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- 2026-05-08 22:44:26
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- The kit for precocious puberty in Korea has been stopped
- by Moon, sung-ho Dec 08, 2021 06:00am
- The increase in the number of precocious puberty patients in Korea is unusual. As the number of patients, which was 80,000 in 2015, exceeded 130,000 in 2020, there are opinions that it should now be recognized as a social problem. In response, some in the medical community and clinical sites predict that the number of precocious puberty patients will increase further as outdoor activities decrease due to the prolonged COVID-19 pandemic. Amid this situation, it has been confirmed that confusion is occurring at front-line medical sites due to the recent suspension of the supply of "diagnostic reagents" that can identify patients with precocious puberty. With the suspension of the supply of diagnostic reagents, which were the only health insurance coverage targets, even the diagnosis of precocious puberty patients, which is rapidly increasing due to prolonged COVID-19, is developing. According to the medical and pharmaceutical industries on the 4th, clinical doctors are suffering from the suspension of supply of injection items that are prescribed precocious puberty as a "diagnostic reagent" since March. The item is Relefact LH-RH supplied by Handok in Korea. As Sanofi, the original developer, decided to suspend the supply of this item in March, stock of reagents for diagnosing precocious puberty has disappeared in Korea. According to the MFDS, the import performance of Relefact LH-RH in 2020 is about 1.132.26 billion won. Considering that it was 650.58 million won in 2015, the performance has increased, but it is lower than expected. The problem is that Relefact LH-RH is the only item as a diagnostic reagent for precocious puberty. Lutrelef of Perring Pharmaceutical Korea, which can be said to be the same ingredient, has already been withdrawn from the domestic market due to the expiration of its validity period. For this reason, medical sites are unable to diagnose precocious puberty patients due to a lack of diagnostic reagents. In the diagnosis of precocious puberty, LH and FSH are measured in the blood for 2 hours at intervals of 15 to 30 minutes after administration of "sexual stimulation hormone secretion hormone." If the maximum concentration of sulfonation hormone is 5 IU/L or higher, it is judged to be activated and diagnosed with precocious puberty. , that is, "sexual stimulation hormone secretion hormone" plays a role in the diagnosis process of precocious puberty, and it is Relefact that diagnoses it. As Relefact has not been imported into Korea, it is difficult to diagnose precocious puberty nationwide, said a professor of pediatrics in a province who asked for anonymity. "As the number of precocious puberty patients has already increased rapidly through the COVID-19 pandemic, I wonder what preparation the health authorities have made." It is prescribed as an "off label" for precocious puberty, which has become difficult to diagnose. If so, how is the medical field responding to the suspension of the supply of diagnostic reagents? As a result of the coverage, it was found that some hospitals and clinics are prescribing other drugs offline as the supply of Relefact has been stopped. In fact, it has been confirmed that some hospitals and clinics apply for approval for excessive use of Ferring's Decapeptyl Depot and use it as a reagent for diagnosing precocious puberty. Decapeptyl is a specialized drug licensed for hormone-dependent prostate cancer, endometriosis and uterine myoma, central puberty early onset in girls under the age of 9 and boys under the age of 10. Another professor who runs a clinic said, "As papers have been presented that they have obtained good results in Thailand, some hospitals in Korea are already receiving health insurance benefits by submitting approval to the HIRA for the use of non-reimbursed drugs beyond the scope of reporting." In fact, the HIRA official also said, "As the supply of Relefact injections has been suspended, off-label use through Decapeptyl is being carried out. Currently, we are considering approving the use of hospitals and clinics that submit overseas papers." It was found that the seriousness of the problem was recognized and countermeasures began to be prepared, focusing on related societies such as the Korean Society of Pediatric Endocrinology. If it is no longer possible to secure Relefact, the use of off-label for Decapeptyl is suggested as an alternative, and some pharmaceutical companies are requesting the re-import of related items. It is only hoped that the suspension of supply will end in a short period of time as a pharmaceutical company that resupplies the drug to Korea.
- Company
- Dire need for a rational pricing system for new drugs
- by Nho, Byung Chul Dec 07, 2021 05:57am
- Improving the drug pricing system through social consensus has been proposed as a prerequisite for the government to achieve the 60 trillion won export and 300,000 job creation in the biohealth industry as one of its 3 new growth engine industries. In addition to the primary purpose of fostering the biopharmaceutical industry to create national wealth, there is no disagreement on the fact that the localization of vaccines and treatments as the nation’s key industry is essential to address the national need and respect and realize the right to life of the citizens in Korea in the COVID-19 pandemic. In particular, the emphasis Yong-Ik Kim, the President of the National Health Insurance Service, made at special lectures, in raising the will for R&D among biopharmaceutical companies through appropriate pricing of new drugs and the joint growth of the nation and its companies, has been interpreted as an exemplary blueprint for the soft landing of Mooncare. Seong-min Park, a lawyer from HnL law firm said, " An irrational pricing system for new drugs may infringe the Korean patients’ access to treatment as well as adversely affect the fostering of a health drug ecosystem with fair competition.” Essentially, 4 rational drug pricing measures were considered eligible for review/introduction through communication with the Ministry of Health and Welfare, as well as the Korea Pharmaceutical and Bio-Pharma Manufacturers Association and other industry pricing managers: ▲ reducing the scope of alternative drugs ▲flexible application of negotiations(diversifying types of pricing negotiations allowed to include refund system, etc) ▲price discount accumulation system ▲pricing premium for new drugs that have conducted Phase III trials on Koreans First, the system to reduce the scope of alternative drugs was proposed to improve the standards for selecting alternative drugs so that new drugs can be compared with each other. According to the industry, one issue in setting prices for new drugs is that the price of originals and generic drugs that have been discounted 53.55% due to patent expiry are all included in the standard used to set new drug prices and are continuing to be discounted due to post-marketing measures. If this intensifies, the price of new drugs could be set at a lower level than alternative generics, reducing the will for companies to research or develop new drugs and also inducing voluntary withdrawal of licenses due to loss of cost. In other words, Korea will not be able to leap forward and become a pharmaceutical powerhouse if the virtuous cycle of ‘R&D-new drug discovery- national wealth creation’ is broken. On this, Park said, “Special measures such as excluding patent-expired products from alternative drugs is necessary. Global competitiveness can be secured only when practical standards are established for the selection of alternative drugs such as those with therapeutic equivalence and the price set at 80-120% of the price in foreign countries.” Under the price discount accumulation system, pricing discounts that are accumulated during a new drug’s patent period after term expiry, effectively preserving the R&D value of a new drug to allow faster recovery of R&D expenses and induce reinvestment. The system does not provide preferential treatment by exempting drug price discounts but defers it, therefore retaining the effect of reducing insurance finances. The irrationality of lowering drug prices of new drugs that are more cost-effective than its alternatives with the price-volume linkage system and the discount applied when a drugs attempts to add indications that are within the scope held by its alternatives, has been constantly raised. For example, compared to other drugs of the same class, Zemiglo had been subject to numerous more price-volume linkage discounts than its number of sales since it was released in 2012. Its price had been discounted a total of 6 times. The pricing premium system for new drugs that have provided Phase III trials on Koreans allows the price of new drugs that conducted Phase III trials on local patients to be set at 95-100% of the market price of substitute drugs rather than at 90% when omitting pricing negotiations. The system does not conflict with international trade as it allows new drugs from multinational pharmaceutical companies that conduct multinational clinical trials to receive benefits while local new drugs that did not conduct Phase III trials of a certain size in Korea to become ineligible for such benefits. The system is already being applied and operated abroad. For example, in Taiwan, a 10% premium is provided for new drugs that conducted clinical trials over a certain size to demonstrate safety and efficacy. In Japan, a new drug that was first-ever to be approved in Japan receives a premium of 10-20% for early introduction (new drugs that explicitly include dosage regimens for pediatric patients area are applied a 5-20% premium, however, the premium is not applied if the clinical trial conducted in Japan do not include pediatric patients). The greatest advantage of the 'pricing premium system for new drugs that have conducted Korean Phase III trials’ is that it provides base data on the safety, efficacy, clinical utility of a drug in Koreans. It is also easy to track and manage, improves R&D ability by the full step of the trial being conducted domestically, provides a performance upgrade for domestic clinical trial institutions, creates jobs, and contributes to new drug development fit to match the condition and diseases of Koreans.
- Company
- Moderna tackles the Omicron variant with booster shots
- by Dec 07, 2021 05:57am
- ” We are developing three vaccine strategies to rapidly respond to the much-concerned Omicron variant. We plan to soon release a booster shot that is most appropriate for the Omicron variant.” Randall N. Hyer, senior vice president of Global Medical Affairs at Moderna, replied so to an inquiry about the company’s plans on responding to the Omicron variant at a press conference that was held at the Somerset Palace in Jongno-gu, Seoul, on the 2nd. According to SVP Hyer, Moderna is preparing three different strategies to respond to the Omicron variant: ▲high dose booster shot; ▲new booster shot to respond to the Omicron and other emerging variants; and ▲an Omicron-tailored booster shot. For the first option, a high-dose booster shot, the company has already completed safety and immunogenicity tests on 306 adults with a 100μg dose that is twice the dose currently in use. As the second option, the company is testing 2 multivalent booster candidates – one that added the Beta variant to the existing vaccine (mRNA-1273.211), and the other that combined the beta and delta variant (mRNA-1273.213). The two candidates include the 4 and 8 variants found in the Omicron variant. As the third option, Moderna is developing the vaccine candidate mRNA-1273.529 that specifically targets the Omicron variant. The development is expected to take 2-3 months. Randall N. Hyer, Senior Vice President of Moderna Inc.i2Hyer said, “We have been developing various booster shots since earlier this year to respond to anticipatable variants. We are reviewing which strategy is most effective among the three. We will be able to identify the effect of the high-dose booster shot within a few weeks.” However, it would take some time for a booster shot that can prevent the Omicron variant to be available for inoculation in the field, as it requires clinical trials and approval by the regulatory authorities. Moderna believes that the benefits of vaccination outweigh the risk even in young adults and children. There were concerns over the risk of myocarditis in young adults with the Moderna vaccine, however, the company says its data demonstrates the fact that its vaccine’s risk is no different than that of Pfizer’s. Some Northern European countries have only allowed the use of Pfizer’s vaccine to children and young adults due to the risk of side effects such as myocarditis and pericarditis among youths and young adults. Korea has also made the same recommendation. Also, the US Food and Drug Administration has deferred extending approval of Moderna’s vaccination to those aged 12-17, saying that the risk of myocarditis in teenagers needs to be reviewed. On this, Hyer said, “The absolute risk of myocarditis after vaccination is very low. Some monitoring results showed that Moderna’s vaccine had a higher risk than Pfizer’s vaccine, but others have also shown that there was no difference at all between the two. The incidence of myocarditis and pericarditis in those 30 years or less who were vaccinated were no different for the two - 0.45(0.45 per 100,000) for Pfizer and 0.49(0.49 per 100,000) for Moderna.” He added, “Please bear in mind that the risk of myocarditis is higher if you are unvaccinated and confirmed with COVID-19 rather than from vaccination with COVID-19 vaccines. Of course, we fully understand the concerns of the health authorities as the results vary by each dataset. Moderna is also conducting its safety investigations to examine the association between myocarditis and mRNA vaccines.” Moderna also stressed the need for smooth communication with the Korean government. That day, Moderna had also announced that it had appointed Ji-young Sohn, former general manager of CSL Behring Korea, as its new general manager for its Korean subsidiary. Hee-Soo Kim, Country Medical Director of Moderna Korea, said, “After the Korean subsidiary was established in May, the general manager and medical director joined the company in November, and various departments have also been established since then.” Kim added, “We are hiring many employees now. Although we had issues communicating with Korean government authorities before, we hope that the establishment of our Korean subsidiary may contribute in various ways, including facilitating the smooth supply of vaccines and R&D partnerships.” As part of such efforts, Moderna has started a fellowship program under which young researchers can learn about the development of mRNA therapeutics, and encouraged active participation of Korean researchers. Hyer said, “We are pleased that 2 Korean professors have joined our Fellowship Promotion Committee. We hope many young researchers in Korea would join us to study mRNA-based therapeutics."
- Company
- Five companies give up challenging Dukarb’s patent
- by Kim, Jin-Gu Dec 06, 2021 05:54am
- Pic. of Boryung Pharmaceutical Five out of the 45 companies that set out to evade the patent of Boryung Pharmaceutical's antihypertensive combination drug ‘Dukarb Tab. (fimasartan+amlodipine)’ decided to give up challenging the patent. The industry has pointed to the fierce competition in the two-drug fixed-dose combination market as one of the causes for the companies’ decision to give up their patent challenge. According to industry sources on the 6th, PharmGen Science voluntarily withdrew the trial to confirm the passive scope of patent rights that it had recently filed for the Dukarb composition patent. If the companies succeed in avoiding the composition patent for Dukarb which is set to expire on August 2031, the companies may release their latecomer drugs for Dukarb after February 2023 after the substance patent for the Kanarb ingredient expires. According to the pharmaceutical market research institution UBIST, outpatient prescription for Dukarb recorrect 36.1 billion last year. Prescriptions amounted to 30.2 billion won by Q3 this year. Other than the single-drug pill Kanarb, Dukarb has made the most prescription performance among the Kanarb family. Due to the outstanding performance of the drug, many companies have filed challenges to the drug’s composition patent. Starting with Arlico Pharm, a total of 45 companies have filed a trial to confirm the passive scope of patent rights. However, Yuyu Pharmaceutical was the first to drop the suit on August 24th. Since then, Hanwha Pharma, Daehan New Pharm, Kims Pharma, PharmGen Science voluntarily dropped their challenges. As a result, a total of 5 companies have now given up challenging Dukarb’s composition patent. The industry’s focus is now on whether more companies will follow suit. Due to the ongoing fierce competition in the antihypertensive drug market for the ARB+CCB class two-drug combo, there is still the possibility that more companies will be giving up patent challenges. In this context, the companies may have determined that the release of a latecomer Dukab generic may not have great marketability. Also, with the strong presence held by Boryung Pharmaceutical, some predicted that the market will be hard to penetrate with the release of several same-ingredient generics at the same time. However, one variable that remains is the impurity issue in the sartan ingredients. In addition to the growing concern over azido impurities in the losartan ingredient in Korea, azido impurities have also been found in irbesartan and valsartan ingredients abroad. If the impurity issue grows to exceed expectations, some expect that this will increase demand for a different ARB-class drug, fimasartan. No impurity has been detected in fimasartan up to date.
- Company
- Moderna Korea appoints Ji-Young Sohn as new GM
- by Dec 03, 2021 05:55am
- Ji-Young Sohn, General Manager of Moderna Korea Ji-Young Sohn, the former GM of CSL Behring Korea, was appointed as the General Manager of the Korean subsidiary of the COVID-19 vaccine developer Moderna. The new GM will be leading Moderna’s business in Korea and is seeking executives to organize teams that can perform various tasks for the company. The company is currently hiring new executives and employees. Sohn majored in Pharmacy at Ewha University and holds an MBA degree from Korea University Business School. Since then, she has accumulated over 20 years of experience in various global pharmaceutical companies. Before Moderna, the new GM had served as the General Manager of CSL Behring Korea and led the establishment of its Korean subsidiary and the launch of its new products. She started her pharmaceutical career at Pfizer Korea, then expanded her scope of business in the industry at Roche Korea and Roche Headquarters. At Pfizer Korea, Sohn had led various marketing and strategy teams and served as the Head/Director of the company’s first Specialty Care Business Unit. At Roche Korea, she had served as the Head of the Oncology Business Unit, driving strong growth of the oncology business and people development. After then, Sohn moved on to become an international portfolio business leader at Roche Headquarters Switzerland and successfully implemented a global strategy of a mature product portfolio worth 1 trillion won. Patrick Bergstedt, SVP of Commercial Vaccines at Moderna, said, “Sohn is a recognized innovative and strategic leader in Korea and global markets, and we look forward to working with her to reinforce Moderna’s place in Korea.” Sohn said, “Korea is a very important market for Moderna, and Moderna has already made various strategic partnerships and considerable investments in Korea. We will work to build major relations and introduce Moderna’s mRNA science technology to Korea, increase stakeholder trust, and strive to help promote the people's health with Moderna’s excellent vaccines and other future treatments to come."
- Company
- COVID-19 vaccinations freeze up the premium vaccine market
- by Chon, Seung-Hyun Dec 02, 2021 05:54am
- The premium vaccine market that consists of vaccines used to prevent diseases like shingles, pneumococcal vaccines, etc has contracted greatly. Analysts believe that the demand for other vaccines had decreased due to medical institutions prioritizing COVID-19 vaccinations. However, the cervical cancer vaccine market continued to show growth due to the increase in demand for Gardasil 9. On the 1st, according to the medical research institution IQVIA, the shingles vaccine market size in Q3 was ₩8.9 billion, down 56.1% from the same period of last year. The cumulative sales by Q3 in the market was ₩29 billion, also a 47.3% drop from last year. Currently, two products - MSD's ‘Zostavax’ and SK Bioscience's ‘Skyzoster’ – are competing in the domestic shingles vaccine market. Since Skyzoster broke the monopoly of Zostavax and entered the market at the end of 2017, the market had recorded rapid growth. The market size had increased to record ₩27.9 billion by Q4 in 2019. Quarterly sales of shingles vaccines (Unit: ₩1 million, Source:IQVIA) However, the market had fluctuated after the full outbreak of COVID-19. In Q1 last year, the shingles vaccine market decreased by 37.8% and recorded ₩12.2 billion. The market size had contracted with patients avoiding visits to medical institutions earlier on during the outbreak. Although the market showed recovery, increasing to ₩22.6 billion in Q2, ₩20.3 billion in Q2, then ₩17.3 in Q4, sales have once again made a downward turn entering this year. Sales in Q3 had fallen 68.1% compared to two years ago, in Q4 2019. Sales of Zostavax and Skyzoster have fallen together. Zostavax sold ₩5.7 billion in Q3, a 53% drop YoY. In the same period, Skyzoster sold ₩3.2 billion and dropped by 60.7%. compared to Q4 2019, when the two vaccines peaked in their sales, Zostavax and Skyzoster’s sales both fell by 66.2% and 70.9%, respectively. The sluggish performance of the shingles vaccine market is analyzed to be an effect of the increased COVID-19 vaccinations. That the medical institutions’ tendency to administer COVID-19 vaccines first had resulted in a relative neglection of other vaccine products, is most convincing. The pneumococcal vaccine ‘Prevenar 13’ that had temporarily enjoyed an upsurge in sales with COVID-19 is also seeing prolonged sluggish sales. Prevenar 13 sold ₩7.4 billion in Q3, which was a 69.6% decrease from the same period of last year. Its cumulative sales by Q3 were ₩24.9 billion, which was also an immense 58.5% drop from the previous year. Quarterly sales of Prevenar 13 (Unit: ₩1 million, Source:IQVIA) ‘Prevenar 13’ is a PCV13 that prevents infection from 13 Streptococcus pneumoniae serotypes (3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). It may be administered to all those aged 6 weeks or older. Prevenar 13 for adults is being distributed in Korea by Chong Kun Dang, and for infants by Korea Vaccine. Prevenar 13’s performance this year is in stark contrast to the sharp rise in sales it made last year with the COVID-19 outbreak. Its sales in Q1 last year was ₩17.6 billion, a 52.2% increase from the previous year, which rose to ₩24.2 billion by Q3 last year. Prevenar13 sold ₩81.2 billion last year and made a 64.8% YoY increase. Demand for Prevenar 13 among adults had surged temporarily earlier in the COVID-19 outbreak with the expectation that while Prevenar13 cannot prevent COVID-19, it can weaken the pneumonia symptoms from COVID-19. However, its sales had greatly dropped entering this year. Sales of the vaccine in Q1 was ₩9.4 billion, a 55.5% decrease from the previous quarter, and continued to drop in the following quarters. Prevenar13’s sales dropped 32.8% compared to the pre-COVID-19 period 2 years ago. In other words, the vaccine, which enjoyed reflective benefits in the early phases of the COVID-19 pandemic, has been on the contrary, been negatively affected by COVID-19 and the increase of its vaccinations this year. Among the various products in the premium vaccine market, the cervical cancer vaccines market solely showed growth. In Q3, the cervical cancer vaccine market increased 22.7% from the previous year and recorded ₩21.9 billion. Cumulative sales by Q3 was ₩66.9 billion, increasing 42.3% from the previous year. Three products – MSD’s ‘Gardasil,’ ‘Gardasil 9,’ and GSK’s ‘Cervarix’ – are competing in the domestic cervical cancer vaccine market. The rapid rise of the relatively expensive Gardasil 9 is analyzed to have driven the growth of the market’s size. Quarterly sales of cervical cancer vaccines (Unit: ₩1 million, Source:IQVIA) Gardasil sold ₩5.4 billion in Q3, which was only a 3.9% increase from the previous year. However, Gardasil 9’s sales rose 37.2% in the same period, recording ₩16.1 billion. Cumulative sales of Gardasil 9 by Q3 was ₩50.8 billion, a 72.6% increase from the previous year. Cervarix’s sales in Q3 were only in the ₩0.3 billion range. Gardasil 9 is a vaccine is an HPV vaccine product that contains 5 additional serotypes (31, 33, 45, 52, 58) to the 4 serotypes (6·11·16·18) contained in Gardasil. It is being distributed at a higher price Among cervical cancer vaccines, it is being distributed at a high price with the distinction that it contains the most HPV types. Based on Q3 numbers, Gardasil 9's accounts for 73.6% of the cervical cancer vaccine market. Unlike Gardasil and Cervarix, Gardasil 9 is not part of the National Immunization Program in Korea. However, its effect in preventing other HPV-related diseases such as anal cancer, genital warts, and precancerous lesions in addition to cervical cancer has spread by word of mouth, increasing the annual number of male vaccinations. The age for its vaccination had also been extended to cover up to 45 years of age, increasing the rate of adult revaccinations.
- Company
- Prevenar 13 sales take ‘roller-coaster’ ride with COVID-19
- by Chon, Seung-Hyun Dec 01, 2021 05:56am
- Sales of the pneumococcal vaccine ‘Prevenar 13’ took a rollercoaster ride in one year, enjoying an upsurge for a short period of time then plummeting in just a single year. The vaccine enjoyed reflective benefits in the early phases of the COVID-19 pandemic but dropped sharply after COVID-19 vaccinations began in earnest. According to the pharmaceutical research institution IQVIA on the 30th, Q3 sales of Prevenar 13 dropped 69.6% compared to the same quarter of the previous year and recorded 7.4 billion won. The cumulative sales by Q3 was 24.9 billion won, also a 58.5% decrease from last year, indicating sluggish sales. Such cases where sales of a product suddenly drops after making unprecedented records just a year ago are rarely observed. ‘Prevenar 13’ is a PCV13 that prevents infection from 13 Streptococcus pneumoniae serotypes. It may be administered to all those aged 6 weeks or older. Prevenar 13 for adults is being distributed in Korea by Chong Kun Dang, and for infants by Korea Vaccine. Quarterly Prevenar 13 sales trend (Unit: 1 million KRW, Source: IQVIA) Sales of Prevenar13 had been steadily rising before the COVID-19 pandemic, recording approximately 10 billion in quarterly sales. Then, its sales surged with the spread of COVID-19. Its sales in Q1 last year was 17.6 billion, a 52.2% increase from the previous year, and rose to 24.2 billion won by Q3 last year. Prevenar13 sold 81.2 billion last year, which was a 64.8% YoY increase. With the claim of some experts that although Prevenar13 cannot prevent COVID-19, it can weaken the pneumonia symptoms of COVID-19 gaining credibility, demand for Prevenar 13 among adults surged temporarily. However, entering this year, its sales had greatly dropped. Sales of the vaccine in Q1 was 9.4 billion won, a 55.5% decrease from the previous quarter, and continued to drop across the following quarters. Analysts believe the rise in demand for Prevenar13 has been watered down due to the prolonged COVID-19 pandemic. Also, the start of COVID-19 vaccinations in earnest had affected the number of other vaccine recipients. Most of the vaccine market for adults is slow this year because of the priority given to COVID-19 vaccines. Also, other analysts see that the temporary surge in demand for COVID-19 vaccines last year lead to the relative gap in demand this year, and the demand for vaccination to reduce pneumonia symptoms has also decreased. The sluggish sales of Prevenar 13 also affected the performance of its distributor, Chong Kun Dang. Chong Kin Dang’s Q3 operating profit fell 23.7% from the same quarter of the previous year and recorded 37 billion won, and its sales recorded 341.3 billion won, a 4.5% YoY decrease.
- Company
- SGLT-2i Jardiance adds chronic heart failure indication
- by Eo, Yun-Ho Nov 30, 2021 05:52am
- The SGLT-2 inhibitor ‘Jardiance’ may now be prescribed for chronic heart failure in Korea as well. According to industry sources, the Ministry of Food and Drug Safety had additionally approved a new indication for Jardiance (empagliflozin),' the SGLT-2 inhibitor used for the treatment of diabetes, to be used for adults with chronic heart failure with reduced left ventricular ejection fraction, regardless of their diabetes status. With the approval, Jardiance became the second SGLT-2 inhibitor following ‘Forxiga (dapagliflozin)’ allowed to be prescribed for chronic heart failure. Forxiga had been approved for the same indication in December last year. Jardiance's heart failure indication was granted Fast Track designation, then approved by the US FDA in June. Its heart failure-related efficacy was confirmed through the Phase III EMPEROR-Reduced clinical trial. Results showed that Jardiance met the primary endpoint, composite of cardiovascular death or hospitalization for heart failure in adults, by reducing the risk by 25% compared to placebo, demonstrating statistical significance. In the analysis of key secondary endpoint, Jardiance reduced the risk of first and recurrent hospitalization for heart failure by 30% and significantly delayed the kidney function index, eGFR, compared to placebo. Also, the sub-analysis results of the EMPEROR-Reduced trial that were presented at the American Society of Nephrology (ASN) ‘Kidney Week 2020’ last year showed that Jardiance’s benefit was consistent across various patient subgroups including patients with severe renal dysfunction, regardless of chronic kidney disease status at baseline in the analysis for the overall population. Meanwhile, Jardiance also made remarkable achievements in acute heart failure. The Phase III EMPULSE study demonstrated Jardiance’s treatment benefit in patients who were hospitalized for acute heart failure. In the EMPULSE study which evaluated the efficacy and safety of Jardiance in adults with and without diabetes that were hospitalized for acute heart failure and have been stabilized, Jardiance demonstrated its clinical benefit by improving all-cause mortality, reducing cases of heart failure, and improving heart failure symptoms.
- Company
- Ildong started developing a treatment for COVID-19
- by Nho, Byung Chul Nov 29, 2021 05:58am
- Ildong Pharmaceutical and Shionogi Pharmaceutical have begun joint development of oral COVID-19 treatments, drawing keen attention to whether they will succeed in commercializing them in the future. Ildong Pharmaceutical officially announced on the 17th that it will participate in the development of S-217622 as a candidate for oral COVID-19 treatment along with Shionogi Pharmaceutical, and attention is being paid to whether it will create the third drug in the world to contribute to the end of the pandemic after Pfizer and MSD. Accordingly, Ildong Pharmaceutical plans to start the development process as soon as the recruitment of patients is completed after obtaining IND approval for the domestic clinical trial (P2/3) of S-217622 from the Ministry of Food and Drug Safety in Korea. According to Ildong Pharmaceutical, it aims to become the EUA of the Ministry of Food and Drug Safety within the first half of 2022. Although Pfizer and MSD, two global big pharmas, are already set to commercialize oral treatments for COVID-19, the pipeline should be expanded in terms of high drug costs worth nearly 850,000 won and protection of doctors and patients' drug options. In particular, S-217622 is a candidate substance for a new drug targeting the COVID-19 virus from the beginning, so it is different from drug re-creation development cases that utilize existing substances that have already been licensed or developed with other indications. According to previous studies, S-217622 prevents virus proliferation by inhibiting protease (3CL-protase), which exists only in the SARS-CoV-2 virus, the source of infection that causes COVID-19. It has also been confirmed that alpha, beta, gamma, and delta COVID-19 mutations all have similar levels of virus proliferation inhibition capabilities. More efficient medication convenience is also drawing attention. Pfizer's Paxlovid requires a total of 30 tablets, twice a day for 5 days, and the 5-day dose of MSD's Lagevrio reaches 40. On the other hand, S-217622 is being developed once a day for 5 days. It is expected to be smaller than the previous two treatments. The prospect that localization of treatments according to the terms of the joint development contract and improvement of access to domestic patients will have an advantage over other competitive drugs is also receiving positive reviews. If Ildong Pharmaceutical succeeds in developing the S-217622, it is planning domestic production through technology transfer. An official from Ildong Pharmaceutical said, "Korea's clinical design aims at more than 200 asymptomatic, mild, and severe patients. If development is successful, stable drug production and supply are expected by establishing sovereignty over treatments. Considering the data so far, it shows excellent safety, he said. Ildong Pharmaceutical and Shionogi Pharmaceutical have maintained a partnership for 40 years since the 1980s. Japan Pharmaceutical introduces and sells Shionogi Pharmaceutical's antibiotic Flumarin and Pirespa, a treatment for idiopathic pulmonary fibrosis, in Korea, and cooperates in the clinical phase for the first time. Shionogi is the world's top 50 pharmaceutical company that has focused on developing innovative treatments by focusing on treatment areas in the fields of anti-infectious diseases and central nervous system disorders, including antibiotics and antiviral drugs, for 144 years since its foundation in 1878. It has also developed large global new drugs such as flu treatment Xofluza, antibiotic Petroja, and hyperlipidemia treatment Crestor.
- Company
- Samsung BIOEPIS set a new sales record in a year
- by Chon, Seung-Hyun Nov 29, 2021 05:58am
- Samsung BIOEPIS has generated the largest quarterly sales since its launch. Overseas sales of biosimilars have increased, and milestones have flowed in due to overseas permits for subsequent biosimilar products. According to the Financial Supervisory Service on the 23rd, SAMSUNG BIOEPIS saw its sales rise 14.4% year-on-year to 271 billion won in the third quarter. It surpassed the previous maximum sales of 236.9 billion won recorded in the third quarter of last year in a year, breaking a new quarterly sales record. The company's cumulative sales in the third quarter were 625.2 billion won, up 9.2% from the previous year. Samsung Bioepis Most of Samsung BIOEPIS sales are generated through overseas sales of its own biosimilar products. SAMSUNG BIOEPIS succeeded in commercializing biosimilars of six products, including Enbrel, Remicade, Herceptin, Humira, Avastin and Lucentis. In Europe, all six products were approved, and in the United States, five products excluding Avastin were approved for sale. SAMSUNG BIOEPIS's performance has slowed slightly as sales have been on the decline for the second consecutive quarter since the third quarter of last year. Sales in the first quarter of this year amounted to KRW 166.7 billion, down 29.6% from the third quarter of last year. With the aim of securing inventory in preparation for the prolonged COVID-19, pre-orders from hospitals and wholesalers in Europe have recovered their performance. However, it rebounded in the second quarter and broke a new sales record in the third quarter, recovering from the sluggishness caused by COVID-19. Overseas sales sold by Biogen and Organon showed growth. Samsung Bioepis biosimilar's overseas sales in the third quarter were $342.8 million (about 406 billion won), up 11% from $369.9 million a year earlier. SAMSUNG BIOEPIS is selling five biosimilars in global markets excluding Korea through marketing partnerships with Biogen and Organon. Quarterly SAMSUNG BIOEPIS sales (unit: 1 million won, data: Financial Supervisory Service) Biogen is in charge of distributing and selling three types of autoimmune disease treatments in Europe, including Enbrel biosimilar Benepali, Remicaid biosimilar Flixabi, and Humira biosimilar Imraldi. Organon (formerly MSD) sells these three products under the product names Renflexis (Remicade biosimilar), Brenzys (Enbrel biosimilar), and Hadlima (Humira biosimilar) in the rest of the world except the United States, Korea, and China. Organon is also in charge of overseas sales of two types of anticancer drugs, Herceptin biosimilar Ontruzant and Avastin biosimilar Aybintio. Sales of biosimilars sold by Biogen reached $22.8 million in the third quarter, up 2% from the previous year. Organon's biosimilar sales in the third quarter rose 41% year-on-year to $140 million. The combined sales of biosimilars sold by Biogen and Organon in the third quarter amounted to $916.2 million (about 1.8 trillion won), up 11% from the previous year. In the third quarter, additional milestones were also introduced with the overseas approval of biosimilars. Lucentis biosimilar Byooviz, developed by Samsung Bioepis in August, was approved for sale by the European Commission (EC), and a month later, it was approved by the U.S. Food and Drug Administration (FDA).
