Indevus Pharmaceuticals, Inc. and Novexel, S.A. have signed a definitive agreement whereby Indevus will out-license the worldwide rights to aminocandin to Novexel.
Indevus originally licensed worldwide rights to aminocandin from sanofi-aventis in 2003. Aminocandin is a member of the echinocandin class of anti-fungal compounds for the treatment of a broad spectrum of systemic, invasive infections.
The terms of the agreement provide Indevus with an up front payment of $1.5 million, a payment of $2.0 million upon initiation of phase II clinical trials, potential milestones totalling an additional $41.0 million and royalties on all future sales of aminocandin. Additionally, Indevus will be relieved from making significant milestone and royalty payments to its licensor. Novexel will be responsible for all future development, manufacturing and commercialization activities and costs.
"Aminocandin is a product with tremendous potential and we are extremely pleased that we have the ideal partner in Novexel who can realize this opportunity," said Glenn L. Cooper, M.D., chief executive officer and chairman of Indevus. "For several months we have said our objective was to find a partner exclusively focused on infectious diseases that could devote the required resources to the development of aminocandin. Novexel, having been created out of the anti-infective unit of sanofi-aventis, is solely focused on developing compounds such as aminocandin and therefore the product is a perfect fit into their portfolio."
"We are excited to see aminocandin in the hands of a company with the experience, focus and know-how to maximize its potential," continued Dr. Cooper. "This agreement enables Indevus to further focus its portfolio of urology, gynaecology and men's health products and realize future economic benefits in a passive manner."
"We are very pleased to return aminocandin to our extensive portfolio of anti-bacterial and anti-fungal compounds," stated Iain Buchanan, chief executive officer of Novexel. "This compound is entirely consistent with our mission to become a company dedicated to the hospital anti-infective market. Novexel will remain focused on the discovery, development and rapid progression to market of novel anti-bacterial and anti-fungal assets. Aminocandin will become an important asset in our broad portfolio and we look forward to continuing the development of this product."
Indevus commenced multi dose phase I studies of aminocandin in October 2004 and showed a favourable pharmacokinetic and systemic safety profile, but the study was subsequently interrupted due to observed cases of local vein irritation. Indevus has since developed new formulations that may overcome this issue.
Indevus originally licensed worldwide rights to aminocandin from sanofi-aventis in 2003. In late 2004, sanofi-aventis assigned the original license agreement to Novexel along with a number of other anti-infective assets, and therefore, Novexel was serving as the licensor of the aminocandin rights.
Aminocandin is a member of the echinocandin class of anti-fungal compounds for the treatment of a broad spectrum of systemic, invasive infections. This class of compound is designed to be fungicidal, that is, to kill fungi rather than fungistatic (to inhibit their growth), and to have broad-spectrum activity against multiple fungal organisms that cause serious systemic infections. Examples of such infections include aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, cryptococcosis and zycomycosis.
Aminocandin has been shown to maintain its activity in circulation for long periods potentially permitting fewer treatments and better compliance. This is in contrast to other echinocandins, which require frequent dosing. The broad spectrum and predicted therapeutic window will potentially allow empirical use of this drug. This would allow early patient treatment even before the identification of the infectious agent. Thus, the Company believes the profile of this compound will be very competitive with other classes of anti-fungal agents and with other echinocandins.
Systemic fungal infections are serious and invasive infections that spread throughout the body causing severe disease in one or more organs, including the blood. These types of fungi affect immunocompromised patients, such as HIV/AIDS patients, transplant patients and cancer patients, and often lead to death. Superficial infections are less serious and normally affect the skin, hair, nails and mucous membranes. Today, there are an estimated 8 million patients worldwide with some form of fungal infection. The global market to treat systemic infections currently represents $3.5 billion and is projected to continue growing to $4.5 billion in the next three years.
There has recently been a growing interest in the anti-fungal market with the spread of the patient population as a result of an increase in the number of transplant recipients and patients receiving chemotherapy, as well as a rise in the HIV population. The standard of care in treating fungal infections is through the use of a class of compounds known as azoles, which were introduced in the 1970s. These products reduce the growth of fungi, but are limited by the inability for long-term use as patients often develop a rapid resistance to these therapies. Another class of antifungal compounds, polyenes, includes an agent known as amphotericin, are used as first-line treatment for certain infections.
Treatment with these agents simply inhibits the spread of the infection. Furthermore, strains of fungi resistant to these agents can develop, leaving patients resistant to therapy. Importantly, patients can experience adverse events in connection with use of these agents as well. Despite the growing patient population and continuing need for new and improved treatment options, physicians had limited treatment options until the introduction of the echinocandins, a new class of anti-fungals, in 2001. Unlike the azoles and polyenes, echinocandins are fungicidal and are designed to have broad-spectrum activity against the fungi that cause serious systemic infections.