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Biogen's Two MS Drugs Get CHMP Nod for Use in Pregnancy

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Biogen Inc. (BIIB - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given a positive opinion recommending use of its interferon beta treatments, including Plegridy and Avonex, during pregnancy and breastfeeding in women with relapsing multiple sclerosis (MS). The CHMP has recommended removing pregnancy contraindications from labels of these drugs.

The recommendation was based on data from real-world pregnancy outcomes in which data showed that exposure to interferon beta before conception and/or during first trimester did not lead to any increase in risk of major congenital anomalies. The data showed that pregnancy outcomes were in line with general patient population.

Please note that sales of Avonex and Plegridy in the United States have been declining due to transition of patients to other oral or high-efficacy MS therapies as well as higher discounts and allowance. Combined interferon revenues (Avonex and Plegridy) in the second quarter were $554 million, down 11% year over year. Avonex revenues declined 13% from the year-ago quarter to $438 million. Plegridy contributed $117 million to revenues, down 6% year over year.

Biogen’s shares have declined 20.3% this year so far against no change for the industry in the said time frame.

Biogen boasts a dominant position in the MS market with drugs like Tysabri and Tecfidera in its portfolio apart from Avonex and Plegridy.

Biogen is also working on consolidating its position in the MS market by bringing new treatments to market. In November 2017, Biogen in-licensed worldwide commercialization rights to Alkermes’ (ALKS - Free Report) Vumerity, which the company claims has a potentially differentiated profile to Tecfidera. The new drug application for Vumerity is under review in the United States with the FDA decision expected in the fourth quarter of 2019.

However, the MS market is gradually slowing down. The competitive landscape remains challenging for Biogen’s MS products with newer, competitive entrants. Its MS franchise sales, mainly Tysabri, have been adversely impacted by the launch of Ocrevus by Roche (RHHBY - Free Report) in 2017. The launch of Novartis’ (NVS - Free Report) new drug Mayzent (siponimod) this year poses competitive threat to Tysabri and Tecfidera.

Biogen 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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