- Onyx Pharma presented at the Robert W Baird Healthcare conference - click here for full presenter schedule and links to my notes.
- ONXX is developing carfilzomib for multiple myeloma, is on the verge of completing the NDA filing - uses Captisol technology licensed from Ligand Pharma LGND.
- See my webcast notes below:
- Goal is to make multiple myeloma a chronic disease
- First trials of carfilzomib started in sickest patients who have run out of options (average 5 lines prior therapy)
- Phase 2b trial was the basis for filing for accelerated approval.
- We expect NDA to be complete in late September or early October as of 2q2011 earnings conference call guidance
- Phase 3 ASPIRE trial underway in relapsed MM patients who have had 2 prior lines of treatment. Carfilzomib in combo with revlimid, global enrollment is expected to complete 1h2012
- Phase 1/2 trials underway in first line MM as combo therapy
- oral backup - envision in future as maintannece tx
- Product could be on US market as early as 1h2012
- Upcomingmilestones:
- NDA filing
- ASPIRE US and EU trials for full approval. Conducted under SPA
- FOCUS EU confirmatory study of carfilzomib vs best supportive care. Enrollment continues, changed endpoint from PFS to OS
- Details on expanded access program? Set up in partnership w/ Multiple Myeloma Research Consortium. Targeted to patients similar to Phase 2b trial, who really need to have access to carfilzomib. Program is similar to the one for Nexavar. The protocol was reviewed by the FDA. We will do our best work when we always do what is in the patients' best interest first
- Velcade sub-cutaneous data - impact on MM market? That doesn't change the Carfilzomib story at all.