At the foundation of President Atsushi “Andy” Fujimoto’s leadership philosophy is a firm belief that the patient always comes first. Each team member is personally accountable for working to help patients and their families. Andy has been with Mitsubishi Tanabe Pharma Corporation (MTPC) for more than 25 years and has been an integral part of growing its U.S. operations over the last 10 years. He has served as President of Mitsubishi Tanabe Pharma America (MTPA) since its inception in 2016. Prior to his current role, he was Vice President of Corporate Strategy and Operations at Mitsubishi Tanabe Pharma Holdings (MTHA), a U.S. holding company owned by MTPC.
MTPC has a 300-year history advancing important treatments in Japan. What does that history mean to you, and how does that experience benefit Mitsubishi Tanabe Pharma America?
MTPC, the second-oldest pharma company in the world, has an extensive background discovering, researching, and refining innovative medicines. MTPA’s mission is to deliver treatment options as quickly as possible to the patients who need them. What this means to me is that we have the experience to understand unmet medical needs, help develop, and bring unique medicines to market that help patients.
You have been working for MTPC in the U.S. for many years, laying the foundation and building respect. Can you walk us through some of the steps MTPC has taken to establish itself in the U.S. over the past few years?
I have supported our Company’s efforts in markets around the world for more than 25 years now. In 2008, I came back to the U.S. to help establish an organization that could commercialize our late-stage compounds.
The approval of Radicava™ (edaravone) for the treatment of amyotrophic lateral sclerosis (ALS) in Japan under the brand name Radicut® was innovative and, due to the rapidly progressive nature of the disease, in which a majority of patients die within two to five years of diagnosis, we felt it was imperative to bring this treatment to patients in the U.S. as quickly as possible.1,2 We received orphan drug status in May 2015 and began serious discussions with the FDA about the pathway to approval.
We officially launched Mitsubishi Tanabe Pharma America in 2016 with the ambitious goal of delivering therapies for some of the most difficult-to-treat diseases, especially those that affect the central nervous system. We’ve been investing our resources and working tirelessly ever since to prepare for the launch of our first product in the U.S. We’ve also been building our team in Jersey City, N.J., with the mission to establish a new culture that is science driven, patient focused, and transparent.
What do you think makes MTPC unique and special? How does this unique strength serve the Company in the U.S. market?
MTPC is unique because it is a growing, science-driven company with a long history of experience advancing important treatments. We also have learned how to best address peoples’ needs from our years of experience in commercialization.
We focus on one underlying priority—patients. In everything we do, we think about how we can help patients and their families.
We also understand that each patient is unique, and that we have to develop new approaches in order to provide treatment options to as many patients possible, as quickly as possible. I believe this way of thinking will serve us well in the U.S. market and will create a new level of trust in the community.
You have overcome many challenges in establishing MTPA and working toward bringing the company’s first product to the U.S. What are you most proud of?
At Mitsubishi Tanabe Pharma America, we are able to achieve great things together because each person is committed to forging new paths to bring medicine to patients who urgently deserve more options.
I'm proud that we are bringing this 300-year legacy to the U.S. and that everyone at Mitsubishi Tanabe Pharma America holds themselves personally accountable for making a positive impact in patients’ lives.
Radicava™ is the first medicine Mitsubishi Tanabe Pharma America is launching in the U.S. What will it mean to you to be able to bring this treatment to patients with ALS here?
All of our efforts have been leading up to the moment when we can deliver this important medicine to people with ALS and their caregivers. This community has been waiting 20 years for a new therapy and knowing we have made a real difference in the lives of patients will make me very happy. But we won’t stop there. Bringing our first product approval to the U.S. is the first meaningful step in our commitment to serving patients with unmet needs.
How many clinical studies did you conduct in patients with ALS and how long did it take you to conduct these studies?
MTPC began its first Phase 2 study of edaravone in November 2001 and completed its pivotal Phase 3 clinical trial in September 2014. Our extensive clinical development effort in ALS spanned over a 13-year period, including one Phase 2 trial and three Phase 3 trials, two of which had six-month extensions. We are thankful for the dedicated study participants, investigators, and scientists who have persevered in order to bring this important medicine to the U.S. and to bring new hope to people with ALS and their families.
How long has MTPC been working to establish a U.S. business?
MTPC group companies have worked diligently for many years to bring our first medicine to the U.S. Our first office was opened in the U.S. in 1990 with a small number of employees. Since then, we have invested in R&D, but have not generated any revenue as Radicava™ will be the first product to be sold in the U.S. by our company. The first U.S. headquarters was established in 2009. We have a number of employees who have been with us since then. These women and men have devoted years to bringing a drug to the U.S. market. In 2016, Mitsubishi Tanabe Pharma America was officially launched. We are very excited to now be able to offer people with ALS an important new treatment option.
Any final thoughts to share regarding your vision for MTPA as you forge new paths to bring other new medicines to patients in the U.S., particularly in rare disease and CNS?
We believe Radicava™ has the potential to be a key tool in the treatment of ALS, and are devoted to helping eventually turn this devastating, terminal disease into a manageable condition.
MTPC is currently developing additional therapies for the U.S., and we expect to bring new advancements to treat diseases with unmet medical needs.