Bristol-Myers ($BMY) is pushing its closely watched immuno-oncology drug nivolumab to the FDA. But the pace is raising questions with some analysts, and that's pressing down on its stock price.
In its Q1 earnings report today the big biotech said that it plans to begin a rolling submission of nivolumab in the next few days with plans to complete the NDA by the end of the year. The decision was made after investigators met with the FDA on the results of its 063 study, a Phase II trial for third-line squamous cell non-small cell lung cancer.
Pressed by analysts to provide additional insight on the timing in a call today, the biotech was stingy with details. And as we've seen in the past, the absence of information on this program raises discomforting speculation, which can trigger a bad case of nerves.
Bristol's timeline looked like a delay to Sanford Bernstein's influential Tim Anderson, reported Bloomberg, The amount of time Bristol gave itself to complete the submission suggests that the FDA may be looking for more clarity on the drug, according to a report from Reuters. But this is one drug that may make it to the market shortly after the submission is complete.
"Bear in mind that if a rolling filing is completed in the 4Q, it's possible the FDA turns it around very quickly which would reduce the perceived lung approval delay from ~6 months to perhaps ~3-4 months which, over the longer term, hardly seems material," noted ISI's Mark Schoenebaum in a message to investors today.
Nivolumab is one of two PD-1 blockers that will soon be under regulatory review. Merck ($MRK) is wrapping up its own rolling submission of MK-3475 in the next few months. By blocking PD-1, nivolumab allows a T cell attack on cancer, gearing up the immune system to fight the disease. And both companies have been racing ahead after seeing some remarkable results from early studies. Roche ($RHHBY), meanwhile, has been advancing a PD-L1 drug--RG7446--while AstraZeneca ($AZN) is gaining attention for its own work in the field.
Back in March a research team that includes investigators from Dana-Farber and Johns Hopkins tallied up some impressive long-term survival stats on a group of melanoma patients taking nivolumab. According to the research, which was published in the Journal of Clinical Oncology, 62% of the patients taking the immunotherapy were alive after one year and 43% were still alive after two years on the drug. And they say that the durable response was also reflected in patients who had stopped taking the drug.
If the drugs pan out as expected, analysts expect the early graduates of this class to rack up some blockbuster numbers. Some peak sales estimates for the group top out at around $12.5 billion, with Bristol-Myers positioned to earn some of the biggest returns. A success here would build on a successful R&D track record for BMS, while Merck is trying to earn back its rep in R&D after a long dry spell on the approval front.
- here's the release from BMS
Special Report: Nivolumab, Bristol-Myers Squibb - 10 top drugs in biopharma's late-stage pipeline