Neutralase

Neutralase

Heparinase I Cardiology An agent used after cardiac bypass surgery to reverse heparin's anticoagulant effects. See Heparin.
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including the following potential future products: Aldurazyme for the treatment of MPS I, Neutralase for the reversal of anticoagulants, Aryplase for the treatment of MPS VI, and NeuroTrans for the delivery of enzymes across the blood-brain barrier.
Neutralase is an injectable heparinase that is targeted to reverse heparin and other new heparin-like anticoagulants during open heart and other surgeries.
BioMarin expects to initiate a Phase III clinical trial of Neutralase for use in coronary artery bypass graft (CABG) surgery in 2002.
Results may differ materially depending on the progress of BioMarin's product programs, including the ability to integrate the programs being acquired from IBEX, the actual results of the current and proposed clinical trials, including the planned clinical trial for Neutralase, actions of regulatory authorities, future availability of capital, future actions in the pharmaceutical market and developments by competitors, and those factors detailed in BioMarin's filings with the Securities and Exchange Commission such as 10Q, 10K and 8K reports.
Neutralase is an injectable heparinase that reverses the anticoagulation of blood by heparin and other new heparin-like anticoagulants.
including the following potential future products: Aldurazyme for MPS I, rhASB for MPS VI, Vibriolysin Topical for burn debridement, Neutralase for the reversal of anticoagulants, and Phenylase for PKU.
Neutralase is a carbohydrate-modifying enzyme that cleaves heparin, a glycosaminoglycan (GAG), in a manner similar to the activity of BioMarin's two enzyme replacement therapies: Aldurazyme(TM) for the treatment of MPS I and rhASB for the treatment of MPS VI.
With the addition of Neutralase, BioMarin will have five drug candidates in clinical trials next year: Aldurazyme, rhASB, Vibriolysin, Neutralase, and a fifth product that will advance from our internal development pipeline.
Co-founder, President, and Chief Operating Officer of IBEX, added, "BioMarin's expertise in enzyme research, production, quality control and assurance, process development, and clinical trials management will greatly enhance the ability to effectively advance Neutralase and Phenylase through their next stages of development.
In addition, preclinical studies have shown that Neutralase may be effective as a reversal agent for the low molecular weight heparins (LMWHs) that are used in many surgeries such as hip and knee replacements as well as for a new class of drugs, pentasaccharides, that are also being developed for these indications.
The confidence demonstrated by our shareholders has given us the resources to aggressively pursue the Neutralase clinical trial program with a target US NDA Filing date in 1999".
These trials are expected to be complete Q1 1999, after which IBEX plans to file for Marketing Approval of Neutralase with the US Food and Drug Administration.