Pharma BD Deal Intelligence
A patient, unglamorous licensing bet that paid off on a decade-long clock: Indevus put up just $7.5M upfront (up to $30M total) for U.S. rights to NEBIDO, and the three-month testosterone shot finally reached FDA approval in 2014 after three prior rejections.
Outcome grade pending — assessed 5 years post-close.
Full analysis, sources & comparables →Springer's Drugs in R&D profile "Testosterone Undecanoate — Schering AG" documents Schering AG's discovery and European development of the depot formulation —…
FierceBiotech notes "AVEED was licensed from Bayer Schering Pharma AG, Germany to Indevus Pharmaceuticals, a company Endo acquired earlier this year," framing…
GEN reported Aveed maintained serum testosterone in normal range for up to 10 weeks at steady state and was approved March 6, 2014 with a REMS — "the fourth…
Source summaries from our enrichment pipeline; follow links for originals.
All 6 sources with sentiment breakdown →
Indevus Pharmaceuticals acquired U.S. rights to NEBIDO/Aveed (testosterone undecanoate), a long-acting injectable testosterone, from Schering AG (Germany) in July 2005. Terms: up to $30M in upfront and milestone payments ($7.5M upfront, $5M on FDA approval, plus regulatory/commercialization milestones) and 25% of net sales to Schering. Endo Pharmaceuticals later inherited the U.S. rights through its 2009 acquisition of Indevus; Aveed was approved by the FDA in March 2014 with a REMS.
Male hypogonadism is the clinical syndrome resulting from failure of the testes to produce physiologic testosterone and/or normal sperm, classified as primary (testicular) or secondary (hypothalamic-pituitary). Prevalence rises sharply with age and metabolic comorbidities, driving symptoms of fatigue, sexual dysfunction, sarcopenia and bone loss that until 2014 lacked a long-acting injectable option in the US.
In 2005 the US testosterone replacement therapy market was led by AbbVie/Solvay's AndroGel (testosterone 1% gel, ~$700M+ peak sales), Auxilium's Testim gel, Endo's Fortesta gel ($65.86M in 2013 per https://www.genengnews.com/news/endo-testosterone-replacement-therapy-aveed-wins-fda-approval/), GSK's Androderm patch, and short-acting intramuscular esters (testosterone cypionate, enanthate) requiring injections every 1–2 weeks. Schering AG's testosterone undecanoate — branded Nebido in Europe after Finnish approval in November 2003 and EU mutual-recognition completion in July 2004 — offered a long-acting depot dosed only ~5 times per year, a major adherence advantage. Indevus Pharmaceuticals (the actual US licensee, later acquired by Endo in 2009 for ~$370M plus up to $267M in NEBIDO/octreotide milestones) acquired US rights from Bayer Schering Pharma AG in July 2005. The asset endured three FDA Complete Response Letters (2008, 2009, 2013) over POME/anaphylaxis concerns before approval as Aveed in March 2014 with a REMS, and by the early 2020s oral testosterone undecanoate competitors Jatenzo, Tlando and Kyzatrex eroded the long-acting injectable's structural advantage.
| Deal | Year | Value | Outcome |
|---|---|---|---|
| Indevus Pharmaceuticals, Inc. / Schering AG (this deal) | 2005 | $30M | — |
| Indevus Pharmaceuticals, Inc. / Valera Pharmaceuticals Inc. | 2006 | $120M | — |
| AstraZeneca PLC / KuDOS Pharmaceuticals Limited | 2005 | $210M | 98 |
| Yamanouchi Pharmaceutical / Fujisawa Pharmaceutical Co. Ltd. | 2005 | — | 92 |
| Sankyo Co., Ltd. / Daiichi Pharmaceutical Co., Ltd. | 2005 | $8.0B | 92 |
| Cephalon Inc. / Salmedix, Inc. | 2005 | $160M | 89 |
| Roche Holding AG / GlycArt Biotechnology AG | 2005 | $182M | 80 |
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