From research and development to your hands

We are one of only a handful of companies to span the entire life-cycle of a medicine from research and development to manufacturing and supply,and the global commercialization of primary care and speciality care medicines.

Our business activities span the entire life-cycle of a medicine. As the diagram illustrates, there are eight phases of this life-cycle:

1. Find potential medicine 

  • Identify unmet medical need aligned with our three therapy areas and undertake scientific research to identify potential new medicines
  • Initiate process of seeking patent protection

2. Pre-clinical studies

  • Conduct laboratory and animal studies to understand if the potential medicine is safe to introduce into humans and in what quantities
  • Determine likely efficacy, side effect profile and maximum dose estimates

3. Phase I trials

  • Begin clinical trials with small groups of healthy human volunteers (small molecules) or patients (biologics) to understand how the potential medicine is absorbed into the body, distributed around it and excreted
  • Determine approximate dosage and identify side effects

4. Phase II trials

  • Conduct trials on small-to-medium sized groups of patients to test effectiveness and tolerability of the medicine and determine optimal dose
  • Design Phase III trials to generate data needed for regulatory approvals and pricing/reimbursement globally

5. Phase III trials

  • Engage in trials in a larger group of patients to gather information about effectiveness and safety of the medicine and evaluate the overall benefits/risk profile
  • Initiate branding for the new medicine in preparation for its launch

6. Regulatory submission and pricing

  • Seek regulatory approvals for manufacturing, marketing and selling the medicine
  • Submit clinical data to regulatory authorities (and, if requested, generate further data increasingly in real-world settings) to demonstrate the safety and efficacy profiles of the medicine to enable them to decide on whether to grant regulatory approvals

7. Launch new medicine

  • Raise awareness of patient benefit and appropriate use, market and sell medicine
  • Clinicians begin to prescribe medicines and patients begin to benefit
  • Continuously monitor, record and analyze reported side effects. Review need to update the side effect warnings to ensure that patients’ wellbeing is maintained
  • Assess real-world effectiveness, and opportunities to support patients and prescribers, to achieve maximum benefit from the medicine

8. Post-launch research and development

  • Conduct studies to further understand the benefit/risk profile of the medicine in larger and/or additional patient populations
  • Life-cycle management activities to broaden understanding of a medicine’s full potential
  • Consider additional diseases or aspects of disease to be treated or better ways of administering the medicine
  • Submit data packages with requests for life-cycle management to regulatory authorities for review and approval

9. Post-exclusivity

  • Patent expiry and generic entry
  • Reinvestment of returns