Viatris likely just lost one of its top product debuts for 2024, thanks to an FDA rejection of its partner Mapi Pharma’s application for a new version of Teva’s multiple sclerosis (MS) drug Copaxone.
Nevertheless, Viatris said the snub shouldn’t weigh on its revenue guidance—and it still expects to net upwards of $550 million from new drug launches this year.
The FDA has issued a Complete Response Letter (CRL) slapping down Mapi’s approval bid for glatiramer acetate depot 40mg—a long-acting version of Viatris’ approved glatiramer acetate injection that can be taken just once a month, rather than multiple times a week or even daily.
Viatris (by way of Mylan) originally scored a green light for two doses of its Copaxone generic back in Oct. 2017. The FDA approved a 40mg dose that needs to be administered three times a week, plus a 20mg version designed for daily use.
Now, the company is working with Israel’s Mapi Pharma to try to get the long-acting product over the regulatory finish line. Mapi is a clinical-stage drugmaker focused on developing extended-release versions of branded drugs.
Viatris and Mapi's long-acting glatiramer acetate depot 40, also known as GA Depot 40, isn't strictly a generic. Mapi claims to make "improved" versions of existing drugs.
In its release, Viatris didn’t say why the FDA had rejected the long-acting version of the drug. The company is reviewing the FDA’s complete response with its partner to “determine next steps.” Viatris and Mapi voiced continued confidence in the potential viability of their once-a-month injection.
The CRL won’t trigger a change in Viatris’ 2024 financial guidance or its new product revenue range of $450 million to $550 million, the company explained in a press release. In a recent earnings presentation, Viatris listed the new glatiramer acetate injection among its key new product launches in North America for 2024. The company is also banking on rollouts of copycats of drugs like the asthma medication Symbicort and the Type 2 diabetes therapy Victoza.
Copaxone earned Teva around $320 million in North America last year, a 17% decline from the $387 million it generated in 2022. The drug hauled in another $231 million in Europe and $39 million in other international markets in 2023. For 2024, Teva expects Copaxone to bring home around $400 million globally.
Aside from Viatris’ approved Copaxone copycats, Sandoz markets its own MS generic dubbed Glatopa, which launched in the summer of 2015 and boasts the distinction of being the first Copaxone generic approved in the U.S.
While being eaten away by Sandoz and Mylan’s generics, Copaxone was still a key sales contributor for Teva back when the long-acting, 40mg version of the drug was denied new patent protections by the U.S. Court of Appeals in 2018. At the time, the court ruled that the once-a-month version of the branded drug wasn’t enough of an advance to warrant a slate of new intellectual property protections.
As of late, Teva—now undergoing a revamp under new CEO Richard Francis—has largely been able to recover from its Copaxone revenue woes, thanks in large part to its steady roster of generics, plus newer brand-name medications like the Huntington’s disease drug Austedo and migraine med Ajovy. The new drugs generated $1.2 billion and $435 million last year respectively.