When Tesaro released their data on the PARP drug niraparib a few days ago, the biotech was determined to make a case for a broad approval, without any need for a diagnostic test to distinguish patients with a particular biomarker for ovarian cancer.
Not everybody, of course, bought in to that argument, with some critics saying that the data were iffy at best. One key objection, though, came from Myriad Genetics, which developed the companion diagnostic test Tesaro used in Phase III and now wants to see put into use. And Tesaro wound up taking them to court in a failed attempt to shut it down.
Livid over a proposed release from Myriad which made an argument against Tesaro’s case, the biotech filed for an injunction in US District Court in New York on October 7, claiming that the Myriad PR included “false and misleading statements” about the data. It vehemently objected to remarks about the “overall toxicity profile” and quotes from some people who, they claimed, had never seen the data.
The judge, said Tesaro’s lawyers, should shut it down as a violation of their partnership agreement.
Judge Richard Sullivan, though, didn’t buy into that argument, noting that Tesaro was already planning to publish the data, Myriad wasn’t breaching their agreement in any case, and Tesaro wasn’t going to suffer irreparable harm.
Motion denied. PR issued.
A spokesperson for Tesaro, though, says they were also able to settle their disagreement over the release.
“We had a disagreement with Myriad about messaging in Myriad’s proposed ESMO press release, so we filed a complaint to stop it from being issued until we could mutually agree on the content,” she said in an email to Endpoints News. “Once the content was agreed upon, the news release was issued, and the suit was dropped.”
Tesaro is left in the same position it was earlier, working to prove that the efficacy data for niraparib qualifies for an approval for use in patients who are either HRD positive or HRD negative. But they’re also in a position of being opposed by a partner who has a solid business case for arguing that the drug should be reserved for patients who would be most likely to benefit. And there are a number of analysts who are siding with Myriad on this one.
The benefit narrows progressively by that last step, and the 3.1-month progression survival benefit for the HRD-negative group in the Phase III — 6.9 months versus 3.8 months — will get plenty of scrutiny by regulators.
The arguing now will move from the courts to the FDA, where the two collaborators can square off against each other once again. The outcome will dictate just how much each company stands to make from this drug.
The best place to read Endpoints News? In your inbox.
Full-text daily reports for those who discover, develop, and market drugs. Join 17,000+ biopharma pros who read Endpoints News by email every day.Free Subscription