Northern Exposure

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Urigen Holdings relocates from California to Vancouver to pursue treatments for urological indications.

With our long-standing history as snowbirds, Canadians have grown accustom to biotech companies packing up and moving down south.
Urigen Holdings Inc. (Vancouver, BC), however, represents the other side of the coin.

In 2000, Dr. William Garner started EGB Advisors (San Francisco, CA), a pharmaceutical business development and commercialization boutique that in-licenses clinical stage therapeutics.
In 2004, EGB licensed a technology from the University of California, San Diego (UC) (San Diego, CA) that was unique enough to warrant special treatment.
“We though this was something so compelling that we really needed to pause and start our own company around (it),” Garner says.

And it was with that that Urigen began. Though initially created in the U.S., Garner says the decision to move to Vancouver one year into the company’s operation was made for strategic reasons.
“The idea was that we’d raised some money in the States, but we decided not to take U.S. venture money,” Garner explains. “We ended up syndicating our own Series A, mostly from U.S. people, but a significant number of Canadians also came in as investors.”

Urigen is also hoping that the move north will allow it to take advantage of Scientific Research and Experimental Development (SRED) tax credits.
Though Urigen is still waiting to hear whether or not it will receive the SRED credits, Garner says the move to Vancouver has still been rewarding, and notes that there is a different feel to the biotech community in Canada versus the U.S.
“In Vancouver, in particular, there’s a pretty collegial environment amongst biotech folks, which is notable,” he says.
It also offers the advantage of being well-situated.

“People do go back and forth on the West Coast between San Diego, the Bay area, Vancouver and Seattle,” Garner says. “We’re close enough (that) people can transition or even commute between the different hubs for different reasons. It’s all a day trip . . . for many of those places, all of which have pretty significant biotech clusters, and Vancouver’s just part of that axis.”

Pipeline
Through its connections on both sides of the border, Urigen raised sufficient funds to initiate a Phase IIb last fall for its lead product U101, the technology licensed from UC.

U101 has completed a Phase IIa clinical trial in which patients experienced relief from pain symptoms associated with interstitial cystitis (IC), a condition that results in pain and an urgent, overactive bladder.

The ongoing Phase IIb trial is expected to be complete by the end of this year.
U101 is an intravesical therapy designed to treat chronic pelvic pain originating from the bladder. Administered in one dose directly to the bladder, Garner says U101 has proven effective at providing relief.
“People tend to see responses in a matter of minutes,” he says.

Because current IC treatments are often oral and can take months to work, Garner says U101 has additional benefits to providing fast pain relief.
“You can use that fact, that people respond in the clinic, to sort out what’s actually going on with the patient, to help with your differential diagnosis,” he says.

If all goes well, the company plans to file a New Drug Application in 2008 and launch U101 in 2009
Featuring the same formulation as U101, U102 and U103 are being developed for additional indications. The company has filed a protocol with the U.S. Food and Drug Administration for U102 for the treatment of radiation cystitis, which affects patients who have had radiation in the pelvic region, often for prostate or cervical cancer.

U103 is being investigated for the treatment of dyspareunia, or painful intercourse. There are currently no approved medications specifically designed to treat the condition.
Urigen also recently licensed two Phase II clinical development programs from
California-based Kalium Inc. The first, U301, uses the licensed technology platform to develop a product for the treatment of acute urethral discomfort. U302 focuses on urethritis, or inflammation of the urethra.

Forward Thinking
Moving forward, Urigen plans to work with someone to develop a sales force for U101.
“In order to capture the most value, you have to be prepared to do that as a biotech company,” Garner says. “It may be a small sales force and then you have co-promotion with a bigger company, but you also have to capture some of that revenue on your own in order to maximize shareholder value.”

At the same time, the company doesn’t plan to rush into things headfirst. Urigen will approach sales when the time is right.
“We won’t plan to take over the head count until the second year of commercial sale, so that we can make sure that we’ve got sufficient revenue to support the sales organization,” Garner says. “A lot of companies get out there, and they get quite a number of (sales) reps on the street with one product, and the sales projections are somehow not met . . . so we want to avoid that by not taking over the sales organization until the second year of marketing.”

Garner picked up this business sense the hands-on way. Having completed medical training in New York, he took advantage of all the city had to offer when it comes to learning the business side.

“I think scientists and physicians have an opportunity, because (New York’s) a very unique place, to make the transition, and I was just one of those,” he says.

“I was interested in being involved in translating things into products, and I think the way to do that is to be involved in the biotech industry and the for-profit sector,” Garner explains, saying he became involved with financing public and private companies. “I think some of those contacts from about 10 years ago are still relevant, some of those same people are still doing business in biotech in the U.S. and in Canada. For me it was better than going to business school.”

Though many smaller biotech companies are often headed by scientific founders, and Garner himself has an MD, he says he thinks business savvy, no matter where it comes from, is essential.
“Once I saw a CFO of a publicly traded biotech company give . . . a quite nice presentation, and he had mentioned that he had previously run a cruise line, and I thought, wow, those good business skills are translatable,” he says.

“I think we need those people, who have good financial skills, good business skills, so that we make sure that the businesses that we have are really businesses and they’re not science projects.”