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- 2025-12-26 19:25:59
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- The market for erectile dysfunction drugs is on the rise
- by Chon, Seung-Hyun Dec 15, 2020 06:03am
- The market for erectile dysfunction treatments is recovering. The market size contracted in the aftermath of COVID-19 in the first half, but it rebounded in the third quarter. Generic for Cialis have been largely succeeful. According to IQVIA, a drug research institute on the 10th, the market for erectile dysfunction treatments in the third quarter was ₩28.6 billion, up 1.1% year-on-year. The market for erectile dysfunction drugs declined 4.8% and 0.4%, respectively, compared to the previous year in the first and second quarters, but turned to an upward trend in the third quarter. Quarterly erectile dysfunction treatment market size (Unit: ₩million, Source: IQVIA) The market for erectile dysfunction treatments showed stable growth every year, but turned downward in the first half of this year. The contraction of the erectile dysfunction treatment market in the first half is analyzed as the aftermath of COVID-19. The industry says that the erectile dysfunction treatment market is vulnerable to external factors such as the epidemic of infectious diseases because the severity is lower than that of chronic diseases such as high blood pressure and diabetes and it is not essential. There is still low recognition that erectile dysfunction is a disease that needs to be treated urgently, which means that changes in the external environment can affect the market growth. Compared to the early days of the spread of COVID-19, the market for erectile dysfunction treatments seems to have recovered as well as people's social activities have become similar to the past. Most of the major leading products were sluggish. Hanmi's PalPal recorded total sales of ₩15.7 billion in the third quarter. PalPal is a generic for Viagra. PalPal accounts for 18.9% of the total erectile dysfunction treatment market. However, the sales volume declined 4.6% compared to last year, and the growth slowed. Cialis’ generic, Cendom by Chong Kun Dang, ranked second place with cumulative sales of ₩7.5 billion in the third quarter, but sales decreased by 3.2% from the previous year. Sales of major erectile dysfunction drugs by item (Unit: ₩million, %, Source: IQVIA) The original drugs were even more sluggish. Pfizer's Viagra recorded sales of ₩6.4 billion, down 10.7% from the previous year, and Lilly's Cialis, with cumulative sales of ₩4.6 billion, down 4.6% from the same period last year. The cumulative sales of Hanmi’s Gugu in the third quarter rose 13.3% from the previous year to ₩5.8 billion. Kolmar Korea's Kamalafil (generic for Cialis) recorded a growth rate of 20.7%.
- Company
- Pfizer's Xeljanz XR (once a day), approved in Korea
- by Dec 14, 2020 05:58am
- Pfizer Korea (CEO Dong-wook Oh) announced on the 10th that it has received approval for Xeljanz XR 11 mg, a rheumatoid arthritis treatment, from the MFDS on the 7th. Xeljanz XR is a sustained-release tablet formulation of the existing Xeljanz 5mg (Tofacitinib). It can be used for the treatment of moderate to severe active rheumatoid arthritis in adults who do not respond adequately to MTX or are not tolerated. Xeljanz, an oral JAK inhibitor, inhibits the JAK signaling pathway (Jak-STAT pathway), which is involved in the production of cytokines that cause inflammation in the body. Following the US in 2012, it was approved in Korea as a treatment for rheumatoid arthritis in 2014. Since then, the indication has been expanded to treatment for ulcerative colitis and psoriatic arthritis. The domestic approval of Xeljanz XR is limited to the treatment of rheumatoid arthritis, and indications for psoriatic arthritis and ulcerative colitis are not applicable. Xeljanz 5mg was taken twice a day when treating rheumatoid arthritis in Korea, but it became possible to take it once a day with Xeljanz XR. Xeljanz XR can be used in combination with MTX or taken alone, which will further increase options for patients and healthcare professionals. Hee-yeon Kim, Managing Director of Pfizer's Inflammation and Immunity Division, said, "We are very pleased that Xeljanz, which has pioneered the domestic JAK inhibitor market as a treatment for rheumatoid arthritis, can provide more diverse treatment options." "We will continue to strive to provide excellent treatment options to patients and to make a meaningful difference in the lives of patients."
- Company
- Bavencio, difficulty in expanding indication
- by Dec 11, 2020 06:16am
- The possibility of approval for a renal cell carcinoma indication for Bavencio(Avelumab), an immunotherapy developed by Merck and Pfizer, is very low. This is because the Central Pharmaceutical Affairs Review Committee of the MFDS has not recognized Bavencio's therapeutic effect. The Central Pharmaceutical Affairs Review Committee held a meeting on October 29th, when Merck and Pfizer applied for Bavencio's indications for renal cell carcinoma, and whether the results of the clinical trials submitted were recognized as the agenda. According to the results of the minutes released on the 9th, none of the six members who attended the meeting did not acknowledge the validity of Bavencio. The committee members were cited on the basis of the existence of alternatives such as ▲not meeting the primary endpoint (OS) ▲alternative treatment and follow-up treatment. One member said, "We believe it is reasonable not to approve the permit because Bavencio's OS results have not been met." He said, "The risk ratio of 0.79, which is the result of an interim analysis of overall survival (OS), is judged to be a clinically insignificant result. This is 'JAVELIN Renal 101' study comparing the combination therapy of Bavencio and VEGF-based targeted anticancer drug Inlyta (Axitinib) with Sutene (Sunitinib) monotherapy, a standard treatment for renal cell cancer patients, to confirm the efficacy and safety. According to the results of an interim analysis released last year, the Bavencio+Inlyta combination treatment group had a progression-free survival (PFS) of 13.8 months, significantly longer than that of the monotherapy group, 7.2 months, but the primary endpoint was 11.6 months each. And 10.7 months, there was no significant difference. The risk of disease progression and death was found to be 39% lower than that of monotherapy. In the mid-term analysis, updated in April of this year, there was no significant difference in OS. Accordingly, another member explained, "Because it did not show superiority compared to the conventional therapy, it was judged that the advantages did not appear when the two drugs were administered in combination." "Data should be presented to show that the addition of a follow-up therapy to an existing therapy improves over the existing therapy." Experts analyzed that the impact of clinical design and follow-up treatment would have had an impact. One member said, "Pembrolizumab (Keytruda) and Nivolumab (Opdivo) have the same design and are approved for their significance in OS, but this drug did not." They said, "This drug is more affected by follow-up treatment than the two drugs, so it is judged that the OS did not come out well." According to the 3rd OS interim analysis, 12% of the combination therapy group and 44% of the control group received follow-up treatment. During the follow-up therapy, more than 40% of the control group received immunotherapy. The combination therapy group was 10%. The company also explained, "It seems that these follow-up treatment factors have affected the OS." Even taking this into account, the committee members were negative about the approval. One member pointed out that "The important thing in determining the success or failure of a study is whether or not the primary endpoint is satisfied, and adverse drug reactions of grade 3 or higher also tend to increase compared to the control group, so it cannot be evaluated as completely harmless." He said, "It is also very important that there are other drugs that have already proved the OS, and I think product approval or conditional approval is impossible." Another member also said, "When considering the follow-up therapy and other alternative therapies, the benefit that patients can receive is not confirmed, so the significance of treatment cannot be recognized." In addition, another member said, "There was a case where the indication was not obtained due to the failure to prove the benefit of OS in the first-line treatment of small cell carcinoma of Keytruda and the first-line treatment of non-small cell carcinoma of Tecentriq. It is reasonable not to allow permission considering the fairness of the screening criteria for anti-cancer drugs." In the end, all six expert committee members concluded that the approval was not valid. An official from the MFDS who attended the meeting also said, "When evaluating the OS, the test group receives 3 drugs including the second treatment, and the control group receives 2 drugs, so if the OS results of the test group and the control group are similar, it doesn't benefit the patient." As all of the Central Pharmaceutical Affairs Review Committee disapproved, it was difficult to obtain Bavencio's indication for renal cell carcinoma in Korea. The Central Pharmaceutical Affairs Review Committee is an expert advisory body, and although the opinion of the Central Pharmaceutical Affairs Review Committee is not a decision of the MFDS, the opinion of the Central Pharmaceutical Affairs Review Committee is rarely reversed. Meanwhile, Bavencio has acquired the indications for the first-line treatment of advanced renal cell carcinoma based on the research in Europe and the United States. It has only indications for Merkel cell cancer in March last year in Korea.
- Company
- AZ supplies 20 million doses of COVID-19 vaccines to Korea
- by Dec 10, 2020 06:09am
- The government announced a contract with AstraZeneca and other COVID-19 vaccine developers on the 8th, and AstraZeneca Korea said, "We are pleased to be able to supply (vaccine) for the public benefit." Korea AstraZeneca (CEO, Sang-pyo Kim) said on the day, "According to the contract with the KDCA, we will supply 20 million doses of AZD1222 (for 10 million people) to Korea." COVID-19 vaccine candidates being developed jointly with Oxford University This is the result of discussions on domestic supply after signing a letter of intent for cooperation with the MOHW and SK Bioscience in July. An official from AstraZeneca Korea said, "We are pleased to be able to supply the vaccine to Korea for the public benefit through the signing of a supply contract for AZD1222 vaccine." He added, "I hope that we will be able to respond to the urgent demands of public health to protect the public's health and contribute to the government's efforts to fight COVID-19." He added, "As we have accurately disclosed the results of interim analysis of vaccine clinical studies through publication in authoritative academic journals, we will continue to verify the effectiveness and safety profile of vaccines based on scientific evidence." Previously, the government signed a contract for supply of 10 million people with AstraZeneca, and the government announced that it has confirmed the supply of 10 million people (20 million batches) from Pfizer and Modena respectively. It also secured about 10 million people from COVAX Facility and 4 million people from Janssen. COVAX Facility aims to equally supply vaccines up to 20% of the population by the end of 2021, focusing on the World Health Organization (WHO), the Coalition for Epidemic Preparedness Innovations (CEPI, vaccine development), and the Global Vaccine Alliance (GAVI, vaccine supply). A total of 44 million vaccines have been secured in this way. The government plans to introduce the vaccine that it purchased in advance from February next year.
- Company
- Prolia's sales this year are ₩54.9 billion
- by Kim, Jin-Gu Dec 09, 2020 05:56am
- ProliaAmgen's osteoporosis treatment Prolia (Denosumab) is popular in the market after the expansion of benefits. Until the third quarter of this year, it was found that the cumulative sales amount increased by 87% compared to the same period last year. This is in contrast to the decline in sales of major osteoporosis treatments excluding Prolia. It is analyzed that Prolia accounts for the sales of existing treatments. According to the pharmaceutical market research agency IQVIA on the 7th, Prolia's cumulative sales in the third quarter of this year amounted to ₩54.9 billion. Compared to ₩29.3 billion in the same period last year, it increased by 87%. Prolia's sales surged after the benefit expansion in April last year. Sales from ₩4.9 billion in the first quarter of 2019 increased 2.5 times to ₩12.3 billion in the second quarter. The government expanded the benefits so that Prolia could be used for primary treatment of female osteoporosis patients. Prolia Since then, sales have been steadily increasing as additional data proving the superior effect compared to existing treatments have been released. From the second quarter of this year, it has exceeded ₩20 billion in quarterly sales. In addition, Amgen's other osteoporosis treatment, Evenity ((Romosozumab), has been reimbursed from this month as a secondary treatment for osteoporosis, which is expected to further expand its influence in the osteoporosis treatment market. Even before the application, it was found that sales of ₩2.8 billion were recorded until the third quarter. Major osteoporosis treatments excluding Prolia were unable to avoid a decrease in sales. Forsteo, which occupied the first place in the market before the advent of Prolia, decreased 12% from ₩15.9 billion in the third quarter of last year to ₩14 billion in the third quarter of this year. In the case of Bonviva and Bonviva plus sold by Handok, the total sales decreased 6% from ₩10.6 billion to ₩10 billion. Fosamax series by MDS also decreased by 16% from ₩10.9 billion to ₩9.1 billion, and Sales of Zoledronic acid by Daewoong dropped 24% from ₩11.1 billion to ₩8.5 billion. Sales of Evista decreased by 18% ( ₩5 billion → ₩4.1 billion), Risenex, 15% ( ₩3.9 billion → ₩3.3 billion), Viviant, 38% ( ₩3.4 billion → ₩2.1 billion), and Teribone, 17% ( ₩2 billion → ₩1.7 billion), Maxmarvil, 23% (₩2.1 billion → ₩1.6 billion). As Prolia is reimbursed, sales of other treatments are declining. However, Hanmi's RaboneD is expected to increase 4% in sales from ₩6.4 billion won to ₩6.7 billion through the 3rd quarter despite the rapid growth of Prolia. Changes in cumulative sales of major osteoporosis treatments in the third quarter (unit: ₩billion, data:IQVIA)
- Company
- What drugs will their patents expire next year?
- by Kim, Jin-Gu Dec 09, 2020 05:56am
- Amosartan155 patents, including Hanmi's Amosartan, will expire next year. The patents of two NOACs (New Oral Anticoagulant), which have grown rapidly in recent years, are also set to expire next year. According to the MFDS on the 4th, there are a total of 155 patents scheduled to expire in 2021. Among these, the item that attracts the most attention is Hanmi’s Amosartan family. Twelve Crystalline Form Patents related to Amosartan, Amosartan Q and Amosartan Plus expire March 29. Hanmi holds 30 patents related to Amosartan, of which 12 patents expire next year. However, it is unclear whether generics will increase rapidly due to patent expiration. This is because there are still other patents other than Crystalline Form Patent. The remaining 18 patents, including composition patents, are about to expire from 2024 to 2036. Only pharmaceutical companies that previously successfully evaded patents for Amosartan can sell generics. About 30 companies, including United Korea, have avoided not only the Amosartan crystalline patent in 2014, but also Crystalline Form Patent, which expires in 2036. They are already selling generics for Amosartan. Patents will be expired for ▲ Dexilant by Takeda ▲ Revolade and Signifor by Novartis ▲ Relvar Ellipta and Seretide by GSK ▲ Mircera by Roche ▲ Baraclude by BMS ▲ Bredinin by Chong Kun-dang ▲ Xarelto by Bayer ▲ Crestor by AstraZeneca ▲ Pradaxa by Boehringer Ingelheim ▲ Prolia, and Amosartan family. Domestic companies have successfully attacked patents for such as Xarelto and Pradaxa. Product Patent for Pradaxa, one of the new oral anticoagulants (NOAC), expires on July 17 next year. Ten companies, including Jeil, which have avoided drug patents that expire in 2023, can release generics after July. Product Patent for Xarelto will expire next October. 23 companies, including SK Chemicals, Chong Kun Dang, and Hanmi, which have succeeded in overcoming the formulation patent earlier, are preparing to launch generics in time for the expiration of their product patents. Product patent for Baraclude for hepatitis B treatment has expired in 2015. The patent expiring in January next year is formulation patent for Baraclude. However, about 10 domestic companies such as Daewoong and Dong-A ST have already successfully avoided this formulation patent and have released generics. The patent for Crestor (AstraZeneca's treatment for hyperlipidemia), will also expire next year. The formulation patent expired in August this year. The use patent will expire in February next year. Prolia (Amgen's osteoporosis treatment) is another item of interest. Four patents for Prolia have been registered. Material patents expire in January and March this year, and patents related to manufacturing methods expire in January next year. The last patent is a composition patent that expires in 2025. If the composition patent is successfully overcome, the early release of generic for Prolia is possible. However, it is confirmed that there is not yet a domestic company challenging Prolia's composition patent.
- Company
- Dong-A ST’s Jublia is growing by 15%
- by Kim, Jin-Gu Dec 09, 2020 05:56am
- Jublia by Dong-a STJublia's sales in the market for athlete's foot treatment for nails increased significantly last summer. Sales of Fulcare, which was a leading item in the existing market, decreased by 30% compared to the previous year. It is observed to have decreased by half compared to 5 years ago. According to IQVIA, a drug market research agency on the 2nd, the most sold product among the treatments for athlete's foot for nails applied in the second and third quarters of this year was Dong-A ST's Jublia. Sales of athlete's foot treatments for nails surged in the second and third quarters of summer. During this period, Jublia's sales amounted to ₩12.2 billion. Compared to ₩10.7 billion in the second and third quarters of last year, it increased by 15%. It is an analysis that Dong-A ST's niche market has been working effectively for several years. Jublia is a prescription drug that has the same efficacy as an oral drug, yet it is an applied formulation. Jublia is the only product in Korea with both features. Menarini Korea's Fulcare, which was a leading item in the market before the appearance of Jublia, declined significantly. Last summer, it only raised ₩5.8 billion in sales. Compared to the previous year's ₩8.4 billion, it decreased by 30%. Fulcare's sales have steadily declined as the range expands and looks over the past five years. Based on the 2nd and 3rd quarter results, it decreased from ₩12.3 billionin 2016 to ₩10.8 billion in 2017, ₩9 billion in 2018, and ₩8.4 billion in 2019. In the past five years, sales have declined by half. Full-care, OTC drug containing Ciclopirox, has gained explosive popularity in the market since its launch in 2013. However, after 2015, as competitors with the same ingredients appeared one after another, sales turned to decline. Since the release of Jublia, a prescription drug containing Efinaconazole in 2017, the decline has increased even more. ▲ 2nd and 3rd quarter sales of Jublia·Fulcare·Romaryl (unit: ₩100 million, data IQVIA) 2nd and 3rd quarter sales of Jublia·Fulcare·Romaryl (unit: ₩100 million, data IQVIA) In addition, it is observed that sales of most of the major products such as ▲Galderma Korea's Loceryl ▲Handok's Loprox ▲Yuhan's Easycare ▲Theu's PureRyl decreased or stagnated. Loceryl decreased 8% from ₩2.7 billion in the second and third quarters of last year to ₩2.5 billion in the second and third quarter of this year, 6% for Loprox from ₩2 billion to ₩9 billion, and 9% for Easycare from ₩1.8 billion to ₩1.6 billion. PureRyl was ₩1.3 billion in both last year and this year. In contrast, Hanmi's Mujonal S and Kolmar Korea's Romaryl increased a slight increase in sales from ₩1.1 billion to ₩1.2 billion. An official from the pharmaceutical industry said, "It is understood that the market situation was somewhat poor this summer compared to last year due to the impact of COVID-19 incident and social distancing campaign." He said that among these, Jublia's success in niche markets almost only resulted in an increase in sales. Changes in sales of major nail treatments for athlete
- Company
- 117 Organon-transferring MSD employees files for a remedy
- by Dec 08, 2020 03:55pm
- A photo of Chair Shim Sang-nam of MSD Korea Labor Union submitting an application for the remedies for unfair transfer to Seoul Regional Labor Relations Commissions 117 employees notified to transfer from MSD Korea to a new subsidiary Organon have requested a remedy for unfair transfer. Resisting against the transfer ordered without consent, the MSD Korea Labor Union filed a remedy for unfair transfer to the Seoul Regional Labor Relations Commission on Dec. 1. The application for the remedy was submitted as MSD Korea on Nov. 10 disclosed the list of employees to be transferred to Organon Korea. The list contained names of 222 employees to be housed by the new subsidiary. Total 117 employees requested the remedies, which is about a half of the 222, who have been notified to be transferred. Currently, the remedy application is processed only by the corporate labor union from two unions in the company (corporate and industrial). About 95 percent of 124 transferring employees, who are also part of the corporate union, are applying for the remedies. The union official stated, “Although the transfer requires individual employee’s consent, MSD Korea has unilaterally ordered the transfer to Organon Korea and ignored respective employee’s agreement. We are asking the commission to order MSD Korea to admit the unfair treatment, and immediately cancel the order.” Specifically, they are skeptical about the new subsidiary Organon offering a similar level of working environment as MSD Korea. Organon’s asset only consists of off-patent items and the R&D department, considered as the future driving force in a pharmaceutical company, is not transferring to the new company at all. And as the physical office space is located in a share office, which could be moved or sold at any time, the employees expect faltering working condition and unstable job security. The employees said, “For instance, Pfizer’s spin-off Pfizer Upjohn has merged with Mylan in just two months after the split and took a new name of ‘Viatris.’ The associated employees had to move twice from Pfizer Pharmaceutical Korea to Pfizer Upjohn Korea, and then to a brand new generic drug company Viatris. Moreover, they emphasized, “The Pfizer’s development unfolded quite different from the management’s original promise to keep the major changes in working environment to a minimum. Hence, there is no guarantee MSD Korea would not repeat the same scenario.” The union claimed, Organon Korea could start offering early retirement programs to the employees, except for the key jobs, or either sell off to a private equity firm or merge with other company for so-called business recovery.” After accepting the application for the remedy, the Seoul Regional Labor Relations Commission would have to make a decision within 60 days to either accept or deny the application through hearing and discussion. The union could file an appeal to the Central Labor Relations Committee, if unsatisfied with the decision.
- Company
- Emerging Chinese company BeiGene readies for Korean market
- by Eo, Yun-Ho Dec 08, 2020 06:12am
- A China-based emerging pharmaceutical company, BeiGene is readying for the South Korean market. The pharmaceutical industry sources reported the Chinese company has opened a South Korean subsidiary recently. The company has already recruited Head of Medical Affairs Kim Jiyoon, previously worked in medical affairs at Sanofi Genzyme, and they plan to hire more staffs for the Regulatory Affairs and Market Access. A global pharmaceutical company Amgen owns a stake in BeiGene, as it acquired 20 percent of the share for USD 2.7 billion (approximately 3.1 trillion) last year. The company supplies three new drugs by Amgen, such as multiple myeloma treatment Kyprolis (carfilzomib) and acute leukemia treatment Blincyto (blinatumomab), for the Chinese market. BeiGene has licensed out PD-1 inhibiting candidate immunotherapy, like Keytruda (pembrolizumab) to Celgene, now acquired by Bristol Myers Squibb (BMS). And the U.S. Food and Drug Administration (FDA) also cleared the company’s BRK inhibiting mantle cell lymphoma (MCL) treatment Brukinsa (zanubrutinib).
- Company
- Coverage expansion this year 70% less than last year
- by Eo, Yun-Ho Dec 08, 2020 06:11am
- Apparently, the number of new drug reimbursement expansion has gone down significantly this year. Daily Pharm surveyed the pharmaceutical reimbursement status from 2019 to 2020 and found the number of reimbursement expansion dropped 70 percent and 75 percent by indication compared to last year. The statistic data includes reimbursement expansion for off-label use. In last year, total 107 items expanded their coverage, but as of Dec. 7, only 33 items have expanded. While 104 indications obtained expanded reimbursement last year, only 30 indications have obtained new coverage this year. The number is low, even if it includes the number of drugs currently in process of negotiating their pricings with the National Health Insurance Service (NHIS), as there is only about a month left in the year. Although the number of reimbursement expansion applications cannot be fathomed accurately, the industry claims the number of application has not been so different from last year. The biggest cause of the situation seems to be COVID-19. In fact, committee meetings essential to reimbursement listing and expansion, such as Cancer Deliberation Committee and the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC), have been delayed multiple times this year. To improve the situation, the government decided to alleviate the relevant regulations and conducted on-paper reviews from September. However, the pharmaceutical industry argues, besides COVID-19, the barrier in reimbursement expansion has gotten more strenuous to overcome than before. Especially the anticancer treatments, the current drug pricing system puts more financial burden on both the government and the pharmaceutical company to settle on an agreement. For instance, except for an immunotherapy Tecentriq, all anticancer treatments have failed to convince the health authority to grant expanded coverage. The progress on adding more reimbursement standards on targeted therapies like poly (ADP-ribose) polymerase (PARP) inhibitors Lynparza and Zejula has been also sluggish. A market access staff in a multinational pharmaceutical company said, “Compared to before, even overcoming the first threshold of Cancer Deliberation Committee has gotten tougher. HIRA used to evaluate the reimbursement expansion and NHIS to negotiate then after, but now the overall schedule is delayed as the Cancer Deliberation Committee evaluates the financial impact as well.” From January through November this year, total 16 new drug items have been listed for the pharmaceutical reimbursement. The number only counts one dose of each item.
