Biopharmaceutical company Æterna Zentaris Inc. (AEZS, AEZ.TO) Friday said it terminated its agreement with Sanofi-aventis U.S. (SNY) for the development, commercialization and licensing of cetrorelix in benign prostatic hyperplasia, or BPH, for the U.S. market. The decision follows Æterna's announcement last week that a phase 3 multi-center efficacy trial of cetrorelix failed to meet its primary endpoint.
Cetrorelix, a luteinizing hormone-releasing hormone antagonist, had been the object of a Phase 3 program in BPH, a non-cancerous enlargement of the prostate. Termination of the agreement, dated March 5, will be effective January 9, 2010.
In the multi-center efficacy trial, results of which were announced last week, patients were administered cetrorelix by intra-muscular injection. The study included 420 patients overall, and all patients were followed up to week 52. There were no clear differences in overall efficacy, with all groups showing an improvement in International Prostate Symptom Score of 6 points that was maintained throughout the 52 weeks.
Juergen Engel, Æterna's President and CEO, said today that the termination of the agreement with sanofi-aventis U.S. was expected in light of last week's announcement.
The company now plans to focus its clinical development efforts on late-stage compounds perifosine, AEZS-108 and AEZS-130.
In oncology, Keryx, Æterna's partner and licensee in North America, has initiated a Phase 3 trial in multiple myeloma with perifosine, the company's oral PI3K/Akt inhibitor compound. The U.S. Food and Drug Administration has granted Special Protocol Assessment to Keryx for the Phase 3 study of perifosine in multiple myeloma. For trials granted Special Protocol Assessment status, the FDA accepts uncompleted Phase III trial's design, clinical endpoints, and statistical analyses. The FDA has also granted Orphan Drug and Fast Track designations for perifosine in this indication.
Æterna is also currently evaluating further development plans for AEZS-108, the company's targeted doxorubicin conjugate, after recent positive Phase 2 results in ovarian and endometrial cancer. In endocrinology, Æterna is in the process of reactivating a Phase 3 trial with its oral ghrelin agonist, AEZS-130, as a diagnostic test for adult growth hormone deficiency.
AEZS closed Thursday's regular trade at $0.86, down from the previous close of $0.89, on 138,300 shares.
AEZ.TO settled on the TSX Thursday at C$0.92, up one cent from the previous close, on 58,600 shares.
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