Press Release: Indevus and Sanofi-Aventis' Spin-Out Company, Novexel, Out-license Anti-fungal
Indevus and Sanofi-Aventis' Spin-Out Company, Novexel, Announce Out-licensing of Aminocandin Anti-fungal LEXINGTON, Mass., and PARIS, Dec. 5 -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV - News) and Novexel, S.A. today announced that they 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 totaling 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, gynecology 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 favorable 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. About aminocandin and the anti-fungal market 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. About Indevus Indevus Pharmaceuticals is a biopharmaceutical company engaged in the acquisition, development and commercialization of products to treat urological, gynecological and men's health conditions. The Company currently co-promotes SANCTURAÂ® for overactive bladder and markets DELATESTRYLÂ® to treat male hypogonadism and currently has six compounds in clinical development. The compounds in development include SANCTURA XR(TM), the once-daily formulation of SANCTURA, NEBIDOÂ® for the treatment of male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens, IP 751 for interstitial cystitis, pagoclone for stuttering, and aminocandin for systemic fungal infections. Except for the descriptions of historical facts contained herein, this press release contains forward-looking statements that involve risks and uncertainties that could cause the Company's actual results and financial condition to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties are set forth in the Company's filings under the Securities Act of 1933 and the Securities Exchange Act of 1934 under "Risk Factors" and elsewhere, and include, but are not limited to: dependence on the success of SANCTURAÂ® and SANCTURA XR(TM); the early stage of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA, SANCTURA XR and NEBIDOÂ®; risks associated with contractual agreements, particularly for the manufacture and co-promotion of SANCTURA and SANCTURA XR; dependence on third parties for manufacturing, marketing, and clinical trials; competition; need for additional funds and corporate partners, including for the development of our products; failure to acquire and develop additional product candidates; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related litigation; our reliance on intellectual property and having limited patents and proprietary rights; dependence on market exclusivity; valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; and other risks. About Novexel Novexel is a pharmaceutical company that researches and develops novel class anti-infectives for the treatment of severe and difficult to treat bacterial and fungal infections. The Company has an extensive portfolio of anti-bacterial and anti-fungal compounds, R&D programs, and intellectual property. Novexel's focus is on novel anti-microbial compounds with activity against multi-resistant organisms, and with a low propensity to generate resistance, together with core expertise in Biology, Medicinal Chemistry, Pharmacology, Microbiology and Clinical Development. This combination positions the Company at the forefront of the discovery and development of novel therapies for infectious disease. At inception, the Paris-based company inherited an advanced portfolio of anti-infective programs and intellectual property, and has received 40 million euros in financing from an international group of leading life science investors led by Atlas Venture and including Sofinnova, 3i, Abingworth and Novo A/S. Novexel's assets include four compounds in formal development. The oral Streptogramin compound NXL103 entered a Phase I multi-dose study in October 2005. In addition to NXL 103, NXL101, an entirely new chemical class topoisomerase inhibitor for the treatment of Gram+ve bacterial infections including MRSA. The Company's preclinical development pipeline includes NXL104, a novel non-beta-lactam beta-lactamase inhibitor for the treatment of nosocomial infections.