Powering the next generation of therapies: A conversation with Astellas US President Mark Reisenauer

Throughout the course of the past year, discussions surrounding the implementation of the Inflation Reduction Act have dominated health care industry circles, including specific provisions within the law and changes needed to continue fostering medical innovation. I recently had the opportunity to sit down with one of our PhRMA board members, Mark Reisenauer, President, Astellas US to discuss promising treatments and the policy reforms that are needed to ensure this critical research and development can continue.

Steve Ubl (SU): Can you touch on some of Astellas' emerging developments from a treatment perspective that you are most excited about? 

Mark Reisenauer (MR): One area that I would say we, as a company, are most excited about is our expanding portfolio of approved and investigational cancer therapies. We remain highly focused on growing the scope and utility of our oncology portfolio and pipeline.

For example, last year we had the opportunity to present positive results from our Phase 3 GLOW trial, evaluating the efficacy and safety of a monoclonal antibody for use in patients with a type of stomach cancer called CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. Stomach cancer is the fifth most diagnosed cancer worldwide, which is why advances like this are so critical.

We also were thrilled to join our partner Pfizer in gaining FDA approval for the combined use of two medicines to treat advanced bladder cancer. Phase 3 data demonstrated that combination nearly doubled the median overall survival for patients compared to chemotherapy.

In addition, Astellas, also in partnership with Pfizer, announced Phase 3 clinical trial data showing our advanced prostate cancer medicine in combination with another drug lowered the risk of metastasis by 58% in patients with non-metastatic hormone-sensitive prostate cancer. Prostate cancer is the most commonly diagnosed cancer in men, after skin cancer.

For these cancers and others, our goal is to pioneer first-in-class treatments that reshape standards of care and help change the course of cancer treatment for patients.

SU: One issue that continues to garner robust bipartisan and public support is pharmacy benefit manager (PBM) reform. What is your primary concern with the way PBMs are allowed to operate, and what changes can be instituted to ensure patients have access to their medicines at the pharmacy counter?

MR: Here in Astellas’ home state of Illinois, we’ve seen policymakers working to rein in PBMs and put patients first. Governor Pritzker created the state’s first comprehensive regulatory framework for PBMs back in 2019, which has already made a difference in helping patients access their medicines and avoid surprises at the pharmacy counter.  

This was an important first step, and we are encouraged to see strong momentum across the states to address PBM tactics and protect patients. However, there is more to be done in the states and at the federal level.

Our primary concern is the lack of transparency and accountability that has allowed PBMs to operate in a black box and raise costs for consumers. PBMs are excluding lower-cost medications from formularies and overcharging patients for medicines they need — all while generating record profits. It’s also vital that compensation for services provided by PBMs be based on a fixed fee, rather than the list price of a medicine (a proposal often referred to as delinking). This will help reduce misaligned incentives in the system.

It’s clear that something needs to be done, and we look forward to further action from policymakers and regulators.

SU: There has been a lot of talk lately about the Inflation Reduction Act's impact on patients' ability to access new and innovative medical treatments. What fixes are needed to the law to help protect patient access to the care they need?

MR: Unfortunately, the Inflation Reduction Act (IRA) is an example of federal policy that may have been well meaning, but will have unintended consequences. As I mentioned, one of Astellas’ primary focus areas is oncology, including medicines targeting prostate, leukemia and bladder cancers. For a mid-sized company like us — and for the patients who rely on our cancer medicines — the IRA’s impacts cannot be ignored.

Perhaps the biggest change needed to the IRA is the timeline for price setting of “small-molecule medicines,” or those that typically come in pill or tablet form. The majority of cancer medicines approved by the FDA are small-molecule medicines, yet the IRA disincentivizes their development. By permitting the selection of these medicines for price setting after just nine years after FDA approval — far earlier than the 13 years post approval for biologic medicines — the IRA will discourage companies from investing in these medicines.

Expanding the number of cancers or stages of disease a medicine can treat takes years of additional clinical research after initial FDA approval.

I referenced earlier our Phase 3 prostate cancer trial (called EMBARK). This research comes 11 years after our oral drug was first approved for one form of advanced prostate cancer.

The trial was scheduled to last four years, but we decided to extend it because we believed in the science. Now, eight years later, these data supported the recent FDA approval of our medicine to treat more prostate cancer patients in earlier stages of the disease.

Under IRA, the business case and ability to invest additional resources and time becomes much more difficult.

We need legislative fixes to ensure companies can make these challenging investment decisions. At the same time, we also need better transparency and predictability in the implementation of the IRA as it currently stands.

SU: The Biden Administration recently unveiled a proposal to give federal agencies the power to take patents away from private companies if they don’t like the prices those companies charge for innovations resulting from any amount of government collaboration. What effect could this announcement on “march-in” rights have on the type of R&D you just described?

MR: The proposed “march-in” framework would deter R&D collaboration between the private sector, academia and the federal government, and discourage the development of future innovative products. And this wouldn’t affect just medicines, but would extend to other technology fields involving government-funded basic research, such as agriculture, clean energy, computer science and AI.

It’s well known that the prostate cancer medicine I mentioned earlier has been in this spotlight, with calls to invoke “march-in” rights on the product being rejected on multiple occasions.

The fact is, this medicine is a prime example of how collaboration between early-stage public research and private development can benefit American consumers — as the Bayh-Dole Act envisioned.

A small amount of government funding helped with the compound’s initial discovery. Astellas and its partners then invested more than $2.3 billion in R&D over more than a decade – with meaningful results for prostate cancer patients, including those announced last year.

Not only would the proposed framework chill the licensing agreements between academia and private companies that are crucial to taking an idea from the lab to the patient, it is hard to fathom a company committing such sustained investments with the knowledge that the product’s patent could be seized by the government at any time.

The U.S. has thrived as an innovation leader because our ecosystem emboldens collaboration and risk-taking. We need to embrace these assets — and work together to fix the true problems in our system that make medicines inaccessible and unaffordable for patients.

Learn more about how our industry is working to improve access and affordability here.