Trimeris and its partner Roche gave up Wednesday on a needle-free device that they had hoped would lead to increase sales of the HIV drug Fuzeon.
Fuzeon must be injected twice a day by needle. The facts the drug had to be administered by needle and by needle have been considered impediments to Fuzeon sales.
After the markets closed Wednesday, Trimeris (Nasdaq: TRMS) and Fuzeonsaid they would withdraw attempts to win regulatory approval for the Biojector 200 device. It is made by Bioject Medical Technologies.
The decision was made based on a “comprehensive assessment” of clinical trials involving the Biojector and what the companies called a “significant delay” in winning Food and Drug Administration approval.
The Biojector device remains available for other uses.
“While the device has shown potential benefit for some patients, we don’t believe it’s the ideal alternative delivery option for all treatment-experienced patients,” said Michelle Zupancic, vice president for HIV at Roche.
“We continue to review other options for administering Fuzeon,” she added. “In addition, we continue to offer Nurse Connections, a free support program that provides patients in the U.S. with personalized, in-home instruction from a highly-trained nurse.”
The nurse program was launched by Trimeris and Roche in an attempt to help patients administer the drug and thus increase sales.
Fuzeon received FDA approval in 2003.
Earlier this year Trimeris and Roche ended their partnership in developing another HIV drug. Trimeries decided to proceed with the project by itself.
Injection site reactions, or ISRs, from administering Fuzeon have occurred in 98 percent of patients studied, and of those 4 percent stopped using the drug, the companies said.
Some patients using the Biojector reported nerve pain lasting up to six months.