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JAMES C. MULLEN BIOGEN IDEC INC. CHIEF EXECUTIVE | ON THE HOT SEAT

Drug maker sees room for change in federal approach

James C. Mullen,Biogen Idec Inc.Chief executive

For Biogen Idec Inc., the return of the multiple sclerosis drug Tysabri to the market and continued sales growth for its cash cow, Avonex, were the highlights of 2006. Chief executive James C. Mullen recently spoke with Globe reporter Jeffrey Krasner about the company's progress and the challenges posed by the 2006 election.

Q How is Biogen Idec doing?

A In spite of the trials and tribulations of 2005 (when sales of Tysabri were suspended), the actual financial results were fine. In 2006, we continue to accelerate on that. Tysabri has made its way back to the market. People are still obsessed with how many prescriptions we have today. That will take care of itself over time. It's on the market in the US and Europe.

Q What percentage of revenue and profits come from Avonex?

A It's probably in the range of a little over 50 percent on both revenues and profits. Rituxan and Avonex generate the bulk of revenues and profits.

Q Are prescriptions of Tysabri, which Biogen markets with Elan Corp., robust enough to become a significant financial contributor?

A Tysabri will become a significant contributor. It won't be this year because it's just getting going. Unless it hits a major pothole like it hit before, it will probably eclipse Avonex over time. People have generally lost sight of Tysabri outside of multiple sclerosis.

We've got indications we're looking at Crohn's disease, oncology indications, rheumatoid arthritis. We're resetting where we're going to go based on what we've learned over the last year. People have lost sight of that, and there's nothing in anybody's models about that. Those will be all positive surprises.

Q How do the acquisitions of the past year help Biogen Idec?

A You don't see all the little deals that are structured underneath the large business development deals. We've got our own internal discovery efforts, we've got discovery efforts in combination with academic labs, National Institutes of Health labs, and we also invest directly in companies as well as venture funds. We invest directly or through funds in 20 companies.

None of those are going to move the shareholder needle this year, but that's all part of building the pipeline over the next 10 years.

Q How will the new Congress affect Biogen Idec?

A The steps to open up Medicare Part D, and change the pricing of drugs -- that feels to the industry like it's moving to some version of price control. We already negotiate with Medicare, Medicaid, the Veterans Administration. Medicare part D is just another surrogate for that.

We've got a big disconnect between the ultimate consumer and who's making the decisions, which is generally an intermediary. You need more transparency down to the consumer level. Until you get that, you're going to have all these intermediaries playing "whose pocket can we steal it from."

Q How responsive is the Massachusetts congressional delegation on healthcare issues?

A Ted Kennedy is the guy on healthcare side, and he's always made himself quite available to listen. Does he always agree? No.

Q What are you looking for from the Deval Patrick administration?

A We need to connect better as a business community with the new administration than we've been able to do. There was an innovation summit in Rhode Island recently. There were representatives from China, South Korea, Japan, Belgium, and Canada in the room, but nobody from the state of Massachusetts. Why is that?

Q What are your current issues with the Food and Drug Administration?

A It would be nice if we ever had a commissioner. In the last six years, we've only had a confirmed commissioner at the FDA for 18 months. We've made a complete political football out of this. You'd have to get the public service bug real bad to actually take this job.

Q Do you support the creation of a new group at the FDA to specifically look at post-marketing studies and analyze the incidence of adverse events?

A We don't need a new group. They definitely need some more systems, and we need some harmonization with the Japanese and European regulators. It's a very poor idea to propose a safety agency. It loses context. Safety can only be reviewed in the context of the medical condition you're treating.

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