Gilead hits unexpected regulatory snag with $1.7 billion hepatitis candidate – Endpoints News

Gilead pursued German biotech MYR GmbH and its hepatitis delta virus candidate for “quite a long 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 anything 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 destroying the $360 million milestone that MYR would have reaped on an FDA approval. So what happened?

Regulators issued bulevirtide — or Hepcludex, as it is marketed in Europe — a CRL over concerns about the “production and supply” of the drug, Parsey revealed on the Q3 call.

“Note that no new clinical studies of safety or efficacy were requested by the FDA,” he said. “We plan to resubmit as soon as possible and will work with the agency on the way forward.”

That leaves no available treatments for HDV in the United States, the most severe form of viral hepatitis. Gilead submitted its application to the FDA in the fourth quarter of 2021, then bolstered its case back in June with 48-week data suggesting that those receiving 2 mg or 10 mg daily doses of bulevirtide achieved “a significantly greater combined virologic and biochemical response (45 . and 48%, respectively) compared to participants who had not received antiviral treatment at this stage of the study (2%).

“We remain confident about bulevirtide and the potential benefits it could bring to people living with HDV, and we will share an update on the US regulatory path when we can,” Parsey said.

Gilead tempered 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 partly 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 the last quarter had been just $304 million, Mizuho analyst Salim Syed said in a note to investors.

Commercial manager Johanna Mercier said Veklury is used in 60% of hospital patients being treated for Covid. Gilead says the drug showed activity against Omicron subvariants, including the currently dominant BA.4 and BA.5 strains. And despite the plunge in sales last quarter, the company is raising the high end of Veklury’s full-year guidance by $0.3 billion.

Gilead also reported that Yescarta sales were up a whopping 81% last quarter due to demand for relapsed or refractory large B-cell lymphoma, and Trodelvy sales were up 78%.

Gilead published the hard data from a group of patients with HR+/HER2 metastatic breast cancer at ESMO this year, showing that patients who received Trodelvy after prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy survived a median of 14 .4 months, as opposed to only 11.2 months for those who received chemotherapy from their doctor. Mercier expects a decision from the FDA in February and said 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 cause was tolerance issues associated with injection site reactions and that “it’s not about the molecule itself.”

“I want to make sure it’s clear that bictegravir as an oral agent continues to be a big part of where we want to go,” he said.

Biktarvy sales increased 22% year-over-year, bringing total HIV sales to $4.5 billion.