* Data can help Revlimid get approved for wider group of
* Analysts expect EU, US regulatory decision in 2015
* Shares up 7 pct
July 11 Celgene Corp said a late-stage
trial of its cancer drug Revlimid met the main goal of improving
survival in newly diagnosed blood cancer patients, potentially
opening up the path for a wider use of the drug.
The company's shares were up 7 percent at $133.07 in morning
Analysts said the data was largely expected and will also
pave the way for a European approval application for the drug.
Celgene had withdrawn the European marketing application for
a wider use of the drug in June 2012, after regulators asked for
"We note that this news removes a key overhang for Celgene
as with these data, they can now file for approval in the EU ...
(The) EU filing may come by end of the year," Deutsche Bank
Analyst Robyn Karnauskas wrote in a note.
Celgene said it will start discussions with regulators and
plans to submit applications in the United States, Europe and
Regulatory decision from United States and European agencies
are expected in 2015, analysts said.
Revlimid is Celgene's flagship blood cancer drug and is
already approved for use in multiple myeloma patients who have
failed at least one prior therapy, mantle cell lymphoma and
transfusion-dependent anemia caused by myelodysplastic syndromes
- a blood disorder.
The late-stage study tested the oral drug in patients with
newly diagnosed multiple myeloma, and showed a statistically
significant improvement in survival without the cancer
The evaluation of safety and efficacy was ongoing and the
results will be presented at an upcoming medical meeting,
Deutsche Bank's Karnauskas said that while the magnitude of
benefit with continuous Revlimid usage was not disclosed, she
expected progression-free survival in the group to be 35-36
"Notably, we expect control arm to do 25-26 months in this
study," she said.
Multiple myeloma is the second most commonly diagnosed blood
cancer. It starts in the plasma cells in the bone marrow and
ultimately disrupts the production of normal blood cells.
The American Cancer Society estimates there will be about
22,350 new cases diagnosed in 2013 and about 10,710 deaths.
Revlimid, Celgene's most important growth driver, brought in
sales of about $1 billion during the first quarter.
The approval for mantle cell lymphoma came in early last
According Thomson Reuters Pharma, Revlimid annual sales are
expected to reach $4.2 billion in 2013 and $5.37 billion in