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Celgene (CELG) Otezla Approved in Japan for New Indications
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Celgene Corporation received encouraging news with the Japanese Ministry of Health, Labor and Welfare granting full marketing authorization to its oral phosphodiesterase 4 (PDE4), Otezla. Otezla has been approved for the treatment of adults with plaque psoriasis, with an inadequate response to topical therapies, as well as adults with psoriatic arthritis.
Celgene’s year-to-date share price movement shows that the stock has outperformed the Zacks classified Medical - Biomedical and Genetics industry. Specifically, the stock has lost 1% year to date, compared with a decline of 26% for the industry.
Following the approval, Otezla has become the first oral treatment in 25 years to be cleared in Japan for the treatment of both psoriasis and psoriatic arthritis patients, both involving dysregulated immune system activity. In addition, the drug’s mechanism of action and oral administration is expected to provide a new treatment option for patients in Japan.
According to Celgene’s press release, plaque psoriasis is a systemic inflammatory condition, estimated to affect 430,000 people in Japan and about 125 million people across the world. Meanwhile, psoriatic arthritis is a chronic inflammatory disease, estimated to affect approximately 38 million people across the world.
We note that Otezla is already approved for these two indications in the U.S. and the EU. In the first nine months of 2016, the drug recorded worldwide sales of $712.1 million. Its sales have benefited from market share gains and increased prescriber adoption.
While physician and consumer campaigns continue to drive demand for Otezla in the U.S, the company is working on securing reimbursement in several key EU markets.
Geographical expansion should boost the drug’s commercial potential substantially. Celgene expects Otezla to achieve the blockbuster status in 2016 itself.
Meanwhile, the company is working on expanding Otezla’s label. It is currently evaluating the product for the treatment of Behçet's disease, ulcerative colitis, and expanded indications in psoriatic arthritis and plaque psoriasis among others.
Celgene carries a Zacks Rank #2 (Buy). Some other favorably placed stocks in this industry include Arbutus Biopharma Corporation (ABUS - Free Report) , Athersys, Inc. and MannKind Corporation (MNKD - Free Report) . All the three stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Athersys’ loss estimates narrowed from 23 cents to 18 cents for 2016 while that for 2017 remained unchanged over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 110.52%. Its share price has gained 58% year to date.
Arbutus’ loss estimates narrowed from $2.15 to $1.71 for 2016 and from $1.96 to $1.46 for 2017 over the last 60 days. The company posted positive surprises thrice in the four trailing quarters with an average beat of 59.31%.
MannKind’s estimates narrowed from loss of 24 cents to earnings of 12 cents for 2016 over the last 60 days. For 2017, loss estimates narrowed from 14 cents to 9 cents over this period. The company posted a positive surprise in two of the four trailing quarters with an average beat of 103.33%.
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Celgene (CELG) Otezla Approved in Japan for New Indications
Celgene Corporation received encouraging news with the Japanese Ministry of Health, Labor and Welfare granting full marketing authorization to its oral phosphodiesterase 4 (PDE4), Otezla. Otezla has been approved for the treatment of adults with plaque psoriasis, with an inadequate response to topical therapies, as well as adults with psoriatic arthritis.
Celgene’s year-to-date share price movement shows that the stock has outperformed the Zacks classified Medical - Biomedical and Genetics industry. Specifically, the stock has lost 1% year to date, compared with a decline of 26% for the industry.
Following the approval, Otezla has become the first oral treatment in 25 years to be cleared in Japan for the treatment of both psoriasis and psoriatic arthritis patients, both involving dysregulated immune system activity. In addition, the drug’s mechanism of action and oral administration is expected to provide a new treatment option for patients in Japan.
According to Celgene’s press release, plaque psoriasis is a systemic inflammatory condition, estimated to affect 430,000 people in Japan and about 125 million people across the world. Meanwhile, psoriatic arthritis is a chronic inflammatory disease, estimated to affect approximately 38 million people across the world.
We note that Otezla is already approved for these two indications in the U.S. and the EU. In the first nine months of 2016, the drug recorded worldwide sales of $712.1 million. Its sales have benefited from market share gains and increased prescriber adoption.
While physician and consumer campaigns continue to drive demand for Otezla in the U.S, the company is working on securing reimbursement in several key EU markets.
Geographical expansion should boost the drug’s commercial potential substantially. Celgene expects Otezla to achieve the blockbuster status in 2016 itself.
Meanwhile, the company is working on expanding Otezla’s label. It is currently evaluating the product for the treatment of Behçet's disease, ulcerative colitis, and expanded indications in psoriatic arthritis and plaque psoriasis among others.
CELGENE CORP Price and Consensus
CELGENE CORP Price and Consensus | CELGENE CORP Quote
Zacks Rank & Key Picks
Celgene carries a Zacks Rank #2 (Buy). Some other favorably placed stocks in this industry include Arbutus Biopharma Corporation (ABUS - Free Report) , Athersys, Inc. and MannKind Corporation (MNKD - Free Report) . All the three stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Athersys’ loss estimates narrowed from 23 cents to 18 cents for 2016 while that for 2017 remained unchanged over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 110.52%. Its share price has gained 58% year to date.
Arbutus’ loss estimates narrowed from $2.15 to $1.71 for 2016 and from $1.96 to $1.46 for 2017 over the last 60 days. The company posted positive surprises thrice in the four trailing quarters with an average beat of 59.31%.
MannKind’s estimates narrowed from loss of 24 cents to earnings of 12 cents for 2016 over the last 60 days. For 2017, loss estimates narrowed from 14 cents to 9 cents over this period. The company posted a positive surprise in two of the four trailing quarters with an average beat of 103.33%.
Zacks’ Best Private Investment Ideas
In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time?
Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>