Extra Pale, still out there?
UPDATE 1-Nabi says to resume developing staph vaccines
Tue Mar 21, 2006 6:04 PM ET
LOS ANGELES, March 21 (Reuters) - Nabi Biopharmaceuticals (NABI.O: Quote, Profile, Research) said on Tuesday it will resume developing vaccines against staphylococcus bacteria after an outside panel agreed that quality problems with a vaccine lot skewed results from a late-stage trial of one vaccine.
The company's shares, which closed at $4.80 on Nasdaq, were 21 percent higher, or $1.03, at $5.83 in after-hours trading.
Nabi said it plans to collaborate with a partner to develop and commercialize the staph vaccine candidates for use in large at-risk populations.
Nabi had announced in November that one of the vaccines, StaphVAX, had failed a Phase III trial and it would also halt work on a second vaccine, called Altastaph.
But now, Nabi said, it has defined subtle elements of the manufacturing process that caused differences in the test results and are important for producing high-quality antibodies, and it was resuming development of both vaccines.
Nabi said its decision was based on an outside advisory panel's review of the company's assessment of StaphVAX confirmatory Phase III clinical study results, which found that the quality of antibodies generated by the vaccine used in that trial was inferior to antibodies generated by vaccine lots used in previous and later clinical studies.
In addition, medical factors associated with kidney disease in dialysis patients impaired their immune response to the vaccine, Nabi said.
"When considered in combination with an increase in the virulence of the bacteria, these factors also contributed to the observed lack of protection in this study population," the company said in a statement.
The company said it is seeking to secure additional intellectual property rights as a result of the findings. |
