Indevus Pharmaceuticals Inc. gained U.S. rights to Nebido, an injectable treatment for hypogonadism developed and previously launched in Europe by Berlin-based Schering AG.
Terms call for Indevus to handle all activities relating to U.S. approval of Nebido, with Schering responsible for manufacturing and supplying the product. Indevus will pay up to $30 million, including a $7.5 million up-front fee and a $5 million payment upon marketing approval. Schering would be entitled to a percentage of net sales that would cover manufacturing costs and royalties.
Indevus could not immediately be reached for comment. The company's stock (NASDAQ:IDEV) gained 7 cents Friday to close at $3.18.
Nebido, the first injectable drug to require dosing only once every three months, has demonstrated in clinical trials the ability to reduce symptoms associated with testosterone deficiency, while maintaining a steady level of testosterone for a three-month period. Because it already achieved regulatory approval in Europe, Nebido has substantial clinical data behind it, and Indevus plans to move rapidly toward submitting a new drug application, anticipated during the second half of 2006.
The testosterone-replacement therapy is expected to be a strategic fit with Indevus' developing pipeline of urology and infectious disease drugs. Nebido also is intended to complement the marketing efforts for Sanctura, an approved drug to treat overactive bladder.
The Lexington, Mass.-based company recently agreed to the transfer of Sanctura marketing rights from Odyssey Pharmaceuticals Inc., of Florham Park, N.J., to Esprit Pharma Holding Co. Inc., formerly called Saturn Pharmaceuticals Inc. Indevus and Esprit hold co-promotion rights, though Indevus gained increased royalty payments through the transferred sales agreement, as well as an option to co-promote one of Esprit's products in the future.
Indevus reports that an estimated 4 million to 5 million men in the U.S. suffer from hypogonadism, a condition characterized by a loss or absence of testosterone secretion that can lead to decreased sexual desire, muscle loss and an increased risk to develop osteoporosis. But only about 5 percent of men with hypogonadism are undergoing testosterone-replacement therapy. Indevus said it hopes the convenience and compliance of Nebido will increase treatment in the overall market.
While preparing to start late-stage development on Nebido, the company also continues work on its other products, such as an extended-release version of Sanctura that requires once-daily administration compared to twice per day. That product, designated Sanctura XR, completed a Phase II trial earlier this year and heads into Phase III development. The company's microbicide product, PRO 2000, aimed at preventing HIV infection, received funding from the UK government for a Phase III study in four African countries. Indevus recently initiated a Phase II study of pagoclone, a non-benzodiazepene, selective GABA-A receptor agonist designed to control stuttering, and has started Phase I programs of IP 751, a synthetic cannabinoid to treat interstitial cystitis, and of aminocandin, a product to treat systemic fungal infections.
Indevus plans to discuss the Nebido acquisition during its second-quarter earning call next week. The company reported a net loss of $9.7 million for the first quarter of 2005. As of March 31, its cash, cash equivalents and short-term investments totaled $117.5 million.