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- 2026-03-18 05:51:35
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- Sillajen acquirer GFB seeks further partnership opportunity
- by Jun 24, 2021 05:55am
- "Using ShillaJen’s anticancer virus platform, we can add many new substances to be developed as novel drugs. Korea owns many excellent early-stage novel drug candidates, and we also may additionally introduce promising new substances in Korea." At the interview with DailyPharm, Ajit Gill, CEO of Greenfire Bio, Ajit Gill expressed his strong will to build additional partnerships with Korean bio-ventures in Korea. CEO Ajit Gill Greenfire Bio (GFB), a U.S. joint bio-venture firm of M2N that recently acquired Sillajen for 6 billion won, has been established by various industry experts including the company’s CEO Agit Gill who had previously headed Nektar Therapeutics, and CBO Sanjeev Munshi who had served over 20 years at MSD (U.S. Merck) as a BD reviewing and introducing new substances. During his service as head of Nektar Therapeutics from 1999 to 2006, Gill had contributed to raising the company’s market value to more than 20 trillion won. CBO Munshi had been in charge of searching biotech companies around the world to develop new drugs for intractable diseases such as Alzheimer's and NASH at MSD. Hanmi Pharmaceutical’s ‘efinopegdutide’ for nonalcoholic steatohepatitis (NASH) is also one of the numerous new drug substances he introduced at MSD, GFB, which has been developing the bio business with M2N Chairman Seo Hong-min, has been interested in developing new drugs using next-generation technology. In this context, Sillajen’s anticancer virus platform has caught the company’s interest. Anticancer virus, or oncolytic virus, induces immunogenic cell death (ICD) by loading viruses that have excellent penetration capabilities with anticancer substances. Globally, the interest in oncolytic virus is high, but no ‘game changer’ has emerged yet. Amgen’s Imlygic that was first introduced in the field did not produce a satisfactory return compared to the investment. However, GFB has a strong belief in the potential of the oncolytic virus market. Gill said, “With immuno-oncology drugs having a response rate around 30%, adding oncolytic virus to the immunotherapy can increase the rate to 50 to 60%. The vaccinia virus used in Sillajen’s next-generation platform has the benefit of being able to load various anticancer substances, due to its large size. Just looking at the monoclonal antibody market, we see many cases in which the bio-industry makes explosive growth with follow-up products that have been improved to complement the shortcomings of the earlier drugs, so there is no concern about the potential of the anticancer virus market." CBO Sanjeev Munshi He added, “For new technology, securing safety is important. Sillajen has the advantage in the market as the company had identified the safety of its platform through clinical trials for many years,” and expects that their accumulated new drug development know-how and financial firepower will create synergy when met with Sillajen’s leading technology. Regarding the increased market concern over the discontinuation of the Phase III trial on Pexa-Vec in 2019, Gill said, “Failing Phase III trials is common in the bioindustry. The point to focus on is whether we own a potential platform. However, we would need to establish a richer pipeline. Just one success is all we need to significantly raise the value of the company.” However, Gill took a cautious stance on the development of Pexa-Vec will continue, stating that the decision will be made after observing the data that will be released after a year. Instead, GFB is eagerly searching for new substances to apply to Sillajen’s platform. CBO Munshi has been focusing on discovering a substance with the highest possibility of success based on his experience at MSD as BD. Munshi said, “We have reviewed over 200 substances over the past 6 months. We want to find the most promising pipeline. Self-development is also a possibility, but it is more likely that we will acquire a substance through external partnerships.” In this sense, GFB is deeply interested in partnering with Korean bio ventures. Munshi said, “Korea owns abundant early-stage research data, but lacks development experience in the US., which is the world’s largest market. GFB can complement this area as the company has a high understanding of the global market and owns extensive global network experience. Please don’t hesitate to reach out anytime if you have an innovative new drug technology. Gill said, “Nektar Therapeutics was also once a 4-person company. It grew to a company with 800 employees when I left. In that time, I had signed countless contracts and raised the 1.5 billion fund in various ways. When combined, GFB’s BD expertise, M2N’s high capital, and SillaJen’s technology will be the right mix of all the essential elements necessary for the development of a blockbuster drug.”
- Company
- Benlysta can be reimbursed in general hospitals
- by Eo, Yun-Ho Jun 24, 2021 05:55am
- Benlysta, which has been covered by insurance benefits for the first time in seven years, can be reimbursed in general hospitals. According to related industries, GSK's Benlysta (Belimumab) has passed the drug committee (DC) of 20 hospitals nationwide, including Aju University Hospital, Chungnam National University Hospital and Hanyang University Hospital. Benlysta, prescribed for treatment of active systemic erythema lupus adult patients who are autoantibody positive, was non reimbursed by the Pharmaceutical Benefits Advisory Committee twice in December 2015 and November 2018. This is because it was difficult to prove cost-effectiveness as old drug such as Prednisolone, Hydroxychloroquine and Azathioprine are alternative drugs. Benlysta is eligible for active systemic ▲Lupus 18 years of age or older, who has been treating autoantibody positive for more than 3 months with standard therapy, if both ▲SELENA-SLEDAI 10 and above ▲ Anti-dsDNA antibody positive ▲ low complement (C3 or C4) conditions. Patients can be treated with 10% of their copay through special cases of calculating rare diseases. The administration method according to the benefit standard is recognized for an additional 6 months if SELENA-SLEDAI is reduced by more than 4 weeks after initial administration ▲ If the evaluation results of the first 24 weeks are maintained, the use is recognized for an additional 6 months. Lupus invades a variety of organs throughout his life, especially in major organs such as the heart, lungs, kidneys, and nerves, which can lead to irreversible damage and death Due to the nature of the disease, most patients are women of childbearing age, and 19% of pregnant women suffer from fetal death, loss of fetal development, low birth weight, and premature birth.
- Company
- PARP inhibitors for primary ovarian cancer can be reimbursed
- by Jun 23, 2021 05:54am
- PARP inhibitors "Jejula" and "Lynparza" are expected to be applied to primary maintenance therapy for ovarian cancer as early as the third quarter. This is limited to BRCA mutations, and most patients without mutations do not benefit. According to the pharmaceutical industry on the 21st, Takeda followed by Lynparza (Olaparib) of AstraZeneca.The pharmaceutical company Zejula (Niraparib) also passed the Pharmaceutical Benefits Advisory Committee of the HIRA and is in negotiations with the NHIS. It is predicted that both products will complete the process of registering their benefits in third quarter. 80 to 90% of all ovarian cancer patients with BRCA negative effects will be excluded from the benefits. Zejula applied for the benefit as an All-Comer regardless of the mutation, but the HIRA's Cancer Drugs Benefit Apparel Committee only recognized positive mutations. Takeda Pharmaceutical has chosen a strategy of preferentially registering salaries for training BRCA. For secondary and higher maintenance, both Lynparza and Zejula have BRCA negative adaptations, but they also did not pass. This is why ovarian cancer patients filed a petition to allow them to use new drugs for BRCA negative. The monthly cost of medicine for non reimbursement is about ₩4.5 million. Lynparza's quarterly sales have been on a gentle rise from ₩2 billion last year to ₩3.7 billion in the first quarter of this year. Zejula, on the other hand, closely followed Lynparza in the first quarter of this year at ₩3.2 billion, up from ₩1 billion last year.
- Company
- Pfizer Korea suspends distribution of Champix
- by Kim, Jin-Gu Jun 23, 2021 05:54am
- Pic. of Champix Domestic supply of ‘Champix (varenicline),’ a smoking cessation product, has been suspended altogether. Pfizer Korea, which is in charge of supplying the product, explained that this was a preemptive measure made regarding the impurity issue. According to industry sources on the 23rd, Pfizer Korea had sent an official notice to domestic distributors that Champix 0.5mg and 1mg is nearly out of stock. In the notice, Pfizer Korea explained that this was due to a ‘disruption in the global distribution.’ Pfizer Korea’s position is that this is a preemptive measure that was made with regards to the concerns over impurities in the product. The Champix supplied in Korea is manufactured in Belgium, and is different from the products that were recalled by the health authorities in Canada earlier this month. Those were a part of the products manufactures in a Pfizer plant located in Quebec, Canada. The Ministry of Health and Welfare also said that the pharmaceutical products manufactured by the same company as those recalled in Canada are not being distributed in Korea. However, Pfizer Korea explained that this preemptive measure was made in consideration of the potential possibility that the impurities may have arisen in the manufacturing process of the finished product, and that the company will suspend supply of the product while testing for the impurities. The MFDS presumes that the impurity in question, ‘N-nitroso-varenicline’ may have developed by a reaction between varenicline and the nitrite that remained during the manufacturing process of the finished product. An official from Pfizer Korea said, “An investigation is being conducted at the global headquarters level on the detection of impurities," he said. "We plan to temporarily suspend domestic supply until the results of the impurities test is released." He continued, “We will submit related data to MFDS as soon as the results of the impurities investigation are released from our HQ. Pfizer Korea will faithfully follow MFDS instructions.” Korean generic companies plan to first focus on testing for the impurities as requested by MFDS. Because their production scale is not large, the companies believe that separate measures to stop supply will not be necessary. Currently, 34 companies in Korea are approved to manufacture CHampix generics. Among these, 12 companies have generated revenue in the first quarter of this year. Hanmi Pharmaceutical’s ‘Nokotine S,’ recorded 500 million won in quarterly sales, and the other companies have recorded less than 100 million won in the same period. An official from a domestic company that sells a Champix generic said, “We plan to first focus on conducting an independent test for impurities. And we will promptly take necessary measures according to its results.” Another official from a different company said, “We currently only hold a permit for the generic. We have discontinued production and supply of our generic since last year. It seems that some of the products that were previously released are still being distributed., but we do not plan to halt that supply or separately recall the products.” he explained.
- Company
- Patients implore for 1st line reimbursement of Tagrisso
- by Jun 23, 2021 05:54am
- After a series of failures in receiving reimbursement extension for the EGFR targeted therapy ‘Tagrisso’ in the first-line setting of lung cancer, the patients have taken the reimbursement issue into their own hands and implored the government to review its reimbursement again. On the 22nd, the 1,713 lung cancer patients and their families delivered a letter of appeal to the government, the Korean Association for Lung Cancer, and AstraZeneca Korea, expressing their “sincere hope for the first-line reimbursement of Tagrisso.” The letter said, “With Tagrisso’s first-line reimbursement thwarted numerous times during the past 3 years despite the desperate hope of patients and the medical community, patients and families that had to use Tagrisso as first-line treatment have been suffering from the immense financial burden imposed by the high-price of the drug. The Health Insurance Review and Assessment Service’s Cancer Drug Review Committee had turned down the application to extend reimbursement of Tagrisso to the first-line setting of non-small cell lung cancer (NSCLC). Since adding this first-line indication in Korea in December 2018, AstraZeneca Korea had been attempting the reimbursement expansion since 2019 but was unable to pass the threshold of the Cancer Drug Review Committee. The Cancer Drug Review Committee’s had an issue with the sub-analysis results of the global FLAURA trial in Asians, although the drug demonstrated an improvement in overall survival in the total population. On this, AstraZeneca further submitted results from the FLAURA China trial on the Chinese cohort patients, however, the reimbursement was once again turned down in April. Faced with this high barrier, patients and families came forward and organized an online signature-gathering campaign. In only one day, over 1,000 people signed the petition, and in one week, 1,713 people joined the campaign. The patients and families implored, “We don’t need the clinical trial results on Asians that was conducted on Chinese patients. Just the domestic cases are enough to recognize that Tagrisso has the best treatment effect in lung cancer and can even prevent brand metastasis and recurrence. We are deeply hurt that the current government, which promised to improve the medical environment for cancer patients, neglected the promise to ‘actively review reimbursement for first-line treatment with Tagrisso’ that was made at a national audit last year.” They continued, “We earnestly ask that you understand the sincerity of our claim, rather than simply dismissing our request for the first-line reimbursement Tagrisso in lung cancer as a ‘protest.’ We sincerely ask you to reconsider the reimbursement of Tagrisso as first-line treatment in lung cancer,” asking for the prompt reimbursement of Tagrisso. They also asked for the Korean Association for Lung Cancer’s support for this initiative. “Many professors in the field recommend Tagrisso as first-line treatment, however, the members of HIRA’s Cancer Drug Review Committee keep deferring reimbursement claiming that it lacks clinical usefulness.” To AstraZeneca Korea, they said, “We feel hopeless faced with the reality of having to pay over 6 million won every 4 weeks for the treatment,” and asked for the company’s additional and multidimensional effort for approval.
- Company
- Pneumococcal vaccination rate drops due to COVID vaccination
- by Whang, byung-woo Jun 23, 2021 05:54am
- Compared to rate of inoculation in 2020, rate of inoculation decreased significantly in first quarter of 2021. As COVID vaccinations begin in earnest, the inoculation rate of pneumococcal vaccines, which rose sharply last year, is decreasing. In particular, it is difficult for health centers to be in charge of vaccination and the situation of clinics is the same. As a result, related pharmaceutical companies also have a significant impact on sales decline due to a decrease in inoculation rates. According to the KDCA and the pharmaceutical industry on the 17th, the vaccination rate of pneumonia groups, which has steadily increased in recent years, has been falling significantly since the first quarter of this year. In fact, looking at the NIP (National Immunization Program) computer registration status announced by The KDCA over the past three years, NIP pneumococcal vaccinations for senior citizens aged 65 or older have risen every year to ▲283,687 in 2018, ▲580,793 in 2019, ▲839,461 in 2020. As of the first quarter of last year, the number of vaccinations decreased by nearly half from 145,796 in 2019 to 74,285 in 2020, but the inoculation rate also increased significantly as pneumococcal vaccinations were available at outside health centers from the second quarter. In particular, concerns about pneumonia, a major complication of COVID-19 infection, spread ahead of the flu epidemic, with a total inoculation rate of 414,596 cases in the third quarter alone, higher than the overall inoculation rate in 2018. However, this year, the rate of vaccination in the first quarter is again lower than previous years due to COVID-19 vaccination. The number of pneumococcal vaccinations in the first quarter of this year was 112,860, down from 145,796 in the first quarter of 2019, before COVID-19 outbreak. This is not NIP, but it was also confirmed by sales of 13 pneumococcal vaccines. According to the drug research firm IQVIA, Pfizer's pneumococcal vaccine Prevenar 13's sales in the first quarter of this year were ₩9.4 billion, down 46.7% from ₩17.6 billion in the first quarter of last year. Compared to the third quarter and ₩24.2 billion, which recorded the highest sales last year, sales declined by nearly 60%, and overall pneumococcal vaccinations decreased regardless of NIP. "The vaccination rate for pneumococcal vaccines has decreased a lot compared to previous years," said physician at a clinic. "We believe that the inoculation rate has decreased because the number of patients visiting the hospital is small and patients are not considered a priority." "There are also cases where patients who are vaccinated against corona do not think they need to get a pneumococcal vaccine," he said. "I'm not sure if we can increase the vaccination rate under the current situation." Prevenar 13's sales were ₩81.3 billion over the year. As it recorded 64.8% growth compared to 2019, its current low sales performance in first quarter could lead to reverse growth in 2021. "For pharmaceutical companies that have consistently emphasized the need for pneumococcal vaccinations, the decrease in inoculation rate is of course very upsetting," a pharmaceutical industry official said. "In particular, sales fell nearly half as of the same quarter last year." In this regard, experts stressed the need to share COVID-19 vaccination and pneumococcal vaccination separately from the concerns of pharmaceutical companies. "The basic principle is that vaccination of COVID-19 vaccines should not destroy the existing vaccination system. "I agree with the need for pneumococcal vaccinations, but the rate may rise as last year," said an official from the Korean association of internal medicine. "Pneumonia is one of the major causes of death, so the government needs to vaccinate and make efforts."
- Company
- Zolgensma applies for reimbursement... ignites discussion
- by Eo, Yun-Ho Jun 22, 2021 05:50am
- Another ultra-high priced ‘one-shot’ treatment has begun it process to be listed for reimbursement. Novartis, the developer of another one-shot treatment ‘Kyrmriah,' has announced its plans to list and release ‘Zolgensma’ in Korea. According to industry sources, Novartis has recently submitted an application for the reimbursement of Zolgensma (onasemnogene abeparvovec-xioi) through the approval-benefit appraisal linkage system. The company had first aimed at an earlier discussion of Zolgensma's reimbursement, but as the safety and efficacy review was completed later than expected, the listing process for the drug had started after the official approval. Zolgensma, which is a treatment for Spinal Muscular Atrophy (SMA) like ‘Spinraza (nusinersen)’ which was approved in 2017, is a gene therapy that contains genetic material that functionally replaces defective genes. The Ministry of Health and Welfare had approved Zolgensma as the second advanced biopharmaceutical after Kymriah. Advanced biopharmaceuticals are cell therapies or gene therapies that use live cells, tissues, or genetic material as ingredients. Under the ‘Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals,’ companies can receive differentiated safety management including long-term follow-up studies as well as support for R&D and product commercialization for their advanced biopharmaceuticals. Despite being a one-shot treatment, the price of the single shot costs 2.5 billion won in the U.S. and 1.89 billion won in Japan. Due to its high price, the listing process for Zolgensma in Korea is also expected to be unsmooth. However, the expectations regarding its efficacy are very high. Results of the Phase III SPR1NT and STR1VE-EU studies for Zolgensma that were presented recently recieved much attention. In the SPR1NT study, all pediatric SMA patients with two SMN Type 2 gene copy (Cohort 1) that were treated presymptomatically survived without requiring ventilatory or nutritional assistance, and achieved sitting independently for 30 seconds or more. Most (11/14) patients achieved age-appropriate motor milestones within the World Health Organization (WHO) window of normal development. In the STR1VE-EU study, most pediatric patients (82%) that were treated with Zolgensma, including those with severe SMA, achieved motor milestones unseen in the natural history of SMA Type 1. Zolgensma is indicated in Korea for the treatment of pediatric patients with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) who ▲ have been clinically diagnosed with SMA Type 1; or ▲ has up to 3 copies of the SMN2 gene.
- Company
- PD-1 inhibitors enhance future value of anticancer treatment
- by Jun 22, 2021 05:50am
- Professor Eui-Cheol ShinSince its first appearance in 2011, cancer immunotherapies have opened a new paradigm in the field of cancer treatment. Moving on from the era of targeted therapies that target specific gene mutation, the new era had opened where a patient’s immune system is activated to remove the malignant tumor. The immunotherapies that have been commercialized until now, such as Opdivo, Yervoy, and Keytruda, are all immune checkpoint inhibitors that target immunomodulators such as CTLA-4 or PD-(L)1. Immunologists Professor James P. Allison and Professor Tasuku Honjo were jointly awarded the Nobel Prize in Physiology or Medicine in 2018 for their discovery of this mechanism. In the wide and complex field of immunity, much is still left to be identified and remains uncharted territory. This is why cancer immunotherapies work according to theory in 30% of the patients, but not as expected in the other patients. To increase the response rate, pharmaceutical companies have been attempting to combine their immunotherapy with other immunotherapies that have different MOAs, or with existing targeted therapies or chemotherapies. Finding a good biomarker to predict the response rate also remains an important task. So how do immunologists view the present and future of cancer immunotherapies? Eui-Cheol Shin, Professor of Graduate School of Medical Science and Engineering at Korea Advanced Institute of Science and Technology (KAIST), said, “PD-1/PD-L1 inhibitors will be essential in all combination therapies that will be established for cancer treatment in the future. The PD-(L)1 and CTLA-4 immune checkpoint inhibitors can also be used in combination to complement the shortcomings of each other.” Professor Shin also added that treatment methods will be established for each cancer type and stage using viable biomarkers and that personalized cancer vaccines may become the next-generation anticancer therapy. The following is the question and answers from an interview with Professor Shin. -The paradigm that was dominated by targeted cancer therapies had shifted with the introduction of cancer immunotherapies. How is immunotherapy different from targeted anticancer drugs in terms of its mechanism of action? =The main difference between cancer immunotherapy drugs and targeted cancer therapies is in the durability of response. Strictly speaking, it is different, but a cancer immunotherapy drug is similar to a vaccine. Both use immunological memory to fight diseases. Just as people can live without concern of a certain disease after vaccination as many vaccines have a lifelong effect, treatment with immunotherapy will allow the immunologic memory to remove cancer even after it starts spreading again. The effect of the drug can last for the rest of the patient's life, even after discontinuing administration of the immunotherapy drug. -The cancer immunotherapies that have been released until now are PD-1/PD-L1 and CTLA-4 inhibitors. I know research is being conducted for new markers, how much progress has been made in this regard? =No one knows how many undiscovered mechanisms remain in the field of cancer immunotherapy. So, it is difficult to say how much progress has been made. Also, how many mechanisms were discovered is not important. Although CTLA-4 inhibitors and various PD-1/PD-L1 inhibitors have been introduced to the market, research results have reported that they work differently from the originally expected principle of action. This means that you do not need to know all the mechanisms to develop a drug. In some cases, the mechanism that you thought you knew well cannot be developed into a drug, and in other cases, you luckily find a drug another way. Research is of course conducted with sufficient theoretical grounds, but even with a solid theoretical base, clinical success cannot be guaranteed 100%. -Is there a reason why many of the developed drugs are PD-1/PD-L1 inhibitors? =In my research, I found PD-1 was the best anticancer immunotherapy target that can be modulated in the process of fighting cancer. Of course, the effect may be different for each cancer type and patient, but as PD-1 has a good effect and has the least side effects, much study has been focused on PD-1. Even in 50 years when cancer immunotherapies that target various other mechanisms are introduced in the market, I (strongly) believe PD-1 and PD-L1 inhibitors will hold their ground as a basic cancer immunotherapy drug. -Studies of combination therapies are also being conducted actively to enhance the effect of cancer immunotherapies. Some studies have been investigating the use of two immunotherapies. Mechanism-wise, is it effective to combine the use of a PD-1 inhibitor and a CTLA-4 inhibitor? =Well, the two are the only immune checkpoint inhibitors that were formally approved as of now, and using the two in combination does have a better effect. Separately, CTLA-4 inhibitors were introduced before PD-(L)1 inhibitor, but have relatively more side effects than the latter. In this sense, response in using the two drugs with the different MOAs has been unexpectedly good in general. It is rare, but using PD-(L)1 inhibitors may trigger hyperprogression of cancer in the treated patient. However, fundamental research findings have shown that hyperprogression may not show up when a CTLA-4 inhibitor is used in combination with a PD-(L)1 inhibitor. Much still needs to be verified, but I believe the immunotherapies may be able to complement each other’s shortcomings. -Patients may develop resistance to cancer immunotherapies as well. What alternatives could the patients use? =One of the reasons for ‘secondary resistance’ is mutation. The body needs to perceive the tumor as a foreign cell, however, the tumor antigen mutates and develops resistance. Cancer cells mutate just as well as viruses. Although it has not been commercialized yet, I expect ‘personalized cancer vaccines’ fit for each patient to become the next-generation anticancer therapy that would address the issue of resistance. These ‘cancer vaccines’ would be different from conventional vaccines that are administered in a healthy state, these are therapeutic vaccines that will prevent growth or recurrence of cancer in patients who have undergone surgeries for cancer removal. In other words, a vaccine that is made based on the changes identified in the mutated cancer cell of each patient to contain new antigens will allow patients to overcome resistance in the future. Of course, these cancer vaccines would also need to be used in combination with PD-1 inhibitors. As such, PD-1 is and will continue to be essential in the field of cancer immunotherapies.
- Company
- Gifticon to MDs attending online sessions might be illegal
- by Kim, Jin-Gu Jun 22, 2021 05:50am
- It has been interpreted that it is illegal to provide economic benefits, including gifticon, to doctors who participated in the online product briefing session, which has recently emerged as a major marketing tool for pharmaceutical companies. Park Sung-min, a lawyer at the HnL Legal OfficePark Sung-min, a lawyer at the HnL Law Office, made the explanation through a presentation on "legal issues on digital marketing" at the KFDC Legal Society's Spring Conference held online on the 18th. According to him, digital marketing has emerged as a major marketing tool in the pharmaceutical industry since the Corona crisis. However, almost all economic benefits related to digital marketing are highly likely to be illegal for the reasons for the lack of relevant regulations. In the case of online product briefing sessions, it is highly likely to be illegal to provide food and beverage to participating doctors. The same is true for posting comments, giving points to doctors who participated in surveys and events, and allowing them to purchase goods. Lawyer Park Sung-min said, "If the law is interpreted strictly, it is likely to be judged as a violation under the current law." In the case of exceptionally allowing economic benefits to doctors, "a salesperson may visit individual medical institutions and provide food and beverage not exceeding ₩100,000 once a day. However, economic benefits of the online product briefing session should not be provided because salespeople did not visit it in person. The same is true of doctors from various medical institutions who participated in online product briefing sessions. This is because it is difficult to apply the concept of "place" legally, although the regulation "if a salesperson visits" is not specified at this time. "This is what the KPBMA stated in the guidebook."There has been no judgment by the prosecution and the court regarding this matter. However, since the KPBMA was consulted by two law firms, there is a high possibility of illegality at the moment." However, he pointed out that the current situation is "because there are no related regulations." "The current regulations that allow doctors to provide exceptional economic benefits were made in an era when digital marketing was not active," he said. "Since Corona, digital marketing has emerged as a new means, we need to come up with relevant regulations." He cited the "detailed standards for supporting online academic conferences" temporarily prepared by the MOHW. "The MOHW's creation of the rule greatly reduced the scope of violations by pharmaceutical companies and doctors, at least in connection with online academic conferences," he said. "In addition, regulations on overall online marketing will reduce confusion in the field." "There are no rules at the moment," he said. "If the current situation continues, there is a high possibility of many violations.The government and the KPBMA should come forward to make very specific and explicit rules. Only then can we do fair marketing in a changed world."
- Company
- Competition between PCSK9 Inhibitors has just begun
- by Eo, Yun-Ho Jun 21, 2021 05:51am
- The competition for prescription of PCSK 9 inhibitors began more than four years after the domestic approval. Sanofi-Aventis' Allepatadine (Olopatadine) was listed on the 7th. It was approved in January 2017. This was the first time in South Korea that PCSK's 9th suppression system was introduced. Later in April of the same year, Amgen's Repatha (Evolocumab) was approved, with a stronger willingness to register benefits. Repatha was first registered as Homozygous Family Hypercholesterolmia (HOFH) in August 2018. Although there were two drugs in PCSK 9 inhibitors, Repatha was the only option. PCSK 9 inhibitors are drugs that have excellent efficacy but had price issues. There were problems not only at home but also at a global level, and Amgen lowered the price of drugs held by 60% in October 2018 and Sanofi in February 2019. Sanofi voluntarily withdrew Praluent's application for registration in October 2018, before the drug price was lowered, and it was registered about two years later. PCSK.9 inhibitors had a wide range of requirements for HOFH and in January 2020, Repatha succeeded in extending the reimbursement standard to patients with atherosclerotic cardiovascular disease (ASCVD) high risk, Heterozygous Family (HeFH), and Statinability. The two drugs are believed to compete in the ASCVD and HeFH. Praluent added HoFH in the United States in April. Praluent has tended to reduce the risk of all-cause death, and is a licensed drug with Praluent 75 mg and Praluent 150 mg, allowing patient-specific dose selection with reference to patient status and LDL-C levels. Repatha, which is first listed, is already prescribed by medical institutions. It can be prescribed at major medical institutions across the country, including the Big 5 general hospitals, including Samsung Medical Center l, Seoul St. Mary's Hospital, AMC, and Sinchon Severance Hospital.
