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Novartis (NVS) Votubia Gets EU Approval for Label Expansion
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Novartis AG (NVS - Free Report) announced that the European Commission has approved its oncology drug, Votubia dispersible tablets, as an adjunctive treatment for patients aged two years and older, whose refractory partial-onset seizures, with or without secondary generalization, are associated with tuberous sclerosis complex (TSC).
This makes Votubia the first pharmacologic therapy to gain approval for refractory partial-onset seizures associated with TSC as well as the third TSC-related indication in the EU.
A look at Novartis’ share price movement over the past one year shows that the stock has underperformed the Zacks classified Large Cap Pharma industry. Specifically, Novartis’ stock dropped 4.1% during this period, while the industry lost 0.1%.
Coming back to the latest news, the EU approval was largely expected as the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a favorable opinion in Dec 2016. Votubia’s approval was based on safety and efficacy data from the phase III EXIST-3 study which found that Votubia, when used as adjunctive therapy, significantly reduced the frequency of refractory partial-onset seizures associated with TSC.
We note that Votubia is approved in the EU for the treatment of adult patients with renal angiomyolipoma associated with TSC who are at risk of complications (based on factors such as tumor size or presence of aneurysm, or ultiple or bilateral tumors) but do not require immediate surgery. The drug is also approved in the EU for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with TSC who require therapeutic intervention but are not amenable to surgery.
In the U.S., Afinitor (U.S. trade name for Votubia) is approved for the treatment of adult patients with renal angiomyolipoma and TSC, who do not require immediate surgery. It is also indicated to treat TSC in pediatric and adult patients with SEGA, who require therapeutic intervention but cannot be curatively resected.
Afinitor/Votubia generated sales of $1.5 billion in 2016, down 5% year over year.
Going forward, we expect approval of new drugs and label expansion of existing ones to bode well for Novartis. Also, strong performance of growth products should be able to offset the impact of generic competition for Gleevec.
Novartis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Sucampo Pharmaceuticals, Inc. , Sunesis Pharmaceuticals and Anika Therapeutics Inc. (ANIK - Free Report) . While Sucampo sports a Zacks Rank #1 (Strong Buy), Anika and Sunesis carry a Zacks Rank #2 (Buy). You can see tthe complete list of today’s Zacks #1 Rank stocks here.
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 all of the four trailing quarters with an average beat of 35.5%.
Sunesis’ loss estimates narrowed 5.06% and 8.80% for 2016 and 2017, respectively, over the past 60 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 33.14%.
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Novartis (NVS) Votubia Gets EU Approval for Label Expansion
Novartis AG (NVS - Free Report) announced that the European Commission has approved its oncology drug, Votubia dispersible tablets, as an adjunctive treatment for patients aged two years and older, whose refractory partial-onset seizures, with or without secondary generalization, are associated with tuberous sclerosis complex (TSC).
This makes Votubia the first pharmacologic therapy to gain approval for refractory partial-onset seizures associated with TSC as well as the third TSC-related indication in the EU.
A look at Novartis’ share price movement over the past one year shows that the stock has underperformed the Zacks classified Large Cap Pharma industry. Specifically, Novartis’ stock dropped 4.1% during this period, while the industry lost 0.1%.
Coming back to the latest news, the EU approval was largely expected as the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a favorable opinion in Dec 2016. Votubia’s approval was based on safety and efficacy data from the phase III EXIST-3 study which found that Votubia, when used as adjunctive therapy, significantly reduced the frequency of refractory partial-onset seizures associated with TSC.
We note that Votubia is approved in the EU for the treatment of adult patients with renal angiomyolipoma associated with TSC who are at risk of complications (based on factors such as tumor size or presence of aneurysm, or ultiple or bilateral tumors) but do not require immediate surgery. The drug is also approved in the EU for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with TSC who require therapeutic intervention but are not amenable to surgery.
In the U.S., Afinitor (U.S. trade name for Votubia) is approved for the treatment of adult patients with renal angiomyolipoma and TSC, who do not require immediate surgery. It is also indicated to treat TSC in pediatric and adult patients with SEGA, who require therapeutic intervention but cannot be curatively resected.
Afinitor/Votubia generated sales of $1.5 billion in 2016, down 5% year over year.
Going forward, we expect approval of new drugs and label expansion of existing ones to bode well for Novartis. Also, strong performance of growth products should be able to offset the impact of generic competition for Gleevec.
Novartis AG Price and Consensus
Novartis AG Price and Consensus | Novartis AG Quote
Zacks Rank & Key Picks
Novartis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Sucampo Pharmaceuticals, Inc. , Sunesis Pharmaceuticals and Anika Therapeutics Inc. (ANIK - Free Report) . While Sucampo sports a Zacks Rank #1 (Strong Buy), Anika and Sunesis carry a Zacks Rank #2 (Buy). You can see tthe complete list of today’s Zacks #1 Rank stocks here.
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 all of the four trailing quarters with an average beat of 35.5%.
Sunesis’ loss estimates narrowed 5.06% and 8.80% for 2016 and 2017, respectively, over the past 60 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 33.14%.
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 >>