Two months after cutting nearly half its work force in the wake of increasing competition to its lead macular degeneration product, QLT (Vancouver, British Columbia) last week reported disappointing preliminary results for the Phase II trial of its light-activated drug lemuteporfin in benign prostatic hyperplasia (BPH).

The company reported major work force cuts late last year tied to competition in the macular degeneration space (Medical Device Daily, Dec. 28, 2005).

Three-month data showed that the BPH product, a photosensitizer formerly known as LT0074, did not meet the primary efficacy objective in the 180-patient study, showing no significant difference between the treatment and control groups.

“These are preliminary data,“ Tamara Hicks, spokeswoman for QLT told Medical Device Daily's sister publication, BioWorld Today. “We will continue to look at the data through six months.“

Essentially, the early data pre-empts immediate plans for a Phase III study and potential approval of lemuteporfin in BPH, a non-malignant form of prostate disease and an indication that could generate worldwide drug sales of $250 million.

“It's another piece of bad news,“ said analyst Paul Latta, with McAdams Wright Ragen (Seattle), while adding that lemuteporfin-injectable is “really outside of the company's core“ program focused on macular degeneratiion.

Wall Street seemed only a little bothered by the report. The company's stock lost just 16 cents Thursday to close at $6.59.

“From our perspective, we regarded the lemuteporfin-injectable study as a bit of a long shot,“ Latta said, “although it certainly would've helped their pipeline, which is a little on the thin side.“

The mild impact on QLT's shares also could be attributed “to the fact that the stock's been beaten up pretty heavily for the last year or two,“ he added.

The company, which was trading at around $15 at this time last year, watched its shares slide since then, as its lead product, Visudyne (verteporfin) photodynamic therapy, faced competition in the wet age-related macular degeneration (AMD) market with the January 2005 launch of Macugen (pegaptanib sodium injection), from OSI Pharmaceuticals (Melville, New York). Interest in Visudyne waned even more after Genentech (South San Francisco, California) released promising pivotal data for its anti-angiogenic drug Lucentis (ranibizumab, now under review at the FDA) (MDD, July 20, 20005).

Shares of QLT fell 11% in November to close at $6.57 when results of a study showed that Lucentis improved visual acuity over Visudyne in a head-to-head study.

Approved in 2000, QLT's photodynamic therapy was the first AMD drug to hit the market, but “right now, it doesn't seem to be the cat's meow among retinal specialists,“ Latta said.

In December, QLT let go employees and reduced guidance on Visudyne sales for 2005, from the $500 million to $530 million range to between $480 million and $485 million.

In the meantime, the company is continuing to study Visudyne in combination with steroids, and focusing on other approaches to treat macular degeneration. QLT also might consider using its Atrigel drug delivery technology to improve the administration of its own AMD drugs or even a competitor's product, Latta said.

“The company hasn't spoken specifically to that, but it would be one way that they can sort of keep their foot in the door,“ he said.

The Atrigel system, which incorporates a biodegradable polymer dissolved into biocompatible carriers for sustained-release over an extended period of time, is used in the company's prostate cancer product, Eligard, an extended-release injectable depot available in one-, three-, and four-month formulations. That product was gained through QLT's 2004 acquisition of Atrix Laboratories (Fort Collins, Colorado) and is partnered with Sanofi-Aventis (Paris).

That technology could prove to be a boon to the AMD market, Latta said.

“The problem with the new competitors like Lucentis, is that while their efficacy in clinical trials seems to be quite compelling,“ he said, “they involve relatively frequent intraocular injections, and patients are not really enthused about the prospect of putting needles into their eyes on a relatively frequent basis.“

Other potential applications for the Atrigel system include a formulation for QLT's octreotide to treat carcinoid tumors syndrome and acromegaly, as well as potential use in diabetic retinopathy.

With QLT, “all's on the table right now,“ Latta said, adding that the company's ability to “defend its existing franchise and build a pipeline of new potential products“ will be the deciding factors for the company's future.

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