic chronic use and reformulating them for topical acute use. We know these compounds are safe in people."

There's no questioning the market demand. A new therapy that could safely and effectively treat male and female pattern hair loss would swiftly seize a huge market. And Zohar says the same technology can potentially be applied to hair removal, skin pigmentation and more. But don't ask her to name the original compounds the company is reformulating for novel use - that's a trade secret for now.

Like any other venture backed biotech start-up, Follica's ultimate fate could lie in any of a number of directions.

"This is the type of company that would attract the interest of the public market," says Zohar. "It's also an exciting acquisition target." And there's a possibility that the company could be expanded to take an approved product and market it - something that Zohar agrees would call for a large sales force.

Right now, though, the Boston-based biotech is moving on with four full-time employees with plans to scale up to 10 or 12 people, keeping everything semi-virtual as it relies on outsourcing for much of the initial investigatory work.

That's the same kind of business development model that PureTech is pursuing for other therapeutic areas as well.

Says Zohar: "We have four new companies we're working on right now."

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Emerging Drug Developer: Follica