Written for and originally published on BioSpace
BioSpace recently spoke with James Oliviero, CEO and president at Checkpoint Therapeutics, an immuno-oncology, late-stage development company. The company’s goal is to bring novel cancer drugs to market to be commercialized at a lower price point than its big pharmaceutical company competition.
Q: What are your daily activities as CEO and president?
A: We’re a small company so my role is very much hands-on. That's part of my personality as well. I like to have my finger on the pulse of the different aspects of the company. I would say half the job of a CEO in a publicly traded biotechnology company is on the investor outreach and relations front, presenting the company to the investment community. And then the other half of the time is managing your development programs and overseeing the company. I am heavily involved in working with my team to design our clinical trials and manage the clinical research organizations that we outsource to.
Q: What background do you have in biotech?
A: My love is clinical development; bringing new, potentially life-saving therapies to the patients who need them. I joined Checkpoint in 2015 after successfully developing and launching a new drug at my former company. I was attracted to Checkpoint for its interesting and cutting-edge pipeline of immunotherapy products. Cancer affects too many of us in so many ways, and so I’m driven to bring our oncology drugs to market and have a positive impact on our world.
Q: What is Checkpoint’s business model?
A: Checkpoint does not discover or invent its products. We license or acquire the rights to novel therapeutics at an early stage of development from academic institutions or other small biotechnology companies. Our most advanced immunotherapy product, cosibelimab, was licensed from the Dana-Farber Cancer Institute in 2015. Dana-Farber employs the scientists that discovered our novel antibody. After obtaining rights to our product candidates, we then conduct the necessary pre-clinical studies, including pharmacology and animal toxicity studies, and manufacturing development, to enable a clinical development program in humans. We use and manage contract clinical research organizations and contract manufacturers to conduct our pre-clinical and clinical development programs.
Q: What is your pricing strategy?
A: Maybe 10 years ago, large pharmaceutical companies would charge $50,000 per patient, per year for a novel oncology drug. So why are they charging $165,000 annually now? It's not because it's so much more expensive to manufacture and develop these drugs. It’s because big pharmaceutical companies need to charge such inflated prices in order to support and continue to grow their large market values. If they lowered their prices, you would see their market capitalizations quickly reflect it in a negative way.
As a small company, we can price substantially lower and our profit margins will be plenty sufficient for us to continue to grow substantially. Our strategy is good for Checkpoint and for the entire health care system, from the insurance companies to patients who can pay up to 20% of the price of a drug as a co-insurance payment. It's a very novel commercialization strategy in oncology. We've already conducted surveys with insurance companies regarding our planned pricing strategy, asking how will you, the insurance company, position our product to help us help you?
We know insurance companies want lower-priced drugs that are comparable in safety and efficacy to established products. And they responded that they would provide our lower-priced products with preferred reimbursement coverage or removal of restrictions on use, effectively positioning our product as first-choice therapy on their formularies, which can influence and increase patient access without the need for a large salesforce on our part. Again, it's truly a unique strategy that hasn't been done before in oncology.
Q: You mentioned that Checkpoint is a fast follower. What does that mean?
A: Part of our strategy in our clinical development is that we're utilizing a fast-follower approach. What that means is when we license our lead immunotherapy product from Dana-Farber, other drugs in the same class are ahead of us or approved. We can use this to our advantage and compare the drugs that we license against them to ensure that we have a drug that is comparable or better than the ones that are out there already. We're just following the path through clinical trials that they've already established. That's what's called a fast-follower approach.
This approach enables us to move very quickly through clinical development as compared to other products. Meanwhile, the FDA has been vocal about bringing competition into the market to lower prices, and we believe the FDA will appreciate our lower price point strategy.
Q: Anything I haven’t asked?
A: We’ve quickly transitioned into a late clinical-stage oncology company and anticipate 2021 to be a transformational year for us. We’re expecting to report pivotal data on cosibelimab by year-end. With a successful study result, we intend to file an application for marketing approval with the FDA early next year.
Upon successfully obtaining marketing approval, our plan is to commercialize our approved products ourselves, at least in the United States. We'll likely evaluate potential commercialization partners for Europe and Asia for our programs. We're looking to change the world, coming out with novel drugs to help patients in need, but also doing so at a fair price point that allows our company and the healthcare community to benefit.