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- 2026-05-15 04:35:15
- Policy
- Oxiracetam’s next...ordeal of brain function enhancers
- by Lee, Tak-Sun Aug 09, 2022 05:56am
- Korean Drug Co.’s It’s a time of ordeal for brain function enhancers. In addition to choline alfoscerate, whose scope of use has been reduced through reimbursement reevaluations, acetyl-L-carnitine failed to demonstrate its efficacy during clinical reevaluations. As a result, acetyl-L-carnitine is expected to completely disappear from the prescription market. Oxiracetam, which accounts for the third-largest share of the brain function enhancer market, is set to receive clinical reevaluations and reimbursement reevaluations soon. If oxiracetam also takes a blow, industry officials predict that the brain function enhancer market itself will greatly retract. On the 5th, the Ministry of Food and Drug Safety announced that it will suspend prescriptions and dispensing of acetyl-L-carnitine as the drug failed to demonstrate its efficacy in ‘secondary degenerative diseases caused by cerebrovascular disease’ during clinical reevaluations. In other words, acetyl-L-carnitine was unable to prove its efficacy in the indication. Acetyl-L-carnitine had previously been unable to demonstrate its efficacy for 'primary degenerative diseases' during clinical reevaluations. Being unable to demonstrate efficacy for both of its indications, the ingredient is set to be removed from the reimbursement list. Acetyl-L-carnitine had been subject to reimbursement reevaluations next year, however, if it is removed from the reimbursement list, the ingredient will naturally be excluded from reevaluations as well. The average annual claims amount of acetyl-L-carnitine over the last 3 years was ₩58.1 billion, the second-best grossing ingredient in the brain function enhancer market next to choline alfoscerate, which boasts a market size of ₩500 billion. The problem is that the next-in-place brain function enhancer is also up for reevaluations soon. The drug up for the next reevaluation is oxiracetam, which is represented in Korea by Korean Drug Co.’s Neuromed tablet. Clinical reevaluation reports for oxiracetam are also due for submission by the end of this year. Like other ingredients, oxiracetam’s indication for improving Alzheimer-type dementia had also been deleted due to the inability to demonstrate its efficacy, and a clinical reevaluation is being conducted to verify its efficacy for the remaining indication, for the 'improvement of vascular cognitive disorder symptoms.’ If the year-end reports submitted are unable to verify the drug’s efficacy in the remaining indication, the prescription and dispensing of oxiracetam will likely be discontinued, just like in acetyl-L-carnitine's case. However, another great obstacle remains even after verifying the clinical efficacy as oxiracetam is also subject to reimbursement reevaluations next year. Oxiracetam’s 3-year average claims amount is ₩23.3 billion, less than that of choline alfoscerate or acetyl-L-carnitine. But as Neuromed raised ₩11.5 billion in prescriptions last year, the amount earned in terms of each item is by no means small. If oxiracetam also suffers a blow from that reevaluation, all the main brain function enhancers will be reduced reimbursement or removed from the reimbursement list, thereby contracting the total market. Brain function enhancers have been widely used to prevent dementia in elderly patients and have well served as a cash cow for domestic pharmaceutical companies. Reimbursement for choline alfoscerate was maintained through the reimbursement reevaluations that were conducted to verify the drug’s efficacy in dementia in 2020. However, the patient coinsurance rate for the main indication in improving cognitive disorders rose from 30% to 80%, and was applied selective reimbursement. Despite this, the previous reimbursement rate is being applied because some of the affected companies appealed the decision, and filed for a stay of execution of the reimbursement reduction disposition. However, Chong Kun Dang and the other companies lost the suit that they filed to cancel the reimbursement reduction, and the stay of execution will be lifted soon. Also, the fact that the companies must demonstrate their drug’s efficacy through clinical reassessments by 2025 will add a significant burden on the companies.
- Opinion
- [Reporter's view] COVID-19 vaccination strategy
- by Aug 09, 2022 05:56am
- The MFDS has begun a preliminary review of the vaccine for COVID-19 in Moderna and Pfizer. The preliminary review is to review the submitted clinical data in advance and to quickly determine whether to grant permission when the company applies for an item permit by adding non-clinical and quality data in the future. The divalent vaccine, which Moderna and Pfizer applied for a preliminary review, is a vaccine that expresses each antigen for the initial coronavirus (Wuhan) and the omicron mutation virus BA. It is a combo vaccine that combines two antigens in half, and the two companies began developing it early this year and announced major clinical results in June. The two vaccines were found to have produced more neutralizing antibodies to omicron mutations than conventional vaccines. The problem is that BA.5, an omicron subvariant, spread rapidly and became dominant in Korea. According to the detection rate of major mutant viruses compiled by the Korea Centers for Disease Control and Prevention, the BA.5 detection rate in the fourth week of July was 66.8%, up 10.5 percentage points from the previous week. It became the dominant species 11 weeks after the first BA.5 stool confirmed in Korea on May 12. Modena and Pfizer's divalent vaccine basically expresses antigens against the circular omicron virus, so it has a higher preventive effect on sub-variations than conventional vaccines. However, it was relatively ineffective as it targeted BA.1. According to the announcement of the two companies, the neutralization value of the bivalent vaccine for BA.4/5 was one-third of the number shown in the BA.1 mutation. That's why the FDA has demanded that Moderna and Pfizer develop a new vaccine containing BA.4/5 which is included. At that time, sub-variations were spreading rapidly in the United States, so the FDA seems to have decided that it was necessary to target these mutations. The two companies are focusing their efforts on developing a new vaccine targeting submutation of omicron. South Korea should also consider what vaccination strategy to establish at a time when the omicron submutation has become the dominant species. The FDA is showing its willingness to inoculate vaccines targeting submutations even while minimizing clinical trials of the new vaccine. If there are more BA5 confirmed patients in Korea, the introduction of a BA4/5 vaccine should be accelerated. At the same time, there are differences between the U.S. and Korea. The United States, the mainland, spends the least time getting permits and vaccines. The U.S. health authorities have already signed a purchase contract for the BA.4/5 vaccine with Moderna and Pfizer. On the other hand, South Korea has relatively late permits, contracts, and domestic introduction schedules. A situation beyond the end of this year may occur. Unlike the United States, which has not been approved for a divalent vaccine, Korea needs to have an alternative solution called a divalent vaccine for omicrons. Health authorities should benefit the public most through reasonable choices within limited time and resources.
- Company
- Baxter International’s GM Dong-Wook Hyun suddenly resigns
- by Eo, Yun-Ho Aug 09, 2022 05:56am
- Former General Manager Dong-Wook Hyun Dong-Wook Hyun, General Manager of Baxter International Korea, resigned. According to industry sources, Hyun submitted his letter of resignation last month and left the company. The exact reason for his resignation remains unknown. With Hyun’s resignation, Baxter is now seeking a new head, during which Kwang-hyuk Im, Vice President of Renal Care at Baxter Korea, will be acting as interim CEO. The former GM Dong-Wook Hyun graduated from the University of California in the U.S. with a degree in Biology and Bioscience. Hyun accumulated extensive experience in the industry, beginning at the medical device company Medtronic from 1999 to 2004. After serving various posts in sales and marketing in the Asia-Pacific region, Hyun was appointed the Country Manager of Medtronic. Since then, Hyun served as the General Manager of Baxter from 2004 to 2008, and then as the Managing Director of MSD Korea for 8 years, after which he was again appointed as the General Manager of Baxter Korea in 2018. Meanwhile, Baxter is a global healthcare company based in the U.S. that entered the Korean market with its hemodialysis business in 1972. The company established its Korean subsidiary in 1991 and has been supplying pharmaceuticals such as anesthetics, intravenous nutrition, etc. as well as medical devices including peritoneal dialysis solutions and automated peritoneal dialysis systems to Korea.
- Policy
- It's hard to prescribe oral medicine for COVID-19
- by Kim, Jung-Ju Aug 09, 2022 05:56am
- Amid the remarkable re-proliferation of COVID-19, the newly proposed National Infectious Disease Crisis Response Advisory Committee advised medical staff to create detailed guidelines for prescriptions in consideration of difficulties in the dispensing process. The National Advisory Committee on Infectious Disease Crisis Response (Chairman Chung Ki-seok) held the 3rd National Advisory Meeting on Infectious Disease Crisis Response on the 4th to discuss such issues. The third meeting was attended by 21 members of the National Advisory Committee on Infectious Disease Crisis Response, including Chairman Chung Ki-seok, the Central Disease Control Headquarters, and the COVID-19 Vaccination Response Promotion Team. The advisory committee first said that in-depth analysis of related cases should be added to establish a data-oriented quarantine policy as re-infected cases and deaths of children and adolescents are being confirmed in relation to the current epidemic. In the prediction of trends, it was asked to create a system that allows a number of research teams to conduct systematic mid- to long-term modeling research that reflects various policy effects beyond supporting the results of mathematical modeling-based predictions. In the case of PO treatments, the operation status of the currently operating one-stop medical institution was checked so that patients visiting the hospital could be prescribed and treated in a timely manner to discuss the need for a system in which all citizens are guaranteed proper COVID-19 treatment services without inconvenience. In particular, the advisory committee said that guidelines should be drawn up so that medical institutions can pay close attention to the on-site procedures and processes of pharmacies that prepare eating treatments. In fact, unlike ordinary dispensing patients in pharmacies, the preparation and medication guidance for COVID-19 oral preparation patients are complicated, and the billing method is differentiated from other health insurance, so it takes a lot of time and requires concentration. In response, the advisory committee reviewed, "The government should also try to expand medical institutions and pharmacies, but it is necessary to produce and distribute detailed prescription guidelines to medical staff so that they can help in the medical field." He suggested that the system needs to be checked and prepared so that children wishing to be vaccinated can be vaccinated quickly as the number of COVID-19 children and adolescents has increased since the Omicron epidemic.
- Company
- Korean companies win first round of Entresto patent suit
- by Kim, Jin-Gu Aug 08, 2022 06:09am
- Pic of Entresto. The first patent dispute over Novartis’s heart failure treatment ‘Entresto (valsartan+ sacubitril) ended with the victory of the Korean generic companies. The exclusive market approval (first generic exclusivity) that received attention is expected to be granted to 10 companies including Hanmi Pharmaceuticals, with the possibility of Daewoong Pharmaceuticals additionally receiving generic exclusivity. However, the industry analysis is that there remain risks for the generic companies' early release of Entresto latecomers as the original company Novartis has announced its plan to appeal, and separate legal disputes such as patent infringement suits and injunction applications are still ongoing. ◆10 companies overcome the fourfold patent hurdle…meets first generic exclusivity requirements According to industry sources on the 28th, the Intellectual Property Trial and Appeal Board ruled in favor of the generic companies in the 2 trials to confirm the passive scope of rights of Entresto’s composition patent that was filed by 9 companies including Chong Kun Dang against Novartis. Nine generic companies including Chong Kun Dang, YooYoung Pharmaceutical, Hanlim Pharm, Hana Pharm, Ahn-Gook Pharmaceutical, Genuone Sciences, GenuPharma, Samjin Pharm, Elyson Pharm received the favorable ruling. With the ruling, on which companies will be receiving generic exclusivity has been somewhat revealed. Hanmi Pharmaceuticals was the first company to overcome all 4 of Entresto’s patents, and with the addition of the 9 companies that received the recent ruling, a total of 10 companies have now paved the way for the early release of their generics. The companies have obtained the ‘first to request for trial’ requirement by filing claims from January 2021. In April, the companies also applied for generic marketing authorization together and fulfilled the ‘application for first latecomer drug approval’ requirement as well. By ‘winning the patent suit,’ the companies met the last requirement to receive first generic exclusivity. The companies would now only need to receive official approval from the Ministry of Food and Drug Safety. Also, Daewoong Pharmaceuticals may also additionally secure first generic exclusivity. Daewoong Pharmaceuticals succeeded in invalidating or avoiding 3 of 4 Entresto’s patents. The company is currently challenging Novartis to invalidate the last remaining patent, and if Daewoong wins the last suit, the company will also be able to satisfy all of the first generic exclusivity requirements like the other 10 companies. The ruling on the trial is expected to be made within this month. ◆"Non-listed and newly-listed patents remain risk factors on the safe release of generics" The industry evaluates that Entresto’s patent dispute has virtually been settled with the generic companies’ win in the first trial. However, there is also an analysis that risks remain for the early release of the generic companies’ generics despite the complete victory they had made in the first round. The biggest risk factor is Novartis’s appeal. Novartis appealed against the first trial ruling and filed a suit for the annulment of the first trial decision, taking the case to the second trial. The company may likely file appeals for the other cases that it had not yet appealed to as well. If the first trial decision is reversed in the second trial, the early release of generics by generic companies will be reinterpreted as patent infringement. In this case, Novartis will file claims for damages on the patent infringement to the companies. In line with this, the generic companies need to overcome the patent infringement suit and the injunction application filed by Novartis to the Seoul Central District Court and others. Novartis filed a suit against the generic companies for infringing Entresto’s patent, and also filed an injunction requesting that the release of generics be banned until the results are made. The results of the injunction application are yet to be released. On the generic companies’ part, Novartis’s remaining non-listed and newly listed patents remain a burden. In the case of Entresto, 2 other patents remain in addition to the 4 patents that generic companies have now overcome. One of the 2 remaining patents is a salt·hydrate patent that was not listed in the patent register. This patent is set to expire in November 2026. Daewoong Pharmaceuticals, Hanmi Pharmaceuticals, and Elyson Pharm have challenged the patent, and a ruling has not been made yet. The other patent is a newly listed use patent that was registered after the generic companies applied for marketing authorization. The new patent will expire in August 2033, and no company has yet challenged the patent. The generic companies can release their generics without avoiding or invalidating the two patents. The two remaining patents will not affect the companies’ acquisition of first generic exclusivity. However, there is the possibility that the court may make a patent infringement judgment apart from the Intellectual Property Trial and Appeal Board’s ruling based on those two patents. From the generic companies’ point of view, the companies cannot rule out the concern over compensation for damages that may arise from this patent infringement. An industry official said, “Entresto is protected with several layers of patents, and generic companies have to bear the burden of overcoming all the patents; On the other hand, Novartis can prevent the early release of its generics even if it wins only one of all of its disputes.” Entresto’s ongoing patent dispute is the largest single product lawsuit in progress in the Korean pharmaceutical industry. 20 Korean companies have filed trials to confirm the passive scope of rights and patent invalidation trials on 4 patents. Novartis countered the suits by filing patent infringement and injunction applications to the Seoul Central District Court. The number of trials and litigations related to Entresto patents that have been filed with the Intellectual Property Trial and Appeal Board, the Patent Court of Korea, and the Seoul Central District Court has reached 130.
- Company
- Revised guidelines for dyslipidemia in Korea
- by Eo, Yun-Ho Aug 08, 2022 06:09am
- In the management of dyslipidemia, it is believed that drug prescriptions will be more aggressive in Korea. In April, The Korean Society of Lipid and Atherosclerosis unveiled some of the contents of the fifth edition of the 2022 dyslipidemia treatment guidelines at the Spring Conference, and will officially announce it in September. What is noteworthy in the new guidelines is that patients with Chronic kidney disease stage 1-3 are considered to be at high risk, and a reduction in low-density lipoprotein cholesterol (LDL-C) is recommended as a basic treatment goal. In 2017, the American Association of Clinical Endocrinologists (AACE) established an extreme risk for cardiovascular disease and recommended that LDL cholesterol be adjusted to less than 55 mg/dL (future unit omitted). The 2019 European Society of Cardiology (ESC) has emerged as an important issue, with LDL-C levels in extreme risk groups considering up to less than 40. On the other hand, in 2018, Korea stuck to the LDL-C treatment target of the ultra-high-risk group at 70. The guideline recognized the need to actively reduce LDL-C for high-risk patients in the trend that "The lower is the better," and the lower the LDL-C level, the higher the cardiovascular disease-related benefits. Drugs that are expected to increase their utilization are Ezetimibe and Atorvastatin. If 70 is viewed as an ideal number, it is correct that Ezetimibe has less needs in primary treatment. However, if LDL-C reduction is targeted in CKD patients, Ezetimibe combination therapy is more likely to be supported as statin alone therapy may not be achieved. The fact that Atorvastatin's mechanism of action is excreted as a liver rather than a kidney is also likely to act as an advantage. Atorvastatin, including Lipitor, is not affected by the plasma concentration or LDL-C reduction effect depending on whether it is a kidney disease, so you can freely select it without having to adjust the dose when administered to the patients.
- Policy
- MFDS beings rolling review of Pfizer’s multivalent vaccine
- by Lee, Hye-Kyung Aug 08, 2022 06:09am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyoung Oh) announced that it had started a rolling review on the clinical trial data that Pfizer Korea submitted on the 5th for its COVID-19 vaccine ‘Comirnaty2 Inj. 0.1mg/mL.' Comirnaty2 Inj. 0.1mg/mL. is a multivalent mRNA vaccine that presents antigens for both the original COVID-19 virus (Wuhan strain) and its variant virus (Omicron strain, BA.1) that was developed as a booster vaccine to be received after primary vaccination. The MFDS plans to promptly and closely review the submitted clinical data. When the company applies for marketing authorization and additionally submits non-clinical data and quality data, the MFDS will promptly and closely review the data, and seek experts' advice on the safety and efficacy of the vaccine under review, including infectious disease specialists. The vaccine is also under rolling review in Europe and other countries. The MFDS said, “We will continue to make our best efforts to supply safe and effective vaccines to our people.”
- Policy
- 500 billion won in K-Bio and Vaccine Fund was created
- by Kim, Jung-Ju Aug 08, 2022 06:09am
- The government has finalized a plan to create a K-Bio and Vaccine Fund" worth a total of 500 billion won this year and has started selecting operators. In the future, the government plans to expand the scale to around 1 trillion won. The MOHW (first vice minister Cho Kyu-hong) announced on the 4th that it will report and confirm the plan to create a K-bio and vaccine fund at the emergency economic welfare meeting on July 27 and launch a public offering for the fund formation as a follow-up measure. To form the fund, the MOHW will announce the selection of operators to operate the fund through Korea Venture Investment from the 4th to 2 p.m. on the 26th, and hold a briefing session for fund managers online and offline on the 9th to guide them in detail. Looking at the purpose and plan of fund creation, the K-Bio and Vaccine Fund is designed to develop new global innovation drugs for domestic pharmaceutical companies, enhance competitiveness in the vaccine industry, and enter the global pharmaceutical and bio markets. The MOHW explained that the market size of domestic pharmaceutical and bio companies, new drug development pipelines and technology exports have been increasing significantly recently, and that there is a growing appeal that there is a lack of funds needed. The government predicted that the demand for funding will increase as domestic vaccine and therapeutic agent companies have investment plans such as production facilities worth about 13 trillion won by 2026. In fact, Samsung BioLogics is planned to have 8.74 trillion won, Lotte Biologics 1 trillion won, SK Bioscience 500 billion won, EuBiologics 101.5 billion won, and Amicogen 876 billion won. The K-Bio Vaccine Fund will be created with a total of 500 billion won, including 100 billion won in government investment, 100 billion won in government-run banks (Korea Development Bank, Export-Import Bank, and Industrial Bank) and 300 billion won in private investment. Among them, 50 billion won in government budgets and 50 billion won in existing fund profits, 45 billion won in KDB Development Bank, 30 billion won in Export-Import Bank of Korea and 25 billion won in IBK Industrial Bank of Korea will be invested. The fund's main investment targets are domestic pharmaceutical and bio companies (more than 60% of the total investment) and domestic vaccine companies (vaccine and vaccine raw materials and equipment-related companies, 15%), which can invest in late clinical trials that require large amounts of funds to create successful global innovative new drugs in Korea. Two funds worth 250 billion won will be created to quickly achieve the fund's target and investment will be initiated, and two operators will be selected. The selected operator operates the fund for eight years from the date of establishment of the fund, sets the base return (IRR) at 7%, and allows Fast-Closing to promote rapid investment execution after forming the fund. The K-Bio and Vaccine Fund management companies selected through the management company contest and the selection process in September will raise private investment funds to complete the formation of the fund within the year and conduct full-scale investment from the end of the year. Lee Ki-il, the second vice minister, said, "We plan to expand to 1 trillion won in the future starting with 500 billion won this year." He said, "I hope this fund will serve as an opportunity to revitalize the bio-health industry, and I hope to create cases of developing innovative new drugs in Korea and leap into a world-centered country in the pharmaceutical and bio sectors."
- Company
- Nabota's sales in US in 1Q of the year were 92 billion won
- by Aug 08, 2022 06:09am
- Daewoong Pharmaceutical's botulinum toxin drug Nabota broke a new quarterly sales record in North America. Sales also improved in the second quarter following the first quarter, surpassing 90 billion won in sales in the first half. Daewoong Pharmaceutical's partner Evolus announced on the 3rd (local time) that its sales of Jubo (Nabota) reached $37.16 million in the second quarter. This is an increase of 46.3% compared to the same period last year. This quarter's sales are the highest since Navota's launch in North America in the second quarter of 2019. It surpassed 34.66 million dollars in the fourth quarter of last year, breaking a new quarterly sales record. Nabota's sales in North America in the first half of the year increased 87% year-on-year to $70.39 million. Since its launch, its cumulative sales have reached $260.2 million. Evolus is a global copyrighted partner of botulinum toxin Nabota developed by Daewoong Pharmaceutical. Since approval by the U.S. Food and Drug Administration (FDA) in February 2019, Nabota has been actively sold in North America. In particular, it resolved the negative factors by ending the International Trade Commission (ITC) dispute with Allergan and Medy Tox early last year. It has become possible to actively market Jubo without legal concerns. Navota's quarterly sales, which stood at $20 million last year, exceeded $30 million for the first time in the fourth quarter of last year. Nabota added 590 new accounts in the second quarter, securing more than 8,100 customers so far. The percentage of re-orders remains above 70%. In the first half of this year, about 180,000 Evolus Reward loyalty programs were used. Evolus is conducting more aggressive marketing. Following the creation of more than 250 million media exposures in the second quarter, it also launched the largest promotional campaign under the name of "Switch Your Tox and Love Evolus Forever" last month.
- Policy
- Supply of Children's Tylenol suspension will be normalized
- by Lee, Tak-Sun Aug 07, 2022 11:30pm
- The product license was withdrawn due to the suspension of the operation of the Jansen Hyangnam plant in Korea, but the new product re-licensed due to technology transfer will be listed as starting in August. This includes child Tylenol suspension, and attention is being paid to whether supply and demand will be normalized with new benefits, given that the product has recently been struggling to supply. According to the industry, Ultracet ER, Ultracet Semi, Ultracet Semi ER, and Children's Tylenol suspension will be newly reimbursed as of August 1. The upper limit is the same as before. Following the withdrawal of the Hyangnam plant, the permission for these products was withdrawn in the first half of last year, and the salary was scheduled to be deleted. In response, Janssen was re-approved as a new product by transferring technology to Handok in the case of three types, including Ultracet ER. Children's Tylenol suspension was also newly licensed as an imported item. Three types, including Ultracet ER, were scheduled to be removed in November and Children's Tylenol suspension in September. However, as new products are listed, prescription gaps are not expected to occur at all. Ultracet ER is a product developed directly by Janssen Korea in 2010, not by global Janssen. Since there were no imported items, Janssen Korea decided to transfer its technology to Handok, and has been taking steps. In March, a new product produced by Handok was approved, and this time, it was even paid. Children's Tylenol suspension was approved in early February as an imported item manufactured in Indonesia. However, due to difficulties in supply, products distributed in Australia were urgently introduced in May during the COVID-19 epidemic. Johnson & Johnson Korea, which distributes and sells Children's Tylenol suspension, announced that supply will be normalized in August. Attention is focusing on whether the supply will begin in earnest with this new product.
