Pharmaceutical developer Pharmacyclics of Sunnyvale, CA, reported last week that it will experience a major delay in commercializing its Gadolite oral MRI contrast in the U.S. while it conducts additional stability tests on the product, which is designed
Pharmaceutical developer Pharmacyclics of Sunnyvale, CA, reported last week that it will experience a major delay in commercializing its Gadolite oral MRI contrast in the U.S. while it conducts additional stability tests on the product, which is designed for bowel delineation. The company said the studies are in response to meetings with Food and Drug Administration regulators.
Gadolite's commercialization is expected to be delayed by at least 18 months as Pharmacyclics conducts the additional studies. The company filed a new drug application for Gadolite in 1995 and received an approvable letter last December, although the FDA had additional questions about the filing that led to last week's decision to conduct further testing. Pharmacyclics has granted North American and European marketing rights for Gadolite to E-Z-EM of Westbury, NY.
In announcing the delay, Pharmacyclics president and CEO Dr. Richard Miller said that Gadolite is of a lesser priority than the company's cancer therapeutic products, Gd-Tex and Lu-Tex, which use Pharmacyclics' core texaphyrin technology. The company will, however, conduct the additional testing required to get Gadolite to market, he said.
Although Gadolite was granted marketing authorization in the U.K. last December, Pharmacyclics said that the status of a product launch in the U.K. and in other European countries was uncertain at this time.
The company's stock dropped two points, or 11%, on March 27, the day after the news was released, to close at $16.25 a share.
