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Celgene (CELG) Gets Favorable CHMP Opinion for Revlimid

Celgene CorporationCELG announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion for oncology drug Revlimid as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma (MM) who have undergone autologous stem cell transplantation (ASCT).

Celgene has outperformed the Zacks classified Medical-Biomedical and Genetics industry in the past one year. Specifically, the stock gained 12.7% during this period, compared with a decline of 7.8% for the industry.

We note that the European Commission generally follows the recommendation of the CHMP but is not bound by it. A final decision is expected in two months.

The CHMP recommendation was based on positive results from two cooperative group-led studies, CALGB 100104 and IFM 2005-02.

Data from the studies revealed that Revlimid monotherapy as maintenance treatment post-ASCT significantly reduced the risk of disease progression or death in patients with MM. The safety profile was in line with other clinical data in newly diagnosed non-stem cell transplant (NSCT) and post-approval safety study in relapsed/refractory MM (rrMM). However, increased incidence of hematologic second primary malignancies (SPMs) was observed in the Revlimid group compared with placebo across both the trials.

Upon approval, Revlimid will become the first and only licensed maintenance treatment available in the EU.

Per estimates, approximately 39,000 people are diagnosed with MM in Europe every year, resulting in 24,000 deaths.

We remind investors that Revlimid is approved in the U.S. and Europe, in combination with dexamethasone, for the treatment of adult patients with previously untreated multiple myeloma (MM) who are not eligible for transplant. The drug is also approved in the U.S. for transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Moreover, in Europe, it is approved for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

The drug, growth engine for Celgene, generated sales of $7.0 billion in 2016, an increase of 20% from 2015 driven primarily by increased volume as a result of increases in duration and new patients.

A label expansion of the drug is expected to boost sales further. Currently, Revlimid is under priority review in the U.S. for use as a maintenance treatment in NDMM patients after they receive an ASCT. A response from the FDA is expected by Feb 24.

Celgene Corporation Price and Consensus

Celgene Corporation Price and Consensus | Celgene Corporation Quote

Zacks Rank & Key Picks

Celgene is a Zacks Rank #3 (Hold) stock.

Some better-ranked stocks in the health care sector include Sucampo Pharmaceuticals SCMP , Anika Therapeutics ANIK and Sunesis Pharmaceuticals SNSS . While Sucampo and Sunesis carry a Zacks Rank #1 (Strong Buy), Anika holds a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank stocks here .

Sunesis' loss estimates narrowed 5.06% and 8.80% for 2016 and 2017, respectively, over the past 90 days. The company recorded a positive earnings surprise in three of the last four quarters, the average being 0.54%.

Anika's earnings estimates for 2016 and 2017 were up 3.9% and 0.5%, respectively, over the last 60 days. The company recorded a positive earnings surprise in each of the last four quarters, the average being 33.1%. Its share price was up 37.2% in the past one year.

Sucampo's earnings estimates were stable at $1.22 for 2016 but have increased from $1.58 to $1.74 for 2017 over the last 60 days. The company posted a positive earnings surprise in each of the four trailing quarters with an average beat of 35.5%.

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Celgene Corporation (CELG): Free Stock Analysis Report

Anika Therapeutics Inc. (ANIK): Free Stock Analysis Report

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Sunesis Pharmaceuticals, Inc. (SNSS): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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