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when it comes to passing muster with FDA inspectors. So Biogen’s secret was to find a way to attach the polymer in a consistent place on an amino acid at the end of the protein, Pickett says.
Biogen will set out to prove this idea in a clinical trial of 1,260 patients called Advance. It will compare two different doses of pegylated interferon—one given every other week, the other given once a month—versus patients on a placebo. The goal will be to reduce the relapse rate from MS for a full year. If this trial is able to recruit patients on schedule, it could produce results in 2011, Pickett says. Regulators at the FDA and European Union have agreed that success in the trial could lead to marketing approval, he says.
Biogen presented a few more details on this program Wednesday at its R&D day with financial analysts. The company has made this drug into a pre-filled syringe, that can be injected just under the skin, instead of deeper into the muscle, said Al Sandrock, Biogen’s senior vice president for neurology R&D. This way, it ought to be especially convenient for patients, and more likely they will stick with the required dosing schedule, Sandrock said.
As confident as Biogen sounds about this program, Sandrock reminded the audience how humbling this business can be. Even though Avonex has been on the market since 1996, scientists still don’t know some very basic things about it. “To be honest, we don’t know exactly how interferon works,” said Sandrock, who’s no dummy (he’s an assistant professor of neurology at Harvard Medical School.)
Scientists think the interferons may interfere with the trafficking of immune system cells that go haywire and start attacking the myelin coating around nerve cells in people with MS, Sandrock says. It’s also possible the interferon may be decreasing the effect of inflammatory proteins called cytokines, or boosting the activity of anti-inflammatory cytokines, Sandrock said.
Whichever way the drug really works, it’s generally a pretty safe bet to take an existing biotech drug and add pegylation to it. The company has 20 programs in Phase II or Phase III clinical trials, and Pickett knows that quite a few will go bust. Just a couple weeks ago, he was stumped by the failure of rituximab (Rituxan) in a pivotal trial of patients with lupus of the kidneys, despite loads of encouraging evidence from earlier studies.
So while he reminded me he’s bullish about pegylated interferon beta’s prospects, there’s no such thing as a sure bet in biotech. “I really hope our late-stage programs have a batting average of 70 percent,” Pickett says.