Indevus Pharmaceuticals, Inc. / Valera Pharmaceuticals Inc.

Advanced (palliative) prostate cancer and central precocious puberty

218K US cases/yr · $2.0B US LHRH agonist prostate cancer market (steady-state, 2 billion+ globally)

Disease Overview

Advanced prostate cancer is treated with androgen deprivation therapy, most commonly LHRH (GnRH) agonists that suppress testosterone to castrate levels for palliative disease control. Central precocious puberty (CPP) is a rare pediatric endocrine disorder where children experience pubertal onset before age 8 (girls) or 9 (boys), driven by premature HPG-axis activation; chronic LHRH agonist therapy delays progression.

Competitive Landscape

By 2006 the LHRH agonist class for advanced prostate cancer was a $2B+ global market dominated by Lupron Depot (leuprolide, TAP/Abbott), Zoladex (goserelin, AstraZeneca), Eligard (leuprolide, Sanofi/Tolmar) and Trelstar (triptorelin, Watson) — all injectable depot formulations dosed every 1-6 months. Valera's Vantas (histrelin) differentiated as the only 12-month subcutaneous hydrogel implant, delivering the most potent LHRH agonist available continuously for a full year, compelling for compliance-challenged or travel-burdened patients. The deal gave Indevus — a urology/men's-health specialist already marketing Sanctura (trospium, OAB) and Delatestryl (testosterone) — a marketed urology asset plus Supprelin LA, the same histrelin implant repurposed for central precocious puberty, which secured FDA approval in May 2007 and became the first 12-month implant in CPP. CEO Glenn Cooper framed the deal as establishing Indevus 'as an emerging leader in the specialty areas of urology and men's health'. Endo Pharmaceuticals subsequently acquired Indevus in early 2009 for ~$370M plus CVRs.