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- 2026-03-10 00:44:53
- InterView
- “AstraZeneca’s sincerity in oncology drives cont. growth"
- by Eo, Yun-Ho Oct 17, 2022 06:03am
- AstraZeneca is known for its ‘sincere attitude’ towards R&D. Not only is the company in the top ranks in terms of its investment amount, but it has also always been at the forefront in terms of R&D-to-Total-revenue ratio as well. In 2021, AstraZeneca’s R&D-to-Total-revenue ratio stood at 26%, the highest in the industry. Due to their invested interest, the company is rarely behind in recognizing new drug development trends. More often, AstraZeneca has led the trend, releasing first-in-class drugs. AstraZeneca developed the antidiabetic SGLT-2 inhibitor ‘Forxiga,’ a drug that has recently been receiving attention for demonstrating cardiovascular benefit, and the oral antiplatelet ‘Brilinta,’ the only contender of Plavix (clopidogrel). Also, 'Crestor (rosuvastatin)’ which had threatened the sales of ‘Lipitor (atorvastatin),’ and the ICS/LABA combination ‘Symbicort’ are also some of AstraZeneca’s well-known products. Building on this solid foundation, AstraZeneca is now busy reinforcing its Oncology pipeline. In addition to the third-generation epithelial cell growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) ‘Tagrisso (osimertinib),’ the company has added the PD-L1 inhibiting immuno-oncology drug ‘Imfinzi (durvalumab)’ to its portfolio. In other words, the company's oncology pipeline is no longer represented by its first-generation EGFR TKI “Iressa (gefitinib).” Dailypharm met with Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca to hear about the company’s oncology drug development. Trained as a clinical oncologist and Ph.D., EVP Galbraith has been leading Oncology R&D at the company for the past 12 years. -Which product were you most deeply involved in developing? I would have to say that I am most fond of Tagrisso. AstraZeneca aspires to become a leader in Oncology. When I joined the company, hormonal treatments such as Faslodex, as well as Iressa were already developed, and Tagrisso was in the development stage. My first work after joining AstraZeneca was to organize the company’s research portfolio. At the time, I suggested that we should focus on products with higher potential rather than products that have less chance of success. This was even before a project name had been coined for the development of Tagrisso, but I believed in the potential of the substance and made the decision to accelerate its development. Many patients who were treated with existing targeted therapies at the time had been developing resistance or intolerance to their treatments. They developed secondary mutations, and the drugs were not binding well in their targeted sites. I saw the potential of Tagrisso in addressing this unmet need. So Tagrisso was first administered to a patient in 2013. The Seoul National University Hospital in Korea also participated in our Phase I clinical trial, and tumor size was reduced in 2 of the 4 patients that were administered Tagrisso at the time. Resistance to existing treatment options -the T790M mutation - is found in around 50% of all EGFR-mutated lung cancer patients. Although we weren’t testing for the T790M mutation at the time, the tumor size reduction in 2 of the 4 patients raised hopes on how the drug targets the T790M mutation and brings therapeutic benefits. I still remember telling the chemist that developed the substance the good news about how promising the substance was. AstraZeneca was able to gain such insight based on solid collaboration with healthcare professionals in Asia. Our collaboration with healthcare professionals in Korea, Japan, and Taiwan greatly contributed to our discovery by helping us secure information on the resistance mechanism in advance. -As you mentioned, AstraZeneca’s oncology pipeline is rising in prominence. The pipeline, which had already existed for a while, seems to be getting stronger. You already own extensive product lines in Respiratory, Cardiovascular, and Endocrinology, does this mean you will be focusing on oncology drugs in the future? That’s not so. Rather than concentrating on either part, we are making efforts to build a balanced portfolio that can cover various treatment areas. Although 40-50% of our R&D budget is being invested in oncology drugs, we also have pipelines in various other treatment areas including Cardiovascular (CV), Renal, Respiratory, Immunology, Vaccines, etc. Oncology drugs do take up much of our interest, but it is not our sole area of interest. We have recently seen reports on how Forxiga, our antidiabetic drug, has significantly improved the risk of cardiovascular death. -It is also impressive that the company collaborated with Asian researchers from early phase trials for Tagrisso. Contrary to how Korea actively attracts Phase III trials, there has been criticism on how global pharmaceutical companies lack investment in early phase trials in Korea. I hope more opportunities will come in the future for Korea to collaborate with AstraZeneca. We are very interested in seeking opportunities in Korea. South Korea has been an innovation hub in developing new drugs for quite a long while and is leading in clinical trials. It is number three in contribution to global oncology clinical trials worldwide. In fact, involvement in the early phase clinical trials is something we have been doing with South Korea for many years and has built on year-on-year. -AstraZeneca’s competitivity has been further reinforced with the addition of the PARP inhibitor Lynparza to the pipeline. On the other hand, your immuno-oncology drug Imfinzi has been showing less impressive performance. Do you believe there is an opportunity for its comeback? We were excited to present data on the first improvement seen in biliary tract cancer for many years with Imfinzi. Biliary tract cancer is quite prevalent in Asia, and the addition of Imfinzi to first-line chemotherapy improved the treatment effect. The Imfinzi combination therapy was approved in the US based on this TOPAZ study, and we look forward to its approval in Japan as well. We also presented data earlier this year for the HIMALAYA study in liver cancer, in which the combination of Imfinzi with ‘Tremelimumab (anti-CTLA4 antibody)’ in a regimen where just one higher dose of Tremelimumab in order to improve the tolerability profile showed an improvement in the long-term survival benefit in liver cancer patients. I hope to hear from the US FDA on an indication based on the HIMALAYA study within the year. In addition, we have also submitted data in the first-line and non-small cell lunger cancer setting for the combination of Imfinzi with Tremelimumab added to chemotherapy.
- InterView
- “Sanofi’s flu vaccine is different...has 100-year legacy"
- by Oct 06, 2022 06:05am
- Sanofi has been making unexpected strides in Korea's flu (influenza) vaccine market this year. The company has not only made a bid for the National Immunization Program (NIP) for the first time this year, but it also started supplying its flu vaccines exceptionally quickly. Multinational pharmaceutical companies usually start the supply of their flu vaccines in October every year due to the longer time required for their release in Korea. However, Sanofi received the approval to release their vaccines at the same time as domestic vaccines and started distributing in mid-August. Its supply price is also not so different from domestic flu vaccines. Sanofi's unprecedented move is not unrelated to this year’s influenza outlook. This year, influenza, which had been on the low side due to COVID-19, is predicted to rise for the first time in 3 years this year. The Korea Disease Control and Prevention Agency issued a nationwide influenza warning last month. According to KDCA, the proportion of suspected flu patients per 1,000 people on the 39th week (September 18th-24th) was 4.9, exceeding the epidemic standards. In particular, Type A H3N2, which is expected to become the dominant strain this year is a successor of the ‘Hong Kong Flu,’ and is known as one of the most virulent strains. This is why the KDCA has been actively encouraging flu vaccinations. Although the 9 types of quadrivalent flu vaccines distributed in Korea are thought to have similar prevention effects, a closer look shows that there are differences. Some vaccines cannot be administered to infants or patients with cardiovascular diseases. Also, domestic vaccines can be administered to pregnant women, but their safety has not been demonstrated through clinical trials. Vaxigrip Tetra (Sanofi) and Fluarix Tetra (GSK) are the only flu vaccines that can be administered in all high-risk groups. This is why Sanofi, which is standing at the same level as domestic companies in terms of price, supply timing, and amount, is showing confidence this time. During an interview with Daily Pharm, Guan Lee Ang, Country Medical Lead at Sanofi Korea, said, “With over 100 years of history in developing vaccines, Sanofi owns a vaccine portfolio for over 20 types of infectious diseases. Our quadrivalent flu vaccine, ‘Vaxigrip Tetra,’ has verified safety and immunogenicity with robust clinical data. Vaxigrip Tetra’s differentiated strength lies in how it is the only vaccine to have verified efficacy and safety in the high-risk group.” Guan Lee Ang, Country Medical Lead at Sanofi Korea The high-risk group, infants over 6 years of age, pregnant women, cardiovascular patients, etc., are known to be at 10 times higher risk of acute myocardial infarction and at 8 times higher risk of strokes when infected with influenza. Infants and children are also at high risk of pneumonia as a related complication. Influenza infection can also lead to death, and an estimated 70-85% of those deaths were observed in patients over the age of 65. Clinical trial results showed that influenza infections from vaccine-like virus strain were reduced by 68%, and infection from all A&B types of influenza virus was reduced by 72% in infants aged between 6 months to 35 months when vaccinated with Vaxigrip Tetra. The risk of influenzas infection in pregnant women was also reduced by up to 72%. Also, the study showed vaccination was related to a reduction in the mortality rate in patients with myocardial infarction or high-risk coronary artery disease. The problem lies in the low public awareness of the need to receive influenza vaccines. Due to the prolonged COVID-19 crisis, people have been receiving vaccinations every 3 to 6 months, which led to increased fatigue over vaccinations and decreased reliability. Also, some are expecting influenza to not spread as much due to the small number of flu patients and the cultural specificity of how people are continuing to wear masks even after the mandatory outdoor mask regulation was lifted, In response, Sanofi's Vaccine Division is concentrating on reinforcing flu awareness. While carrying out a campaign to raise awareness of influenza among the general public, the company plans to hold a webinar for healthcare professionals on the preventive benefits of vaccinations based on clinical data. Ang said, “65% of employees in the vaccine division serve in departments related to quality testing, and most of the vaccine production period is devoted to quality testing. Also, we are working with distributors who have established thorough cold chains to stably supply our high-quality products. We will continue to strive to improve access to influenza vaccines for high-risk groups and improve public health in Korea.”
- InterView
- “Will rise independently as Organon in the industry”
- by Eo, Yun-Ho Sep 08, 2022 05:59am
- So Eun Kim, Managing Director of Organon Korea Spin-offs, which are made for various reasons in various circumstances, bring out various positive and negative issues in the process. Organon’s course of the spin-off was also quite eventful. However, the company quickly straightened its affairs after completing the spin-off and being reborn as an independent organization in June last year. Organon was established in 1923 in Netherland and had become part of MSD. In 10 years since then, the company again was separated from MSD and reborn as Organon. Utilizing the power of its existing legacy brand, the company heralded its new leap into a pharmaceutical company specializing in biosimilar and women’s health. Dailpharm met with So Eun Kim (51), the founding Managing Director of Organon Korea, to hear about the company’s vision and value. -A year has already passed since the establishment of Organon Korea. Has the company undergone many changes? During the past year, the company had made efforts -small and large – to lay the foundation to realize our women's health vision. Above all, we were able to achieve organizational stability, and in terms of business, Global Organon has earned the trust of its investors by making a stable start from the first year. Organon Korea made a 4% YoY growth in the first year of the spin-off, expanding its product influence. -There must have been difficulties as well. One of the things our employees had the most trouble with was meeting with various healthcare professionals who were unfamiliar with our name, ‘Organon.’ The heightened COVID-19 situation had further rendered sales activities and external meetings with partners and stakeholders difficult. Therefore, we focused on utilizing digital channels in communicating with healthcare professionals. One main example of this is ‘Organon Connect,’ a portal site we prepared for HCPs. Korea was the first among all Organon subsidiaries globally to launch the portal and had launched it upon the establishment of the company. Through the system, we have continued to hold symposiums during the pandemic. -In addition to your existing items, what other products are you preparing for your goal to become a women’s health pharmaceutical company? Organon has signed agreements for 6 solutions in the field of women’s health where unmet needs remain. In the case of our solution for postpartum hemorrhage, the solution has been approved by the FDA and is being sold in the US. XACIATO, the bacterial vaginosis treatment, has been granted accelerated approval by the FDA. We are preparing to introduce these treatments to Korea as soon as possible, through market analysis in Korea. Clinical trials or preclinical trials on solutions for premature birth, endometriosis, breast cancer, contraception, etc. are also being completed. We are preparing to launch the products in development according to their development stage. Also, the contraception, infertility, childbirth, and postmenstrual treatments that we already own have much potential in the Korean market. Although the company was unable to pay sufficient attention to these products but based on Organon Korea’s vision, we plan to make the most of the opportunities owned by each and every product. -With so many of your women's health products in development, it seems like not many products are readily available for introduction to Korea. In this sense, the company would have to focus on its chronic disease area. What kind of efforts and attempts have you made to increase your influence in women’s health in Korea? Well, we expect that Korea will be able to participate in various stages of applicable clinical trials of the various products in development, and is preparing plans for such trials. Also, for the FDA-approved products, we are working to quickly introduce them to Korea. The chronic disease business accounts for over 90% of Organon Korea’s business. This field will be our main business for the few years to come, during which we will be making efforts to expand our portfolio and share in women’s health. -has the labor-management issues that you experienced in the course of your spin-off been resolved? Many of the concerns and anxiety held by our executives and employees with regard to the spin-off have been resolved. At the time of the spin-off, we focused on listening and communicating with our executives and employees about their various concerns and received consent from each through discussion with the union. After the spin-off, we worked to relay the direction of the company and build solidarity among our executives and employees. We are regularly communicating with the union every week, and are holding a labor-management council to listen to the opinions and answer questions held by the employees, facilitating smooth communication between the union, executives & employees, and the company. For your reference, only a very few employees left the company due to the spin-off. -What are your future ambitions? Based on Organon’s global ESG reporting standards, we believe we need to find areas where Organon can contribute to Korean society and increase our influence in Korea. Building on the vision and confidence we have today, we plan to grow together with our executives and staff and strive to lay the foundation for bigger dreams, toward our vision of women's health.
- InterView
- "Leclaza’s mOS data of 38.9 months is remarkable"
- by Kim, Jin-Gu Jul 04, 2022 05:55am
- “The fact that Leclaza (lasertinib) achieved an OS (overall survival) of over 3 years is remarkable.” New OS data on the homegrown novel lung cancer drug Leclaza that was presented at the AOS 2022 & KCA Annual Meeting 2022 that was held recently in Seoul drew the pharmaceutical industry's attention. The results were from a trial that evaluated the efficacy and safety of continuous daily oral administration of Leclaza 240mg on 78 adult patients with EGFR mutation-positive NSCLC whose disease had progressed after EGFR TKI that was conducted in 17 centers in Korea. Analysis results on the 76 EGFR T790M mutation-positive patients showed that the median overall survival (mOS) was 38.9 months This updated data is being received with significance in the field. The OS data is comparable to the results of the 3rd-generation EGFR mutation-positive NSCLC treatment ‘osimertinib (product name: Tagrisso),’ while owning the potential for its use as monotherapy. Ji-Youn Han, Professor of Hemato -Oncology at the National Cancer Center who presented Leclaza’s OS results at the AOS 2022 & KCA Annual Meeting 2022, said, “The most important index used to assess the efficacy of anticancer drugs in clinical trials ultimately comes down to the patients' OS improvement. Long-term follow-up results of LASER201 trial showed that mOS of patients that received Leclaza reached 38.9 months. This is remarkable performance.” ◆"Cannot make direct comparisons…but results are as good as Tagrisso’s” Han highly rated the fact that Leclaza showed comparable performance to existing targeted therapies, although a direct comparison cannot be made to its competitor, osimertinib. Although various clinical trials are in progress for the first 3rd-generation EGFR targeted therapy. osimertinib, due to varying clinical trial designs and characteristics of registered patients, it is difficult to individually compare each trial's results with Leclaza’s. Also, Leclaza's trials are in their Phase I/II stage, but osimertinib's trials have progressed to Phase III. However, according to the Phase III AURA trial, osimertinib’s representative trial, the mOS was around 26 to 28 months in general, with some differences between countries. “Compared to osimertinib, which is used as the global standard of care, Leclaza is only available for use in Korea. However, data shows that Leclaza’s results are as good as the standard of care. Leclaza’s clinical data as demonstrated through LASER201 is being received without disagreement globally.” ◆" Leclaza has a low incidence of interstitial pneumonia·thrombocytopenia" Han also emphasized Leclaza’s safety. Leclaza has a lower incidence of adverse events than even its competitor osimertinib as well as 1st- and 2nd-generation EGFR targeted therapies. 1st and 2nd generation EGFR targeted therapies had higher skin toxicity. The drugs, although effective against lung cancer cells, also targeted normal skin cells, resulting in patients suffering from skin troubles such as rashes or itching. On the other hand, 3rd generation-targeted therapies selectively target mutations and therefore is less toxic and more efficient. This comes as a significant difference to the patients in terms of quality of life. In particular, Han explained that the two 3rd generation targeted therapies – osimertinib and Leclaza -differ in the adverse events aspect. With her experience prescribing Leclaza over the past year, Han explained that “long-term use of osimertinib may cause interstitial pneumonia or thrombocytopenia in the patients. One aspect I found interesting while monitoring the long-term safety profile of Leclaza demonstrated through the Phase I/II trial was that it had a very low incidence of interstitial pneumonia or thrombocytopenia. “ Han added, “From the patient’s perspective, Leclaza’s lower incidence of adverse events during the 3 years of intake may come as a great advantage. Grade I or II level numbness has been found with the use of Leclaza, but was infrequent.”
- InterView
- Tremfya to bring generation shift in the IL inhibitor market
- by Jun 23, 2022 05:50am
- The competition among latecomers is intensifying in the interleukin inhibitor market with the scope of their indications expanding to psoriatic arthritis. The leader in this market is Janssen’s IL-12/23 inhibitor, ‘Stelara (Ustekinumab).’ Although 10 years have passed since its approval, the drug still boasts a growth rate in the 30% range. Based on IQVIA, sales of Stelara recorded ₩36.1 billion last year. Janssen’s new goal in the market is to successfully make a generation change and replace Stelara with its follow-up drug, ‘Tremfya (guselkumab),' the first-in-class IL-23 inhibitor that was released in Korea in 2018. However, Tremfya is being challenged in the market by the second IL-23 inhibitor ‘Skyrizi (risankizumab)’ that entered the market. Therefore, making the successful generational shift from Stelara to Tremfya without losing any market share to other companies’ competitors is an important task at hand for Janssen. ▲ JungHyun Lee, Tremfya Marketing Manager at Janssen Korea Janssen Korea’s Tremfya Marketing Team has been working quickly to achieve this goal. The three members of the Tremfya Team at Janssen Korea have been focusing on conducting marketing activities for the psoriatic arthritis indication that was granted insurance benefits last month. In an interview with Dailypharm, Product Manager Jung-Hyun Lee, who had been in charge of Tremfya since it started preparations for marketing authorization at the end of 2016, said, “There are many treatments including Tremfya available for plaque psoriasis, and awareness on the availability of theses drugs have now increased significantly among psoriasis patients. Just as we have concentrated on marketing Tremfya in plaque psoriasis last year, we plan to concentrate on carrying out activities to make known the importance of early diagnosis and treatment in psoriatic arthritis this year.” Lee pointed to the low disease awareness of psoriatic arthritis as the reason for this year’s specific focus of interest. PM Hye-Ji Kang who newly joined the Tremfya Marketing Team this year, said, “It is important for patients with psoriasis to manage comorbidities such as psoriatic arthritis. Therefore, we need to raise awareness of psoriatic arthritis so that doctors and patients can suspect and allow for early diagnosis and treatment of their condition when joint pain occurs while maintaining skin symptom improvement in their course of treatment.” In addition to Tremfya, the IL-17 inhibitors Cosentyx (secukinumab) and Taltz (ixekizumab) are also approved for use in psoriatic arthritis. Also, Skyrizi added a psoriatic arthritis indication in January this year. Although Skyrizi is yet to be approved for reimbursement, Janssen may not rest assured as Abbvie is speeding up its reimbursement expansion process for Skyrizi. Ultimately, it is in the hands of Tremfya’s Marketing Team to highlight the characteristics of Tremfya that differentiate the drug from other IL-17 inhibitors, while appealing to the strengths of Tremfya compared to the other same class IL-23 inhibitor. Lee said, “Inhibiting radiographic progression of joint damage is considered the most important indicator in treating psoriatic arthritis because there is no way to reverse damage in the joints. Tremfya administered every 4 weeks has demonstrated statistically significant inhibition of radiographic progression of joint structural damage compared to placebo.” Lee added, “In over 70% of the cases, psoriasis skin symptoms appear before psoriatic arthritis, and as treatment effect in the main disease of psoriasis is most important until arthritis progresses, Tremfya’s long-term effect in maintaining skin clearance indicates how our drug brings greater treatment benefit than its competitors.” The lasting long-term effect of Tremfya that was mentioned by Lee was demonstrated through a 5-year long-term clinical trial and a 5-year real-world data on domestic patients, evidencing the differentiated benefit of Tremfya over the latecomers. Another positive aspect of Tremfya is that a survey on patients with severe psoriasis in the Asia-Pacific region including Korea showed that patients consider lasting, long-term effects as most important. ▲ Hye-JeeKang, Tremfya Marketing PM at Janssen KoreaAlso, the company had demonstrated the superiority of Tremfya through a head-to-head trial. Janssen’s ECLIPSE study that directly compared the efficacy between the first-in-class IL-23 inhibitor Tremfya and the IL-17 inhibitor Cosentyx showed that Tremfya’s mechanism of action allows for psoriasis lesions to not recur and provides long-lasting improvement of skin symptoms. Kang said, “Only Tremfya was found to maintain regulatory T cells that are involved in lesion recurrence and reduce the rise of resident memory T-cells. The trial was informative in understanding the different mechanisms of action between classes. Through such data, the IL-17 and IL-23 inhibitors are being differentiated in the field, and IL-23 inhibitors, as a higher level mechanism than IL-17 inhibitors, have provided convenience to the patients with their longer dosing interval.” Of course, opposing data also exists. Novartis’ ARROW trial is one example. However, no statistically significant difference was found in the proportion of patients that achieved a “clear” or “almost clear” status of the target plaques at Week 16, which was the primary outcome measure of the trial. Kang explained, “Results from the ARROW trial show no statistical difference between the two drugs, therefore, it is difficult to say there is a difference between the two drugs based on that data. Also, the study was conducted on only 40 patients in the short term of 16 weeks, different from the large-scale ECLIPSE trial that was conducted for one year on 1,048 patients.” On how the drug is different from Skyrizi, a same-class drug, the marketing team pointed out that Tremfya is the only ‘fully human monoclonal antibody.’ In antibody drugs, reducing immunogenicity by minimizing the sequence of other species such as mice is important as it can cause side effects and reduce the efficacy of a drug. If the humanized monoclonal antibody Skyrizi has nearly a 90% human-generated nucleotide sequence, Tremfya has a 100% human-generated nucleotide sequence. Lee also added that the team will continue to strengthen Tremfya’s status in the market through the provision of various customized data. Lee said, “With most drugs now being able to provide clear skin, the needs of the patients and medical are becoming more specific and subdivided. Some wish for the occasional lesions or itching to go away after skin clearance, others wish to get rid of the pigmentation left after treatment. We will work to provide customized data to fit the needs of these patients.”
- InterView
- “Roche reborn through customer-centric reorganization”
- by Eo, Yun-Ho Jun 21, 2022 05:54am
- Nic Horridge, General Manager of Roche Korea Multinational pharmaceutical companies are known to endlessly pursue change. In addition to active acquisitions, mergers, and spin-offs, the companies boldly reduce and expand their many originations in line with the new drug development trend, and show no hesitation in consolidating or reorganizing departments. Their endless evolution for efficiency and survival continues on even now. The same goes for Roche. Roche, which used to hold a strong image as a company specializing in anticancer drugs, have continued to maintain its strength in that area while expanding its interest to other diseases. The company released ‘Xofluza,’ a follow-up of its antiviral ‘Tamiflu,’ and is also spurring up the development of its new Alzheimer's treatment in CNS. The company had also undergone great change in the organization as well. The company had promoted ‘"agile transformation" at the global level to improve flexibility and responsibility as an organization. Unlike conventional organizations where employees are assigned specific products, at Roche, employees are assigned to each disease-specific indication. Roche Korea also joined in this transformative journey in 2018. In the process, quite a few issues in personnel adjustments and departures arose. General Manager Nic Horridge, who has been running Roche Korea for 4 years since being appointed GM in October 2018, has led this transformation in Roche Korea. Dailypharm met with Nic Horridge to hear about the transformations made and those to come for Roche Korea in the future. -Two years have passed since the company decided to undergo an agile transformation. What are the advantages of agile transformation? Agile transformation is an innovation that is being pursued at the global level to transform our organizational culture. In line with the rapidly changing healthcare technology, medical environment, and the exponential increase in information, Roche’s portfolio has continuously evolved and entered new treatment areas. The company had determined it would be difficult for Roche to achieve its goal of bringing the best results faster to our patients with the existing ways of business and operation model and decided to pursue agile transformation. We now have teams organized according to the treatment area or patient group to identify the practical needs necessary for each patient’s treatment journey and make optimal decisions. In the past, we had unmet needs in rapidly identifying how diagnoses and treatments were being made in areas unfamiliar to Roche, such as Alzheimer’s and Ophthalmology, but this organizational evolution now allows each team to rapidly identify, understand and strategize what’s needed. -The transformation process would not have been easy. How did the employees and executives at Roche Korea receive the change? We have now passed the adaptation period, and our efforts are now coming to fruition. The autonomous decision-making system was one thing that many employees and executives had first found difficult, as each employee, as his/her own leader, was required to contemplate and find an answer on 'what role he/she should play to bring value to the domestic medical ecosystem?’ Some employees have decided to part ways with the company in the process. I consider this positive as these former Roche employees continue to contribute to the development of the healthcare industry in their respective positions. At the time, we had candid discussions with the employees who believed the new business model was not right for them, and some had decided to seek new opportunities. In the process, younger employees were given the opportunity to take on a leadership role in the company, and this gave rise to fresh and new perspectives that could help achieve Roche's vision. The ideas were successfully incorporated into the organization. --Roche is developing ‘gantenerumab’ as a treatment for Alzheimer’s disease. Many other companies that have jumped into the scene are struggling, such as in the case of Aduhelm. What is your opinion on this? Roche’s gantenerumab is an anti-amyloid-beta monoclonal antibody that reduces brain amyloid plaques, which are known to induce brain cell death, to improve symptoms of Alzheimer’s disease. Its Phase III trial results are expected to come up in the second half of the year, and we are confident that we would be able to see good results. Also, in treating Alzheimer’s, Roche believes early detection of the disease is as important as new drug development. If a patient is prescribed treatment after his or her symptoms have progressed to a certain extent, the brain damage that has already occurred will most likely not be regenerated. Assuming that gantenerumab's clinical findings are successful, we believe that Roche’s approach of early detection and treatment will provide patients with an invaluable solution. -You served 4 years as the head of Roche Korea. What is your impression of the Korean healthcare ecosystem? I am pleased to have been awarded this opportunity to promote various changes in Roche Korea for the past 4 years. Due to the unprecedented crisis brought on by the pandemic, we have undergone many changes in our daily life and work, but I believe the Korean government showed excellent leadership in the containing COVID-19, and that Korea has received less damage than neighboring countries. This was very impressive. Statistics show that Korea’s accessibility to new drugs is 35%, which is significantly lower than other countries such as the US (87%), the UK (59%), and Japan (51%). Also, it takes an average of 601 days to reimburse listing, and new drugs account for only around 20% of the pharmaceutical expenditures spent in NHI finances. This is far below average in other OECD countries. I believe there would be a way to increase access to innovative drugs without significantly increasing the overall drug expenditure without affecting national finances. Roche will do its best to support the government in fulfilling its pledge on relevant tasks.
- InterView
- Otrivin package made user-friendly for pharmacist & patient
- by Eo, Yun-Ho Jun 13, 2022 05:55am
- Yewon Moon, Brand Manager, GSK Consumer Healthcare One strong perception of allergic rhinitis is that its symptoms worsen during the change of seasons and then decrease in summer. However, the large temperature difference between indoors and outdoors in summer due to excessive operation of air conditioners can dry out the mucous membranes and further weaken the immune system. Topical decongestant nasal sprays are one of the most popular products sought by customers due to rapid symptom relief. The spray constricts the blood vessels in the nasal mucosa to relieve symptoms of nasal obstruction to offer faster symptom relief than oral formulations and is effective in those who experience severe nasal congestion. However, people are reluctant to use the spray formulation due to the risk of side effects that can occur if users do not follow the correct method of its use. One well known side effect is rhinitis medicamentosa, or rebound congestion, which worsens the dryness in the nose and rhinitis. For its proper use, topical decongestant nasal sprays should not be used more than 3 times a day (up to 2 times a day for oxymetazoline products) and should not be used for more than a week at a time in adult patients. Also, a recovery period is required after its use for one week in a row. GSK Consumer Healthcare Korea announced a package renewal plan for its leading nasal decongestant ‘Otrivin.’ Dailpharm met with Yewon Moon, Brand Manager at GSK Consumer Healthcare who has been working to deliver the correct method of use of nasal decongestants. -Otrivin’s logo and the package have been renewed after 3 years. Its strong visual consistency seems to be one of its leading features. Could you introduce the changes? We used intuitive icons and vivid colors in the design. Consumers can easily locate Otrivin thanks to the ‘BlueRing’ design, and the package is structured to provide easier and quicker understanding of the product's efficacy and effect. Consumers would want to quickly find and purchase the product they need to relieve their nasal congestion. Therefore, we focused foremost on how to improve the convenience of purchase for our consumers in our package renewal. -What design element did you focus most on?? Of course, we considered each and every element in the process of renewing the package with a particular focus on the front design. The BlueRing design in the front allows consumers and pharmacists to quickly locate the Otrivin brand. The key focus of the renewal had been on clearly conveying the effects of each product. -What did consumers respond best to in the consumer testing process? Global test results showed that the consumers’ purchase intent increased because the new package provided a clearer understanding of each product’s effect. Brand search rate has also increased, and the modern design of the package contributed to increasing the positive image of the product. -I believe the new package will be useful not only for the consumers who purchase the product but on the pharmacy’s part as well. How will pharmacies and pharmacists benefit from the renewed package? As the design change allows for clearer delivery of the effect of each product, I believe this would help pharmacists conduct easier medication counseling on which Otrivin should be used according to each patient’s age and symptom. -When will it be released in Korea? Where can we find the renewed version? The period of each product’s release may differ somewhat, but we are preparing so that the renewed Otrivin 0.05% Pediatric, Otrivin Menthol 0.1%, Otrivin Baby Natural, and our newest product ‘Otrivin S’ can be found at pharmacies in Korea within the second quarter of this year. For your reference, the package design renewal is being made as a global project, but the period of renewal in each country will be conducted sequentially, subject to each country’s situation. -Do you have any other plans on providing support for pharmacies other than changing the package, with posters, etc.? We plan to improve access to Otrivin within pharmacies with the new package design during the change of seasons when an increasing number of consumers seek nasal decongestants. With the colors more easily discernable than in the past, the new Otrivin package will aid consumers in selecting the product they need and stand out from other products on display at pharmacies. Even when it is behind counters, pharmacists will be able to save the time that they had previously wasted looking for Otrivin due to the easily identifiable package. Also, we are preparing communication with pharmacies to facilitate smoother medication counseling on Otrivin for consumers at pharmacies.
- InterView
- “Allowing safe use of JAK inhibitors over restrictions"
- by Eo, Yun-Ho May 26, 2022 05:56am
- Professor Ki-Jo Kim Nowadays, safety is as important as a drug’s efficacy. In particular, reaffirming the safety of drugs that require long-term administration post-approval is essential. JAK inhibitors, which have entered the market as an oral option to treat various autoimmune diseases such as rheumatoid arthritis and ankylosing spondylitis, have been embroiled in controversy since last year. In 2021, the US FDA had warned of increased risk of cardiovascular events and cancer on the use of Jak inhibitors, and the MFDS also issued a Dear Healthcare Professional Letter on the issue. In the end, the FDA decided to include the increased risk of major heart-related events, thrombosis, and death in the black box warnings. The risk is undoubtedly an issue that cannot be overlooked. The risk of cardiovascular disease is a common issue that tags all treatments used for chronic diseases, but more accurate judgment on this risk is needed for JAK inhibitors as some patients do certainly benefit from its use. Also, various factors including age and race need to be investigated. On this, Ki-Jo Kim, Professor of Rheumatology at Catholic University St. Vincent Hospital, lectured on the ‘'Management of Rheumatoid Arthritis considering Safety” at the KCR 2022 (the 42nd Korean College of Rheumatology Annual Scientific Meeting and the 16th International Symposium) that was held from the 19th to 21st. Dailypharm met with Professor Kim to hear about the efficacy and safety of JAK inhibitors. -Could you tell us about your lecture? When first introduced, JAK inhibitors opened a new paradigm in the treatment of rheumatoid arthritis. Its safety issue had risen last year with the announcement of the Oral Surveillance study results that showed that JAK inhibitors may increase the risk of some cardiovascular disease and cancer. This prompted a fierce debate in academic societies in the US, Europe, and Korea. I have reviewed and reevaluated relevant data, studied how to read the results and interpret the studies that followed, and investigated whether different JAK inhibitors showed different results for the presentation. -What was your conclusion? When looking into the ORAL Surveillance results in detail, data showed that the JAK inhibitors had a slightly higher risk of developing cardiovascular disease and cancer compared to TNF inhibitors. But in detail, even this slight difference was limited to North American patients aged 65 or older. Also, supplementary data in the paper showed that a higher proportion of North American patients in the study had a high risk of developing cardiovascular disease, due to factors such as being over 65 years of age, obesity, high blood pressure, diabetes, and various drugs intake, etc. In this sense, the high-risk patients in the North American patient group may have driven such results. The real-world data that followed studied all patients with rheumatoid arthritis. No difference was found in these patients, and there was no difference when patients aged 50 or older that had 1 risk of cardiovascular disease were extracted and investigated as in the ORAL Surveillance study. A tendency was there, but with no statistically significant difference. When considering these factors, the ORAL Surveillance study data may have shown a larger difference due to its various limitations and regional variations. .The FDA seems to be quite strict in monitoring the risk of cardiovascular events .I understand that it is that much of a serious issue, but also suspect the decision made for JAK inhibitors had been somewhat influenced by this tendency. I agree to a certain extent .Moreover, due to the recent COVID-19 pandemic and the rapid introduction of vaccines, many patients seem to have become more sensitive about safety, not only for the vaccines but for all drugs in general .This may be why the FDA made such preemptive measures based on just one study result .-The rising concern is that due to the issue, authorities may limit the prescription of JAK inhibitors to ‘patients that are unable to use Anti-TNF therapies.’ What is your opinion on this? It’s a shame .JAK inhibitors have the advantage of being an oral formulation .There is stress in receiving regular shots, especially in the case of intravenous agents .There are patients who clearly show an effect when prescribed JAK inhibitors .It’s not that the anti-TNF therapies are lacking in effect, it’s just about what better fits the patient .Some patients who seem fine and are well controlling their inflammations but complain of pain or bad conditions were relieved of their inconveniences with JAK inhibitors .All drugs have adverse reactions that are identified with the use in their respective indications .We carefully examine these to select an appropriate drug for each patient .I believe it is better to let the doctors in the field use their discretion for the safe use of JAK inhibitors rather than impose regulations and restrict its use to the second-line.
- InterView
- We are making all efforts to reimburse ‘Vyndamax’
- by Eo, Yun-Ho Apr 21, 2022 06:03am
- 김희정 전무 Rare disease patients suffer more due to the 'rarity' of their condition. Due to the small number of affected patients, even drugs that are already available cannot be easily listed for reimbursement due to difficulty in demonstrating cost-effectiveness or predicting their fiscal impact on the NHI budget. Rare diseases are diseases that affect fewer than 20,000 people or those for which the number of affected patients cannot be estimated due to difficulties in diagnosis. As rare diseases are difficult to diagnose and treat and have a significant impact on the life expectancy of the patients, it is imperative to ensure patient access to the treatments. However, due to the small number of affected patients, initiating clinical trials for such treatments in itself is quite difficult. In this context, Pfizer's Rare Disease Busines Unit has been currently exerting all its efforts to list its ‘Vyndamax (tafamidis 61mg),’ a treatment for ATTR-CM (ATTR amyloidosis with cardiomyopathy) for reimbursement in Korea. However, the process has not been so smooth. The company has already failed twice and is now making its third attempt at reimbursing the drug. Dailypharm met with Hee-Jeong Kim, Rare Disease Lead of Pfizer Korea to hear about the company’s position and state of affairs. -In Korea, it is not an exaggeration to say that reimbursement determines the success or failure of a new drug. As much as the government provides good coverage for the reimbursed drugs, this also makes it more difficult for drugs to be listed for reimbursement. Have you felt this while leading the Rare Disease BU at Pfizer? Korea’s strength is in its coverage (range of coverage). Patients in Korea can receive broader benefits in the course of their treatment due to Korea’s consistent policy and predictable supply under the single-payer system, once the drug is listed. Other markets abroad operate under various schemes. Access to new drugs is a little more difficult in Asia than in other regions. In Europe, new drugs are introduced at a relatively faster rate. In Spain, separate funding is operated for each region, and in the UK, the NHS has allocated alternative funding schemes for necessary drugs. The prompt introduction of new drugs is indeed difficult in Korea due to the wide scope of use of NHI finances from the patient’s perspective. The advantages of the single-payer system that I mentioned previously are partially offset by the strict standards set for new drugs. -This is the third attempt at reimbursement for ‘Vyndamax.’ It seems that the company’s determination will be as important as the government's will in obtaining the reimbursement approval. What efforts have Pfizer been making for the reimbursement?’ All employees at Pfizer Rare Disease have a strong desire to deliver the value of Vyndamax’ to patients in Korea. We plan to continue making attempts through various tracks available in Korea. ATTR-CM is a rare disease that lacks studies and trials to identify the exact prevalence of the condition itself. We fully understand the government’s concerns regarding this ambiguity and have continuously been in discussions with our head office to prepare an innovative risk-sharing plan as requested by the government. However, the agenda has not even passed the Drug Reimbursement Standard Subcommittee, therefore, we are not at the stage to discuss the risk-sharing plan being prepared by the company. We did not expect the drug to fail at setting the reimbursement standard stage so many times, therefore, our prime focus is on passing the Drug Reimbursement Standard Subcommittee this time. We will continue exerting our utmost effort at every stage that follows. -What about collaboration with academic societies and patient groups? The academic societies and patients groups recognize the need for the prompt reimbursement of ‘Vyndamax’ and have expressed their opinion to the government several times. Due to the small number of affected patients, it takes a significant time for HCPs to accumulate the expertise required. The Rare Disease BU cannot exist if the company only considers performance and numbers. In this perspective, having a sense of mission seems to be more important in our line of work. Our drug is necessary for further diagnosis of rare diseases, and we are sorry that there is no treatment currently available for use for HCPs and patients in Korea after the patients are diagnosed with ATTR-CM.
- InterView
- "Will make R&D partnerships, introduce new drugs in Korea"
- by Apr 14, 2022 05:56am
- The China Shanghai-based Antengene has started its activities in earnest in the domestic pharmaceutical market. Marking its start with Xpovio (selinexor), a blood cancer drug that was approved in July last year, the company aims to introduce more new drugs in cancers with high unmet needs. Antengene is an anticancer drug developer that has received investments from global pharmaceutical companies, including BMS. Its founder and CEO Jay Mei, has extensive experience in the field, working at the National Cancer Institute as well as various global pharmaceutical companies including Johnson & Johnson, Novartis, and Celgene, where he led global clinical trial programs. Based on this experience, the CEO founded Antengene, with its key focus of interest in blood cancer. Antengene is one of the few Chinese biotechs that have entered Korea. The company decided to enter Korea as it considers the country an important base in the Asia-Pacific region. The company is also actively engaged in open innovation with bio companies in Korea. It is currently conducting joint research with LegoChem Bio. Through such efforts, Antengene aims to address the unmet medical needs in the Asia-Pacific region, and further expand into a global company. At a virtual interview with Dailypharm on the 14th, CEO Mei (57) said, “We had decided early on that we would need to enter Korea as the country owns a top-class healthcare system, a solid infrastructure for clinical trials, and has a good environment for R&D. We plan to continue expanding our business through joint research in partnership with various Korean companies including Lego ChemBio.” The following is the QA with Antengene’s CEO Jay Mei. Jay Mei, CEO of Antengene-You chose selinexor, an oral anticancer drug you brought in from Karyopharm as the first product for commercialization in Korea. What do you think of selinexor’s vision? =Selinexor was approved as a treatment for multiple myeloma (MM) and diffuse large B-cell lymphoma (DLBCL) treatment by the FDA in July 2019. The drug has been also approved for the two indications in Korea in July last year. Selinexor is an oral selective inhibitor of nuclear export (SINE) that can be used in combination and as monotherapy. We are conducting trials in other blood cancers such as myelofibrosis and acute myeloid leukemia, and are investigating its use in T cell or NK cell-related lymphoma as well. WE plan to continue expanding selinexor’s indication in consideration of its scalability. -What is your key platform technology and pipeline? =Antengene has opted for a two-track approach in which the company seeks growth through partnership-based technology introductions and the development of original pipelines. In addition to Karyopharm, we have made partnership agreements with AstraZeneca, Celgene, and LegoChem Bio. For individual development, our scientists are developing new drugs by investigating new targets. We have a total of 15 progress in progress ranging from non-clinical trials to Phase III trials that are investigating small-molecule drugs, monoclonal antibody therapies, bispecific antibody drugs, ADCs, etc. The trials are underway in Asia and the United States, as well as in Japan and Europe. -What other product do you have in plan to commercialize following selinexor? =We are developing a new drug substance that has the same XP01 inhibiting mechanism of action as selinexor. We are conducting various clinical trials with Karyopharm for the drug, eltanexor (code name ATG016). The target indication is the high-risk group with myelodysplastic syndrome, and a global clinical trial currently in progress is a pivotal clinical trial prepared to be used as the basis for approval reviews. Also, Antengene is developing 6 other new drug candidates for commercialization. First, ‘ATG008' is a new drug candidate that can be used with mTOR inhibitors for the treatment of cervical cancer. The company plans to conduct a global trial if the ongoing clinical trial brings positive results. Also, a clinical trial for a PD-1-based bispecific antibody ‘ATG101' is underway in Australia for patients who cannot see a further effect from existing PD-(L) 1-based immunotherapies. Within the company, ATG101 is considered a unique substance that has the potential to become a ‘best-in-class’ drug. -What is the background on your partnership with LegoChem Bio in Korea? What is your prospect for ADC treatments? = 'ATG022' that we have in our pipeline is an ADC-based treatment that targets claudin-1. Claudin is quite often found in gastric cancer. Antengene is deeply interested in cancers with high prevalence in Asia like gastric cancer and has taken an interest in next-generation ADCs while developing ADCs. In our search for companies with new innovative technology for developing anticancer substances to conjugate with ADC platforms such as linkers or payloads, we came across LegoChem Bio. We believe LegoChem Bio owns a unique technology and strong potential for next-gen ADC development. Both companies have been searching intently for a new candidate substance after signing the partnership. -In addition to Antengene, the global entry of China-based biotechs and their collaboration with big pharmas have been increasing recently. What do you make of this trend? = Despite the remarkable economic development the region had made over the past 30 years, the unmet medical need in the Asian region is still relatively high. Just in the fields of multiple myeloma and lymphoma that Antengene frequently monitors, only half of the drugs approved in the Western countries are approved in Asia. As such, there are still many areas where patient accessibility needs to be increased. Thanks to the development of the economy and healthcare systems, the talent pool is rapidly increasing in Asia as well. As more and more Asian talents with graduate degrees or higher in biology, chemistry, and medicine enter society, there is now an abundant opportunity for Asia-based biopharmaceutical companies to utilize these talents. We believe that these environmental changes played a part in increasing collaboration opportunities for Asian-based biotech companies that have not entered the global market before. The entry of these companies will provide benefit the global patients by developing new drugs based on new technologies and medical knowledge. If European and American companies had fared well in the past 50 or 60 years, I think it is not time for Asian-based companies, including Korea, to play this role now. I think now is the right time to go global. -Many Korean biotechs are also seeking to enter the global market. However, the companies have trouble communicating with the FDA and designing the clinical trial protocols. As a biotech that has commercialized various products, what know-how do you have to share with the Korean companies? =To become a successful bio-company, the company should first own a competitive product or candidate substance. Next is talent. The company needs to recruit a lot of talented people who have global vision and experience, a deep cultural understanding of various countries and can work smoothly as a team with people from other cultures. In the case of our company, we had set the global strategy to expand into Asian countries including Korea, then to go global from the early stages of establishment. So we thought securing the two factors mentioned above was of utmost importance. In particular, as pharmaceuticals are one of the most highly regulated industries, collaboration with regulatory authorities is very important. Also, we have put in a lot of effort to secure a talented workforce that owns such job competencies. Also, finding a reliable local partner can be helpful if you don’t have enough time to set up a solid team in each market. Finding a good partner is as important as securing good talent in-house. This is why we have established partnerships with various companies including Karyopharm, AstraZeneca, Celgene, and LegoChem Bio. -Your Korean branch celebrated its 1st anniversary this year. What other activities do you have in plan for the Korean branch as well as other countries? = Antengene has established subsidiaries in Korea, China, Australia, Singapore, Hong Kong, Taiwan, and the United States, and is aiming to continue expanding in the future in terms of expanding pipelines and talent pools in addition to geographic areas. Currently, Antengene is positioning itself as an 'Asia+' company, and our urgent mission is to meet the unmet medical needs in many Asian countries. Selinexor has been approved in for this purpose in Korea, Australia, Singapore, and China, and is scheduled to be approved in Taiwan and Hong Kong within the year. The second step is to broaden the partnership with the self-developed substances to advance and become a truly global company. I first visited Korea while serving as head of a global clinical program at Novartis, and was also able to broaden my business understanding of Asian counties at Celgene. Building on my experiences, I am determined to drive Antengene's strong growth and expand its businesses in Asia.
