is reducing its staff by 60 positions to focus resources on the approval and commercialization of its lead candidate, DX-88
for hereditary angioedema (HAE). The company also expects to reassess its pipeline to save more money.
Just four days ago, FDA told Dyax that it needed a Risk Evaluation and Mitigation Strategy and more information on the chemistry, manufacturing, and controls section of the BLA. Dyax believes that it will be able to submit this additional data in a timely fashion.
Dyax expects the reduction in personnel costs along with other external expenses will contribute approximately $18 million in annual savings. It reports that remaining staff will be able to advance the development of and regulatory efforts behind its DX-88 franchise and select pipeline compounds. The company will also continue to support its licensing and funded research program.
The company anticipates a one-time charge of approximately $2 million during the first quarter.
DX-88, a recombinant small protein, is also in Phase II trials for the prevention of blood loss during on-pump cardiothoracic surgery with Cubist Pharmaceuticals. The license covers the intravenous formulation for surgical indications in North America and Europe.