Blind World

Macular Degeneration.
Competition Is Due To Heat Up In Market To Treat Eye Disease.

July 12, 2004.


For millions of older people, life is a big blur. You can't see in front of you. You can't recognize a familiar face. You can't read or watch TV. All you can see is the stuff on the sidelines.

That's how it is if you've lost your central vision due to age-related macular degeneration, or AMD. The disease mostly afflicts people over 55. About 500,000 new cases of the more severe and aggressive "wet" version are diagnosed every year.

"It's by far the leading cause of blindness in the U.S. today," said Frederick Ferris, clinical director of the National Eye Institute.

Only one drug has received Food and Drug Administration approval to help stem progression of wet AMD. It's a photodynamic laser therapy, called Visudyne, from Canadian biotech QLT Inc. (QLTI) It's been on the market four years.

At least three companies are racing to get new treatments approved and to the market. The new drugs include Eyetech Pharmaceutical's (EYET) Macugen, Alcon's (ACL) Retaane and Genentech's (DNA) Lucentis.

Eyetech is furthest along. It filed for FDA approval last month, several weeks earlier than expected. And its Macugen product got fast-track status due to the unmet needs the drug addresses.

Macugen data are expected to be released on August 27, when an FDA advisory committee will review the drug. It could go on the market in the fourth quarter.

Alcon will release results for Retaane, also on FDA's fast track, in October at a meeting of the American Academy of Ophthalmology. The company expects to file with the FDA in the fourth quarter and looks to have its drug on the market in the first half of 2005.

"We view this as our No. 1 development project," said Doug MacHattan, Alcon's vice president of investor relations.

Genentech's Lucentis is still in clinical trials. Ferris says some early-stage patients taking the drug have shown impressive results. But, he adds, "the acid test awaits the real clinical trials." The trials are expected to run for at least another year. 'No Cure.'

Like QLT's Visudyne, the new drugs don't offer most patients hope of restored vision. But they show promise of slowing or stopping the progression of the disease.

Visudyne reduces a patient's chance of going legally blind about 50% when caught early enough, says Paul Hastings, QLT's chief executive.

"There is no way to cure this disease," he said. "All these approaches attempt to either block the leakage (in the back of the eye), which Visudyne does, or to stop the formation of new blood vessels from creating more leakage."

Through drug injections in or around the eye, Macugen and Lucentis try to block the protein that causes the vessels to multiply and cause leakage.

Retaane uses a somewhat different approach a modified steroid molecule to inhibit the abnormal vessels from branching out.

Eyetech's Macugen and Alcon's Retaane, backed by powerful marketing machines, could each take in $1 billion in annual sales, says Charles Olsziewski, health care analyst for KeyBanc Capital Markets.

Eyetech's marketing partner is drug giant Pfizer. (PFE)

Alcon, with $3.8 billion in yearly sales, is "the 800-pound gorilla" in eye care, Olsziewski says.

"It sounds like it'll be a pretty big battle between Macugen and Retaane," he said. "People are looking at Retaane as a major driver of revenue."

Where does that leave legacy drug Visudyne?

"It's tough not to assume the presence of Alcon or Pfizer wouldn't restrict its growth a bit or cause the product to stagnate somewhat," Olsziewski said.

QLT's stock has certainly lagged. Since hitting a 52-week high of 30.70 on April 23, shares have declined about 40%.

The company, whose marketing partner is Novartis, (NVS) gets virtually all of its revenue from Visudyne. It recently announced plans to broaden its medicine chest with the pending buy of Atrix Laboratories.

Sales of Visudyne continue to grow, however. QLT expects the product to generate about $450 million in sales this year, up 20% from last year.

"Probably what's more important than what investors think is what retinal specialists who treat patients think," Hastings said.

If data show the drugs have similar outcomes, patients will then turn to convenience, he says.

With Visudyne, a dye is injected into a patient's arm and gloms on to abnormal blood vessels in the eye. A laser burns only the bad vessels and not the retina itself. The procedure is done two or three times a year.

With Macugen, the drug is injected in the eyeball nine times a year, Hastings says. Retaane is injected into the back of the eye in a simple surgical procedure once every six months.

Meanwhile, some observers are interested in conducting additional studies to address the less serious dry form of AMD, since it can advance into the more aggressive wet form. Alcon is currently enrolling patients in a study of Retaane on patients with dry AMD.

Wet AMD makes up only 10% to 15% of all AMD cases, but it causes 90% of the blindness attributable to the disease.

Investor's Business Daily, Inc. 2000-2004.

End of article.

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