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- 2026-03-18 17:36:35
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- The market share of GLP-1 diabetes drug Trulicity is 99%
- by An, Kyung-Jin Nov 30, 2020 06:21am
- TrulicityTrulicity, a diabetic treatment administered once a week, continues to dominate in the GLP-1 analog market. Despite the confusion of COVID-19 outbreak, it has set a new quarterly sales record, reaching ₩40 billion in annual sales. It is leading the market expansion by recording a market share of over 99% with only a single item. According to the drug market research agency IQVIA on the 26th, four GLP-1 analogues such as Trulicity (Dulaglutide), Lyxumia (Lixisenatide), Victoza (Liraglutide), and Byetta (Exenatide) in the third quarter made ₩11 billion in sales. This is an increase of 7.8% from ₩10.2 billion in the same period last year. The GLP-1 analog is a drug developed using the hormone GLP-1 (Glucagon-Like Peptide-1), which is involved in the regulation of blood sugar in the body. GLP-1 hormone promotes insulin secretion immediately after a meal, thereby lowering blood sugar, and when blood sugar falls below a certain level, it reduces insulin secretion and helps prevent hypoglycemia. Trulicity, the latest release, virtually ranked the entire market with 99.4% market share. The sales of Trulicity in the third quarter were ₩10.9 billion, a 9.8% increase from ₩10 billion a year earlier. Excluding Trulicity, the quarterly sales of the three items did not reach ₩70 million. The accumulated sales of Trulicity in the third quarter of this year amounted to ₩30.8 billion. Trulicity is the only long-lasting drug administered once a week among GLP-1 analogs on the market. Despite the fact that it was released to the market as the latest among the drugs of the same class in May 2016, sales continued to rise sharply every quarter, increasing its influence in the GLP-1 analog market. It started with ₩1.4 billion in the first year of its launch and exceeded the high of ₩12.2 billion the following year, and the sales in 2018 were ₩27 billion and ₩37.5 billion in 2019, causing a blast. If the current trend continues, annual sales could exceed ₩40 billion. Quarterly sales and Trulicity share of major GLP-1 analogues (Unit: ₩million, %, Source: IQVIA) Lilly Korea has been conducting joint sales activities with Boryung since the launch of Trulicity. It is with the intent to expand the partnership that has been built up through the anticancer drug GemZar into the area of diabetes. With the synergy between the two companies' partnership, Trulicity accounts for about one-third of Boryung's sales after 4 years of release. The quarterly sales of three GLP-1 analogues such as VIctoza, Byetta, and Lyxumia were around ₩3 billion, but the total market size expanded rapidly after the release of Trulicity. It was 2.5 times larger than ₩4.4 billion in the first quarter of 2016, just before the release of Trulicity. Unlike the existing GLP-1 analogue, which had to be injected once or twice a day due to a fast-acting mechanism, the number of injections was reduced once a week, and the convenience was improved with a pen-type formulation. The fact that the recommended level of GLP-1 analogues was raised in domestic and foreign diabetes treatment guidelines, and that the combination therapy with basal insulin was recognized as a benefit at the end of 2017 also acted as a catalyst for the increase in sales. On the other hand, the GLP-1 analog administered once a day continues to be sluggish. Sanofi's Lyxumia is in the process of withdrawing from the market. Sanofi formalized a plan to withdraw two formulations of Lyxumia earlier this year. The total amount of ₩152 million until the third quarter of this year is the inventory that was previously held by wholesalers. At the time, no specific reason was disclosed, but the fact that the company decided to reduce investment in the diabetes business unit was pointed out as the background for the withdrawal of the permit, as sales decreased rapidly after the emergence of competitive products. AstraZeneca's Byetta has a cumulative sales of ₩2 million this year. Novo Nordisk's Victoza barely exceeded ₩150 million in sales for 9 months. Unlike the obesity treatment Saxenda, which differs only in dosage with the same ingredient, it does not show its presence in the market. As a variable for the GLP-1 analog market in the future, Novo Nordisk's generics can be discussed. Novo Nordisk is in fierce competition with Trulicity in the global market as it obtained the approval of the U.S. Food and Drug Administration (FDA) for the GLP-1 analog Ozempic(Semaglutide) administered once a week at the end of 2017. In September of last year, Rybelsus, which converted Ozempic to oral use, received FDA approval. It is an analysis that the market can be reorganized depending on the timing of the two products being released in Korea.
- Company
- First generic release isn't related to original price cuts
- by Kim, Jin-Gu Nov 30, 2020 06:20am
- The Supreme Court of South Korea finally ruled that the company that launched First Generic due to the success of its patent strategy had no reason to be responsible for lowering the drug price of the original drug. The results of the Zyprexa (Olanzapine) lawsuit came out after 10 years. The result of this lawsuit received great attention from domestic companies in that the strategy for early release of generics was decided. On the 26th, the Supreme Court's Civil Affairs Division dismissed Lilly's appeal in a lawsuit against Hanmi for drug price cuts. The Supreme Court's Civil Part 3, which was held at the same time, also took the side of Myungin in a lawsuit for damages that Myungin filed against Lilly Korea. This complicated lawsuit, which has lasted more than 10 years, began in 2008 when a trial was filed for invalidation of the patent for Lilly's schizophrenia treatment Zyprexa. At that time, Hanmi claimed Zyprexa's patent invalidation trial and won the second trial, and then released Olanza, generic for Zyprexa in 2011. Myungin, which confirmed this judgment result, later released Neurozapine, generic for Zyprexa, too. However, the Supreme Court overturned the second trial, and Lilly filed damages to both companies (Hanmi and Myungin) on the basis of this. It was intended to compensate for the profits obtained from selling generics. However, Lilly also filed a lawsuit against Hanmi and Myungin to compensate for damages as the drug price of Zyprex was lowered due to the release of the generic. It was the first in Korea to claim damages for the price cut of the original drug. The cost of the lawsuit was ₩1.5 billion to Hanmi and ₩47 million to Myungin. In this case, Hanmi won both the first and second trials, but Myungin lost both. Regarding Hanmi, the court ruled in favor of both the first and second trials, saying, "Hanmi released the generics through a legitimate patent challenge, and the drug price cut is due to exercise of the discretion of the MOHW and no causal relationship is formed. On the other hand, for Myungin, the court ruled against defeat with the effect of "since it released generics after recognizing the drug price cut of Zyprexa, it must compensate for the damages caused by the drug price cut." In 2016, Lilly appealed to Hanmi and Myungin appealed to Lilly. The Supreme Court's ruling on this day is the final result of a lawsuit that has been going on for the past 10 years. It is the first lawsuit in Korea to dispute whether or not to compensate for the price cut of the original drug, and as a result of this, the first-generic strategy of generic pharmaceutical companies itself could collapse, which attracted great attention from the industry. In fact, if domestic companies lose, they could suffer from cost cuts of the original product, which could amount to tens of billions of billions of won. However, the final decision of the Supreme Court provided an opportunity for domestic pharmaceutical companies to actively pursue patent challenges for the early release of generics. Kim Yoon-ho, chairman of The KPPI (Korea Pharmaceutical Patent Institution), said, "We have completely escaped from a situation where domestic companies' patent challenges for the launch of first generics may be reduced." In particular, he said, "It is a meaningful decision that not only establishes an active patent strategy, but also reduces the burden of health insurance finances and drug costs for patients."
- Company
- Prevenar and Sky Cellflu soar, Keytruda tops again
- by Chon, Seung-Hyun Nov 30, 2020 06:20am
- The novel coronavirus infection (COVID-19) has shuffled the top pharmaceutical market leader board. While immunotherapy Keytruda topped the market again, the sales in a pneumococcal 13-valent conjugate vaccine Prevenar 13 and a flu vaccine Sky Cellflu 4 surged dramatically. The sales in innovative new drugs like Tagrisso and Prolia also grew noticeably. According to a pharmaceutical market research firm IQVIA on Nov. 25, MSD’s Keytruda generated 41.6 billion won in last third quarter. Compared to the same quarter last year, the figure soared by 25.9 percent and topped the market for three consecutive quarters, pushing Lipitor down. Top ten pharmaceutical sales in the third quarter of 2020 (Source: IQVIA) Keytruda took the lead for the first time in last first quarter by making 34.7 billion won and approximately 40 million won difference with cholesterol-lowering Lipitor. In the second and third quarters, Keytruda widened the gap with Lipitor. At the third quarter point, Keytruda accumulated sales of 113.8 billion won, which was 8.6 billion won more than Lipitor with 105.2 billion won. If the drug continues the trend, it is highly likely to take the top spot this year, when it marks the sixth year of launch. Released to the South 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 August 2017 as a second-line therapy treating patients with non-small cell lung cancer (NSCLC). Keytruda’s sales in the first quarter of 2018 surpassed 10 billion won, and climbed up to the 20 billion won-line in the following fourth quarter. From the second quarter last year, it has reached the 30 billion won-line, and exceeded 40 billion won in this year’s third quarter. The demand for Keytruda in the prescription market continued to grow amid COVID-19. A pneumonia vaccine Prevenar 13 had an exponential growth. In the third quarter, the vaccine made 24.2 billion won, doubling last year third quarter’s sales. Prevnar 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). Provided to all age groups older than 6-week-old, the vaccines for adults are distributed by Chong Kun Dang, whereas Korea Vaccine is in charge of distributing vaccine for children and infants. Prevenar 13’s sales usually peak in the fourth quarter, when typically the demand for vaccination surges, and drop in the first quarter. This year’s first quarter sales grew more than the previous quarter, making 17.6 billion won, and its growth continued on for the second and third quarters, surpassing the quarterly sales 20 billion won-line for the first time. Quarterly sales growth of Prevenar 13 (Unit: KRW 1 million) Source: IQVIA The sources analyze Prevenar 13’s sales soared due to COVID-19. They evaluate the use of the vaccine in adults has leapt sharply as many were convinced by a number of experts claiming the vaccine can weakened the pneumonia symptoms induced from COVID-19, although it cannot prevent the pneumonia itself. Besides Prevenar 13, Sky Cellflu 4 also entered the top ten as it generated 21.1 billion won amid COVID-19. Sky Cellflu Quadrivalent by SK Bioscience Sky Cellflu is an influenza vaccine solely developed by SK Bioscience that earned the health authority’s approval in 2015. Unlike typical egg-based vaccine, the Korean-made quadrivalent vaccine is produced with top-of-the-line aseptic culture system, which does not require preservative. As all flu vaccines for this year were quadrivalent and the supply for the vaccines increased with COVID-19, Sky Cellflu 4’s sales skyrocketed. The amount of influenza vaccines distributed to the South Korean in this influenza season was about 29.5 million doses with an increase of 20 percent from last year. The Korean company raised the Korean market distribution volume as it predicted the surge in flu vaccine demand due to COVID-19. SK Bioscience shipped about 9 million doses with 70 percent jump compared to last year. AstraZeneca’s anticancer treatment Tagrisso continued to generate significant sales. The third quarter sales were 32.4 percent higher than last year, as it generated 27.9 billion won. 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 the healthcare reimbursement from December 2017, Tagrisso has been growing consistently in South Korea. The sales in the third quarter of 2017 marked 2.7 billion won, but it grew by tenfold in just two years time. Amgen’s osteoporosis treatment joined the top ten by making 20 billion won in the third quarter. Released to the South Korean market in November 2016, Prolia is a biologic osteoporosis treatment directed against receptor activator of nuclear factor-κB ligand (RANKL), which interferes with the formation, activation, and survival of osteoclasts. The drug’s sales started taking off since it was listed for reimbursement in 2017 as a second-line treatment. And Prolia’s sales exploded when it successfully expanded the reimbursement as a first-line treatment from April last year. Also its sales partnership with Chong Kun Dang gave a boost as well.
- Company
- Beovu treating AMD passes the first gate to reimbursement
- by Eo, Yun-Ho Nov 26, 2020 06:05am
- A novel neovascular age-related Macular Degeneration (AMD) treatment Beovu (brolucizumab) has passed the first threshold to win the healthcare reimbursement in South Korea. The pharmaceutical industry sources reported the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC) recently green lit Novartis Korea’s Beovu. On Nov. 13, DREC approved of the drug reimbursement feasibility, but it was ultimately decided as a conditional non-reimbursement due to the conflict in drug pricing. However, as Novartis Korea accepted the offered conditions, the drug’s reimbursement feasibility was then cleared. A next generation treatment for wet AMD, Beovu is an anti-vascular endothelial growth factor (anti-VEGF) drug that suppresses endothelial cell proliferation and vascular permeability. The drug is administered once-monthly for the first three months, and once every three months then after. A Phase II HAWK study and a Phase III HARRIER confirmed Beovu’s efficacy by comparing against Eylea (aflibercept). The two studies, incorporating 1,817 patients aged 50 and over with wet AMD, found the drug to have non-inferiority versus the reference group through the primary endpoint—the change in best-corrected visual acuity (BCVA) at year one (week 48). In both clinical trials, approximately 30 percent of patients gained at least 15 letters at year one. In HAWK and HARRIER, Beovu showed superior effect of improving retinal fluid compared to the reference drug, as fewer patients had intra-retinal (IRF) and/or sub-retinal fluid (SRF) after receiving Beovu as a treatment. A professor of ophthalmology at Seoul National University College of Medicine, Yu Hyeong Gon said “Beovu’s outstanding anatomical effect is proven based on the clinical data showing improved vision and fewer numbers of patients with remaining retinal fluid compared to the reference drug. As the treatment can be administered in three month interval, the patients with wet AMD would enjoy the new treatment option that comes with convenience and less burden.”
- Company
- Janssen's young man who saved her life after a hit & run
- by Eo, Yun-Ho Nov 26, 2020 06:04am
- Ji Hyun-joo, Director "When I got my mind, I knew I was under the car. I was just shouting for help, but someone talked to me." At eleven o'clock on the night of February 17, Ji Hyun-Joo (48 yrs old) Korea Johnson & Johnson (J&J), general director of Consumer Health Care AP, returned to the company (LS Yongsan Tower) after a dinner in late winter, when it was still cold. She lost her mind when she recognized the car rushing towards her after getting off the taxi at the back door of the building. The car struck her as it was, and crushed her left arm. She fell stunned and injured her right shoulder, which could endanger her life. Was she lucky? Im Ji-hoon (37 yrs old) Korea Janssen (located in the same building as a J&J subsidiary), who left the office late after work, heard the sound of a bang and ran to the site. A bigger crisis awaits at the site of the accident. What happened to the car that caused the accident, it was a situation where the director would step on the body without stopping. He ran straight away and pushed the vehicle first. It is a later story, but he said that he thought that he was "already dead" when he saw Ji director at the time. He intuited,'Oh, this driver is drinking.' He told the driver to get out of the car. The driver was drunk as expected. It is said that he smoked a cigarette while jovializing at him taking pictures for evidence. He left the driver first, called 911 and approached her. Fortunately, she came back to consciousness, and he got her husband's phone number and contacted her. Thirty minutes after the accident, a 911 ambulance was able to carry her to the hospital emergency room, and she underwent emergency surgery. The driver left the car as it was at that time, and later surrendered, and a trial is currently underway. Director Ji Hyun-Joo, who returned after an unexpected accident, and Deputy General Manager Im Ji-hoon, a lifesaver◆6 months of rehabilitation and return to work With a fracture of both humerus and the resulting rotator cuff tear, she almost lost both arms. She couldn't move her arms right after the surgery to pin her muscles, and her daily life was impossible at all. She expected to be able to use her arm after removing the cast, but she couldn't listen because her muscles were already stiff. A caregiver, who resides 24 hours a day, had to stand by her for about five months. Eventually, after six months of long rehabilitation, she was able to return to work. The company's help was great for her return. J&J suggested returning to work in a part-time form first, checking her physical condition from time to time. Her arm condition (left) and the monitor and chair supported by the company The company, which had implemented a flexible work system due to the aftermath of COVID-19, provided a dedicated monitor and ergonomics chair at her home for her with discomfort. She is currently working at J&J through telecommuting. “The company has helped me a lot for my return. Even after I return to work, the company checks my condition regularly and discusses the timing of the full-time transition. There is no anxiety about returning to normal, nor the pressure for a quick return. We are sending encouragement and support in line with 'me'." Deputy Director Im Ji-hoon◆Joint donation made with life saver and settlement money "He is literally a lifesaver. I can't really thank you in words. I wanted to somehow compensate, so I offered some of the settlement money as a token of gratitude, but I refused. But I said again that my heart was too heavy. , They offered to donate to the Children's Foundation under a joint name." It saved a person's life, but he did not come forward and commended his work, awarded a citation, and shared examples of talks through town hall meetings, but he is still embarrassed. "I'm glad she was just alive. If anyone other than me saw the situation, she would have run to help. I could go to the hospital 5 months after the surgery, but she recovered to some extent. I was really grateful to see it. Oh, the Children's Foundation was originally a place where there was exchange such as voluntary activities at the company level, and it was a personal support. Her accident is, of course, an accident that should never happen again. However, due to this accident, J&J and Janssen, which felt like subsidiaries but actually different companies, united as one. The company also offered psychological counseling using in-house programs to prepare for the trauma that may have been received by him. J&J and its subsidiary Janssen are emphasizing 'Credo', which has been passed down since its inception. The first is the patient and the doctor, the second is the staff, the third is the community, and the company's Credo, which respects the care and values of people, hangs everywhere. Credo, which has been spreading consistently, is perhaps deeply engraved in the company's employees.
- Company
- Yuhan secured ₩230 billion in two years
- by Chon, Seung-Hyun Nov 25, 2020 06:24am
- Yuhan has secured about ₩230 billion in new drug technology fees over the past two years. It has signed five technology transfer contracts, and has also collected milestones of more than ₩100 billion in the development stage after technology export. Front view of Yuhan headquartersYuhan announced on the 24th that it will receive a staged technology fee (milestone) of $65 million (₩72.3 billion) for the anticancer drug Lazertinib from Janssen Biotech. An additional milestone occurred as Janssen started recruiting subjects for a phase III clinical trial of its own anticancer drug, Amivantamab and Lazertinib. Lazertinib is a third-generation EGFR targeted anticancer drug that Yuhan handed over to Janssen Biotech in November 2018. The total contract size, including a down payment of $50 million without obligation to return, is up to $1.25 billion. Lazertinib's additional milestone is the second since the temporary export. Yuhan received $35 million milestone for Lazertinib from Janssen Biotech in April. Janssen paid an additional milestone to Yuhan when he began a trial of Amivantamab and Lazertinib combination therapy at the time. Yuhan has secured a total of $150 million, including a down payment of $50 million, only by the transfer of Lazertinib technology. 40% of Lazertinib's technology fees are redistributed to the original developer, Oscotec. For Yuhan, technology fees have been a major source of revenue since 2018. Yuhan has signed a total of five new drug technology export contracts since July 2018. In July 2018, it transferred the technology of YH14618, a treatment for degenerative disc disease, to Spine Biopharma in the United States. It received a down payment of $650,000, and was guaranteed $217.5 million for milestones in stages according to development, licensing and sales. In November 2018, it signed a technology export contract with Janssen for Lazertinib. In January of last year, it signed a license and joint development contract with Gilead Sciences for new drug candidates that act on two drug targets for the treatment of non-alcoholic steatohepatitis (NASH). It is a condition of receiving a down payment of $15 million and receiving $777 million in milestones for each stage of development, licensing and sales. In July of last year, Yuhan signed a technology transfer contract with Boehringer Ingelheim for a total of $870 million related to the NASH treatment YH25724. The down payment without obligation to return is $40 million. Out of the $40 million down payment, they agreed to receive $10 million upon completion of the non-clinical toxicity test, but after the nonclinical toxicity test was completed in 9 months, the remaining down payment was received in April. In August, it signed a technology transfer contract with Processa Pharmaceuticals of the United States for a functional gastrointestinal disease treatment candidate YH12852. Yuhan received a down payment of $2 million as shares, which were not obligated to return. Yuhan has secured a total of $2,765 million (about ₩230 billion) in technology fees for about two years since 2018. It is more than 18 times the operating profit of ₩12.5 billion last year. Quarterly Yuhan technology fee operating profit (Unit: ₩million, Source: Yuhan, the FSS) Yuhan's recent technology fees are higher than operating profits. As of this year, Yuhan has recognized a total of ₩77.9 billion in technology fees. In the first and second quarters, ₩1.1 billion and ₩35.7 billion were reflected, respectively, and an additional ₩16.9 billion was recognized in the third quarter. Yuhan's cumulative operating profit in the third quarter was ₩57.1 billion. It is calculated that if there was no inflow of technology fees, it would have recorded a deficit. Yuhan's technology fee revenue was ₩23.2 billion last year, far exceeding its operating profit (₩12.5 billion). From 2019 to the third quarter, Yuhan recognized a total of ₩101.1 billion in technology fees. In the future, additional technology fee revenues reflected in earnings exceed ₩100 billion.
- Company
- HCP and patients waiting for new T-cell lymphoma option
- by won, jong-hyuk Nov 25, 2020 06:24am
- The performances of anticancer therapies are improving as time goes by. But some cancer types still use chemotherapy as a standard of care (SOC) developed in 1970s to this date, regardless of the technological advancement in the anticancer area. One of them is Peripheral T-Cell Lymphoma (PTCL). Typically, PTCL is one kind of non-Hodgkin lymphoma found in T lymphocytes. The condition is categorized as a malignant tumor and an aggressive lymphoma. The tumor frequently spreads in liver, spleen and skin, and also has high risk of relapse and rapid advancement speed. The problem is that the patients usually do not respond to the current SOC of a combined chemotherapy, and the prognosis of PTCL patients who fail in the first-line therapy or show relapse is not so positive with the median survival period lasting about 5.8 months. Rare blood cancer area stuck with ‘70s chemotherapy showing low survival rate and frequently observed toxicity #The current first-line SOC in PTCL treatment is a combination of chemotherapy including cyclophosphamide, doxorubicin hydrochloride (hydroxydaunorubicin), vincristine sulfate, and prednisone, or also known as CHOP, used from the ‘70s. The CHOP chemotherapy has been used as a first-line treatment for decades, but the academic societies are torn about the therapy’s survival rate and toxicity. According to a clinical trial in Japan, PTCL patients’ three-year survival rate was only about 52 percent after receiving CHOP chemotherapy. And high dosage of chemotherapy causing adverse reaction is considered as the biggest problem when treating the patients. Blood toxicity, such as leukopenia, anemia, thrombopenia could be caused by myelosupression, or the patients usually experience loss of hair, peripheral neuropathies, infection and nausea. The reason why such high risk SOC is still used until today is because the disease has no other alternative options. The treatment scene is not so different in South Korea. The National Cancer Information Center explains there are cases of the patients with PTCL or other non-Hodgkin lymphoma participating in clinical trials using new drugs, when they did not respond well enough to the SOC. A professor of hematology and oncology at Samsung Medical Center, Kim Seok Jin explained, “Patients with PTCL are usually diagnosed in their 50s or 60s, and they are likely to get complications due to bone marrow suppression triggered by chemotherapy. Especially the patients in their 70s, some give up their treatment as they cannot endure the adverse reaction, and a lot of them see underwhelming treatment effect as they have to reduce the dosage considering the high risk of adverse reaction.” ”Desperately need to improve PTCL treatment access in South Korea” with the updated NCCN guideline Although the PTCL treatment scene lacks varying treatment options with the said situations, a lymphoma treatment Adcetris (brentuximab) earned a new indication to treat PTCL and expanded the treatment option in December last year. Adcetris is an antibody-drug conjugate (ADC) directed to CD30, expressed on the surface of several types of PTCL. A Phase III ECHELON-2 study evaluated the drug’s clinical benefit, where patients with CD30-positive PTCL have improved the overall survival (OS), compared to the SOC CHOP chemotherapy, without discovering more issue with adverse by using brentuximab as a first-line treatment. During the study, a patient group receiving brentuximab plus CHP (cyclophosphamide- doxorubicin-prednisone) combination lessened the risk of death by 34 percent and significantly enhanced the OS, in comparison to the patient group using CHOP. Also the Adcetris combination therapy demonstrated an outstanding treatment efficacy proven with other indicators of anticancer treatment efficacy like progression-free survival (PFS), objective response rate (ORR) and complete remission (CR). The median PFS in the Adcetris combination therapy group reached 48.2 months, which almost doubled the median PFS in the CHOP patient group with 20.8 months. The statistics prove that the combination therapy has brought down the risk of disease progression by 29 percent. Based on the reported clinical efficacy, the current National Comprehensive Cancer Network (NCCN) guideline recommends using Adcetris plus CHP combination therapy for a first-line treatment in patients with CD30-positive PTCL as a ‘preferred regimen.’ However, the PTCL treatment scene in South Korea has a long way to go. The drug expanded the indication late last year, but it still has not resolved the healthcare reimbursement required for more practical prescription. The drug faces the first threshold of winning the healthcare reimbursement, the Cancer Deliberation Committee meeting schedule on Nov. 25. And regarding the drug Professor Kim commented, “Both the patients and healthcare providers are happy to have a new treatment option with superior efficacy than the existing SOC, as there were limited prescription options for patients with PTCL. There is definitely a big difference between not having an option at all and having option that cannot be accessed.” The professor continued, “It is regrettable the patients are giving up on treatment, because of financial reasons, regardless of the new available option with lessened toxicity and good efficacy. I wish their access to treatment can be better as soon as possible for them to live longer. And granting the healthcare reimbursement on the drug would be cost-effective as there are only a handful of PTCL patients in South Korea.”
- Company
- Atozet follow-on drugs conflicted over price manipulation
- by Chon, Seung-Hyun Nov 24, 2020 09:03am
- The South Korean dyslipidemia treatment Atozet market seems to be heating up with competition and conflict among consignment manufacturers. Companies in process of preparing for the Atozet generic have stated they would take a legal action against Chong Kun Dang’s violation of Fair Trade Act, claiming the Korean company is rigging the follow-on drug pricing. According to the pharmaceutical industry sources on Nov 23, three of South Korean pharmaceutical companies are considering on filing a complaint to the Fair Trade Commission about Chong Kun Dang’s attempt to fix the generic pricing. The three companies argue Chong Kun Dang has tried to monopolize the generic pricing as it called for consignment manufacturers for the atorvastatin plus ezetimibe combination drug. MSD’s dyslipidemia treatment Atozet Chong Kun Dang has recently received a government approval on Atoezy, a combination of atorvastatin and ezetimibe, after finishing off a clinical trial. The approved drug has the same substances as Atozet developed by MSD. Chong Kun Dang announced its plan to have consignment manufacturing and called for manufacturers for the deal. Basically, the company is to provide authorization to manufacture the generic to the manufacturers with the entire clinical data related to Atoezy. An authorized generic would have exact same product as an original but in different packaging. Chong Kun Dang has accepted total 22 manufacturers, who submitted an approval application on the authorized Atoezy generic. But the three generic companies are claiming Chong Kun Dang is manipulating the market. Apparently, the company included a condition to ‘apply for pricing to the Health Insurance Review and Assessment Service (HIRA) immediately after completing the approval process’ in the consignment contract, and the three companies say it violates the Fair Trade Act that forbids a ‘practice to decide, sustain or change pricing.’ In other words, they are arguing Chong Kun Dang is trying to bring down the follow-on drugs’ pricing by having the consigned manufacturers to agree on simultaneously apply for listed drug pricing. The generic companies plan to take the case to the Fair Trade Commission this week along with a couple of law firms. The key point of the conflict between Chong Kun Dang and generic companies centering the authorized Atoezy generic is in the pricing. When 22 authorized Atoezy generics receive approval and reimbursed pricing, other drugs to be approved later would have significantly lower pricing. The revised drug pricing system effective from last July stipulates a stepped drug pricing that reduces the upper limit pricing of the 21st generic drug with same substance down to 85 percent of a lowest priced drug. When 22 authorized Atoezy generics complete the reimbursed pricing procedure, other following Atozet generics would be applied with the stepped drug pricing, which would bring down the pricing to 61.4 percent of the upper limit price of a drug with same substances. According to the Ministry of Health and Welfare (MOHW), when the number of listed drugs with same substance exceeds 20, a new reimbursed pricing applicant drug would receive pricing of the lowest between ‘85 percent of drug pricing with two unmet qualifications,’ or ’85 percent of the lowest price among the same substance drugs.’ The 85 percent of drug pricing with two unmet qualifications is calculated as 61.4 percent of the upper limit pricing (upper limit pricing*0.85*0.85*0.85). If one of authorized Atoezy generic drops the pricing greatly, other Atozet generic’s pricing would be priced even lower. At the moment, Atozet generic cannot enter the market. Some companies are preparing for a generic release by conducting a bioequivalence test with Atozet as reference drug, but they can only apply for approval after Jan. 22 next year when Atozet’s post-marketing surveillance period ends. Because of the said complications, companies readying the Atozet generic products were sensitively monitoring the number of authorized Atoezy generics. The Atozet generic companies question the Chong Kun Dang’s action and insist “Chong Kun Dang has intentionally called for over 20 manufacturers to push other generics’ pricing down.” In fact, some of companies that actually developed Atozet generics have joined the group of manufacturers signing the deals on authorized Atoezy generics. An insider from an Atozet generic developer complained, “If any one of the authorized Atoezy generics takes a substantially low pricing, then other Atozet generics cannot even launch their products due to unprofitable income structure. Due to the government’s stepped pricing, the companies’ immense effort to develop a generic could be gone instantly.”
- Company
- Takeda rejoins KRPIA after 5 years
- by Eo, Yun-Ho Nov 24, 2020 09:02am
- Takeda Pharmaceuticals Korea is returning to Korean Research-based Pharmaceutical Industry Association (KRPIA). The pharmaceutical industry sources recently reported Takeda has officially joined KRPIA as a member company. The company is gaining back its member company status as well. The KRPIA membership was inherited from Shire Pharmaceutical that Takeda has completed acquiring in July. Since its launch in 2016, Shire has been an active member of KRPIA. After opening the South Korean branch in 2011, Takeda started off as a member of Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) and also joined KRPIA in 2013, when former President of GSK Korea President Kim Jin-ho was a chair of KRPIA. However, the company left KRPIA in 2015 and only sustained the membership at KPBMA. Takeda’s decision to rejoin KRPIA seems to have been influenced by its new drug pipelines. The company has launched an autoimmune disease treatment Kynteles (vedolizumab), a multiple myeloma treatment Ninlaro (ixazomib) and anticancer treatment Zejula (niraparib) from last year, and it has a series of other new drugs in preparation to launch. As new drug healthcare reimbursement is a controversial issue in South Korea and KRPIA is focusing on government affairs at the moment, the company could have taken a strategic action accordingly. KRPIA has various multinational pharmaceutical companies as member companies. Including a number of Japan-based companies, such as Takeda, Daiichi Sankyo, Mitsubishi Tanabe Pharma, Santen Pharmaceutical, Astellas, Kowa, Kyowa Kirin, the list of member companies also has Galderma, Sandoz, Fresenius Kabi, Fresenius Medical Care and Baxter.
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- An employee at drug company earns average KRW 41M
- by Chon, Seung-Hyun Nov 24, 2020 09:02am
- Apparently, the government statics say the average annual salary of the South Korean pharmaceutical industry is 41.4 million won. It was just shy of the general industry average. Depending on the pharmaceutical companies, some had average salary gap over 10 million among their employees. A university undergraduate’s average salary started from 34.77 million won, which is 11 million won more than the high school graduates. On Nov. 19, Ministry of Employment and Labor (MOEL) disclosed the wage by industry as of June 2020 through the wage and job information system. For the second time, MOEL has presented the analysis of wage based on the employment due diligence as of June this year by job types from 2017 through 2019. Average salary in pharmaceutical companies by employment size (Unit: KRW) Source: MOEL According to the statistics, the jobs in the medical substance and pharmaceutical manufacturing industry make annually average salary of 41.4 million won. Basically, the pharmaceutical industry’s average annual salary is 1.88 million won less than the general industry’s average of 43.28 million won. However, the annual salary at pharmaceutical companies varied widely depending on the size. The employees at pharmaceutical companies with over 300 employees are making average annual salary of 48.14 million won, which is 11 million won more than employees at companies with five to 29 employees (36.79 million won). Employees at companies with 30 to 99 employees and with 100 to 299 employees are making 38.29 million won and 44.73 million won, respectively. Also the average annual salary varied depending on the education level of the employees. The average salary of employees with undergraduate degree is 47.85 million won, making 14.42 million won more than the high school graduate employees with 33.43 million won. Average salary in pharmaceutical companies for an entry level employee with less than a year employment size (Unit: KRW) Source: MOEL An entry level employee with less than a year of employment is making average of 30.45 million won a year. Specifically, the employees at pharmaceutical companies with over 300 employees are earning 36.57 million won a year, or 5.19 million won more than employees at companies with five to 29 employees (25.36 million won). An entry level employee with an undergraduate degree is earning 34.77 million won per year, whereas ones with two-year college degree or high school diploma are earning 29.72 million won and 23.42 million won, respectively. Average salary in pharmaceutical companies for an entry level employee with less than a year employment size (Unit: KRW) Source: MOEL The statistics on average salary by employment years in pharmaceutical companies found employees, who have worked over 25 years, are earning average of 64.43 million won. By third to fifth year, the salary exceeds 40 million won, and it exceeds 55.29 million won by 15th to 20th year. A male employee (45.72 million won) is making average 10 million won more than a female employee (34.17 million won) in the entire pharmaceutical industry. The salary gap seems to be big as the male employees tend to be employed longer compared to female employees.
