FluBlokÂ® 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 FluBlokÂ®: Gaining Regulatory Approval Following Phase 3 Studies. His presentation was structured around the following points:
â¢ Company overview: business segments
â¢ Proprietary insect cell platform technology
â¢ Lead vaccines: FluBlokÂ® and PanBlok Â®
â¢ Quality by design
â¢ Challenges to approval
â¢ Take-home lessons
Why not download the full presentation and find out more about FluBlokÂ®!
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