Positive news for Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA), after the US Food and Drug Administration (FDA) rejected Viatris and Israeli company Mapi Pharma’s 40 mg dose of the long-acting version of Copaxone, which requires just one injection every four weeks for multiple sclerosis patients. The application for approval of a new drug was submitted to the FDA by the companies following outstanding results in clinical trials.
Viatris is supposed to pay Mapi tens of millions of dollars from sales of the product.
Viatris today reported that it had received an important letter from the FDA regarding its request for approval for the drug and the companies are examining the content of the letter and will decide on their next steps. Viatris reported that the companies continue to believe in the potential of the product as an important treatment.
Viatris was founded from a merger between the generic companies of Mylan and Pfizer. In the past Mylan has launched a 20 mg generic version of Copaxone, which was approved and launched in 2017. Back then, Teva’s revenue from Copaxone was extremely significant and responsible for a major portion of the company’s profit. Today Teva is less dependent on Copaxone, and in 2023 its revenue from sales of the drug in North America totaled $320 million, a 17% decline from 2022. Copaxone’s global sales totaled $590 million and are expected to fall to $400 million in 2024.
Ness Ziona based Mapi Pharma was founded by Dr. Ehud Marom, a former leading member of the Copaxone development team at Teva. In addition to Mapi Pharma, Marom also founded Pharma 2B and a stem cell company in the development stages. Mapi is the most advanced company in the group, which has raised $150 million to date including more than $40 million from Mylan, before it became Viatris. Mapi is due to receive milestone payments from Viatris worth tens of millions of dollars as well as royalties from sales of the product if it reaches the market. Other investors in Mapi are venture capital fund aMoon and Chinese pharmaceutical company Jingxin Zhejiang.
In addition to long-acting generic Copaxone, Mapi is developing drugs for treatment of diabetes and schizophrenia. These drugs are fully owned by Mapi and are not part of the agreement with Viatris.
Teva, managed by CEO Richard Francis, is traded on the NYSE and TASE with a market cap of $14.9 billion, having risen 27% since the start of 2024.
Published by Globes, Israel business news – en.globes.co.il – on March 11, 2024.
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