New chief takes helm at Promedior and steers a course for Boston

Just a couple of months after Promedior lined up its $21.5 million D round for fibrosis drug work, a new CEO has stepped up to the helm with plans to abandon Philadelphia and head for the bustling biotech hub in Boston. 

"I think it's just a time of change generally," newly named CEO Suzanne Bruhn tells FierceBiotech. "After the closing of the Series D, it's a nice, well financed company for the future, moving to later stage clinical trials. The decision was made to transition to a more product-focused company." 

Bruhn had been senior vice president, strategic planning and program management for Shire's Human Genetic Therapies division. She replaces Dominick Colangelo, who left the small biotech in the proverbial pursuit of "other opportunities."

Promedior has an early-stage study under way for idiopathic pulmonary fibrosis. And there's a mid-stage trial being planned for myelofibrosis, currently slated to get under way early next year. Bruhn says she hasn't yet decided where to move to in the Cambridge/Boston area.

Like a lot of early-stage biotechs, Promedior has always aimed at keeping the staff small, relying on outsourcing much of the work to vendors. The company's payroll has stayed consistently at about a dozen. Bruhn says the company may expand on that a little, but not a lot. And she adds Promedior will be hiring in Boston, though she adds that staffers in Philadelphia are still mulling over the prospect of moving.

- here's the press release

Related Article:
Promedior lands $21.5M D round for fibrosis pipeline

European committee backs AZ, BMS and Novartis drugs for approval

Several drug companies received nods of support for getting their prized drugs approved for the European market. The Committee for Medicinal Products for Human Use (CHMP) revealed its recommendations today, with positive news for Amag Pharmaceuticals ($AMAG), AstraZeneca ($AZN), Bristol-Myers Squibb ($BMY), Novartis ($NVS), Incyte ($INCY), and Takeda Pharmaceutical.

The CHMP backed AZ and BMS's dapagliflozin for approval to treat Type 2 diabetes, after the FDA shot down the companies' bid to gain an OK to sell the drug in the U.S. in January because of regulators' safety concerns about the program. The EU committee, however, noted the need for new diabetes drugs, citing the World Health Organization's estimate last year that 346 million people worldwide have the disease, which often leads to serious health problems such as cardiovascular disease. 

Incyte and Novartis got more good news for the companies' JAK inhibitor known as INC424, with the CHMP pushing for approval of the drug in the EU for treating a blood cancer known as myelofibrosis. Incyte, which controls U.S. marketing of the drug, grabbed FDA approval for the product in November. Patients with the disease have few treatment options, giving the drug a leg up with regulators.

Amag and Takeda scored the CHMP's backing for the drug ferumoxytol for treating anemia in patients with kidney disease. Takeda is taking the lead on European development of the drug, which it plans to sell under the name Rienso.

- see the CHMP release
- here's Novartis' release
- check out the Reuters report on dapagliflozin

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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."  

- here's the press release

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YM gets boost after posting promising anemia data on myelofibrosis drug

Shares of YM Biosciences ($YMI) got a bump this morning after several analysts gave the developer a pat on the back for the updated midstage results released for its myelofibrosis drug CYT387, a JAK1/JAK2 inhibitor.

TheStreet's Adam Feuerstein started the round of applause this morning, noting that the developer's drug maintained a positive anemia response, with about half of the 68 myelofibrosis patients in the study who were transfusion dependent at the launch of the study becoming transfusion independent for at least 12 weeks during treatment. And of the 26 transfusion-dependent patients getting the 300 mg dose, 62% were transfusion independent for 12 weeks. Both groups maintained hemoglobin levels at or above 8 g/dl.

"These '387 anemia response data are stronger and more credible than what was presented last spring because Monday's results are culled from many more patients enrolled at multiple clinical trial sites," notes Feuerstein. And producing the positive anemia response after significant doubts had been raised will help favorably position the drug against rivals on the market."We expect these results to accelerate partnership discussions, and are increasingly optimistic about the potential of CYT387 in other hematologic indications," wrote analyst Avik Roy.

"In this multicenter study, CYT387 continues to demonstrate a unique ability to render and maintain myelofibrosis patients transfusion independent for clinically-relevant periods, while also producing significant and durable improvements in their splenomegaly and constitutional symptoms," said Dr. Nick Glover, the CEO of YM BioSciences. "In addition, MRI results obtained from a subset of subjects confirm the meaningful improvements in splenomegaly as measured by palpation. Moreover, CYT387 was well tolerated, with dosing up to and exceeding two years."

- check out the YM release
- here's the story from TheStreet

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