* Contradictory Revlimid data confuses investors
* Celgene stock down 2.7 pct in early afternoon
(Adds analyst's comment, updates share movement)
BOSTON, Dec 8 - Celgene Corp investors
were struggling on Tuesday to sort through confusing results
from a key trial of the company's cancer drug Revlimid. The results, released late on Monday at the the American
Society of Hematology, revealed a surprisingly positive result
on the one hand, and an unexpectedly negative result on the
other. On balance, analysts said the positive outweighed the
negative, and the results should increase the use of Revlimid
in newly diagnosed patients with multiple myeloma. But investors were unconvinced, sending the company's
shares down 2.7 percent at $54.01 on the Nasdaq in early
afternoon, off an earlier low at $53.00. At the heart of the conundrum is that patients who took
Revlimid in combination with the standard treatments melphalan
and prednisone (MPR) did not do any better in delaying disease
progression than those who took melphalan and prednisone (MP)
alone. That was a surprise. But the comparison was not the main
goal of the trial. The main goal was to show that patients who took MPR for
nine cycles and followed that regimen with Revlimid alone
(MPR-R) did significantly better in delaying disease
progression than patients who took MP alone, suggesting longer
treatment with Revlimid is better. The trial met that goal. The results are robust and send a clear message to
clinicians that there is dramatic benefit to using Revlimid
continuously, said Aaron Reames, an analyst at Wachovia.
Based on these data we expect the median duration of use, and
revenue, to increase over time. Analysts had, in addition, been looking to see if adding
Revlimid as a follow-up therapy to MPR would confer a benefit
over MPR alone. It did, and that was a positive surprise,
though confusing since MPR did not confer a benefit over MP. Trial investigators said the lack of difference in
progression-free survival in the MPR and the MP arms -- about
13 months for both -- may have been due to the use of a
relatively low dose of Revlimid. Either way, the lack of difference raises questions among
investors about both the approvability of the MPR regimen in
front-line use, and the commercial viability of Revlimid
front-line use generally, said Geoffrey Porges, an analyst at
Sanford Bernstein. Revlimid is approved, in combination with dexamethasone, to
treat patients with multiple myeloma who have received prior
treatments. The company is seeking to market the drug for newly
diagnosed patients. Physicians in the United States already prescribe Revlimid
for newly diagnosed patients on an off-label basis, even
though it has not been formally approved for such use. In
Europe, physicians are not allowed to do that. Discussion among physicians now will likely focus on which
drug or combination of drugs to give newly diagnosed patients.
especially in Europe. Potential combinations include Takeda
Pharmaceutical's (4502.T) Velcade, as well as Celgene's own
drug Thalomid. We see good rationale for use of Revlimid, Velcade or
Thalomid, said Brian Abrahams, an analyst at Oppenheimer & Co.
The unclear results of MPR in MM-015 could slow physician
uptake and enable more aggressive Velcade counter-detailing. Detailing is the term used in the pharmaceutical industry
to describe visits by sales representatives to physicians to
explain the benefits of their products. MPR may not be the best regimen, said Howard Liang, an
analyst at Leerink Swann, but nonetheless we expect the
regimen to be used.
(Reporting by Toni Clarke, editing by Dave Zimmerman and
Matthew Lewis)