West Coast Editor

Almost a year after in-licensing the P-glycoprotein membrane inhibitor tariquidar from Xenova Group plc, QLT Inc. said it is starting two Phase III trials to explore the drug's use as an adjunct with first-line chemotherapy in non-small-cell lung cancer (NSCLC).

"The major message for us is that this is our first major foray out of ocular disease, and it's our own product with total rights in North America," said Paul Hastings, president and CEO of Vancouver, British Columbia-based QLT.

QLT markets Visudyne (verteporfin), first approved to treat the wet form of age-related macular degeneration. The product is partnered with Novartis Ophthalmics, of Atlanta, the eye-health unit of Basel, Switzerland-based Novartis AG.

The anticancer drug allows QLT "a possibility of being less reliant on others and more reliant on ourselves," Hastings said, noting that Visudyne garnered $223 million in revenues last year, and this year is expected to bring in $275 million to $300 million.

"We split the profit from that revenue with Novartis," he said.

Tariquidar (formerly known as XR9576) will be tested in both trials for multidrug resistance in cancer. In those trials, Stage IIIb/IV NSCLC is the indication, and they will be held at 100 centers in North America and Europe.

One trial will be in patients given paclitaxel/carboplatin with either tariquidar or placebo, and the other will be in patients given vinorelbine with either tariquidar or placebo. The primary endpoint in both trials is overall survival. An interim analysis is expected in the middle of next year, and QLT hopes to file for FDA approval by the end of 2005.

A Phase IIb trial of tariquidar in patients with refractory breast cancer is under way at the University of Texas M.D. Anderson Cancer Center in Houston. The drug may be useful in cancers as wide ranging as those of the kidney, prostate and colon, Hastings said, and in hematological cancer as well as solid tumors.

"It's just a matter of prioritizing those indications after we have proof of concept," he added.

Last summer, Vancouver, British Columbia-based QLT agreed to pay a $10 million licensing fee up front to Xenova, of Slough, UK, and may pay as much as $50 million in milestones, while funding up to $45 million for Phase III trials. Xenova gets royalties of 15 percent to 22 percent, depending on the level of sales in North America. (See BioWorld Today, Aug. 15, 2001.)

For the U.S., Canada and Mexico, QLT retains marketing rights, with Xenova handling marketing in the rest of the world. The companies believe they can market the drug, which works by inhibiting the membrane-based "pump" that expels chemotherapeutic drugs from the tumor cell, with at least 12 cytotoxins.

"Long before QLT was an ocular company with Visudyne, we were looking at phototherapy in cancer," Hastings said. "If you look at high unmet need, you obviously look at oncology."

Visudyne will enter a Phase III study in non-melanoma skin cancer this year, he told BioWorld Today.

QLT isn't getting out of the phototherapy business, either. Its drug QLT 0074, described as an improved form of Visudyne for new indications, is entering a proof-of-concept study in benign prostatic hyperplasia and in alopecia, or male pattern baldness.

"In BPH, it's delivered into the prostate through a catheter, and a ray of light is delivered exactly the same way [to activate it]," he said. "It's a drug combined with a device. In alopecia, it's delivered relatively locally, and a ray of light is shone across the affected area."

Although the Novartis deal for Visudyne is "going really well," Hastings said, "we're definitely interested in more collaborations like [the one with Xenova]. We market ourselves to small biotech companies. We can say, We know where you're coming from. We've been where you are.'"

QLT's stock (NASDAQ:QLTI) closed Friday at $13.35, up 40 cents. Xenova's shares (NASDAQ:XNVA) ended the day at $7.74, up 98.6 cents.

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