Sanofi-Aventis: near-term benign prostatic hyperplasia prospects look bleak

Following negative Phase III data, Sanofi-Aventis has terminated the licensing agreement with AEterna Zentaris for the development of cetrorelix in benign prostatic hyperplasia. This leaves Sanofi-Aventis with limited options to protect its revenue in this market after the patent expiry of Xatral in 2011.

AEterna Zentaris has announced the termination of its agreement with Sanofi-Aventis for the development, commercialization and licensing of cetrorelix for the treatment of benign prostatic hyperplasia (BPH) in the US, which was signed in March 2009. Sanofi-Aventis' decision does not come as a surprise following recent negative Phase III data, and Datamonitor does not expect AEterna Zentaris to continue the development of the product for the treatment of BPH. While some Phase II data were positive, Datamonitor had concerns over a potentially unfavorable side-effect profile, which included the reduction of testosterone and possible menopausal symptoms. Combining this with the failure to meet primary efficacy endpoints in Phase III, cetrorelix is a poor candidate for BPH.

BPH is a non-cancerous enlargement of the prostate which affects over 15 million men over 50 years of age across the seven major markets. Drug treatments target the symptoms - which include frequent urge to urinate, nocturia and overflow incontinence - rather than the causes of BPH. Despite proven efficacy, these drugs often provide inadequate symptom relief, cause sexual side effects and cannot reverse the course of the disease in the long term so many patients will ultimately have to undergo surgery.

Cetrorelix is a gonadotropin-releasing hormone antagonist in development for the treatment of BPH and endometriosis. The product is available on the market for the treatment of infertility under the brand name Cetrotide, attaining relatively modest global sales of $32m in 2008, according to IMS Health.

With the licensing deal for cetrorelix, Sanofi-Aventis aimed to protect and consolidate its share of the BPH market after the expiry of Xatral (alfuzosin) in the US (which is expected in 2011). Indeed, Xatral achieved global sales of $448m in 2008, making it one of the leading BPH brands. Having terminated the agreement, Sanofi-Aventis will have to look elsewhere to retain its near-term presence and revenue in this market. However, this may prove to be a difficult task: there are less than 20 products in the pipeline in Phase II and above, of which only a handful are promising.

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