Apr
19
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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 $30 million upfront for the Singapore-based biotech, Bianco committed the company to an unspecified set of milestones for the treatment. The treatment has already won orphan designation in the U.S. and Europe.
Aside from persistent questions about Cell Therapeutics' shaky financing, its new drug may also present a challenge in the clinic. Late last year, while reviewing positive Phase II results, S*Bio also outlined safety issues with the drug. The biotech reported that "17 patients (50%) discontinued, including 8 (24%) due to nausea, sepsis, increased bilirubin, subdural hematoma, allergic reaction, GI bleed, and 2 due to thrombocytopenia, five for disease progression and two for lack of response. Of the (adverse events) leading to discontinuation, only increased bilirubin, allergic reaction and intermittent nausea were considered possibly drug related. Ten patients required dose reduction for adverse events."
In early 2010, regulators and experts scathingly objected to Cell Therapeutics' development process and application for pixantrone, bluntly objecting to the data as inadequate for an approval. Cell Therapeutics found itself opposed by Richard Pazdur, the powerful oncology drug-review chief at the agency. And in January Cell Therapeutics sparked considerable confusion when it unexpectedly yanked its new application for the treatment after claiming it needed more time to prep for an advisory committee review.
- here's the press release
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Jan
30
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Two years after Cell Therapeutics ($CTIC) took one of the worst regulatory beatings of the decade at the time the FDA and its experts rejected the company's cancer drug pixantrone, the Seattle-based biotech has pulled a puzzling about-face. After reportedly boasting for months that it was on track to win an approval, the company pulled its new NDA for pixantrone, claiming it needed more time to prepare for an upcoming advisory committee review and that regulators were unwilling to simply reschedule for a later date.
"The NDA was withdrawn because, after communications with the U.S. Food and Drug Administration, CTI needed additional time to prepare for the review of the Pixuvri (pixantrone) NDA by the FDA's Oncologic Drugs Advisory Committee at its February 9, 2012 meeting," the company said in a statement. And while there was no explanation of just what the FDA had been communicating, it's reasonable to assume that there wasn't much hope to glean from the exchange.
In early 2010, regulators and experts scathingly objected to Cell Therapeutics' development process and application, bluntly objecting to the data as inadequate for an approval. And Cell Therapeutics found itself opposed by Richard Pazdur, the powerful oncology drug-review chief at the agency. Now it'll be forced to start the process over again, filing another NDA later in the year and asking for a new PDUFA deadline as the company regroups yet again.
According to Adam Feuerstein at TheStreet, a longtime critic of Cell Therapeutics CEO Jim Bianco, Wall Street sources had been saying that the company has been claiming an approaching regulatory win for pixantrone. Cell Therapeutics' shares dropped about 20% on the news, landing right around $1.05.
- read the release
- here's the story from TheStreet
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