On August 30, 2017, the U.S. Food and Drug Administration (FDA) announced what they called a “historic action” – the first approval in an expected wave of novel and highly personalized therapies that target cancer and other deadly diseases in an entirely new way, by modifying a patients' own cells to fight them. Novartis’ Kymriah, a T-cell therapy that uses groundbreaking chimeric antigen receptor (CAR) technology, was approved for limited use in children and young adults with acute lymphoblastic leukemia. Just seven weeks later, Gilead Sciences followed suit on the heels of its $11.9 billion acquisition of Kite Pharma with a second CAR-T cell therapy approval, Yescarta, for the treatment of adult patients with diffuse large B-cell lymphoma.
These approvals are validation of an entirely new model of human therapy that is gaining momentum and promises to shake up the biopharmaceutical industry beyond patient treatment. Although the up-front cost is high – $475,000 for a course of treatment with Kymriah in the U.S. and $373,000 for Yescarta – supporters assert that the costs are justified based on potentially curative results. New models of pricing and reimbursement are already under discussion that would take into account factors such as individual patient outcomes. At the same time, other forms of immunotherapy, such as antibody conjugates, are continuing to win approval. Even newer therapies such as gene therapy are also advancing.
Please join Foley for our upcoming web conference, which will explore the business and legal landscapes of CAR-T and other cell-based immunotherapies, including:
- Factors that investors should consider when looking at immunotherapy companies to assess their long-term prospects, including the extent to which existing healthcare systems may impact their success in comparison to traditional antibody conjugates or other therapies such as gene therapy
- Subject matter eligibility and patent protection for immunotherapeutic inventions, options for fast-track review via the U.S. Patent and Trademark Office’s “Patents 4 Patients” Cancer Immunotherapy Pilot Program, and alternative monetization strategies
- The FDA’s commitment to supporting the development of cell-based therapies, pathway options for expedited approval, and other regulatory considerations
- How payors will respond to CAR-T, what is needed to justify the value and expense of the dramatically higher-priced gene therapy under an outcomes-based approach to reimbursement, and the likelihood for alternative payment models
- The viability of immunotherapies as a profitable, sustainable business strategy, given that one-time treatments to small, targeted patient populations limits the chances for drug companies to recoup their investment, and the role technologies like CRISPR may play in lowering development costs
Foley's presenters will be joined during the program by Richard Warburg, PhD, Managing Director, Intellectual Property & Licensing, Auven Therapeutics.
There is no fee to attend this program, but advance registration is required. Please let us know if you can attend by clicking here.
Foley & Lardner LLP will apply for CLE credit after the program, wherever applicable. Foley & Lardner LLP certifies that this activity has been approved for California MCLE credits by the State Bar of California. Foley & Lardner LLP is a State Bar of California MCLE approved provider. New York licensed attorneys admitted two years or less are not eligible to earn CLE credit through nontraditional formats. This program is appropriate for experienced New York attorneys only. Certificates of attendance will be distributed to eligible participants approximately eight weeks after the web conference via email.
Special Instructions for Kansas/New York/New Jersey CLE Credit
Those seeking Kansas, New York, and/or New Jersey CLE Credit are also required to complete an Attorney Affirmation Form. On the form, please be sure to enter the CLE code that will be provided during the presentation. Please email the form to Allison Jones at ajones foley.com immediately following the program.