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- 2026-04-16 08:12:13
- Company
- Giotrif competitor Vizimpro close to receiving reimbursement
- by Eo, Yun-Ho Sep 15, 2020 06:27am
- Sources report, Pfizer Korea is speeding up the procedure to introduce epidermal growth factor receptor (EGRF) tyrosine kinase inhibitors (TKI) into the market. According to the industry sources, a fifth EPGF TKI Vizimpro (dacomitini) has passed the Health Insurance Assessment and Review Service (HIRA) Cancer Deliberation Committee in last July, and it is waiting for Drug Reimbursement Evaluation Committee’s (DREC) deliberation in October. Although the DREC deliberation was initially scheduled be convened in September, the deliberation was delayed due to the resurging number of confirmed COVID019 cases. Currently, the first generation EGFR TKI ‘Iressa (gefitinib)’ by AstraZeneca and Tarceva (erlotinib) by Roche, and the second generation Giotrif and the third generation Tagrisso (osimertinib) by AstraZeneca are prescribed in South Korea. As its direct competitor Giotrif (afatinib) has already settled in the market already, Vizimpro chose the drug pricing negotiation exemption track. As a result, its launch would be able to convince the product from then on in the second half of the year. Vizimpro’s efficacy has been confirmed in Phase III ARCHER 1050 trial. The study compared Vizimpro and the first-generation Iressa head-to-head with total 452 patients fighting against non-small cell lung cancer (NSCLC). In the trial, the medicine reduced the risk of progression-free survival (PFS) by 41 percent than Iressa, when Vizimpro patient group’s median PFS was at 14.7 months and Iressa group’s was at 9.2 months. The study reported Vizimpro lowered the risk of progression or death by 41 percent against Iressa, and the median progression-free survival (PFS) was 14.7 months in the Vizimpro group and 9.2 months in the Iressa group. Nevertheless, Vizimpro showed worse cases of adverse reactions. In the Vizimpro group, the frequently demonstrated severe adverse reactions included dermatological issues with pimple (14 percent) and diarrhea (8 percent), whereas changes in liver enzymes (8 percent) were significant in the Iressa group. Around 60 percent of Vizimpro patient group had to adjust their medication dose due to adverse reaction. Vizimpro is a second-generation targeted therapy indicated to treat patients with EGRF-mutation-positive NSCLC. The U.S. Food and Drug Administration (FDA) approved the anticancer treatment in September 2018 after granting Priority Review in January same year. Currently, the drug is approved and used in the U.S., EU and Japan. In Korea, the medication has been approved as a first-line treatment for patients with locally advanced or metastatic EGFR-mutated NSCLC, and it is also indicated treat patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations, who has not been treated before.
- Policy
- Crovalimab by Roche is conducting phase III in Korea
- by Lee, Tak-Sun Sep 15, 2020 06:27am
- Soliris sold by HandokSoliris (Eculizumab), which has recorded high sales as a treatment for paroxysmal nocturnal hemoglobinuria (PNH), a rare disease, is undergoing phase III clinical trial in Korea. It is Crovalimab, excavated by Chugai in Japan and developed by Roche. On the 11th, the MFDS approved a phase III IND for 'RO7112689' submitted by IQVIA Korea. RO7112689 is the name of the development of Crovalimab that Roche is developing. IQVIA, a global CRO, is expected to conduct phase III clinical trial of Crovalimab. It is a multinational clinical trial, and out of the total 250 subjects, 5 were recruited in Korea. This is a phase III trial to evaluate the efficacy and safety of Crovalimab versus Eculizumab in adult and adolescent subjects with paroxysmal nocturnal hemoglobinuria (PNH) and currently receiving complement inhibitor therapy. Eculizumab is generic for Soliris sold by Handok in Korea. Soliris is a large-scale drug that is sold to patients with PNH, recording annual sales of ₩43.8 billion (as of IQVIA 2019). There are few patients as a treatment for rare diseases, but it is generating high profits with expensive drugs of ₩5.13 million per bottle. Ultomiris, an upgraded version of this drug, received item approval in May. PNH is one of the rare blood diseases in which red blood cells are destroyed by complement, which is a part of the immune system. If not treated after diagnosis, 4 out of 10 people die within 5 years. It is known that there are about 200 patients in Korea. Soliris, which was introduced in Korea in 2012, is the only treatment for now. Crovalimab, which was approved for phase III clinical trial this time, is known to have a mechanism to inhibit the complement chain reaction by inhibiting the C5 protein like Soliris. Japan's Chugai derives the substance, and Roche is currently developing commercialization. Lately, generic biotech companies such as Samsung Bioepis are also drawing attention to the PHN market, such as developing a Soliris biosimilar.It is noteworthy whether a new drug will become a rival drug for Soliris.
- Policy
- Famvir licensed by Ildong is now manufactured locally
- by Lee, Tak-Sun Sep 15, 2020 06:26am
- Ildong Pharmaceutical is anticipating Famvir profit to improve as the drug licensed out by Novartis would be manufactured in South Korea. A shingles treatment Famvir is an original famciclovir drug that Novartis received approval to market in South Korea in year 2002. In 2018, Ildong Pharmaceutical acquired the sales rights over Famvir in South Korea, and signed a deal with Novartis to transfer relevant technology to directly manufacture and sell the drug locally. Since then, the Korean company has conducted a bioequivalence test and prepared local production of Famvir. According to Ministry of Food and Drug Safety (MFDS), Famvir 750 mg tablet and 250 mg tablet have been registered to be manufactured in Korea as of July 28 and Sept. 9, respectively. Previously, the drug was manufactured overseas and imported by Novartis. However, Ildong Pharmaceutical is not the actual manufacturer; Famvir 750 mg tablet and 250 mg tablet are respectively manufactured from JW Shinyak’s Pyeongtaek plant and Dong Wha Pharmaceutical’s Chungju plant. These plants also manufacture other generic drugs. The locally manufactured Famvir 750 mg tablet has changed its label and was distributed to vendors. But Famvir 250 mg tablet was just transferred to a local manufacturer, so the products from the Korean plant would be distributed around January next year. Although manufactured in Korea, Famvir is expected to maintain the high sales record as an original drug. According to IQVIA last year, the original drug generated 7.7 billion won and made the highest sales among the same substance drugs. In Korea alone, there are 125 famciclovir drugs in the market. And as the drug is now manufactured in Korea, Famvir is projected to generate even larger profits.
- Company
- The sales of antiemetic drug Nasea plummeted
- by Kim, Jin-Gu Sep 15, 2020 06:26am
- Nasea Sales in the domestic market declined after three types of domestic copyright rights, including the antiemetic drug Nasea (Ramosetron), were transferred from Astellas to Daiichi Sankyo, a Japanese pharmaceutical company. According to IQVIA, a drug research institute, Nasea's sales in the first half of this year were ₩12.7 billion, down 30% from ₩18.3 billion in the first half of last year. Compared to the second half of last year (₩16.4 billion), it also decreased by 22%. This is in contrast to the 50% increase in sales of other Ramosetron-based treatments from ₩10.2 billion to ₩15.4 billion over the same period. In addition to Nasea, Treatments including Ramosetron are ▲Boryung's Naseron ▲ Hana's Ramset ▲Parvis Korea’s Ramea ▲Astellas' Irribow ▲Kyongbo’s Ramocan, etc. In the case of Naseron, sales increased 63% from ₩6.1 billion in the first half of 2019 to ₩9.9 billion in the first half of this year. During the same period, Ramset increased 37% from ₩2.7 billion to ₩3.7 billion, and Ramea decreased 24% from ₩800 million to ₩600 million. Half-annual sales of Nasea and Ramosetron-based antiemetics (unit: ₩ billion, data from IQVIA) Nazea is a leading item in the antiemetics market with annual sales of over ₩30 billion. However, as sales declined significantly, the gap with the second-largest Ramosetron (Naseron) narrowed. The difference in sales between Nasea and Naseron in the first half of last year was ₩12.2 billion, but the gap has decreased to ₩2.8 billion in the first half of this year. Previously, Daiichi Sankyo Korea received three types of copyrights, including Nasea, Oldeca, and Perdipine sold by Astellas Korea from December last year. In the case of Perdipine, only injections were transferred to Daiichi Sankyo. On July 31, last year, Daiichi Sankyo headquarters signed a transfer agreement for the three drugs sold by Astellas in six Asian countries, including Korea, and the domestic copyright also changed. There was no significant change in the other two items except for Nasea. Oldeca posted sales of ₩900 million in the first half of last year and the first half of this year. In the case of Perdipine injection, the market size was very small, with semiannual sales of less than ₩100 million. It was a 15% decrease from ₩18.35 million in the first half of last year to ₩15.61 million in the first half of this year.
- Policy
- New osteoporosis drug Evenity passed deliberation
- by Lee, Hye-Kyung Sep 15, 2020 06:26am
- Amgen Korea's bone formation promoting and bone resorption inhibitor Evenity PFS (Romosozumab) passed the deliberation. On the 11th, the HIRA (President, Sun Min Kim) released the results of the deliberation on the adequacy of medical benefits for the drugs applied for decision deliberated by the '9th Pharmaceutical Benefits Advisory Committee in 2020'. The drug deliberated this time was one item of Amgen's Evenity, and the deliberation was made in writing for two days from 9 to 10 due to COVID-19. Evenity is a drug that has been recognized for the appropriateness of reimbursement in one year and four months after obtaining domestic approval in May of last year. Indications of Evenity are ▲treatment of postmenopausal female osteoporosis patients with a high risk of fracture ▲Bone density increase in male osteoporosis patients with high fracture risk. Effectiveness is based on phase III studies 'FRAME' and 'ARCH' studies and phase III clinical 'BRIDGE' study for male osteoporosis patients Through FRAME, a placebo-controlled phase III clinical trial, Evenity showed the effect of lowering the risk of vertebral fracture in postmenopausal female patients with a high risk of fracture, with a T-score of -2.5 to -3.5 in the total hip or femur neck. In the first year of treatment with Evenity, the risk of new vertebral fractures was reduced by 73% in the Evenity group compared to the placebo group. In the second year of treatment after 1 year of Evenity treatment, the risk of new vertebral fractures was reduced by 75% compared to the group of patients who switched from placebo to Prolia. On the other hand, the HIRA is evaluating the adequacy of reimbursement of medicines after deliberation on the committee in accordance with Article 11-2 of the Rules on the Standards of National Health Insurance Medical Care Benefits. In the case of drugs that have been evaluated for reimbursement appropriateness, the final evaluation result may be changed in the event of changes in the detailed drug reimbursement range and standard items, changes in the permission details of the item requested for determination, and withdrawal of permission (cancellation).
- Company
- Listed pharma companies financially sound despite COVID-19
- by Kim, Jin-Gu Sep 14, 2020 06:16am
- Apparently, major South Korean pharmaceutical and bio companies have been maintaining the level of financial soundness from late last year for the first half of this year. One of their financial soundness indicators, net liabilities, showed similar level as late last year, which the experts analyze the industry is performing relatively well, regardless of COVID-19. According to Financial Supervisory Service (FSS) on Sept. 14, 30 listed Korean pharmaceutical companies’ net liabilities reached 7.63 trillion won as of the end of first half of the year. Compared to 7.61 trillion won as of same time last year, the figure was slightly increased by 0.3 percent (24.1 billion won). Technically, the net liabilities have not changed much. The net liabilities indicate a company’s financial liquidity. The less net liabilities, the better financial soundness is. The net liabilities are the difference between the total current liabilities and the total current assets accounting only cash or cash equivalents. In other words, it is the value of the debt a pharmaceutical company has minus the total sum of all liquidatable cash (or cash equivalent assets). On paper, the 30 pharmaceutical companies’ total debt has surged, but their total assets have also increased as much and canceled out the inclined the net liabilities. The total liabilities of the 30 pharmaceutical companies, as of late June, were 10.65 trillion won, growing 9 percent (841.5 billion won) from last year same time at 9.81 trillion won. In the same period, the total cash and cash equivalent assets grew by 37 percent (817.4 billion won) from 2.20 trillion won to 3.17 trillion won. The cash and cash equivalents are assets without real estate, stock, intellectual property and some of financial assets, and most of them are operating profit. As for financial instruments, only the ones that acquire the income in three months (or expire) are accounted. The 30 companies’ sales and operating profit have reportedly improved over 40 percent in the first half of the year, regardless of COVID-19. The overall change in total liabilities, cash and cash equivalents and net liabilities in 30 listed pharmaceutical companies (Unit: KRW 100 million) Source: FSS Also some companies have significantly improved their financial soundness by decreasing the net debt. Hugel has apparently improved its financial soundness the most with its net liabilities dropping by 203.1 billion won. Also, Yuhan (154.8 billion won), Dong Hwa Pharm (71.8 billion won), Daewoong Pharmaceutical (56.9 billion won) and Dong-A ST (37.3 billion won) were able to reduce the net liabilities. Particularly, Hugel and Dong Wha Pharm have recorded negative net liabilities as of late June. Basically, the two companies can pay off their debts with the cash they can immediately liquidate. Meanwhile, Dong Kook Pharmaceutical (90.3 billion won), Samsung Biologics (88.6 billion won), GC Pharma (74.5 billion won), Celltrion (41.8 billion won), Hanmi Pharmaceutical (41 billion won), Kyung Dong Pharm (36 billion won) and JW Life Science (35.8 billion won) had their net liabilities increased. Overall, 22 companies out of the 30 companies had their net liabilities increased. The total liabilities, cash and cash equivalents and net liabilities in 30 listed pharmaceutical companies (Unit: KRW 100 million) Source: FSS The experts analyze the top listed pharmaceutical companies were able to maintain the net debt level on par with last year, because the industry is relatively thriving despite COVID-19 pandemic. A credit rating agency’s report found most of industries including, semi-conductor, automobile, distribution, display, hospitality and duty free, airline, shipbuilding and steel, have worsened their financial soundness in the first half of the year.
- Policy
- Fluarix Tetra, full-scale competition for flu vaccines
- by Lee, Tak-Sun Sep 14, 2020 06:15am
- Fluarix Tetra by GSKThe quadrivalent flu vaccine 'Fluarix Tetra', which was first introduced in Korea in 2015, was approved by the Ministry of Food and Drug Safety, and began to compete in the market in earnest. GSK's Fluarix Tetra is a representative imported vaccine that has been ranked at the top since its launch in 2015. However, it is expected to act as a variable in the competitive market as it does not participate in the quadrivalent flu vaccine NIP (National Immunization Program) project starting this year. On the 8th and 10th, the Ministry of Food and Drug Safety approved Fluarix Tetra PFS, an imported quadrivalent flu vaccine from GSK. As a result, the approval of most products expected to be sold this year was achieved. As the NIP began this week, the flu vaccine market entered a rebound competition. Among them, Fluarix Tetra is attracting attention as it is a quaternary vaccine aid and top-notch product. Fluarix Tetra was the first tetravalent vaccine to be launched in the domestic market in 2015. In Korea, it has been sold through Yuhan Corporation, and GC Pharma has been selling it since last year. Last year, sales amounted to ₩7.9 billion, followed by 'SKY Cellflu Quadrivalent (₩13.1 billion) by SK Bioscience and GC Pharma's 'GCFLU Quadrivalent (₩12.4 billion)'. The fourth place was Sanofi Aventis Vaxigriptetra with ₩4.6 billion based on IQVIA. Last year, it was pushed down to the third place after being pushed by domestic products, but from 2015 to 2018, it continued to be the number one. However, there are many variables this year. Above all, the tetravalent vaccine NIP starting this year is expected to have an impact. While most of the products participate in the NIP, Fluarix Tetra is only launching products in the market without NIP. Accordingly, it is unclear whether Fluarix Tetra will maintain its existing market share. It is also of interest how the sales company GC Pharma will conduct marketing through differentiation from its own 'GCFLU Quadrivalent'. For the first time, it is expected to take a dual strategy of actively promoting GCFLU Quadrivalent in the NIP, and putting the first tetravalent vaccine and imported product, Fluarix Tetra, in the market. However, as the price of products in the market is expected to decrease due to the participation of many products in the NIP, the price of which Fluarix Tetra chooses will also act as a variable. This year, the demand for flu vaccines is expected to be higher than ever due to the COVID-19 epidemic. The government also recommends influenza vaccination because COVID-19 and flu have similar symptoms, and confusion in quarantine is expected if they occur simultaneously. There are a total of 12 flu vaccines scheduled to be distributed in Korea this year. GSK and Sanofi are the only foreign pharmaceutical companies to import and sell flu vaccines.
- Company
- Expectations on Zejula are high
- by Sep 14, 2020 06:15am
- “The biggest burden on recurrent ovarian cancer patients is definitely 'relapse'. Zejula can play an important role for patients by preventing recurrence through primary maintenance therapy. In particular, it can be used as an All-comer. The appearance of Zejula is likely to make a big difference in the treatment of ovarian cancer.” Soo-Young Hur, a professor of obstetrics and gynecology at Seoul St. Mary's Hospital, said at an online press conference for PARP inhibitor Zejula (Niraparib) on the 10th, about Zejula's significance of expanding the indications for primary ovarian cancer maintenance therapy. Takeda Korea's ovarian cancer drug Zejula is the first PARP inhibitor that can be used regardless of whether the BRCA gene has been mutated. It was approved for the first time in Korea in March 2019 as ‘a single maintenance therapy for adult patients with platinum-sensitive recurrent highly serous ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who have fully or partially responded to platinum-based chemotherapy at least 2nd order’ Since then, the indications have been expanding. In December last year, it became available for 4 or more monotherapy, and in August, it also acquired indications for first-line maintenance therapy. Soo-Young Hur, a professor of obstetrics and gynecology at Seoul St. Mary This online meeting was set up to explain the clinical research and treatment significance that served as the basis for the expansion of the indications for the primary maintenance therapy of In the case of ovarian cancer, recurrence occurs within 1-3 years in most patients after chemotherapy. After chemotherapy, the progression-free survival (PFS) is very short, ranging from 8 to 14 months, so maintenance therapy is selected to prolong it. Maintenance therapy options include Bevacizumab, a VEGF inhibitor, and PARP inhibitors such as Olaparib , Veliparib, and Niraparib. According to Professor Antonio González-Martín (The University Clinic of Navarra, Spain), the principal of PRIMA's clinical study, which was the basis for the expansion of the indications for the first-line maintenance therapy of Zejula, "The results of the PRIMA study show that the median PFS of Zejula in the HRd group is 21.9 months, and the placebo group (10.4 months). Also he said. "It also showed an effect in the HRp patient group." In particular, although the PRIMA study mainly included patients with high risk of recurrence, it was explained that it was effective in all patient groups regardless of biomarkers such as HRd or BRCA mutation. As for the safety profile, hemologic adverse reactions were observed in some patients, but they were manageable through dose reduction or suspension of medication, he added. In particular, he said about a comparative analysis with the combination therapy of Olaparib (Lynparza) + Bevacizumab (Avastin), which was approved as the first line maintenance therapy for HRd ovarian cancer patients regardless of BRCA mutation in the United States. "The PAOLA study shows that the combination with Olaparib is better than Bevacizumab alone, and this only appeared in the HRd patient group." However, he commented, "It is not clear how much additional value added to Bevacizumab plus Olaparib provides." He added, “When deciding on a treatment option that is suitable for a patient, we need to consider both options, as we need to consider several factors including clinical factors. There will be some patients in the group where Bevacizumab is not suitable, and also in the HRp group. Zejula is the only drug that has proven its effectiveness.” Professor Hur also focused on the fact that Zejula shows effects regardless of biomarkers. He said, "Olaparib can only be used when there is a BRCA mutation, but among ovarian cancer patients, the BRCA mutation is a small proportion of about 20%. In addition, Bevacizumab does not require a biomarker, but it is used depending on the patient's stage, and there are concerns about side effects such as toxicity." In addition, he said, "Zejula can be used as an all-comer, and if the dose is adjusted according to individual patients, the effect can be maintained while reducing side effects." He said, "I expect that Zejula can be used as an all-commer after ovarian cancer treatment, which will bring about a huge change." And he added that the indications have recently been expanded, and due to restrictions on reimbursement, there is not much experience in prescribing Zejula as the first maintenance therapy. As data accumulates in the future, it will be of great help to patients as a first-line maintenance therapy.
- Company
- Kolmar shareholders agree to dispose CMO and Kolmar Pharma
- by Chon, Seung-Hyun Sep 14, 2020 06:15am
- Kolmar Korea’s shareholders have agreed to dispose of the corporate asset valued at 500 billion won. Kolmar Korea announced the shareholders have deliberated at a general meeting convened on Sept. 10 to pass the agenda of selling the company’s pharmaceutical CMO and Kolmar Pharma to IMM Private Equity (PE). Previously in last May, Kolmar Korea signed a deal to sell off its 62.1 percent share of Kolmar Pharma and the entire pharmaceutical CMO sector to IMM PE for 512.4 billion won The private equity firm was to take over the pharmaceutical CMO sector valued at 336.3 billion won and Kolmar Pharma at 176.1 billion won. Prior to their general shareholders’ meeting, one of the top shareholders, National Pension Service (NPS) voted against the asset disposal. Regardless, the general shareholders have agreed to dispose the asset as planned. Voting against the asset disposal, NPS recently said, “The asset’s transfer scope and value of shares have not been finalized for the shareholders to deliberate.” Currently, NPS owns 11.75 percent of Kolmar Korea’s shares. However, the proceeds from sale could be lessened due to the result of additional negotiation between Kolmar Korea and IMM PE. Kolmar Korea disclosed the business transfer notice stating “The company is currently undergoing additional negotiation with the transferee about the scope of transferring asset, and the proceeds from sale may be lowered up to 15 percent, depending on the negotiation result.” Kolmar Korea’s shareholders may exercise their appraisal right until Oct. 5. An appraisal right is the statutory right of a shareholder, who opposed to an issue that the majority voted for in the general shareholders’ meeting, to demand the company to acquire their shares. The obliged purchasing price of the share is at 42,556 won. As the price is lower than the share price recorded on the day of the shareholders’ meeting at 45,900 won, the shareholders are unlikely to exercise their rights.
- Company
- The issue is that the NHIS is entitled to indemnity or not
- by Kim, Jin-Gu Sep 14, 2020 06:14am
- A legal dispute has begun between the NHIS and 36 domestic pharmaceutical companies regarding Valsartan's claim for right to indemnity. At the first trial, the issue emerged as an issue whether the NHIS exercises the right to indemnit. The judiciary questioned whether they were eligible to claim from the NHIS, not from patients under the Product Liability Act. On the morning of the 10th, the 21st Division of Civil Affairs of the Seoul Central District Court proceeded to a lawsuit for the existence of a debt filed by 36 pharmaceutical companies, including Daewon Pharmaceutical, against the NHIS. It was the first trial on the right to indemnify Valsartan. Previously, the NHIS requested ₩2.1 billion worth of compensation from 69 pharmaceutical companies related to the Valsartan case in July last year. The reason was that the pharmaceutical company should take responsibility for the health care finances being invested due to Valsartan. Accordingly, 36 companies, including Daewon Pharmaceutical, filed a lawsuit against the NHIS for the existence of debt. The intention was that there was no need to fulfill the right to indemnify the NHIS. It was argued that impurities were detected irresistibly even though pharmaceuticals were manufactured in a legal process not only domestically but also globally, and it was excessive to ask pharmaceutical companies to be liable for compensation as the impurities were recognized with the development of science. In the first trial, the qualifications of the NHIS were the main issue. The judge asked, "If a pharmaceutical company sells medicines, the NHIS buys them directly?" It was a question asking whether the NHIS, not the direct buyer, was entitled to claim the right to indemnify. In response, the NHIS replied, "If a patient receives a diagnosis, prescription and takes medicines, it can be a buyer because it pays money in the form of reimbursement in the end." The plaintiff, Daewon Pharmaceutical, gave the NHIS tit for tat. Daewon Pharmaceutical said, "The defendant is said to be the final and ultimate buyer, but it is impossible under civil law. The NHIS is not entitled to claim." The judge asked again that it was only partially supported by the health insurance system for the patient's purchase of medicines according to the claims of the NHIS, and wasn't that the party?" Then, the NHIS said, “As the patient stopped taking medicines, they began to use generic substitution, and damage occurred to the NHIS accordingly. Under the Product Liability Act, the qualification to claim (reimbursement rights) is not a 'consumer' but a 'victim'. However, how to interpret the victims specified in the Product Liability Act was no longer covered in this trial. In the next trial, a fierce legal dispute between the plaintiff and the defendant is expected over the interpretation of the victim under the Product Liability Act. The next trial is scheduled for 11 AM on November 19th.
