Biogen Idec To Show Off MS Drugs at Seattle Neurology Meeting

Biogen Idec is the world’s largest maker of multiple sclerosis drugs, and to keep it that way, the company needs to stay on the good side of neurologists. So when a large number of these docs get together for a scientific meeting, it’s time to start wooing.

This is at the top of Biogen’s agenda for the week ahead, as the American Academy of Neurology, the nation’s biggest group of doctors who treat multiple sclerosis, Alzheimer’s, Parkinson’s and other neurodegenerative diseases, is holding its annual meeting April 26 through May 1 in Seattle.

So before the wining and dining begins, I lined up an interview with Al Sandrock, Biogen’s senior vice president of neurology R&D, to talk about the key points the company will try to make to doctors. The company heads into this meeting with weakening demand, as natalizumab (Tysabri) produced $227 million in first-quarter sales, quite a bit short of Wall Street’s expectations of $246 million.

Biogen plans to keep natalizumab on center stage at the meeting. After all, it’s regarded by many as the most effective MS drug on the market, although it also carries the risk of subjecting patients to PML, a potentially fatal brain infection. On the other hand, Biogen also has plenty to say about another drug, an experimental version of its best-selling MS drug, interferon-beta (Avonex), that’s supposed to require fewer shots, and reduce flu-like side effects. The company also is preparing the first clinical trial of a drug designed to regenerate the myelin coating around nerves, which gets damaged by MS.

“Physicians and patients will be thrilled to see how large the MS pipeline is and how far we’ve come in the past 10 years,” Sandrock says.

Biogen’s head of drug safety, Carmen Bozic, is expected to give an overview of the risk/benefit balance for natalizumab. The drug’s prescribing information has stated that patients run a 1 in 1,000 risk of getting PML, ever since the drug was re-introduced to the market in July 2006. But Bozic’s presentation will point out that after almost three years on the market, there are now more than 40,000 patients taking the product, and there have been six confirmed cases of PML, Sandrock says. Five of the six patients diagnosed with PML since the drug returned to the market are still alive, said spokeswoman Shannon Altimari.

“When the drug was approved, it was said the risk of PML was 1 in 1,000, and it was fatal,” Sandrock says. “Now we can see the risk is likely less than 1 in 1,000, and PML is a more manageable than we thought. We think physicians will draw some comfort from that.”

The company will also show data from a Phase I trial of its pegylated interferon-beta1a. This is the drug that Biogen is counting on will extend the life of its franchise drug, Avonex, a treatment for newly-diagnosed MS patients, which generated more than $2.2 billion in sales last year.

This drug is supposed to last longer in the blood stream, and avoid the peaks and valleys of concentration in the blood that are common with standard interferons. The peaks are associated with flu-like symptoms that patients really dislike, and the valleys raise the possibility of MS flare-ups, Sandrock says. By making a drug that requires a shot once every two weeks or once a month, and by keeping a steady concentration in the blood, it ought to reduce the amount of flu-like symptoms patients encounter, allow them to take fewer shots, and maintain high levels of effectiveness, Sandrock says.

When Biogen started this trial, it thought the longer-lasting drug might worsen the flu-like symptoms because it went for a higher concentration in the blood, but that didn’t happen, Sandrock says. Based on this study, Biogen is so high on this drug that it has leapfrogged Phase II trials to go straight to the final stage, Phase III, of development needed to win FDA approval.

“We wanted to improve overall exposure and biological response while keeping the tolerability profile, and make sure it’s not worsening,” Sandrock says. “Patients will still get flu-like symptoms at the time of injection, but if you can reduce their injections to once or twice a month, that’s a significant improvement. Many of our competitors need to be taken more than once a week.”

Of course, Biogen won’t be the only company wooing the docs in Seattle. Competitors like Germany-based Merck KGaA and Switzerland-based Novartis will be presenting results of their drugs which attempt to establish a new paradigm with oral pills to control MS, instead of injections. Merck KGaA said in January its contender, cladribine, was successful at reducing MS flare-ups by 58 percent in a two-year study. The company said it planned to ship off the data to U.S. and European regulators by mid-2009 to ask for permission to start selling the drug, although it didn’t offer full data on the drug’s side effect profile in its press statement.

Biogen will look through the data to see whether cladribine is able to help reduce the disabling effects of MS, an important score to patients and physicians considering new treatment, Sandrock says. Since an intravenous version of cladribine works by disrupting DNA repair, it’s possible it could have side effect of damaging fast dividing cells in the bone marrow, Sandrock says.

If Biogen sees any worrisome side effects here, you can bet it will play up the safety of its interferon, which has been on the market for more than a decade with a well-understood safety profile that would carry over to the longer-lasting injectable. “If you can take an injection once a month, that’s almost as attractive as a daily pill for patients,” he says.

Novartis has also reported positive results for its oral MS drug, called FTY720, when compared directly to Biogen’s interferon-beta1a in a trial called Transforms. But Biogen is also going to look for side effects when data is presented at the meeting. It will need something to help it catch up, because Biogen’s own oral candidate, BG-12, isn’t likely to have first-mover advantage. “We’re about two years behind, I’d say,” Sandrock says.

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