have the risk of causing birth defects, Wattier says.
Valocor has shown in mouse studies that this drug can be delivered specifically to the right depth in the skin. It has already run one clinical trial in healthy human volunteers, which essentially confirmed that the drug can be distributed in people’s skin like it is in mice.
So that’s encouraging enough to get a little bit of financing for an important test of effectiveness, Wattier says. A new trial, of 64 patients, ought to be up and running by early 2011, he says. It will enroll people with acne, and apply the light-activated drug to just one side of the face, so researchers can use the other side of each patient’s face as an experimental control. Patients will let the drug be absorbed in the skin for 30 minutes, and then will get different durations of light between 7 and 30 minutes. Results on whether this works should be conclusive after about 12 weeks, Wattier says.
If it works, I laughed, won’t these patients look funny with zits covering half their face and clear skin on the other side? Yes, Wattier says, they will. But the protocol will allow patients to get the drug on the other (zit-covered) part of their faces after the trial concludes and the full 12-week effectiveness data has been recorded. Assuming that trial goes well, Valocor still has a lot of work to do. It will need to do a much bigger clinical trial that randomly assigns patients to its light-activated drug, and some other control, Wattier says.
Acne isn’t as severe a disease as, say, cancer or macular degeneration, so I wondered how lucrative this opportunity might really be. Back before some of the more ominous warnings were made about Accutane, that drug generated about $800 million in worldwide sales in 1999, Wattier says.
Wattier, 42, has been following the dermatology market for a long time. He had an eight-year run at QLT in sales and marketing positions. Before QLT ran into the Genentech buzz-saw, he oversaw the planning and preparation for a 100-person U.S. sales and marketing team that launched the anti-acne product dapsone gel (Aczone), now marketed by Allergan. Earlier in his career, he worked at Centocor for a couple of years and oversaw the U.S. launch of infliximab (Remicade), which is now part of Johnson & Johnson, and is one of the world’s biggest selling drugs.
Even though some huge biotech drugs are used for dermatology conditions, like Amgen’s etanercept (Enbrel) for psoriasis, the whole field of dermatology still doesn’t have much innovation, Wattier says. This reminded me of a funny line I heard last year at Xconomy’s annual XSITE conference in Boston, where a national healthcare IT leader recalled the essential basic principles dermatologists need to follow when dealing with problem skin.
“If it’s wet, make it dry. If it’s dry, make it wet,” joked John Halamka, now the chief information officer for Harvard Medical School. And, don’t forget, “always use steroids,” he said. (He wasn’t talking about muscle-building anabolic steroids, but corticosteroids, which are blunt immune-system suppressors that can tamp down autoimmune reactions against the skin like hives or psoriasis.)
When I relayed that remark to Wattier, he laughed and didn’t disagree with it. That lack of innovation is precisely why Valocor negotiated for the rights to three other small-molecule compounds from QLT’s pipeline, still in preclinical testing, which all have novel ways of working against dermatology conditions. I didn’t have time for the chapter and verse of those drugs, but presumably if the lead acne drug pans out in clinical trials, there could be more resources to take those other programs forward.
“These are really novel. I don’t think there’s anything like this out there in the ‘derm’ space,” Wattier says. “We’re pretty excited about the prospects. I’m convinced there’s a huge need because of the lack of innovation in derm. There’s really no pipeline in derm. Our objective is to become the pipeline.”
