Gilead's $1.7B hep D drug just ran into a roadblock at the FDA

27 Oct 2022
endpts.com
Vaccine
Gilead was following German biotech MYR GmbH and its hepatitis delta virus candidate for “quite some time” before finally pulling the trigger on a $1.7 billion buyout deal. With an EU authorization already under its belt, an OK in the US was all but a done deal — or so it thought. The company reported an FDA rejection during its Q3 earnings call on Thursday, leaving CMO Merdad Parsey “disappointed” and spoiling the $360 million milestone that MYR would have reaped on an FDA approval. So what happened? Regulators issued bulevirtide — or Hepcludex, as it’s marketed in Europe — a CRL over concerns about the “manufacture and delivery” of the drug, Parsey revealed on the Q3 call. “Note that no new safety or efficacy clinical trials were requested by the FDA,” he said. “We plan to resubmit as quickly as possible and will work with the agency on the path forward.” That leaves no available treatments for HDV in the US, the most severe form of viral hepatitis. Gilead filed its application with the FDA in Q4 2021, then bolstered its case back in June with 48-week data that suggested those who received 2 mg or 10 mg daily doses of bulevirtide achieved “a significantly greater combined virological and biochemical response (45% and 48%, respectively) when compared to participants who had not received antiviral treatment at this stage of the study (2%). “We remain confident in bulevirtide and the potential benefits that it can bring to people living with HDV, and we’ll share an update on the US regulatory pathway when we can,” Parsey said. Gilead cushioned the CRL news by raising its full-year sales guidance, the high end of which is now $26.6 billion, up from $25 billion. That’s partially due to higher-than-expected Veklury sales, which still came in 52% lower than the same quarter last year at $925 million due to lower Covid-19 hospitalizations, as well as the uptake of vaccines and other treatments. A decline was expected, Gilead noted, and the consensus for last quarter had been just $304 million, Mizuho analyst Salim Syed said in a note to investors. Chief commercial officer Johanna Mercier said Veklury is used in 60% of hospitalized patients being treated for Covid. Gilead says the drug demonstrated activity against Omicron subvariants, including the currently dominant BA.4 and BA.5 strains. And despite the plummet in sales last quarter, the company is upping the high end of Veklury’s full-year guidance by $0.3 billion. Gilead also reported Yescarta sales were up a whopping 81% last quarter due to demand in relapsed or refractory large B-cell lymphoma, and Trodelvy sales were up 78%. Gilead released the hard data from a group of patients with HR+/HER2- metastatic breast cancerHR+/HER2- metastatic breast cancer at ESMO this year, showing that patients who received Trodelvy after prior endocrine therapy, CDK4/6 inhibitorsCDK4/6 inhibitors and two to four lines of chemo survived a median of 14.4 months, as opposed to just 11.2 months for those who received physician’s choice chemotherapy. Mercier expects a decision from the FDA in February and said that the team has already begun preparing for a potential launch. Gilead also revealed in its presentation slides that a subcutaneous version of Biktarvy has been removed from the pipeline. Parsey noted that the reason was tolerability issues associated with injection site reactions, and that “it’s not about the molecule itself.” “I want to make sure that it’s clear that bictegravir as an oral agent continues to be a huge part of where we want to go,” he said. Biktarvy sales saw a 22% boost year-over-year last quarter, bringing total HIV sales to $4.5 billion.
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