Flavin Ventures Experience
Below is a summary of the relevant transactions in which we have played a leading role:
- Successfully interfaced with and finalized a special protocol assessment (SPA) with the FDA for novel oral antibiotic, Restanza™ (cethromycin), for treatment of community acquired bacterial pneumonia (CABP).
- Met with FDA in over a dozen face-to-face meetings to establish regulatory pathway in CABP and biodefense indications including anthrax, plague tularemia and Burkholderia pseudomallei
- Successfully lobbied BARDA to adjust Broad Agency Announcement rules to reflect FDA requirements, including clinical development of antibiotics for commercial indications to support biodefense approval.
- Led the submission of New Drug Application (NDA) to FDA for Restanza.
- Negotiated a development and commercialization agreement for the Asia Pacific region with Wyeth for Restanza.
- Negotiated Standby Equity Distribution Agreement and raised $15 million through stock sales for ADLS.
- Secured $4 Million award with the DTRA for biodefense contract to develop Restanza in plague, tularemia and Burkholderia pseudomallei
- Completed $35 Million IPO for ADLS.
- Negotiated with the State of Illinois Department of Economic Opportunity for $500,000 grant for ADLS.
- Led the negotiation for license to acquire a Phase 3 antibiotic, Restanza, from Abbott Laboratories.
- Completed sale of MediChem Life Sciences (MCLS) to DeCODE Genetics for $84 Million.
- Completed $54 Million IPO of MCLS.
- Managed MCLS acquisition and integration of two biotechnology companies, ThermoGen and Emerald BioStructures.
- Formed Sarawak MediChem Pharmaceuticals (SMP) a joint venture with the Government of Sarawak, Malaysia and recruited $20 million investment from the Sarawak Government to develop calanolide A, a natural product found in the Malaysian rainforest as a treatment for HIV/AIDS.
- Completed a $35 Million private equity and debt financing at MCLS.
- Founded MCLS as medicinal chemistry contract research organization.
- Completed two Private Investments in a Public Equity (PIPEs) $36 Million and $20 Million each, for ADLS.
- Secured over $6 million in research and development contracts with NIAID to develop Restanza as a broad spectrum medical countermeasure for biodefense.
© 2011 Flavin Ventures, LLC.