Apotex Inc

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(No Transcript)
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Apo-TriAvir fixed-dose combination for treatment
of HIV

• Canadas Pharmaceutical Company
• The decision to get involved
• Our Experience
• Observations
• Recommendation

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• We are the largest Canadian-owned Pharmaceutical
  Company
• Planned expenditures of 2 billion over the next
  10 years on Research and Development
• Develop and manufacture 300 quality affordable
  medicines in 4000 formats which are exported to
  115 countries
• Over 605 medicines under development including
  generic, innovative and
  biotechnology

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The Decision to Get Involved

• A Core Apotex Value
• Access to affordable medicines
• A Critical Unmet Need
• Epidemic of catastrophic proportions
• Millions have no access to effective, high
  quality, affordable medicine
• A Corporate Commitment
• Initial commitment in 2002
• 5 anti-retrovirals at cost

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The Challenge

• Apotex Contacts Canadian Govt. / CIDA
• Direct contact with governments in sub-Sahara
  Africa
• Logistical challenges / lack of WHO
  pre-qualification
• Lack of infrastructure for effective
  distribution
• No Mechanism to facilitate
  the process

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Legislative Changes

• 2004 Bill C-9 / JCPA
• WHO pre-qualification
• Follows Health Canada Approval
• Ensures broadest access
• Efficacy and safety assured
• Transparent to all
  interested countries

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Our Experience

• Consultation
• MSF outlined the critical need
• Advised on the most needed FDC
• Lamivudine, Zidovudine, (Combivir) Nevirapine
• Committed to providing Apo-Triavir at our cost
• Health Canada / Industry Canada / CIPO
• Defined the approval route
  and CAMR process
• Outlined an expedited
  approval process

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Our Experience

• Development
• Work began in April 2005
• 2 Million invested to date
• Expedited by personal commitments of
• our employees

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Our Experience Cont..

• Approval Status
• Health Canada Approval Received
• Dossier filed December 2005
• Approval June 2006
• On patent hold as per Bill C-9
• CAMR requirements
• Licensing Voluntary vs. Compulsory
• CAMR requires recipient country
  to be identified up front
• Country needs to initiate request

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Our Experience Cont..

• WHO pre-qualification achieved
• Follows Health Canada approval
• Assures Recipient Countries of
• Efficacy and Safety
• Authenticity
• Availability
• Widely accessible
• Unlike PEPFAR

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Observations

• Effectiveness compromised by lack of clarity
• Define the objective of CAMR
• High quality medicines for critical diseases in a
  timely manner?

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Observations

• Current approach tries to balance interests of
  industry
• Consumes resources
• Compromises ability to meet the objective
• Apotex unlikely to repeat the current process
• Remain blocked at level of country request

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Recommendation

• Look after the interests of those affected
• CAMR is weighted towards balancing industry
  interest
• Need a model that prioritizes the need
• Current model perpetuates the human crisis
• CAMR makes sense only in the Developed World
• Overly complex
• Most recipient countries do not have the
  expertise or resources to initiate the request
  and deal with the bureaucracy

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Recommendation

• 2. Streamline the process
• Move directly to defined compulsory license upon
  regulatory approval
• Speeds up process
• Limits costs Legal costs are substantial
• Terms are already defined

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Recommendation

• 3. Transfer the Ownership
• Canadian Government needs move from facilitator
  to implementer
• Profit-based industry is constrained by costs
• Fully non-profit is a challenge for public
  profit-based industry
• Generic and Brands
• Apotex Inc, more latitude as private company
• Pricing is not the only issue under CAMR
• Industry priorities compromise long-term view
• Competitive challenges
• Government agencies already established
• e.g. CIDA

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Recommendation

• 3. Transfer of Ownership cont..
• Not-for-profit development and manufacturing of
  these products can be done at existing Govt.
  sponsored, University based facilities under
  compulsory license agreements
• Industry collaboration to support development,
  training and production at these facilities
• Incorporated into Canadian University programs
• Products approved by Health Canada with
  subsequent WHO prequalification
• CIDA or other agency manage supply agreements

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Benefits

• Clear Purpose
• Clear Ownership and Accountability
• Sustainable Process
• Transparency

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• Thank You