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Biogen's (BIIB) Oral MS Drug Vumerity Gets Approval in Europe
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Biogen (BIIB - Free Report) announced that the European Commission (EC) has approved its marketing authorization application for its next-generation, oral multiple sclerosis drug, Vumerity (diroximel fumarate) for treating a relapsing-remitting form of the disease.
The approval was expected as the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (“CHMP”) had approved Vumerity in September.
The EC approved Vumerity to treat relapsing-remitting multiple sclerosis (RRMS) based on data from pharmacokinetic bridging studies that compared Vumerity with Biogen’s older MS drug, Tecfidera (dimethyl fumarate) for establishing bioequivalent exposure of monomethyl fumarate, the active metabolite for both drugs. The approval was also partly backed by the established long-term efficacy and safety profile of Tecfidera.
Moreover, 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 was also assessed. 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.
We note that Biogen in-licensed worldwide commercialization rights to Vumerity from Alkermes (ALKS - Free Report) in 2017.
Alkermes receives a royalty on total global sales of Vumerity under the in-licensing agreement between the companies. Alkermes earned $11 million in royalties on sales of Vumerity in the first nine months of 2021.
Shares of Biogen have increased 7% so far this year against the industry’s decrease of 14.6%.
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We note that Vumerity was approved in the United States in 2019. The drug has generated sales of $285.5 million in the first nine months of 2021 ,, showing strong sequential growthThe trend is expected to continue going forward on the back of strong rise in demand. Most importantly, the drug is helping Biogen to partially offset the loss of sales of its key MS drug, Tecfidera, whose sales has been declining amid generic competition. Biogen has a strong portfolio of six MS drugs that generated approximately 70% of total revenues in the first nine months of 2021. However, Tecfidera sales declined almost 55% year over year.
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.
The MS drug from Roche was approved by the FDA in 2017 and generated CHF 3.7 billion in sales in the first nine months of 2021, reflecting year-over-year growth of 17%. Roche pays Biogen royalty on sales of Ocrevus as the drug has been developed as part of a collaboration between the companies that amounted to $730.5 million in the first nine months of 2021.
Loss per share estimates for Sarepta have narrowed from $6.95 to $4.99 for 2021 and from $4.78 to $3.61 for 2022 in the past 30 days. Sarepta delivered an earnings surprise of 11.06%, on average, in the last four quarters.
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Biogen's (BIIB) Oral MS Drug Vumerity Gets Approval in Europe
Biogen (BIIB - Free Report) announced that the European Commission (EC) has approved its marketing authorization application for its next-generation, oral multiple sclerosis drug, Vumerity (diroximel fumarate) for treating a relapsing-remitting form of the disease.
The approval was expected as the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (“CHMP”) had approved Vumerity in September.
The EC approved Vumerity to treat relapsing-remitting multiple sclerosis (RRMS) based on data from pharmacokinetic bridging studies that compared Vumerity with Biogen’s older MS drug, Tecfidera (dimethyl fumarate) for establishing bioequivalent exposure of monomethyl fumarate, the active metabolite for both drugs. The approval was also partly backed by the established long-term efficacy and safety profile of Tecfidera.
Moreover, 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 was also assessed. 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.
We note that Biogen in-licensed worldwide commercialization rights to Vumerity from Alkermes (ALKS - Free Report) in 2017.
Alkermes receives a royalty on total global sales of Vumerity under the in-licensing agreement between the companies. Alkermes earned $11 million in royalties on sales of Vumerity in the first nine months of 2021.
Shares of Biogen have increased 7% so far this year against the industry’s decrease of 14.6%.
We note that Vumerity was approved in the United States in 2019. The drug has generated sales of $285.5 million in the first nine months of 2021 ,, showing strong sequential growthThe trend is expected to continue going forward on the back of strong rise in demand. Most importantly, the drug is helping Biogen to partially offset the loss of sales of its key MS drug, Tecfidera, whose sales has been declining amid generic competition. Biogen has a strong portfolio of six MS drugs that generated approximately 70% of total revenues in the first nine months of 2021. However, Tecfidera sales declined almost 55% year over year.
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.
The MS drug from Roche was approved by the FDA in 2017 and generated CHF 3.7 billion in sales in the first nine months of 2021, reflecting year-over-year growth of 17%. Roche pays Biogen royalty on sales of Ocrevus as the drug has been developed as part of a collaboration between the companies that amounted to $730.5 million in the first nine months of 2021.
Biogen Inc. Price
Biogen Inc. price | Biogen Inc. Quote
Zacks Rank & Stock to Consider
Biogen currently carries a Zacks Rank #3 (Hold).
Sarepta Therapeutics (SRPT - Free Report) is a better-ranked stock to consider from the same sector, carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for Sarepta have narrowed from $6.95 to $4.99 for 2021 and from $4.78 to $3.61 for 2022 in the past 30 days. Sarepta delivered an earnings surprise of 11.06%, on average, in the last four quarters.