Space-rocket Spectrum Pharma's shares may sputter (SPPI)
Specrtum Pharmaceuticals (Nasdaq: SPPI) are lower in very early premarket trading after the FDA asked for data from the company’s already completed Phase III study to support the company’s proposed labeling of its product Zevalin as a first-line consolidation therapy for treating non-Hodgkins lymphoma.
No additional clinical studies have been requested. The additional data requested do not involve new data analyses.
Still, the request appears to be a hiccup for shareholders who may have been expecting a fairly straightforward process for getting a supplemental biologics license application this month for Zevalin from the FDA in treating one of the five most common cancers in the U.S. Timing for approval was generally expected shortly after the FDA set a target date of July 2, 2009 for its review.
Spectrum shares have been one of the most spectacular momentum names in biotech, rising to more than $7 in recent weeks, up from less than $1 in October, 2008. The stock was last quoted at $6.17.
It is not clear what objections the FDA may have regarding the proposed labeling of the product, and how the labeling may affect potential sales. Under the proposed labeling, it had been assumed that the license would have increased by roughly 18,000 the target market for Zevalin, which costs about $25,000 per treatment.
The company plans to formally respond to the FDA’s requests by this Wednesday, July 8, 2009.
The company’s first-line indolent trial, or so-called FIT trial of Zevalin in December 2007 demonstrated both the efficacy and safety of Zevalin in a multinational study involving more than 400 patients. Zevalin significantly improved median survival to 37 months from 13 months.
Anticipating an approval, Spectrum has been working to set up the sales infrastructure for Zevalin ahead of the expected license approval. – Mike Tarsala
