Drug Development
Strategy
Novozymes GroPep seeks out early stage product opportunities that have a scientifically robust demonstration of treatment effect. The Company then applies its extensive experience in process and analytical methods development, clinical trials management and intellectual property management to advance the product into clinical trials and establish proof of concept in humans (Phase II results). It is expected that in most cases the later stages of product development and marketing will be licensed to major pharmaceutical companies with established sales franchises.
Therapeutic and Technological focus
The Company is seeking new product opportunities in the areas of inflammatory processes and immune pathologies based on cytokine technologies (particularly, growth factors). We also consider opportunities from related to medical and technological fields.
Product Development Stages
It typically takes 10 – 12 years to develop a new drug. The development process is expensive and very risky but the returns can be exceptional.
A compound is first 'discovered', often in a University or research institution, where it is initially demonstrated to have a treatment effect in animal models (in vivo proof of concept). During the pre-clinical stages, investigators produce a scientifically robust set of data supporting the safety (toxicology) and activity (efficacy) of the drug. This is achieved by testing the effect of the drug in living organisms (in vivo) and in cells in the test tube (in vitro). Results of all testing must be provided to regulatory agencies for review before any clinical trial can commence.
Getting the drug into human trials is a major milestone for the drug developer and the successful completion of each subsequent trial indicates a significant increase in the value of the product.
Biomedical clinical trials of an experimental drug may proceed through four phases:
Phase 1 clinical trials are usually conducted in a small group (eg. 20-80) of healthy normal volunteers to evaluate safety (determine a safe dosage range and identify side effects), tolerability and pharmacokinetics.
Phase 2 clinical trials are the first trials of the experimental drug in patients suffering from the condition for which the medicine is intended. The principle aim of these studies is to determine efficacy and safety in the patient population and to establish the therapeutic range and maximum tolerated dose.
Phase 3 clinical trials investigate the efficacy of the drug in larger groups of patients (from several hundred to several thousand). The aim of these studies is to determine whether the medicine confers clinical benefit (often by comparison to other standard treatments), and that the incidence and nature of the side effects are acceptable.
Phase 4 studies are conducted after the medicine has been marketed and are designed to monitor the effectiveness of the medicine in the general population and collect information about adverse events associated with widespread use.
Novozymes GroPep is currently investigating two potential drug candidates:
PV903 - Recurrent Miscarriage
Market Opportunity
Scientific Background
Development Strategy
Core Peptide Technology
Market Opportunity
Scientific Background
For further information, please contact:
medicaldepartment@gropep.com.au
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