A TG Therapeutics multiple sclerosis drug that’s new to the U.S. market will be commercialized in Europe and other regions under a partnership that pays the biotech $140 million up front.
According to deal terms announced Tuesday, Neuraxpharm’s payment gets it an exclusive license to commercialize the drug, Briumvi, outside of the U.S. for relapsing forms of MS. The license excludes Canada and Mexico, where New York-based TG retains rights, as well as certain regions in Asia that are already partnered.
TG is in line to receive an additional $12.5 million payment upon Neuraxpharm’s launch of Briumvi in the first European Union country. The company could receive up to $492.5 million more in milestone payments tied to Neuraxpharm’s commercialization progress with the drug in other countries. TG will also receive royalties from Neuraxpharm’s sales of the product.
In multiple sclerosis, the immune system attacks the central nervous system, damaging myelin, the protective layer covering nerves. The course of MS is classified into four types. Briumvi was developed for treating patients with relapsing forms of MS. The antibody drug is designed to target CD20, a target on the B cells that drive the disease. That approach is similar to two other drugs, Ocrevus from Roche and Kesimpta from Novartis. Both are blockbuster sellers.
Briumvi is administered as a one-hour infusion twice a year following a starting dose. TG launched the drug in January following its FDA approval last December. In its report of second quarter 2023 financial results on Tuesday, TG said Briumvi is gaining traction in the U.S. market. More than 1,200 prescriptions have been written for the drug, which has generated $24 million in revenue since its launch.
The European Commission approved Briumvi in June. Dusseldorf, Germany-based Neuraxpharm, a central nervous system disorder-focused company, said it plans to launch the drug in Europe within the next six months. The agreement gives TG some flexibility in the event it is acquired. If there is a change in control of TG, the company has an option to buy back all rights to Briumvi covered under the deal. This provision is in effect for two years.
“We are very excited to be partnering with Neuraxpharm to launch Briumvi in Europe,” TG CEO Michael Weiss said in a prepared statement. “Their neurology-focused approach, broad European platform and entrepreneurial organization really resonated with us as an attractive partner for Briumvi.”
Briumvi is TG’s only commercialized product but it’s not the company’s first one. TG had steered cancer drug Ukoniq to an accelerated FDA approval and a commercial launch in 2021 as a treatment for marginal zone lymphoma. That drug is a PI3K inhibitor, part of a class of medicines that have fallen under greater FDA scrutiny for safety risks. Last year, TG paused its cancer drug research and voluntarily withdrew Ukoniq from the market. Other companies have withdrawn their PI3K inhibitors from the market as well.
Photo by TG Therapeutics