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Novartis Announces Positive Data on Sickle Cell Disease Drug
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Novartis AG (NVS - Free Report) announced positive results from a post hoc subgroup analysis of the phase II study, SUSTAIN on pipeline candidate, crizanlizumab.
The multicenter, multinational, randomized, placebo-controlled, double-blind, 12-month study was conducted to evaluate the safety and efficacy of the anti-P-selectin antibody crizanlizumab with or without concomitant use of hydroxyurea therapy in patients with sickle cell-related pain crises.
Results from the study showed that crizanlizumab deferred the time to first sickle cell pain crisis (SCPC) in patients compared to placebo in key subgroups of adult patients with sickle cell. crizanlizumab at 5.0 mg/kg per month increased the estimated median time to first SCPC versus placebo by approximately two-fold or more.
The results were published in The New England Journal of Medicine.
The data from the study will enable the company to conduct discussions with regulatory agencies. A filing in the United States is expected by the end of 2018.
We believe that the approval of new drugs and label expansion of existing drugs will boost the company’s top line.
Novartis’ stock has rallied 2.9% in the last six months compared with the industry’s 6.3% gain.
Novartis is currently going through a transitional stage. The company’s blockbuster drug, Diovan, is facing stiff generic competition in the United States, EU and Japan. The loss of patent protection for these top-selling drugs continue to hurt sales. Exforge is also facing generic competition in the United States and the EU. Oncology drugs are facing new competition from immuno-oncology therapies. Moreover, certain patents and extensions covering Afinitor and Gilenya will expire in 2018, 2019 and 2020. The negative impact of generic competition will impact sales by $2.5 billion in 2017.
Moreover, Sandoz holds a leading position in the biosimilars space with a portfolio of five marketed biosimilars currently and a deep pipeline. The biosimilar version of Roche Holdings’ (RHHBY - Free Report) Rituxan (rituximab) is one of them. Rixathon was approved by the European Commission in June 2017. It is currently under review in the United States. The biosimilar version of AbbVie, Inc. (ABBV - Free Report) 's Humira is also under review in the EU.
Zacks Rank & Key Pick
Novartis currently carries a Zacks Rank #3 (Hold).
Sucampo’s earnings per share estimates have moved up from 99 cents to $1.19 for 2018 over the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 15.63%.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
Image: Bigstock
Novartis Announces Positive Data on Sickle Cell Disease Drug
Novartis AG (NVS - Free Report) announced positive results from a post hoc subgroup analysis of the phase II study, SUSTAIN on pipeline candidate, crizanlizumab.
The multicenter, multinational, randomized, placebo-controlled, double-blind, 12-month study was conducted to evaluate the safety and efficacy of the anti-P-selectin antibody crizanlizumab with or without concomitant use of hydroxyurea therapy in patients with sickle cell-related pain crises.
Results from the study showed that crizanlizumab deferred the time to first sickle cell pain crisis (SCPC) in patients compared to placebo in key subgroups of adult patients with sickle cell. crizanlizumab at 5.0 mg/kg per month increased the estimated median time to first SCPC versus placebo by approximately two-fold or more.
The results were published in The New England Journal of Medicine.
The data from the study will enable the company to conduct discussions with regulatory agencies. A filing in the United States is expected by the end of 2018.
We believe that the approval of new drugs and label expansion of existing drugs will boost the company’s top line.
Novartis’ stock has rallied 2.9% in the last six months compared with the industry’s 6.3% gain.
Novartis is currently going through a transitional stage. The company’s blockbuster drug, Diovan, is facing stiff generic competition in the United States, EU and Japan. The loss of patent protection for these top-selling drugs continue to hurt sales. Exforge is also facing generic competition in the United States and the EU. Oncology drugs are facing new competition from immuno-oncology therapies. Moreover, certain patents and extensions covering Afinitor and Gilenya will expire in 2018, 2019 and 2020. The negative impact of generic competition will impact sales by $2.5 billion in 2017.
Moreover, Sandoz holds a leading position in the biosimilars space with a portfolio of five marketed biosimilars currently and a deep pipeline. The biosimilar version of Roche Holdings’ (RHHBY - Free Report) Rituxan (rituximab) is one of them. Rixathon was approved by the European Commission in June 2017. It is currently under review in the United States. The biosimilar version of AbbVie, Inc. (ABBV - Free Report) 's Humira is also under review in the EU.
Zacks Rank & Key Pick
Novartis currently carries a Zacks Rank #3 (Hold).
A better-ranked health care stock is Sucampo Pharmaceuticals with a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Sucampo’s earnings per share estimates have moved up from 99 cents to $1.19 for 2018 over the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 15.63%.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
Click here for the 6 trades >>