Rituxan Joins List of Treatments

By KEITH J. WINSTEIN

April 15, 2008; Page B9

Rituxan, a top-selling drug from Genentech Inc. and Biogen Idec Inc., failed to slow the course of the most severe form of multiple sclerosis in a large study, the companies said.

The findings make Rituxan at least the sixth unsuccessful attempt to treat so-called primary-progressive MS, or PPMS. In the U.S., about 35,000 to 40,000 people have primary-progressive MS, out of roughly 350,000 to 400,000 total MS patients.

There are no approved treatments for PPMS. Genentech and Biogen had hoped that Rituxan -- which is approved for blood cancer and rheumatoid arthritis -- might become the first such treatment. The drug costs about $20,820 a year at the dosage used.

But in the companies' study, which followed 439 patients for 96 weeks, Rituxan didn't significantly slow the course of the disease, which gradually robs patients of motor function and causes tremors, tingling and fatigue. Secondary results -- like whether Rituxan improved MRI scans of patients' brains -- weren't released.

"We are disappointed in the outcome of the primary endpoint, but not surprised given the significant clinical challenges presented by PPMS," said Hal Barron, chief medical officer at Genentech, in a statement.

A successful result could have yielded $236 million to $359 million in annual sales to the two companies, according to a Bear Stearns estimate. Genentech gets 60% of the profits from Rituxan, with 40% going to Biogen. Total sales were $2.3 billion last year.

In a smaller study last year, Rituxan slowed down the less-severe form of MS, which has several approved drugs, including Biogen's Avonex and Tysabri. The companies have disagreed over what to do next. The matter is subject to an arbitration hearing this summer.

Rituxan is being studied in lupus, another immune-system disease with few treatment options. Genentech has said results may be released within a few weeks.

Write to Keith J. Winstein at keith.winstein@wsj.com

Drug Fails to Slow Nerve Damage

By BLOOMBERG NEWS

Published: April 15, 2008

Genentech and Biogen Idec’s cancer drug Rituxan failed to slow the disabling effects of the most difficult form of multiple sclerosis in a large clinical trial, the companies said Monday.

Rituxan failed to reach its main goal of slowing disability for people with primary progressive multiple sclerosis after almost two years of treatment, compared with a placebo, the companies said. If the trial had succeeded, it would have made Rituxan the first drug to work against the primary progressive form of multiple sclerosis.

Rituxan, a blood-cancer drug that is also approved for rheumatoid arthritis, generated $2.29 billion in sales in the United States in 2007. It is designed to work by killing inflammatory B cells, a different approach from approved multiple sclerosis drugs. About 400,000 people in the United States have multiple sclerosis, and one in 10 have the primary progressive form that gradually damages nerve fibers over time without remissions, according to the National MS Society.

”While the primary results are not what we had hoped, we continue to believe in the potential of B cell therapy for patients living with MS,” said Michael Panzara, Biogen’s vice president and chief medical officer of its neurology strategic business unit.

The companies plan to continue analyzing the results and submit them at a medical meeting, the companies said.

©2008 The New York Times Company ©2008 Christian MS Society. All right reserved.

Day-to-day challenges that come with having multiple sclerosis

Even when you're feeling fine and you're taking your medication to treat the underlying disease, there are day-to-day challenges that come with having multiple sclerosis. Learn more about what you can do to make every day the best it can be when you're living with multiple sclerosis.

Physical impact of multiple sclerosis From vision problems and tingling to poor balance and muscle weakness, there are ways to help manage your multiple sclerosis symptoms. This section provides helpful suggestions for managing the physical challenges of multiple sclerosis.

Emotional impact of multiple sclerosis While many people focus on the physical effects of multiple sclerosis, the emotional effects of the disease also deserve attention. You may not realize it, but that recent struggle with feeling blue or a tendency to be worried and anxious could very well be related to multiple sclerosis. Read more about how multiples sclerosis affects your emotions and how to find help. If you are feeling depressed, talk to your health care provider and learn more about getting help for depression

Financial impact of multiple sclerosis Worries about paying for MS treatment, concerns about insurance coverage and fears of losing income all play a role in your day-to-day challenge with multiple sclerosis. Here you'll find solid, practical advice on addressing the financial impact of multiple sclerosis.

©Biogen Idec. All rights reserved. ©2008 Christian MS Society. All rights reserved.

Announcing the new Congressional Multiple Sclerosis Caucus in the Senate

Take Action! Ask your Senator to join

• The National Multiple Sclerosis Society is pleased to announce the formation of the Congressional Multiple Sclerosis Caucus in the U.S. Senate. Senator Bryon Dorgan (ND) and Senator Orrin Hatch (UT) stepped forward as leaders and co-chairs of the new Senate MS Caucus. Click here to ask your Senator to join.

• Since the summer of 2007, the Congressional MS Caucus has been successful and effective in the House of Representatives. Currently, the House MS Caucus 76 members, and it continues to grow every day.

• The Congressional MS Caucus provides you, as an MS activist, with a set of champions in Congress to count on for leadership and support of MS issues. It will help bolster our advocacy efforts and give us an even more effective presence on Capitol Hill. The bi-partisan MS Caucus serves as a forum for members of Congress, their staff, related organizations, and individuals to discuss critical health care, disability, research, and other issues affecting people living with MS and other conditions. The MS Caucus raises awareness of the disease and helps us as we move closer to a world free of MS.

• The Society is thrilled with the enthusiasm, experience and leadership that both Senators Dorgan and Hatch bring to the MS Caucus. Now is the time to begin recruiting Senators to join the caucus and the MS movement. Click here to send an e-mail asking your Senators to join this important group.

Thank you for being an MS activist. Join the movement at www.nationalMSsociety.org/advocacy. To keep future MS activism messages out of your junk folder, add the following address to your contacts or safe sender list: MSActionNetwork@nmss.org