One More Weapon in the Non-Hodgkins Lymphoma War (BIIB, RHHBY)

September 17, 2009 · Filed Under Cancer, fda 

There was some key news out yesterday from Roche’s (RHHBY) Genentech and Biogen Idec (NASDAQ: BIIB) that is good news in the war against follicular lymphoma.  It also snuck under the radar.  The Phase III PRIMA study showed that patients who continued receiving Rituxan alone after responding to Rituxan and chemotherapy lived longer without their disease worsening than those who did not continue to receive Rituxan.

Since PRIMA met its endpoint during a pre-planned interim analysis, the study was stopped early on the recommendation of an independent data and safety monitoring board.  Also noted was that the safety profile of Rituxan observed in the study was consistent with that previously reported.

Follicular lymphoma is a common and slow developing form of non-Hodgkin’s lymphoma that is currently uncurable and accounts for about one in four of all cases.  As far as investors are concerned, this is effectively a blockbuster treatment potential alone. We wanted to look back to define just how large this drug is already.  Genentech listed its 2008 Rituxan U.S. sales as follows: Q1 $605M; Q2 $651M; Q3 $655M; Q4 $677M; All 2008 as $2.587 billion.  Biogen listed its portion of Rituxan sales was roughly $1.1 billion for 2008.

Genentech, Roche and Biogen now plan to discuss which next steps to take with the FDA and E.U. authorities for a new indication for Rituxan.

This is an interesting study because this falls in line with the ‘maintenance program’ treatment that so many cancer patients need after they have completed their round of chemotherapy or other treatments for cancer.  Many drugs out there can only be taken in so many doses within a certain time frame.

Rituxan is co-marketed in the United States by Genentech, which was recently bought out by Roche, and co-marketed by Biogen.

JON C. OGG
SEPTEMBER 17, 2009

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