As Drug Maker Quickly Positions Replacement For Rituxan, Questions Of Business Ethics Arise

Swiss pharmaceutical giant Roche announced on Wednesday that a late-stage study involving patients with indolent non-Hodgkin's lymphoma demonstrated a benefit when treated with a drug called Gazyva.

Roche is saying Gazyva – marketed as Gazyvaro in the European Union and Switzerland – extends a surrogate marker of progression-free survival, meaning that patients appear to live longer without their disease getting worse when treated with Gazyva and Bendamustine followed by Gazyva monotherapy.

This doesn't mean these patients in fact lived any longer than other patients, nor does it mean their quality of life differed or they had fewer symptoms. It simply means that their disease did not progress.

Progression-free survival (PFS) is a dodgy clinical trial end point since it doesn't confer any benefit on the patient and means next to nothing clinically.

Roche looking to make Gazyva a quick replacement

Roche is positioning Gazyva as a replacement for Rituxan, which earns the company billions of dollars every year but is facing the loss of patent protection.

Roche would ideally like to swap as many patients as possible to Gazyva before Rituxan faces competition from cheaper copies when its patent protection expires.

What did patients get in the other arm of the study, you wonder? They got Bendamustine alone, which is fine for patients with indolent B-cell lymphomas but it isn't used in the same way that Gazyva is, meaning that this study was designed for Bendamustine to fail.

According to Reuters, analysts at Deutsche Bank said this:

"[This study] suggests Gazyva works in a Rituxan refractory (relapsed) population that offers sales potential in the $500 million to $1 billion range."

Right now, Roche has prepared Gazyva to triumph over Rituxan in a pair of head-to-head late-stage trials. Naturally the data will miraculously show that Gazyva outperforms Rituxan, even though Rituxan is one of the great cancer drug breakthroughs of all time.

A switch like this is going on right now among patients with chronic myeloid leukemia who are or were taking Gleevec. As this "wonder drug" loses its patent, Novartis has been busy building the beast that will cannibalize Gleevec and Tasigna.

To so shamelessly develop a drug that will not be any better than what you have already contributed shows Roche at its worst: as a bloated and unimaginative example of a big pharmaceutical company aiming for the low-hanging fruit.