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for recruitment and retention of highly qualified scientific and management personnel;
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for qualified subjects for our clinical studies of our drug candidates, which may result in longer and more costly clinical trials;
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with competitors’ drugs that may result in effective, commercially successful treatments for the same cancers we target; and
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for partners to co-develop and advance our drug candidates through all stages of development.
In the area of small molecule anti-cancer therapeutics, we have identified a number of companies that have clinical development programs and focused research and development in small molecule approaches to cancer, including: Amgen, Inc. Ariad Pharmaceuticals, Inc., Astellas Pharma, Inc., Array BioPharma Inc., Astex Therapeutics, Cell Therapeutics, Inc., Curis, Inc., Exelixis, Inc., Evotec AG, FORMA Therapeutics, Gilead Sciences, Inc., Incyte Corporation, Infinity Pharmaceuticals, Inc., Novartis, Pfizer, Principia Biopharma, Inc., Roche, Sunesis Pharmaceuticals, Inc. and many others.
In addition, with respect to tivantinib, we are aware of a number of companies that are or may be pursuing a number of different approaches to MET inhibition, including Amgen, AstraZeneca/Hutchison MediPharma, AVEO Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Exelixis, Incyte Corporation, Gilead Sciences, Johnson & Johnson, Merck, Mirati Therapeutics, Pfizer, Roche, Takeda and others. With respect to second line HCC, our most advanced indication, we are aware of a number of companies with products under development, including AbbVie, Bristol-Myers Squibb, Celgene Corporation, Dainippon Sumitomo, Eisai Co., Eli Lilly, Exelixis, Incyte Corporation, Merck, Novartis, Polaris Group, Roche, Servier, and 4SC AG. In addition, Bayer’s drug, regorafenib, is approved for second line HCC treatment,
With respect to ARQ 087, we are aware of a number of companies that are or may be pursuing a number of different approaches to FGFR inhibition, including Ariad Pharmaceuticals, Astra Zeneca, Bayer, BioClin Therapeutics, Debiopharm, Boeheringer Ingelheim, Eisai, Five Prime, Incyte Corporation, Johnson & Johnson, Novartis, Pfizer, Principia Biopharma, Servier and Taiho. With respect to iCCA, our lead indication for ARQ 087, we are aware of a number of companies with products under development, including Agios Pharmaceuticals, Inc., Bayer, Bristol Meyers Squibb, Cellact Pharma Gmbh, Concordia Healthcare, Dainippon Sumitomo, Delcath Systems, Inc., Exelixis, Novartis, Oncotherapy Services, Inc. and Spectrum Pharmaceuticals, Inc.
Regarding ARQ 092, we are aware of a number of companies that are or may be pursuing different approaches to AKT inhibition, including Astra Zeneca, Bayer, Eli Lilly, Merck, Novartis, Rexahn and Roche. Moreover, numerous companies have pursued and are pursuing inhibitors of PI3K and mTOR, two kinases in the PI3K-AKT-mTOR pathway; these drugs include Idelalisib, an approved PI3K inhibitor, and Everolimus, Temsirolimus and Rapamycin, approved mTOR inhibitors.
With respect to ARQ 531, we are aware of a number of companies that are or may be pursuing different approaches to C481S-mutant BTK inhibition, including Aptose Biosciences Inc., RedX Pharma PLC, Roche and Sunesis Pharmaceuticals. Moreover, numerous companies are also pursuing inhibitors of wild type BTK, including AbbVie with its drug, IMBRUVICA™. Other companies with BTK inhibitors currently in development include Astra Zeneca, BeiGene, Ltd., EMD Merck, Eli Lilly, Gilead, Principia Biopharm and others. Other approved drugs that may compete to treat ibrutinib refractory patients, including patients with C481S-mutant BTK, include AbbVie’s Bcl-2 inhibitor, VENCLEXTA™.
There can be no assurance that our competitors will not develop more effective or more affordable products or technology or achieve earlier product development and commercialization than ArQule, thus rendering our technologies and/or products obsolete, uncompetitive or uneconomical.
GOVERNMENT REGULATION
Virtually all pharmaceutical and biotechnology products that our collaborative partners or we develop will require regulatory approval by governmental agencies prior to commercialization. The nature and the extent to which these regulations apply vary depending on the nature of the products. In particular, human pharmaceutical products are subject to rigorous preclinical and clinical testing and other approval procedures by the FDA or the applicable regulatory authorities in countries other than the U.S. Various