PDF Released June 6thhttps://content.cdntwrk.com/files/aT05OTEwMjgmdj0xJmlzc3VlTmFtZT1xdWFydGVybHktcmVwb3J0LXExLTIwMTgmY21kPWQmc2lnPTU5YmJhZDA5NmI3NWU5OWVlODcwOWQzMWFmNGUxZDg3 (from pages 8-9) The Corporation intends to:
Focus initially on its lead candidate PBI-4050 to:
- Develop, obtain regulatory approval and commercialize, directly, or in partnership PBI-4050 for the treatment of IPF.
- Develop, obtain regulatory approval and successfully commercialize PBI-4050 for thetreatment of Alstrm (“AS”).
- Thereafter, use the evidence of clinical efficacy in AS patients to expand the use of PBI-4050 and or its follow on analogues to treat other large unmet fibrotic diseases such as cardiac pulmonary or kidney fibrosis, NASH or other types of liver fibrosis pulmonary hypertension and scleroderma.
(from page 16) The Corporation intends to initially focus on:
• Filing amendments to its BLA wth the US Food and Drug Administration (FDA), and thereafter to
successfully commercialize RyplazimTM (plasminogen) in North America independently for the
treatment of congenital plasminogen deficiency, once approved.
• Develop and obtain regulatory approval and successfully commercialize RylazimTM (plasminogen)
for the treatment of other indications where the acute plasminogen deficiency is known to be the
source of medical complications (e.g. thrombosis, ALI/ARDS, IPF).
• Develop and obtain regulatory approval and successfully commercialize Plasminogen (sub-
cutaneous) for hard-to-treat wounds such as DFU and TMP.
Thereafter, the Corporation will:
• Advance our other plasma-derived drug candidates (e.g. IVIG) through clinical development and
leverage our plasma purification platform to discover and develop new drug candidates (e.g. IAIP).
• Build a leading, fully integrated, commercialization organization with a specialized MSL and sales
force and focused team.
• Invest in our plasma protein manufacturing and raw material sourcing capabilities.
• Create value through strategic collaborations and indication and/or regional geographic commercial
agreements.