Drug Development

Rigel co-founder, R&D staff jettisoned in the long-awaited lead up to an FDA pitch

Rigel didn’t quite manage to convince analysts a couple of weeks ago that its Syk inhibitor was as appealing as it made it out to be in a late-stage study for immune thrombocytopenia. But the biotech $RIGL is absolutely determined to shift over to a commercial operation to back a prospective fostamatinib launch, and it’s jettisoning its research group to clear the way for the transition, well ahead of any decision from the FDA.

The South San Francisco-based biotech, which has had its pratfalls over the years, says it is axing 46 staffers — 38% of the work force — as it carves back in R&D and starts to develop a commercial group to sell fostamatinib. The departures includes company co-founder and R&D chief Donald G. Payan, who is “retiring” in the changeover.

Payan’s spot in the company hierarchy is being taken by Eldon C. Mayer III, who’s been recruited to lead commercialization work, if they get an approval.

At the end of August, the company reported an 18% response rate for ITP, the low end of what was needed to get to the FDA. That encouraged some analysts, who now expect that the second Phase III, with a readout due within a couple of months, should also be positive.

“While the effect size is not numerically high (18% responders),” noted Jefferies Eun Yang at the time, “positive data from first Ph3 of fostamatinib (fosta) in an orphan indication ITP is a much-needed positive event for RIGL. Both RIGL/study PI note a high likelihood of 2nd Ph3 success in ~Oct/Nov.”

The biotech’s share price hasn’t benefited much from the progress it’s reported. It’s now trading just under its 12-month high.

Back in 2013 fostamatinib flopped in a Phase III study of rheumatoid arthritis, forcing AstraZeneca to wash its hands of their partnership and leaving Rigel to undergo an overhaul, shedding staff and reorganizing around dry eye diseases (R348) and lupus (R333). They both quickly failed Phase II. Another drug, R118, had to be abandoned after investigators tracked some serious side effects.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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