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- Opinion
- [Reporter’s View] Support domestic COVID-19 vaccine first
- by May 10, 2021 05:56am
- The U.S had expressed support for waiving intellectual property (IP) protections for COVID-19 vaccines. Such support can induce the production of copies of Pfizer and Moderna’s COVID-19 vaccine, ultimately increasing vaccine supply. The U.S administration’s support was received with expectations, concerns, support as well as opposition. It is not an exaggeration to say that the key to mRNA vaccines -such as Pfizer’s and Moderna’s vaccines – lie in its patent. A sophisticated lipid nanoparticle (LNP) technology is required to deliver mRNA, which is vulnerable to the surrounding environment, well into the body. This technology has been preemptively patented by many companies. Moderna has also been paying another company for the LNP technology used in its COVID-19 vaccine. Therefore, if the production of mRNA-based COVID-19 vaccines is possible without employing patent avoidance strategies, many more companies may make the attempt to produce COVID-19 vaccines. However still, the prominent opinion among experts is that this is not the right solution for addressing the current vaccine crisis. According to foreign media, Scott Gottlieb, a former F.D.A. chief had said, “The production of COVID-19 vaccines requires a complex process and difficult materials. Allowing other manufacturers to use the patented technology will not increase supply immediately.” Chad Landmon, the chair of Axinn, Veltrop & Harkrider’s Intellectual Property and FDA practice groups, pointed out, “IP has not been the barrier to the production — it’s really been the technology and how complicated” it is to manufacture COVID-19 vaccines. He continued, “Also, the issues in the supply chain, such as shortage of raw materials will also be a challenge.” Without the cooperation of big drug companies, patent waivers are unlikely to expand the global supply of coronavirus vaccines, said “Vaccines are difficult to make because they use biological systems which are much more difficult than small molecules. Patents are only codified information. To make it work, the multinational pharmaceutical companies would need to share their actual technological know-how, quality control, manufacturing process. It is like a 3-Michelin Star restaurant. Even if the restaurant shares its recipe, it cannot be simply replicated. “ Rather than follow the false demand for IP waiver, experts advise that the government should listen to the voices of people with abundant drug development experience and implement practical support measures to increase vaccine supply. For example, Gottlieb suggested cooperating with vaccine developers rather than confronting them by increasing manufacturing capacity by assisting in the production of raw materials and purchasing special equipment. So how would this apply to Korea? Even if the controversial IP waiver passes through, the overall opinion stays that it will be difficult for the Korean industry to develop a generic mRNA vaccine. Rather, the focus should be on supporting the development of domestic COVID-19 vaccines that are already in progress. 5 domestic companies - SK Bioscience and Celid, Genexin, Eu Biologics, Cellid – have started clinical trials for their vaccines. It would be more effective for Korea if the government set specific guidelines for their Phase III trial and support the smooth operation of their clinical research.
- Company
- The cobas SARS-CoV-2 & Influenza A/B Test was approved
- by May 10, 2021 05:56am
- Roche Diagnostics Korea announced on the 6th that it has obtained permission from the MFDS to "cobas SARS-CoV-2 & Fluenza A/B," which can diagnose COVID-19 and flu at the same time. The cobas® SARS-CoV-2 & Influenza A/B Test is a multiplex reverse transcription polymerase chain reaction (RT-PCR) assay intended for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus in nasal or nasopharyngeal swab samples collected from individuals suspected of a respiratory viral infection consistent with COVID-19 by their healthcare provider. It is based on automated molecular diagnostic equipment 'covas 6800' and 'covas 8800', and can proceed from nucleic acid extraction to gene amplification, test, result analysis, and report through one-stop automation method. The cobas 6800 provides 384 tests per eight hours and the cobas 8800 provides 960 tests. The intervention of personnel to replace reagents and consumables reduced the cobas 6800 to once every eight hours and the cobas 8800 to once every four hours, respectively, improving the convenience of the medical staff's COVID-19 test. This automated test prevents errors caused by manual work through an all-in-one solution that is inspected in a single equipment from extracting nucleic acids to producing test results, and also reduces the risk of contamination caused by external substances. The cobas SARS-CoV-2 & Influenza A/B confirmed over 97% sensitivity and specificity through clinical studies. For COVID-19, the sensitivity associated with the false (fake-positive) risk was 100.00%, and the specificity associated with the false (fake-positive) risk was 99.82%. For influenza A, sensitivity and specificity were 97.14% and 99.04% respectively, and for influenza B, sensitivity and specificity were 100.00%. The cobas SARS-CoV-2 & Influenza A/B was approved for EMA by the FDA in September 2020 and obtained European Medical Device Certification (CE) in the same month. Johnny Tse Roche, CEO of Diagnostics Korea, said, "We expect high-capacity fully automatic cobas SARS-CoV-2 & Fluenza A/B not only improves the speed and convenience of testing, but also helps prevent the spread of infections and provide appropriate treatment for patients."
- Product
- Will Kypris become dominant in multiple myeloma markets?
- by Whang, byung-woo May 10, 2021 05:56am
- "New treatments will also emerge in the treatment of myeloma. However, its importance is still expected to continue when Kypris compares combined therapy features with a single formulation and other formulations." As multiple myeloma is difficult to completely heal and many recurrences occur, recurrence and non-responsive polymyeloma is considered the key to treatment. In the domestic treatment situation, Kyprolis-focused KRd therapy (Carfilzomib, Lenalidomide, and Dexamethasone) became the main treatment strategy, as third-generation proteasome inhibitors (PI drugs) became the standard of treatment. However, since March, IRd therapy (Ixazomib+Lenalidomide+Dexamethasone), which is centered on the oral PI drug Ninlaro, has become convenient, and the market for prescribing recurrent and non-responsive multiple myeloma has begun to become active. Accordingly, let's listen to the strategies and perspectives of treating multiple myeloma through Joseph Mikhael, a professor of applied genomics at the Korean Society of Hematology International Conference. First of all, what he emphasized in his presentation at the Korean Society of Hematology conference is the importance of early treatment strategies for patients with recurrent and unresponsive multiple myeloma. As recurrence and non-responsive multiple myeloma have various options not only in the U.S. but also in Korea, optimal measures that take into account the characteristics of patients should be considered first. Professor Joseph Mikhael said, "It is very encouraging that there are more treatment options to choose from now on compared to the past. We expect more options for treating recurrent and unresponsive multiple myeloma in the future." Professor Joseph Mikhael pays attention to the fact that Kyprolis has achieved a 12-month extension of the PFS (Present Progressive Survival Period) compared to conventional treatments in treatment of recurrent and non-responsive multiple myeloma. "The improvements in the duration of the existing treatment are significant, compared to four to six months and eight months at the most," he said. "It's a great achievement in that about six months is a common improvement in other treatments." Professor Mikhael emphasized that Kypris clearly has an advantage in terms of efficacy compared to other PI agents, Velcade (Bortezomib) and Ninlaro (Ixazomib). "Kyprolis still has the greatest effectiveness of PI drugs used to treat multiple myeloma," he said. "A study directly compared to Velcade concluded that Kyprolis is the most effective treatment needed by medical staff and patients." Treatment options for increased myeloma. What's the situation in the U.S.? In Korea, as IRd therapy has recently been reimbursed, options for clinical doctors have also increased. In the United States, where both KRd and IRd therapy were available, how would the choice of prescription between the two treatments appear? Professor Mikhael said that KRd therapy is preferred, assuming that there are many options. "If a patient has an autologous hematopoietic stem cell transplant, there is a maintenance therapy based on Levlimide, and Kyprolis and Ninlaro are available options," He said. "KRd therapy is mainly chosen because Kyprolis is more effective." IRd therapy can be selected if patients want to avoid Kyprolis because they are concerned about abnormal reactions related to the heart, but IRd therapy is less used in the United States than KRd therapy. However, as Professor Mikhael mentioned earlier, Kyprolis' biggest concern is that patients with heart-related comorbidities require attention. Considering that multiple myeloma comes from older people aged 65 or older, concerns about heart failure and hypertension abnormalities of Kyprolis cannot be ruled out. Professor Mikhael acknowledged the abnormal response that could appear as Kypris, but evaluated it as manageable. "After more than 10 years of use of Kyprolis, experience in abnormal reactions can be accumulated and reduced to 2%," he said. "2% of patients should stop taking medication, but this situation is very small in the actual field."
- Company
- The trend to advertise vaccines is diversity and young men
- by May 07, 2021 06:02am
- GSK Rotarix model Jo Jeong-seok, MSD Gardasil9 model Jeong Gyeong-ho, Yoo Byeong-jae, Jo Se-ho, and Pfizer Pharmaceutical PREVENAR13 model Choi Gwi-hwaVaccine advertisements by pharmaceutical companies are diversifying. Instead of the flu vaccine, it has diversified into vaccines for rota virus, pneumococcus, cervical cancer, and whooping cough. This is to raise awareness of vaccinations for vaccines that have not been well-known until now as interest in preventing infectious diseases has increased due to COVID-19. The main model was a young male entertainer. According to the pharmaceutical industry on the 7th, MSD Korea is the most active. MSD selected singers Mommy Son, comedian Jo Se-ho and Yoo Byung-jae as models for the advertisement of the HPV virus (cervical cancer) vaccine Gardasil9 only last year. Also recently, actor Jung Kyung-ho was selected as the new Gardasil 9 model. The reason MSD has introduced a variety of male models is to emphasize the importance of vaccination against the HPV virus in men. Until now, the HPV virus vaccine was widely known as a cervical cancer vaccine, so there was a strong recognition that it was only suitable for young women. However, although this virus is rare, it can also cause anal cancer and genital warts in men. As a result, MSD, which focused on women's marketing with comedian Park Na-rae as a model, began to use a large number of young male models to improve awareness. Mami Son's rap and Jo Seho and Yoo Byungjae's parody competition aroused the interest of young men. In April, it emphasized a clean concept with actor Jung Kyung-ho as a model. GSK also introduced actor Jo Jung-seok, who is considered the best advertising star since August of last year, as a model of the rotavirus vaccine Rotarix. His credible image and comfortable voice are favored by young people, regardless of gender. In particular, Rotavirus vaccine is suitable for newborns, and at the time of selection, Jo Jung-seok also became a parent with the child. This is Rotarix first public TV commercial. GSK said, "To inform the necessity of vaccination against Rotavirus that does not apply to NIP, and to raise brand awareness, we will conduct a public advertisement with Jo Jung-seok." GSK also launched a public TV commercial for the whooping cough vaccine Boostrix this year. Since the main target of Boostrix is adults over 50, we decided to be the main model as actor Seong Dong-il. GSK emphasized the importance of vaccination by arousing the attention of silver generations to whooping cough with Boostrix advertisements. GSK introduced various versions of Boostrix advertisements, and raised consensus with the camping entertainment program" the Wheeled House Camping Edition' starring Sung Dong-il. Pfizer Pharmaceuticals selected actor Choi Gwi-hwa as a new model for the pneumococcal vaccine PREVENAR13 in November of last year. As interest in pneumococcal vaccine increased amid the COVID-19 crisis, a public TV advertisement was held in two years. Choi Ki-hwa, with his wife, child, and grandparents going to receive PREVENAR13, appealed to the point that it is a vaccine that is suitable for the whole family. The number of vaccine advertisements, which had not been in public marketing until now, has increased, but the widely-known flu vaccine advertisement has somewhat slowed down. In 2019, GSK, GC Pharma, and SK Bioscience showed active public advertisements, led by actors Cha In-pyo and Yoon Se-ah, but last year the frequency of advertisements decreased significantly. Sanofi Pasteur was the only one to run an advertisement with singer Song Ga-in as a model for Vaxigrip. It is analyzed that this was affected by the widening of NIP targets due to COVID-19.
- Company
- Cherry Huang to succeed Jenny Zheng as head of Janssen Korea
- by Eo, Yun-Ho May 07, 2021 06:01am
- Janssen will continue to have a foreign leader head its Korean subsidiary. According to industry sources, Janssen Korea has appointed Cherry Huang as the next CEO of Janssen Korea to take Jenny Zhuang’s place after Zhuang’s term ends in April. Cherry Huang, who is currently the CFO of Janssen Asia Pacific, will be leading Janssen Korea from June this year. Hwang had served over 20 years in Johnson & Johnson since 1997 and has held various finance roles within the company. She had built her career in finance in various regions including in the Southeast Asian cluster, China, and Singapore. With Jenny Zhuang’s transfer, the board of directors (BOD) of the Korean Research-based Pharmaceutical Industry Association has also undergone some change. Following the resignation of Jenny Zhuang as director, KRPIA appointed Hye-young Lee, CEO of Viatris Korea as its new board director. Zheng has served as the Area Managing Director of Janssen Korea/Taiwan/Hong Kong since 2018. She holds a Bachelor of Engineering, Naval Architecture degree from Shanghai Jiao Tong University, and completed her Master of Business Administration (MBA) with Honors from the University of Chicago Booth School of Business.
- Company
- “Evenity is effective in patients at very-high-risk of OP"
- by May 07, 2021 06:01am
- The strategic paradigm for osteoporosis treatment has shifted. Compared to the past where not many patients were treated for osteoporosis and those who were treated used bone resorption inhibitors like bisphosphonate, a more aggressive treatment paradigm has landed in the field of osteoporosis treatment. The development of new drugs had triggered such changes in the treatment trend. Unlike bone resorption inhibitors, the only option patients used to have as a bone-forming agent was teriparatide; however, the introduction of Amgen’s ‘Evenity (romosozumab)’ brought all the difference. Evenity is the first and only bone builder with a dual mechanism of action that increases bone formation and inhibits bone resorption. With the introduction of this promising new drug, the American Association of Clinical Endocrinology∙American College of Endocrinology (AACE∙ACE) newly defined a Very-high-risk group for osteoporosis fractures by revising the 2020 guidelines for the diagnosis and treatment of postmenopausal osteoporosis, to recommend aggressive drug treatment from early on. Dailypharm met with Dr. Felicia Cosman, professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons, to hear about the latest advances and trends in the treatment of osteoporosis. Professor Felicia Cosman. Dr. Cosman is explaining the latest advances in the treatment of osteoproosis in a virtual webinar held on the 4th. (Pic. From the virtual interview) -- Last year, the international guideline newly defined the 'very-high-risk group for osteoporosis fracture' and presented different treatment strategies according to the patient’s level of risk. Could you tell us the background and specifics of the revised guideline? =Academic societies in Korea and abroad have newly defined patients with high risk of fractures as a ‘very-high-risk group for osteoporosis fracture’ and recommends bone-forming agents to be more effective in increasing bone strength. These group of patient can be considered ‘at emergency of osteoporosis’ and are at high risk of experiencing fractures in the near future. The international osteoporosis foundation defined the very-high-risk group for osteoporosis fracture as ‘patients with a 10% or higher probability of experiencing fractures within 2 years.’ Also, according to a retrospective cohort study by Professor Balasubramanian that researched 377,561 women that are 65 years or older who recently experienced fractures, the cumulative risk of subsequent fractures in these women were 10% and 18% in 1 and 2 years, respectively. One notable fact is that the risk and area of subsequent fractures varied according to the initial fracture site. Patients with initial vertebral fracture had the highest risk of refractures at 14%, and those with initial ankle fracture had the lowest risk at 5%. However, as the 2-year risk of refracture in patients with ankle fractures was also 10%, these patients were also categorized as a very-high-risk group. Multiple fracture patients are also classified as a very-high-risk group, regardless of their recent fracture events. This very-high-risk group should use bone-forming agents from early on for rapid bone formation. In the past, bone resorption inhibitors were considered as the first treatment option for these patients; however, the paradigm has shifted to using bone-forming agents from early on. -The new guidelines recommended 4 kinds of treatment strategies for the very-high-risk group. Evenity, which shows a dual effect to increase bone formation and inhibit bone resorption, was also first recommended in the revised guidelines. What is your opinion on this, and how should we devise treatment strategies using the recommended therapies? =As I mentioned before, the paradigm has changed to acknowledge that starting treatment with bone-forming agents like Evenity, followed by bone resorption inhibitors may be more effective for bone formation. This is why Evenity was also included as an option in the new guideline. There aren’t many head-to-head studies on Evenity and teriparatide; however, there is one that was published on NEJM in 2014. The Phase II trial that studied women aged 55 to 85 with low bone mineral density showed that Evenity had improved the BMD in hip, femoral neck and spine more than teriparatide. Evenity also had a higher effect in increasing bone density compared to teriparatide in the hip and spinal area a follow-up study, In practice, the approach needs to be set differently for each patient. For example, a patient in his/her 60s who had experienced spinal fracture may have a low BMD in his/her spine, but a normal BMD in the hip area. If the patient has no other risk factors, he/she may choose to use teriparatide. -As the lead author of the Phase III FRAME (FRActure study in postmenopausal woMen with ostEoporosis) trial, you found that Evenity-Prolia was more effective in reducing the risk of fracture than placebo-Prolia. =The FRAME study compared patients treated with Evenity and placebo for 1 year, both followed by Prolia for 1 year to assess the risk of fractures. Study results showed that at month 12, Evenity reduced the risk of new vertebral and all clinical fracture risk by 73% and 38%, respectively, compared to placebo. Also, patients treated with Evenity saw a mean percent increase in BMD over placebo of 13.3% at the lumbar spine, 6.8% at the total hip, and 5.2% at the femoral neck. This is a superior increase in BMD compared to both mono and dual therapies. Based on such results, the researchers were able to reconfirm that Evenity is the top priority treatment option for patients at very high risk of fractures as it quickly reduces the risk of fractures while increasing bone formation. In particular, Evenity is more suitable for patients with a low BMD in the hip and nonvertebral areas, as well as the vertebrae area. -Despite Evenity’s potency, why do patients need to switch to Prolia after 1 year? Could patients who saw much benefit from Evenity extend their treatment period? =The treatment period reflects the results of the Phase II trial on Evenity. In the Phase II trial, Evenity showed a very high bone-forming effect for 1 year. After that, its effect was comparable to those of bone resorption inhibitors. While no additional benefits were seen in the second year of Evenity treatment, such as an increase in bone mass, patients who switched to Prolia after 1-year of Evenity treatment saw the better effect. Based on such findings, the 1-year treatment period was deemed reasonable considering the administration cycle and number. -- What are your thoughts on the risk of adverse cardiovascular events that were added to the indications in Europe, U.S., and Korea? =The only clinical study on Evenity that presented adverse cardiovascular events was the Phase III ARCH trial that compared Evenity with alendronate. In the study, a higher rate of major adverse cardiac events (MACE), which is defined as the composite of cardiovascular deaths, myocardial infarction, or stroke, was reported at week 12 in patients treated with Evenity (2.0%, 41/2,040 participants) compared to those treated with alendronate (1.1 %, 22 /2,014 participants). However, when including heart failure events, there was no significant difference in MACE between the two groups. In conclusion, the risk and benefits that each patient may see from using Evenity need to be analyzed and compared. Of course, the decision must comply with the recommendations set in the approval process. In the U.S., use of Evenity is restricted for patients that are at very high risk of experiencing cardiovascular events. This includes patients who have experienced strokes or myocardial infarction within 1 year. -In Korea, the reimbursement standards directly affect treatment strategy. In consideration of the reimbursement standards currently set for Evenity in Korea, what areas do you think require further discussion? = When I saw Korea’s reimbursement criteria for Evenity, I wondered whether its application after 2 or more fractures was appropriate. As I have mentioned before, there is ample evidence to support the validity of prescribing Evenity even after just a single fracture. Also, the criteria that first requires the use of bisphosphonates is quite similar to the pre-revised international guideline. The problem is that prescribing bone-forming agents after the use of bisphosphonates doesn’t provide as good an effect in reducing fractures. Korea also needs to consider the paradigm shift in osteoporosis treatment that has already begun. In the past, the global consensus was to first use bisphosphonate; however, this has completely changed now. With the introduction of Evenity, it has been recognized that the right time to use bone-forming agents for optimal effect is in the early stages when patients are identified to be at very-high-risk of fractures.
- Product
- Pharmacists & employees in their 20s receive Pfizer vaccine
- by May 07, 2021 06:01am
- Pharmacists and employees under the age of 30 who were excluded from the AZ vaccination are expected to receive the Pfizer vaccine next month. The KCDA announced on the 4th that the Pfizer vaccine for social essential personnel and military soldiers under the age of 30 who have been suspended from vaccinating AZ vaccine due to "thrombotic side effects" will begin in June. According to statistics of the Korea Institute for Pharmaceutical Policy affairs, 1,784 pharmacists under the age of 30 have completed their personal reports to The Korean Pharmaceutical Association, and 2,000 including pharmacists who have not reported. "Pharmacists are also among the essential social workers," a pharmacist said. "We have not yet been informed of specific vaccination personnel by the KCDA, but pharmacists and employees under the age of 30 who were excluded from the vaccination will be vaccinated this time." According to COVID-19 vaccination status released byCOVID-19 vaccination task force, 197,092 out of 335,017 people who were vaccinated as of midnight on the 2nd completed the vaccination rate, recording 58.8%. If this includes personnel who will receive the Pfizer vaccine, the inoculation rate is expected to increase slightly.
- Policy
- 40 new drugs licensed last year
- by Lee, Tak-Sun May 07, 2021 06:01am
- Last year, a total of 40 new drugs were licensed in Korea, with five items manufactured by domestic pharmaceutical companies. One item of Yooyoung Pharmaceutical Co., Ltd.'s anti-arthritis treatment and four items of Hwanin Pharmaceutical Co., Ltd. were listed as new drugs. Rare drugs have also been licensed, up sharply from the previous year. The expedited review of treatments such as Remdesivir was also made due to the epidemic of COVID-19 infectious diseases. Domestic pharmaceutical companies were found to have been active in developing salt modified drugs for compounding drugs and patent avoidance purposes. The MFDS announced that it published the "Approval report of 2020 drugs" on the 30th of last month, which contains the current status of drug approvals and reports for the previous year. A total of 3,496 drugs were licensed and reported last year, with 40 new drugs, 24 rare drugs, 6 new drugs developed in Korea, and 2 equivalent biosimilar drugs developed in Korea. Last year's major characteristics of licensed medicines include ▲ expedited review of COVID-19 treatments ▲ increase in rare drug permits ▲ increase in new drug product permits ▲ the largest proportion of licensed drugs. In July last year, the MFDS quickly approved the COVID-19 treatment "Veklury (Remdesivir)" (Gilead Science Korea) as an imported medicine for stable treatment of domestic patients. This is an example of a preemptive response to the national health crisis and establishing a system to supply medical supplies. Rare drug approval has also increased significantly. The number of rare drug item permits declined slightly from 34 items in 2016 to 11 items in 2019, but it turned upward last year and 24 items (14 active ingredients) were licensed. This is believed to be due to the industry's sufficient compliance with the requirements for submission of item permits for rare drugs, which were strengthened under the revised regulations in July 2015, and the level of safety management for rare drugs has also increased. The number of new drugs has been steadily increasing since 40 items were licensed last year, with 35 new imported drugs and five new domestically manufactured drugs being licensed. The new drug was licensed from 15 items (12 ingredients) in 2018 to 35 items (21 ingredients) in 2019 and 40 items (20 ingredients) in 2020. 34 items of chemicals and 6 items of biological drugs (all imported) were licensed, and 13 items of anti-cancer drugs were licensed by the medicinal group, accounting for a high proportion of 32.5% of the total. New drugs developed in Korea decreased from a year earlier to six items, but biosimilars were licensed for two items, similar to the previous year. Five new chemo drugs in Korea are one treatment for slime arthritis and four anti-epidemic drugs, while six new biomedical drugs include PNH treatment and macular degeneration treatment. Permits for "new products" were also increased last year. Of the 326 items subject to the safety and validity review last year, 182 items (55.8%) were licensed and developed intensively, with 154 items (84.6%) containing Rosuvastatin calcium for hyperlipidemia. The development of drugs using new salts or isomers ,which are used for patent avoidance purposes, also increased sharply from two items in 2019 to 74 items in 2020. This is due to the development of a new salt for active ingredients used in diabetes drugs, which is analyzed to be due to the industry's strategy to preempt the diabetes drug market. Of the total 3,110 licensed items, "blood circulation medicine," which includes "HTN treatment," was the most licensed item with 581, accounting for 18.7%. This is similar to 902 items licensed in 2019, accounting for 18.8 percent of the total, and it is analyzed to be due to the continued expansion of the blood pressure drug market, including aging population. 554 fever, pain and anti-inflammatory drugs (17.8%), 425 digestive medicine (13.7%), 337 other metabolic and diabetic drugs (12.1%), 121 blood and body medicine (3.9%), 102 allergy drugs (3.3%), and 95 antibiotic drugs (3.1%) were licensed.
- Policy
- The National Assembly is trying to enact GMP legislation
- by Lee, Jeong-Hwan May 06, 2021 06:07am
- As domestic pharmaceutical manufacturers' GMP (Good Manufacturing Practice) violations occur one after another, the National Assembly and the MFDS are struggling to prevent recurrence by strengthening regulations. The National Assembly is considering reinforcing the administrative disposition of pharmaceutical companies violating GMP through the legalization of the Ordinance of the Prime Minister and the Pharmaceutical Affairs Act of the GMP regulation, which is operated by public notice, and the MFDS is trying to organize a special planning inspection team regularly and operate it on a regular basis. On the 4th, the National Assembly and the MFDS are discussing to resolve the problem of GMP violations in Binex, Vivozon, and Chong Kun Dang. The National Assembly is reviewing a bill that raises the current GMP regulations, centering on members of the Health and Welfare Committee. Currently, the MFDS is issuing a GMP conformity certificate based on the Ordinance of the Prime Minister, the safety regulations for pharmaceuticals. Other detailed GMP regulations are managed by administrative regulations. The National Assembly is preparing to legislate as it is necessary to raise and legislate the GMP regulations to the Pharmaceutical Affairs Act rather than administrative rules due to the illegal manufacturing situation of domestic pharmaceutical companies. It is to raise the GMP regulations and conformity assessment to the Pharmaceutical Affairs Act and to establish a legal basis for the cancellation of GMP certification for pharmaceutical companies that violate the regulations. Some pharmaceutical companies' discretionary manufacturing will strengthen the overall pharmaceutical industry's GMP regulations and penalties for violations. The MFDS is planning to request an increase in manpower for the regular organization and regular operation of the GMP special planning and inspection team for pharmaceutical manufacturing establishments, and taking this voluntary manufacturing situation as an opportunity to monitor pharmaceutical manufacturing establishments at any time to strengthen quality control. Currently, the MFDS operates a GMP special planning and inspection team as a TF composed of two teams. In addition, the factory's intentional and unethical illegal activities are being detected. It is the duty to detect acts such as changing the permission information or falsely writing or concealing manufacturing records without approval from the MFDS. The MFDS will appeal to the National Assembly and related ministries about the need to increase manpower in order to incorporate regular personnel in the planning and inspection team in the future. An official in the National Assembly's Health and Welfare Committee said, "The issue of GMP violation has had a significant impact on the overall pharmaceutical industry in Korea, and various changes have occurred. It influenced the legislation of the National Assembly, and the pharmaceutical association and the pharmaceutical industry reflected on themselves.The National Assembly is determining the need to strengthen GMP regulations." He added, "It is a violation of some pharmaceutical companies, but the necessity of strengthening GMP regulations has been steadily raised. If additional legislation can prevent recurrence of drug quality problems, it is a situation that should be discussed prospectively while avoiding over-regulation."
- Company
- Why SK and GC's deal for Xarelto exclusivity right misfired
- by Kim, Jin-Gu May 06, 2021 06:07am
- SK Chemicals's discussions with GC Pharma on handing over the exclusivity rights of Xarelto (rivaroxaban) had broken down in the end. The reason is known to be that the scope of the patent avoided by SK Chemicals does not match the composition of the generic developed by GC Pharma. According to industry sources on the 5th, the sale of the exclusivity rights of Xarelto between SK Chemicals and GC Pharma ended in misfire. The two companies had been discussing selling the exclusivity rights of Xarelto. GC Pharma's intent to enter the generics market 9 months earlier than other companies seemed to be in line with SK Chemicals's intent to sell its exclusivity rights. However, the discussion ended in a misfire. Officials from both companies stated, “It is true that there had been discussions, but the deal was broken off.” The industry points to the scope of a patent avoidance that SK Chemicals owns as the cause of the breakdown. SK Chemicals, along with Hanmi Pharmaceutical, succeeded in avoiding the composition patent for Xarelto 2.5mg. After winning the first trial in November 2015, the companies obtained the exclusivity right through the first Marketing Authorization Application (MAA) in July of the following year. However, the scope of the exclusivity right the two companies have obtained was limited to the 2.5mg dosage. The component patent of the remaining doses of Xarelto, 10mg, 15mg, and 20mg, had not been registered by Bayer in the first place. When filing for patent avoidance of Xarelto's composition patent, the argument of SK Chemicals and Hanmi Pharmaceutical was that its "manufacturing process was different from the original.” The original tablet is manufactured through a wet granulation process after suspending rivaroxaban in a hydrophilic binder. On the other hand, the generics developed by SK Chemicals and Hanmi Pharmaceutical are made by first spray drying the lactose hydrate and hypromellose+solvent solution into fine powder instead of granules, then adding excipients for tablet manufacturing, followed by compression and tableting. The Intellectual Property Trial and Appeal Board (IPTAB) and the court acknowledged the significant difference in manufacturing and ultimately ruled that SK and Hanmi's generic does not violate the original’s scope of patent. However, the problem was that this manufacturing method was different from the method used in the generic that was self-developed by GC Pharma. As GC Pharma's generic was manufactured in a different way than the one that was acknowledged as 'different from the original drug' by IPTAB, GC Pharma would not be able to exercise the exclusivity rights even if they purchased it. So, GC Pharma either had to develop a new generic with the method through which SK Chemicals avoided the original patent or give up the deal. GC Pharma's decision was to give up the deal. “The two companies started negotiations without specific knowledge of the scope of the exclusivity right, so the deal eventually ended up nowhere,” explained a pharmaceutical industry official. On whether to proceed with the sale of exclusivity rights of Xarelto with other companies, an official from SK Chemicals said, “We haven’t yet made other deals after discussions with GC Pharma had broken down.” According to the pharmaceutical market data research firm UBIST, the outpatient prescription sales of Xarelto recorded 50 billion won last year. This was a 1% decrease from the 50.8 billion won in 2019. In the first quarter of this year, 11.9 billion won worth was sold. In the new oral anticoagulant (NOAC) market, Xarelto stands in second place after Lixiana and is followed by Eliquis and Pradaxa.
