Enrollment has been completed for Keryx's/NASDAQ: KERX Sulonex as a treatment for diabetic neuropathy. With 6 months of treatment, the study should be completed in December 2007 and top-line data is likely to be announced in mid-January or early-February 2008 with the expectation of an NDA filing a few months later. If so, approval potentially could occur in late 2008 at the earliest but is more likely to occur in 2009.
Then there is perifosine. Keryx continues to examine the drug in renal cell carcinoma, sarcomas and multiple myeloma. Keryx plans to have a clinical strategy established for this compound around the end of 2007 and begin pivotal trials in one or more of these indications. Meanwhile, preliminary data presented at ASCO in June 2007 was very encouraging but in an early stage. And in early November, Keryx reported preliminary data at the 13th annual meeting of Connective Tissue Oncology Society demonstrating the tolerability and clinical activity of perifosine in patients with refractory, rare sarcomas. Also, at the 25th Chemotherapy Foundation Symposium, Keryx provided an update on Phase I (safety and efficacy) and II (clinical activity) data that was positive for perifosine in patients with advanced renal cell carcinoma.
In late September, Keryx announced an impressive licensing deal for Zerenex, with Japan Tobacco covering Japanese rights to the product as a treatment for end stage renal disease. The deal included $20 million in an up-front payment and near-term milestones, and $80 million in additional milestones. Keryx will also receive tiered royalties on net sales in Japan.
Due to the progress being made with the ongoing Sulonex’ pivotal program, the Phase II perifosine programs and with Zerenex, which potentially establishes a renal franchise for Keryx, its share price should be able to reach $20.
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