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- 2026-03-18 17:36:35
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- 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.
- Company
- Roche Xofluza to be prescribed for flu prevention in Korea
- by Eo, Yun-Ho Dec 08, 2020 06:11am
- The prescription of a next-generation influenza new drug Xofluza is to get accessible in South Korea for prevention purpose. According to the pharmaceutical industry sources, Roche Korea applied for approval on Xofluza to the Ministry of Food and Drug Safety (MFDS) after the drug’s new indication to prevent influenza was cleared by the U.S. Food and Drug Administration (FDA) in November. The ministry is currently reviewing the application and the final decision would be made from the beginning of 2021. Endo-nuclease inhibiting Xofluza is a new influenza treatment, approved two decades after the launch of ‘Tamiflu (oseltamivir),’ and it treats flu patients with a single dose (Tamiflu requires five-day administration). The flu prevention efficacy was confirmed in Phase III BLOCKSTONE study, where Xofluza lowered the risk of influenza infection by 86 percent compared to a placebo. The primary endpoint of the study was to evaluate the proportion of participants who tested positive for the influenza virus, and the secondary endpoints was the proportion of patients, who tested positive through a reverse transcription polymerase chain reaction (RT-PCR) test with no apparent symptom like fever, and patients, who tested positive through RT-PCR test with severe influenza symptoms or fever higher than 37 degrees Celsius. The primary endpoint found 1.9 percent of Xofluza-treated subject group was tested positive, compared to 13.6 percent of the control group. And the protective effect was even more highlighted during the subgroup analysis targeting non-vaccinated, high-risk and children and adolescent groups. Moreover, the Xofluza group and placebo group did not show significant difference in adverse reaction with 22.2 percent and 20.5 percent, respectively. Xofluza is currently in process of receiving the National Health Insurance (NHI) reimbursement in South Korea. When listed, the industry expects the drug would be quickly prescribed widely. Targeting to expand the influenza drug market share, Roche has inked the co-promotion deal for Xofluza with Chong Kun Dang in last March.
- Company
- Daewoong succeeded in evading patent for Belkyra
- by Kim, Jin-Gu Dec 07, 2020 06:06am
- Daewoong has passed the final gateway for the early release of a generic for Belkyra (Deoxycholic acid), an injection for improving submandibular fat. The original company Allergan succeeded in avoiding the remaining one of the two divisional patents. According to the pharmaceutical industry on the 3rd, the Intellectual Property Trial and Appeal Board recently decided on 'Establishing a Claim' in a trial to confirm the passive scope of rights that Daewoong recently filed for formulation patent for Belkyra. Daewoong succeeded in evading Belkyra’s patent. Daewoong successfully avoided Belkyra's formulation patent on June 19 and November 20. It was Belkyra's last patent. Daewoong's patent challenge for Belkyra began in January 2018. Daewoong filed a judgment on formulation patent for Belkyra to confirm the scope of the passive rights. Daewoong won the patent trial. In June, the Intellectual Property Trial and Appeal Board filed a trial decision for the settlement of the claim, and it was confirmed on July 23, when Allergan abandoned the appeal. However, there were two more obstacles that Daewoong had to overcome. In January and April this year, when Daewoong and Allergan were in the midst of a fight, Allergan registered two more new Belkyra patents. Allergan removed and registered only some of the existing patents. It was part of the 'evergreening strategy' that continues its duration through divisional applications. In the end, Daewoong had to challenge the two split patents. In March of this year, Daewoong filed a trial for a passive confirmation of the scope of rights to the newly registered formulation patent for Belkyra. With this trial decision, Daewoong succeeded in targeting all three patents. In the case of a trial decision made earlier in June, Allergan accepted the result without appealing to the Patent Court of Korea and was confirmed. The two trial decisions are also likely to be confirmed. Daewoong is developing its own injection for improving submandibular fat under the name DWJ211. Since March of last year, it has entered phase III clinical trial for 150 patients at Konkuk University Hospital and Chung-Ang University Hospital. The indication for DWJ211 is improvement of moderate and severe submandibular fat, which is the same as that of Belkyra. When the development is complete, Daewoong may be sued for patent infringement from Allergan. The trial decision is expected to be appropriately used for defense purposes.
- Company
- Ninlaro starts pricing negotiation after three long years
- by Eo, Yun-Ho Dec 04, 2020 05:55am
- An oral multiple myeloma treatment, Ninlaro is initiating the drug pricing negotiation to seek for the National Health Insurance (NHI) reimbursement. The pharmaceutical industry sources reported the drug has started the pricing negotiation with the National Health Insurance Service (NHIS) on the only oral option in multiple myeloma treatment, Ninlaro (ixazomib), according to the Ministry of Health and Welfare’s (MOHW) order to negotiate given on Nov. 30, as the drug passed the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC). The treatment was designated as an orphan drug in May 2017, and was approved for the South Korean market in July same year. But its reimbursement application has been pending for over three years. The supplier, Takeda Pharmaceutical, has been providing the treatment to the South Korean market for free of charge since October last year. Although the drug could not utilize risk sharing agreement (RSA) with its competitor already in the market first, the multiple myeloma drug was able to sign the refund type RSA and receive clearance from the DREC as a law was passed recently to stipulate RSA on follow-on drugs as well. Ninlaro, combined with lenalidomide and dexamethasone, can be prescribed to treat multiple myeloma patients who have not responded to at least one standard therapy. The proteasome inhibiting drug Ninlaro confirmed its efficacy and safety I Phase III TOURMALINE-MM1 clinical trial conducted with 722 patients with relapsed or refractory multiple myeloma. The study found the triplet regimen of ixazomib, lenalidomide, and dexamethasone had significantly improved the duration of progression-free survival (PFS) to average 20.6 months, 14.7 months longer than a combination of placebo, lenalidomide and dexamethasone. Meanwhile, the triple combination therapy with Revlimid is the most recommended multiple myeloma treatment option according to the U.S. National Comprehensive Cancer Network (NCCN) guideline and the European Society for Medical Oncology (ESMO). And Revlimid (lenalidomide) is the backbone for all triple combination therapies. Following are some of major triple combination therapy options for second line and later treatments; Amgen’s Kyprolis (carfilzomib) KRd combination (Kyprolis, Revlimid, dexamethasone); BMS’ Empliciti (elotuzumab) ERd combination (Empliciti, Revlimid, dexamethasone); Takeda’s Ninlaro (ixazomib) IRd combination (ixazomib, Revlimid, dexamethasone); and Janssen’s Darzalex (daratumumab) DRd combination (Darzalex, Revlimid, dexamethasone).
- Company
- The liver cancer treatment market is fluctuating
- by Kim, Jin-Gu Dec 04, 2020 05:53am
- Nexavar (left) and Lenvima The liver cancer treatment market is fluctuating greatly. Sales of Nexavar (Sorafenib), which occupied an absolute position in the market, declined significantly, while sales of Lenvima (Lenvatinib) increased. Hanmi's Soranib, which succeeded in overcoming Nexavar's patent, is scheduled to be released, and attention is focused on whether the change in this market will be faster in the future. According to the drug market research agency IQVIA on the 3rd, the cumulative sales of Nexavar in the third quarter of this year is ₩15 billion. Compared to the cumulative ₩20 billion in the third quarter of last year, it decreased by 25%. Lenvima, another liver cancer treatment, surged from ₩4.6 billion to ₩8.8 billion over the same period. The gap in sales between the two treatments sharply decreased from ₩15.3 billion to ₩6.3 billion in a year. In this situation, Nexavar's generic 'Soranib' will be released soon. The MFDS approved Hanmi’s Soranib on October 30th. Hanmi can sell generic for Nexavar exclusively until July 29, next year. Nexavar's sales may further decline further. Changes in cumulative sales in the third quarter of Nexavar and Lenvima, the primary tx for liver cancer (left) and quarterly sales (unit: ₩billion, data IQVIA) Currently, the only first-line treatments for liver cancer that have been released in Korea are Nexavar and Lenvima. The advantages and disadvantages of both drugs are clear. When analyzing clinical data, Lenvima precedes Nexavar. As a result of conducting a one-to-one comparative clinical trial with Nexavar, it was found that the objective response rate (ORR) and progression-free survival (PFS) were improved. The advantage of Nexavar is that it has a follow-up drug. Stivarga (Regorafenib) and Cabometyx (Cabozantinib) can be used as follow-up drugs. Lenvima cannot use Stivarga or Cabometyx as a follow-up drug if the first-line treatment fails. In the case of both treatments, indications and benefit standards are also limited to patients who have failed Nexavar treatment. Even though Lenvima was released with better data after 10 years of Nexavar's release, the reason why Lenvima still struggles is that there is no follow-up drug. Accordingly, opinions on allowing Stivarga to be used even for patients who have failed Lenvima treatment have been steadily raised by the medical community and patients, but the discussion is still in the beginning. If Lenvima solves the problem of follow-up drugs, future sales are expected to increase even more rapidly.
- Company
- Sanofi's multiple myeloma tx Sarclisa was approved in Korea
- by Dec 04, 2020 05:53am
- Sanofi-Aventis Korea (CEO Kyung-Eun Bae) announced on the 2nd that its relapsed and refractory multiple myeloma treatment Sarclisa (Isatuximab-irfc) was approval from the MFDS on the 1st. Sarclisa was previously approved as a combination therapy with Pomalidomide and Dexamethasone in patients with multiple myeloma who received more than one treatment, including Lenalidomide and proteasome inhibitors. Sarclisa is a monoclonal antibody treatment that induces tumor cell death by binding to a specific epitope of the CD38 receptor present in multiple myeloma cells. Despite receiving more than two treatments, it is expected to provide better treatment benefits to patients with advanced myeloma in Korea. The Phase III clinical ICARIA-MM study, which was the basis for approval, was conducted in 307 adult patients with relapsed and refractory multiple myeloma who previously received two or more treatments including Lenalidomide and proteasome inhibitors. Clinical results showed that the Sarclisa + Pomalidomide + Dexamethasone combined treatment group (hereinafter referred to as Isa-Pd therapy) reduced the risk of disease progression or death by 40% compared to the standard therapy, Pomalidomide + Dexamethasone combination administration group (hereinafter referred to as Pd therapy). Progression-free survival (PFS), was extended by 5 months. President of Sanofi Genzyme, Park Hee-kyung said that the approval of Sarclisa will provide another treatment option to patients with multiple myeloma in Korea who are suffering from recurrence despite two or more treatments. Sarclisa is a combination therapy with Pomalidomide and Dexamethasone in adult patients with relapsed and refractory multiple myeloma who previously received two or more treatments including Lenalidomide and proteasome inhibitors from the US Food and Drug Administration (FDA) in March 2020. Licensed. In May 2020, the European Medicines Agency (EMA) had experience of two or more treatments, including Lenalidomide and proteasome inhibitors. In addition, it was approved as a combination therapy with Pomalidomide and Dexamethasone in adult patients with advanced relapsed and refractory multiple myeloma.
