UPDATED: Cell Therapeutics lands myelofibrosis drug with $30M upfront

Less than three months after announcing a puzzling about-face on its long and troubled quest for an approval of pixantrone, Cell Therapeutics ($CTIC) has stepped back up with a deal to buy S*BIO's pacritinib, an oral JAK2 inhibitor now in a late-stage study for myelofibrosis, for $15 million in cash and $15 million in stock.

"We believe a highly selective JAK2 inhibitor that also inhibits the JAK2 clonal mutation (JAK2V617F) offers a distinct biological and clinical advantage over marketed or development stage compounds which are non-selective inhibitors of the JAK pathway," said Cell Therapeutics CEO Jim Bianco. "We believe that the lack of suppression of red blood cell and platelet formation seen with pacritinib has the potential to satisfy a medical need not currently addressed with existing non-selective JAK1/JAK2 inhibitors."

In addition to the $30 million upfront for the Singapore-based biotech, Bianco committed the company to an unspecified set of milestones for the treatment. The treatment has already won orphan designation in the U.S. and Europe.

Aside from persistent questions about Cell Therapeutics' shaky financing, its new drug may also present a challenge in the clinic. Late last year, while reviewing positive Phase II results, S*Bio also outlined safety issues with the drug. The biotech reported that "17 patients (50%) discontinued, including 8 (24%) due to nausea, sepsis, increased bilirubin, subdural hematoma, allergic reaction, GI bleed, and 2 due to thrombocytopenia, five for disease progression and two for lack of response. Of the (adverse events) leading to discontinuation, only increased bilirubin, allergic reaction and intermittent nausea were considered possibly drug related. Ten patients required dose reduction for adverse events."  

In early 2010, regulators and experts scathingly objected to Cell Therapeutics' development process and application for pixantrone, bluntly objecting to the data as inadequate for an approval. Cell Therapeutics found itself opposed by Richard Pazdur, the powerful oncology drug-review chief at the agency. And in January Cell Therapeutics sparked considerable confusion when it unexpectedly yanked its new application for the treatment after claiming it needed more time to prep for an advisory committee review.

- here's the press release

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