AEterna Zentaris' Partner, Spectrum, Provides Update on Ozarelix in Benign Prostatic Hyperplasia
Spectrum indicated that ozarelix demonstrated sufficient clinical activityto justify its continued development in BPH. Based on these results, Spectrumis planning to submit a protocol to the FDA for the next study of ozarelix inBPH.
"We are pleased that Spectrum is proceeding with plans for their upcomingstudy," stated Paul Blake, M.D., Senior Vice President and Chief MedicalOfficer of AEterna Zentaris. "AEterna Zentaris remains committed about thepotential of LHRH antagonists for BPH, particularly for our lead candidatecetrorelix, which has produced robust and consistent findings in Phase 2trials and is currently being evaluated in three multi-center Phase 3 trialsin the United States, Canada and Europe." He said that results from thecetrorelix Phase 3 program are expected in the third quarter of 2009.
About Ozarelix and Partnerships
Ozarelix is an injectable fourth generation LHRH antagonist administeredas an intramuscular injection. In August 2004, AEterna Zentaris grantedSpectrum Pharmaceuticals an exclusive license to develop and market ozarelixfor all potential indications in North America (including Canada and Mexico)and India, while AEterna Zentaris retained exclusive rights to the rest of theworld. In addition, Spectrum was granted the right to receive 50% of anyupfront and milestone payments, royalties and/or profits from sales ofozarelix in Japan.
On July 26, 2006 AEterna Zentaris licensed the Japanese rights for allozarelix potential oncology indications to Nippon Kayaku, a key player in theJapanese oncology market.
Cetrorelix pamoate is an investigational agent that has demonstrated inPhase 2 studies to provide fast and long-lasting relief of BPH symptoms whilebeing well tolerated, with a low incidence of sexual side effects. Cetrorelixis part of AEterna Zentaris' LHRH antagonist therapeutic approach. Thispeptide-based active substance was developed by the Company in cooperationwith Nobel Prize winner Prof. Andrew Schally, currently of the U.S. VeteransAdministration in Miami.
Cetrorelix acetate is marketed under the brand name Cetrotide(R), thefirst LHRH antagonist approved for therapeutic use as part of in vitrofertilization programs (controlled ovarian stimulation/assisted reproductivetechnologies) in Europe, the U.S. and Japan. It was launched on the marketthrough Serono (now Merck Serono) in the United States, Europe and in severalother countries, as well as in Japan through Shionogi.
About the Cetrorelix Phase 3 Program in BPH
Cetrorelix pamoate is being studied in three Phase 3 trials which willinclude approximately 1,500 men with symptomatic BPH in the United States,Canada and Europe. One Phase 3 efficacy trial, primarily in the United Statesand Canada and with additional sites in Europe, involves approximately 600patients (which are fully enrolled) and is being led by Herbert Lepor, M.D.,Professor and Martin Spatz Chairman of Urology, New York University School ofMedicine, New York. In the trial, patients enter a 4-week run-in no-treatmentobservation period to confirm severity and stability of voiding symptoms basedon the International Prostate Symptom Score (IPSS). Patients are then randomlyallocated to cetrorelix or placebo in a double-blind fashion. Patients areadministered cetrorelix by intra-muscular (IM) injection at Week 0, 2, 26 and28 and are followed up to Week 52. Then, in an open-label extension, patientswill receive cetrorelix by IM injection at Week 52, 54, 7
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