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American College of Rheumatology meeting in Philadelphia, but it was essentially too late to be included among just a handful of such presentations, Schatzman says. The plan is to release this data through a peer-reviewed scientific publication, and probably to present the data at the other top rheumatology meeting, the European League Against Rheumatism (EULAR) being held in Rome in June.
Without giving away his scoop—which medical journals and meeting organizers frown upon—Schatzman said that the mid-stage rheumatoid arthritis data was “consistent” with some publicly released data on ALD518 as a treatment for extreme cancer-related fatigue and atrophy, known as cachexia. “It’s very effective in rheumatoid arthritis,” Schatzman says. “We did an outstanding job of suppressing inflammation, and the onset of activity was fast.”
Still, this doesn’t mean Alder and Bristol are ready to leap headlong into a pivotal clinical trial with several thousand patients and rush off to the FDA for approval to start selling the drug. If these companies are ever going to beat powerhouse treatments from Amgen and Abbott, it will have to be delivered like those drugs are, through a thin-needle injection patients can give themselves under the skin. Alder’s studies to date have been run in a one-hour long intravenous infusion, Schatzman says.
So Alder and Bristol’s next step will be to take an interim step in a mid-stage study that looks at a variety of doses, and that examines how often the injections must be given, with a self-injectable form of the drug. That trial will probably take six to nine months, and should set the stage for a pivotal trial that looks at both the IV and self-injectable forms of the therapy, Schatzman says.
Even before waiting for that data to roll in, Bristol has its eyes on using ALD518 against a variety of other autoimmune diseases, in which the immune system goes haywire and attacks healthy tissue. This ability to treat rheumatoid arthritis, psoriasis, psoriatic arthritis, and other related conditions is part of what has made Amgen and Pfizer’s etanercept (Enbrel) exceed more than $7 billion in annual worldwide sales. Schatzman didn’t say which diseases Alder and Bristol have on their list.
What’s important strategically for Alder is that it didn’t give away the entire store through this partnership. It retained the commercial rights to ALD518 as a treatment for cancer cachexia, the debilitating fatigue many cancer patients feel when they have excess inflammation, including elevated levels of IL-6 proteins, Schatzman says. Alder will use some of its new cash horde—the $85 million upfront payment from Bristol—to enhance its own development plan for that use.
Beyond that, Alder will have some money to do some hiring, and to build up a pipeline of drugs behind ALD518 that use the same yeast-based technology for manufacturing antibodies. Alder has about 45 employees now, and Schatzman wouldn’t say how many he plans to add. But he did say that Alder expects to advance a second drug candidate into clinical trials in 2010, and a third clinical pipeline candidate will emerge the following year.
For those new to the Alder story, the big idea is really in manufacturing antibody drugs in a new way. Alder does this through a technology that turns yeast cells into mini-factories for antibody drugs, instead of the standard Chinese hamster ovary cells. Since yeast is a cheap raw material, and the cells divide much faster than the hamster cells, drugs made this way could cut manufacturing costs to a fraction of what it takes to make big sellers like Enbrel or Genentech’s Avastin, Schatzman said in an Xconomy story in September 2008.
The yeast production techniques have a number of other advantages besides cost, as Schatzman went on to explain at the Invest Northwest conference last March. The Alder drug can last longer in the bloodstream than its competitors, so it can be injected less frequently, possibly just three or four times a year instead of once a month, he said. Alder can also give its treatment in one-tenth the dose because it’s more potent, which improves profit margins and could allow Alder to undercut competitors on price. Plus, since Alder’s drugs are made in those fast-dividing yeast cells, its production process is about four times … Next Page »
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