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- 2026-04-15 18:24:24
- “Developing lazertinib as dramatic as movie production”
- by Moon, sung-ho Feb 04, 2021 06:09am
- The developer of South Korean-made lung cancer new drug Leclaza (lazertinib), Professor Cho Byoungchul at Yonsei Cancer Center compared his dramatic five-year journey of seeking South Korea’s Ministry of Food and Drug Safety (MFDS) approval on the drug as a movie production; discovering the candidate substance was a casting call, clinical finding presentation was a premiere and lastly, the authorization was the grand opening. Based on a young director’s unique perspective and passion, a work worthy of the global spotlight was complete. In the end, the drug was licensed out to a global pharmaceutical company and won the South Korean health authority’s clearance. Like how a nameless director emerges as an international star director, Professor Cho is now a principal investigator (PI) of global clinical trial backed by his performance so far. #"Lazertinib was my destiny, it would be a role model for developing a new drug" Lazertinib he developed is a third-generation oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that highly selectively targets EGFR T790M mutation. Recently, MFDS has authorized lazertinib, with condition to provide further clinical evidence, as a treatment in EGFR T790M mutation-positive patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Professor Cho Byoungchul has been leading the development and clinical studies of lazertinib from the time when Yuhan Corporation licensed in the candidate medicine from a South Korean bio venture Oscotec at the pre-clinical phase in 2015. The professor said it like he was destined to encounter the candidate medicine at an early stage. Professor Cho reminisced and commented, “I was offered to lead the clinical trial, when the drug was still a candidate medicine in 2012, but I had to turn it down because the lab was too small and the company offering the job could not afford the entire project. But in 2015, I visited Yuhan Corporation’s central R&D lab invited by Professor Nam Soo Yeon, and I thought it was a destiny to receive the clinical study offer again there. For five years then on, I put my everything into the research and the result is now out finally.” Besides the romantic metaphor, the professor faced a number of challenges to this date. The biggest shake-up of the new drug development process was the news of a competing drug obtaining the National Health Insurance (NHI) reimbursement in South Korea. After receiving the market authorization in May 2016, another third-generation EGFR TKI Tagrisso (osimertinib) by AstraZeneca was listed for reimbursement in December 2017, with a second-line treatment indication lazertinib was also targeting for. Currently, AstraZeneca is negotiating with South Korean health authority like the Health Insurance Review and Assessment Service (HIRA) to expand Tagrisso’s reimbursement as a first-line therapy. Basically, when lazertinib was trying out for the South Korean market, the competitor was already working on indication expansion from second-line to first-line. Professor Cho confessed the devastating year 2017, when Tagrisso got the NHI benefit, demotivated him the most. “I remember experiencing the biggest challenge in the clinical studies as Tagrisso received the NHI reimbursement. Our registration for clinical participants was excruciating. I was deeply concerned that the company would lose its motivation in the pipeline. Lazertinib’s Phase I only started when the competitor was conducting a Phase III, and so many were pessimistic that the drug development was too late already,” he elaborated. "Lazertinib’s global clinical study to confirm efficacy and safety as a first-line treatment” Currently, lazertinib is in process of conducting a global Phase III trial (LASER301) to overcome the limitation of the conditional approval. The Phase III trial aims to evaluate the potential of lazertinib as a first-line treatment in 380 patients with EGFR mutation-positive NSCLC. At the moment, 27 hospitals, including Severance Hospital, Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital and Seoul Asan Medical Center, are participating in the clinical trial. Also, the drug is conducting another Phase III trial as a combination therapy with a bispecific antibody anticancer treatment amivantamab developed by a multinational pharmaceutical company Janssen. # Professor Cho explained, “Lazertinib’s efficacy and safety have to be confirmed as a first-line treatment. It would be directly compared against a first-generation Iressa (gefitinib). We also have to conduct a head-to-head clinical trial comparing lazertinib plus amivantamab combination therapy against Tagrisso to confirm progression-free survival (PFS).” He also noted Tagrisso and lazertinib should also step away from a strict competitor relationship, but should rather come together as a mutual relationship to survive in the EGFR TKI market. He stressed, “I think lazertinib and Tagrisso should be good friends. Global pharmaceutical giants like Pfizer and Novartis have given up on the new drug development for various reasons, but think how unfortunate the lung cancer patients would be to have only one treatment. Considering all lung cancer patients, a wide variety of combination therapy is needed to provide more treatment options.” At the same time, he was confident to claim lazertinib does not shows notable difference between Asian and non-Asian races, which can be one of toughest challenges to overcome when shooting for the international market. The professor explained, “Regarding the treatment for advanced or metastatic NSCLCL, EGFR TKI would unlikely to show much difference in Asian and non-Asian races. Already there has been a study done to test the pharmacokinetics in different races, and I do not see much of a difference in efficacy. The ongoing LASER301 study would also give more detailed answer to the question.” Finally, Professor Cho also gave a personal view on the lazertinib pricing procedure to follow after the conditional approval. He firmly argues there should not be a discount for being a home-grown new drug. He emphasized, “Considering the level of efficacy and safety lazertinib performs, it should be priced on par with Tagrisso until the Phase III trial outcome is out. Basically, the health authority should not press for a discounted pricing, only because the drug is made in Korea. The people of the country worked on the drug and even a global company licensed out the technology. Based on the new drug development infrastructure in Korea, they should properly acknowledge the value of the drug.”
- Company
- Eisai Parkinson’s disease drug Equifina listed and launched
- by Eo, Yun-Ho Feb 04, 2021 06:08am
- Eisai’s Parkinson’s disease treatment Equifina has been released to the South Korean market on Feb. 2 with the National Health Insurance (NHI) reimbursement. The Ministry of Health and Welfare (MOHW) notice issued on Jan. 29 granted the NHI benefit on Equfina (safinamide) as an adjuvant treatment to levodopa for idiopathic Parkinson’s disease patients, as well as the nursing insurance reimbursement for using the drug within its approved label and general principles of anti-Parkinson’s disease treatment. South Korea’s Ministry of Food and Drug Safety (MFDS) authorized the treatment on June 24, 2020, as a once-daily oral add-on therapy to levodopa for patients with Parkinson’s disease. A new third-generation monoamine oxidase B (MAO-B) inhibitor, working dual mechanism on dopaminergic and non-dopaminergic neurotransmission, Equfina conducted a Phase III trial and demonstrated a significant efficacy in Parkinson’s disease patients with motor fluctuation. Mostly, levodopa is used as a standard of care in Parkinson’s disease, but the drug has reportedly shown 75 percent risk of complications when used for over five years. And apparently, Equfina, as an add-on to levodopa, increases the drug effect period that could wear off if administered for a long term. A Phase III SETTLE study evaluated the efficacy and safety of Equifina in patients with Parkinson’s disease showing motor fluctuation symptoms, and confirmed the drug significantly improving the “on” time in patient group who have taken the drug for 24 weeks, compared to the placebo group. Equifina has also proved to reduce the “off” time of levodopa, and shortened the “off” time of the other combined drug regardless of the drug type or severity of the motor fluctuation symptoms. In the SETTLE study, the Parkinson’s Disease Questionnaire (PDQ-39) was given out to the participating patients to assess their quality of life, and the group administered with 50-100 mg per day showed changes of -3.17 from the baseline, which was an improved result compared to -0.68 in the placebo group. Another Phase III trial, Study 016 also found statistically meaningful result of PDG-39 in Equifina-administered group (100 mg) compared to that of the placebo group. Particularly in the mental wellbeing questionnaire, the Equifina group’s changes from the baseline to week 24 marked -5.14, which improved compared to the placebo group. CEO Koh Hong-byung of Eisai Korea noted, “By releasing Equifina, I am happy to provide a new treatment option to Parkinson’s disease patients in South Korea, who were short of treatment options. And as we launch the drug with the healthcare benefit, we hope to lessen the financial burden on those patients in South Korea.”
- Company
- Stomach ulcer drug rebamipide market makes over KRW 100 bln
- by An, Kyung-Jin Feb 03, 2021 06:10am
- The impurity contamination in ranitidine was discovered in 2019 has in turn expanded a gastritis treatment rebamipide market. Although the market was sluggish for a long time, rebamipide prescription surged and broke through the 100 billion won point last year. The impurity contamination incident impacted the entire stomach disorder drug market including H2 receptor antagonist, proton pump inhibitor (PPI) and wormwood-induced natural medicine. A pharmaceutical market research firm UBIST reported on Feb. 2, the rebamipide prescription market last year generated 110.6 billion won, growing by 14.8 percent compared to the year before. The market’s annual growth has been stagnating around 4 percent, marking 85.4 billion won, 88.2 billion won and 91.9 billion in year 2016 through 2018, respectively. But the figure soared 20.4 percent last year compared to two years ago. Rebamipide treats gastroduodenal ulcers by increasing the blood flow in the stomach mucous to protect them. The substance is also indicated to treat stomach ulcer and enhance mucosal defense. About three decades ago, Korea Otsuka Pharmaceutical released an original Mucosta, and 239 generics entered the market since 2003. Regardless of the expanded options, the prescription volume did not change significantly. But similar to PPI and wormwood-induced natural medicine, the industry experts say the rebamipide market benefited from the impurity contamination incident. The South Korean Ministry of Food and Drug Safety (MFDS) banned the sales of all products of H2 receptor antagonizing antiulcer drug ranitidine due to unacceptable amount of cancerous N-Nitrosodimethylamine (NDMA) found in late September 2019. Ranitidine drugs used to form a large market making about 180 billion won annually as of 2018. But the overall sales ban drove the prescribers to seek after other drugs with similar indications. The analysis on quarterly prescription volume of rebamipide found the volume started increasing from the fourth quarter of 2019. In the third quarter of 2019, the rebamipide drug prescription generated 21.5 billion won only, but it leapt to 29.6 billion won as of 2019 fourth quarter. Although patients avoided visiting hospitals amid COVID-19 last year and the general prescription volume faltered, the quarterly rebamipide prescription volume was maintained at around 27 billion won. The prescription volume by item showed fluctuating differences. Generally, the generics had more significant increase in prescription. The original Mucosta’s prescription fell 5.5 percent last year, despite making 17.3 billion won, compared to the year before. The best-selling generic Samjin Pharm’s Bamedin prescription also fell by 3.3 percent last year compared to the previous year and marked 4.6 billion won. Meanwhile, Huons’ Mucoramine prescription soared by 61.9 percent compared to the year before and narrowed the gap with Bamedin. KyungDong Pharmaceutical’s Rebamide prescription volume grew 11.8 percent from the year before and marked 3.8 billion won, when CMG Pharmaceutical’s Remipid and Celltrion Pharm’s Rebat grew by 11.3 percent and 35.8 percent, respectively. The industry projects the rebamipide market competition would get even more intensified this year with extended release products launching. Four South Korean companies like Yuhan Corporation, GC Pharma, Daewoong Pharmaceutical and Daewon Pharmaceutical won the health authority’s approval on extended release rebamipides late last year. And the authority also granted approval on Korea Otsuka Pharmaceutical’s Mucosta SR tablet last month. Although some of their indications differ from each other a bit, the administration convenience improved from three times a day to twice-daily.
- Company
- Pfizer's Vizimpro can be prescribed at general hospitals
- by Eo, Yun-Ho Feb 03, 2021 06:09am
- Pfizer's EGFR TKI and Vizimpro are now available in general hospitals with insurance benefits. According to related industries, Vizimpro (Dacomitinib monohydrate), a second-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), listed in December. It passed the drug committee (DC) of general hospitals such as International St. Mary's Hospital, Chonnam National University Hwasun Hospital, NCC, SMC, KCCH, Konyang University Hospital, Kosin University Gospel. Hospital, and Pusan National University Yangsan Hospital. Vizimpro is a second-generation EGFR mutant-positive non-small cell lung cancer targeted anticancer drug that was designated as a priority review by the US FDA in January 2018 and was approved in September of the same year. Currently, it is prescribed in the United States, the European Union, and Japan. Vizimpro was approved in Korea as a first-line treatment for locally advanced or metastatic EGFR mutant non-small cell lung cancer in February this year. It has indications for the treatment of locally advanced or NSCLC (Non-Small Cell Lung Cancer) with an EGFR exon 19 deletion or exon 21 L858R substitution mutation with no previous experience. In Korea, the first-generation drug AstraZeneca's Iressa (Gefitinib), Roche's Tarceva (Erlotinib), Giotrif (Afatinib), and AstraZeneca's Tagrisso (Osimertinib). EGFR TKI is being prescribed, and Leclaza (Lazertinib) was recently approved. Giotrif, a competing drug has already settled in the market, Vizimpro chose a track to skip drug price negotiations. It passed the HIRA's Cancer Drugs Benefit Appraisal Committee in July last year, passed the Pharmaceutical Benefits Advisory Committee in October, and succeeded in listing in December. From this year, fierce competition among the first and second generation EGFR TKIs is expected for the first line therapy for non-small cell lung cancer. The listing of insurance benefits in the first-line therapy of Tagrisso and Leclaza is also of interest. The effectiveness of Vizimpro was proven through ARCHER 1050, a phase III clinical trial. The study directly compared Vizimpro with the first-generation drug IRESSA((Gefitinib), and a total of 452 non-small cell lung cancer patients were enrolled. As a result, Progression-Free Survival (PFS) reduced the risk ratio by 41% compared to Iressa, and the median PFS value was 14.7 months for Vizimpro, ahead of 9.2 months for the Iressa group.
- Policy
- Re-evaluation of benefits, scheduled to be conducted annuall
- by Kim, Jung-Ju Feb 03, 2021 06:09am
- At the end of last year, the government is about to begin the main evaluation of the five active ingredients following the pilot project of reevaluation of the adequacy of registered drugs for Choline alfoscerate (reevaluation of the benefits of registered drugs). It seems to have taken into account the time taken for the procedure, such as review and re-evaluation, review of the Pharmaceutical Benefits Advisory Committee, and report to the Health Insurance Policy Review Committee. The government (insurer) plans to prepare a system for recovering drug costs for damages in the first half of the first half of the first half of the year in relation to the increase in administrative litigation, which has become more controversial due to the suspension of execution of choline alfoscerate. Yang Yoon-seok, head of the health insurance department of the Ministry of Health and Welfare, reported the reevaluation plan as a negative agenda at the 2nd plenary meeting of the 2021 the Health Insurance Policy Review Committeeon the afternoon of the 29th, and then met with the Korea Special Press Association to explain the government's position. He said, "I know the pharmaceutical bio industry is struggling with the re-evaluation of registered drug benefits," and "It will be conducted on an annual basis, but in the long term, we are also seeking a plan to evaluate it every 4 to 5 years (regularly). " The following is the contents of questions and answers with Yang. ▶ It is understood that it reported to the Health Insurance Policy Review Committee that a plan to compensate for financial losses due to suspension of execution was prepared in the first half of the year. Please explain this. “The government is aware of the problem of benefits due to the suspension of execution. Last year, the National Assembly also pointed out this issue. Measures to improve the system (which allow the reimbursement of drug costs, etc. paid during the suspension of execution) is being reviewed internally. We are not in the process of making any specific disclosures yet.” ▶ The contract to redeem the Choline alfoscerate drug has not been negotiated since 56 pharmaceutical companies filed lawsuits. The deadline is until the 10th of this month, are there any plans to extend the negotiation deadline in consideration of the litigation situation? "The negotiation period has not been completed yet. I think the NHIS will proceed with the negotiations as much as possible within the deadline. It will report the status of the negotiations after the negotiation period is over, and I will review the details and review again. " ▶ If the system is improved, is it a premise to amend the law? "Improving the system doesn't mean amendment of the law." ▶ Last year, the NHIS conducted a research on this. Do you proceed based on the result? "I'll refer to that, but how to actually legislate is a matter for the government to review and decide." ▶ Does it mean to proceed with government legislation? "The form of legislation has not yet been decided." ▶ This is a question about the reevaluation of the five ingredients that will be notified to the pharmaceutical company this month. The re-evaluation plan has been reported to the committee, please tell me the direction of the future. "It seems that the third quarter will have to go through the process of re-evaluating all five ingredients. Eventually, the re-evaluation will not be able to proceed in an annual cycle. Therefore, it can be considered that the process is being carried out in an annual plan." ▶ Do you have anything else to comment? "Last year, I had a lot of motivation and ambition as the head of the insurance drug department, but I had a lot of difficulties with COVID-19. Re-evaluation of benefits would be an inconvenient issue for the pharmaceutical industry. However, when applying benefits, it is correct to provide effective medicines to the public when applying benefits. Although it is currently undergoing annual evaluation, it is also seeking a plan for a long-term evaluation for the next four to five years, and a series of lawsuits filed by companies are guaranteed rights under the constitution, that's why a full legal review will be needed for the (under review) redemption bill."
- Company
- Menarini Korea presents Fulcare's digital campaign video
- by Feb 03, 2021 06:09am
- Fulcare’s new digital campaign capture Menarini Korea (CEO Hyeyoung Park) announced on the 2nd that it is releasing a new digital campaign video 'Re, Start Again' of Fulcare, a treatment for nail athlete's foot. The new campaign was planned as part of Fulcare's brand campaign 'Clear Again' from 2020. By emphasizing the keyword 'again' by focusing on 're' at the back of Fulcare's English spelling, it tried to deliver a message of support to consumers to overcome COVOID-19 and start again in the new year. The video for the new digital campaign was produced in two versions, 'Exercise Edition' and 'Hobby Edition'. In the daily life that had been withdrawn from COVID-19 for a while, it contained a message to regain healthy and clear nails with Fulcare's triple solution, along with narration and video to start over with small movements or hobbies. At the end of the video, a message was added to support the Korean pharmacists who are working in the field to take responsibility for the health of the local community despite the difficult situation of COVID-19. The new video was released on various online media including Fulcare's YouTube channel from the 1st. Menarini Korea marketing manager said, "Our daily life has changed over the past year due to the COVID-19 Incident. We will be conducting this campaign with the aim of re-starting the new year of 2021 with Fulcare hopefully. In 2021 we hope that Fulcare's triple solution, which has strengths 1, 2, and 3 for penetration, protection, and growth promotion, for patients in need of treatment for athlete's foot will be able to recover their daily life from athlete's foot and clear nails." Fulcare is OTC that can be purchased at pharmacies. Fulcare's own global patented technology, ONY-TEC technology, has the convenience of applying once a day without the need to grind or wipe the nails, making it easy to manage athlete's foot. It has been strengthening its position as a brand specializing in athlete's foot by launching 'Fulcare Plus Cream', a special treatment for athlete's foot.
- Product
- Frequently consumed OTC drug prices differ in pharmacies
- by Kang, Shin-Kook Feb 03, 2021 06:09am
- The price gap of Tyrenol ER, Gelfos and Tak-Sen widened up to 150 percent among different pharmacies selling the drugs, which contrasted against high-priced bundle-packaged drugs showing barely any gap. Daily Pharm surveyed 22 pharmacies in Incheon for their frequently sold over-the-counter (OTC) drug retail prices as of February, and it found Tyrenol ER Tablet (6 tablets per package) is sold at maximum 2,500 won and minimum 1,600 won showing around 156 percent, or 900 won difference in prices. The average price for the product is 2,176 won. Gelfos M Suspension (4 packets per package) is sold at maximum 4,500 won and minimum 3,000 won, which also showed about 150 percent, or 1,500 won difference among pharmacies. The average is at 3,940 won. Average priced at 2,976 won, Tak-Sen Soft Capsule (10 tablets per package) are sold at maximum 3,000 won and minimum 2,000 won with 1,000 won (150 percent) price gap. A bundle of Insadol Plus Tablet (100 tablets per package) is priced at maximum 34,000 won and minimum at 31,000 won with an average price of 32,000 won. Insadol’s competitor Igatan F Capsule (100 tablets per package) is also similarly priced at maximum 34,000 won and minimum at 30,000 won showing insignificant price difference among pharmacies. Igatan’s average price is 32,500 won. The pharmacies seem to have found the stabilized price for Aronamin Gold Tablet (100 tablets per package) as they are sold at maximum 28,000 won and minimum at 24,000 won. Also Beecom-C Tablet and Comp Urusa Tablet’s price gap among pharmacies are 4,000 won and 3,000 won, respectively. .Ranging from 70,000 won to 50,000 won, B-max Meta Tablets (120 tablets per package) are sold with about 20,000 won difference (140 percent) .And Impactamin Premium Tablet (120 tablets per package) prices ranged from 60,000 won to 50,000 won with 10,000 won gap .The drug’s average price is 59,000 won .Meanwhile, there are frequently consumed drugs with no price gap .Low-priced drinks like Gas Whal Myung Su-Q and Benachio-F Solution had no price difference across all pharmacies .The detailed OTC drug prices across the Incheon region surveyed by Daily Pharm can be found in the following website: (Click HERE for the website) Daily Pharm monthly surveys and discloses frequently consumed OTC drug prices to promote stabilized pricing of the OTC drugs .As frequently consumed OTC drugs are sold with low margin rate, the fair pricing of these drugs is an integral issue for the pharmacist society .Even regional pharmacist organizations are campaigning ‘Fair Pricing for OTC Drugs.’ To make frequently consumed OTC drugs a boost for pharmacy business and not marketing bait for consumers, the fair pricing with adequate rate of margin should be enforced .
- Company
- Profitable lazertinib makes 5-year income for Oscotec
- by An, Kyung-Jin Feb 02, 2021 06:25am
- Product image of Leclaza For last couple of years, Oscotec has generated 57 billion won from licensing out a new drug candidate. The South Korean company earned more than five years of income by selling a profitable new drug candidate to Yuhan Corporation. On Jan. 26, Oscotec announced Yuhan Corporation would pay out USD 22.1 million (approximately 24.8 billion won) out of the license-out milestone payment received from Janssen Biotec. The expected transaction would be processed within three months from the official announcement. The company explained, “The income is from the epidermal growth factor receptor (EGFR) targeted therapy candidate license-out deal signed with Yuhan Corporation in 2015. 40 percent out of the total milestone payment would be paid out to both Oscotec and a subsidiary company Genosco.” The payment Oscotec announced is for Janssen reaching the milestone of administering the combination of the company’s own dual anticancer treatment amivantamab and an EGFR targeted therapy lazertinib licensed in from Yuhan to initiate a Phase III trial. Lazertinib is the main substance of Yuhan’s non-small cell lung cancer (NSCLC) treatment Leclaza approved as the 31st new drug developed in South Korea. Oscotec and its subsidiary Genosco inked 1.5 billion won worth of a license-out deal with Yuhan in July 2015 for the EGFR targeted therapy candidate lazertinib. Within 30 days of the contract signing, the upfront payment of 1 billion won was received, and 500 million won is to be paid out after Yuhan’s Phase I clinical protocol is cleared. In the contract, Yuhan added a term to split the income 60 to 40 for the upfront payment and the clinical milestone payments from the global pharmaceutical company licensing out the candidate medicine. Yuhan took over the development rights on lazertinib in the preclinical trial phase, and licensed out the drug in November 2018, after optimizing the substance, designing the pipeline and undergoing the preclinical and clinical trials in South Korea. The deal is valued at maximum 1.26 billion dollars (approximately 1.5 trillion won) covering the initial contract payment of 50 million dollars and phase-by-phase milestone payments. Yuhan has earned total of 150 million dollars for last two years from licensing out lazertinib. Janssen provided 35 million dollars for achieving the milestone of initiating the global Phase I/II trial with a combination of amivantamab and lazertinib in last April. Also another 6.5 million won was given to Yuhan in last November for starting a global Phase III trial on the combination therapy. During the process, Oscotec also improved its income significantly. Oscotec received the upfront payment of 17 million dollars from Yuhan as the Janssen’s upfront contract payment went through in 2018. And as of the second milestone, additional 34 million dollars were paid out from splitting the income. The lazertinib license-out deal basically generated 51 million dollars (approximately 57 billion won) in last two years for the initial contract and further development. In five years from 2015 through 2019, Oscotec has made 48.9 billion won. The license-out deal signed six years ago generated more than the five-year income in just two years. The industry highly anticipates positive effect in Oscotec’s income structure based on lazertinib progressing smoothly. Janssen is also expediting the global Phase III clinical trial on amivantamab and lazertinib combination as the company confirmed a positive outcome during the initial clinical trial. In last December, the company applied for amivantamab Biologics License Application (BLA) to the U.S. Food and Drug Administration’s (FDA), and it also aims to complete the New Drug Application (NDA) for lazertinib by 2023. Besides Janssen’s progress, Yuhan is also independently conducting a global Phase III trial on lazertinib.
- Policy
- Samyang Biopharm started to develop generic for Votrient
- by Lee, Tak-Sun Feb 02, 2021 06:25am
- It was found that a domestic pharmaceutical company started developing Votrient’s generic for Novartis' blockbuster kidney cancer treatment. Generic for Votrient is attracting attention in that there are no commercialized items yet. The MFDS approved the bioequivalence test protocol of Samyang Biopharm’s SYO-1987 on the 28th of last month. Samyang Biopharm is expected to demonstrate equivalence with Novartis' reference drug in a bioequivalence study. This reference drug is used for ▲progressive renal cell carcinoma, and ▲progressive soft tissue sarcoma (the efficacy and safety of this drug in patients with liposarcoma or gastrointestinal stromal tumors have not been proven) previously administered chemotherapy. The drug with this indication is Novartis Korea's Votrient (Pazopanib), a kidney cancer treatment approved by GSK in Korea in 2010, and Novartis owns the copyright as GSK's anticancer drug was sold to Novartis. Advanced kidney cancer treatment is a drug that competes with existing Sutene (Sunitinib, Pfizer) and has become a blockbuster. according to IQVIA, the sales amount in 2019 was ₩13.2 billion, and in the first half of last year, it recorded ₩6.7 billion. Votrient's re-examination expired in August 2016, and the patent is also expected to end on July 24, 2022. With the introduction of generic exclusivity in 2015, domestic pharmaceutical companies challenged the patent through a trial to invalidate the extension of the term, but it was withdrawn or invalidated. This is because they challenged without a strategy. Since then, there has been no news about the development of generics. Samyang Biopharm is a company that focuses on localizing anticancer drugs, and also owns blockbuster products such as Genexol (Paclitaxel). When a generic for Votrient is developed, it is expected to be supplied at a lower price, reducing the economic burden on patients.
- Company
- COX-2 inhibitors recover and grow 56% in 5 years
- by Kim, Jin-Gu Feb 02, 2021 06:25am
- The prescription volume of cyclooxygenase-2 (COX-2) inhibiting nonsteroidal anti-inflammatory drugs (NSAIDs) seems to be increasing rapidly. A major product Celebrex (celecoxib) had its pricing cut by half after its patent was expired in 2015, but the prescription volume soared by 56 percent in five years until last year. The industry experts say the increased prescription frequency canceled out the decreased pricing. While the original Celebrex is still going dominating the market by annually making 40 billion won, 100 or so generics have doubled the prescription volume in five years and made a 65-billion-won market. However, other follow-on originals like Acelex (polmacoxib) and Arcoxia (etoricoxib) are making disappointing performance with narrow indication. ◆Half-priced COX-2 inhibitor prescription volume soars by 56% On Jan. 28, a pharmaceutical market research firm UBIST reported the COX-2 inhibitor NSAID market reached the volume of 112.9 billion won as of last year. Compared to 113.5 billion won recorded in 2019, the market shrunk by 1 percent, but considering the last six years, the market has been growing at a remarkable rate. The market size marked 72.3 billion won in 2015 grew by 11 percent, 7 percent, 19 percent and 11 percent in 2016 at 80.2 billion won, 2017 at 85.8 billion won, 2018 at 102.2 billion won and 2019 at 113.5 billion won, respectively. Except for 2017, the market has been making a two-digit growth annually until 2019. Considering the star product of the market Celebrex got its pricing halved to 53.55 percent since the patent expiration in June 2015 and a series of generic launched at similar pricing, the prescription volume itself has almost tripled. ◆20 years in South Korean market, Celebrex still generated 40 billion won The market is predominantly filled with celecoxibs. As of last year, the original Celebrex and celecoxib generics took up 36 percent and 57 percent of the market, respectively. In fact, Celebrex’ market presence is still substantial as it made 40.6 billion won last year, regardless of the patent expired five years ago. Although compared to the previous year (44.3 billion won), the prescription volume dropped 8 percent, but the market experts analyze it was due to the drug’s temporary shortage. Celebrex was out of stock for about two months last year due to delayed manufacturing schedule from February. Launched for the South Korean market in 2000, Celebrex prescription volume peaked in 2014 with 70 billion won. But the volume plummeted to 58.8 billion won the following year as the patent expired, and it continued to drop to 40.2 billion won and 36.5 billion won in 2016 and 2017, respectively. Mainly the generics entering the market and pricing cut caused the steep drop in the volume. Since 2018, however, the drug gained back the prescription volume up to 40 billion won. Releasing higher dose, expanding indication and healthcare providers’ high demand for the original seem to have affected the recovery. As the generic pricings were leveled with the off-patent original, the healthcare providers are firmly demanding for the original. ◆Over 100 generics released, the prescription volume doubles in five years Celebrex generic prescription volume was doubled in just five years. As soon as the patent expired in June 2015, 60 companies released their celecoxib generics. And as of late last year, over 100 companies are apparently supplying generics. The total prescription volume of the generics was at 64.9 billion won. Compared to 32.1 billion won in 2016, it is more than twice as much. While the COX-2 inhibitor market volume shrunk by 1 percent last year, the generic prescription was increased by 7 percent. The top selling generics were as follows; Samjin Pharm’s Klicox (4.2 billion won), Hanmi Pharmaceutical’s Coxib (4.2 billion won), Korea Arlico Pharm’s Celcobrex (3.5 billion won), Chong Kun Dang’s Coxbito (3.1 billion won), and Hutecs Korea Pharmaceutical’s Cybrex (2.5 billion won). ◆Original Acelex and Arcoxia generate below 5 billion won each Other original COX-2 inhibitors—Acelex and Arcoxia—are showing rather underwhelming performances. Acelex is a domestically developed new drug by Crystal Genomics. It emerged to the market in August 2015 and Dong-A ST handles the local sales. The two companies have signed a 8.5-billion-won exclusive local sales deal. But from 2018, Daewoong Pharmaceutical joined the force to accelerate the Acelex sales. The company was in charge of small and medium hospitals with 300 and less beds, whereas Dong-A ST marked general hospitals. Acelex’ prescription volume was at 4.2 billion won, 5.8 billion won, 4.9 billion won and 5.5 billion won in 2016 through 2019, respectively. The volume plummeted by 24 percent last year and made only 4.2 billion won. MSD’s Arcoxia is also underperforming. Ever since an older version of COX-2 inhibitor Vioxx was delisted from the market due to adverse reaction reports, MSD ambitiously launched Arcoxia as a follow-up. To avoid concerns on safety, the multinational company also conducted a clinical trial in South Korea as well. But its prescription generated 3.7 billion won, 5.7 billion won, 5.6 billion won, 3.4 billion won and 3.3 billion won in 2016 through 2020. The industry says the two originals’ limited indications are widening the prescription volume gap between Celebrex, and Acelex and Arcoxia. Currently, Acelex and Arcoxia are only indicated to treat osteoarthritis, when Celebrex is indicated to treat rheumatoid arthritis, ankylsoing spondylitis, primary dysmenorrheal and acute pain.
