WASHINGTON, Jan. 29 (UPI) -- Genentech warned doctors Lucentis may increase the risk of stroke in some patients, but some analysts don't think this will hamper uptake of the macular degeneration drug.
Genentech said last Friday it issued a "dear doctor" letter informing physicians the SAILOR study showed a statistically significant increase in the incident of stroke in patients receiving the 0.5 mg dose of Lucentis compared to those taking only 0.3 mg. The 0.5 mg arm of the trial exhibited a 1.2-percent rate of stroke compared with 0.3 percent in the 0.3 mg arm.
Michael King Jr., an analyst with Rodman & Renshaw, said the letter represented "no big concern" and he thinks Lucentis will continue to deliver a strong performance.
"We believe Lucentis and Avastin will continue to be top-line drivers in 2007 with potential upside from both products," King stated in a research report. "We reiterate our 'market outperform' rating and $96 price and would be buyers on any weakness."
King noted that the Lucentis data were already presented in Genentech's fourth-quarter earnings report issued earlier this month. In addition, the company has already spoken with the Food and Drug Administration about the results, and the agency has not indicated that it plans to change Lucentis' labeling.
"The label already states that although uncommon, conditions associated with certain blood clots (arterial thromboembolic events) may occur," King stated.
He noted a small increased risk of stroke was seen in two previous phase 3 trials, MARINA and ANCHOR. The risk disappeared after two years in the MARINA trial and was highest in the 0.3 mg arm of ANCHOR, suggesting the risk was not dose-dependent and may be random in nature.
Genentech stock took a hit Friday from the Lucentis news, falling 89 cents to close at $86.57.
But King said that was unjustified and may have been a result of investor panic rather than valid concerns about the drug or the company.
"The late sell-off in Genentech stock was largely unwarranted as the FDA is well aware of the entire Lucentis adverse event profile, and corresponding data from recent clinical trials have shown no clear trend," he stated.
King did not respond to a request from United Press International for comment.
Dawn Kalmar, a spokeswoman for Genentech, told UPI the company was not changing its guidance on Lucentis sales and called the letter "a proactive effort to inform physicians."
Asked what the findings mean for Lucentis, Kalmar said, "It doesn't mean anything right now."
The company has also shared the data with the FDA, which has given "no indication there will be a change to our label based on this information," she said.
Genentech intends to follow patients to monitor the situation further, Kalmar said.
Genentech posted a strong fourth-quarter 2006 earlier this month that was driven by strong performances from both Lucentis and Avastin. With sales of $217 million, Lucentis soundly beat Wall Street's consensus estimate of $159 million.
However, Lucentis' numbers were probably a temporary spike from patients receiving their first three to four initial injections and are expected to level off.
"We believe that as these initial patients move into a less frequent dosing schedule beyond their first three to four doses, the sales will plateau or even decline," Credit Suisse analyst Michael Aberman stated in a research report.
"Thus, while we have increased our Lucentis estimates for 2007 and 2008, we remain cautious about moving too aggressively as we do expect the frequency of dosing to taper off when the number of patients who have already got past the initial bolus exceeds the new patients (approximately 35,000 per year based on DNA's estimate of 55 percent new patient market share)," Aberman added.
Lucentis may be facing another challenge in the future from an upcoming National Institutes of Health trial comparing the drug to Avastin, which is approved for colorectal and lung cancer but some doctors have been using off-label for treating eye patients because of its lower price.
The results "may pose an overhang to Lucentis' long-term potential as well as our belief that Regeneron's VEGF Trap has the potential to be best in class for this disease," Aberman stated.
UPI was unable to reach Aberman for comment.
