FluBlok®: Gaining Regulatory Approval Following Phase 3 Studies

FluBlok® is one of many vaccines in development in the fight against flu.

Dan Adams, Executive Chairman, Global Head of Business Development, Protein Sciences Corporation presented a case study at the World Influenza Congress in 2011, discussing his company’s product FluBlok®: Gaining Regulatory Approval Following Phase 3 Studies. His presentation was structured around the following points:

•    Company overview: business segments
•    Proprietary insect cell platform technology
•    Lead vaccines: FluBlok® and PanBlok ®
•    Quality by design
•    Challenges to approval
•    Take-home lessons

Why not download the full presentation and find out more about FluBlok®!

Snapshot of presentation:

• Founded in 1983, privately held vaccine company, Meriden, CT
• Patented platform technology using the baculovirus and insect cell system (BEVS)
• Adopters include: BI Vetmedica; Astellas; Wako (Takeda); Dendreon; Diamyd; BARDA; NIH
• Patented high density manufacturing technology – insect & CHO cells
• Recombinant platform: novel human & veterinary prophylactic & therapeutic vaccines
• Lead influenza vaccine (FluBlok) on track for FDA approval early in 2012
• Grown from 40 to >90 employees in past 18 months
• Profitable, cash flow positive business
• $147 million BARDA contract funds work on FluBlok and PanBlok
• Japanese contracts & licensees generate significant current cash & royalties in 2012-2024
• Simplified balance sheet in 2010: debt free; only common stock
• Avoided VCs and “death by a thousand cuts”
• Settled all issues related to failed hostile takeover attempt by EBSI

Download the full presentation here!

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