Difficult Obstacles for SciClone

With all the new technologies and discoveries, some drugmakers are undoubtedly going to be left in the dust. SciClone Pharmaceuticals (Nasdaq: SCLN  ) , with its lead drug Zadaxin, might be one such drugmaker.

On Thursday, SciClone announced that patients in a large phase 3 trial testing Zadaxin as a treatment for hepatitis C had completed dosing and that top-line clinical trial data would be announced in the fourth quarter.

Zadaxin has been tested for a range of indications including hepatitis B, melanoma, and hepatitis C. In February, SciClone released "blinded" data from one point in this phase 3 study showing that 31% of patients who had failed with other hepatitis C therapies had no detectable levels of the virus in their bloodstream at the end of 48 weeks in the trial.

The most commonly used hepatitis C standard-of-care drugs from Schering-Plough (NYSE: SGP  ) and Roche have cured up to 16% of patients in clinical testing. The catch with comparing the Zadaxin phase 3 data with this data is that the interim look at the Zadaxin trial contains both placebo and drug-treated patients -- that's what "blinded" means -- so the high response rate could theoretically be mostly placebo patients (or vice-versa, if you are a SciClone optimist). Also, this 31% response rate was at the end of treatment, so we'll need to wait for the full results to see where the long-term hepatitis C cure rates from this study will fall.

There are other potential issues for Zadaxin as well. But the bigger problem is that even in a perfect-case scenario -- it makes it onto the market at this point (despite significant hurdles) -- data from other compounds like Vertex Pharmaceuticals' (Nasdaq: VRTX  ) protease inhibitor telaprevir show them to be extremely effective in similar patients. So they may be ahead in the race to be the next hepatitis C drug onto the market. Being second on market and potentially inferior to the competition is not a winning recipe for commercial success with a drug.

Zadaxin is already approved for marketing in hepatitis B in China, which is undoubtedly the Wild West of pharmaceuticals, so who knows how Zadaxin will fare over there. But its potential as a treatment for hepatitis C in the U.S. and European Union looks rough at this point because of formidable competition.

Vertex Pharmaceuticals is a pick of our Rule Breakers newsletter. You can check out all our other recommendations and get access to our message boards and exclusive content with a 30-day free trial

Fool contributor Brian Lawler does not own shares of any company mentioned in this article. The Fool has an A+ disclosure policy.


Read/Post Comments (0) | Recommend This Article (4)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 674741, ~/Articles/ArticleHandler.aspx, 10/24/2014 4:31:33 AM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...


Advertisement