Lucentis safety issues.
TORONTO (Dow Jones)--Safety issues surrounding Genentech Inc.'s (DNA)
Lucentis drug could push doctors to give QLT Inc.'s (QLTI) Visudyne another
chance, an analyst said.
Visudyne was the first treatment approved for the wet form of age-related
macular degeneration, a leading cause of blindness in the elderly. But the
drug's market share has been quickly eroding as a result of newer treatments,
namely Genentech's Lucentis, approved last year, which has performed better
than expected. Lucentis was recently approved in Europe, putting another
Visudyne stronghold at risk.
But Sprott Securities analyst David Dean wonders if new data about the risk
of stroke with Lucentis use could cause doctors to more seriously consider
combination therapy with old stalwart Visudyne.
In a research note, the analyst said he's seen a copy of an email composed by
a "thought leading doctor at a major U.S. retinal site" distributed by the
American Society of Retinal Specialists list server saying that Genentech's
Phase IIIb SAILOR study has found that the risk of stroke in the high dose
(0.5mg) group was 1.3% compared to 0.3% in the low-dose (0.3mg) group. That's a
fourfold increase and a statistically significant number.
Genentech spokeswoman Dawn Kalmar told Dow Jones that the information was
disclosed in a letter to retinal specialists which will soon be posted on its
Web site. She also said the imbalance, seen in a six-month interim analysis of
the study, was discussed on a recent conference call, is consistent with
previous studies of the drug, and that no changes to the label are anticipated.
On Jan. 10, Lucentis stated on a conference call that an interim analysis
showed a higher incidence of stroke in the high-dose group, and that patients
with a history of prior stroke appear to be at a higher risk of subsequent
strokes. But the exact magnitude of the increase wasn't revealed until now.
Kalmar added that it's only through large studies like SAILOR that rare
events can be detected, and the company is pleased the data are consistent with
previous studies. The company will provide further updates as more data become
available. "Genentech takes patient safety very seriously and this letter was a
voluntary letter on our part," she said.
Analyst Dean said in his report that a meaningful reduction of Lucentis use
would likely be a positive for Visudyne sales.
"Although speculative, there is growing evidence to suggest that if Visudyne
is used alongside Lucentis, that improved efficacy can be attained with much
less Lucentis exposure," Dean wrote. "Incrased safety concerns with increased
Lucentis exposure is bound to accelerate the acceptance of a protocol to reduce
Lucentis doses, and the only we way we see that happening is if Visudyne is
also used."
Dean added that, if the email foreshadows a broader announcement from
Genentech about the increased stroke risk, he expects QLT's stock to be
"positively impacted" as well.
Separately, there was also a development on the patent litigation front,
which has been another cloud hanging over QLT. Merrill Lynch analyst Hari
Sambasivam said in a note that QLT's appeal versus Tap Pharmaceuticals Inc.
(TAP.XX) was stayed on Jan. 9 at the request of both parties. "We believe that
this could potentially signal behind-the-scenes discussions between the
companies, potentially to reach a settlement," he wrote.
Analysts believe a settlement could cost QLT between $100 million and $150
million.
Sambasivam noted that "an acceptable settlement could remove a major
uncertainty and a stock overhang."
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