- Biogen has secured exclusive rights to develop, manufacture and sell an experimental copycat version of Actemra, the blockbuster anti-inflammatory drug which recently came into the spotlight as a promising treatment for COVID-19.
- The deal announced Thursday would hand Bio-Thera Solutions, a China-based biotech company, $30 million upfront provided its biosimilar, known as BAT1806, achieves "satisfactory results" in an ongoing late-stage study testing it in patients with moderate to severe rheumatoid arthritis.
- BAT1806 and Actemra both work by blocking a pro-inflammatory protein called IL-6. Since it hit the U.S. market in 2010, Actemra's been approved to treat about half a dozen diseases, including several kinds of arthritis. In 2020, the drug brought in sales of 2.9 billion Swiss francs — or roughly $3.1 billion — for its developer, Roche.
Last year, for the first time in two decades, Biogen saw its annual revenue fall.
The decline was due to several factors. Biogen's cornerstone business of treating multiple sclerosis was under pressure, with generic competition starting to eat away at its top-selling product. Sales of the company's main growth driver, a muscular atrophy drug called Spinraza, also took a hit, both because of newer treatments brought to market by Novartis and Roche, and because of the coronavirus pandemic.
"Patients are scared to go to the centers, so they delayed the dosing. Some sites are being closed or limited capacity or staffing in order to dose the patients," Biogen CEO Michel Vounatsos said on an earnings call in February, detailing the recent challenges his company's had selling Spinraza.
Biogen is now banking on an experimental, potentially first-of-its-kind drug for Alzheimer's disease to offset these problems. An approval decision for the drug is expected in the next couple months, but there's no guarantee it will go in Biogen's favor. And even if it does, the company still expects annual revenue to slide again this year.
Amongst all these moving parts, Biogen has also been building up a business focused on biosimilars — medicines that mimic marketed biologics, somewhat like how generics imitate small molecule drugs. For 2020, sales from Biogen's biosimilar portfolio, which includes products that reference Humira, Enbrel and Remicade, rose 8% to nearly $800 million.
Over the past several years, Biogen has worked closely with Samsung Bioepis to bring more of these drugs to market. The companies have set their sights on developing biosimilar versions of the lucrative eye medications Lucentis and Eylea, and recently submitted their Lucentis copycat for approval with the Food and Drug Administration.
Thursday's deal with Bio-Thera Solutions would give Biogen access to an Actemra biosimilar, providing another opportunity to enter a multibillion-dollar market. Actemra sales rose 32% last year and accounted for more than 6% of total sales in Roche's pharmaceutical division.
Currently, there are no Actemra biosimilars approved in the U.S.
Per deal terms, Biogen will acquire exclusive rights to BAT1806 in all countries but China. The company will have rights to the drug in Hong Kong, Macau and Taiwan.
Bio-Thera, meanwhile, is eligible for the upfront payment as well as milestone payments should BAT1806 achieve certain commercial goals. Biogen has also agreed to pay its partner tiered royalties.
The companies expect their deal to close before the beginning of July.