An early 2006 launch of Genentech's wet age-related macular degeneration candidate Lucentis could impact sales of OSI/Eyetech's competing therapy, Macugen , by an estimated $75 mil. that year, OSI said.

"The impact of the earliest possible Lucentis launch with the strongest possible Lucentis label could be as much as $75 mil. on top-line U.S. net sales of Macugen," CEO Colin Goddard said during a conference call Nov. 21 addressing OSI Pharmaceutical's acquisition of Eyetech.

The chief exec characterized the estimate as a "worst-case" scenario. Absent a Lucentis launch, Macugen (pegaptanib) is expected to generate sales of $175 mil.-$190 mil. in 2005.

OSI completed the $935 mil. acquisition of Eyetech Nov. 14 after announcing plans to buy the firm in August as a way of extending the company's therapeutic focus beyond oncology (¹ Also see "OSI Joins Genentech In Eye Disease Market With $935 Mil. Eyetech Purchase" - Pink Sheet, 29 August, 2005., p. 21). OSI markets the cancer drug Tarceva (erlotonib) with Genentech.

The acquisition has been greeted with skepticism from OSI shareholders due to the looming competition faced by Eyetech's vascular endothelial growth factor receptor inhibitor.

However, Goddard assured analysts, "we are by no means convinced that Lucentis will enter the market in 2006, and even if it does, the timing of this and more importantly, the label the drug may achieve are the subjects of considerable conjecture for which there are multiple...possible financial outcomes."

Lucentis (ranbizumab) is in late-stage development and Genentech plans to seek priority review when it files a BLA for the ophthalmologic, likely in December.

The release of preliminary Phase III ANCHOR data by Genentech Nov. 7 showing that 94% of patients treated with 0.3 mg and 96% treated with 0.5 mg Lucentis maintained or improved vision compared with 64% of those treated with Novartis' photodynamic therapy Visudyne , briefly stalled OSI's acquisition of Eyetech.

Macugen has only been shown to retard vision loss, and Eyetech said Nov. 10 that its board of directors wanted to assess the impact of the data.

During the Nov. 21 call, however, Eyetech said it would maintain its previous forecast for combined revenue of $600 mil. in 2006.

"We are not updating our guidance at this time," CFO Morgan Browne said. "We've alerted you to the fact that if certain timing scenarios for a possible Lucentis launch were to materialize that they could have a material impact on our top line."

"With Lucentis, the NDA is not even filed yet, there is no decision on priority review or on the label, so it is premature to contemplate altering guidance at this time," Browne said.

OSI/Eyetech Chief Operating Officer Paul Chaney pointed out that for now, Macugen remains the only VEGF inhibitor approved by FDA to treat all types of wet AMD.

It appears the company may try to push the safety profile of Macugen for long-term use in anticipation of new competitors entering the market.

"We also believe that Macugen-targeted VEGF inhibition may potentially have important safety benefits over pan VEGF or non-selective blockade by Lucentis or Avastin , especially as the treatment of wet AMD becomes chronic and long-term," Chaney said.

Genentech's oncologic Avastin (bevacizumab) has been used off label by retina specialists to treat retinal vascular diseases, but Chaney maintained that "widespread interest in off-label use of Avastin has not necessarily translated into widespread use."

"There is virtually no data on the efficacy, safety or appropriate dosing of intravitreal Avastin," he said.

OSI/Eyetech also is evaluating Macugen in early-stage AMD and diabetic macular edema.

OSI expects to realize savings of $20 mil. in 2006 and $28 mil. in 2007 under its Eyetech integration strategy. Savings will stem from facility consolidation, headcount reductions and the elimination of other duplicate costs.

The company plans to eliminate 135 of Eyetech's 311 personnel positions, resulting in savings of $14 mil. in 2006 and $19 mil. in 2007, the firm said.

OSI Takes Wait-And-See Approach To Lucentis Impact On Macugen

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