|Daniel O'Day, COO of Roche's pharmaceuticals division|
With biosimilar competition beginning to appear on the market horizon, Roche believes it has a shot at pushing its late-stage pipeline drugs to the market in time to stay ahead of the threat to its bottom line. And its PD-L1 cancer drug star atezolizumab is once again being pushed onto center stage as Roche appears determined to place most of its bets on its in-house pipeline.
Roche ($RHHBY) pharma chief Daniel O'Day put the spotlight squarely on "atezo" this morning as he outlined plans to push for its first approval in 2016.
"We've got 10 new Phase III starts with atezolizumab," O'Day told reporters and analysts today. "Where we see a strong signal, we're going deep and strong."
|Roche CEO Severin Schwan|
They'll need to. Roche CEO Severin Schwan told CNBC today that many of the assets up for grabs come with price tags they consider way too high.
"Valuations are very high, and we have to consider whether we can generate value for our shareholders," Schwan said. "It's not only about science, it's not only about strategic fit, it's about price, and many of the assets we look at we are not acquiring exactly for this reason."
Roche is late to the immuno-oncology market. An aggressive Merck ($MRK) has been jockeying with market leader Bristol-Myers Squibb ($BMY) in the drive on landmark approvals, riding their drug Keytruda as Bristol-Myers pushes Opdivo toward more regulatory successes. Those are PD-1 drugs, though, giving Roche a shot at first-mover status on the PD-L1 side of IO, which is dismantling cancer cells' cloak of invisibility and unleashing an immune system assault.
The rest of Roche's hopes appear focused on the multiple sclerosis drug ocrelizumab and the hemophilia drug ACE910, lebrikizumab--another 2016 filing hopeful for asthma--with two late-stage programs underway in Alzheimer's for crenezumab and gantenerumab.
Just weeks ago Roche heralded the success of its late-stage studies for ocrelizumab, putting the company on track to regulatory filings in early 2016. But there as well the company faces some stiff competition from rival oral therapies.
Alzheimer's is no sure bet, either.
Roche was expected to push ahead with its Phase III of crenezumab, which is partnered with Switzerland's AC Immune. Mixed data from their latest study of the amyloid beta drug compares well against the two-time losers that were put back into the clinic at other pharma companies. But gantenerumab is more of a head scratcher for analysts. The drug was a complete flop in Phase III, but Roche now believes that it would have seen more positive data--reflected in rival drugs like Biogen's ($BIIB) aducanumab--if investigators had upped the dosage.
But while Roche says that it's continuing to pursue the program, it hasn't said exactly what its plans are. There's no decision on mounting a new trial, with O'Day noting that Roche will "continue to make decisions on that program based on the data to come." And with analysts growing increasingly frustrated with Roche's near-term prospects, dawdling on gantenerumab won't help their case.
- read the CNBC story