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Novartis (NVS) Reports Encouraging Data on MS Candidate
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Novartis AG (NVS - Free Report) announced encouraging data from the phase III study, EXPAND, on oral, once-daily siponimod (BAF312) in patients with secondary progressive multiple sclerosis (“SPMS”).
Siponimod is an investigational, selective modulator of specific subtypes of the sphingosine-1-phosphate (S1P) receptor.
The results will be presented at the 70th American Academy of Neurology Annual Meeting, in Los Angeles which is scheduled to be held from Apr 21 to 27.
The randomized, double-blind, placebo-controlled, EXPAND study is comparing the efficacy and safety of siponimod versus placebo in SPMS patients.
Data from the study showed that siponimod reduced the risk of disability progression largely disassociated from relapses in patients with SPMS.
New post-hoc analysis also demonstrated that the risk reduction with siponimod is largely disassociated from relapses. The data from the study showed that siponimod resulted in significant benefit on cognitive processing speed, the key cognitive function impacted by MS which impacted the affected patients.
Meanwhile, Novartis has initiated the submission of siponimod in the United States for the approval in SPMS. Filing for EU approval is planned to follow later in 2018.
A potential approval will strengthen Novartis’ MS portfolio which includes Gilenya (fingolimod, an S1P modulator) approved for relapsing forms of MS and is also in development for pediatric MS. Extavia (interferon beta-1b for subcutaneous injection) is approved in the United States for the treatment of relapsing forms of MS.
Novartis also has another MS candidate in its pipeline apart from siponimod- ofatumumab (OMB157), a fully human monoclonal antibody being evaluated in two phase III studies for relapsing MS. The generic division, Sandoz, markets Glatopa (glatiramer acetate injection) 20 mg/mL and 40 mg/mL, generic versions of Teva's (TEVA - Free Report) Copaxone.
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, SPMS and primary progressive MS.
However, the competition is stiff in the market. Biogen (BIIB - Free Report) is a dominant player in the MS market with drugs like Avonex, Tysabri, Tecfidera, Plegridy and Zinbryta. The FDA recently issued Refusal to File letter to Celgene’s New Drug Application for ozanimod, which is in development for the treatment of patients with relapsing forms of multiple sclerosis.
Novartis’ stock has lost 4.5% in the last six months compared with the industry’s 6.0% decline.
Shares have declined further following first-quarter results which were reported yesterday. While revenues and earnings beat estimates, sales of psoriasis drug Cosentyx fell short of expectations while Sandoz revenues declined due to pricing pressure.
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
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Novartis (NVS) Reports Encouraging Data on MS Candidate
Novartis AG (NVS - Free Report) announced encouraging data from the phase III study, EXPAND, on oral, once-daily siponimod (BAF312) in patients with secondary progressive multiple sclerosis (“SPMS”).
Siponimod is an investigational, selective modulator of specific subtypes of the sphingosine-1-phosphate (S1P) receptor.
The results will be presented at the 70th American Academy of Neurology Annual Meeting, in Los Angeles which is scheduled to be held from Apr 21 to 27.
The randomized, double-blind, placebo-controlled, EXPAND study is comparing the efficacy and safety of siponimod versus placebo in SPMS patients.
Data from the study showed that siponimod reduced the risk of disability progression largely disassociated from relapses in patients with SPMS.
New post-hoc analysis also demonstrated that the risk reduction with siponimod is largely disassociated from relapses. The data from the study showed that siponimod resulted in significant benefit on cognitive processing speed, the key cognitive function impacted by MS which impacted the affected patients.
Meanwhile, Novartis has initiated the submission of siponimod in the United States for the approval in SPMS. Filing for EU approval is planned to follow later in 2018.
A potential approval will strengthen Novartis’ MS portfolio which includes Gilenya (fingolimod, an S1P modulator) approved for relapsing forms of MS and is also in development for pediatric MS. Extavia (interferon beta-1b for subcutaneous injection) is approved in the United States for the treatment of relapsing forms of MS.
Novartis also has another MS candidate in its pipeline apart from siponimod- ofatumumab (OMB157), a fully human monoclonal antibody being evaluated in two phase III studies for relapsing MS. The generic division, Sandoz, markets Glatopa (glatiramer acetate injection) 20 mg/mL and 40 mg/mL, generic versions of Teva's (TEVA - Free Report) Copaxone.
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, SPMS and primary progressive MS.
However, the competition is stiff in the market. Biogen (BIIB - Free Report) is a dominant player in the MS market with drugs like Avonex, Tysabri, Tecfidera, Plegridy and Zinbryta. The FDA recently issued Refusal to File letter to Celgene’s New Drug Application for ozanimod, which is in development for the treatment of patients with relapsing forms of multiple sclerosis.
Novartis’ stock has lost 4.5% in the last six months compared with the industry’s 6.0% decline.
Shares have declined further following first-quarter results which were reported yesterday. While revenues and earnings beat estimates, sales of psoriasis drug Cosentyx fell short of expectations while Sandoz revenues declined due to pricing pressure.
Zacks Rank
Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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