Spectrum Pharmaceuticals (NasdaqGM: SPPI), a commercial-stage
biotechnology company with a primary focus in oncology, today announced
that it is discontinuing development of ozarelix in benign prostatic
hypertrophy (BPH).
“While ozarelix is a potent GnRH antagonist, low-dose intermittent
therapy has been disappointing in the treatment of lower urinary tract
symptoms in men with BPH. As a result, we have made the strategic
decision to discontinue the ozarelix BPH program”
“While ozarelix is a potent GnRH antagonist, low-dose intermittent
therapy has been disappointing in the treatment of lower urinary tract
symptoms in men with BPH. As a result, we have made the strategic
decision to discontinue the ozarelix BPH program,” said Rajesh C.
Shrotriya, MD, Chairman, Chief Executive Officer, and President of
Spectrum Pharmaceuticals. “By discontinuing the ozarelix program, the
savings of more than $40 Million we had budgeted for the clinical trials
and other related costs will help us advance other programs that have
the greatest likelihood of commercial success in providing patients with
more effective treatment options. This is part of a concerted effort at
streamlining and prioritizing our portfolio.”
Ozarelix, a luteinizing hormone-releasing hormone (LHRH) antagonist, was
in late stage trials for the treatment of benign prostatic hypertrophy.
However, the mixed results of the Company’s earlier Phase 2b study and
the recently announced failure of AEterna Zentaris’s large, Phase 3,
registrational trial of cetrorelix (another LHRH antagonist) in BPH does
not support continued development in this indication.