Over the past few years economic headwinds have resulted in fewer deals, with companies and private equity firms alike reassessing where to spend money. But one portion of the pharmaceutical industry is bucking this trend in a major way. Since 2018, licensing deals totaling over US$60 billion have been signed regarding ADCs, with 2023 alone having at least 18 deals. As a result, worldwide ADC sales are projected to reach US $20-30 billion per year in the near future.

ADCs are a class of chemotherapy medicines used in the treatment of cancers. These drugs combine an antibody and cancer treating drug to minimize the impact of chemotherapy on the healthy tissue in patients, while maximizing their impact on the cancer. The antibody is chosen to target the specific cancers cells and guide the cancer drug to the specific part of the body requiring treatment. Earlier cancer treatments were unable to localize the impact of the powerful chemotherapy drugs and caused more collateral damage in the body. ADCs do a better job of specifically targeting the part of the body being treated. This can also lead to a smaller dose of the cancer drug in the body, further reducing the overall negative impact on the patient while still treating the cancer.

ADCs are not a new technology, as the first ADC was approved in 2000 to treat leukemia. Continued development of the technology has given regulators, pharmaceutical companies, and doctors more confidence in the clinical efficacy of these treatments. More than 140 new ADCs are currently in clinical development.

The rapid expansion of this area of technology raises many business and legal questions. We will explore many of these throughout the upcoming articles in this series. These topics include:

1. Issues related to deals and licensing for ADCs/antibody therapeutics
2. Patent/IP challenges to consider for ADCs/antibody therapeutics
3. Clinical trial issues for ADCs/antibody therapeutics
4. FDA/regulatory issues for ADCs/Antibody therapeutics
5. Litigation issues for ADCs/antibody therapeutics