Our first family of complement inhibitor patent applications includes fourteen issued
U.S. patents. We have received an issued U.S. patent covering the composition of matter on our lead drug candidate,
ACH-4471,
and its medical use (U.S. Patent No. 9,796,741). We have also received
thirteen additional U.S. patents covering other factor D inhibitors (U.S. Patent Nos. 9,598,446, 9,643,986, 9,663,543, 9,695,205, 9,732,103, 9,732,104, 9,758,537, 9,828,396, 10,005,802, 10,081,645, 10,087,203, 10,100,072, and 10,106,563).
Two of the subfamilies in the first family of complement inhibitor patent applications are currently pending in a number of
foreign jurisdictions including the major market countries (China, Australia, Canada, Japan and South Korea) and three regional patent offices (European Patent Office, or EPO, African Regional Patent Office, or ARIPO, and Eurasian Patent Office, or
EAPO).
Our second family of complement inhibitor patent applications covers several of our most advanced complement factor D
inhibitors, including
ACH-5228
as well as an issued composition of matter U.S. patent on
ACH-5548.
This family has five issued U.S. patents covering factor D inhibitors
(U.S. Patent Nos. 10,000,516, 10,011,612, 10,092,584, and 10,138,225,10,011,516). Selected applications are currently pending in a number of foreign jurisdictions including the major market countries (China, Australia, Canada, Japan and South Korea)
and three regional patent offices (EPO, ARIPO, and EAPO).
Our third family of complement inhibitor patent applications was
entered into the international phase with PCT applications in August 2016 and then entered into the national phase of prosecution in February 2018.
Our fourth family of complement inhibitor patent applications was entered into the international phase with PCT applications in March 2018 and will enter the national phase of prosecution in September
2019.
We rely on trade secrets to protect our technology, especially where we do not believe patent protection is appropriate
or obtainable. However, trade secrets are difficult to protect. In order to protect our proprietary technology and processes, we also rely in part on confidentiality and intellectual property assignment agreements with our corporate partners,
employees, consultants, outside scientific collaborators and sponsored researchers, and other advisors.
Manufacturing and Supply
We rely on contract manufacturers to produce drug substances and drug products required for our clinical trials under
current good manufacturing practices, or cGMP, with oversight by our internal managers and third parties. We plan to continue to rely upon contract manufacturers and collaboration partners to manufacture commercial quantities of our drug product if
and when approved for marketing by the FDA. We do not have long-term agreements with any of these third parties. If any of our existing manufacturers should become unavailable to us for any reason, we may incur some delay in identifying or
qualifying replacements. We currently manage our supply by having additional inventories on hand that are intended to be available should it become necessary for us to engage alternate sources of supply for clinical trial materials.
Sales and Marketing
We
intend to establish our own sales and marketing capabilities if and when we obtain regulatory approval of our product candidates. In North America and Western Europe, patients in the markets for our product candidates are largely managed by medical
specialists in the areas of immunology, nephrology, and hematology. Historically, companies have experienced substantial commercial success through the deployment of specialized sales forces which can address a majority of key prescribers.
Therefore, we expect to utilize a specialized sales force in North America for the sales and marketing of product candidates that we may successfully develop. We currently have no marketing, sales or distribution capabilities. In order to
participate in the commercialization of any of our product candidates, we must develop these capabilities on our own or in collaboration with third parties. We may also choose to hire a third party to provide sales personnel instead of developing
our own staff.
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