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AbstractA Swiss company seeks partners to assist in completion of preclinical development and transition through Phase I trials of two new products: (i) an antibiotic for intravenous treatment of serious systemic multidrug-resistant Gram-negative infections; and (ii) an antibiotic with a novel mode of action for prophylaxis and topical treatment of infections caused by multidrug-resistant Gram-positive cocci. Data accrued to date indicate that development of both products can proceed rapidly.DetailsThe company, located in Switzerland, in-licenses late preclinical/early clinical-stage compounds targeting multidrug-resistant bacterial pathogens and progresses them through seamless, focused development based on a thorough understanding of their efficacies and safety profiles. R & D invested in anti-infectives has a better track record of successful product launches than most other therapeutic areas due to the relatively high predictivity of clinical efficacy based on in vitro susceptibility testing, animal models of infection, and pharmacokinetics.The company has acquired development rights to two products: (a) A novel antibiotic, belonging to a well-known GRAS drug class, for intravenous treatment of serious systemic Gram-negative infections caused by multidrug-resistant Enterobacteriaceae and non-fermentative bacilli. Gram-negative infections represent both a crucial unmet medical need and a very significant market opportunity. Drugs for treating Gram-negative infections constitute ca. 60% of the overall hospital infections market (valuations between US$ 9.9 billion and US$ 15 billion, according to Datamonitor 2009 and IMS 2007, respectively), with a cumulative annual growth rate of ~15% (based on 2002-2008 figures; Datamonitor 2009). Considering the paucity of anti-Gram-negative drugs in development, this product is set to become an agent of choice for empiric coverage of hospitalized patients at risk of infection with Gram-negative pathogens. (b) An antibiotic, belonging to a unique chemical class and with a novel mode of action, for topical treatment of infections caused by Gram-positive cocci, including multidrug-resistant streptococci, methicillin-resistant staphylococci, and glycopeptide-resistant enterococci. In 2006 the global topical antibiotic market was valued at ~US$800 million [Daum et al., Nat. Rev. Drug Discov. 6: 865 (2007)], dominated by mature products, such as mupirocin and fusidic acid, whose efficacy has eroded with time. The virtues of topical antibacterials were summarized by Cho et al. [J. Invest. Dermatol 131: 907 (2011)], as follows: “ ... topical antibiotic therapy can have an important adjunctive role in the treatment of superficial S. aureus skin infections, such as impetigo, infected lacerations, and in areas with poor blood supply (i.e., diabetic foot ulcers) as well as in the prevention of postsurgical wound infections. Furthermore, topical antibiotics can be used alone for uncomplicated superficial skin infections such as impetigo and infected lacerations, as a higher local concentration of the antibiotic reaches the site of infection and reduces the potential for systemic side effects.” Nearly all anti-Gram-positive compounds currently under development represent incremental improvements over established bacterial classes and are intended for systemic use. Therefore, introduction of a novel topical product highly active against Gram-positive cocci would constitute a very welcome addition to the clinician's antimicrobial armamentarium. Innovative Aspects: The products selected by the company for development represent significant advances in the treatment/prophylaxis of infections caused by multidrug-resistant bacteria, a very serious problem that threatens a return to the pre-antibiotic era unless new therapeutic modalities are identified. Both antibiotics are novel products with a modest cost of goods, very encouraging safety pharmacology profiles, and excellent in vitro and in vivo (animal models of infection) efficacies. Evidence to date suggests low proclivity for endogenous resistance development by both products. Data collected to date indicate that the two experimental products in the company's portfolio will have improved efficacies in their respective clinical indications, representing significant advances in the treatment of multidrug-resistance pathogens compared to antibiotics already on the market. Nearly all anti-Gram-positive compounds currently under development represent incremental improvements over established bacterial classes and are intended for systemic use, so introduction of a novel topical product highly active against Gram-positive cocci would constitute a new treatment approach. Similarly, considering the paucity of anti-Gram-negative drugs in development, the company's product targeting Gram-negative pathogens has the potential to become an agent of choice for empiric coverage of hospitalized patients at risk of infection with multidrug-resistant Enterobacteriaceae and non-fermentative bacilli.
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