'BMS will invest in and improve access to new drugs in KOR'

Emma Charles, Senior Vice President of Intercontinental Markets at Bristol-Myers Squibb

“Received approval for 6 new drugs in 2 years…fruit of open innovation”

“Reimbursement is a global issue…will strive to find consensus with health authorities”

Emma Charles, Senior Vice President of Intercontinental Markets at Bristol-Myers Squibb

Multinational pharmaceutical companies are masters of adaptation and transformation.

 

They adjust their pipelines and introduce new drugs through various mergers and acquisitions and technology export agreements to meet the rapidly changing trends in the healthcare industry.

 

This involves a great deal of foresight.

 

The companies need to assess the marketability of a new drug from the earliest stages of development, which is extremely costly and time-consuming.

 

Bristol Myers Squibb is one representative company that has been actively adapting and seeking transformation.

 

The company, which was once considered to have no item after its hepatitis B drug 'Baraclude Tab.' and theimmuno-oncology drug ‘Opdivo’ that it had co-developed with Ono Pharmaceutical, has received approval for 6 new drugs in Korea alone in the past 2 years after making small and large mergers and acquisitions, including the one with Celgene, which owns ‘Revlimid.’ In addition, the company has received reimbursement approval for the myelofibrosis treatment ‘Inrebic’, acute myeloid leukemia treatment ‘Onureg,’ plaque psoriasis treatment ‘Sotyktu,’ and ulcerative colitis treatment ‘Zeposia’ in Korea, and is working to list its obstructive hypertrophic cardiomyopathy drug ‘Camzyos’ for reimbursement as well.

 

Dailypharm met with Emma Charles, Senior Vice President of Intercontinental Markets at Bristol Myers Squibb, who recently visited Korea, to learn more about the company's vision and strategy.

 

The VP is in charge of overseeing the international market, which includes Asia, Oceania, Canada and Latin America.

 

-BMS had once been perceived as a pharmaceutical company that specialized in certain diseases, such as cardiovascular disease, liver disease, and diabetes, but the 6 new drugs you recently launched are all in different therapeutic areas. BMS is in the stage of opening a new chapter for the next decade.

 

We have a number of activities underway to identify the direction we will take in the future, in therapeutic areas such as cardiovascular, immunology, oncology, and hematology.

 

In cardiovascular disease, we are working to develop a pipeline with new indications, including Camzyos, while building on our strengths.

 

In immunology, we will maintain the long-standing leadership we built with our rheumatoid arthritis treatment ‘Orencia’ and continue to develop our new drug ‘Sotyktu’ as well as other drugs for autoimmune diseases such as lupus that are already underway.

 

In addition, the areas of oncology and hematology will continue to serve as important pillars for BMS.

 

-BMS has been actively securing various pipelines and drug candidates through mergers and acquisitions The company has sought aggressive M&A strategies for R&D to bring innovative new medicines to patients and continue growth.

 

The company currently has over 30 pipelines in development.

 

For example, the acquisition of RayzeBio and Mirati Therapeutics has strengthened our oncology area by adding targeted therapy candidates to our pipeline.

 

We recently completed the acquisition of Karuna Therapeutics and acquired KarXT, which is indicated for psychiatric disorders such as schizophrenia and Alzheimer's disease.

 

We plan to launch the drug in the U.S.

 

this year and roll the drug out globally in the future.

 

South Korea is also a very important market for us in driving R&D.

 

We are actively conducting R&D on about 50 drug candidates in Korea.

 

Taken together, we expect BMS to achieve much growth over the next decade and beyond.

 

-I heard that you are conducting clinical studies for the CAR-T drugs ‘Breyanzi’ and 'Abecma’ in Korea.

 

Do you have any specific plans for their launch in Korea?

 

Unlike oral drugs, CAR-T drugs require a complex process of sending the patient's blood to a laboratory to extract T cells and manufacture them into therapeutic drugs.

 

BMS is currently exploring ways to facilitate the introduction of CAR-T therapies in intercontinental markets and which markets to first target.

 

It is clear that South Korea is a ready market, that already has CAR-T therapies available and the capacity to manage the complexities involved in their supply.

 

While it's difficult to say exactly when we'll be able to introduce our drug to Korea, we want you to know that we're committed to bringing this revolutionary new medicine to the world.

 

-Korean companies have been focusing on exporting technology through open innovation rather than full development.

 

I would like to hear the BMS's view on open innovation and Korea’s performance in the area. Innovation is at the core of everything we do at BMS.

 

We invested approximately USD 9.29 billion in R&D last year to provide life-changing treatments for patients, a portion of which was used for open innovation.

 

In fact, products developed through open innovation account for more than 60% of BMS's revenue, making open innovation an important part of BMS's DNA for sustaining R&D and building new pipelines.

 

BMS continues to collaborate with biotechs in various regions with promising candidates, as evidenced by the recent technology transfer agreement we made with the Korean company Orum Therapeutics.

 

The open innovation program in Korea is not the same as in other countries.

 

This shows that Korea values science and innovative drug development.

 

- 6 new drugs have been approved and 4 have entered reimbursement.

 

This is a significant achievement considering Korea’s insurance system, but there are remaining challenges. Reimbursement is a global challenge; it is never easy in any country.

 

We have to prove the drug’s value over the standard of care through clinical trials, and as we negotiate to bring first-in-class treatments to market in areas where there were no treatments, we have to also emphasize how introducing innovative new drugs can save direct and indirect cost compared to existing treatments.

 

Korea’s reimbursement system, which requires the company to prove the value of treatment by designing a clinical study and confirming the efficacy and safety through it, must be challenging for the team.

 

But I trust the Korean team.

 

They are doing their best to build an ecosystem through cross-departmental collaboration to quickly deliver innovative new drugs to patients.

 

-Korea is pushing to make the use of real-world data (RWD) or real-world evidence (RWE) mandatory in the post-marketing evaluation of new drugs.

 

What is your opinion on this? First of all, regardless of the pros and cons, I think it is important to continue collecting RWE after a drug is approved for the benefit of the patients, clinical sites, and the industry.

 

For example, the company is accumulating RWE on Eliquis on its value and safety profile for stroke prevention in patients around the world.

 

We believe that RWE can be actively used during negotiations with regulatory authorities to illustrate its benefits to patients and its complementary economic benefits to hospitals and healthcare systems, but whether it is appropriate to include it as a requirement will depend on market conditions.