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- 2026-03-17 09:48:44
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- Esophageal cancer, added to indication of Opdivo·Keytruda
- by Eo, Yun-Ho Mar 22, 2022 05:53am
- Cancer immunotherapys are advancing into the esophageal cancer area one after another. According to related industries, Opdivo (Nivolumab) and MSD's Keytruda recently were added esophageal cancer indications in Korea. Opdivo obtained final approval from the MFDS last month and Keytruda on the 7th. With this permission, Opdivo can be prescribed as an auxiliary therapy for adult esophageal or GEJ cancer patients with residual pathological diseases after CRT. The efficacy of this drug against esophageal cancer was confirmed through a phase III clinical CheckMate-577 study. As a result of the study, the median PFS period for patients treated with Opdivo after surgery was 22.4 months, twice as long as 11 months for placebo-treated patients. The median treatment period of the Opdivo treatment group was 10.1 months, and the placebo group recorded 9 months. Keytruda is the primary combination therapy. This drug can be prescribed in combination with platinum-based anticancer drugs in the primary of non-removable local progressive or metastatic esophageal cancer and gastroesophageal junction cancer. The effectiveness of Keytruda in esophageal cancer was demonstrated through a phase 3 clinical KEYNOTE-590 study. The combination therapy of Keytruda and 5-FU+Cisplatin demonstrated statistically significant OS and PFS improvements over 5-FU+Cisplatin in all pre-designated study groups. Combination therapy with Keytruda, 5-FU, and Cisplatin reduced the risk of death by about 27% compared to 5-FU+Cisplatin, and the risk of disease progression or death by about 35%. It was analyzed that Keytruda, 5-FU, and Cisplatin reduced the risk of death by 38% and the risk of disease progression or death by 49% compared to 5-FU+Cisplatin in the patient group with PD-L1 expression rate of 10 or higher. Meanwhile, Keytruda recently listed primary lung cancer therapy on the insurance benefit list. Opdivo has recently slowed the expansion of gastric cancer benefits, but has not passed the Cancer Disease Review Committee.
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- Celltrion was fined 13.9 billion won
- by Kim, Jin-Gu Mar 22, 2022 05:53am
- Financial authorities imposed a fine of 13.9 billion won on three Celltrion companies that prepared and disclosed financial statements in violation of accounting standards. The Financial Services Commission held its fifth regular meeting on the 16th and decided on this. The fines decided at the meeting are 6 billion won for Celltrion, 6.04 billion won for Celltrion Healthcare, and 992.1 million won for Celltrion Pharmaceutical. Fines of 415 million won were imposed on two people, including Celltrion CEO, and 483.9 million won on three people, including Celltrion Healthcare CEO, respectively. Penalties imposed on the three Celltrion companies and company managers totaled 13.93 billion won. An accounting firm that was judged to have neglected the audit process was also fined. 1.065 billion won was imposed on EY accounting firms and 410 million won on KPMG. Earlier on the 11th, Securities & Futures Commission under the Financial Supervisory Commission decided on measures such as recommending the dismissal of executives in charge and designating auditors for serious violations in the accounting process of the three Celltrion companies. According to the results of the investigation and supervision, these companies committed violations such as overestimating development costs, sales, and inventory assets, or not listing transaction notes with related parties in their financial statements. The Securities & Futures Commission has decided not to file a complaint with the prosecution, saying it is difficult to say that the violation was intentional. Accordingly, Celltrion was not subject to the Korea Exchange's transaction suspension.
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- Concerns over fungal infection due to COVID-19
- by Eo, Yun-Ho Mar 21, 2022 05:56am
- There is concern about the gap in fungal infections due to the re-proliferation of COVID-19. The most commonly reported fungal infections in COVID-19 patients include COVID-19 associated pulmonic aspergillosis (CAPA), COVID-19 associated mucomycosis (CAM), and Candida auris. These COVID-19-related fungal infections can lead to serious diseases and deaths. If left untreated, CAPA-related morbidity reaches up to 80%, and CAM mortality is close to 100%. CAPA is a secondary fungal infection mentioned as a clinical complication of COVID-19 infection in the government's COVID-19 response guidelines, and CAPA has been confirmed in Korea. ◆The number of patients who need antifungal drugs in Korea also surged According to the KSID Autumn Conference presentation data in November last year, 57.8% (126/218) of 218 patients with severe COVID-19 were treated by ICU, and the cumulative incidence rate of CAPA related to COVID-19 was 4.5% (10/218) and 11.2% (10/89) of COVID-19 patients admitted to intensive care units. In-hospital mobility was 11.9% (26/218) in COVID-19 patients and overall mobility in CAPA patients was 50% (5/10). It was found that CAPA secondary infection affected the survival of COVID-19 patients. COVID-19-related CAPA mainly occurs in severe COVID-19 patients who use ventilators in intensive care units, and patients often show non-specific symptoms, and it is difficult to diagnose because samples need to be collected deep in the lungs. Choo Eun-joo (Professor of Infectious Medicine at Bucheon Hospital at Sooncheonhyang University) said, "As experienced through the COVID-19 pandemic, it is important to preemptively secure drugs necessary for treating acute infectious diseases at the government level. New antimicrobial and antifungal drugs, which are essential for treating infectious diseases, are having difficulties in development around the world despite high clinical needs," she said. Surgical surgery and antifungal agents including Amphotericin B, Posaconazole or Isavuconazole can be used for COVID-19-related CAM treatment, and Voriconazole is not recommended for CAM treatment. Posaconazole has indication for the treatment of CAPA patients in Korea, so if CAPA or CAM is suspected in COVID-19 patients, Cresemba (Isavuconazole) is the only drug that can be used preemptively at the same time as fungal culture. Cresemba is an antifungal agent that has indications for both invasive CAPA and invasive CAM. Cresemba was designated as a national essential drug in June 2021. This drug is licensed and used in March and October 2015, respectively, in the United States and Europe (EMA), but it is not reimbursed in Korea. Professor Choo said, "In Korea, new antibiotics are allowed, but insurance benefits have not yet been registered. There are no antibacterial and antifungal drugs that have entered the right to benefit for the past five to seven years. Drugs necessary to treat fatal infectious diseases should not be evaluated only from an economic perspective, as they play a key role in preventing the spread of infectious diseases as well as the survival of individual patients."
- Company
- 5 companies challenge breast cancer drug Ibrance’s patent
- by Kim, Jin-Gu Mar 21, 2022 05:55am
- Pic. of Ibrance The number of companies challenging the patent of Pfizer’s breast cancer treatment ‘Ibrance (palbociclib)’ has increased to 5. According to the pharmaceutical industry, Boryung Pharmaceutical, Shinpoong Pharm, Daewoong Pharmaceutical, and Samyang Holdings had filed a series of claims to confirm the passive scope of rights on Ibrance’s crystalline form patent. Kwang Dong Pharmaceutical had been the first to challenge the patent on the 3rd of this month. With the additions, a total of 5 companies will be attempting to avoid the crystalline form patent of Ibrance. In the case of Kwang Dong Pharmaceutical, the company had also received approval for a bioequivalence test to develop a generic version of Ibrance. Ibrance’s crystalline form patent will expire on February 8th, 2034. If the companies succeed in avoiding the patent, they will be able to release a generic version after the drug’s substance patent expires on March 22nd, 2027. The substance patent was originally set to expire on January 10th, 2023, but Pfizer had extended the duration of the patent by over 4 years for the time taken on clinical trials and permits. If generic companies additionally challenge to invalidate the extended term of the patent, it is possible that the date of release of the generic products may be further advanced. Until now, generic companies have not aggressively pursued patents challenges for anticancer drugs as the chances of success of the generic is not high due to the high preference of original drugs in the field. Therefore, the development and release of generics after overcoming the patents was not profitable for the companies. Despite the barriers, the reason why so many companies are challenging Ibrance’s patent is because of the reputation built by the drug in the breast cancer treatment market. According to the market research institution IQVIA, Ibrance has continued to expand by double-digit sales every year since it was approved in Korea in August 2016. In fact, Ibrance's sales, which recorded ₩6.6 billion in 2017, then to ₩25.3 billion in 2018, ₩43.7 billion in 2019, ₩57.3 billion in 2020, and to ₩65.6 billion in 2021. Also, the fact that domestic companies started to make an impact in the generic market for anticancer drugs, which had been considered impenetrable, can also be a reason for the increased challenges filed against Ibrance. Recently, Hanmi Pharmaceutical, Samyang Holdings, Boryung Pharmaceutical, and Chong Kun Dang had been showing significant performance in the market. Hanmi had released its generic version of Bayer’s liver cancer treatment Nexavar, ‘soranib,’ Samyang released BMS’s Taxol generic ‘Genexol,’ Chong Kun Dang released generic version of AstraZeneca’s lung cancer treatment Iressa, ‘Iretinib' to chase the market occupied by original drugs.
- Company
- K-Bio has become a global production hub
- by Kim, Jin-Gu Mar 18, 2022 05:55am
- The Korean pharmaceutical bio industry has become a global coronavirus vaccine and treatment consignment production hub. With the consignment production of coronavirus vaccines and antibody treatments in charge, the company will be in charge of consignment production of oral treatments for the supply of underdeveloped countries. On the 17th, the MOHW announced that Celltrion and DongbangFTL were selected as generic producers of the oral corona treatment Paxlovid developed by Pfizer. Celltrion produces finished products and DongbangFTL produces Nirmatrelvir. The products produced here are supplied to 95 underdeveloped countries. MPP, along with two Korean companies, selected a total of 35 companies from 12 countries around the world. There are 19 in India, 5 in China, 1 in Bangladesh, Vietnam, Brazil, Dominican Republic, Mexico, Jordan, Israel, Serbia and Pakistan. In January, International Pharmaceutical Patent Pool also selected three Korean companies as generics of the oral coronavirus treatment developed by MSD. Hanmi Pharmaceutical was selected along with Celltrion and DongbangFTL. Ildong Pharmaceutical is jointly developing another oral treatment candidate material "S-717622" with Shionogi of Japan. Ildong Pharmaceutical plans to produce oral treatments with Shionogi and supply them globally as soon as the clinical trial is completed. It is interpreted that the stable production capacity of Korean companies has been verified by the world over the fact that they have been selected as a producer of oral treatments one after another. Korean pharmaceutical companies are being used as consignment production bases for COVID-19 vaccines and antibody treatments by multinational pharmaceutical companies. In the case of COVID-19 vaccines, five domestic companies have decided to commission production of five global vaccines. SK Bioscience has been producing AstraZeneca and Novavax vacine since last year. Samsung Biologics has signed a contract with Moderna and is producing a coronavirus vaccine. Although it has not yet begun full-scale supply, the Korus Pharm consortium can commission Russian vaccine Sputnik V, while Hanmi Pharmaceutical and Enzychem can commission ZyCoV-D developed by Indian pharmaceutical company Zydus Cadila. In addition, Samsung Biologics is commissioned to produce AstraZeneca Evusheld and Eli Lilly's Bamlanivimab, which are corona antibody treatments. Celltrion has produced and is supplying its own antibody treatment drug Regkirona globally. At the end of last year, it was approved for use in Europe. An official from the pharmaceutical industry said, "Korea has large-scale facilities for consignment production and has high reliability in quality. With the Corona incident, the status of the Korean pharmaceutical bio industry will increase, and the value of the K-bio brand will also increase on the global stage in the future."
- Company
- Largest shareholder of Medipost changed to a private equity
- by Chon, Seung-Hyun Mar 18, 2022 05:55am
- View of Medipost HQ The largest shareholder of the bio venture company Medipost will be changed from the founder and CEO Yoon-sun Yang to a private equity consortium. Medipost plans to receive an investment of approximately ₩140 billion from a private equity fund to invest in its cell and gene therapy business. On the 17th, Medipost announced that it had signed an investment agreement worth ₩140 billion with Skylake Equity Partners and Crescendo Equity Partners. Under the agreement, Medipost will issue a paid-in capital increase through a third-party allotment worth ₩70 billion to Skylake and Crescendo. A total of 374,314 shares will be newly issued. Medipost will issue registered non-guaranteed private Equity Convertible corporate bonds worth ₩35 billion each to Skylake and Crescendo. Skylake and Crescendo etc. will be investing ₩140 billion just in paid-in capital increase and convertible bonds alone. Medipost’s largest shareholder had been CEO Yoon-sun Yang, who had owned 1,001,002 shares (6.16%). However, with the capital increase alone, the number of shares owned by Skylake and Crescendo exceed the number owned by CEO Yang, thereby changing the largest shareholder of the company. In addition, Yang had transferred 400,000 shares to Skylake, etc. at ₩90 billion. When the conversion of convertible bonds to common stocks is complete in addition to the paid-in capital increase the shares bought, Skylake, etc. will own 32.7% of Medipost’s shares. In total, Skylake, etc. is investing ₩230 billion for the acquisition of Medipost shares. Medipost plans to invest ₩85 billion of the secured funds in gene cell therapy CDMO company based in the North American region. Currently, Medipost is in exclusive negotiations with a CDMO company to sign an investment agreement within May this year. The company plans to invest 55 billion won in clinical trials conducted for the osteoarthritis treatment Cartistem and SMUP-IA-01 in the US to accelerate its entry into the US osteoarthritis treatment market. Medipost has pointed to the CDMO business for gene cell therapy as the optimal new The company expects that the business will serve as a production base that can produce and supply clinical regents for Cartistem and SMUP-IA-01 in the US, as well as efficiently manage the manufacture and supply of the company’s products after marketing approval. A Medipost official said, “This funding is significant in that we were able to secure a shareholder who can actively support overseas businesses, based on which we could aggressively promote businesses overseas and maximize corporate value.” An official from Skylake said, “We evaluated Medipost's global potential for global expansion highly as the company owns world-class stem cell screening and culture technology and promising stem cell therapies such as Cartistem, and decided to invest in the company in consideration potential and synergy that will be made with the global cell gene therapy CDMO business and growth." An official from Crescendo said, “We decided to invest in Medipost because we were confident that Medipost could grow into a global champion with Crescendo's overseas business experience and global network, including our ties in the US.” Skylake and Crescendo’s investment will be safeguarded in a depository for one year.
- Company
- Multinational pharmaceutical companies are changing logos
- by Mar 18, 2022 05:55am
- Organon Korea returns after 13 years of absence with a new logo, "Women's Health" starts anew. Multinational pharmaceutical companies are trying to transform their image with new logos. Pfizer entered the unexplored area of mRNA and changed its logo in about 70 years. Sanofi also emphasized "one Sanofi" as an integrated brand logo. Analysts say that multinational pharmaceutical companies are expressing the spirit of science and innovation with new logos as they jump into areas where it is difficult to develop treatments. Sanofi-Aventis Korea announced on the 15th that it will remove the separate brands attached to each division and merge them into a single brand. Until now, the vaccine division has been called Sanofi Pasteur and the specialty care division has been called Sanofi Genzyme. In the future, Pasteur and Genzyme will be excluded and all will be integrated into "Sanofi." However, the existing corporations divided into Sanofi-Pasture and Sanofi-Aventis are not integrated. Old Sanofi logo (left) and New logo (right) The intention is to unite distributed brands and present common goals and identities. Founded in 1973, Sanofi has included companies it has acquired, including Sanofi-Synthelabo, Aventis, and Genzyme, in its business team brand names. Then, in 2019, it announced the improvement of the constitution of the new drug pipeline and began to change. It will boldly give up pipelines with poor growth engines such as chronic diseases and invest heavily in new growth fields such as immunity, rare diseases, and nervous system diseases. In other words, Sanofi's four business units ▲ Sanofi Pasteur (vaccine) ▲ Sanofi Genzyme (specialty care) ▲ General Medicine ▲ Consumer Healthcare is a plan to integrate and expand Pasteur and Genzyme. The logo has also been transformed as part of the first brand integration in Sanofi's history. The new shape, which means innovation, adaptation, and growth, has changed the existing logo, which used to form a circle, to a lowercase logo with two purple dots at the beginning and end of the name. The new logo is inspired by the simple yet dynamic nature of the tech industry. The purple dot on S means the starting point for asking the question What if? The purple dot of i is the end point that results in the discovery of innovative solutions. The new logo represents Sanofi's scientific journey from the starting point to the ending point. Sanofi said, "In the future, we will think and move as a company under a new and common purpose and identity," adding, " we hope the new integrated brand unveiled this time will serve as an opportunity to inform employees, partners, medical experts and patients of Sanofi's identity and orientation." The old Pfizer logo (left) and the new logo (right) Pfizer, which is improving its constitution to develop innovative new drugs, also introduced a new logo for the first time in 70 years. The pill-shaped oval background, which has been representative of Pfizer, has been boldly discarded. The new logo represents a double helix with two tones of blue bands symbolizing Pfizer. This means that the substance of double helix is revealed by unlocking the original pill form. The logo extending upward conveys an upward movement, and the rotating form means "reversing the old reality for innovation." Pfizer, which planned to spin off its patent expiration division and change its logo, finally selected a design produced by Brooklyn Studio Team in the U.S. Just in time, Pfizer succeeded in transforming its image by introducing the COVID-19 vaccine. Pfizer, which commercialized the mRNA-based vaccine for the first time, has also drastically trimmed its pipeline to suit the new logo. It has begun to develop mRNA-based drugs in earnest. mRNA-based drugs are a new mechanism that has just begun commercialization, and there are still many unexplored areas. Old organon logo (left) and new logo (right) Organon, which was spun off from MSD, has started to break away from its past image with a new logo. Founded in the Netherlands in 1923, Organon is the place where the early substance of the immuno-cancer drug Keytruda was developed. It has a history of being absorbed into MSD through a merger with Schering-Plough. About 10 years later, it was separated from MSD again and reborn as an independent corporation. Organon, which focused on women's health in the past, focused on three areas: women's health after independence, chronic diseases, and biosimilars. The name Organon Korea is the same, but it changed the logo in the sense of starting anew. Unlike the old logo, which was a turquoise oval band, the new logo has a circular point in green, blue, and sky blue and a scarlet dash pattern forming a geometric pattern. The central dot means women's health, and the surrounding dots indicate that the company is paying attention to various environments that affect women's health. The dash pattern contains a commitment to improving human life, a vision for a healthier life for all women, and a mission to supply meaningful medicines. The geometric pattern created by gathering dots and dashes means that the company's appearance today and its vision for tomorrow communicate and integrate with each other. Organon Korea said, "In the past, Organon Korea has also made a lot of innovations in women's health," adding, "The new Organon Korea will provide new solutions for women's health, which was relatively unmet."
- Company
- Same ‘one-shot’ but different? Zolgensma reimb slow
- by Eo, Yun-Ho Mar 17, 2022 05:59am
- Although both drugs are from the same pharmaceutical company and are both one-shot, high-priced drugs, the two drugs are showing a stark difference in their results. Discussions on the reimbursement listing for Novartis Korea’s Zolgensma (onasemnogene abeparvovec) is not progressing so smoothly. The company had applied for the reimbursement listing of its Spinal Muscular Atrophy (SMA) treatment Zolgensma in May last year through the approval-benefit appraisal linkage system, but the agenda has not been deliberated by the National Health Insurance Service DREC until now. As it is a rare disease drug, the Drug Reimbursement Standard Subcommittee must set reimbursement standards, and the drug pass DREC deliberations to receive reimbursement. According to industry sources, the government had numerously requested data supplementation to the company, upon which the company repeatedly submitted additional data. Originally, drugs should receive DREC deliberations within 150 days of submitting an application under the National Health Insurance Act, but this period has long been exceeded. This is different from the results made for the company’s new CAR-T therapy ‘Kymriah (tisagenlecleucel).’ Kymriah has passed DREC deliberations last January. Last month, Yong-Myung Jang, HIRA’s Director of Development at the Health Insurance Review and Assessment Service (HIRA) mentioned Zolgensma at a press meeting with the Special Press Corp last month, raising hopes on the progress to be made for Zolgensma. Director Jang said, “We have collected opinions from the society, experts, and held an expert advisory meeting to discuss its clinical use. DREC deliberations are in the way for the drug.” However, Zolgensma was not on the list for deliberations in February. Meanwhile, Zolgensma is a gene therapy that contains a genetic material that functionally substitutes defective genes. The Ministry of Food and Drug Safety approved Zolgensma as the second advanced biologic product after Kymriah. Advanced biopharmaceuticals are cell therapies or gene therapies that use live cells, tissues, or genetic material as ingredients. Under the ‘Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals,’ advanced biopharmaceuticals can receive differentiated safety management including long-term follow-up studies and support for R&D and product commercialization. Despite being a one-shot treatment, the price of the single shot costs 2.5 billion won in the U.S. and 1.89 billion won in Japan. Due to the high price, the listing process for Zolgensma in Korea is also expected to walk a rocky road However, expectations for its efficacy are very high. The Phase III SPR1NT and STR1VE-EU results for Zolgensma that was presented recently gained much attention. In the SPR1NT study, all pediatric SMA patients with two SMN Type 2 gene copies (Cohort 1) that were treated presymptomatically survived without requiring ventilatory or nutritional assistance and achieved sitting independently for 30 seconds or more. Most (11/14) patients achieved age-appropriate motor milestones within the World Health Organization (WHO) window of normal development. In the STR1VE-EU study, most pediatric patients (82%) that were treated with Zolgensma, including those with severe SMA, achieved motor milestones unseen in the natural history of SMA Type 1. An official from the company said, “Patients and their families are longing for the prompt reimbursement of Zolgensma. We are working closely with relevant ministries so that we can receive reimbursement as soon as possible and not deprive the opportunity for patients desperately waiting to be treated with Zolgensma.”
- Company
- Molnupiravir can be supplied on the day of approval
- by Mar 17, 2022 05:58am
- MSD is trying to contribute a lot to overcoming the COVID-19 pandemic. Molnupiravir is fully prepared to be supplied on the same day as soon as it is approved. Kevin Peters, CEO of MSD Korea, made the remarks at a press conference held on the 16th. MSD developed the COVID-19 treatment Molnupiravir last year and received the U.S. Food and Drug Administration (FDA) EUA in December of that year. This is the second COVID-19 treatment after Pfizer's Paxlovid. 13 countries, including the UK, Japan, Australia and Taiwan, approved the use of Molnupiravir. The WHO has included Molnupiravir as a treatment option in the revised COVID-19 treatment guidelines. In November last year, MSD also applied for EUA of Molnupiravir to the MFDS. However, it has not been approved even after about three months. This is in contrast to the approval of Paxlovid, which filed an application at the same time, in about a month. Some point out that Molnupiravir's effectiveness fell short of expectations as a result of clinical trials. In phase 2/3 conducted by MSD, Molnupiravir reduced hospitalization and death risk by about 30%. Paxlovid had up to 89% effect in its own clinical practice. For this reason, the FDA advisory committee also considered whether to approve Molnupiravir. Although they managed to recommend approval, 10 people, or 40%, opposed it. Regarding the progress of approval of Molnupiravir, CEO Peters said, "I think both vaccines and treatments should provide as many options as possible to effectively overcome the pandemic." Molnupiravir is used in many countries around the world, contributing a lot to treatment, he said. He then said, "MSD is cooperating as much as possible so that Molnupiravir can be used quickly," adding, "What I can promise is that it can be supplied immediately as soon as approval is given. We are fully prepared to supply it from the day of approval."
- Company
- Verzenio makes "bid with verified data” against Ibrance
- by Mar 17, 2022 05:58am
- The breast cancer treatment ‘Verzenio’ is working hard to expand its market. Although it is a latecomer in the CDK 4/6 inhibitor market, Lilly is showing confidence that it can bring different results from other previous treatments. In fact, Verzenio is pioneering the base of use of CDK4/6 inhibitors from metastatic breast cancer to early breast cancer based on its powerful data. The cyclin-dependent kinases (CDK) 4/6 inhibitors that control cell division and growth selectively inhibit the proliferation of cancer cells. The drugs target human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, which accounts for 60% of all breast cancers. The drug that had opened the door to the CDK 4/6 inhibitor market was ‘Ibrance (Palbociclib).’ After it was introduced in August 2016, the drug became namely ‘the' breast cancer treatment. In this sense, the market was formidable for the latecomer Verzenio (abemaciclib), which was approved in May 2019, because of the solid position established by Ibrance during the past three years. Also, the misconception that “all CDK4/6 inhibitors are same” and the introduction of the third CDK4/6 inhibitor,‘ Kisqali (ribociclib),' had intensified competition in the market. However, Lilly is showing extreme confidence in Verzenio. In an interview with Dailypharm, Jihee Kim, a Sr. Brand Manager for Verzenio at Lilly Korea, said, “Verzenio has shown consistent effect regardless of the patient's menopausal status, and extended overall survival (OS) in patients who were known to have a relatively poor prognosis. Its molecular structure is slightly different from the other two drugs, which makes differences in efficacy, side effects, and administration period. This is why Verzenio is preferred in treating patients with poor prognosis." Results of the MONARCH-2 trial that allowed for the approval of Verzenio showed that the use of the Verzenio+fulvestrant combination demonstrated a significantly longer median overall survival (OS) of 46.7 months compared to the median OS of 37.3 months with fulvestrant monotherapy. The primary endpoint, median progression-free survival (PFS) was 16.4 months vs 9.3 months. Significant results were also obtained from its sub-analysis. Verzenio had shown consistent prolongation effects in breast cancer patients with poor prognosis such as those with liver metastasis or high-grade tumors, progesterone receptor-negative patients, and those with metastasis in other areas than the bone. These study data were also positively received by the clinical field and are making an impact. Sales of Verzenio had surged after its reimbursement listing in June 2020 (based on IQVIA), raising ₩11.2 billion last year. This is a 136% rise YoY. Its sales are still far below Iblance’s sales of ₩65.6 billion, but is considered to be a smooth start. Also, the hidden efforts of the marketing team had shone through. Sr. Manager Kim said, “Not many doctors were aware of the latecomer Verzenio at the time, and it was difficult to change the prescription pattern of the doctors as the doctors regarded all CDK4/6 inhibitors the same. To overcome this, we have actively conducted symposiums and product briefings. Among the healthcare professionals who attended our briefings, some hed given feedback that they would consider prescribing our drug to eligible patients and prescribed them. I felt proud that we were able to deliver the value of Verzenio all the way to the patient." Also, another characteristic of Verzenio is that it is the only CDK 4/6 inhibitor that does not require a "treatment holiday." CDK 4/6 inhibitors are taken for 2 years at the longest, and therefore the management of its side effects in the early stages is very important. Also, regular toxicity monitoring is essential in the early stages of administration is also essential. Other drugs have a 1-week break period after 3 weeks of administration, therefore when these drugs are discontinued due to side effects, this period is extended, causing difficulties in toxicity management. On the other hand, management of the daily-taken Verzenio is much simpler. If a side effect arises, the patient may temporarily discontinue taking the drug and restart use after dose adjustments or the same dose as needed. Verzenio can also expand the field covered by CDK4/6 inhibitors, as it has acquired positive data in early breast cancer. Verzenio achieved its primary endpoint in an average follow-up period of 15.5 months as adjuvant therapy in patients with early HR+/HER2- breast cancer. Although its indication has not been extended to breast cancer in Korea yet, expectations are high among HCPs in the field on the use of CDK4/6 inhibitor in early breast cancer. Until then, it is most important for HCPs to use Verzenio in metastatic breast cancer and learn for themselves the characteristics of the drug and establish trust in the drug.
