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Why Multiple Sclerosis is a Promising but Risky Space?
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The Multiple Sclerosis (MS) space hit the headlines once again following biotech bigwig, Biogen (BIIB - Free Report) and partner AbbVie’s (ABBV - Free Report) decision to withdraw their jointly owned MS drug, Zinbryta voluntarily on a worldwide basis due to risk of liver injury. Both companies decided to withdraw the drug on grounds of the complex and evolving benefit/risk profile of Zinbryta, given the limited number of patients treated.
In November 2017, the European Medicines Agency (EMA) concluded its review of Zinbryta. The review found that unpredictable and potentially fatal immune-mediated liver injury can occur during treatment with Zinbryta and for up to 6 months after stopping treatment. In clinical trials, 1.7% of patients receiving Zinbryta had a serious liver reaction.
Given the complexity of the market, MS drugs have a long history of serious side effects, making it a risky therapeutic area. An autoimmune inflammatory disease of the centrol nervous system, MS disrupts the normal functioning of the brain, optic nerves and spinal cord through inflammation and tissue loss. There are three types of MS widely known to affect adults — relapsing-remitting MS (RRMS), secondary progressive MS (SPMS) and primary progressive MS (PPMS).
The market for MS changed drastically with the introduction of oral formulations which are mostly preferred than injections. While there a variety of drugs available for MS, they come with their own set of risks mostly.
Biogen is a dominant player in the MS market with drugs like Avonex, Tysabri, Tecfidera, Plegridy and Zinbryta. However, the company has been under the scrutiny for pricing of MS drugs in 2017. Earlier, the emergence of progressive multifocal leukoencephalopathy (PML) cases, a type of brain infection, associated with the use of Tysabri and Tecfidera had marred the prospects of MS drugs. The FDA thereafter updated the label of Tecfidera. Nevertheless, the company is a name to reckon with in the MS market.
Earlier, the FDA also issued a warning against Novartis’ (NVS - Free Report) Gilenya for PML. The drug was recently granted Breakthrough Therapy designation to Gilenya for the treatment of children and adolescents 10 years of age or older with relapsing MS. The drug is already approved for the same among adults. Novartis has another MS drug in its portfolio, Glatopa, a generic version of Copaxone 20 mg. Sandoz, the company’s generic arm, recently won FDA approval for a generic version of Copaxone 40mg.
Israel-based Teva Pharmceuticals (TEVA - Free Report) has long been in the MS market through its widely used drug Copaxone which is facing stiff competition for the last few years.
Meanwhile, in the past, seizures were known side-effects of another MS drug, Ampyra. Seizure risk was seen to increase with higher blood levels of the drug. As a result, the FDA had to update Ampyra’s label to clarify recommendations that kidney function should be checked in patients before starting Ampyra and monitored at least annually while Ampyra treatment continues.
Nevertheless, the risks associated with the drugs have not deterred newer entrants which claim better formulations with lesser side effects. Consequently, the market has become too crowded.
In March 2017, the FDA approved Roche’s (RHHBY) Ocrevus to treat adults with relapsing forms of MS and primary progressive multiple sclerosis. However, there were questions if Ocrevus was a new innovation or a reformulation of Roche’s older drug Rituxan. The drug sales aren’t that impressive yet either.
The FDA recently issued Refusal to File letter to Celgene’s New Drug Application (NDA) for ozanimod, which is in development for the treatment of patients with relapsing forms of multiple sclerosis. The FDA determined that the nonclinical and clinical pharmacology sections in the NDA were insufficient to permit a complete review. Hence, the company is now gearing up to meet the FDA and determine the future course of action. While there haven’t been any safety issues reports, the delay will definitely open up avenues for competition.
Given that so much is happening in this space, we expect investors to remain glued for further updates.
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.
Image: Bigstock
Why Multiple Sclerosis is a Promising but Risky Space?
The Multiple Sclerosis (MS) space hit the headlines once again following biotech bigwig, Biogen (BIIB - Free Report) and partner AbbVie’s (ABBV - Free Report) decision to withdraw their jointly owned MS drug, Zinbryta voluntarily on a worldwide basis due to risk of liver injury. Both companies decided to withdraw the drug on grounds of the complex and evolving benefit/risk profile of Zinbryta, given the limited number of patients treated.
In November 2017, the European Medicines Agency (EMA) concluded its review of Zinbryta. The review found that unpredictable and potentially fatal immune-mediated liver injury can occur during treatment with Zinbryta and for up to 6 months after stopping treatment. In clinical trials, 1.7% of patients receiving Zinbryta had a serious liver reaction.
Given the complexity of the market, MS drugs have a long history of serious side effects, making it a risky therapeutic area. An autoimmune inflammatory disease of the centrol nervous system, MS disrupts the normal functioning of the brain, optic nerves and spinal cord through inflammation and tissue loss. There are three types of MS widely known to affect adults — relapsing-remitting MS (RRMS), secondary progressive MS (SPMS) and primary progressive MS (PPMS).
The market for MS changed drastically with the introduction of oral formulations which are mostly preferred than injections. While there a variety of drugs available for MS, they come with their own set of risks mostly.
Biogen is a dominant player in the MS market with drugs like Avonex, Tysabri, Tecfidera, Plegridy and Zinbryta. However, the company has been under the scrutiny for pricing of MS drugs in 2017. Earlier, the emergence of progressive multifocal leukoencephalopathy (PML) cases, a type of brain infection, associated with the use of Tysabri and Tecfidera had marred the prospects of MS drugs. The FDA thereafter updated the label of Tecfidera. Nevertheless, the company is a name to reckon with in the MS market.
Earlier, the FDA also issued a warning against Novartis’ (NVS - Free Report) Gilenya for PML. The drug was recently granted Breakthrough Therapy designation to Gilenya for the treatment of children and adolescents 10 years of age or older with relapsing MS. The drug is already approved for the same among adults. Novartis has another MS drug in its portfolio, Glatopa, a generic version of Copaxone 20 mg. Sandoz, the company’s generic arm, recently won FDA approval for a generic version of Copaxone 40mg.
Israel-based Teva Pharmceuticals (TEVA - Free Report) has long been in the MS market through its widely used drug Copaxone which is facing stiff competition for the last few years.
Meanwhile, in the past, seizures were known side-effects of another MS drug, Ampyra. Seizure risk was seen to increase with higher blood levels of the drug. As a result, the FDA had to update Ampyra’s label to clarify recommendations that kidney function should be checked in patients before starting Ampyra and monitored at least annually while Ampyra treatment continues.
Nevertheless, the risks associated with the drugs have not deterred newer entrants which claim better formulations with lesser side effects. Consequently, the market has become too crowded.
In March 2017, the FDA approved Roche’s (RHHBY) Ocrevus to treat adults with relapsing forms of MS and primary progressive multiple sclerosis. However, there were questions if Ocrevus was a new innovation or a reformulation of Roche’s older drug Rituxan. The drug sales aren’t that impressive yet either.
The FDA recently issued Refusal to File letter to Celgene’s New Drug Application (NDA) for ozanimod, which is in development for the treatment of patients with relapsing forms of multiple sclerosis. The FDA determined that the nonclinical and clinical pharmacology sections in the NDA were insufficient to permit a complete review. Hence, the company is now gearing up to meet the FDA and determine the future course of action. While there haven’t been any safety issues reports, the delay will definitely open up avenues for competition.
Given that so much is happening in this space, we expect investors to remain glued for further updates.
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 >>