Indevus Pharmaceuticals Inc. licensed worldwide rights to aminocandin, a broad-spectrum antifungal compound, to infectious disease firm Novexel SA in a potential $44.5 million deal.
Novexel is a 2004 spinout of Paris-based Sanofi-Aventis Group, which originally out-licensed the drug to Indevus in 2003 for development in systemic, invasive infections.
"Our strategy back then was a little bit different," said Brooke Wagner, vice president of corporate communications for Lexington, Mass.-based Indevus. "We had more of a broad-based focus in bringing drugs into the company to move forward."
Since then, however, the firm gained FDA approval for its overactive bladder drug, Sanctura, and added to its pipeline two products for male hypogonadism: Delatestryl, a marketed injectable purchased from East Brunswick, N.J.-based Savient Pharmaceuticals Inc., and Nebido, a long-acting injectable from Berlin-based Schering AG.
"Since our focus is in urology and men's health, it became our objective to out-license [aminocandin] to a company with an infectious disease focus," Wagner told BioWorld Today, and Novexel is "ideally positioned to devote the required resources" to the product's development.
Indevus will receive a $1.5 million up-front payment, an additional $2 million upon initiation of Phase II trials with aminocandin - Wagner said Novexel anticipates beginning Phase II work in 2008 - and up to $41 million in milestones. Upon commercialization, Indevus would be entitled to "tiered, single-digit" royalty, he said.
About 8 million people worldwide are affected by some form of fungal infection. The system infections market is about $3.5 billion, and that figure is expected to grow to $4.5 billion within the next three years.
Aminocandin, a member of the echinocandin class, is designed to kill fungi and to act against multiple infections, such as aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, cryptococcosis and zycomycosis. In addition to its broad-spectrum activity, the compound "also has a long half-life, so it's believed that it has the potential as a prophylactic treatment," Wagner said. "It's a drug with great potential."
Indevus conducted Phase I testing of the compound with promising results, though some incidences of local vein irritation at the injection site prompted the company to develop some new formulations.
"Novexel may do some more [preclinical] work on that, but their intention seems to be to get it back in the clinic as quickly as they can," Wagner said.
Aminocandin will join Novexel's early stage pipeline, which also includes NXL103, an oral streptogramin in Phase I against respiratory pathogens, and NXL101, a topoisomerase inhibitor aimed at treating hospital Gram-negative infections with high morbidity and mortality rates, which also is in Phase I.
After out-licensing aminocandin, Indevus has five products in development, leading off with Sanctura XR, a once-daily formulation for overactive bladder that is awaiting FDA approval.
The company also has two ongoing Phase III studies of male hypogonadism drug, Nebido, with results expected in May and a new drug application anticipated in the summer of 2007.
Two Phase III studies also are ongoing with PRO 2000, a topical microbicide designed to prevent transmission of HIV and other sexually transmitted diseases. Those trials are being conducted in Africa and are funded by the UK's Medical Research Council and the National Institutes of Health.
Indevus also has pagaclone, a GABA selective receptor modulator, which is preparing to start Phase III development in persistent development stuttering and is hoping to get back into Phase I testing of IP 751, an anti-inflammatory and analgesic compound for interstitial cystitis.
The company reported a net loss of $13.4 million, or 28 cents per share, for the three months ending June 30. At that time, it had cash and cash equivalents of $53.3 million, though the firm brought in an additional $34.8 million in a July equity financing.
Shares of Indevus (NASDAQ:IDEV) gained 28 cents Wednesday to close at $7.88.