Biogen Idec, Roche, and Genentech now discussing new FDA filing.

Biogen Idec and partners Genentech and Roche are discussing the filing of a new indication for Rituxan (rituximab) on the back of Phase III data suggesting that patients with follicular lymphoma who continue to receive Rituxan maintenance treatment after responding to Rituxan and chemotherapy demonstrate significantly improved progression-free survival.

The international Phase III PRIMA trial enrolled 1,200 patients with previously untreated, advanced follicular lymphoma. It compared the efficacy of maintenance Rituxan therapy with observation alone among participants who responded to initial treatment with Rituxan plus either CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), CVP (cyclophosphamide, vincristine, prednisone), or FCM (fludarabine, cyclophosphamide, mitoxantrone).

The study met its primary endpoint during a preplanned interim analysis and was stopped early on the recommendation of its independent DSM board. “PRIMA showed that the extended use of Rituxan helped patients live even longer without their disease advancing,” explains Hal Barron M.D., evp, global development, and CMO at Genentech.
Rituxan is co-marketed in the U.S. by Biogen Idec and Genentech (which was bought by Roche for $46.8 billion in March this year). Roche itself markets the drug as MabThera in the rest of the world except Japan, where Rituxan is co-marketed by Chugai and Zenyaku Kogyo. Genentech is responsible for global manufacture of rituximab.

Rituxan was first approved in the U.S. as a single agent for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive B-cell non-Hodgkin’s lymphoma (NHL) as a single agent. Approval in the EU followed in 1998. Rituxan/MabThera has since been approved for the treatment of various forms of NHL in combination with other agents or after chemotherapy. In February 2006, the drug received FDA approval as combination therapy with methotrexate for treating the signs and symptoms of rheumatoid arthritis.

In May 2009, Biogen Idec and Genentech submitted two supplemental BLAs to FDA for Rituxan® plus standard chemotherapy as a treatment for patients with previously untreated or treated chronic lymphocytic leukemia (CLL). In 2008, BLAs were also submitted for the use of Rituxan in rheumatoid arthritis patients with an inadequate response to disease modifying antirheumatic therapies such as methotrexate. The drug is also undergoing Phase III studies against ANCA-associated vasculitis and lupus nephritis.

Biogen Idec reported revenues from its unconsolidated joint business arrangement for Rituxan of $1.1 billion in 2008, up 22% on 2007 figures. Rituxan-related revenues for the second quarter of 2009 were $276 million. U.S. net sales of Rituxan were $696 million in the second quarter of 2009, up 7% from the same period last year.

In its 2008 annual report Biogen Idec said Genentech recorded net sales of Rituxan to third-party U.S. customers of $2.58 billion in 2008 compared to $2.28 billion in 2007. Year-on-year increases were primarily due to higher unit sales with respect to the treatment of B-cell NHL and chronic lymphocytic leukemia (which remains an unapproved use of Rituxan), increased utilization for RA, and increases in the wholesale price of Rituxan. Biogen Idec reported revenues on sales of Rituxan outside the U.S. of $335.0 million in 2008 up from $250.8 million in 2007.

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