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- 2026-03-17 09:48:44
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- The sales of Prolia & Evenity exceed ₩100 billion
- by Mar 10, 2022 05:53am
- From the left, Amgen Prolia and EvenityAmgen has opened an era of 100 billion won in the osteoporosis treatment market. Sales of the two products are increasing rapidly as sequential treatments leading to Evenity-Prolia are being put forward. According to IQVIA, a pharmaceutical research institute, sales of Amgen's osteoporosis treatment, Denosumab, stood at 92.1 billion won last year, up 22.7% from 75.1 billion won a year earlier. Sales of another treatment, Evenity, increased 220.3% from 3.8 billion won in 2020 to 12.3 billion won last year. The total sales of the two products amounted to 104.4 billion won. Amgen introduced Prolia in Korea through GSK in 2014 and has been devoted to the osteoporosis treatment market by recovering its copyright in 2016. By actively selling Prolia in partnership with Chong Kun Dang, sales surged from 3.7 billion won in 2017 to 14.3 billion won in 2018 and 47.3 billion won in 2019. Prolia, which entered the 70 billion won range in 2020, reached 92.1 billion won last year, approaching the entry of 100 billion won blockbuster drugs. Prolia, a bone absorption inhibitor, has become the first standard treatment therapy for osteoporosis with superior effect and convenience of administration than the previously widely used bisphosphonate (BP). Bisphosphonate formulations are tricky, such as taking sufficient amounts of water and not lying down for at least 30 minutes after taking them on an empty stomach 1-2 hours before meals. In addition, it was difficult for patients to continuously take medicine because side effects such as gastrointestinal disorders could occur when used for a long time. Prolia only needs to be administered once every six months. Even after 10 years of long-term treatment, the effect of continuous bone density improvement and consistent safety profile were confirmed. As Prolia has become a standard treatment, all BP drugs are on the decline. Lilly's Forsteo, once called the strongest in the market, saw its sales fall 24.8% from 17.1 billion won in 2020 to 12.9 billion won last year. During the same period, Daewoong Pharmaceutical's Dowong Zoledronic Acid Inj also fell 12.9% from 11.2 billion won to 9.8 billion won. MSD's Fosamax products maintained sales from 12.2 billion won to 12.1 billion won. Amgen's new osteoporosis treatment Evenity approved in June 2019 is also cruising. Evenity, which raised 3.8 billion won in 2020, has been listed since last year and surpassed 10 billion won at once. Evenity is the first osteoporosis treatment that has both the effect of "promoting bone formation" and "suppressing bone absorption." It is a mechanism that stimulates mature osteoblasts and promotes bone formation by activating tissue osteoblasts, while also acts as a regulator of osteoblasts to suppress bone absorption. AACE/ACE recommend using Evenity from the initial treatment of ultra-high risk groups with a high risk of fracture. Amgen is proposing a "sequential treatment" strategy that treats patients with high risk of fracture with Prolia after one year of treatment with Evenity. By emphasizing the importance of continuous treatment of osteoporosis, it is intended to establish an environment in which patients can be treated with Prolia for a long time. Domestic societies such as the KSBMR are also carrying out various activities such as policy symposiums and revision of medical guidelines to improve awareness of osteoporosis. It is also worth noting whether Prolia and Evenity will expand their benefit range. Currently, the administration period of osteoporosis drugs is based on the bone density level of T-Score. Benefits are recognized only for patients with T-Score -2.5 or less. If the level is higher than -2.5 in follow-up observation one year after administration of the treatment, the salary is no longer recognized. Evenity can also be reimbursed when bisphosphonate is used first and then used as a secondary drug, especially T-Score -2.5 or less and two or more osteoporosis fractures must be met. In response, it is pointed out that Evenity should be used as the primary drug and improved so that it can be used even if a fracture occurs once. If the standards of Prolia and Evenity are expanded in the future, the two products are expected to face another turning point in sales.
- Company
- Why the Patent Court rejected the ‘prodrug strategy’
- by Kim, Jin-Gu Mar 10, 2022 05:53am
- Dong-A ST is challenging the substance patent of AstraZeneca’s SGLT-2 inhibitor antidiabetic treatment ‘Forxiga (dapagliflozin).’ The industry’s eyes are focused on Dong-A ST’s challenge, with the expectation that Dong-A ST’s success would bring a new strategy that can overcome the substance patent of originals. However, Dong-A ST’s attempt has been put to a stop by the Patent Court of Korea. The final decision will be made by the Supreme Court, but attention is focused on why the Patent Court of Korea overturned the first instance court's ruling and ruled in favor of AstraZeneca in its appeal against Dong-A ST. ◆ "Clear difference between the original drug and prodrug” judged in both the first and second trials According to the ruling on the 28th, the Patent Court of Korea ruled in favor of AstraZeneca on the grounds that the principle of action between the original substance of Forxiga and Dong-A ST's prodrug was the same. Pro-drug is a ‘pro’ drug that is considered a similar but different drug from the original drug. Its chemical structure is partially different in the substituents with the original drug from its manufacture to immediately before administration. However, once administered, the drug shows the same effect as the original By principle, it sounds similar to salt-modified drugs, but the difference Is clear. The salt can be changed through simple ion bonding. Its chemical structure itself does not change. However, prodrugs change the substituents through a more difficult covalent binding method. It has a different chemical structure to the original drug. The first and the second court both made the same judgment on whether the prodrug could be considered a completely new substance. Both the Intellectual Property Trial and Appeal Board (IPTAB) and the Patent Court of Korea interpreted Dong-A ST’s prodrug as a completely different substance to the original substance. The IPTAB judged that the “difference in chemical structure is clear, therefore, Dong-A ST’s prodrug is outside the scope of rights held by Forxiga’s patented invention.” ◆ Patent Court of Korea “a skill that can be easily conceived by an ordinary skilled person" However, the two courts' rulings differed in the ‘ease of substitution issue.’ The courts made different judgments on whether an ordinary skilled person in the industry may easily produce Dong-A ST’s prodrug. While the first court judged that developing the prodrug was not easy, the second instance court judged that it "was a substance anyone with ordinary skills in the industry could produce.” The evidence AstraZeneca submitted for the appeal played an important role in the ruling. The Patent Court of Korea explained, “the specific form of ‘formate ester’ that Dong-A ST used to develop its Forxiga prodrug has been found in various literature.” ◆Deleted ‘produg’ in the patent registration process …Court decides it was “common practice" at the time Dong-A ST appealed using the fact that the term ‘prodrug’ was deleted in the process of AstraZeneca’s patent registration. In fact, when AstraZeneca first filed the substance patent for Forxiga in 2006, it listed its scope as “compounds with chemical structural formula I, or other pharmaceutically acceptable salt or stereoisomer, or prodrug ester thereof.” However, the prodrug part was deleted after the first patent claim was rejected by the Korean Intellectual Property Office. The final patent registered specifies the scope as “compounds with chemical structural formula I, or other pharmaceutically acceptable salt or stereoisomer,” without the prodrug part. Dong-A ST claimed that the deletion of "prodrug esters" from the claim indicates the waiver of those rights on the company’s part. However, the Patent Court of Korea turned down the claim. The court judged “AstraZeneca did not consciously delete the part, and “it was KIPO's practice at the relevant time not to allow the term "prodrug" in patent claims for formal reasons.” ◆Up to the supreme court…’ strategy to overcome substance patents of original drugs’ at a crossroad Dong-A ST expressed dissent at the Court’s decision and filed an appeal. The case will therefore be judged by the Supreme Court. If the Supreme Court determines that there is a problem with the second trial ruling, the patent strategy of the entire domestic pharmaceutical industry may be revised. Like Dong-A ST, other companies will opt to challenge the substance patent of original drugs using the prodrug strategy. On the other hand, if the Supreme Court confirms the judgment of the second instance court, the substance patent of original drugs may continue to remain impenetrable.
- Company
- Keytruda for esophageal cancer indications is imminent
- by Eo, Yun-Ho Mar 08, 2022 06:08am
- Keytruda, an immuno-cancer drug, is expected to be able to be prescribed for esophageal cancer. According to related industries, the MFDS has finally reviewed the first round of local progressive or metastatic esophageal cancer (GEJ), in which PD-1 inhibitory immuno-cancer drug Keytruda (Pembrolizumab) of MSD is non-resectable. Permission is expected as early as the second quarter. Following colon cancer in June last year and triple negative breast cancer in July last year, the area of indications is rapidly expanding. Keytruda's indications for esophageal cancer and gastroesophageal junction cancer were approved by the U.S. FDA in March last year and the European EMA in June last year. Keytruda's effectiveness for esophageal cancer has been proven through a phase 3 clinical KEYNOTE-590 study. Keytruda, 5-FU, and Cisplatin combination therapy demonstrated statistically significant OS and PFS improvements over 5-FU+cisplatin in all pre-designated study groups. Keytruda, 5-FU, and Cisplatin reduced the risk of death by 27% compared to 5-FU+Cisplatin, and the risk of disease progression or death by 35%. In the patient group with a PD-L1 expression rate of 10 or higher, Keytruda and 5-FU+Cisplatin reduced the risk of death by 38% and the risk of disease progression or death by 49%, compared to 5-FU and Cisplatin. In patients treated with Keytruda, 5-FU, and Cisplatin combination therapy, the objective response rate (ORR) was 51.1%, of which the CR ratio was 5.9% and the PR ratio was 45.2%.
- Company
- Generation shift of ALK targeted drugs... rise of Alecensa
- by Mar 08, 2022 06:08am
- The targeted cancer therapy market for patients with ALK mutations has been restructured around second-generation drugs. The share of the first-generation drug Xalkori, which used to occupy 2/3 of the market fell to 20%, and the representative second-generation drug ‘Alecensa' took over the market. However, Alunbrig, a latecomer into the second-generation treatment market, has been rapidly chasing the market leader Alecensa that has currently occupied over half of the market. According to the pharmaceutical research institution IQVIA on the 8th, the Anaplastic Lymphoma Kinase (ALK) tyrosine kinase inhibitor (TKI) market recorded ₩54.4 billion last year, which was an 11.9% and ₩48.6 billion increase from the previous year. The ALK TKI market, whose doors were first opened by ‘Xalkori (crizotinib),’ is used to treat patients with ALK-positive non-small-cell lung cancer (NSCLC). With the introduction of next-generation drugs that have demonstrated improved efficacy, a total of 5 drugs are currently present in the market. In addition to second-generation drugs ‘Zykadia (ceritinib),’ ‘Alecensa (alectinib),’ ‘Alunbrig (brigatinib),’ a third-generation drug ‘Lorviqua (lorlatinib)’ has also entered the market last year. Compared to 2017, the market transition from first-generation to second-generation drugs is quite clear. In 2017, Xalkori had an oligopoly over the market as the only ALK TKI option and accounted for 86% of the market. Its sales had recorded nearly ₩36.5 billion that year, followed by the first second-generation drug, ‘Zykadia,' which made ₩5.1 billion, then Alecensa's ₩1.1 billion. However, in 4 years in 2021, the landscape had completely shifted with the proof that second-generation drugs have a better effect in patients with brains metastasis. With doctors opting for second-generation drugs in the first line, Alecensa’s market share rose to 60%. Shares of another second-generation drug, Alunbrig, took over 15% of the market, making ₩8 billion in sales. Xalkori’s sales fell to 24%, making ₩13.1 billion. Roche’s Alecensa and Takeda’s Alunbrig are representative second-generation ALK TKIs. By market entry, Alecensa entered the market 2 years earlier than Alunbrig. Alecensa expanded its indication to the first-line in 2018 and was granted reimbursement in December of the same year to quickly replace Xalkori. In 2018, Alecensa sold ₩10.4 billion, which was 1/4 of the sales made by Xalkori (₩49.6 billion). After receiving reimbursement in 2019, Alecensa sold ₩22.1 billion and exceeded the Xalkori's ₩20.3 billion in sales. Alecensa's sales increased to ₩29.3 billion in 2020 and ₩32.7 billion in 2021. Alunbrig, which was approved in December 2018, aimed to rapidly enter the market and catch up with Alecensa. As soon as it was approved for the first linein August 2020, the company applied for its reimbursement and succeeded in expanding its reimbursement in only 7 months. With the reimbursement approval as a first-line treatment that was granted in April last year, the company is working to expand its share in the market. Sales in 2020 were ₩3.9 billion won, far short of that of Alecensa and Xalkori, sales increased 102.9% to ₩8 billion after the reimbursement expansion. On the other hand, the first second-generation drug, Novartis’s Zykadia, has been going down a completely different path. Zykadia’s sales which had surged to ₩5.1 billion in the past had started to fall sharply with the introduction of Alecensa. It sold ₩2.2 billion in 2018, ₩0.9 billion in 2019, and only ₩0.5 billion last year. The anlaysis is that this rapid drop in sales is due to the relatively higher instance of side effects compared to Alecensa or Alunbrig. The first third-generation ALK TKI was introduced last year. Xalkori’s developer Pfizer had introduced the first-ever third-generation drug Lorviqua. Lorviqua was first to be approved as a second-line treatment for ALK-positive NSCLC in July last year and rose as a new alternative due to its ability to manage the resistance developed after first-line treatment. Lorviqua can manage the resistance caused by G1202R mutation, as well as those by F1174L (Zykadia), I1171T/N/S (Alecensa), E1210K (Alunbrig). Lorviqua is not listed for reimbursement yet and is expected to generate sales in earnest after passing the National Health Insurance Service’s Drug Reimbursement Evaluation Committee and drug negotiations with the authorities. In particular, as Lorviqua is attempting to expand its territory into first-line treatment for ALK-positive patients, its its competition with second-generation drugs are also being expected to arise soon. The drug already owns a first-line indication for ALK-positive NSCLC in the US and Euope.
- Company
- Domestic production of Sputnik V was delayed
- by Kim, Jin-Gu Mar 08, 2022 06:08am
- Due to the war between Russia and Ukraine, shipments of domestic companies that consignment produce the COVID-19 vaccine Koruspharm developed by Russia are also being postponed indefinitely. Koruspharm said in a telephone interview with Dailypharm on the 4th, "We are continuously talking to the Russian side via e-mail or phone call even after the war broke out," adding, "For now, product shipments have been stagnant due to the Ukrainian crisis." According to Koruspharm, the company has currently produced Sputnik undiluted solutions for 10 million people, of which 5.3 million have completed the production of finished products. This means that the quantity that can be shipped immediately amounts to 5.3 million people. Koruspharm originally planned to supply the finished vaccine to Southeast Asia, the Middle East, and South America in line with the Russian order. Administrative procedures for shipment have also been completed. However, orders from Russia have been delayed day by day, and shipments have not been expected recently due to the outbreak of war. Koruspharm is looking for buyers directly through its own network. The company explained that it has even confirmed its intention to purchase from some Middle Eastern countries. An official from Koruspharm said, "Iit is true that Russia lacked marketing capabilities. We are looking through our own network and have confirmed our intention to purchase from some places." He went on to say, "Russia and the country must officially sign contracts in order to lead to actual shipments. When the contract between the two countries is signed, we plan to ship it immediately, he said. "We have concluded discussions with Russia to ship the rest of the vaccines in this way in the future." Regarding the payment for consignment production of vaccines, he said, "Uncertainty has grown in the collection of payments as the U.S. and Europe imposed massive economic sanctions against Russia." "To solve this problem, we are discussing with the Russian side how to receive payments directly from vaccine buyers instead of Russia," he said. Koruspharm signed a "Sputnik V consignment production contract" with RDIF in September last year. Since then, Koruspharm has formed a consortium with six companies and one institution, including Binex, Boryung Biopharma, ISU Abxis, Chong Kun Dang Bio, Quratis, and Andong Animal Cell Demonstration Support Center. The consortium plans to build production facilities of more than 100 million doses per month.
- Company
- Changes in the lung cancer treatment market are detected
- by Mar 07, 2022 05:50am
- Changes are detected in the EGFR targeted anticancer drug market, which Tagrisso dominated. Tagrisso sales stagnated for the first time due to sluggish primary treatment benefits. Leclaza, the only domestic new drug in the market, is threatening Tagrisso. According to IQVIA, a pharmaceutical research institute, on the 5th, the size of the domestic EGFR TKI market last year was 156.4 billion won, up 2.8% from 152.1 billion won a year earlier. Compared to the growth trend so far, it has slowed down somewhat. The market surged from 55.4 billion won in 2017 to 104.3 billion won in 2018 and 132.2 billion won in 2019. Tagrisso's sales stood at 106.5 billion won last year, the same as the previous year. Tagrisso, which had been increasing sales at a frightening pace for four years since its approval in 2016, suffered a stagnation for the first time last year. Tagrisso is the first third-generation EGFR-TKI in Korea. It is a next-generation targeted anticancer drug following the first generation Iressa, Tarceva, and second generation Giotrif and Vizimpro. Tagrisso was first listed in December 2017 after being approved as a secondary treatment in May 2016. Sales of Tagrisso jumped from 2.3 billion won in 2016 to 10.3 billion won in 2017, and surged to 59.4 billion won in 2018. It surpassed 100 billion won for the first time, raising 106.5 billion won in 2020 following 79.2 billion won in 2019. However, it did not exceed 100 billion won last year. This is in contrast to a 16% increase in global sales from $4.3 billion to $5 billion last year. This is analyzed as a result of reflecting the specificity of the Korean market. Tagrisso obtained a primary treatment indication for EGFR mutated non-small cell lung cancer in December 2018 and began to expand the benefit, but failed to pass the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service for three years. Since then, AstraZeneca has appealed for Asian effects by submitting FLAURA China data for Chinese people, but failed to pass the Cancer Disease Review Committee in November last year. Another factor that caused congestion was the emergence of a new domestic drug Leclaza. Leclaza is a third-generation EGFR TKI developed by Yuhan Corporation. In January of last year, it was approved as the 31st new drug in Korea and was listed in July of that year. It was registered 165 days after the permit while quickly applying for insurance registration. Leclaza is also the only domestic treatment in the EGFR targeted anticancer drug market. Leclaza quickly entered large hospitals and made full-fledged sales in the second half of last year. Sales for the first six months amounted to 4.1 billion won. This is the highest sales in the past six months among new anticancer drugs developed in Korea. Yuhan Corporation is chasing Tagrisso by entering a global phase 3 with the aim of indicating Leclaza's primary treatment. Beringer Ingelheim's Giotrif stood at 22 billion won last year, up 18.4% from 18.6 billion won the previous year. Giotrif is steadily increasing its sales to 10.9 billion won in 2017, 13.6 billion won in 2018, and 16.6 billion won in 2019. Iressa fell 14.1% from 19.6 billion won in 2020 to 16.8 billion won last year. Tarceva also fell 23.6% from 7.3 billion won to 5.6 billion won. First-generation EGFR-TKI, which once accounted for 80% of the market, gave way to next-generation drugs, falling to 14%.
- Company
- Immuno-oncology drugs make ₩400 billion after 7 years
- by Mar 07, 2022 05:49am
- The immuno-oncology drug market exceeded ₩400 billion in annual sales only 7 years since its debut in Korea. With Keytruda in the lead making over ₩200 billion in sales, the latecomers Tecentriq and Imfinzi are chasing the lead with its rapid growth. According to the market research institution IQVIA on the 4th, the total immuno-oncology treatment that consists of 6 immuno-oncology drugs in Korea has made ₩407 billion last year, a ₩285.6 billion increase and a 42.5% YoY increase from the previous year. This record was made in 7 years since the first immuno-oncology drug Yervoy (Ipilimumab) was approved in December 2014. The release of Yervoy marked the start era of immuno-oncology treatments in Korea. Since then, Ono Pharamcueitals’ Opdivo (nivolumab), MSD’s Keytruda (pembrolizumab), Roche’s Tecentriq (atezolizumab), AstraZeneca’s Imfinzi (durvalumab), Merck’s Bavencio (avelumab) followed, recording a total of 6 immuno-oncology drugs to be sold in the Korean market. ◆'Keytruda’s sales exceed ₩200 billion… ‘Opdivo’ shows later growth ' Half of the ₩400 billion immuno-oncology drug market is currently occupied by Keytruda. Keytruda made ₩200.1 billion to top pharmaceutical sales in Korea last year. This is the second consecutive year Keytruda has topped the leaderboard since it first recorded took the lead in 2020. Looking back on its sales for the past 5 years, Keytruda first sold ₩12.2 billion in 2017, then rose 476.2% the next year after reimbursement to make ₩70.3 billion in 2018. In 2019 it made ₩124.8 billion, then ₩155.7 billion in 2020, a 77.5% and 24.8% YoY growth, respectively. Then, the drug’s sales exceeded ₩200 billion for the first time last year. With its reimbursement applied to first-line treatment in NSCLC, its sales are again expected to show rapid growth this year. The 2nd place was Opdivo, which recorded ₩85 billion in sales last year. This is a 27.4% YoY increase from the previous year. Opdivo’s sales jumped from ₩12.5 billion to ₩57.5 billion after it was listed for reimbursement in 2017, then slowed down to maintain the ₩67 billion range in 2019 and 2020, then again gained growth last year. However, Opdivo has made relatively slow growth compared to Keytruda, which received approval on the same day. Opdivo is seeking external growth by increasing its indications. After receiving approval in the first-line for non-small cell lung cancer in December 2020, it also added a first-line indication for gastric cancer last year and became the first immuno-oncology drug to add a first-line indication in the field. The company also added 5 more indications this year. ◆Latecomers Tecentriq and Opdivo succeed by targeting unattended markets The relative latecomers Tecentriq and Opdivo are intently chasing the leaders at a rapid pace. The drugs, which have entered the market 2-4 years later than Ketruda·Opdivo, have rapidly penetrated the unattended markets. Tecentriq, which made ₩0.7 billion the first year, recorded ₩4.4 billion the following year. In 2019, its sales rose 238.6% to record ₩14.9 billion. Also, Tecentriq’s sales rose over twofold last year to ₩37 billion in 2020. Last year, its sales rose 81.6% to record ₩67.2 billion. Tecentriq was the first PD-L1 immuno-oncology drug to be introduced to Korea. The drug was first indicated for bladder cancer (urothelial carcinoma), an area that Keytruda and Opdivo hadn’t entered at the time. Also, the drug was the first to enter the field of triple-negative breast cancer. It was also relevantly quickly introduced into the reimbursement setting, in one year since its approval. The company embraced the government’s ‘'performance-based reimbursement proposal' in 2019 to accelerate reimbursement expansion for its drug. Imfinzi, which was approved in December 2018, also made over ₩50 billion in annual sales only 3 years after its release. Imfinzi’s sales which recorded ₩3.4 billion in 2019, jumped 7 times to record ₩24.6 billion in just a single year. Last year, its sales grew 91% to record ₩47.1 billion.
- Company
- Organon is focusing on expanding the women's health lineup
- by Mar 07, 2022 05:49am
- The demand for unmet diseases related to women's entire life cycle was relatively high. Organon will focus on improving treatment accessibility so that all women can enjoy healthier daily lives." At a press conference held by Organon for the first time since its launch at The Plaza Hotel in Jung-gu, Seoul on the morning of the 2nd, CEO Kim So-eun made the remarks about the company's vision. Kim Soeun, CEO of Oganon Korea Organon, which spun off from MSD, was officially launched in June last year. Founded in the Netherlands in 1923, Organon was merged with Organon and absorbed into MSD. After about a decade, it was separated from MSD again. Organon, headquartered in New Jersey, USA, has subsidiaries and six manufacturing facilities in more than 60 countries around the world. More than 60 products are supplied to 140 countries. Organon focuses on three areas: women's health, chronic diseases, and biosimilars. Women's health includes women's inherent diseases or diseases that can have a significant impact on women. In chronic diseases, it has about 50 treatments for cardiovascular, respiratory, dermatology, musculoskeletal system, and urinary system. Biosimilars have five products in cooperation with Samsung Bioepis. Fosamax, Atozet, Cozaar, Propecia, etc. are representative. The chronic disease sector accounts for the majority with 70%. CEO Kim said, "We plan to expand our portfolio by identifying women's health needs that are not met in all women's life cycles such as pregnancy and childbirth, and we plan to explore new indications and expand our lineup in chronic diseases." Since its actual launch, Organon has aggressively expanded its portfolio. In June last year, it acquired Alydia Health, a women's health medical device company. Alydia is a company that developed the JADA system, a postpartum bleeding solution. In July, it signed a global license agreement with ObsEva, which developed a premature birth treatment solution. In December, it then acquired Forendo, which has a pipeline of endocrinology-related treatment solutions such as endometrium. CEO Kim said, "We are working on commercializing postpartum bleeding solutions and endocrine treatments outside the United States, and we will make sure that new solutions can be accessed as soon as possible." Organon is preparing for competition of generic for Atozet, which accounts for the largest portion of sales. CEO Kim said, "Generics for Atozet were released last year. We plan to make efforts to expand sales. "We plan to introduce JADA, which was released first in the U.S., in Korea in the near future, and we are looking for new opportunities such as expansion and introduction of indications in other chronic diseases."
- Company
- First RSA drug ‘Erbitux’ to receive second reevaluations
- by Eo, Yun-Ho Mar 04, 2022 05:57am
- The term of risk-sharing agreements of major anticancer drugs are again nearing expiry. Starting with Merck’s ‘Erbitux (cetuximab), the first drug to be reimbursed with the RSA scheme in Korea, a series of other drugs are also awaiting reevaluations until 2023. According to industry sources, the colorectal cancer treatment Erbitux’s RSA term expires in June. Also, RSA terms for Astella’s ‘Xtandi (enzalutamide),’ Amgen’s ‘Kyprolis (carfilzomib),’ Lilly’s ‘Cyramza (ramucirumab),’ Janssen’s ‘Darzalex (daratumumab),’ Biogen’s ‘Spinraza (nusinercen),’ Sanofi’s ‘Dupixent (dupilumab)’ is nearing expiry. With reevaluations imminent, the mixed concerns held by the stakeholders (government, pharmaceutical companies, patients) are resurfacing. For Erbitux, this is the second time the drug is up for RSA renewal. As all these drugs would need to cut prices, therefore whether the company may reach a consensus with the government and succeed in renewing its agreement remains a focus of attention. Of course, no drugs have failed to renew their RSAs yet, but as the price of the drugs would need to inevitably fall as re-evaluation progresses, every news renewal brings tension to its stakeholders. In Korea, RSA drugs are required to undergo evaluations for clinical efficacy and cost-effectiveness every time their term expires, unlike general drugs that demonstrate their cost-effectiveness at the time of approval through pharmacoeconomic evaluations. The cost-effectiveness evaluations are inevitably affected by the price of its alternatives at the time of evaluations, and during the 5-year RSA term, the price of the alternative drugs are cut through various post-management mechanisms (reduction of original drug prices due to generic listings, volume-price linkage system, price cap discounts due to reimbursement expansions, etc). In addition, the revisions made in 2020 now allow latecomers to sign RSA agreements, therefore the price of the latecomers can now directly affect the cost-effectiveness of the first entrants. This has added to the already-long list of issues that had been constantly raised about RSA renewals in the industry. However, the entry of latecomer drugs into the RSA scheme has been a long-awaited wish from the industry’s perspective, and the government made the decision to expand RSA benefits after various discussions. Also, it is not unreasonable for price adjustments to be made for drugs that have alternatives with the same mechanism of action, even if their indications are not identical. An official from a multinational pharmaceutical company said, “All companies ahead of reevaluations have their own concerns. If the government alleviates the standards by resetting the reevaluation period or by simplifying the data required for submissions, it will be easier to reach an agreement,” he said. He added, “If the RSAs are not renewed and the drugs become non-reimbursed, the confusion will only be transferred to the field and the patients. It is now time to prepare the right mechanism to maintain the RSA system, the main scheme that is being used to list high-priced drugs.”
- Company
- ↓↓Sales of smoking cessation txs by 75% in 4 yrs
- by Ji Yong Jun Mar 04, 2022 05:56am
- The market for Varenicline, a non-smoking supplement, has fallen to a quarter in four years. This is because the distribution of the original drug Pfizer Champix, which led the market, was suspended due to an impurity crisis in the second half of last year. According to IQVIA, a pharmaceutical research institute, sales of Varenicline last year were 16.2 billion won, down 22.1% from the previous year. Compared to the sales of the Varenicline system of 65 billion won in 2017, it decreased by 75.1% in four years. (Data: IQVIA) Most of the sales of Varenicline products came from the original product Champix. However, as Champix's sales fell, the overall market size also fell. Champix's sales fell 65.6% from the previous year to 9.2 billion won last year. The reason for the sharp drop in sales of Champix last year is the impurity crisis. In June last year, Champix's worldwide distribution was suspended due to excessive detection of NNV, which is believed to be a carcinogen. Of the 9.2 billion won in sales posted by Champix last year, 93.4% posted in the first half. Champix's sales in the third and fourth quarters of last year were only 600 million won and 28,000 won, respectively. Champix was released on the market in 2007 with permission from the MFDS. Varenicline partially binds to nicotine receptors in the brain to relieve smoking needs and withdrawal symptoms. Compared to anti-smoking aids that absorb Nicotine into the body to control withdrawal symptoms and smoking needs, Champix gradually stood out with this mechanism. Sales of Champix increased sharply as the government's anti-smoking treatment support policy began in 2015. The smoking cessation treatment support policy is a policy that provides full support for drug prices to participants who complete all smoking cessation treatment programs for 12 weeks. Drugs such as Varenicline, Bupropion, and Nicotine supplements are fully supported. Champix's sales in 2015 amounted to 24.2 billion won, nearly quadrupling from the previous year. Since then, it has risen vertically to 48.8 billion won in 2016 and 65 billion won in 2017. However, since 2018, sales have declined due to a decrease in drug prices and a decrease in participants in smoking cessation treatment support projects. Champix's sales fell nearly half from 41.2 billion won in 2018 to 20.7 billion won in 2020. Sales of generic Jeil's Nico Chams are increasing as Champix is kicked out of the market due to controversy over impurities. Ten generics are currently on sale in the Varenicline market, but sales are not very large except for Nico Chams. Nico Chams is an item manufactured by Jeil. Nico Chams recorded 2.9 billion won in sales last year. Nico Chams appeared in the market in the third quarter of 2020 and sales were 40 million won until the second quarter of last year. Sales of Nico Chams have grown since the third quarter of last year. Nico Chams' sales rose sharply from 700 million won in the third quarter of last year to 2.2 billion won in the fourth quarter. Nico Chams replaced Champix because the amount of impurities detected in Varenicline drugs met the standards of the MFDS. In September last year, the MFDS allowed NNV to be released only if it was 185 ng/day or less. Initially, in Korea, CTC Bio and Jeil were in charge of manufacturing Varenicline product of seven domestic pharmaceutical companies and 24 domestic pharmaceutical companies, respectively. Among them, only the Varenicline produced by Jeil had NNV detection of 16.70 to 43.28 ng/day, which was lower than the MFDS' standard, enabling distribution. CTC Bio's manufacturing items exceeded the shipping availability standard. Jeil is planning to increase Nico Chams' prescription. Nico Chams is prescribed in 9,000 out of 15,000 hospitals and clinics.
