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- Korean companies to showcase clinical data at ASCO 2020
- by An, Kyung-Jin May 14, 2020 06:24am
- A view of ASCO 2019 from last year in Chicago The American Society of Clinical Oncology Annual Meeting (ASCO) 2020 is coming up in a couple of weeks. The 56th ASCO is one of the biggest pharmaceutical and bio industry events along with JP Morgan Healthcare Conference. Every year, about 40,000 pharmaceutical and bio industry and academic representatives are invited to the conference in Chicago from 76 countries around the world to see the up and coming research trends and technologies. For five days from May 29 to June 2 local time, thousands of new anticancer treatment clinical results are scheduled to be presented, virtually. Affected by the COVID-19 pandemic, the organizer of the event has announced the event would be held online. On May 3, the organization official stated, “Due to the COVID-19 pandemic, all events of ASCO 2020 would be conducted virtually in late May. Putting the safety of oncology researchers and their patients first, the online presentations would be provided according to the announced schedule.” Korean pharmaceutical companies like Yuhan, GC Pharma, Genexin Hanmi Pharmaceutical and Alteogen are planning to unveil data from their novel anticancer treatment in development at ASCO 2020 Virtual Scientific Program. At 5 p.m. local time on May 13, ASCO would publish their selection of research abstracts its website. In the poster presentation session, Yuhan is presenting three sets of clinical data related to a next-generation lung cancer treatment Lazertinib (YH25448). The data is collected from a follow-up study on the phase 1/2 study conducted in Korea, which was presented during the poster session in ASCO 2019. Three Korean healthcare provider participants—Professor Kim Sang-we (Seoul Asan Medical Center), Professor Han Ji-youn (National Cancer Center Korea) and Professor Lee Ki Hyeong (Chungbuk National University Hospital)—are to respectively provide detailed analysis and key findings in efficacy and safety of Lazertinib 240 mg in patients with epidermal growth factor receptor (EGFR) T790 mutation; Lazertinib’s antitumor effect on patients with non-small cell lung cancer (NSCLC) and brain metastases; and Lazertinib’s impact on circulating tumor DNA (ct DNA) in the bloodstream. Yuhan’s third generation EFGR-targeted therapy Lazertinib has been licensed out to Janssen Biotech in 2018. The novel anticancer treatment has been evaluated as a promising first-line treatment in patients with EGFR-mutation positive NSCLC and as a second-line option for EGFR T790-mutated patients with NSCLC. Yuhan has signed the joint development deal potentially worth USD 1.25 billion with Janssen Bitotech for all exclusive rights around the world, except in Korea. The Korean company has received upfront payment of 50 million dollars (approximately 56 billion won) and another 35 million dollars recently as the targeted therapy was a part of an initiated combination therapy clinical study with Janssen’s investigational anticancer treatment 'JNJ-372.' As a poster, GC Pharma is to present phase 1b/2a study outcome on its investigational drug ‘GC1118’ in joint development with Mogam Institute for Biomedical Research. The interim report analyzes outcome of combining GC1118 and other chemotherapies including irinotecan and FOLFIRI for treating patients with metastatic colorectal cancer (mCRC). The company is coming back to ASCO meeting in four years since 2016 to present the newest findings in the drug. GC1118 is a novel monoclonal antibody targeting overexpressed EGFR. By binding with EGFR that triggers proliferation of tumor cell and metastasis, the targeted therapy inhibits proliferating cancer while promoting killing of tumor cells by activating lymphocytes. The Korean company would showcase GC1118’s promising data as a second-line treatment option in EGFR mutation positive patients with metastatic colorectal treatment. Hanmi Pharmaceutical is planning to release various clinical data with a number of license out partners. The company’s U.S. partner Athenex is reportedly preparing for a presentation on phase 2 clinical study on Oraxol, developed based on Hanmi Pharmaceutical’s platform technology, Orascovery. The study has tested the anticancer treatment’s effect and safety in patients with unresectable cutaneous angiosarcoma. In December 2011, Hanmi Pharmaceutical has licensed out novel anticancer medicine candidate Oraxol to the U.S.-based Athenex (then named Kinex). The Korean company combined Orascovery platform technology to turn intravenously injected paclitaxel into an oral form, and enhanced the absorption rate by integrating an oral absorption enhancer, encequidar. The enhancer blocks off p-glycoprotein that inhibits oral absorption of anticancer treatment. With the upcoming ASCO presentation, the U.S. company plans to initiate the commercialization procedure of Oraxol. Last month, Athenex representative reportedly had a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) officials to fine-tune the application submission date. The company plans to expand the market scale in the future by adding more indications in treating metastatic breast cancer, angiosarcoma, gastroesophageal cancer, bladder cancer and NSCLC. Hanmi Pharmaceutical’s another partner, Spectrum Pharmaceutical is anticipated to present a new lung cancer drug Poziotinib, following the presentation at American Association for Cancer Research Annual Meeting (AACR) 2020. Similar to the prior presentation, the company would talk about the first cohort analysis from phase 2 global clinical study, ZENITH20 conducted on EGFR Exon 20 insertion-mutated patients with NSCLC. Poziotinib is a pan-HER2 anticancer therapy licensed out by Hanmi Pharmaceutical in 2015. The partner company, Spectrum now owns the development and commercialization rights over poziotinib in the global market, except for in Korea and China, and it has been seeking for the drug’s various oncologic uses including the treatment in NSCLC. Late last year, the company has gone through a detrimental experience as its stock price dropped by more than 60 percent after announcing it has failed to meet primary phase 2 trial endpoint. Regardless, the company reaffirmed its determination to press on with the pipeline by recently revising the research model. Other Korean biopharmaceutical companies are getting ready to give presentations at the ASCO 2020. Unveiling positive outcome in DNA vaccine 'GX-188E' at AACR 2020, Genexin is planning to present another set of clinical data in a combination therapy at ASCO 2020. The findings are from phase 1b/2 clinical study testing the hyleukin-7 plus immune checkpoint inhibitor Keytruda (pembrolizumab) combination therapy in patients with advanced triple-negative breast cancer (TNBC). Apparently, the TNBC advances faster than other types of breast cancer and shortens patient’s survival period. According to Genexin, the immune checkpoint inhibitor’s treatment rate in relapsed patients was recorded at around 5.2 percent. The company’s poster at ASCO 2020 would list out detailed outcome of enhancing TNBC patient’s treatment rate in different dosage of hyleukin-7 plus pembrolizumab. ASCO 2020 also selected the abstract of a first-in-human clinical study on Alteogen’s breast cancer treating antibody-drug conjugate (ADC) ‘ALT-P7.’ MedPacto is to reveal phase 1 clinical data testing a transforming growth factor beta (TGF-β) inhibitor vactosertib plus leukemia treatment Gleevec. NK Max reported it would publish phase 1/2a clinical study results in ‘SNK01,’ used to enhance anti-tumor effect in targeted therapy.
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- α-GPC has been prescribed more than twice in 3 years
- by Chon, Seung-Hyun May 14, 2020 06:23am
- Sales of Choline alfoscerate, a brain function improving agent, continue to grow. The effectiveness controversy has recently been raised, but the market size has increased by more than 20% this year. Over the past three years, the market size has doubled, exceeding the quarterly prescription size of ₩100 billion. However, the decline was slightly lower than in the fourth quarter of last year, and the upward trend was somewhat slow. According to UBIST, a drug research agency on the 6th, the outpatient prescription amount of Choline alfoscerate-based drugs in the first quarter was ₩109.9 billion, up 22.2% from the same period last year (₩89.9 billion). Choline alfoscerate is a drug used to improve brain function, such as decreased sense of memory and confusion and reduced concentration. The prescription amount of Choline alfoscerate has been increasing rapidly over the past few years. The total prescription amount in the first quarter of 2015 has more than tripled in 5 years from ₩34.7 billion. it has doubled comparing to the first quarter of 2017, three years ago. Since the prescription amount exceeded ₩100 billion in the third quarter of last year, it has been recording ₩100 billion for the third consecutive quarter. Quarterly outpatient Rx amount for Choline alfoscerate (Unit: ₩1 million, Source: UBIST) Despite the recent controversy over the effectiveness of choline alfoscerate, it continued to rise. 식품의약품안전처는 지난해 11월 제약사들로부터 콜린알포세레이트제제의 유효성 자료를 제출받았다. 허가사항의 효능·효과별 유효성을 입증하는 자료와 국내외 사용현황을 토대로 허가변경 여부를 검토하겠다는 의도다. 복지부도 콜린알포세레이트제제의 급여 타당성을 검토 중이다. The MFDS received data on the effectiveness of Choline alfoscerate formulations from pharmaceutical companies in November last year. The intention is to examine whether or not to change the permit based on data proving the efficacy and effectiveness of the permit, and the status of domestic and foreign use. The MOHW is also considering the feasibility of supplementing Choline alfoscerate. Since last year's government audit questioned the effectiveness of Choline alfoscerate formulations and spending on health insurance finances, it began to verify efficacy. In a state audit, In-Soon Nam, Democratic Party of Korea asked that we should promptly re-evaluate the clinical usefulness and efficacy of the Choline alfoscerate formulation and reasonably re-establish health insurance coverage standards.” Although Choline alfoscerate is not a drug that fundamentally treats dementia, it is analyzed that the market size has expanded rapidly as pharmaceutical companies have focused on the brain functioning market aimed at the rapidly growing elderly. However, compared to the previous quarter, the growth trend is somewhat slow. Prescription results for choline alfoscerate in the first quarter fell 0.2% from the fourth quarter last year. The market for Choline alfoscerate products has declined from the previous quarter for only two years since the fourth quarter of 2017. The industry has analyzed that the market growth has slowed somewhat due to COVID-19 outbreak along with the recent controversy over effectiveness. It is possible that the number of new patients has decreased as patients are reluctant to visit medical institutions, Looking at the prescription amount by item, Daewoong Bio's 'Gliatamin' recorded the highest prescription amount of ₩23.6 billion. It was 4.3% higher than the same period last year. Chong Kun Dang's 'CKD Gliatilin' recorded prescription results of ₩19.6 billion in the first quarter, up 7.9% from the previous year. Both the prescription amounts of Gliatamin and CKD Gliatilin were slightly lower than the previous quarter. Gliatamin's 1st quarter prescription amount decreased 3.2% from the fourth quarter of last year and CKD Gliatilin decreased 1.1% from the previous quarter. Yuhan's Alfoatilin, Korea Prime Pharm’s Gria, and Daewon Pharmaceutical’s Alfocholine were prescribed more than ₩4 billion in the first quarter with a growth rate of more than 15% compared to the previous year.
- Company
- Boryung, acquires domestic sales rights for Lilly's GemZar
- by Kim, Jin-Gu May 13, 2020 05:53am
- GemZarBoryung acquired the domestic right for the anticancer drug 'GemZar (Gemcitabine HCl)' held by Eli Lilly. Boryung announced on the 8th that it had signed a contract to transfer assets to Eli Lilly and Gemzar. Through this agreement, Boryung has all rights, including domestic rights and licenses of Gemzar. Boryung and Eli Lilly have been conducting 'Gemzar' co-promotion since 2015. Gemzar is widely used in pancreatic cancer, non-small cell lung cancer, bladder cancer, breast cancer, ovarian cancer, and biliary tract cancer. It is used alone or in combination therapy in primary and secondary treatment. As of last year, Gemzar's domestic sales totaled ₩14.2 billion (based on IMS). Boryung expects to strengthen its anticancer drug portfolio and maximize its market share and profit margin. Currently, Boryung has a high market share in the domestic anticancer drug market with Oxalitin (Oxaliplatin) and Genexol (Paclitaxel). As of the fourth quarter of last year, among domestic pharmaceutical companies, it ranked No. 1 in the market for anti-tumor drugs and immunomodulators. David A. Ricks, chief executive officer of Eli Lilly said "I hope this contract will help further improve the treatment performance of Korean cancer patients," Jae-Hyun Ahn, Boryung’s CEO, emphasized, "Boryung, which is building the best anti-cancer drug business in Korea, can strengthen the line-up of anti-cancer drugs and make more stable profits with this brand acquisition." He said, "In the future, we will strengthen our portfolio for the anti-cancer area as well as grow it as a representative business of Boryung through active investment such as open innovation."
- Company
- Itaewon club-linked COVID-19 threatens the industry
- by An, Kyung-Jin May 12, 2020 06:28am
- Seoul Square building in Jung-gu, Seoul The pharmaceutical industry is straining as the number of confirmed COVID-19 from Seoul Itaewon Club increases. Pharmaceutical companies in the Seoul Square building where COVID-19 confirmed patients visited Itaewon went into emergency telecommuting, and nearby pharmaceutical companies are also watching closely. According to the industry on the 11th, MSD Korea and Korea Mundipharma, who entered the Seoul Square building in Jung-gu, Seoul, entered an emergency telecommuting work on this day. This is due to the fact that an employee of Pernold Ricard Korea, a company that imports and distributes alcoholic beverages, was confirmed COVID-19 after a visit to the area near Itaewon in Seoul. Pernold Ricard Korea has an office on the 10th floor of Seoul Square. Seoul Square carried out quarantine of the entire building over the weekend and closed the 10th floor. The policy is not to close the entire building immediately, but to decide whether to close the building based on the results of the epidemiological investigation. On the 10th, MSD Korea and Korea Mundipharma, which had received notice of outbreak of confirmed cases, decided to carry out telecommuting for one day on the 11th and implemented their own quarantine. These companies have just started working in the office again, and are worried about whether they will return to work from home. MSD Korea has returned to normal business since the 27th of last month. The office workers work in the office, and the sales positions are made to be flexible depending on the workplace. Mundipharma has also applied its own guidelines to resume office activities as far as possible, while office workers go to the office three times a week from the end of April. Both companies are observing the trend for one day on the 11th and then deciding whether to go to work on the 12th through management meetings. Pharmaceutical companies that are not companies in Seoul Square are also watching carefully. Companies near the building with confirmed patients are more nervous. Beringer Ingelheim Korea is located in the Yonsei Severance Building, just next to Seoul Square. Employees of Boehringer Ingelheim are currently working normally on the 11th. Instead of switching to telecommuting right away, they are watching the occurrence trend of Itaewon's confirmed cases, including the news of the partial closure of the Seoul Square building. GSK and Janssen Korea, which have offices in Yongsan-gu, Seoul, do not have any changes in their attendance policy at this time. GSK ended telecommuting on the 6th and began to go to the office, and Janssen Korea has been applying for a policy to go to work every other day since the end of April. The two companies worked in telecommuting in February when a confirmed patient occurred in the office on the 16th floor of the same building. It is said that the situation is being watched by the spread of Itaewon club-linked COVID-19 and measures to close nearby buildings, but there are no plans to resume telecommuting at this time. The Yongsan LS Tower, where GSK and Janssen Korea resides, is located a 10-minute walk from the LG Uplus Yongsan office building, which was closed from the 11th. LG Uplus, a telecommunications company, shut down the Yongsan office building in Seoul for three days from the 11th, when an employee went to the Itaewon Club on the 10th and was confirmed positive. An official from the pharmaceutical industry said that the company attempted to resume sales marketing activities while switching to distancing in daily life, but concerns about COVID-19 re-proliferation are increasing. He said he was worried about going back to a month ago.
- Company
- Delay in choline alfoscerate reimbursement reevaluation
- by Kim, Jin-Gu May 12, 2020 06:28am
- Popular brand drugs with choline alfoscerate, Gliatamin and Gliatirin The sources speculate the Korean pharmaceutical industry’s hot potato, the reimbursement feasibility reevaluation on choline Alfoscerate would be postponed to the latter half of the year. On May 11, pharmaceutical industry sources reported the reimbursement reevaluation on choline alfoscerate has been pressed on since the last year’s National Assembly audit. Answering to Democratic Party Lawmaker Nam In-soon’s criticism on the underwhelming efficacy of choline alfoscerate during the audit session, the Minister of Health and Welfare Park Neung-hoo said, “The reevaluation would be promptly completed by June next year (2020).” From then on, the choline alfoscerate’s efficacy has been questioned increasingly. Ultimately, Health Insurance Review and Assessment Service (HIRA) convened a meeting for Drug Reimbursement Evaluation Committee (DREC) in last February addressing the plan to reevaluate the said substance. Seemingly, the reevaluation plan was close to being set on stone, but the committee meeting did not get to officially discuss over the subject, because it was addressed within ‘reporting agenda,’ not ‘deliberation agenda.’ Regardless, the table has turned as the novel coronavirus started spreading rapidly in Korea from March. As HIRA fully concentrated its capacity on COVID-19 treatment related work, other pharmaceutical affairs have been pushed aside indefinitely. After the February meeting, none of choline alfoscerate reevaluation related vis-à-vis meeting, expert consultation or pan-governmental collaboration have been progressed. Amid the pandemic, HIRA has confirmed ‘completing the reevaluation by June’ is practically impossible. On a phone interview with Daily Pharm, a HIRA official stated, “Due to the COVID-19 pandemic, it is true that [the discussion on the reevaluation] is getting delayed,” and “Since [the DREC meeting in] February, the government agency has not seen any progress on the matter. None of prospective scheduling has been set.” The official explained the agency would be unable to fully conclude the reevaluation within June as the actual time is running out, even if HIRA resumes the discussion immediately. For the reevaluation to rekindle the discussion and to proceed to reimbursement adjustment, the procedure would have to undergo consultation with industry officials, finalize the reevaluation decision, set detailed reimbursement standards, and have the Minister of Health and Welfare to notify the reimbursement standards. The overall procedure would take at least over a month. The pharmaceutical industry also gave a similar outlook. An industry official commented, “Technically, the government’s initial plan to reevaluate the substance in June is unlikely to happen,” and “The practical discussion could resume only in the latter half of the year.” The pharmaceutical industry seems to be relieved by the delayed talks on the reimbursement reevaluation. Prior to the outbreak, the industry officials have continuously requested the government to postpone the listed drug reevaluation. In March, the Federation of Korean Industries (FKI) claimed “The listed drug reevaluation should be postponed for a year.” And in April, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) again urged the government to “defer the listed drug reimbursement reevaluation.” Currently, Ministry of Food and Drug Safety (MFDS) and Ministry of Health and Welfare (MOHW) are respectively deliberating the choline alfoscerate reevaluation discussions. MFDS is contemplating on whether to remove a part of three approved indications during a Special Reevaluation session after the drug renews its item license. With HIRA, MOHW is considering on reducing reimbursement on some of the drug’s indications or switching the reimbursement type to selective reimbursement. As MOHW has constantly expressed negative stance on providing reimbursement on choline alfoscerate, the ministry would highly likely to reduce reimbursement on some of the three approved indications or to turn the reimbursement type into selective benefit. At the moment, choline alfoscerate has been indicated to treat patients showing secondary symptoms of cerebrovascular insufficiency and degenerative brain-organic psychiatric syndrome— impairment of sense of direction, motivation, judgment and concentration due to confusion and degenerated memory, judgment and motivation; changes in emotions and behaviors—emotionally insecure, hypersensitive to stimulation, and indifferent to surrounding; and senile pseudo-depression.
- Company
- Teva gave Celltrion ₩200 billion in copyright deposit
- by An, Kyung-Jin May 12, 2020 06:27am
- 허쥬마(왼쪽)와 트룩시마 제품사진 Celltrion group surpassed the exclusive rights of the two biosimilars in North America, and it was found that it generated a technology fee of nearly ₩200 billion. In a report submitted to the Securities and Exchange Commission (SEC) on the 7th (local time), multinational pharmaceutical company Teva revealed the history of a biosimilar copyright agreement signed with Celltrion Healthcare in the past. According to the report, the company confirmed that in October 2016, it paid out $160 million to Celltrion Healthcare under the condition of exclusive supply of 'Truxima' and 'Herzuma' in the United States and Canada. At the time, both products were subject to a condition of being refundable for $60 million of the down payment because they were prior to obtaining official approval. At present, both 'Truxima' and 'Herzuma' have been approved by the FDA and Health Canada, and their condition has expired when they start selling products. This is the first time that Celltrion Healthcare has revealed the amount of license revenue received from handing over biosimilars' exclusive overseas distribution rights. Celltrion Healthcare was an unlisted company when it signed an agreement with Teva, and did not disclose details of the contract. In the business report submitted to the Financial Supervisory Service by Celltrion Healthcare, only the timing of the contract (October 4, 2016) and distribution countries (USA, Canada, Puerto Rico) were mentioned for the 'Truxima' and 'Herzuma' supply contract' with Teva. The main thing to note in this contract is the size of the down payment. The $160 million secured by Celltrion Healthcare is the third largest among technology transfer contracts signed by domestic pharmaceutical bio companies. In 2015, three types of diabetic new drugs, which Hanmi exported to Sanofi, received the largest contract amount of €204 million. Hanmi's long-lasting obesity diabetes treatment drug ($105 million) was handed over to Janssen for the second largest down payment. SK Biopharmaceuticals signed a technology transfer contract with Able Therapeutics of Switzerland in February last year for a new drug candidate for encephalopathy, 'Cenobamate'. 'Truxima' is a biosimilar product of 'Mabthera' (Rituximab), a flagship product of multinational pharmaceutical company Roche. Mabthera is prescribed for autoimmune diseases such as rheumatoid arthritis, including blood cancer. In the U.S. alone, it is forming a market of about ₩5 trillion (based on 2018 IQVIA). Celltrion Healthcare and Teva were approved for FDA sales of Truxima in November 2018, and launched in the U.S. market starting in November 2019. In February this year, the product was launched in Canada. 'Herzuma' is a biosimilar product of Roche's anti-cancer drug 'Herceptin' (Trastuzumab), which is prescribed for breast cancer, stomach cancer, etc. Herzuma was approved by the FDA in December 2018, and began selling in the US in March this year. In Canada, it was released in January this year. Under the agreement, Teva and Celltrion Healthcare share revenue from product sales in the United States and Canada. An official of Celltrion Healthcare said, "The $ 160 million that Teva released was a pre-paid deposit when it signed a biosimilar license transfer agreement in October 2016. There was a provision that Teva would refund $ 60 million if it did not get FDA approval." "There is no obligation to return when we start selling locally." "Other details cannot be mentioned at a public expense," he said.
- Company
- Samsung Biologics, ranked No.1 in the market cap
- by An, Kyung-Jin May 11, 2020 06:19am
- Samsung Biologics (left) & Celltrion headquarters Samsung Biologics is taking third place in the market capitalization of KOSPI with the reflex profit of COVID-19. Difference in market capitalization with Celltrion is about ₩10 trillion, and it has been holding a position as a bio leading stock for 7 months. According to the Korea Exchange on the 8th, Samsung Biologics closed the transaction at ₩588,000, up 3.6% from the previous trading day. Compared to last year's closing price of ₩433,000, the stock price jumped 71.6% in five months. Celltrion's closing price on this day was ₩21,500, up 3.2% from the previous trading day. Although it increased 16.3% from the closing price last year, it did not significantly exceed Samsung Biologics' share price growth during the same period. Changes in market cap of Samsung Bioepis & Celltrion (Unit: ₩100 million, Source: the Korea Exchange) As of 8th, Samsung Biologics' market capitalization is ₩38.90 trillion, ranking third in the KOSPI market. It surpassed Celltrion's market capitalization of ₩28.36 trillion by more than ₩10 trillion, recording the largest market capitalization among pharmaceutical bios. Samsung Biologics' market ranking dropped to 12th place in May last year due to the prosecution investigation by suspicion of fraudulent accounting. However, after the third quarter of last year, the share price turned to a recovery, reflecting good earnings and expectations for growth of subsidiary Samsung Bioepis. Prospects that demand for contract manufacturing organization (CMO) will increase with the spread of COVID-19 this year increased market cap. After signing a CMO contract worth $360 million with Vir Biotechnology in the US last month, as the possibility of market reorganization was raised with regard to additional contract manufacturing organization (CMO) for COVID-19 treatment, it served as a trigger for the share price rise. Samsung Biologics completed the technology transfer process with Vir Biotechnology this year and will start production next year. It is said that the CMO work has been addressed at the 3rd plant, which resolved the concerns about utilization rates raised by some people. On the 10th of last month, when the contract was signed with Vir, Samsung Biologics' market capitalization jumped to more than ₩500 million a day, at ₩3.7 billion. Since then, the market cap continues to rise, and the market capitalization approaches ₩40 trillion at its peak. During the same period, Celltrion's market cap fell slightly from ₩27.17 trillion to ₩26.89 trillion (₩128.3 billion), and the gap with Samsung Biologics widened by more than ₩10 trillion. At the end of last year, Celltrion's market capitalization rose by more than ₩5 trillion over the past five months from ₩23.23 trillion to ₩28.36 trillion. Celltrion, like Samsung Biologics, is on the rise following the COVID-19 crisis, but its growth is far less than that of Samsung Biologics, and falls short of a bio leading stock. The securities firm predicts that this year, the two companies will have the highest performance ever. FnGuide, a financial information company, predicted that Celltrion would record an operating profit (stock price estimate average) of ₩569 billion, up 58.1% from the previous year based on separate financial statements. It is predicted that Samsung Biologics will increase operating profit by ₩228.4 billion, an increase of 149.1%.
- Company
- COVID-19 affected off-patent drug market share plunge?
- by Chon, Seung-Hyun May 11, 2020 06:18am
- Although off-patent originals have been consistently expanded their market shares in recent years unaffected by the army of generics entering the market, the original’s market share shrunk in last first quarter. The Korean pharmaceutical industry experts analyze the originals struggled to grow in the market against intense marketing of generics amid COVID-19 pandemic. ◆Lipitor and Crestor market shares stagger in the first quarter On May 10, pharmaceutical industry research firm UBIST stated Pfizer’s antihypertensive Lipitor (atorvastatin) has generated 47 billion won from outpatient prescription in the first quarter showing 0.2 percent decrease from the same time last year. Its prescription volume has been surging for last few years, but the growth seems to have slowed down. Compared to the first quarter last year, the prescription volume has increased only by 5.5 percent. The overall prescription volume of individual atorvastatin drugs in the first quarter reached 138.2 billion won with 2.3 percent increase from the year before. The overall market volume has grown but the original’s prescription volume has gone down. Quarterly prescription volume (left) and market volume (right) of Lipitor (Unit: KRW 100 million) Source: UBIST In the individual atorvasatin drug market, Lipitor’s pie took up 33.98 percent, which was reduced by 1 percent point compared to last year (34.83 percent). Even compared to the fourth quarter (34.92 percent) last year, the first quarter’s volume fell by 1 percent point. Since the third quarter of 2016 (33.66 percent), Lipitor’s quarterly market share has hit the lowest point in 42 months. Regardless of over 100 generics entering the market from 2009 as Lipitor’s patent was expired, the original has been constantly growing in the market. Lipitor’s market share steeply expanded from 31.70 percent in the first quarter 2015 to 34.92 percent in the fourth quarter last year. Although it maintained the market share over 34 percent since the fourth quarter of 2016, the figure plummeted this year at around 33 percent. Besides Lipitor, many of off-patent drugs that showed off their strong growth until last year saw their market share drop, simultaneously. Quarterly prescription volume (left) and market volume (right) of Crestor (Unit: KRW 100 million) Source: UBIST In the first quarter, Crestor (rosuvastatin) has made 22.5 billion won, recording a 5.1-percent drop from the same time last year (23.7 billion won). Compared to the previous year, Crestor had an 11.8-percent growth in last year’s first quarter, generating 23.7 billion won. The overall individual rosuvastatin drug market in the past first quarter has generated 84.1 billion won, jumping 5.2 percent from the same time last year. Despite the general growth in the market, Crestor’s first quarter market share has gone down significantly from 29.67 percent last year to 26.76 percent this year. Even against the last fourth quarter, this year’s first quarter market share fell by 2 percent point from 28.63 percent. Although it defended the market share of around 30 percent against over 100 generics for a while, this year’s first quarter market share has hit the lowest point. ◆Prescription volumes in Plavix, Aricept and Exforge also plunge The anticoagulant agent clopidogrel’s market also demonstrated similar trend. The first quarter prescription volume in Plavix (clopidogrel) was at 23.0 billion won with 1.4 percent increase than the previous year. The growing tendency continued but it was sluggish. In last year’s first quarter, Plavix generated 22.7 billion won, increased by 10.7 percent from the year before. In the first quarter of 2018, the drug’s prescription volume was 6.8 percent higher than the previous year. The overall individual clopidogrel drug market generated 2.6 percent more in the first quarter this year at 89.8 billion won, compared to 87.6 billion won in 2019. In the first quarter clopidogrel market, Plavix’ share was brought down to 25.65 percent by 0.38 percent point from 25.93 percent in last year. Compared to the fourth quarter last year at 26.27 percent, this year’s first quarter share was decreased by 0.62 percent point. The drug’s quarterly market share recorded the lowest in 18 months since the third quarter of 2018. Quarterly prescription volume (left) and market volume (right) of Plavix (Unit: KRW 100 million) Source: UBIST Moreover, other major off-patent drug market manifested noticeable plunge in original’s market share. The overall market of an Alzheimer’s disease-associated symptom treating agent donepezil has made 58.2 billion won this past first quarter with 1.0 percent increase from the same time the year before. Compared to 21.6 billion won made last year, the original brand drug Aricept has only made 23.0 billion won in last first quarter, recording 6.0 percent fall. In 2017 and 2018, Aricept’s first quarter prescription volume marked 18.9 billion won and 20.9 billion won, respectively, and showed a continuous growth but it turned downward this year. Aricept’s market share in the first quarter within the donepezil market has hit the lowest at 37.21 percent. Compared to last year at 39.99 percent, the first quarter share this year fell by 3 percent point. And from the fourth quarter last year, the number was again dropped by 0.3 percent point. Quarterly prescription volume (left) and market volume (right) of Aricept (Unit: KRW 100 million) Source: UBIST An amlodipine and valsartan combined antihypertensive, Exforge has also slipped. The first quarter prescription volume was at 20.2 billion won marking 1.6 percent drop from the year before. In the first quarter of last year, Exforge has generated 22.0 percent more in prescription volume against the year before. Influenced by the impurity found in valsartan in July 2018, the prescription volume of Exforge has surged but it has been stagnating recently. Taking up 41.54 percent of the combination drug market in this year’s first quarter, Exforge’s share has plummeted by over 3 percent point from 44.91 percent last year. Quarterly prescription volume (left) and market volume (right) of Exforge (Unit: KRW 100 million) Source: UBIST ◆Despite showing continued growth until last year, off-patent drugs crippled this year, possibly affected by COVID-19 In fact, patent-expired novel drugs continued to show strong growth up until last year, regardless of the generics intensely tackling the market. The industry experts claim the originals have advantages in market share growth due to Korea’s unique drug pricing system. When a generic is first released to the market, the original’s reimbursed price is reduced down to 70 percent of its initial pricing. And after a year from then, the pricing is again adjusted to 53.55 percent of the pricing before the patent expiration. The maximum pricing of a generic can be up to 59 percent of the original’s price before the patent expiration, and a year later the price also drops to 53.55 percent of the original’s pre-patent expiration price. The experts argue the prescribers seemingly prefer originals as it gets priced on par with generic pricing before the patent expiration. In this year, however, generics’ market share has gone up significantly. In this first quarter, the overall generic outpatient prescription volume has reached 3.70 trillion won with a 2.7-percent surge from last year at 3.60 trillion won. The industry experts analyze most of the original market has been engulfed by generics. Trend in monthly outpatient prescription volume (Unit: KRW 100 million) Source: UBIST Some experts carefully question if the COVID-19 pandemic has affected the dull growth of overall off-patent drugs. When multinational pharmaceutical companies have halted their salespeople from visiting healthcare institute amid COVID-19 outbreak, Korean companies could have assertively approached the healthcare providers and convinced them to prescribe generics. Since the first confirmed case of COVID-19 in Korea on Jan. 20, a growing number of pharmaceutical companies have refrained from visiting healthcare institutes, starting from the multinational companies. Most of the pharmaceutical company salespeople have started working from home as the number of confirmed cases skyrocketed since the discovery of the 31st confirmed case on Feb. 19. The experts also speculate many of chronic disease patients could have received prescription for a longer period of time at once to avoid visiting their healthcare providers. They also noted more clear trend in prescription drug market would be visible after April or May, when the pandemic heavily influenced the prescription volume.
- Company
- Zolgensma & Kymriah will be entered the Korean market
- by Eo, Yun-Ho May 08, 2020 06:34am
- Two very expensive new drugs by Novartis enter the Korean market. According to a related industry, Novartis Korea submitted an application for the approval of a treatment for Spinal Muscular Atrophy (SMA), Zolgensma (Onasemnogene abeparvovec) & CAR-T (Chimeric Antigen Receptor T cells) cell gene therapy, Kymriah (Tisagenlecleucel) earlier this year. The two drugs are expected to be approved in Korea in the second half of the year as soon as they have obtained approval in Japan following the United States. Zolgensma is an SMA treatment such as Biogen's Spinraza (Nusinersen), which has attracted attention as an expensive drug, but it was also priced very expensive. Currently, it costs about ₩2.5 billion per dose. The United States has approved the world's highest price for $2.1 million as a single treatment. For reference, Spinraza's domestic insurance upper limit is ₩92,359,131 per bottle. However, Spinraza is administered six times in the first year and three times each year from the following year, whereas Zolgensma is administered only once. Zolgensma is a gene therapy product designed to produce SMN proteins that do not function properly in patients with spinal muscular atrophy in specialized motor neurons that can regulate muscle contraction. The indications for the first CAR-T drug Kymriah are 'recurrent or refractory B-cell Venous Lymphoma in patients under the age of 25' and 'relapsed or refractory diffuse large B-cell lymphoma after two or more adult systemic treatments'. In Korea, it was already designated as an orphan drug in March last year. Novartis prepared a document based on ELIANA data, a global phase II clinical trial, and submitted a New Drug Application (NDA) in Korea. Kymriah was first commercialized in the United States in the world in August 2017, and approved in Europe in 2018. However, CAR-T is also very expensive. Although this drug is approved for domestic market with a cost of about ₩500 million per dose, it is judged that it will be difficult to be placed in the reimbursement list. For reference, Kymriah is administered once. Meanwhile, Novartis is also preparing to commercialize the macular degeneration treatment drug Beovu (Brolucizumab) in Korea. Beovu has proved its effectiveness through the HARRIER trial that directly compares to Eylea (Aflibercept).
- Company
- Jeil got a domestic exclusive promotion for Amitiza
- by Lee, Seok-Jun May 08, 2020 06:34am
- Jeil distributes FDA-approved constipation drugs in Korea. Jeil announced on the 6th that it has signed an exclusive promotional contract (distribution, marketing, and sales rights) in Korea with Amitiza soft capsule (Lubiprostone), a chronic constipation treatment for Takeda. Amitiza received FDA approval in 2006. In Korea, the approval process was completed in May last year. It is a type II chlorine ion channel local accelerator in small intestinal lining cells, and it has indications for the treatment of narcotic analgesic (opioid)-induced constipation △in adult patients with chronic non-cancerous pain, and △in adults patients with chronic idiopathic constipation. Amitiza is expected to be released this year. As of 2018, global sales amounted to ₩680 billion.
