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Company
Will P-CABs take over PPIs in GERD treatment market?
by
Whang, byung-woo
May 12, 2021 05:58am
With HK Inno.N’s K-Cab increasing its influence in the potassium-competitive acid blocker (P-CAB) market, the introduction of new P-CAB products raises the question of whether the products may increase the P-CABs' share in the market. In addition to Daewoong Pharmaceutical’s Fexuprazan, which is expected to be approved in Korea within this year, there are expectations that the already-approved Takeda Pharmaceuticals Korea’s Vocinty (vonoprazan) may also be released this year. Since its introduction, P-CABs were regarded as the next-generation drug that would replace proton pump inhibitors (PPIs) in the market. P-CABs have been known to have resolved most of PPIs' limitations, including the slow onset of action, varied effect according to mealtime, inter-individual variability according to CYP2C19 genotype, and drug interaction concerns. In particular, HK Inno.N’s K-Cab is the world's first P-CAB that received approval for all major indications of gastric acid blockers including erosive and non-erosive Gastroesophageal reflux disease (GERD), It has 4 indications in total. Although reimbursement is not applied to all four indications yet, K-Cab has shown clear growth every year after preoccupying Korea’s P-CAB market. According to the pharmaceutical market data research firm UBIST, since recording 29.8 billion won in sales in 2019, K-Cab’s sales have more than doubled last year to record 72.6 billion won. Also, just in the first quarter of 2021, it already recorded sales of 22.5 billion won. Simple calculations show that if K-Cab’s sales continue at a similar level, the company may surpass 100 billion won in sales this year. However, the industry's prevailing view is that it will take more time to see a shift in the overall market, given that the sales of PPIs are still record around 200 billion won. This is why some predict that if Daewoong Pharmaceutical’s Fexuprazan is approved and released in Korea in the current environment, the rivalry between the two products may actually expand the P-CAB market. An official from A Pharmaceuticals said, “It seems that HK Inno.N’s also knows that the overall share of the pie, the market share of P-CABs in general needs to be expanded to shift the market trend from PPIs to P-CABs. Just like how the PPI market grew due to the introduction of many products in its class, Daewoong Pharmaceutical’s entry into the P-CAB market with its strong sales power will certainly make some waves in the current market situation.” In other words, the rivalry between HK Inno.N and Daewoong’s products may bring synergy in their market. Another product receiving attention in this context is Takeda Pharmaceuticals Korea’s Vocinty. Vocinty, known as the originator of this class of next-gen GERD treatment, was approved in March 2019, but no clear news on its release has been shared yet. An official from Takeda Pharmaceuticals Korea said, “We are working to provide innovative medicines to patients according to our decision-making priorities. However, we cannot disclose specifics on whether or not and when certain products will be released." However, with K-Cab looking to sell over 100 billion won this year and Daewoong Pharmaceutical’s entry imminent in Korea, the industry expects that Takeda may not be able to postpone the launch of Vocinty any longer. However, one obstacle for Vocinty, which is sold under the name Takecab in Japan, is its price. In Japan, the 10mg Vocinty tab. is sold at 130.3 yen (1,339 Korean won) and the 20mg Vocinty tab. is sold at 195.5 yen (2,005 Korean won). This is more expensive than the 50mg K-Cab tab that is currently sold at 1,300 won in Korea. On this, an official from B Pharmaceuticals said, “Many considerations need to be made for a product’s release including the adjustment of its price. However, the company may be able to contemplate much longer, considering the increased P-CAB market in Korea. In addition to Vocinty, which verified its competitivity in Japan, the introduction of Daewoong’s Fexuprazan in the market may trigger a three-way race in the P-CAB market."
Policy
The preventive effect of Moderna vaccine is 94%
by
Lee, Tak-Sun
May 12, 2021 05:58am
The MFDS' verification advisory group, consisting of outside experts, has recognized the prevention effect of Moderna COVID-19 vaccine for permission. The Central Pharmaceutical Affairs Review Committee, a court advisory body, will seek permission advice on the Moderna COVID-19 vaccine on Wednesday. COVID-19 vaccine safety and effectiveness verification advisory group by the MFDS held a meeting on the 9th and made this decision. The meeting of the verification advisory group is one of the procedures in which the MFDS collects advice from experts in various fields, including clinical, non-clinical, and quality, prior to consulting the Central Pharmaceutical Affairs Review Committee. At the meeting, the verification advisory group judged on the effectiveness of the Moderna vaccine, "The submitted data confirmed the effectiveness 14 days after the second dose of 18 years of age or older, so preventive effects for permission can be recognized." In addition, safety profiles were judged to be acceptable in clinical trials. They also said that it is reasonable to additionally observe abnormal cases that occurred during clinical trials through the "risk management plan" to secure safety after permission, and collect and evaluate information. In clinical trials, the Moderna vaccine was evaluated for its preventive effectiveness in 28,207 people (14,134 in vaccine groups and 14,073 in control group) who did not contract COVID-19 before administering a vaccine or control drug (0.9% in physiological saline). Since the 14th day of the second dose of the vaccine, 11 people have been confirmed with COVID-19 and 185 controls, showing 94.1% prevention effect, and more than 86% prevention effect regardless of age or presence of underlying disease. In addition, there were 31 cases of severe death due to COVID-19 in the control group (30 confirmed severe cases and 1 death) and none in the vaccine group. In the case of "Neutralizing antibodies," which can be combined on the surface of the COVID-19 virus particle to neutralize the infection of the virus, the "seroconversion rate," which means the proportion of people who have more than quadrupled since the second dose, was 100%. Of the 33,351 people eligible for clinical trials, 1.0% (147 people) of the vaccine group and 1.0% (153 people) of the control group reported "significant abnormal cases." There were nine cases of significant drug-abnormal reactions (including facial welling, nausea, vomiting, rheumatoid arthritis, autonomic nervous system imbalance, peripheral oedema, dyspnoea, and small B-cell lymphoma). However, most of them were recovering at the time of submitting clinical trial data. The MFDS plans to hold a Central Pharmaceutical Affairs Review Committee on the 13th to receive permission advice. The results are expected to be released later in the day.
Policy
Koselugo is about to be approved in Korea
by
Lee, Tak-Sun
May 12, 2021 05:57am
Koselugo (Selumetinib) is the FIRST and ONLY FDA-approved prescription medicine that is used to treat children 2 years of age and older with neurofibromatosis type 1 (NF1) who have plexiform neurofibromas that cannot be completely removed by surgery. It is not known if Koselugo is safe and effective in children under 2 years of age. And, it is about to be approved in Korea. The FDS last year supported the drug by designating it as an "Expanded Review target for Expedited Review". According to industries on the 7th, the MFDS recently completed a safety and validity examination of AstraZeneca's Koselugo. Koselugo is a new drug used in the treatment of type 1 neurofibromatosis, which is inoperable in children over the age of three. In October last year, the MFDS designated the drug as an Expedited Review target, saying that it is life-threatening and constitutes a serious disease treatment. "If designated as an Expedited Review target, we can receive a Priority Review compared to other medicines. The screening period will be shortened to up to 90 days. Koselugo was quickly reviewed by the FDA and approved in April last year after six months. Neurofibromatosis Type I is a genetic nervous system disorder in which tumors proliferate in the nerve region, showing the characteristics of tumors destroying normal cells such as faces. Therefore, it causes skin discoloration, damage to the nervous and skeletal system, and risk of developing benign and malignant tumors. There has been no fundamental treatment method, so symptomatic treatments such as medication and lesion resection have been carried out depending on symptoms. Koselugo's release is expected to make patient care much easier. Clinical trials used Koselugo every 28 days to compare tumor size changes and tumor-related mortality. As a result, the objective response rate (ORR) of the Koselugo treatment group was 66%, and patients with 82% ORR continued to respond for more than 12 months. As the MFDS' review has been completed, it is expected to be approved as soon as possible unless there are other supplements.
Company
Trials to suspend refund negotiations for CA drugs fail
by
Chon, Seung-Hyun
May 11, 2021 06:00am
Once again, the pharmaceutical companies have failed to suspend the execution of negotiations for the retrieval of insurance that has been paid for 'choline alfoscerate.' Both of the trials that were filed by two groups of pharmaceutical companies against the health authorities in Korea were dismissed by the court. According to industry officials, the Seoul High Court 1-1 ruled to dismiss the appeal by 28 companies including Chong Kun Dang filed to suspend the execution of negotiations on the retrieval of insurance. After the Seoul Administrative Court rejected the claim for the suspension of execution on January 29th, Chong Kun Dang and the other companies immediately appealed, but to no avail. The court of the second trial also dismissed the case. The law firm Kim & Shin is in charge of the lawsuit. At the end of last year, the Ministry of Food and Drug Safety (MFDS) ordered the National Health Insurance Service (NHIS) to make refunding deals for 230 choline alfoscerate products. The deal, which contains the condition 'If the trial fails, the whole amount of insurance paid for choline alfoscerate drugs that are prescribed from the date the clinical trial protocol is submitted to its the product's deletion from the benefits list shall be paid back in full by the company,' meant the deal was a 'negotiation for the retrieval of insurance.' In other words, the ministry intends to make a contract with the pharmaceutical companies so that when the clinical re-evaluation for choline alfoscerate that is being conducted on order by MFDS fails, the companies would have to pay back all of the insurance received for every prescribed choline alfoscerate drug from the date the clinical trial protocol was submitted to the date their license is revoked. Pharmaceutical companies have unanimously filed an administrative suit and complaint to suspend the execution of the order to pay back the insurance for choline alfoscerate drugs. The companies divided into two groups for the lawsuit. Lee&Ko is in charge of the suit for the 28 companies including Daewoong Bio, and Kim & Shin is in charge of the suit for the 28 companies including Chong Kun Dang. Daewoong Bio and the other companies have filed for the suspension of execution on December 30th of last year, but the first and second trials were both dismissed. The second trial was turned down on February 4th, a month after the case was filed, and the case is currently pending in the Supreme Court. Chong Kun Dang. and the other companies filed their complaint to suspend execution on January 8th of this year and received the dismissal ruling on January 29th. Chong Kun Dang and the companies appealed, but the case was again dismissed in the second trial recently. The administrative suit on choline alfoscerate has not been ruled yet. The Daewoong Bio's group and the Chong Kun Dang's group have both filed suits to the Seoul Administrative Court to cancel the negotiation order and notification, against the MFDS and NHIS separately. The cases of the two groups are to be merged for review, and the first proceedings are scheduled in July. Recently, NHIS failed to reach an agreement with pharmaceutical companies regarding the reimbursement of their choline alfoscerate products. NHIS and the companies were unable to reach an agreement after extending the negotiation period two times. As a result, the MFDS will have to delete the products from the benefits list or order renegotiations.
Policy
Dongkook develops new triple-drug combo for hypertension
by
Lee, Tak-Sun
May 11, 2021 06:00am
Dongkook Pharmaceutical has started the development of a single-pill, triple-drug combination that contains S amlodipine. Although two-drug combinations are already available, no triple-drug combination with a substance added for high blood pressure currently exists in the market. On the 10th, the Ministry of Food and Drug Safety approved the Phase I clinical trial protocol for the hypertension treatment ‘DKF-361’ by Dongkook Pharmaceutical. DKF-361 contains 3 medications: S amlodipine, olmesartan, and hydrochlorothiazide. The original three-drug combination for hypertension that combined Amlodipine besylate-olmesartan medoxomil and hydrochlorothiazide is Daiichi Sankyo Korea’s ‘Sevikar HCT tablet.’ Sevikar HCT has gained popularity as the first three-in-one combination therapy introduced in Korea for the treatment of hypertension. The drug is indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled with the combination of olmesartan medoxomil and amlodipine, taken as dual-component formulation. Generic versions of Sevikar HCT that contain the same substances have also been sold in Korea since March 2019. So far, 18 generics have been released in Korea. However, Dongkook Pharmaceutical's DKF-361 is the first product developed to combine S amlodipine instead of amlodipine. S amlodipine is a substance separated from amlodipine that contains the actual effect of amlodipine. By removing R- amlodipine, which is more closely connected to side effects, the new substance is known to have the same effect of lowering blood pressure at half the dose of conventional amlodipine with reduced side effects. The domestic pharmaceutical industry developed S amlodipine as a means to avoid the patent on amlodipine and succeeded in its commercialization. The efficacy of Dongkook Pharmaceutical's product is similar to Sevikar HCT. It is for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled with the combination therapy of olmesartan medoxomil and S amlodipine. Dongkook Pharmaceutical has a two-drug combination therapy of S amlodipine besylate and olmesartan medoxomil, ‘Omevikar Tab.’ It also has a generic version of Sevikar HCT, ‘Amrovikar HCT tab.’ If the company succeeds in commercializing the three-in-one combination therapy, the drug may become an alternative to patients who failed to control their blood pressure with the Omevikar tab. Also, it may complement Amrovikar HCT, creating a synergistic effect between products. According to UBIST, the outpatient prescription sale of Omevikar was 2.1 billion won, and 0.5 billion won for Amrovikar HCT tab. The Phase I clinical trial for DKF-361 will be conducted at the Gil Medical Center, on 38 healthy adults.
Opinion
[FOCUS] Uncomfortable co-development regulation of medicines
by
Chon, Seung-Hyun
May 11, 2021 05:59am
There is a growing possibility that a bill will be implemented to regulate joint drug development by pharmaceutical companies. Recently, the National Assembly's Health and Welfare Committee held a bill subcommittee to pass a partial revision to the pharmaceutical practices law that limits the number of drugs that can be licensed through a single clinical trial. It allows up to four drugs that can be licensed with one biological equivalence test or clinical trial data. It does not apply to biopharmaceuticals or generic drugs. Biological equivalence testing is a kind of clinical trial for generic development, which effectively limits drug co-development by pharmaceutical companies. In fact, regulating the number of pharmaceutical companies participating in joint drug development by law is hard to find even in foreign countries. Sharing strategies for drug development through cooperation among pharmaceutical companies is an area of free business activities. The government does not directly intervene by law. If regulations on biological equivalence testing are applied, additional social costs may arise because the same drugs produced in the same manufacturer must be tested separately. This is why the Regulatory Reform Committee has opposed it. At a meeting of the Regulatory Reform Committee in October 2010, the restriction of biological equivalence tests was called a strange system, saying that "unscientific and logical regulations should be abolished." As the government pushed for the regulation again, the Regulatory Reform Committee opposed last year, saying, "Restricting pharmaceutical companies to enter the market also has low direct improvement in drug quality and safety and minimal R&D promotion." IMD's joint development regulations are also seen as the government's involvement in pharmaceutical companies' R&D strategies. There have been many ways to jointly develop new improved drugs while sharing clinical costs with small and medium-sized pharmaceutical companies that do not have enough funds. If development costs are divided and paid, this is to reduce risks caused by failure of development or sluggish sales after commercialization. In other words, the government restricts voluntary R&D cooperation of pharmaceutical companies. The MFDS, which is in charge of the project, is also burdened with regulations on joint development. According to the minutes of the bill subcommittee, Kim Jin-seok, deputy director of the MFDS, said, "I think mentioning the same part as joint R&D in pharmaceutical law exceeds the legal scope." Like Rx drugs, OTC can be cloned indefinitely through consignment, but it is hard to understand that only specialized drugs are subject to regulation. The KPBMA, one of the leading interest groups in the pharmaceutical industry, is welcoming the bill immediately after it is passed by the subcommittee. It is somewhat unusual for the industry to express its support for tightening regulations. It is undeniable that the "limit on the number of joint drug developers" is a strange system in science or common sense. What is even more uncomfortable, however, is the deformed environment of the domestic pharmaceutical industry, which led to the introduction of a strange system. More than 100 pharmaceutical companies are entering the large generic market and are excessively competing. As of December last year, according to the HIRA. A total of 139 pharmaceutical companies released Atorvastatin products. It increased by 40 from 99 in 2015. It has increased from 118 in 2018 to 133 in 2019 and 139 companies in recent years. In 2015, there were 91 domestic pharmaceutical companies that released Clipidogrel, but five years later, it increased to 133 companies, increasing to 42 companies. There were 112 pharmaceutical companies that released Atorvastatin in 2018, and 21 more joined in two years. The number of companies that released Donepezil reached 134 in two years from 89 in 2018. The value of generic is also gradually decreasing. In foreign countries, when the patent of the original drug expires, cheap generic dominates the market. The situation in IMD is similar. The joint development of IMD is seen as trying to curb generics' entry into the market. The new generic drug price system, which took effect in July last year, includes a stair-type drug price system in which the upper limit is lowered as the benefit is registered late. If more than 20 generic items are listed in the specific ingredient market, the upper limit for newly registered items will be up to 85% of the existing lowest price. If a certain pharmaceutical company develops IMD through clinical trials and recruits more than 20 delegated generics, the generic price will drop significantly. Doubts have been raised that many pharmaceutical companies may be trying to reduce the motivation for entering generics through sharing IMD clinical data. As a result, it led to the introduction of a strange system that also limits IMD clinical data sharing companies. With the reorganization of the drug price system, IMD infinite cloning of delegated generics has emerged to preempt high drug prices, and side effects of "intentionally registering drugs at low prices to induce competitors to receive lower prices." It is hard for anyone to understand the recent unprecedented phenomenon of drug production. Whenever regulations are made to solve urgent problems such as the general crisis, it is likely to backfire in the market. Overseas, inexpensive generic drugs are encouraged, and at some point, generic drugs have been ignored in Korea. It is time to reflect on where it went wrong and what responsibilities the government and pharmaceutical companies have and gather wisdom.
Policy
Clinical results for Janssen Vaccine to be submitted
by
Lee, Tak-Sun
May 11, 2021 05:59am
If Janssen COVID-19 Vaccine, the third-largest licensed clinical trial in Korea, is completed by the end of this year, the permits will also be subject to change. Janssen COVID-19 Vaccine was approved on April 7 for the prevention of COVID-19 in adults aged 18 and older. However it has not been officially introduced in South Korea yet. According to the Central Pharmaceutical Affairs Review Committee minutes, a court expert advisory body that determines whether Janssen COVID-19 Vaccine is licensed, the company plans to complete two inoculation trials by the end of this year and submit the results to the MFDS. The Central Pharmaceutical Affairs Review Committee meeting was held at 10 a.m. on April 1 at Osong Food and Drug Administration headquarters. During the meeting, the commissioners connected with the company and asked about future plans. The company explained, "Phase 1 and Phase 2 clinical trials are scheduled to be followed for two years, and phase 3 clinical trials plan to further analyze immunogenicity by 18 months." "The immunogenicity subgroup is scheduled to be monitored for 24 months, and the fastest immunogenicity results in Phase III clinical trials are expected to be available in the third quarter of this year," it added. "Although it is difficult to give an accurate answer, it is expected to be possible by this year." Janssen COVID-19 Vaccine designed and conducted clinical trials with the first dose of inoculation, but since the end of last year, phase 3 clinical trials have been underway twice. The vaccination effect was 66% at one time, and it is expected that the effect will increase at the second time. At the meeting, an official from the MFDS replied, "According to the results of the clinical trial of two doses, we can consider changing the permits if necessary." Officials at the Central Pharmaceutical Affairs Review Committee said that it is reasonable to grant permission on the condition that the final results of clinical trials are submitted because the vaccination profit from Jansen vaccine is generally high. Product licensing also followed the Central Pharmaceutical Affairs Review Committee's opinion. There were some concerns about its effectiveness and safety. In terms of effectiveness, the lack of preventive effectiveness and safety in subjects aged 65 and older were about thrombotic risks, such as AstraZeneca vaccines. The Janssen vaccine has a preventive effect of 44% since the 28th for those aged 65 or older. In response, the MFDS said, "Foreign regulators also considered the fact that it was a subgroup analysis, it was difficult to confirm statistically meaningful effects due to the small number of cases in the subgroup, and 0.52% 8 days later." "If there was a risk factor, it was 67% effective in severe patients." "The prevention effect is less than 50% after 28 days in subjects with general risk factors such as high blood pressure," a member said. "The same hypothesis cannot be applied to subgroup analysis, but is the validity of the submitted data appropriate considering that most subjects are risk factors?" In response, the MFDS said it would give conditions to South Koreans after marketing them. He also mentioned the need to strengthen monitoring of thrombosis risks. "CVST (cerebral sinus thrombosis) is a rare disease, but it is a problem because the prevalence rate has increased in Germany, and the incidence rate is very low, so continuous monitoring is needed." Since its approval in Korea, the U.S. has temporarily suspended vaccinations against Janssen due to concerns over side effects such as CVST. However, the EMA and the CDC resumed vaccination, saying that the benefits of vaccination outweigh the risks. The MFDS plans to continue to monitor abnormal reactions such as CVST through a risk management plan after approval. Meanwhile, Janssen COVID-19 Vaccine is the third-largest licensed vaccine in Korea, a viral vector vaccine such as AstraZeneca. Janssen COVID-19 Vaccine is a recombinant viral vector vaccine that utilizes Ad26 as a vector (or carrier) of the genetic code for the SARS-CoV-2 antigen (called the spike protein) to create an immune response.
Policy
Hemlibra is likely to establish criteria for reimbursement
by
Nho, Byung Chul
May 11, 2021 05:59am
Hemlibra's reimbursement standard applied in February this year is ▲for patients who fail ITI, ▲ if there is a doctor's opinion that it meets the requirements for ITI but cannot be implemented, and ▲approved only if antibodies are regenerated after ITI success. These benefits criteria could be cut from the HIRA's screening after prescribing drugs depending on interpretation, resulting in discontinuation of administration for some pediatric patients, and patients' carers have sought solutions from various angles, including filing a national petition to the HIRA. The HIRA and the patient's group, led by the Anti-Correction and Civil Rights Commission, held a recent meeting and exchanged in-depth mutual opinions and positions on the validity of ITI prerequisites. According to the industry, the HIRA subcommittee is expected to proactively consider ITI when treating hemophiliacs under the age of 12, but discuss salary standards on a case-by-case basis based on prescriptions for communications and respect for medical rights. Treatment of Hemlibra subcutaneous injections in pediatric hemophiliacs, which are currently suspended, is likely to resume as early as this month or next month. In particular, the suspension of administration of pediatric antibody patients is expected to have a significant positive impact on the establishment of Hemlibra's standards for non-antibody patients. Analysis of Hemlibra clinical data shows that donor licensing is superior to factor VIII preparation and can help improve the quality of life of patients by improving the convenience of administration with subcutaneous injections. First-in-class Hemlibra, which has gained an advantage in economic evaluation due to its cheaper and easier to administer than conventional treatments, is currently expanding benefits to hemophilia A non-antibodies even among A7 countries. Patients exposed to factor XIII drugs inevitably produce antibodies at a certain rate, and factor XIII alone is likely to fail to control bleeding. Hemlibra is a dual antibody mechanism that replaces factor XIII, which is considered a new alternative to hemophilia treatment as it is free from intravenous pain in both pediatric and adult patients and avoids concerns about antibody production. According to the hemophilia patient group, the full treatment of Hemlibra in pediatric non-antibody patients must be paid by the patient, and the patient group is constantly asking the HIRA to set a benefit standard for this.
InterView
"The reason why BI is the ‘Crown Jewel’ among all MNCs"
by
Eo, Yun-Ho
May 10, 2021 06:22pm
Bom-Mai Park, Head of HR/HRBP at Boehringer Ingelheim Korea Multinational pharmaceutical companies are a dream job for many workers in the industry. With its high salary, good welfare, and smart business system, many multinational pharmaceutical companies have all the requirements that office workers desire. Even among these multinational pharmaceutical companies, Boehringer Ingelheim is considered to be top tier. Headquartered in Ingelheim, Germany, the company has maintained its ‘family-operated system' for over 100 years. Since its establishment in 1976, its Korean subsidiary, Boehringer Ingelheim Korea, has also been known as an ‘employee-oriented company that you can work for until retirement.’ Like other companies, Boehringer Ingelheim Korea had also implemented the Early Retirement Program (ERP) in 2014 and 2018 and made reductions in its workforce. However, its downsizing scale and frequency were much smaller and less than other subsidiaries in Korea. The company also showed an encouraging response to the current situation where COVID-19 had swept the world, changing everyone’s daily lives. Boehringer Ingelheim Korea took 'Our FOCUS' and 'Future of Work' as their key message to drive change to fit the new era with their employees. DailyPharm met with Bom-Mui Park (52), VP of Boehringer Ingelheim Korea who heads Human Resources (HR), to hear about the company’s vision and strengths. -What are Boehringer Ingelheim Korea’s strengths in HR? There are official strengths, and those I personally consider as strengths. Officially, the company considers the employee-company relationship in the long term. The policies HQ took during the COVID-19 crisis that broke out last year are a good example. The company made policies to preserve the level of income for employees in sales, such as MRs, who had suffered economic damage due to reduced incentives, etc. from COVID-19. Also, the company provided paid leave for employees who went to do volunteer activities related to COVId-19. I was moved by the immediate response to crisis and rewards provided for employees by the company. Personally, I believe the strength of Boehringer Ingelheim Korea lies in the provision of an ‘environment that allows learning from mistakes.’ Our company has a forgiving nature that allows employees to grow with feedback rather than being punished for a single mistake. Also, as Boehringer Ingelheim is a limited liability company that pursues long-term performance and value creation, it is relatively more stable than the other companies that I have previously worked for. -On the other hand, the company’s ‘forgiving’ culture could be abused and be considered an ‘easy company’ to work for, allowing employees to become lax in their work. I disagree. Those who make mistakes are those who made attempts. Employees who do nothing are the bigger threat to a company. Boehringer Ingelheim has a well-established organizational culture that silently pressures those who do nothing. In other words, our organizational culture is established so that everyone must do their part. The roles and responsibilities of each employee are clearly set, and the evaluation standards for assessing each employee’s performance are also set quite high. In these aspects, Boehringer Ingelheim is not an easy company to work for. Also, our system is constantly evolving to fit the changes, and our employees grow in line with the changes. -What is the ‘Future of Work’ that the company has newly implemented? The Future of Work was implemented in our headquarters to establish a flexible work culture and create a good environment for employees to work for which actively embraces the internal and external changes seen in the current era of change. We worked hard to change the role of the office, which was just a mandatory space for work, into a space for cooperation and innovation. In line with the efforts, Boehringer Ingelheim Korea also opened a smart office on April 5th. The newly transformed office was designed to maximize collaboration, work efficiency, creativity, and employee’s health and well-being based on the company’s vision of ‘creating value through innovation.’ The office is no longer a mandatory workspace, but rather a place of collaboration and innovation which may be selected according to an employee’s nature of work and personal preferences. Our new space has various kinds of meeting rooms and an Innovation Zone, as well as a Quite Zone where employees could focus on their work. We also offer telecommuting, so employees may work at the office or from home. The new office was designed so that all employees and executives may work efficiently and creatively without spatial constraints. - What kind of talents do Boehringer Ingelheim Korea seek for its employees? We have a very specific type of talent we desire in our employees. We want responsible individuals that are alert to change and have entrepreneurship, and not fear innovation or taking risks. This is not limited to Boehringer Ingelheim Korea; it is what Boehringer Ingelheim wants for all its employees and is what we strive to become. With work these days being conducted non-face-to-face and a leaner culture being set within the organization, the work culture in Korea as well has well moved away from the apprenticeship method. In other words, employees nowadays need to lead their own work independently as soon as they enter the company. Of course, feedback is provided; however, the learning curve has also become shorter than in the past, and employees must become on-set quickly. So, we need people who do not feel burdened by learning. We need learners with positive minds that say, ‘I will learn if I don’t know,’ that can strictly manage themselves. -What kind of organization does Boehringer Ingelheim Korea wish to become in the future? Much has changed with COVID-19. The biggest change that occurred is the non-face-to-face work through digital. At first, I had my concerns. But in fact, the flow now is better than expected. We had experienced changes every year, but after COVID-19, we started to consider how to engage and immerse employees in the non-face-to-face environment. In the past, I believed team-building was only possible face-to-face. But I changed my mind after working non-face-to-face. I now believe it is more about the vision set by the company. The vision itself should make the employee's heart beat faster, and a goal needs to be set so the employees can bond over and take pride in its achievement.
Policy
Korea United Pharm has started developing a combined IMD
by
Lee, Tak-Sun
May 10, 2021 05:57am
[ It is confirmed that Korea United Pharm has started developing a triglyceride treatment compound called "Pravastatin-Fenofibrate." The intention is to commercialize Fenofibric Acid, which can be taken with or without meals, as it is more convenient than conventional drugs. On the 28th of last month, the MFDS approved a Phase I clinical trial plan for UI061 for Korea United Pharm's treatment of complex dyslipidemia. This test is designed to identify the safety and pharmacokinetic properties of UI061 in healthy adult subjects. The event will be held at Chungnam National University Hospital for 10 people. The component of UI061 is Pravastatin-Fenofibrate. It also selected Yooyoung's "Pravastatin-Fenofibrate" as a control drug. Pravafenix is a drug introduced by Yooyoung from Belgian pharmaceutical company SMB in 2009 and is gaining popularity as a combination of triglyceride treatment. Based on UBIST, amount of out-of-pocket prescriptions last year was $21.6 billion, which is also playing a role of cash cow for companies. In particular, it is currently the only Pravastatin-Fenofibrate compound in Korea. United used Fenofibric Acid instead of Fenofibrate. Fenofibric Acid was first introduced as 'Fenocid' in 2012. In 2019, United were granted Fenorics EH (Fenofibric Acid). Fenofibric Acid can be taken independently of meals. Fenofibrate must be taken with food to increase absorption. So, Fenofibrate-based Pravafenix should be taken for dinner. If Fenofibric Acid is combined with Pravastatin and made into a compound, it can be taken independently of the meal. However, it is difficult to be sure of the possibility of commercialization at this time because United is still conducting clinical trials for the first time. In the meantime, United has new IMDs such as CilostanCR. Attention is focusing on whether there will be new drug development items that will make competitors nervous again this time.
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