Exelixis, Inc., Eli Lilly and Company, FORMA Therapeutics, Gilead Sciences, Inc., GlaxoSmithKline plc, Incyte Corporation, Infinity Pharmaceuticals, Inc., Johnson and Johnson, Merck, Merck KGaA, Novartis AG, Pfizer, Inc., Principia Biopharma, Inc., the Roche Group, Sunesis Pharmaceuticals, Inc., Takeda Pharmaceuticals Co. Ltd., and many others.
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., Roche and Sunesis Pharmaceuticals. Moreover, numerous companies are also pursuing inhibitors of wild-type BTK, including AbbVie with its drug, IMBRUVICA, and AstraZeneca with its drug, CALQUENCE. Other companies with BTK inhibitors currently in development include Astra Zeneca, BeiGene Co., Ltd., Merck KGaA, Eli Lilly, Gilead, GlaxoSmithKline, Principia Biopharma 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, and Verastem Oncology’s COPIKTRA.
With respect to miransertib (ARQ 092) in rare diseases, we believe Roche is developing taselisib for PIK3CA-Related Overgrowth Syndromes (PROS). Regarding miransertib in oncology, 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 Pharmaceuticals, Inc. 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 derazantinib (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 Astra Zeneca, Bayer, BioClin Therapeutics, Debiopharm Group, Boehringer Ingelheim International GmbH, Eisai Co., Ltd., Five Prime Therapeutics, Incyte, Johnson & Johnson, Novartis, Pfizer, Principia Biopharma, Servier and Taiho Oncology. 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 Healthcare Pharmaceutical, Bristol-Myers Squibb, Cellact Pharma Gmbh, Concordia Healthcare, Dainippon Sumitomo Pharma Co., Ltd., Delcath Systems, Inc., Exelixis, InCyte, Novartis, Oncotherapy Services, Inc. and Spectrum Pharmaceuticals, Inc.
Even if we are successful in bringing products to market, we face substantial competitive challenges in effectively marketing and distributing our products. Companies and research institutions, including large pharmaceutical companies and biotechnology companies with significantly much greater financial resources and more experience in developing products, conducting clinical trials, obtaining FDA and foreign regulatory approvals and bringing new drugs to market are developing products within the field of oncology. Some of these entities already have competitive products on the market or product candidates in more advanced stages of development than we do. By virtue of having or introducing competitive products on the market before us, these entities may gain a competitive advantage. In addition, there may be product candidates of which we are not aware at an earlier stage of development that may compete with our product candidates. Some of our competitors have entered into collaborations with leading companies within our target markets.
We are in a rapidly evolving field of research. Consequently, our technology may be rendered non-competitive or obsolete by approaches and methodologies discovered by others, both before and after we have gone to market with our products. We also face competition from existing therapies that are currently accepted in the marketplace and from the impact of adverse events in our field that may affect regulatory approval or public perception.
We anticipate that we will face increased competition in the future as new companies enter the market and advanced technologies become available. If we are unable to successfully compete in our chosen field, we will not become profitable.
We may not be able to recruit and retain the scientists and management we need to compete.
Our success depends on our ability to attract, retain and motivate highly skilled scientific personnel and management, and our ability to develop and maintain important relationships with leading academic institutions, clinicians and scientists. We are highly dependent on our senior management and scientific