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- 2026-04-16 11:26:58
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- Cancer Committee leaves Keytruda confused, now what?
- by Eo, Yun-Ho Aug 28, 2020 06:19am
- An immunotherapy Keytruda (pembrolizumab) indicated as a first-line treatment on lung cancer is still lost in a thick fog with its attempt to expand healthcare coverage. And it has been three years already. Health Insurance Review and Assessment Service’s (HIRA) Cancer Deliberation Committee was gathered on Aug. 26 to deliberate granting healthcare reimbursement on breast cancer treatment Kadcyla, leukemia treatment Venclexta (venetoclax), and Keytruda. The conversations on Kadcyla and Venclexta were relatively simpler, and the committee eventually passed those products. On the contrary, the talk on Keytruda started off with a financial plan the Cancer Deliberation Subcommittee worked on for three meetings to provide the health insurance benefit while lessening the financial burden on National Health Insurance. But, still to the next day of meeting on Aug. 27, the pharmaceutical industry was conflicted over the committee’s unclear conclusion either ‘passing’ or ‘rejecting’ the reimbursement decision. Even the press coverage delivered completely contrasting news. ◆First question—was the financial plan not good enough? Then what actually went down with the committee? Still, there is no clear answer. But according to Daily Pharm’s investigation, the Cancer Deliberation Committee’s decision on Keytruda was close to ‘differing’ it, yet again. A member of the committee who was present at the meeting commented, “We were not satisfied with the revised financial plan brought to the table. Some even said it was worse than the initial version [MSD submitted to the government body in May, prior to the June Cancer Committee meeting]. The company should have put more effort on it.” This is the part, where some were convinced the committee has ‘rejected’ expanding the coverage on Keytruda. Nevertheless, from a commonsensical perspective, the assumption is unconvincing. The subcommittee that first deliberated the financial plan included members not only from the government or financial experts, but also from the Cancer Deliberation Committee. Actually, the pharmaceutical company itself was excluded from the conversation. In other words, the financial plan the subcommittee members, including the Cancer Committee representatives, worked on for three times was technically worsening the financial strain. And if the committee member at the meeting was present at the subcommittee meetings, it means the member was not convinced with the financial plan they worked on. It could be that the Cancer Committee member was skeptical with the way the subcommittee was amending the plan. And regardless of the subcommittee’s settlement, the Cancer Committee could have been largely unconvinced about the plan. In such case, then the decision should have been clear that it was ‘rejected.’ ◆Second question—sending the unsatisfying financial plan back to the company? But they say the conclusion was not a rejection. If it was then the talks on expanding Keytruda’s coverage should have ended, technically. But after the Cancer Committee meeting, HIRA informed that the financial plan would be sent back to MSD. An insider from HIRA said, “The meeting’s conclusion has not been clearly decided, yet. The discussion details would be compiled and sent to MSD as an offer.” In case of rejecting the decision, the government agency could have simply announced so. But HIRA’s action means the coverage could be expanded depending on MSD’s decision to accept the offered financial plan. The Cancer Committee and HIRA’s stories do not coincide. The government has yet to follow with a clear explanation. Putting all clues together, the following can be deducted; The expanded coverage on Keytruda has been heavily demanded by patient support groups. As no clear answer was provided for a long time, the patient group’s fury was directed towards both the government and the company. In such tight spot, the Cancer Committee and the government would have felt pressured to ‘reject’ the decision. Moreover, the last Cancer Committee’s deliberation on Keytruda was an exceptional case; to revise the financial plan, the committee convened the subcommittee and discussed specifically about financial issues without much of a concern on ‘clinical efficacy.’ Even if MSD accepts the revised plan, Keytruda would have to go through the Cancer Committee again, and not skip ahead to Drug Reimbursement Evaluation Committee (DREC). The latest decision could have meant the Cancer Committee was “skeptical about the subcommittee’s revision,” and yet they are “willing to discuss the plan again, after the pharmaceutical company accepts the offered plan.” In other words, the committee passed on the ticking bomb to MSD. As for the company, all eyes are now on the company while they are burdened to make a decision to accept the revised financial plan. A market access expert from a multinational pharmaceutical company pointed out, “Seeing the updates on Keytruda listing talks, it is unlike other anticancer treatment listing process with so many unprecedented happening. The entire procedure is veiled and far from being transparent. The government needs to put down a clearer guideline for the coverage expansion procedure.”
- Company
- Sky Zoster has the highest market share ever
- by An, Kyung-Jin Aug 28, 2020 06:17am
- SKY Zoster & Zostavax The shingles vaccine market successfully rebounded out of the affected area of COVID-19. Sky Zoster by SK Bioscience set a new record in market share by increasing market influence while sales of competitive products slowed. According to the drug market research agency IQVIA on the 28th, the size of the shingles prevention vaccine market in the first half of this year was estimated at ₩14.8 billion. This is a 11.4% decrease from ₩39.3 billion a year earlier. The domestic shingles vaccine market consists of the combined sales of MSD's Zostavax and Sky zoster by SK Bioscience. In the first quarter of last year, sales of two types of vaccine against shingles in Korea were ₩12.2 billion, a half year-on-year. This is the aftermath of the sharp drop in visits to medical institutions by patients due to the spread of COVID-19. However, in the second quarter, as the spread of COVID-19 in Korea decreased, sales recovered to ₩22.6 billion, and accumulated sales decline in the first half was reduced. It is an analysis that the sales exponentially caused by COVID-19 epidemic was large due to a preventive vaccine rather than a treatment used in an emergency situation. Zostavax and Sky Zoster quarterly sales trend (Unit: ₩100 million, Source: IQVIA) Zostavax and Sky Zoster rebounded in sales in the second quarter. However, as the quarterly sales of 'Sky Zoster' increased significantly compared to the competition, it recorded the highest market share since its release. In the first half of the year, the sales of Sky Zoster were ₩14.7 billion. In the second quarter, the cumulative sales in the first half declined only 2.1% from the previous year, with sales of ₩9.8 billion, up 32.7% year-on-year. As of the second quarter of this year, the market share was 43.2%, the highest level since its launch. The sales of Zostavax in the first half of this year fell 17.2% to ₩20.1 billion from ₩24.3 billion last year. Sales in the second quarter were ₩12.8 billion, an increase of 4.4% compared to the same period last year, failing to keep up with the growth of Sky Zoster. Market share of two shingles vaccines on the market in the first half of 2020 (Unit: %, Source: IQUVIA)
- Policy
- 21 generics for Forxiga acquired the exclusivity from April
- by Lee, Tak-Sun Aug 28, 2020 06:17am
- ForxigaForxiga (Dapagliflozin), generic for SGLT-2 inhibitory diabetes treatment has obtained generic exclusivity that will be applied from April 2023. This is because the material patent ends in April 2023. Excluding this patent, the pharmaceutical companies that acquired the generic exclusivity succeeded in patent challenges. However, as a second trial decision is scheduled in the Patent Court of Korea next month, it is expected that Exercise of rights for generic exclusivity will be decided according to the conclusion. As of the 25th, the MFDS obtained generic exclusivity right for 21 single drugs containing Dapagliflozin as an active ingredient. The period of prohibition of the sale of the same drug is from April 8, 2023 to January 7, 2024. There are 21 generic exclusivity items are including Dongwha Dapagliflozin 10mg, Focidi M 5mg, Youngjin Dapagliflozin 5mg, Dongwha Dapagliflozin 5mg, Jepoga 10mg, Focigli 10mg, Dapor 10mg, Dapozin 10mg , Chongkundang Dapagliflozin 10mg, Genshiga 10mg, Dapalon 10mg, Zenciga 5mg, Dapalon 5mg, Dapazin 10mg, Focigli 5mg, Boryung Dapagliflozin 10mg, Hanwha Dapagliflozin 10mg, Youngjin Dapagliflozin 10mg, Hanwha Dapagliflozine 5mg, Focidi M 10mg, and Chongkundang Dapagliflozin 5mg. These are cases where the initial application for permission, the first request for trial (within ~14 days), and the success of the patent challenge are satisfied. In particular, it won a request for an invalidation trial against the second substance patent, which is scheduled to end on January 8, 2024. Currently, the case is an appeal from the patentee AstraZeneca, and a ruling is scheduled in the patent court on the 17th of next month. In this case, if the generic companies win, the exercise of the right is possible as planned, but if the conversely loses, there is a possibility that the right will not be properly exercised. In particular, the industry's analysis is that if the company loses it, it may fall under the effect of the ban on sales under Article 50 of the Pharmaceutical Affairs Act. The MFDS is in the position that it will closely review the provisions of the law after the decision. Currently, Dong-A ST is the only pharmaceutical company that has succeeded in challenging Forxiga's first substance patent. Dong-A ST is known to have succeeded in patent evasion by developing a prodrug. However, Dong-A ST's prodrug is currently in clinical development and has not yet been approved for product.
- Company
- Obesity drug market expands despite COVID-19 as Qsymia soars
- by An, Kyung-Jin Aug 28, 2020 06:17am
- Product image of Saxenda (left) and Qsymia The obesity treatment market in South Korea has marked a significant growth in the first half of the year. The treatment market expanded, although the consumers became reluctant to open their wallets amid COVID-19 pandemic. A newcomer Qsymia is now leading the market alongside with Saxenda, or so-called ‘Gangnam Diet Shot.’ On Aug. 26, a pharmaceutical market research firm IQVIA found Korea’s obesity treatment market in the second quarter jumped 13.2 percent from last year at 33.2 billion won to 37.6 billion won. The cumulative sales in the first half of the year grew 7.6 percent from last year at 65.4 billion won and generated 70.4 billion won. If the market continues to see the positive growth, it would be able to break through the 100 billion won mark for two consecutive years. Quarterly sales of obesity treatment market in South Korea (Unit: KRW 100 million) Source: IQVIA Novo Nordisk’s Saxenda and Alvogen Korea’s Qsymia were two stars of the market leveraging the growth. In the first half of the year alone, Saxenda made 18.3 billion won. Compared to last year at 19.8 billion won, the quarterly sales dropped by 7.4 percent, but the injection is still the top obesity treatment in the Korean market. Its market share in the first half of the year was at 26.0 percent. Saxenda was the world’s first obesity treatment to be approved as a glucagon-like peptide-1 (GLP-1) receptor agonist. Saxenda shares the same substance liraglutide with Victoza, prescribed to type 2 diabetes patients, but its administration route and dose are different. As the users became aware of the medication to be comparatively safer with its mechanism of working like appetite-regulating and weight loss-inducing GLP-1, Saxenda has been enjoying unprecedented popularity for last two years. Started off with 2018 third quarter sales at 1.7 billion won, Saxenda’s sales surged to 5.6 billion won in the fourth quarter and took the lead in the market. Ever since the sales in first quarter of 2019 broke through 10 billion won point, Saxenda has maintained the sales around 10 billion won and defended the market leader title. In the third quarter last year, the treatment sales peaked and it dominated market share of 33.7 percent. But Saxenda’s easy race was shaken up, when Qsymia has announced its release in last January. Quarterly sales of major obesity treatments in South Korea (Unit: KRW 100 million) Source: IQVIA Immediately after the launch, Qsymia generated 4.3 billion won in the first quarter and came in second in the Korean obesity treatment market. After making another 5.8 billion won in the second quarter, Qsymia accumulated 10.2 billion won in the first half of the year and consolidated its strong market presence next to Saxenda. As of the first half of 2020, Qsymia’s market share has reached 14.4 percent. The figure doubles the market share of Daewoong Pharmaceutical’s Dietamin (6.7 percet) that used to be the second in the market until the fourth quarter last year. Alvogen Korea licensed in phentermine and topiramate combined Qsymia from the U.S.-based pharmaceutical company Vivus in 2017 for the sales in the South Korean market. Alvogen Korea also signed a co-marketing deal with Chong Kun Dang late last year and came into the market with powerful sales and marketing activities. Well experienced in the obesity treatment market with Furing and Furimin, Alvogen Korea created a mutual synergy effect with Chong Kun Dang’s vast sales power and quickly took over the market. Except for Qsymia, other treatment generally experienced stagnating growth. Three products out of the top five—Daewoong Pharmaceutical’s Dietamin, Huon’s Hutermin and Alvogen Korea’s Furing—saw their sales fall compared to last year same time. Hutermin made 3.1 billion won and raised the sales only by 0.8 percent from last year, whereas Dietamin (4.7 billion won) and Furing’s (2.7 billion won) sales volume fell by 0.2 percent and 0.4 percent, respectively, against last year. The market was expecting an intense competition eyeing on the market share left by a blockbuster drug Belviq as it exited the market with risk of developing cancer. But the market experts say the pandemic and release of Qsymia have grounded them from soaring in the market.
- Company
- The KRPIA appoints Kim Minyoung to succeed Kim Seongho
- by Eo, Yun-Ho Aug 28, 2020 06:17am
- Kim Seong-ho (62), the former executive director of the KRPIA, has been decided to succeed. According to related industries, KRPIA has recently confirmed Kim Min-young, who was in charge of the JAPAC regional headquarters (region) in Amgen Asia, as the general manager of insurance policy and external cooperation. The position is executive director. He is known as a person with experience in marketing and sales, as well as foreign cooperation such as MA (Market Access). Meanwhile, former executive director Kim Seong-ho left the association, which he had been with for about eight years since 2012, ending last April. Kim, who has been in charge of policy affairs at the association, was at the forefront of communication with the government for the reform of the drug price system. It also played an important role in the process of improving the system, such as expanding the targets of the Risk Sharing Agreement (RSA) and applying the RSA, a generic drug awaiting announcement. Since the resignation of former vice chairman Lee Sang-seok (67), the KRPIA and its member companies, which had no officials from the government, were concerned about the gap of him, an expert in drug price and policy management. As such, interest in the successor was also high.
- Company
- Janssen's investment in Lazertinib has scientific basis
- by An, Kyung-Jin Aug 27, 2020 06:25am
- Professor Byeong-cheol ChoJanssen, a global pharmaceutical company, is supporting the development of a new anticancer drug, 'Lazertinib,' introduced by Yuhan. Since the introduction of the technology in November 2018, a total of three global clinical trials have begun in a year and a half. In April, It showed its willingness to continue development by paying a large-scale technology fee for the development of a combination therapy of Amivantamab and Lazertinib, which is being developed on its own. It is also strong to enter global phase III clinical trials related to the combination therapy of Lazertinib within this year. Although there may be a difficult process to pass through the final gateway of the US Food and Drug Administration (FDA), it is a great pleasure that a new drug candidate developed with domestic technology is fully supported by Big Pharma. The competing drug, Tagrisso (Osimertinib), which acts as a similar mechanism to 'Lazertinib', has been approved by major countries around the world early and is being actively prescribed, which raises further questions. What secrets are hidden in Janssen's aggressive investment confidence? Professor Byeong-cheol Cho (Oncology, Yonsei Cancer Center), an authority in the field of lung cancer, said, "(Janssen) has enough scientific evidence to be greedy. the answer is hidden in the ongoing clinical results of Amivantamab and Lazertinib." Professor Cho has been working on the development process of Lazertinib and Amivantamab for a long time. From the preclinical stage, Janssen and Yuhan are actively participating in ongoing clinical research. The results of the CHRYSALIS study evaluating the combination therapy of Lazertinib and Amivantamab will be presented at the annual conference of ESMO 2020, which will be held online in the middle of next month. The global oncology community is drawing attention as the first clinical data that can confirm the synergistic effects of the two drugs in patients with advanced non-small cell lung cancer showing EGFR (epithelial cell growth factor receptor) mutation findings. In particular, there is a lot of interest in the results of administration to patients who developed resistance after administration of Tagrisso. He said, "There are many EGFR-targeted anticancer drugs such as Iressa and Tarceva, but there are still no alternatives for patients who have failed Tagrisso treatment. It is a pity as a clinician because they know that they have no choice but to use strong chemotherapy, and it would be nice to look forward to the safety data of the Amivantamab combination therapy." Janssen received approval for a global phase I clinical trial plan related to 'Lazertinib' monotherapy in June last year, after 7 months of technology export. Three months later, it started to develop in earnest by entering into clinical trials related to the combination therapy of Amivantamab and Lazertinib. Johnson & Johnson (J&J) also showed affection at the group level, pointing out Amivantamab and Lazertinib as promising pipelines for the pharmaceutical division. Recently, a global phase III clinical trial plan related to the combination therapy of Lazertinib and Amivantamab was newly registered on Clinical Trials, a clinical trial registration site operated by the National Institute of Health (NIH). Patient recruitment starts in October of this year and ends in January 2024. It is evaluated that it has reaffirmed the goal of completing the NDA application for new drug approval by the US Food and Drug Administration (FDA) by 2023.
- Opinion
- [Reporter’s Note] Why so cautious with all-comers drug?
- by Eo, Yun-Ho Aug 27, 2020 06:24am
- Within the pharmaceutical industry, a drug targeting ‘all-comers’ mean it is indicated to treat all patients in non-specific stages of disease. A drug proving treatment efficacy regardless of receptor or genetic mutation sound interesting and appealing. However, the South Korean government is still conservative on the all-comers drug to this date. In some ways, it seems obvious. A wide use of a drug means increase volume of the drug used, which could develop a whole financial issue. But there seems to be more than a financial issue why the government is taking a rather cautious stance, or the careful approach on the all-comers drug. Some say the government is skeptical about the efficacy. A poly ADP-ribose polymerase (PARP) inhibitor Zejular (niraparib) is currently indicated to treat patients with ovarian cancer, and it proved its treatment efficacy in all approved treatment lines regardless of the mutation in targeted BRCA gene. However, the proven efficacy actually shows different levels of efficacy. Zejula improved median progression-free survival (mPFS) by four times in gBRCA-mutated patients, and doubled it in patients without the mutation. And the efficacy gap between the Zejula group and the control group narrowed even more for gBRCA-mutated, homologous recombination deficiency (HRd)-negative patients. Surely, the medicine demonstrated the effect and received Ministry of Food and Drug Safety’s (MFDS) approval, while its levels of efficacy differ in various patient groups. As the mechanism of the medicine has a clearly targeted gene, the government is still limiting the healthcare reimbursement on the ‘BRCA mutation’ indication, although the treatment’s other indications have also proved the efficacy. The government’s stance is understandably cautious and taking more time would not necessarily be bad. Referring to precedents, however, taking more time did not mean better decision. A first immunotherapy to be indicated for all-comers in non-small cell lung cancer (NSCLC) was a PD-1 inhibitor Opdivo (nivolumab). Initially, all specialized doctors agreed ‘PD-L1 expression rate’ was a not a marker, but the government reserved the decision on all-comers coverage and listed the treatment in 2017 on limited indication. More talks followed after then, but the coverage standards remain the same to this date. Although being careful does not hurt, the government should also take patients’ treatment access into account and consider making a compromise. Only about 15 percent of epithelial ovarian cancer patients are known to have BRCA 1/2 mutation. In other words, about 85 percent of the patients do not have BRCA gene mutation. When even doctors are concerned of financial burden and opposing against expanding coverage on a health authority-approved drug, a pharmaceutical company’s reckless demand should not be accepted. But if there is a plausible compromise plan, shouldn’t the government be more open to the discussion?
- Company
- Champix has the lowest sales in 5 years
- by Kim, Jin-Gu Aug 27, 2020 06:24am
- ChampixSales of Pfizer's stop-smoking aid, 'Champix (Varenicline)' declined. In the second quarter of this year, sales fell 26% compared to the previous quarter. Quarterly sales are the lowest since the third quarter of 2015. Despite the aggressive patent defense strategy, the number of applicants for the government's smoking cessation project steadily declined, and in the first half of this year, the COVID-19 outbreak led to a decline in sales. Moreover, since the generics were released in earnest after July, when the material patent expired, sales are expected to decrease significantly from 3Q. According to IQVIA on the 26th, 2Q sales of Champix amounted to ₩5.1 billion. It decreased by 8% compared to the second quarter of last year (₩5.5 billion), and It decreased by 26% compared to the first quarter of this year (₩6.9 billion). There is a big difference from what was once (Q1 2017) quarterly sales of ₩21.4 billion. Champix's sales surged as the government expanded its smoking cessation business. However, starting in the first quarter of 2017, the number of participants in the smoking cessation project steadily declined. In November 2018, with the release of generics, the drug price was reduced by 38.9% (₩1,100 ←₩1,800). In order to prevent a decline in sales, Pfizer has devoted all efforts to patent defense. In January 2019, the Supreme Court's ruling on Solifenacin was decisive. The Supreme Court ruled that it was illegal to evade a patent for salt-modified drugs. Most of the pharmaceutical companies that released generics for Champix withdrew from the market. This is because the legal dispute with Pfizer was a burden as the loss in the future became influential. In the end, in December of the same year, the Patent Court ruled the same on the salt-modifying drug for Champix. Even some of the generics that had not been withdrawn from the market were banned from selling. Pfizer's patent defense seemed to have some effect. In fact, sales rose slightly until the first quarter of this year after ruling on Solifenacin. Quarterly sales from ₩5.5 billion in the second quarter of 2019 recovered to ₩5.7 billion in the third quarter, ₩6.5 billion in the fourth quarter, and ₩6.9 billion in the first quarter of 2020. However, in the second quarter, sales decreased again to ₩5.1 billion. It is the lowest since the third quarter of 2015 (₩4.9 billion). This was before the government launched a smoking cessation support project. It is expected that sales will decline more sharply from 3Q. This is the effect of the massive release of generics as patent of Champix expired on July 20th. According to the MFDS, it is confirmed that as of August 25, 34 companies launched 66 generic items. An official from the pharmaceutical industry said, "The number of participants in the smoking cessation business drastically declined due to the COVID-19 incident in the first half, and the effect appeared in the second quarter. It will be greatly reduced."
- Company
- Dong-A ST, exports ₩3 billion in the first half
- by Kim, Jin-Gu Aug 27, 2020 06:24am
- Dong-A ST's Nesp biosimilar is targeting the Japanese market. After launching the product in the Japanese market at the end of last year, it made exports for the first time in the first half of this year. Chong Kun Dang is also targeting the Japanese market in earnest after launching Nesp biosimilar in the Japanese market around the same time as Dong-A ST. Two domestic biosimilar products increase the possibility of a soft landing in the Japanese market. According to the pharmaceutical industry on the 25th, Dong-A ST is selling a Nesp biosimilar named 'Darbepoetin-α (DA-3880)' in Japan. Dong-A ST obtained an item license for this product in Japan in last September, and started officially launching it from the end of November. Sales in Japan are handled by the local partner, Sanwa Kagaku Kenkyusho (SKK). It exported about ₩3 billion in the first half of this year. An official from Dong-A ST explained, "The amount that Dong-A ST exported to Japan was ₩700 million in the first quarter and ₩2.4 billion in the second quarter." Considering the fact that Dong-A ST's exports to Japan were hardly ever until the end of last year, it is calculated that virtually all of them are Nesp biosimilars. Chong Kun Dang, which entered Japan at the same time as Dong-A ST with the same Nesp biosimilar, also performed well. In the case of Chong Kun Dang, the product was released in December of the same year after obtaining an item permission for Nesp biosimilar 'Nesbell (CKD-11101)' from the Japanese government in September last year. Like Dong-A ST, sales are conducted through local partners. The Japanese subsidiary of the global pharmaceutical company Mylan is in charge of local sales. Chong Kun Dang's exports to Japan in the first half of this year were ₩21.4 billion, an increase of about ₩5.3 billion (32.7%) from ₩16.1 billion in the first half of last year. This is the total amount exported to Japan, including Nesbell. Considering that Chong Kun Dang's semiannual exports to Japan have been around ₩17 billion over the past five years, it is interpreted that such an increase in exports can be viewed as a result of Nesp biosimilars. A Chong Kun Dang official said, "It is difficult to disclose the sales performance of individual items in Japan, but the increase in exports to Japan is due to the even growth of not only Nesbell but also various products." Regarding this, an official from the pharmaceutical industry said, "Since both products are still in the early stages of release, it seems to be positive to enter the Japanese market, and the performance in Japan is expected to improve further." Nesp, the original of the two products, is a second-generation anemia treatment developed jointly by Amgen in the United States and Kyowa Kirin in Japan. It is mainly used for the treatment of anemia in chronic renal transition patients and anemia by chemotherapy. Nesp's global sales are estimated at $3 billion, of which Japan's sales are estimated at ₩560 billion, which is about 15%.
- Company
- Keytruda sales hit KRW 72.3 bln topping H1 2020
- by Chon, Seung-Hyun Aug 27, 2020 06:24am
- Apparently an immunotherapy Keytruda has made the highest sales revenue in the first half of the year. Keytruda has beaten the long-term industry leader, Lipitor. Two innovative new drugs from multinational pharmaceutical companies, Tagrisso and Spinraza have shown outstanding performances, and the sharp surge in pneumococcal pneumonia vaccine Prevenar 13 was notable as well. According to the pharmaceutical market research firm IQVIA on Aug. 24, MSD marked the highest sales in the first half of 2020 with Keytruda making 72.3 billion won. Compared to 57.2 billion won made last year, the figure leapt by 26.4 percent and placed itself on the top of the leader board. Top 10 pharmaceuticals in the first half of 2020 (Source: IQVIA) In the first quarter, Keytruda took the top spot by making 40 million won more than the dyslipidemia treatment Lipitor with 34.7 billion won. The gap between Lipitor was widened by 2.9 billion won in the second quarter as Keytruda defended the top title. Released in the Korean market in 2015, Keytruda is an immune checkpoint inhibitor that blocks PD-L1 receptor from biding with PD-1 pathway on the surface of T-cell and activates immune cells to treat the tumor cells. Immediately after the market release, Keytruda’s sales have remained around 3 billion won, but the figure grew rapidly since the second half of 2017. The demand on the drug has surged as the healthcare insurance coverage was granted from Aug. 2017 as a second-line therapy treating non-small cell lung cancer (NSCLC). Keytruda’s sales in the first quarter of 2018 surpassed 10 billion won, and it has been staying around the 30 billion won line from the second quarter last year. Keytruda quarterly sales (Unit: KRW 100 million) Source: IQVIA Pfizer’s Lipitor came in second with 69.3 billion won generated but it dropped by 4.8 percent from last year same time. Lipitor has been topping the chart since April 2015, but it stepped down to the second place from the last first quarter after four years. Meanwhile, anticancer treatment Tagrisso and rare disease treatment Spinraza continued their strong performance to this quarter. Making 51.1 billion won in the first half of this year, AstraZeneca’s Tagrisso came in fourth by growing the sales by 33.5 percent from last year. Tagrisso is a second-line treatment prescribed to NSCLC patients who developed tolerance in EGFR tyrosine kinase inhibitors (TKIs) like Iressa, Tarceva and Giotrif. The medicine is considered a third-generation treatment that overcame EGFR-TKI tolerance. After receiving healthcare reimbursement from December 2017, Tagrisso has been growing consistently. The sales in third quarter 2017 marked 2.7 billion won, but it grew by eight times in two years time. Product images of Tagrisso (left) and Spinraza Biogen’s rare disease treatment Spinraza landed itself on the ninth place by generating 38.9 billion won in the first quarter. After making 20.2 billion won in the first quarter, the treatment made 18.7 billion won in the second quarter. Spinraza has been consistently making more or less 20 billion won since it entered the market making 10.2 billion won in the second quarter last year. The rare disease treatment Spinraza is indicated to treat a genetic neuromuscular disorder called spinal muscular atrophy (SMA) that causes muscle twitching from damaged motor neurons in spinal cord and brain stem. The patient’s cognitive function stays normal, while their daily life is disrupted with weakening muscle and contracting tongue muscle. Approved by South Korean health authority in December 2017, Spinraza was listed for healthcare reimbursement after settling on a pricing of 92.35 million won per vial (5 ml) in pricing negotiation with National Health Insurance Service (NHIS). Although the eligible patient size is small, the patients have to undergo a complicated pre-review prior to the administration. Regardless of the long procedure to use, the treatment’s quarterly sales have reached 20 billion won quickly with its exceptionally high price. Product image of Prevenar 13 Meanwhile, a pneumococcal pneumonia vaccine Prevenar 13 had an abrupt exponential growth due to the novel coronavirus infection (COVID-19). Prevenar 13’s sales in the first half of 2020 skyrocketed by 70.2 percent from last year and made 36 billion won. Prevenar 13 is a pneumococcal conjugate vaccine (PCV13) that prevents infection from 13 types of pneumococcal pneumonia (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). The vaccine can be given to all age group older than 6-week-old. Chong Kun Dang is in charge of distributing the vaccine for adult in South Korea, whereas for infant and children vaccine distribution is handled by Korea Vaccine. The use of the vaccine in adults has surged sharply as many were convinced by some experts claiming the vaccine can weakened the pneumonia symptoms induced from COVID-19, although it cannot prevent the pneumonia itself.
