California-based SciClone Pharmaceuticals' shares shot up as much as 14 percent earlier this week after preliminary study data showed the adjuvant Zadaxin increased immune response when used in combination with Novartis' H1N1 vaccine Focetria.
The ongoing study randomized hemodialysis patients to receive either two 3.2- or 6.4-mg injections of Zadaxin, or the vaccine alone. Eighty-nine percent and 88 percent of those receiving the low dose and high dose achieved seroconversion, respectively. However, only 56 percent of those in the vaccine-only group achieved seroconversion, according to a SciClone statement. The company is partnering with Sigma-Tau S.p.A. for the Zadaxin H1N1 study. The product already is used in some countries to treat HVB and HVC, and SciClone is testing the product in Stage IV melanoma, an indication for which it is seeking FDA approval, according to the company's website.
"We hope that this pilot study will be completed successfully and that we can proceed thereafter with applications for regulatory approval [for] Zadaxin... using a one or two shot dosing regime," Friedhelm Blobel, SciClone's president and CEO, says in a statement.
BWS Financial analyst Hamed Khorsand says the top-line efficacy results are impressive. But, it's tough to put a value on the aspects of Zadaxin because it's not the vaccine itself, according to a Reuters article. Khorsand expects the company to market the adjuvant in countries like China, but said "it's more of a 2011 kind of story."
- check out SciClone's statement
- read Reuters' coverage