We have a new Client - An Illinois company developing innovative therapies for resuscitation from sudden cardiac arrest has appointed Aagami to support their partnering needs.
Our Client requires EPO for their Phase 3 stage asset for resuscitation from Sudden Cardiac Arrest (SCA). They are looking for EPO Supplier/Co-development partner/Strategic Investor.
What is needed:
EPO (alfa or beta) drug product with a supporting Drug Master File (DMF) and the Chemistry, Manufacturing, and Controls (CMC) quality, compliant with FDA requirements specified in the Code of Federal Regulations (CFR) for biological drugs (i.e., 21 CFR 314.420) in the appropriate electronic common technical document (eCTD) format, to support an investigational new drug (IND) application for a Phase 3 clinical study.
Strategic Models open for EPO manufacturer partnership and/or collaboration:
- Supply EPO (alpha or beta) for the Phase 3 clinical trial, to be purchased by our client.
- Supply EPO drug product for the Phase 3 clinical trial, with additional costs borne by the manufacturer as intent for strategic co-development partnership with our client.
- Supply EPO drug product and full support for the phase 3 clinical trial, including the BLA as part of a long-term partnership or investment into our client.
Brief highlights of the asset:
- First treatment targeting reperfusion injury during resuscitation from sudden cardiac arrest.
- IND application to be submitted for a Phase 3 pivotal clinical trial supporting options for expedited drug development.
- Option for orphan drug designation for additional market exclusivity in United States and Europe.
- Patented – “Facilitation of Resuscitation from Cardiac Arrest by Erythropoietin” (US 8,067,366 B2; EP 2349454 B1).
- Experienced management team and scientific advisors in resuscitation research.
- Pipeline of emerging therapies and strategies for resuscitation from life-threatening medical emergencies in pre-hospital and hospital settings in both civilian and military environments.
Please contact us for more details if you would be interested in this opportunity.