Table of Contents
of the companies against which we are competing or against which we may compete in the future have significantly greater financial resources and expertise in research and
development, manufacturing, preclinical studies, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical
and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant
competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with us in recruiting and retaining qualified scientific and
management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or that may be necessary for, our
key competitive factors affecting the success of all of our product candidates, if approved, are likely to be their efficacy, safety, convenience, price, the level of generic
competition and the availability of reimbursement from government and other third-party payors.
commercial opportunity could be reduced or eliminated if our competitors develop and commercialize drugs that are safer, more effective, have fewer or less severe side effects, are
more convenient or are less expensive than any drugs that we may develop. Our competitors also may obtain FDA or other regulatory approval for their drugs more rapidly than we may obtain approval for
ours, which could result in our competitors establishing a strong market position before we are able to enter the market. In addition, our ability to compete may be affected in many cases by insurers
or other third-party payors seeking to encourage the use of a lower cost alternative for the indication, including generic drugs. Generic drugs for the treatment of the indications on which we
currently plan to initially focus are currently on the market, and additional drugs are expected to become available on a generic basis over the coming years. If we obtain marketing approval for our
product candidates, we expect that they will be priced at a significant premium over competitive generic drugs.
our product candidates may compete with many existing drugs and other therapies, to the extent they are ultimately used in combination with or as an adjunct to these therapies, our
product candidates will not be competitive with them. Some of the currently-approved drug therapies are branded and subject to patent protection, and others are available on a generic basis. Many of
these approved drugs are well-established therapies and are widely-accepted by physicians, patients and third-party payors.
our product candidates are approved, they will compete with currently marketed drugs and potentially with product candidates currently in development focusing on the same mechanism of
action which include:
HSD1: We believe that Bristol-Myers Squibb Company, or BMS, Eli Lilly & Co., and Roche Holding AG are studying their
11b HSD1 inhibitors in clinical trials.
- BACE: We believe that Merck & Co., AstraZeneca PLC and
Eisai Co., Ltd. in collaboration with Biogen Idec are studying BACE inhibitors in clinical trials.
- RORgt: We believe that a number of
including large pharmaceutical companies and large biotech companies are actively assessing RORgt inhibitors in preclinical studies.
- LXRb: We believe that BMS is studying an
LXRb inhibitor in cardiovascular clinical trials and Alexar Therapeutics, Inc. is developing an LXRb inhibitor for
We do not have any manufacturing facilities or personnel. We rely on third parties for the manufacture of our product candidates for
preclinical studies and clinical trials, as well as the commercial manufacture if our product candidates receive marketing approval. We obtain our supplies from these manufacturers on a purchase order
basis and do not have long-term supply arrangements in place. For all of the product candidates being developed by us, we intend to identify and qualify additional manufacturers to provide the active
pharmaceutical ingredient, or API, and fill-and-finish services prior to