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Biogen Begins Improved Dosing Regimen on Tysabri in Phase III
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Biogen Inc. (BIIB - Free Report) announced that it has enrolled the first patient in a phase IIIb study to evaluate an extended interval dosing (EID) of Tysabri (natalizumab) for treating patients with relapsing multiple sclerosis (MS). Notably, Tysabri 300mg is approved as an every four-week dosing regimen.
The global NOVA study will evaluate the safety and efficacy of Tysabri with every six-week dosing routine compared with the standard interval dosing (SID) in patients with relapsing MS. The primary endpoint of the open-label two-year study is to check the number of new or newly enlarging T2 hyperintense lesions at week 48.
The NOVA analysis was initiated following an examination, which showed that the every six-week dosing regimen of Tysabri led to a significant reduction in the risk of progressive multifocal leukoencephalopathy (PML), a serious brain infection. As a result, this study will now further assess the drug’s benefit-risk profile in the given dosing regimen.
Shares of Biogen have lost 10.4% in the past year, narrower than the industry’s decrease of 24.2%.
Apart from Tysabri, Biogen has several MS products in its portfolio including Avonex, Tecfidera and Plegridy. Tysabri is available in more than 80 countries across the planet. However, the drug’s sales have not been encouraging of late due to the launch of Roche’s (RHHBY - Free Report) Ocrevus (ocrelizumab), which was approved for the treatment of relapsing MS (RMS) and primary progressive MS (PPMS) in March 2017. Although Ocrevus gives strong competition to Biogen’s MS drugs, the latter receives royalties on U.S. sales of the former.
Meanwhile, Biogen is working on consolidating its position in the MS market by bringing new treatments to the space. In November 2017, Biogen in-licensed the worldwide commercialization rights to Alkermes’ (ALKS - Free Report) BIIB098, a novel oral fumarate, which the company claims has a potentially differentiated profile to Tecfidera. Last month, Biogen along with Alkermes submitted a new drug application (NDA) to the FDA for diroximel fumarate (BIIB098), currently being developed for the treatment of relapsing forms of MS.
If approved, Biogen plans to market diroximel fumarate (BIIB098) under the brand name Vumerity, which has been conditionally accepted by the FDA and will be confirmed upon approval.
Zacks Rank & Key Pick
Biogen currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Genomic Health, Inc. , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Genomic Health’s earnings estimates have been revised 61.8% upward for 2019 over the past 60 days. The stock has soared 75.5% in the past year.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
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Biogen Begins Improved Dosing Regimen on Tysabri in Phase III
Biogen Inc. (BIIB - Free Report) announced that it has enrolled the first patient in a phase IIIb study to evaluate an extended interval dosing (EID) of Tysabri (natalizumab) for treating patients with relapsing multiple sclerosis (MS). Notably, Tysabri 300mg is approved as an every four-week dosing regimen.
The global NOVA study will evaluate the safety and efficacy of Tysabri with every six-week dosing routine compared with the standard interval dosing (SID) in patients with relapsing MS. The primary endpoint of the open-label two-year study is to check the number of new or newly enlarging T2 hyperintense lesions at week 48.
The NOVA analysis was initiated following an examination, which showed that the every six-week dosing regimen of Tysabri led to a significant reduction in the risk of progressive multifocal leukoencephalopathy (PML), a serious brain infection. As a result, this study will now further assess the drug’s benefit-risk profile in the given dosing regimen.
Shares of Biogen have lost 10.4% in the past year, narrower than the industry’s decrease of 24.2%.
Apart from Tysabri, Biogen has several MS products in its portfolio including Avonex, Tecfidera and Plegridy. Tysabri is available in more than 80 countries across the planet. However, the drug’s sales have not been encouraging of late due to the launch of Roche’s (RHHBY - Free Report) Ocrevus (ocrelizumab), which was approved for the treatment of relapsing MS (RMS) and primary progressive MS (PPMS) in March 2017. Although Ocrevus gives strong competition to Biogen’s MS drugs, the latter receives royalties on U.S. sales of the former.
Meanwhile, Biogen is working on consolidating its position in the MS market by bringing new treatments to the space. In November 2017, Biogen in-licensed the worldwide commercialization rights to Alkermes’ (ALKS - Free Report) BIIB098, a novel oral fumarate, which the company claims has a potentially differentiated profile to Tecfidera. Last month, Biogen along with Alkermes submitted a new drug application (NDA) to the FDA for diroximel fumarate (BIIB098), currently being developed for the treatment of relapsing forms of MS.
If approved, Biogen plans to market diroximel fumarate (BIIB098) under the brand name Vumerity, which has been conditionally accepted by the FDA and will be confirmed upon approval.
Zacks Rank & Key Pick
Biogen currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Genomic Health, Inc. , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Genomic Health’s earnings estimates have been revised 61.8% upward for 2019 over the past 60 days. The stock has soared 75.5% in the past year.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>