BOTHELL – Berlex Laboratories will kick off critical tests of Leukine, a potential treatment for Crohn’s disease that is central to the company’s plans for a drug manufacturing plant in Snohomish County.
Reinhard Franzen, Berlex’s president and chief executive officer, said that patient recruitment for two phase 3 trials on Leukine is beginning.
Phase 3 trials usually are the last ones done before asking the FDA for approval to market a drug for a particular illness.
“These phase 3 trials follow the positive results observed in the recently completed phase 2 trial and offer hope to the hundreds of thousands of patients who suffer from this debilitating disease,” Franzen said.
Up to 500,000 Americans suffer from Crohn’s, a chronic and sometimes debilitating disease of the gastrointestinal tract. No cure exists; patients usually rely on therapies that suppress the symptoms and the immune system response.
Conversely, Leukine works by enhancing the cells of the immune system. Since it was first approved by the U.S. Food and Drug Administration in 1991, the drug has helped cancer patients who’ve undergone chemotherapy, bone marrow or stem-cell transplants.
One of the phase 3 studies, to take place in this country, will look at patients who’ve already shown a response to Leukine in earlier treatments. A second study, to take place in approximately 10 other nations, will study patients’ initial response to the drug.
Overall, more than 1,000 patients will be involved in the clinical trials program.
New Jersey-based Berlex is the U.S. division of Germany’s Schering AG. The company bought the Leukine program in 2002 when Seattle’s Immunex, which developed the drug, was acquired by Amgen Corp. Since then, Berlex has used its Seattle and Bothell offices to produce and market Leukine.
On Monday, Berlex announced plans to build a $60-million manufacturing plant in Lynnwood. Assuming it receives FDA approval for Crohn’s disease, Leukine would be the primary drug made at that new facility.
Reporter Eric Fetters: 425-339-3453 or email@example.com.