Momenta Pharmaceuticals Inc. said Thursday it halted a clinical trial of a pancreatic cancer drug after an independent panel concluded the experimental therapy wasn’t effective enough to justify continuing the study.
The move was a setback for Momenta, a 16-year-old Cambridge company that markets two generic medicines and is developing generic biotech drugs and its own therapies. The pancreatic cancer drug, called necuparanib, was its lead novel drug candidate, targeting a disease that has been stubbornly resistant to treatment.
“Emotionally, this is difficult one for the company,” Momenta chief executive Craig A. Wheeler said. “Going after an unmet need like pancreatic cancer [therapy], it meant a lot to us.”
Momenta’s shares fell around 5 percent, to $11.16.
Its clinical trial of necuparanib enrolled 138 patients with advanced metastatic pancreatic cancer, and Momenta planned to continue enrollment into the fall. But analyzing interim data, the independent monitoring board concluded the therapy didn’t appear to be slowing the progression of the deadly disease.
“The conclusion was that if we were to continue the trial to the end, it would have been unlikely to demonstrate a meaningful benefit,” said Momenta chief medical officer Jim Roach.
Momenta executives decided Wednesday night to end the trial. As they complete their own review of the data over the next few weeks, it will be up to clinical investigators at the sites of the trials to decide whether patients should continue on necuparanib, administered in combination with two other drugs.
Despite the disappointment, Wheeler said, he remained encouraged by Momenta’s business as a whole. He said the company hopes early next year to launch a new formulation of its generic Copaxone for multiple sclerosis. Momenta’s first drug on the market, a generic version of the anti-blood-clotting drug Lovenox, was approved in 2010.
The company has about 270 employees in Cambridge and reported revenues of $89.7 million last year.
Wheeler said Momenta next year plans to file its first application for a biosimilar — a generic version of a biotech drug—for Humira, a brand-name drug that treats arthritis, Crohn’s disease, and ulcerative colitis.
“I’m really pleased with where we are as a business,” he said. “This [necuparanib setback] is a body blow, but not a fatal blow.”
By: Robert Weisman (Boston Globe).
Photo: LinkedIn.
Review: Emerging Market Formulations & Research Unit, FLAGSHIP RECORDS.
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