Global Challenge to Acquire New Drug Candidate
— A step into the New Field of RNA-targeted Medicine —
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In March 2025,
Ono Pharmaceutical acquired worldwide development and commercialization rights
to a new drug candidate that had been researched and developed by a U.S. biopharmaceutical company.
This was the first time
that ONO took on the challenge of acquiring
worldwide rights
to a late-stage
clinical development drug candidate
in the new field of RNA-Targeted Medicines.
It was also an important step in terms of
expanding and enhancing ONO’s pipeline in the near future.
And above all,
this achievement has the potential to
revolutionize disease areas
where patients do not have enough access to treatment options.
This significant leap forward was achieved thanks to the members who rose to the challenge of overcoming corporate
and cultural differences and persisted despite navigating through uncharted territory.
SECTION 01
ONO’s Encounter
with a New Drug Candidate
That Could Become a New Hope for Patients
Terai We in the Business Development Department are responsible for considering partnerships with other companies when it comes to the development rights and marketing rights to new drug candidates. If drug discovery research is about creating the future 10 to 15 years from now, then business development is about creating the future 5 to 10 years from now. Here at the Business Development Department, we search the world for new drug candidates that have the potential to be released as drugs in the near future, and we evaluate the value of those new drug candidates and hold discussions with the companies that developed them while simultaneously considering whether they could become a good option for our company and, most importantly, for patients.
Yamamoto I was transferred to the Business Development Department in 2022. It was the same year that I learned of this new drug candidate through a team that was exploring partnership opportunities in the United States. It is a drug candidate for a blood disease called “polycythemia vera,” which causes an excessive production of red blood cells, making the lungs, heart, brain, and other parts of the body prone to thrombosis. Currently, the main treatments for polycythemia vera include phlebotomy, in which blood is periodically withdrawn to reduce the number of excessive red blood cells, low-dose aspirin to prevent thrombosis, and drug therapy to inhibit the production of red blood cells and other blood cells. The new drug candidate for which we have obtained rights to is highly convenient for patients and has the potential to reduce the burden of treatment. It could bring hope to patients around the world who are battling with polycythemia vera. In addition, I found the possibility of contributing to ONO's growth very appealing.
Terai I also believe that introducing this new drug candidate into the world could turn out to be a new hope for patients. The company that has been involved in this research is a leading company in the field of RNA-Targeted Medicines and boasts the largest number of patent applications in the world. Naturally, not only ONO but many other pharmaceutical companies are likely paying close attention to the new drug candidates that the said company is developing. And moreover, even in terms of timing, they were in the late stages of development with the final step of clinical trials just around the corner, so it was by no means an easy task to have their new drug candidate, which they had nurtured like a precious son or daughter, entrusted to our company.
SECTION 02
Interpersonal Relationships
Steadily Built in the United States
Yamamoto In the Business Development Department, we evaluate new drug candidates from two primary perspectives: scientific assessment and business feasibility. Unfortunately, limited clinical data was available, during the first assessment, so the evaluation had to be discontinued. We were very disappointed, but if we had the opportunity to consider introducing this new drug candidate again, we would love to be in charge of it, and we were regularly communicating with members in the U.S.
Terai The members in the U.S. also felt the same way, and they kept going back to the company and kept contacting them, never giving up, in an effort to find another opportunity to renegotiate. Through repeated face-to-face meetings, sometimes even talking about hobbies and family, they deepened their understanding of what each other valued and built a relationship of trust, both as people and as a company.
Yamamoto In order to conduct the evaluation correctly, we must have the necessary information and data disclosed by the other party. Such data is vital to pharmaceutical companies. Therefore, through negotiations with our partner company, I learned firsthand how important it is to sincerely communicate our intentions and reasoning—not just through written exchanges, but by directly and honestly explaining why Ono Pharmaceutical needs this information.
Terai In addition, the field of RNA-Targeted Medicines itself is an unprecedented challenge for ONO. If we didn't understand something or had a question, we conveyed those matters to the other party without hiding anything. We took our time and persisted in discussions with each other until we reached a mutual understanding. I think it was this repeated process and our strong desire to deliver new drugs to patients in need that paved the way for negotiations to conclude the contract.
SECTION 03
A Contract Secured
Through United Collaboration
Okino It was just before the end of the year that the Licensing Department reached a critical point in contract negotiations. Normally, it takes one month for an internal review of the first draft of the contract and the preparation of a counterproposal. However, this project required a faster response than the usual timeline based on the time frame the client company wanted to conclude the contract. We carefully explained the importance of this contract to those in the relevant departments and asked them to quickly confirm it so that the other company could review ONO's counterproposal and accelerate discussions early in the new year. At that time, even though everyone had other core duties to fulfill, they all understood the significance of introducing this license, and so they worked in unison to compile a counterproposal, which ultimately led to the conclusion of the contract. After the contract was signed, we were informed that ONO's “development number” was attached to this new drug candidate, and I was happy to realize that from now on we would be developing the product ourselves.
Terai Concluding a single contract is no easy feat. When I was stationed in the U.S., I once cried so much that I trembled upon learning that a project that I had spent so much time repeatedly negotiating on had been awarded to another company at the last minute. There are always other companies competing to license new drug candidates, so it is necessary to approach negotiations with all hands on deck, not only in terms of financial conditions, but also in terms of building trust and responding swiftly. That is why we in the Business Development Department and the Licensing Department always work closely together on a daily basis to gain the understanding and cooperation of many people, including the departments involved in development and manufacturing down the line. I believe that we were able to conclude this contract so quickly thanks in large part to ONO's teamwork, which was truly a united effort.
SECTION 04
We Can Increase
the Value of Our Drugs
Through Our Ingenuity
Yamamoto Most of the new drug candidates introduced by ONO until now have been related to domestic rights. This time, however, it will be on a larger scale since it will be acquiring worldwide rights, thereby paving the way to deliver the product to patients all around the world. Once the contract is concluded and ONO obtains the rights, we will be developing the product globally on our own, which will present a series of unknown challenges.
Terai For this reason, collaboration between not only the contracting company and ONO, but also with Deciphera, which just joined the Ono Group last year (June 2024), was essential for this project. We expect Deciphera to become a key player in global development and sales for the ONO Group.
Yamamoto Although integration through group consolidation is proceeding in parallel, Deciphera and ONO have different corporate cultures, business practices, values, and work methods. Under these circumstances, it was necessary to quickly align with Deciphera’s team members and work together toward concluding an agreement. And in order to do so, we started by building relationships with each other.
Terai There was a big gap between what we were seeing and what Deciphera was seeing, so it was important for both sides to see eye to eye. For example, the way a clinical trial is designed can greatly increase the value of a drug by finding new value in the drug’s efficacy and safety, or by shortening the time to market and getting it to many patients quickly. We learned from Deciphera the perspective of how important it is to increase the drug’s value in the European and U.S. markets, and realized that we can further increase that value through our own originality and ingenuity. As a result of these discussions, we believe that we were able to make proposals, to the companies with whom we have concluded contracts with, that will help them develop the new drug candidates they have created into even better products.
Okino We in the Licensing Department also take great care in how we deal with other companies. When negotiating a contract with a company, we properly assert our ideas and thoughts in order to maximize our company's profits and explain matters in detail so that the other company understands exactly where we are coming from. On the other hand, we feel that it is important for both companies to move forward in a mutually agreed upon manner, listening to each other's arguments and looking for areas where both parties can come to a mutual compromise, rather than insisting only on our opinions.
SECTION 05
What Options Can We Offer
in the Near Future,
Namely, 5-10 Years
Down the Road?
Yamamoto I was deeply moved by the fact that I was transferred to the Business Development Department and for the first time was placed in charge of a new drug candidate for which, despite being once abandoned, we have now obtained the worldwide rights. Although the field of RNA-Targeted Medicines is an entirely new field for us, the members of ONO, including those in the Manufacturing Division, were very proactive about this new challenge, and it was also an opportunity for me to rediscover the corporate culture in which ONO has delivered new value to patients through breakthroughs.
Okino I find this job very rewarding, as I am directly involved in the mission to increase the number of new drug candidates for our company. This time, we were able to conclude a contract for one new drug candidate. However, I eagerly await the further expansion of ONO's pipeline for the sake of patients and for the company. I look forward to continuing taking on new challenges in the future so that we may introduce the next new drug candidate.
Terai The introduction of a new drug candidate is a complex process that involves various factors. Is it possible to accurately put together a future sales forecast? Since the licensing company also has shareholders, will it be able to offer appropriate financial conditions to the other party? Is there a scientific basis for this? And above all, can it become a better treatment option for the end patient? Under such circumstances, we in the Business Development Department have adopted and committed ourselves to the slogan, "Co-create a new standard.” The timeline that we are looking at is 5-10 years ahead. What kind of options can we offer in that near future? We interact with many people on a daily basis, both within and outside the company, and each of us will continue to challenge various possibilities while exercising sensitivity and creativity.
Overcoming global boundaries,
challenges specific to the field of
RNA-Targeted Medicines,
and cultural differences to co-create
with like-minded people.
We do not shy away from taking
on new challenges in uncharted territory.
As long as there are patients waiting for
options they have yet to discover,
we will stay committed.
Business Development, Business Lead
Hiroshi Yamamoto
Attracted by ONO's approach to drug discovery, he joined the company in 2009. After engaging in drug discovery research and research alliance activities, he was transferred to the Business Development Department and engaged in partnership activities focusing on new drug candidates. Currently, he works in the Business Lead Section to develop strategies and tactics for the activities of the Business Development Department to achieve the medium-term business plan.
Senior Director, Business Development
Koichiro Terai
Joined ONO in 1995. After engaging in research in the field of immunology and allergy, he supported sales activities in the Sales Division, and was responsible for planning the development of in-house developed products for the U.S. and Japan in the Development Division, as well as expanding the pipeline in the International Division. He also worked in the U.S. for approximately four and a half years. Currently, as the head of the Business Development Department, he promotes licensing activities that aim to introduce new drug candidates.
License I
Manami Okino
Joined the company in 2017. As a medical representative (MR) in the Kobe and Osaka area, she engaged in activities to deliver information on therapeutic drugs to the medical field. After that, she was transferred to the Licensing Department to take on the challenge of an in-house recruitment system. She works on a wide range of tasks related to licensing, including contract review and negotiation, sales forecasting, and business profitability studies.
2025 May
