Biogen Inc. (BIIB - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion on, and has recommended marketing authorization to Vumerity (diroximel fumarate) for the treatment of adults with relapsing-remitting multiple sclerosis (“RRMS”). The opinion will now be reviewed by the European Commission.
The positive CHMP opinion was based on data from pharmacokinetic bridging studies that compared Vumerity to Biogen’s another multiple sclerosis (“MS”) drug, Tecfidera.
The CHMP assessed data from the multi-center, double-blind phase III EVOLVE-MS-2 study, which evaluated the gastrointestinal (“GI”) tolerability profile of Vumerity versus Tecfidera in patients with RRMS. Data from the same showed that the rate of overall treatment discontinuation was lower in patients who were treated with Vumerity compared with those who received Tecfidera. The treatment discontinuation rate due to GI tolerability was 0.8% in the Vumerity arm compared to 4.8% in the Tecfidera arm.
Vumerity, an oral fumarate, was approved in the United States for the treatment of relapsing forms of MS in adults in 2019. In the first six months of 2021, Vumerity recorded sales worth $164.6 million.
In late 2017, Biogen in-licensed worldwide commercialization rights to Vumerity from Alkermes (ALKS - Free Report) .
Shares of Biogen have rallied 22.6% so far this year compared with the industry’s growth of 0.9%.
Biogen holds a strong position in the MS market, with a wide range of products, including Avonex, Tysabri, Tecfidera and Plegridy. However, multiple generic versions of Tecfidera have been launched, which are significantly eroding the drug’s sales.
The market remains challenging for Biogen’s MS products with newer, competitive entrants. The launch of Ocrevus, a new MS drug by Roche (RHHBY - Free Report) , is adversely impacting sales of Biogen’s MS franchise. However, Biogen receives royalties on U.S. sales of Ocrevus.
Biogen is working on consolidating its position in the MS market by bringing in new treatments.
Zacks Rank & Key Pick
Biogen currently carries a Zacks Rank #3 (Hold). A top-ranked stock in the biotech sector is Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , which has a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron’s earnings estimates have been revised 17.8% upward for 2021 and 13.8% upward for 2022 over the past 60 days. The stock has surged 35% year to date.
Buy 5 Stocks BEFORE Election Day
Biden or Trump? Zacks is releasing a FREE Special Report, Profit from the 2024 Presidential Election (no matter who wins).
Since 1950, presidential election years have been strong for the market. This report names 5 timely stocks to ride the wave of electoral excitement.
They include a medical manufacturer that gained +11,000% in the last 15 years… a rental company absolutely crushing its sector… an energy powerhouse planning to grow its already large dividend by 25%... an aerospace and defense standout that just landed a potentially $80 billion contract… and a giant chipmaker building huge plants in the U.S.
Don’t Wait. Download FREE >>
Biogen Inc. (BIIB - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion on, and has recommended marketing authorization to Vumerity (diroximel fumarate) for the treatment of adults with relapsing-remitting multiple sclerosis (“RRMS”). The opinion will now be reviewed by the European Commission.
The positive CHMP opinion was based on data from pharmacokinetic bridging studies that compared Vumerity to Biogen’s another multiple sclerosis (“MS”) drug, Tecfidera.
The CHMP assessed data from the multi-center, double-blind phase III EVOLVE-MS-2 study, which evaluated the gastrointestinal (“GI”) tolerability profile of Vumerity versus Tecfidera in patients with RRMS. Data from the same showed that the rate of overall treatment discontinuation was lower in patients who were treated with Vumerity compared with those who received Tecfidera. The treatment discontinuation rate due to GI tolerability was 0.8% in the Vumerity arm compared to 4.8% in the Tecfidera arm.
Vumerity, an oral fumarate, was approved in the United States for the treatment of relapsing forms of MS in adults in 2019. In the first six months of 2021, Vumerity recorded sales worth $164.6 million.
In late 2017, Biogen in-licensed worldwide commercialization rights to Vumerity from Alkermes (ALKS - Free Report) .
Shares of Biogen have rallied 22.6% so far this year compared with the industry’s growth of 0.9%.
Biogen holds a strong position in the MS market, with a wide range of products, including Avonex, Tysabri, Tecfidera and Plegridy. However, multiple generic versions of Tecfidera have been launched, which are significantly eroding the drug’s sales.
The market remains challenging for Biogen’s MS products with newer, competitive entrants. The launch of Ocrevus, a new MS drug by Roche (RHHBY - Free Report) , is adversely impacting sales of Biogen’s MS franchise. However, Biogen receives royalties on U.S. sales of Ocrevus.
Biogen is working on consolidating its position in the MS market by bringing in new treatments.
Zacks Rank & Key Pick
Biogen currently carries a Zacks Rank #3 (Hold). A top-ranked stock in the biotech sector is Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , which has a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron’s earnings estimates have been revised 17.8% upward for 2021 and 13.8% upward for 2022 over the past 60 days. The stock has surged 35% year to date.
Buy 5 Stocks BEFORE Election Day
Biden or Trump? Zacks is releasing a FREE Special Report, Profit from the 2024 Presidential Election (no matter who wins).
Since 1950, presidential election years have been strong for the market. This report names 5 timely stocks to ride the wave of electoral excitement.
They include a medical manufacturer that gained +11,000% in the last 15 years… a rental company absolutely crushing its sector… an energy powerhouse planning to grow its already large dividend by 25%... an aerospace and defense standout that just landed a potentially $80 billion contract… and a giant chipmaker building huge plants in the U.S.
Don’t Wait. Download FREE >>
Get the latest research report on REGN - FREE
Get the latest research report on BIIB - FREE
Get the latest research report on RHHBY - FREE
Get the latest research report on ALKS - FREE