Updated from 11:57 a.m. EDT
plans to file a complete biologics license application with U.S. regulators for the investigational eye-disease drug Lucentis in December.
The company was recently notified that the Food and Drug Administration didn't grant its request for fast-track designation for Lucentis, which would have allowed a rolling submission of data for the application. The decision won't affect the timing of the application submission before the new year or the potential to get priority review for Lucentis.
A Genentech representative said the company originally planned to start submitting data as it was completed in December and finish by the end of the first quarter. Now, the plan is to file the complete application in December and then submit supplemental information later, a decision that had been made before the FDA turned down the fast-track request.
The agency gives a product fast-track status when it believes the treatment can serve an unmet need for a particular condition.
Genentech also said it's discussing with the FDA plans to begin late-stage clinical trials by the end of the year on the safety and effectiveness of Lucentis. One-year data presented
in July showed that Lucentis not only met the primary goal of maintaining a patient's vision, but actually improved sight in some patients.
are currently conducting a head-to-head comparison study of Lucentis and Novartis' Visudyne, which is currently on the market. The trial is taking place in the U.S., Europe and Australia. Results are expected in the fourth quarter.
Yet another study is comparing Lucentis with a sham injection in a subgroup of AMD patients. One-year results from this study are expected in the first half of 2006.
Lucentis garnered heavy coverage in the financial press earlier this year, partly because of the effect its potential had on another company,
Eyetech, which is being acquired by
, already has a wet AMD drug on the market called Macugen. The company markets the product with
Macugen has been shown to decrease vision loss, but after Genentech released its preliminary Lucentis data a few months ago, shares of Eyetech sank. The stock was at $18.44 on Wednesday, vs. a 52-week high of $47.92. OSI is offering to buy the company for $20 a share.
Also Wednesday Jim Reddoch, a biotech analyst at Friedman Billings Ramsey, downgraded Genentech to market perform but maintained his price target of $94.
"The bulk of stock-driving events for 2005 -- data for Avastin, Herceptin, Rituxan and Lucentis -- have already happened," he wrote in a research note. "The next events are less-exciting 'execution' events -- primarily filings; slippage on any of these could jeopardize DNA's ability to meet high 2006 expectations."
Although he believes Lucentis sales could reach an estimated $80 million in 2006, "chances for material, headline-making upside are limited." Genentech shares were recently down $3.03, or 3.2%, to $91.56.
Friedman seeks to receive compensation for investment banking services from the companies it covers.