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Novartis (NVS) Gets Positive CHMP Opinion for Key Drugs
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Novartis AG (NVS - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of its arthritis drug, Ilaris (canakinumab), in Europe for an additional indication.
A look at Novartis’ year-to-date share price movement shows that the stock has underperformed the Zacks classified Large Cap Pharma industry. It has lost 16.5% so far this year, which compares unfavorably with the 5.1% fall for the industry.
Note that the CHMP has given an opinion in favor of an approval of Ilaris for the treatment of three rare and distinct Periodic Fever Syndromes.
Upon approval, Ilaris will be the only approved biologic treatment in Europe for Tumor Necrosis Factor-Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) and Familial Mediterranean Fever (FMF).
The CHMP also recommended the use of a new formulation of Ilaris – a 150 mg/ml solution for injection based on results from the pivotal phase III study, CLUSTER.
In Sep 2016, the FDA approved Ilaris for the treatment of TRAPS, HIDS/MKD and FMF. We remind investors that in August, the European Commission had granted Ilaris a license extension for the treatment of patients with Adult-Onset Still's Disease (AOSD).
Notably, Ilaris is approved and marketed for the treatment of Systemic Juvenile Idiopathic Arthritis (SJIA) in both the U.S. and the EU, as well as for AOSD and the symptomatic treatment of refractory acute gouty arthritis in the EU.
Additionally, the CHMP has adopted a positive opinion for Novartis’ oncology drug, Votubia dispersible tablets, as an adjunctive treatment of patients aged two years and older, whose refractory partial-onset seizures, with or without secondary generalization, are associated with tuberous sclerosis complex (TSC). We note that Votubia is approved in the EU for the treatment of adult patients with renal angiomyolipoma associated with TSC.
Note that the EC generally takes the CHMP’s recommendation in consideration while reviewing a candidate. The final decision from the CHMP is expected within two months or earlier. Afinitor (trade name in the U.S.) is approved in the U.S. and EU, for locally advanced, metastatic or unresectable progressive neuroendocrine tumors (NET) of pancreatic origin and for the treatment of adult patients with nonfunctional NET of gastrointestinal (GI) or lung origin.
Approval of new drugs and label expansion of existing ones should bode well for Novartis as it has been facing stiff generic competition for some of its key drugs like Gleevec in recent times.
Separately, Novartis announced that it will acquire Ziarco Group Limited in a move to bolster its dermatology portfolio.
Novartis currently has Zacks Rank #4 (Sell).
Key Picks in the Sector
Some better-ranked stocks in the health care sector include Heska Corp. , Sucampo Pharmaceuticals, Inc. andVanda Pharmaceuticals (VNDA - Free Report) . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Sucampo’s earnings estimates increased from $1.03 to $1.22for 2016 and from $1.30 to $169for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.
Heska’s earnings estimates increased from $1.13 to $1.35 for 2016 and from $1.38 to $1.53 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 301.64%. Its share price has increased 89% year to date.
Vanda’s loss estimates narrowed from 62 cents to 52 cents for 2016, while its earnings estimates increased from 13 cents to 22 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 77.4% year to date.
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Novartis (NVS) Gets Positive CHMP Opinion for Key Drugs
Novartis AG (NVS - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of its arthritis drug, Ilaris (canakinumab), in Europe for an additional indication.
A look at Novartis’ year-to-date share price movement shows that the stock has underperformed the Zacks classified Large Cap Pharma industry. It has lost 16.5% so far this year, which compares unfavorably with the 5.1% fall for the industry.
Note that the CHMP has given an opinion in favor of an approval of Ilaris for the treatment of three rare and distinct Periodic Fever Syndromes.
Upon approval, Ilaris will be the only approved biologic treatment in Europe for Tumor Necrosis Factor-Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) and Familial Mediterranean Fever (FMF).
The CHMP also recommended the use of a new formulation of Ilaris – a 150 mg/ml solution for injection based on results from the pivotal phase III study, CLUSTER.
In Sep 2016, the FDA approved Ilaris for the treatment of TRAPS, HIDS/MKD and FMF. We remind investors that in August, the European Commission had granted Ilaris a license extension for the treatment of patients with Adult-Onset Still's Disease (AOSD).
Notably, Ilaris is approved and marketed for the treatment of Systemic Juvenile Idiopathic Arthritis (SJIA) in both the U.S. and the EU, as well as for AOSD and the symptomatic treatment of refractory acute gouty arthritis in the EU.
Additionally, the CHMP has adopted a positive opinion for Novartis’ oncology drug, Votubia dispersible tablets, as an adjunctive treatment of patients aged two years and older, whose refractory partial-onset seizures, with or without secondary generalization, are associated with tuberous sclerosis complex (TSC). We note that Votubia is approved in the EU for the treatment of adult patients with renal angiomyolipoma associated with TSC.
Note that the EC generally takes the CHMP’s recommendation in consideration while reviewing a candidate. The final decision from the CHMP is expected within two months or earlier. Afinitor (trade name in the U.S.) is approved in the U.S. and EU, for locally advanced, metastatic or unresectable progressive neuroendocrine tumors (NET) of pancreatic origin and for the treatment of adult patients with nonfunctional NET of gastrointestinal (GI) or lung origin.
Approval of new drugs and label expansion of existing ones should bode well for Novartis as it has been facing stiff generic competition for some of its key drugs like Gleevec in recent times.
Separately, Novartis announced that it will acquire Ziarco Group Limited in a move to bolster its dermatology portfolio.
Novartis currently has Zacks Rank #4 (Sell).
Key Picks in the Sector
Some better-ranked stocks in the health care sector include Heska Corp. , Sucampo Pharmaceuticals, Inc. andVanda Pharmaceuticals (VNDA - Free Report) . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Sucampo’s earnings estimates increased from $1.03 to $1.22for 2016 and from $1.30 to $169for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.
Heska’s earnings estimates increased from $1.13 to $1.35 for 2016 and from $1.38 to $1.53 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 301.64%. Its share price has increased 89% year to date.
Vanda’s loss estimates narrowed from 62 cents to 52 cents for 2016, while its earnings estimates increased from 13 cents to 22 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 77.4% year to date.
Zacks' Top Investment Ideas for Long-Term Profit
How would you like to see our best recommendations to help you find today’s most promising long-term stocks? Starting now, you can look inside our portfolios featuring stocks under $10, income stocks, value investments and more. These picks, which have double and triple-digit profit potential, are rarely available to the public. But you can see them now. Click here >>