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- 15 domestic pharmaceuticals, focus on 'COVID-19' treatment
- by Nho, Byung Chul Mar 11, 2020 06:27am
- Domestic pharmaceutical bio companies and government agencies are concentrating on developing COVID-19 vaccines and treatments. In response to COVID-19, opinions are urged to strengthen government support and expand public-private cooperation in order to preemptively respond to similar infectious diseases. According to the KPBMA, 15 domestic pharmaceutical bio companies are undertaking or preparing to develop COVID-19 vaccines and therapeutics. Four government agencies have also started to develop their own vaccines and treatments. In the case of preventive vaccines, the development is centered on companies that already have development capabilities such as flu vaccines such as GC Pharma or SK Bioscience. As they have the capacity to produce their own vaccines, they will be able to supply domestically if they successfully develop vaccines. However, even if the vaccine is immune to COVID-19, it will take about 1 year and 6 months to confirm the safety and effectiveness. Therefore, the vaccine should be developed in the long term. Development Status of Korean Pharmaceutical Company for COVID-19 related vaccines (Source: the KPBMA) In the case of therapeutics, development will be done by finding new candidates that can cure COVID-19, or by verifying the efficacy of COVID-19 in existing drugs. Hanmi, Celltrion, Komipharm, Immunemed, and Panafax are among the leading companies that are actively developing COVID-19 treatments. In particular, the Korea Research Institute of Chemical Technology and the Pasteur Institute of Korea are expected to find candidates for COVID-19 therapeutic drugs by analyzing the drug efficacy of 5000 drugs last month and provide them to leading doctors by early next month. Immunemed is launching a clinical trial of its own antiviral drug for the treatment of COVID-19 and is currently preparing for phase II after completing phase 1. Komipharm and Cellivery will be conducting clinical trials as candidates to suppress cytokines, an immune overexpression reaction. Development Status of Korean Pharmaceutical Company for COVID-19 related treatment (Source: the KPBMA) Public-private cooperation models are also being activated, in which domestic government agencies, research institutes, and pharmaceutical companies converge to develop vaccines and treatments. The Korea National Institute of Health has recently announced eight research projects for the development of rapid diagnostics, vaccines, and therapeutics necessary for quarantine. The Ministry of Science and ICT is conducting collaborative research with various research institutes in Korea such as Korea Research Institute of Bioscience and Biotechnology. As the development of vaccines and treatments is difficult to achieve in a short period of time, in terms of regulations and technical aspects, such public-private cooperation is expected to speed up development and increase the probability of success. The KPBMA stressed that benchmark overseas cases, such as the European Innovative Medicines Initiative (IMI) and the National Institutes of Health's AMP (New Drug Development Promotion Cooperation), should be benchmarked to accelerate the development of vaccines and treatments, and increase the possibility of development completion. The IMI is a joint venture between the European Commission and members of the European Federation of Pharmaceutical Industries and Associations (EFPIA), which is one of the world's largest public-private partnerships in the field of biohealthcare. Academia, industry, patient groups, regulatory and medical technology evaluation agencies have joined together to carry out a variety of projects, and invested €45 million (approximately ₩59 billion) on COVID-19 to develop therapeutics and diagnostic products. In addition, the Coalition for Epidemic Preparedness Innovations (CEPI), an international non-profit organization for the prevention of infectious diseases and vaccine development, is supported by four governments, as well as by non-profit foundations such as the Bill Gates Foundation. Current Status of government-affiliated organization for COVID-19 related R&D (Source:the KPBMA) In Korea, public-private cooperation projects are under way, supported by the government, including ₩36.8 billion in R&D projects related to COVID-19, especially in universities and government-funded research institutes). However, it is pointed out that public-private cooperation system should be established in order to increase the effectiveness of the project, such as bold government support and research results leading to the actual product development and release. Hee-Mok Won, President of the KPBMA, said that special measures are needed to protect medicinal sovereignty, including the rapid development of vaccines and treatments in national disaster situations. Also, He added that he will overcome the crisis based on public-private cooperation supported by the government in the pharmaceutical bio industry's R & D capacity. Currently, alternative medicines used in COVID-19 include AIDS treatment Kaletra, malaria treatment Chloroquine, ebola treatment Remdesivir, swine flu treatment Avigan, antiviral (interferon) combination therapy, and hepatitis C treatment Ribavirin.
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- Next-gen flu drug Xofluxa revs up for reimbursement listing
- by Eo, Yun-Ho Mar 10, 2020 06:29am
- Next-generation flu treatment Xofluza is now seeking for National Health Insurance reimbursement. Pharmaceutical industry sources reported, Roche Korea has submitted a reimbursement listing application for Xofluza (baloxavir). Finally approved after two-decade-long reign of Tamiflu (oseltamivir), Xofluza grabbed the industry’s attention with its new mechanism of blocking endonuclease and convenient one-dose oral administration (Five-day administration for Tamiflu). Antiviral drug could always develop tolerance, and no other drug except for neuraminidase inhibitors is recommended for influenza treatment at the moment. Although Korea has the top vaccination rate in the world, approximately 2.26 million people have contracted influenza virus in 2018. As the public’s interest on antiviral agent has been heightened amid COVID-19 outbreak, the reimbursement review on Xofluza would be timely conducted. Xofluza’s approval in Korea was based on CAPSTONE-1 study on healthy patients aged 12 to 64 years who were diagnosed with symptomatic, uncomplicated influenza, and CAPSTONE-2 study on patients aged 12 and older who were at high risk of complications from the flu. The key outcomes of CAPSTONE-1 with healthy adult and adolescent patients found Xofluza’s median time to symptom alleviation was 26.5 hours shorter than placebo. Also, Xofluza showed faster virus shredding than placebo. In about 24.0 hours, Xofluza halved the viral shedding, which was significantly shorter than placebo (96.0 hours) and Tamiflu (72.0 hours). During the CAPSTONE-2 study with high-risk influenza patient groups including senior and chronic disease patients, the high-risk patient group treated with Xofluza demonstrated median symptom alleviation time of 73.2 hours, which was about 29 hours shorter than placebo group (102.3 hours). In the same study, Xofluza halved the viral shedding in 48.0 hours, improved by approximately 50 percent than placebo (96.0 hours) and oseltamivir (96.0 hours). Professor Lee Jae-gab of Hallym University Medical Center Infectious Disease Department commented, “Besides the advantage of convenient one-dose oral administration, Xofluza is expected to be used for various indications as it has a different mechanism of action compared to other existing options”.
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- How long do pharmaceuticals have to work from home?
- by Kim, Jin-Gu Mar 10, 2020 06:28am
- More domestic pharmaceutical companies have decided to work from home to prevent the spread of COVID-19. Following Dong-A ST and GC Pharm, Chong Kun Dang joined the ranks of all employees from home. Chong Kun Dang said five days ago that it will start working from home for all employees. it will be up to the 13th. Chong Kun Dang and its affiliates do not go to the office, not only salespeople, but also internal employees, except for core employees. On that day, the entire headquarters became quiet as if it had been muted. Among major domestic pharmaceutical companies, Dong-A ST, LG Chem, and GC Pharm made a decision to work from home. In the case of Dong-A ST, the trigger was COVID-19 confirmed staff at the Yong-in R&D Center. On the 27th of last month, Dong-A ST research staff member A was confirmed and the Yong-in research center was closed. Dong-A ST decided to work from home at the head office on the next day. GC Pharm has joined the full-time workforce from the 2nd. This was a quick response to concerns over community infections, including the first confirmed person in Yongin, Gyeonggi-do, on the 23rd, and five more people confirmed by March 1. With Chong Kun Dang's joining, the decision to work from home is spreading among domestic pharmaceutical companies. A Chong Kun Dang official said, “We extended the telecommuting scope to all employees to prevent the spread of COVID-19 and protect our employees”. Most multinational pharmaceutical companies have already started telecommuting. At the end of last month, when the KPAI conducted a questionnaire, none of the 10 surveyed members went to work normally. It has been confirmed that all employees have worked from home or only those who wish to work from home. Other pharmaceutical companies that have not made a full-time telecommuting decision are responding flexibly. Only sales workers with a high risk of infection or transmission will be telecommuted or decided to work from home at the discretion of the team leader or general manager. It includes Yuhan Corporation, Daewoong pharm, Hanmi, Ildong, Jeil Pharm, Dong-Wha, Daewon, Korea United Pharm, LG Chem, Whan In Pharm, and Samil-Pharm. ◆Distributed working system' spreads instead of working from home, every other day Recently, more and more companies are doing distributed work instead of working from home. Two or three teams are organized to work from home once every two days or once every three days. Samjin Pharm has all of its sales staff working from home. In the case of in-office work, two groups are organized to distribute work days. Kolmar Korea and CJ Healthcare are similar. Internal workers have been telecommuting every other day since this week. SK Chemicals has been working in three groups and working from home on every fourth day since the 4th. The first group works at home and the other two companies. Instead, they ordered them to work in different spaces, even if they went to work. It is a compromise between normal work and telecommuting. A pharmaceutical company who introduced distributed work explained, "It is intended to reduce the inefficiency caused by all employees' telecommuting work, and to prevent large gaps in case of COVID-19 confirmed patients". ◆No choice but to determine the length of work from home based on the situation While a few pharmaceutical companies have entered the COVID-19 special action, attention is focused on 'How long will telecommuting work period?' Companies that actually decide to work from home are notified whether they are working from home on a weekly or daily basis. The complaint is currently being raised, but the company is in a difficult position to announce in advance because the situation is so urgent. A domestic company official who is working at home or working at office voluntarily said, “The decision, including the extension of telecommuting, is at the discretion of the company's senior management, which is difficult at this point and the extension will be decided based on the situation”. An official at another pharmaceutical company that has started all employees' telecommuting said, “Work from home was decided until this week. The COVID-19 situation is very urgent, and if the company goes to work normally, it is being discussed to exclude all salespeople or sales workers in Daegu-Gyeongbuk region first”. In response to this, the government announced in a regular briefing on the 5th that the number of new COVID-19 confirmed patients will gradually decrease. According to the government, the number of confirmed patients has declined to 400 at midnight on the 5th after peaking at 813 on last Feb 28. As the mass inspection of Shincheonji Believers in Daegu was completed, it is carefully judged that the biggest peak was passed. Daily COVID-19 confirmed patients status (Based on March 5, 0:00, Source: the KCDC) The government has delayed the opening of kindergartens and elementary and high school schools nationwide by Mar 23. Given this situation, it is cautious that each pharmaceutical company will resume its normal work in the second week (March 9) or third week (March 16). An official of a domestic pharmaceutical company said, “We are waiting for the government to lower the crisis alert stage from serious to boundary. However, it is not easy to continue working from home without worry. We expect to return to normal work before the 23rd, the beginning of elementary and secondary school”. A foreign pharmaceutical company official who has been working from home for about a month said that the employees who are working from home are complained of decreased work efficiency and increased fatigue, and the company is discussing a resumption next or next week.
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- Verzenio pricing negotiation to overlap with Ibrance
- by Eo, Yun-Ho Mar 09, 2020 08:00am
- Ibrance and Verzenio After passing Ibrance, Health Insurance Review and Assessment Service (HIRA) continuously passed Verzenio. The newly passed drug would likely to overlap its pricing negotiation with Ibrance. Korean pharmaceutical industry source reported Lilly’s cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor Verzenio was given a green light for National Health Insurance (NHI) reimbursement from HIRA’s Drug Reimbursement Evaluation Committee (DREC). The medication is in process of settling risk sharing agreement (RSA) to receive reimbursement to treat patients with HER2- advanced breast cancer in combination with AstraZeneca’s Faslodex (fulvestrant). As soon as Ministry of Health and Welfare (MOHW) gives a nod, Lilly would initiate negotiation with National Health Insurance Service (NHIS) for 60 days. Pfizer’s Ibrance, already at the negotiation table with NHIS after DREC’s clearance, would overlap its negotiation period with Verzenio. And as Faslodex’ financial impact evaluation data has been submitted, the two would be competing against each other intensely. On the other hand, Cancer Deliberation Committee has cleared another competitor, Novartis’ Kisqli (ribociclib), in last January. The industry is also keen on the third CDK4/6 inhibitor’s listing process. Ibrance’ efficacy of significantly improving progression-free survival (PFS) as a second-line therapy has been confirmed during PALOMA-3 clinical study. Besides for patients with early stage breast cancer, the CDK4/6 inhibitor showed consistent effect on patients with stage 4 metastatic breast cancer that affected their lungs and bones. As for Verzenio, recently completed MONARCH2 study attracted the industry’s interest as it not only improved PFS, but also improved overall survival (OS). The achievement was unprecedented for a DDK4/6 inhibitor. As a part of secondary endpoints, the OS of both pre and postmenopausal women was observed.
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- Tylenol leads the pain relief market
- by Kim, Jin-Gu Mar 09, 2020 07:59am
- Tyreno made the most sales in the antipyretic analgesic market last year. Tylenol 8hrs ER performed poorly due to safety controversy, but overall brand sales increased slightly as Tylenol sold more. Geworin, the second-largest product, has grown significantly in the last five years. However, the sales gap between the 1st and 2nd places is unlikely to narrow. 2018~2019 Sales Change of Major Antipyretic Analgesic Brands (Unit: ₩100 Million, Source: IQVIA) ◆Tylenol ranks first with ₩29.8 billion Tylenol 8hrs ER's sales impact was minimal. According to drug research institute IQVIA on the 5th, Janssen's Tylenol series posted sales of ₩29.8 billion last year. It is up 5.8% from 2018's ₩28.2 billion. Expanding the scope to the past five years, the increase is 7.8% from ₩27.7 billion in 2015. The change in sales of individual items is very interesting. The two flagship products, Tylenol and Tylenol 8hrs ER , are plotting opposite sales figures. First, Tylenol tablets are steadily increasing. The company recorded ₩11.7 billion in 2015, ₩12.3 billion in 2016, ₩13.1 billion in 2017, ₩14.5 billion in 2018, and ₩18.3 billion in 2019. On the other hand, Tylenol 8-hour ER is showing signs of slowing. The figure is decreasing every year, including ₩13.8 billion in 2015, ₩13.3 billion in 2016, ₩12.9 billion in 2017, ₩10.8 billion in 2018, and ₩8.5 billion in 2019. In 4 years, it has dropped 38.0%. Sales changes of Tylenol and Tylenol 8hrs ER in the last five years (Unit: ₩100 Million, Source IQVIA) This is attributed to the safety controversy of Tylenol 8 hour ER. This product has been constantly worried about liver damage caused by misuse. As a result, the Ministry of Food and Drug Safety implemented measures to strengthen safety in 2018. In the process, the Tylenol ER was renamed Tylenol 8hrs ER . In addition to Tylenol 8hrs ER, other slow-release tablets are observed to be on a similar path. Since 2015, Penzal's 8-hour ER has decreased by 19.3% and Maxibufen ER by 23.0%. ◆Geworin 25% increase over 4 years Samjin's flagship product, Geworin was followed. Geworin's revenue last year was ₩15.2 billion, up 9.7% from ₩13.8 billion in 2018. This is an increase of 25.1% compared to 2015, five years ago. However, the gap between the 1st and the 2nd places did not seem to narrow. The gap between Tylenol and Geworin remains around ₩15 billion, including ₩15.6 billion in 2015, ₩14.2 billion in 2016, ₩16 billion in 2017, ₩14.4 billion in 2018, and ₩14.7 billion in 2019. Sales changes of major antipyretic analgesic brands in recent 5 years (Unit: ₩100 Million, Source IQVIA) Third place was Hanmi’s Maxibufen. Last year, it recorded sales of ₩7.5 billion. It has been ranked third for five years in a row, but sales are on the decline. Compared with 2015 (₩8.5 billion), it decreased 11.7%. In addition to the Maxibu fen ER, the sales of Maxibufen are also on the decline. Daewoong Pharm's EZN series ranked fourth with ₩6 billion. Contrary to Maxibufen, the growth rate is steep. It is up 82.5% from last year's ₩3.3 billion. The ranking in the antipyretic analgesic market also jumped from eighth to fourth in the same period. In addition, GC Pharma's Taksen (₩5.6 billion), Ildong’s Carol (₩5.5 billion), Chong Kun Dang’s Penzal (₩5.5 billion), Ahn-gook’s Anyfen (₩5.2 billion), Samil’s Brufen, and Dong-A’s Champ were in the top ten. In addition to last year's rankings, the increase in sales over the last five years has increased for Tylenol, Geworin, EZN, Taksen, Carol, Champ, Advil, and Gnal-N. In particular, growth of Champ (246.6%), Gnal-N(91.5%), and EZN (82.5%) is noticeable. On the other hand, Maxibufen, Penzal, Anypen, Brufen, and Trisfen have generally lost sales. The reduction ranged from a minimum of 1.5% to a maximum of 61.7%.
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- Fear of unstable Indian API supply spreads with COVID-19
- by Chon, Seung-Hyun Mar 09, 2020 07:59am
- Due to the outbreak of 2019 novel coronavirus (COVID-19), Indian government started limiting the export of active pharmaceutical ingredient. Pharmaceutical companies’ concern of supply shortage is now imminent as COVID-19 could impede pharmaceutical ingredient export from China and India in a long-term. According to industry sources on Mar. 4, the Indian government has decided to restrict the export of 26 active pharmaceutical ingredients (API) as of Mar. 3 (local time), because pharmaceutical shortage they are experiencing with COVID-19. The restricted export list includes pain reliever acetaminophen (paracetamol), vitamin and antibiotics. Indian companies would have to receive the government’s approval to export the APIs. Almost 10 percent of APIs exported from India is on the restricted list. India means to limit the pharmaceutical export before the country is faced with pharmaceutical shortage from COVID-19 outbreak. As most of APIs manufactured in India use chemical substance imported from China, the API manufacturing in India would be affected if China were to struggle exporting the substance due to the outbreak. Restriction on Indian-made API export could affect Korean pharmaceutical industry. API and finished product import volume by year (Unite: USD 1,000) Source: MFDS Korea’s Ministry of Food and Drug Safety (MFDS) said the total import volume of Indian-made pharmaceuticals reached USD 204.13 million in 2018, making it the tenth biggest pharmaceutical exporter to Korea. Although the Indian-made finished product takes up only five percent of overall pharmaceutical market in Korea, the export restriction would still affect Korea as most of the imported products are API used by Korean companies. In 2018, total of 195.59 million dollars of Indian-made APIs was imported, following the top export volume from China and Japan. The Indian API import volume has been constantly increasing over the years. The figure surged by 39.3 percent in seven years, starting from 140.43 million won in 2011. The API import volume from India was at sixth place in 2011, following Japan, China, Italy, Germany and France, but the Korean pharmaceutical industry’s dependency on India has not ceased to grow. Top API exporting countries to Korea by year (Unit: USD 1,000) Source: MFDS Along with Chinese-made APIs, Indian-made imported API volume has gone up the most, mostly because of the low cost. Experts assess Korean pharmaceutical companies have been increasingly preferring APIs from China and India to reduce production cost. Some point out the Korean companies’ demands for inexpensive APIs have soared as the Korean government continuously lowered pricing of finished products and did not sufficiently compensated for their value, while their sales marketing activities have been strained with tightened regulation against illegal rebate. But also, the enhanced quality of Chinese and Indian-made APIs has influenced the companies’ preference. Pharmaceutical companies are now calculating the impact of Indian API export restriction. The companies fear of the direct impact on pharmaceutical manufacturing caused by Indian-made API supply issues, as COVID-19 outbreak has already affected API supply from China. The Korean companies are already struggling with Chinese API supply of stomach ulcer treatment cimetidine. Chongqing Qingyang Pharmaceutical, based in Chongching City, China, has temporarily stopped manufacturing cimetidine API due to the outbreak. As the outbreak is relentlessly spreading, the industry has to prepare for the actual API shortage of some herbal medicinal product ingredients solely depended on China. As a result, pharmaceutical companies would have to seek for other API manufacturing sites to substitute Chinese or Indian-made APIs. Apparently, most of APIs from China and India could be alternatively sourced from either Korea or other countries. However, registering new API is not as easy. MFDS has to approve of the use of currently unregistered imported API, but the ministry has suspended all overseas on-site inspection. Also the companies are worried about increase in production cost by changing the API source. A pharmaceutical company insider complained, “Majority of APIs imported from China and India are substitutable. Although we could use reserved stock of APIs for a while, prolonged COVID-19 outbreak would inevitably cause problem in manufacturing schedule of drug products.”
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- MOHW: “Cancer Committee to be rescheduled in March”
- by Eo, Yun-Ho Mar 06, 2020 06:06am
- The Cancer Deliberation Committee meeting initially canceled due to COVID-19 outbreak would be rescheduled again soon. Pharmaceutical industry sources reported Korea’s Ministry of Health and Welfare (MOHW) plans to review some of drugs on paper, but to conduct vis-à-vis review on significant drugs applying for reimbursement expansion within March. Specifically, major pharmaceuticals like AstraZeneca’s targeted therapy Tagrisso (osimertinib) and Ono Pharmaceutical and Bristol-Myers Squibb’s Opdivo (nivolumab) would resume their reimbursement listing talks. Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso is under review for expanding reimbursement as a first-line therapy for EGFR mutation-positive non-small-cell lung cancer (NSCLC). PD-1 inhibitor Opdivo has a number of indications seeking for reimbursement, such as renal cell carcinoma-treating first-line combination therapy with Yervoy, second-line treatment for renal cell carcinoma, second-line treatment for relapsed or metastatic head neck squamous cell carcinoma, and second-line treatment for classical Hodgkin’s disease. But, the controversial indication of second-line treatment for NSCLC regardless of expression of PD-L1 was omitted from the application. Also, Ipsen Korea’s Cabometyx (cabozantanib) was supposed to be deliberated as well. After getting listed as a second-line treatment for advanced renal cell carcinoma last month, Cabometyx has applied for reimbursement on its liver cancer indication as well. The medication also could resolve the issue of Eisai’s Lenvima (lenvatinib) without a second-line therapy option. MOHW official said, “Although the government is hectic with COVID-19 outbreak, we have decided the reimbursement listing review for anticancer treatment cannot wait. The ministry would finalize the schedule as promptly as possible to push on with the listing procedure, including Cancer Deliberation Committee, without a delay.” Meanwhile, MSD’s immunotherapy Keytruda would be excluded from this month’s agenda, but would be included in April’s agenda of the Cancer Deliberation Committee. Keytruda is waiting for the committee to deliberate reimbursement feasibility of its expanded indications. The global company’s listing application included indications for first-line treatment for NSCLC, bladder cancer and Hodgkin’s lymphoma, which have been denied previously, but also two new indications of first-line treatment for metastatic non-squamos NSCLC as a combination therapy with pemetrexed and platinum chemotherapy, and first-line treatment for metastatic squamous NSCLC as combination therapy with carboplatin and paclitaxel were included as well.
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- MFDS clears varicella vaccine license for GC Pharma
- by Lee, Seok-Jun Mar 06, 2020 06:06am
- GC Pharma announced on Mar. 4 its chickenpox vaccine ‘Varycella’ injection has recently won an item license from Ministry of Food and Drug Safety for the Korean market. Like other existing chickenpox vaccines, the company stated Varycella is a live attenuated varicella virus vaccine. The Korean company was able to push up the production yield significantly by improving the productivity. And also it increased the content of live varicella virus and enhanced stability of the product as well. In Phase III transnational clinical trial conducted in Korea and Thailand with infants aged either over or under 12 months, Varycella injection confirmed its non-inferiority against reference vaccine. GC Pharma aims to penetrate the USD 2.3 billion-worth global varicella vaccine market with Varycella injection. The Head of Development Department at GC Pharma, Lee Jaewoo said, “We are committed to contribute to lessen the social strain and cost of varicella prevalence around the world by providing upgraded varicella vaccine. Besides supplying to the Korean market, the company plans to target the global market after passing the World Health Organization’s Prequalification (PQ).”
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- Industry fears sales ban as NDMA risk in metformin rekindled
- by Chon, Seung-Hyun Mar 06, 2020 06:06am
- The risk of impurity found in metformin could resurface due to another warning from the U.S.-based private research firm. The pharmaceutical industry’s concern deepens as the same research firm that warned about ranitidine risk last year published the metformin analytic data. Already pharmaceutical companies fear global health authorities would order a complete sales ban on metformin after they collect and probe the products. ◆ Valisure “16 out of 38 metformin batches showed NDMA exceeding acceptable level” According to industry sources on Mar. 3, Valisure, a private research institute based in the U.S., has detectd cancerous N-nitrosodimenthylamine (NDMA) exceeding acceptable level of daily intake in some metformin products, which used in the U.S. as antidiabetic drugs. Valisure investigated NDMA in 38 metformin production batches manufactured by 22 pharmaceutical companies, following the liquid chromatography-mass spectrometry (LC-MS) protocol. Apparently, Valisure has found NDMA exceeding acceptable level of daily intake in 16 batches from 11 companies. One of the batches had NDMA content level 16.5 times higher than the acceptable daily intake level of 96 ng. Valisure has requested the U.S. Food and Drug Administration (FDA) to recall the metformin products containing levels of NDMA in excess of the daily acceptable intake limit. Valisure’s list of metformin production batch found containing NDMA exceeding the acceptable level of daily intake (96 ng) (Source: Valisure Citizen Petition on Metformin) The analytic findings from the firm contrast from the statement issued a month ago by FDA. On Feb. 3, the U.S. health regulator informed their analysis on 10 metformin products distributed in the U.S. market found two products with low level of NDMA content, which the regulator recommended not to use. ◆ Industry tenses up as Valisure warned of risk of ranitidine and nizatidine last year The pharmaceutical industry is keenly watching the private research firm, because Valisure first warned of impurity found in ranitidine last year. Housed in New Haven, CT, Valisure operates online pharmacies in 38 states in the U.S. and regularly publishes analytic findings regarding pharmaceutical safety. Interestingly, Valisure’s metformin impurity risk warning is similar to the actions taken for ranitidine impurity risk. FDA issued a statement last year announcing the presence of low levels of NDMA in ranitidine drugs like Zantac, but did not mention a specific plan to recall the product. Since then, Valisure disclosed their own investigation showing high levels of NDMA in ranitidine drugs including Zantac, and requested FDA to recall the products. As a result, majority of ranitidine drugs were detected with unacceptable level of NDMA and the drugs were recalled in the U.S. and Europe. Valisure also urged FDA to initiate investigation on nizatidine by presenting findings of NDMA in the drug. Korea’s Ministry of Food and Drug Safety (MFDS) also decided to ban sales and recall 13 nizatidine products in last November due to the presence of excessive level of NDMA. Such development of the decisions by global health regulators is the reason the pharmaceutical companies are tensed up about MFDS’ actions following the metformin analysis. The risk of NDMA in metformin was first raised from Singapore. On Dec. 4 last year, Singapore’s Health Sciences Authority (HSA) recalled three items out of 46 metformin-containing drugs they have tested. The result confirmed high levels of NDMA exceeding the acceptable daily intake level. MFDS is currently probing NDMA in metformin active ingredient and finished products. Although it has already been three months since the Singaporean health regulator spoke of the risk in metformin, the Korean ministry has not yet revealed the investigation outcome. In last December, MFDS had pharmaceutical companies to submit record of using metformin. And on Jan. 15, the ministry presented NDMA testing methodology for metformin. The ministry is still probing NDMA contamination in collected active metformin ingredients. Over a month has passed since FDA has presented the interim result of metformin-NDMA investigation, but the Korean health regulator has not even mentioned of a next step. Three days after the news of Zantac detected with NDMA in the U.S., MFDS announced interim test result of NDMA level in Zantac on last Sept. 16 and said the impurity has not been detected. But for the ranitidine issue, the Korean government ordered sales ban on the product in a mere of 10 days. MFDS official stated, “Currently an inspection on contamination in metformin is ongoing.” The ministry is reviewing NDMA contamination in over 900 metformin samples. ◆ Pharmaceutical companies anxious of stringent actions like ranitidine or valsartan risk Clearly, the pharmaceutical industry is edgy on the MFDS-confirmed level of NDMA in metformin from Korea and their response, because Korean regulator’s action on NDMA-detected drug so far has been more stringent than that of the U.S. or European regulators. MFDS has banned sales of finished product that used the controversial active ingredient at least once since January of 2015. Many of the products were probably banned from the market even if the controversial active ingredient was not used recently. In the U.S., only the products using active ingredient from Zhejiang Huahai Pharmaceutical were recalled by batches. An order of complete sales ban on the product was never given. The level of action taken by European health regulator was on par. While every ranitidine product was banned in Korea, pharmaceutical companies voluntarily recalled the products by batches in the U.S. and Europe. Whereas 13 nizatidine products were banned from sales in Korea, Japan only recalled a number of the products and the U.S. and Europe have not given a recall order. The Korean regulator has decide to recall specific batches of nizatidine with high levels of NDMA, but those products were temporarily banned from sales until the recall was completed. Valisure pointed out the level of NDMA in metformin varies depending on each batch, although they were manufactured by a same company. They argued the pharmaceutical substance could be the unstable factor. The MFDS’ decision to weed out ranitidine products was made because ‘ranitidine has an unstable quality, therefore, it is always exposed to the risk of generating NDMA.’ A tremendous chaos in the whole of pharmaceutical industry would be inevitable if the ministry is to take actions as stringent as before when it finds high levels of NDMA in some of metformin. According to pharmaceutical market research firm UBIST, pharmaceuticals with metformin generated 473.2 billion won last year from outpatient prescription. The market continues to grow as the volume has doubled since 2014. Pharmaceutical companies argue the Korean regulator should take similar level of actions as the U.S. or Europe, even if they find high levels of NDMA in some of metformin available in Korea. Especially because a research was published claiming NDMA found in valsartan and ranitidine would not be harmful to human body. In last December, MFDS stated, “Reviewing individual dose and administration period of patients actually taking finished product containing valsartan manufactured from Huahai Pharmaceutical with NDMA, the possibility of causing cancer was low enough to ignore.” FDA also issued a statement last November, “The risk of causing cancer by NDMA detected in ranitidine is close to the risk exposed from having barbecued meat or smoked meat.” A pharmaceutical company insider urged, “Regardless of unconfirmed harm of pharmaceuticals detected with NDMA, the produces were banned from sales and recalled. Accordingly, pharmaceutical companies had to endure immense loss and the public’s apprehension has deepened. On products with impurities found in the future, the Korean government should order a batch-basis recall like the U.S. and European government have.”
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- 86% of generics for erectile dysfunction are domestic
- by Chon, Seung-Hyun Mar 05, 2020 06:33am
- The sales rate of generic products developed in Korea in the erectile dysfunction market is very high. Hanmi pharm's Palpal is one of hottest items, and Chong Kun Dang's Cendom continued to rise. Domestically developed drugs account for 86% of the erectile dysfunction drug market, and the influence of domestic products is expanding. According to IQVIA, a drug research agency on the 2nd, the market for erectile dysfunction drugs last year was 5.3%, up 5.3% year-on-year. It is growing continuously every year, from ₩98 billion in 2016 to ₩104.5 billion in 2017 and ₩108.2 billion in 2018. Hanmi's Palpal still showed its unrivaled position in the market. Palpal's sales last year were up to ₩22.4 billion, an increase of 7.0%. In the overall market for erectile dysfunction drugs, Palpal's market share is nearly 20%. Palpal, which was released shortly after Viagra's patent expired in 2012, sells most since beating Viagra in 2013 and Cialis in 2015, respectively. Sales of Major Erectile Dysfunction Therapeutics (Unit: KRW million,%, Source: IQVIA) Palpal has more than doubled the sales of its original product, Viagra (₩9.6 billion). Considering that Palpal is less than half the price of Viagra, it can be calculated that the actual sales volume is more than four times. In recent years, Chong Kun Dang's Cendom (generic for Cialis) sells well. Cendom sold ₩10.4 billion, up 8.7% from last year. Among the total erectile dysfunction treatment products, Cendom is the only product that has exceeded annual sales of ₩10 billion. Cendom, which was released after the Cialis patent expired in September 2015, gradually surpassed Cialis in 2017 as its market share gradually increased. Last year, it was overtaking even Viagra. Hanmi Pharm The progress of Hanmi Pharm's Gugu (generic for Cialis) was also noticeable. Gu gu's sales reached 4th place last year, reaching ₩7 billion, an increase of 13.7% over the previous year, and it beated Cialis for the first time since release. Three generics including Palpal, Cendom, and Gugu, accounted for more sales than the original drugs. Viagra and Cialis continued to decline last year, beghind in generics. Viagra's sales last year were ₩9.6 billion, down 2.3% year-on-year. Cialis fell 1.0% from ₩6.5 billion in 2018 to ₩6.4 billion last year. Among domestically sold erectile dysfunction treatment products, there are two products of Viagra and Cialis, and they sold a total of ₩16 billion last year. Bayer's Levitra announced the withdrawal of the domestic market in April. New drugs and generic products released by domestic companies account for a total of 86.0%. After 83.3% in 2017 and 84.8% in 2018, the market share is increasing. Domestically developed new drug products, such as SK Chemicals' 'Mvix' and 'Mvix S', and Dong-A ST's 'Zydena', also generate annual sales of ₩6 billion. In the domestic pharmaceutical market, generics continue to strengthen in the erectile dysfunction treatment market. In general, it is extremely unusual for generics to exceed sales of original drugs. That's because it's not easy for generics to surpass the reliability established by original products over time. Recently, in Korea, new drugs whose patents of multinational pharmaceutical companies have expired are increasing. According to UBIST, Last year, Lipitor’s outpatient prescription amount was ₩17.6 billion, an increase of 8.4%. Since 2014, the prescription amount have risen for six consecutive years. Sanofi's anti-thrombotic drug Plavix, last year's prescription performance was ₩88.9 billion, an increase of 17.3%. Prescription amount for Plavix increased 28.1% in two years from ₩69.4 billion in 2017. Original drugs, such as AstraZeneca's Crestor, Boehringer Ingelheim's Twynsta, Ezai's Aricept and Novartis' Exforge, also showed a rise in prescriptions from last year. Due to the nature of the original drug and generic insurance cap, the focus on the original increases. On the other hand, in the non-reimbursed drug market, where suppliers such as erectile dysfunction drugs set the price, it is analyzed that generics have increased their market share by aggressively operating at lower prices than the original drugs. Looking at the sales of erectile dysfunction treatments by company, Chong Kun Dang is facing a challenge to Hanmi Pharm. Sales Trend of Erectile Dysfunction Therapeutics by Company (Unit: KRW 1 million,%, Source: IQVIA) Hanmi Pharm recorded 25.8% of the total market last year with sales of ₩29.4 billion with Palpal and Gugu. The gap was widened with latecomers with a growth rate of 8.5% year-on-year. Chong Kun Dang recorded 6.1% year-on-year growth with the joint venture of ₩11.3 billion in three generics: Cendom, Cengla, and Yaila. Chong Kun Dang succeeded Hanmi Pharm with a 11.5% market share. Chong Kun Dang is gradually expanding its influence in the Viagra market even though it has fallen behind competitors. Chong Kun Dang signed a business alliance with Bayer in 2007 and renamed Levitra under the name of Yaila, failing to enter the Viagra generic market in 2012. Chong Kun Dang entered the Cialis market shortly after clearing his partnership with Bayer in 2015, and in 2017 launched Cengla, generic for Viagra, five years later than its competitors. Cengla's sales last year stood at ₩1.9 billion, ranking third among the generics for Viagra after Palpal and Nurigra. In 2018, Chong Kun Dang was licensed under Yaila, which previously sold Levitra. Chong Kun Dang is the only company that has all three generic drugs for erectile dysfunction. Pfizer made a joint venture between Viagra and Viagra L film last year at ₩10.1 billion. Chong Kun Dang was the second-largest market share, down 3.3% from the previous year. Sales of two types of erectile dysfunction treatment drugs, SK Chemicals and Daewoong Pharmaceuticals, exceeded Cialis, and ranked 4th and 5th, respectively.
