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Universal Vaccination Against Influenza – Are We Ready? Atlanta, Georgia October 24-25, 2005.
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Universal Vaccination Against Influenza – Are We Ready? Atlanta, Georgia October 24-25, 2005
The foregoing information contains so-called “forward-looking” statements. These include statements regarding ID Biomedical’s expectations and plans relating to the integration of the vaccine business acquired from Shire, statements about ID Biomedical’s expectations, beliefs, intentions or strategies for the future, which may be indicated by words or phrases such as “anticipate”, “expect”, “intend”, “plan”, “will”, “we believe”, “ID Biomedical believes”, “management believes”, and similar language. All forward-looking statements are based on ID Biomedical’s current expectations and are subject to risks and uncertainties and to assumptions made. Important factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include: (i) the company’s ability to successfully integrate the Shire vaccine business; (ii) the company’s ability to successfully complete preclinical and clinical development of its products; (iii) the company’s ability to manufacture its products; (iv) the seasonality of the flu-vaccine business and related fluctuations in the company’s revenues from quarter to quarter; (v) decisions, and the timing of decisions, made by the health regulatory agencies regarding approval of its products for human testing; (vi) the company’s ability to enter into distribution agreements for its products, and to complete and maintain corporate alliances relating to the development and commercialization of its technology and products; (vii) market acceptance of its technologies and products; and (viii) the competitive environment and impact of technological change and other risks detailed in the company’s filings with the Securities and Exchange Commission. ID Biomedical bases its forward-looking statements on information currently available to it, and assumes no obligation to update them.
Leading Vaccine Company • Focused on the development and commercialization of proprietary vaccines which address large markets and can be premium priced • Attractive clinical and preclinical pipeline • Over 700 highly skilled employees with expertise to take products from development through to commercial manufacturing • One of only two North American-based manufacturers of injectable flu vaccines
Leading Vaccine Company • Infrastructure includes: • Modern flu manufacturing facilities • State-of-the-art development / pilot scale manufacturing facilities • Research & development facility • Positioned to become the largest manufacturer of flu vaccine in NA • 75 M doses annually in 2007 • Positioned for near-term profitability
Employee Breakdown As of June 1, 2005 718 employees FunctionNumber of Employees Research 19 Development 202 Manufacturing 268 QA / QC 142 Administration 80 Commercial 7
Injectable Flu Vaccine (Fluviral in Canada) Highlights • Classical intramuscular flu vaccine • Leading flu vaccine in Canada with 75% market share • Long-term CDN $300 million supply contract with Canadian government (ending March 2011) • Production capacity being expanded • 75 million doses per year in 2007 • Clear regulatory path to licensure in U.S. market • Accelerated approval • Priority review • Fast track • U.S. purchase agreements with three leading flu vaccine distributors
Injectable Flu Vaccine U.S. Purchase agreements • Long-term agreements (2007-2014) with leading flu vaccine distributors • Henry Schein, Amerisource Bergen, McKesson • As a group, these are the largest non-manufacturer influenza vaccine • distributors in U.S. • Agreements starting upon FDA approval • Beginning in 2007-08 flu season, annual purchases of 38 million doses • Estimated revenues to ID Biomedical over the term of the agreement = $US2.3 billion
Injectable Flu Vaccine Manufacturing facilities • Quebec City expansion and Laval upgrade - fully operational in 2007 • 250,000 square feet in Quebec City • 400 employees • 75 million doses of trivalent influenza vaccine annually • Expansion and upgrade investment in excess of CDN $80 million
Injectable Flu Vaccine U.S. regulatory pathway • Eligibility for accelerated approval and priority review + fast track status granted: FDA major regulatory mechanisms to facilitate rapid licensure • Pivotal Phase III Clinical Trials • Safety and immunogenicity studies conducted in 2005 • Data to be included in BLA filing • File Biologics License Application (BLA) with FDA: Q4 2005 • Potential approval: first half 2006 • Priority review gives FDA up to 6 months to review BLA • Manufacture for U.S. market: Q2 2006 • Post approval confirmatory studies • Efficacy studies beginning Q4 2005 • Immunogenicity studies in elderly - 2006
Influenza Vaccine US supply vs. demand Marketplace challenges • The only thing consistent about each flu season is its inconsistency. • Demand drives supply • This is an important fundamental concept • Year after year at risk supply jeopardizes the consistency of supply • Possible near term shortages guarantee long term supply • Vaccines – misunderstood healthcare • What have we learned • Education has resulted in minimal success • Fear – increases interest and demand • Adult vaccination program – a new paradigm • Public – Private partnerships brought to a new level • HHS et al • Manufacturers • Distributors • Healthcare providers
Pandemic preparedness Seasonal supply Universal recommendation – pandemic planning • Aside from what are the obvious benefits of a universal recommendation • Consistency of demand and therefore supply • Increased awareness of vaccine benefits • Pandemic readiness • Manufacturer commitment to the US market • Seasonal supply • Pandemic supply – contracted • We have a unique opportunity – we must seize the moment!!