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GEN News Highlights : Dec 7, 2012
BioCryst Halves Staff After Setbacks
BioCryst said today it will lay off half its workforce—38 positions—as part of a restructuring that will refocus the company on advancing its hereditary angioedema (HAE) and antiviral drug programs.
The restructuring comes a week after BioCryst and Presidio Pharmaceuticals ended talks toward a $101 million merger, and following two months of clinical-trial setbacks affecting its hepatitis C and HAE drug candidates.
BioCryst said it expects to save between $15 million and $18 million in 2013 from the layoffs, which are anticipated to nearly halve the company’s spending of cash to between $22 million and $25 million in the coming year, from $40 million in 2012. The company will take a restructuring change during Q4 2012 of between $2 million and $4 million.
“To succeed, we must significantly decrease our operating costs and carefully manage cash, while efficiently advancing our three priority programs,” Jon P. Stonehouse, BioCryst’s president and CEO, said in a statement.
Those three, he added, are the BCX4161 HAE, BCX4430 broad spectrum antiviral, and BCX5191 hepatitis C (HCV) programs, for which he said BioCryst will direct cash and other resources primarily toward achieving near-term milestones. The company said it won’t change an earlier decision to seek a partner for a fourth drug program that would take over Phase III development and commercialization of a drug candidate for the ulodesine gout program.
On Oct. 30, BioCryst withdrew its IND for BCX5191, after the FDA raised concerns about the drug candidate’s preclinical toxicity profile. BioCryst said today it has since launched a study on the efficacy of low doses of BCX5191 in chronically HCV-infected chimpanzees, with the goal of demonstrating meaningful antiviral activity at low doses. Results are expected early in the new year. BioCryst has said it will determine based on those results whether to continue development of BCX5191.
By the end of January 2013, BioCryst said, it will complete its analysis of disappointing Phase III trial results for its peramivir anti-flu drug candidate, then discuss results with the U.S. Biomedical Advanced Research and Development Authority (BARDA). After those talks, the company said, it will decide whether to scuttle peramivir. The drug candidate resulted in such a small difference in time to clinical resolution between patients taking peramivir and a control group that the company’s independent data monitoring committee “recommended that the study be terminated for futility,” the company disclosed on Nov. 7.
Also last month, FDA placed a clinical hold on BioCryst’s Phase I trial for BCX4161 after applying GMP manufacturing standards to the process of compounding capsules of the HAE drug candidate at the clinical site where oral dosing studies were planned. BioCryst said today it now expects to start its Phase I program for BCX4161 “around the end of the first quarter 2013.” The program will aim to demonstrate safety, adequate drug exposure via oral administration, and pharmacodynamic effect on kallikrein inhibition.
As for BCX4430, the company said today it submitted a manuscript describing BioCryst’s third priority drug candidate against certain filoviruses to a journal for consideration, and is seeking additional government funding for development of the drug. Last month the company trumpeted preclinical results showing that Syrian Golden Hamsters treated with BCX4430 showed 80% to 100% improvement in survival against yellow fever virus compared to animals receiving saline placebo, who showed between 20% and 30% improvement.
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