With Gilead's expansion attempts in other therapy areas so far yielding limited success, the group is returning to the scene of its previous triumph: hepatitis. Having all but cured hep C, it is focusing on the much less tractable hep D, with a €1.15bn ($1.4bn) cash purchase of the private German company MYR. Gilead has ostensibly struck the deal for Hepcludex, which was given conditional approval in Europe in July for the treatment of chronic hep D. MYR had been planning to file in the US in the middle of 2021, and this event should be made easier by Gilead’s regulatory experience. Given the nature of hep D – the disease is characterised by co-infection with hep B and can have mortality rates of up to 50% – there is clearly a need for an effective treatment. If Gilead had been considering other hep D options, the field is relatively narrow, with only Replicor and Eiger looking like viable alternatives. As such, there must have been disappointment that Gilead passed Eiger over. Investors in the group, however, appeared optimistic that one of its big pharma partners might emulate Gilead: Eiger's shares rose 12% in morning trading.
|Slim pickings in the hepatitis D space|
|Hepcludex (bulevirtide)||Viral entry inhibitor||Gilead (ex MYR)||Conditionally approved in Europe; US filing planned for H2 2021; global ph 3 ongoing|
|Lonafarnib||Farnesyl transferase inhibitor||Eiger/Merck & Co||Ph 3 trial D-Livr due to complete enrolment in 2021; drug approved as Zokinvy in progeria|
|PEG-IFN-lambda||Pegylated Interferon lambda||Eiger/Bristol Myers Squibb||Ph 3 trial design agreed by regulators, yet to start|
|JNJ-3989||RNAi antiviral||J&J/Arrowhead||Ph 2 Reef-D trial ongoing|
|REP 2139-Mg||HBsAg inhibitor||Replicor||Ph 2 trial planned in Europe|
|Source: EvaluatePharma & clinicaltrials.gov.|