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.
