BioMarin halts Neutralase drug development program
BioMarin Pharmaceutical, from Novato, CA, has halted its Phase IIIa study of Neutralase for the reversal of anticoagulation by heparin in primary Coronary Artery Bypass Graft (CABG) surgery and that it has terminated its Neutralase program for all indications.
BioMarin Pharmaceutical, from Novato, CA, has halted its Phase IIIa study of Neutralase for the reversal of anticoagulation by heparin in primary Coronary Artery Bypass Graft (CABG) surgery and that it has terminated its Neutralase program for all indications.
The decision to halt the study resulted from a recommendation from an independent Data Safety Monitoring Board (DSMB) and was based on a review of data from enrolled patients, which indicated with high probability that Neutralase would not demonstrate favorable safety and efficacy. Given the expected poor risk/benefit profile for Neutralase, BioMarin has stopped the development of the drug for all indications.
As a result of abandoning Neutralase development, BioMarin has lowered its projected net loss by $5m (€4.3m]) for 2003 and by $13m (€11m) for 2004. Fredric Price, chairman and ceo of BioMarin said: 'While we are disappointed that Neutralase will not become a successful product, it is better to have learned this relatively early in its development at BioMarin. We have planned BioMarin's product portfolio carefully, and have adequate resources for our other promising product opportunities, including Aryplase, which is in a pivotal Phase III trial.'
Regarding Aryplase, the company has announced positive long-term results from Phase I and Phase II clinical studies of the investigational enzyme replacement therapy for the treatment of mucopolysaccharidosis VI (MPS VI). Long-term data from both studies indicate that Aryplase is generally well-tolerated and that patients continue to benefit from Aryplase treatment.