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buckiii2

03/23/15 5:11 PM

#189012 RE: DewDiligence #188982

Does XOMA get any of this?

I did not know this.

BERKELEY, Calif., Jan 22, 2009 (GlobeNewswire via COMTEX News Network) -- XOMA Ltd. (Nasdaq:XOMA) today announced that it has received a milestone payment of $500,000 for the initiation of a Phase 3 clinical trial from Pfizer Inc. (Pfizer), the world's largest research-based biomedical and pharmaceutical company, pursuant to the parties' previously-announced license agreement. The agreement grants Pfizer non-exclusive, worldwide rights to XOMA's patented bacterial cell expression (BCE) technology for phage display and other research, development and manufacture of antibody products. The milestone payment arises from the initiation by Pfizer of Phase 3 clinical trials for an antibody drug candidate, tanezumab, for the treatment of chronic pain due to osteoarthritis. Less

DewDiligence

03/01/21 4:17 PM

#237280 RE: DewDiligence #188982

PFE/LLY—FDA_adcomm_for Tanezumab_in_OA—scheduled_for 3/24-25/21:

https://www.fda.gov/advisory-committees/arthritis-advisory-committee/march-24-25-2021-joint-meeting-arthritis-advisory-committee-and-drug-safety-and-risk-management

The PDUFA date was in Dec 2020 (https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_accepts_regulatory_submission_for_tanezumab_a_potential_first_in_class_treatment_for_patients_with_chronic_pain_due_to_moderate_to_severe_osteoarthritis ), but the FDA was apparently unable to schedule the adcomm until recently.

This BLA will be controversial given the safety problems encountered at various stages of development program, which dates back to 2009! The problems have been thought to derive from the drug’s working too well at relieving OA pain, encouraging users to become more active and thereby causing more serious joint damage.