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IP trouble defers launch of Novo’s long-acting hemophilia therapy

Long-acting hemophilia therapy Esperoct has won FDA approval, but US patients will have to wait until next year to access it, in a blow for maker Novo Nordisk which is looking to stave off Roche’s recently launched rival therapy Hemlibra.

Hemophilia A, or classic hemophilia, is a genetic disorder caused by a missing or defective clotting protein called factor VIII that causes prolonged bleeding or internal bleeding. To manage symptoms, an intravenous injection comprising the clotting factor is usually administered.

Esperoct — which is designed for use every four days — was granted approval on Tuesday, but the launch (cue drumroll) is planned for next year due to some pesky IP issues. In a statement the Danish drugmaker said it will not be able to launch Esperoct before 2020 due to third-party IP agreements. A company spokesperson declined to provide more detail.

Esperoct’s price will be announced in connection with the launch, the spokesperson added.

Novo $NVO already sells a hemophilia therapy called Novoeight, which is typically used every other day or three times a week for prophylaxis. Approved in October 2013 by the FDA, patent issues pushed the drug’s launch until 2015.

Meanwhile, Roche’s Hemlibra — approved in 2017 and launched in 2018 — is pegged to attain blockbuster status. It can be self-administered subcutaneously, versus traditional intravenous infusions, and has multiple dosing options: weekly, fortnightly and monthly.

Shire (now a part of Takeda) is another significant player in hemophilia. The company made its foray into the hemophilia market with its $32 billion buyout of Baxalta in 2016.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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