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- Yuhan secured ₩230 billion in two years
- by Chon, Seung-Hyun Nov 25, 2020 06:24am
- Yuhan has secured about ₩230 billion in new drug technology fees over the past two years. It has signed five technology transfer contracts, and has also collected milestones of more than ₩100 billion in the development stage after technology export. Front view of Yuhan headquartersYuhan announced on the 24th that it will receive a staged technology fee (milestone) of $65 million (₩72.3 billion) for the anticancer drug Lazertinib from Janssen Biotech. An additional milestone occurred as Janssen started recruiting subjects for a phase III clinical trial of its own anticancer drug, Amivantamab and Lazertinib. Lazertinib is a third-generation EGFR targeted anticancer drug that Yuhan handed over to Janssen Biotech in November 2018. The total contract size, including a down payment of $50 million without obligation to return, is up to $1.25 billion. Lazertinib's additional milestone is the second since the temporary export. Yuhan received $35 million milestone for Lazertinib from Janssen Biotech in April. Janssen paid an additional milestone to Yuhan when he began a trial of Amivantamab and Lazertinib combination therapy at the time. Yuhan has secured a total of $150 million, including a down payment of $50 million, only by the transfer of Lazertinib technology. 40% of Lazertinib's technology fees are redistributed to the original developer, Oscotec. For Yuhan, technology fees have been a major source of revenue since 2018. Yuhan has signed a total of five new drug technology export contracts since July 2018. In July 2018, it transferred the technology of YH14618, a treatment for degenerative disc disease, to Spine Biopharma in the United States. It received a down payment of $650,000, and was guaranteed $217.5 million for milestones in stages according to development, licensing and sales. In November 2018, it signed a technology export contract with Janssen for Lazertinib. In January of last year, it signed a license and joint development contract with Gilead Sciences for new drug candidates that act on two drug targets for the treatment of non-alcoholic steatohepatitis (NASH). It is a condition of receiving a down payment of $15 million and receiving $777 million in milestones for each stage of development, licensing and sales. In July of last year, Yuhan signed a technology transfer contract with Boehringer Ingelheim for a total of $870 million related to the NASH treatment YH25724. The down payment without obligation to return is $40 million. Out of the $40 million down payment, they agreed to receive $10 million upon completion of the non-clinical toxicity test, but after the nonclinical toxicity test was completed in 9 months, the remaining down payment was received in April. In August, it signed a technology transfer contract with Processa Pharmaceuticals of the United States for a functional gastrointestinal disease treatment candidate YH12852. Yuhan received a down payment of $2 million as shares, which were not obligated to return. Yuhan has secured a total of $2,765 million (about ₩230 billion) in technology fees for about two years since 2018. It is more than 18 times the operating profit of ₩12.5 billion last year. Quarterly Yuhan technology fee operating profit (Unit: ₩million, Source: Yuhan, the FSS) Yuhan's recent technology fees are higher than operating profits. As of this year, Yuhan has recognized a total of ₩77.9 billion in technology fees. In the first and second quarters, ₩1.1 billion and ₩35.7 billion were reflected, respectively, and an additional ₩16.9 billion was recognized in the third quarter. Yuhan's cumulative operating profit in the third quarter was ₩57.1 billion. It is calculated that if there was no inflow of technology fees, it would have recorded a deficit. Yuhan's technology fee revenue was ₩23.2 billion last year, far exceeding its operating profit (₩12.5 billion). From 2019 to the third quarter, Yuhan recognized a total of ₩101.1 billion in technology fees. In the future, additional technology fee revenues reflected in earnings exceed ₩100 billion.
- Company
- HCP and patients waiting for new T-cell lymphoma option
- by won, jong-hyuk Nov 25, 2020 06:24am
- The performances of anticancer therapies are improving as time goes by. But some cancer types still use chemotherapy as a standard of care (SOC) developed in 1970s to this date, regardless of the technological advancement in the anticancer area. One of them is Peripheral T-Cell Lymphoma (PTCL). Typically, PTCL is one kind of non-Hodgkin lymphoma found in T lymphocytes. The condition is categorized as a malignant tumor and an aggressive lymphoma. The tumor frequently spreads in liver, spleen and skin, and also has high risk of relapse and rapid advancement speed. The problem is that the patients usually do not respond to the current SOC of a combined chemotherapy, and the prognosis of PTCL patients who fail in the first-line therapy or show relapse is not so positive with the median survival period lasting about 5.8 months. Rare blood cancer area stuck with ‘70s chemotherapy showing low survival rate and frequently observed toxicity #The current first-line SOC in PTCL treatment is a combination of chemotherapy including cyclophosphamide, doxorubicin hydrochloride (hydroxydaunorubicin), vincristine sulfate, and prednisone, or also known as CHOP, used from the ‘70s. The CHOP chemotherapy has been used as a first-line treatment for decades, but the academic societies are torn about the therapy’s survival rate and toxicity. According to a clinical trial in Japan, PTCL patients’ three-year survival rate was only about 52 percent after receiving CHOP chemotherapy. And high dosage of chemotherapy causing adverse reaction is considered as the biggest problem when treating the patients. Blood toxicity, such as leukopenia, anemia, thrombopenia could be caused by myelosupression, or the patients usually experience loss of hair, peripheral neuropathies, infection and nausea. The reason why such high risk SOC is still used until today is because the disease has no other alternative options. The treatment scene is not so different in South Korea. The National Cancer Information Center explains there are cases of the patients with PTCL or other non-Hodgkin lymphoma participating in clinical trials using new drugs, when they did not respond well enough to the SOC. A professor of hematology and oncology at Samsung Medical Center, Kim Seok Jin explained, “Patients with PTCL are usually diagnosed in their 50s or 60s, and they are likely to get complications due to bone marrow suppression triggered by chemotherapy. Especially the patients in their 70s, some give up their treatment as they cannot endure the adverse reaction, and a lot of them see underwhelming treatment effect as they have to reduce the dosage considering the high risk of adverse reaction.” ”Desperately need to improve PTCL treatment access in South Korea” with the updated NCCN guideline Although the PTCL treatment scene lacks varying treatment options with the said situations, a lymphoma treatment Adcetris (brentuximab) earned a new indication to treat PTCL and expanded the treatment option in December last year. Adcetris is an antibody-drug conjugate (ADC) directed to CD30, expressed on the surface of several types of PTCL. A Phase III ECHELON-2 study evaluated the drug’s clinical benefit, where patients with CD30-positive PTCL have improved the overall survival (OS), compared to the SOC CHOP chemotherapy, without discovering more issue with adverse by using brentuximab as a first-line treatment. During the study, a patient group receiving brentuximab plus CHP (cyclophosphamide- doxorubicin-prednisone) combination lessened the risk of death by 34 percent and significantly enhanced the OS, in comparison to the patient group using CHOP. Also the Adcetris combination therapy demonstrated an outstanding treatment efficacy proven with other indicators of anticancer treatment efficacy like progression-free survival (PFS), objective response rate (ORR) and complete remission (CR). The median PFS in the Adcetris combination therapy group reached 48.2 months, which almost doubled the median PFS in the CHOP patient group with 20.8 months. The statistics prove that the combination therapy has brought down the risk of disease progression by 29 percent. Based on the reported clinical efficacy, the current National Comprehensive Cancer Network (NCCN) guideline recommends using Adcetris plus CHP combination therapy for a first-line treatment in patients with CD30-positive PTCL as a ‘preferred regimen.’ However, the PTCL treatment scene in South Korea has a long way to go. The drug expanded the indication late last year, but it still has not resolved the healthcare reimbursement required for more practical prescription. The drug faces the first threshold of winning the healthcare reimbursement, the Cancer Deliberation Committee meeting schedule on Nov. 25. And regarding the drug Professor Kim commented, “Both the patients and healthcare providers are happy to have a new treatment option with superior efficacy than the existing SOC, as there were limited prescription options for patients with PTCL. There is definitely a big difference between not having an option at all and having option that cannot be accessed.” The professor continued, “It is regrettable the patients are giving up on treatment, because of financial reasons, regardless of the new available option with lessened toxicity and good efficacy. I wish their access to treatment can be better as soon as possible for them to live longer. And granting the healthcare reimbursement on the drug would be cost-effective as there are only a handful of PTCL patients in South Korea.”
- Company
- Atozet follow-on drugs conflicted over price manipulation
- by Chon, Seung-Hyun Nov 24, 2020 09:03am
- The South Korean dyslipidemia treatment Atozet market seems to be heating up with competition and conflict among consignment manufacturers. Companies in process of preparing for the Atozet generic have stated they would take a legal action against Chong Kun Dang’s violation of Fair Trade Act, claiming the Korean company is rigging the follow-on drug pricing. According to the pharmaceutical industry sources on Nov 23, three of South Korean pharmaceutical companies are considering on filing a complaint to the Fair Trade Commission about Chong Kun Dang’s attempt to fix the generic pricing. The three companies argue Chong Kun Dang has tried to monopolize the generic pricing as it called for consignment manufacturers for the atorvastatin plus ezetimibe combination drug. MSD’s dyslipidemia treatment Atozet Chong Kun Dang has recently received a government approval on Atoezy, a combination of atorvastatin and ezetimibe, after finishing off a clinical trial. The approved drug has the same substances as Atozet developed by MSD. Chong Kun Dang announced its plan to have consignment manufacturing and called for manufacturers for the deal. Basically, the company is to provide authorization to manufacture the generic to the manufacturers with the entire clinical data related to Atoezy. An authorized generic would have exact same product as an original but in different packaging. Chong Kun Dang has accepted total 22 manufacturers, who submitted an approval application on the authorized Atoezy generic. But the three generic companies are claiming Chong Kun Dang is manipulating the market. Apparently, the company included a condition to ‘apply for pricing to the Health Insurance Review and Assessment Service (HIRA) immediately after completing the approval process’ in the consignment contract, and the three companies say it violates the Fair Trade Act that forbids a ‘practice to decide, sustain or change pricing.’ In other words, they are arguing Chong Kun Dang is trying to bring down the follow-on drugs’ pricing by having the consigned manufacturers to agree on simultaneously apply for listed drug pricing. The generic companies plan to take the case to the Fair Trade Commission this week along with a couple of law firms. The key point of the conflict between Chong Kun Dang and generic companies centering the authorized Atoezy generic is in the pricing. When 22 authorized Atoezy generics receive approval and reimbursed pricing, other drugs to be approved later would have significantly lower pricing. The revised drug pricing system effective from last July stipulates a stepped drug pricing that reduces the upper limit pricing of the 21st generic drug with same substance down to 85 percent of a lowest priced drug. When 22 authorized Atoezy generics complete the reimbursed pricing procedure, other following Atozet generics would be applied with the stepped drug pricing, which would bring down the pricing to 61.4 percent of the upper limit price of a drug with same substances. According to the Ministry of Health and Welfare (MOHW), when the number of listed drugs with same substance exceeds 20, a new reimbursed pricing applicant drug would receive pricing of the lowest between ‘85 percent of drug pricing with two unmet qualifications,’ or ’85 percent of the lowest price among the same substance drugs.’ The 85 percent of drug pricing with two unmet qualifications is calculated as 61.4 percent of the upper limit pricing (upper limit pricing*0.85*0.85*0.85). If one of authorized Atoezy generic drops the pricing greatly, other Atozet generic’s pricing would be priced even lower. At the moment, Atozet generic cannot enter the market. Some companies are preparing for a generic release by conducting a bioequivalence test with Atozet as reference drug, but they can only apply for approval after Jan. 22 next year when Atozet’s post-marketing surveillance period ends. Because of the said complications, companies readying the Atozet generic products were sensitively monitoring the number of authorized Atoezy generics. The Atozet generic companies question the Chong Kun Dang’s action and insist “Chong Kun Dang has intentionally called for over 20 manufacturers to push other generics’ pricing down.” In fact, some of companies that actually developed Atozet generics have joined the group of manufacturers signing the deals on authorized Atoezy generics. An insider from an Atozet generic developer complained, “If any one of the authorized Atoezy generics takes a substantially low pricing, then other Atozet generics cannot even launch their products due to unprofitable income structure. Due to the government’s stepped pricing, the companies’ immense effort to develop a generic could be gone instantly.”
- Company
- Takeda rejoins KRPIA after 5 years
- by Eo, Yun-Ho Nov 24, 2020 09:02am
- Takeda Pharmaceuticals Korea is returning to Korean Research-based Pharmaceutical Industry Association (KRPIA). The pharmaceutical industry sources recently reported Takeda has officially joined KRPIA as a member company. The company is gaining back its member company status as well. The KRPIA membership was inherited from Shire Pharmaceutical that Takeda has completed acquiring in July. Since its launch in 2016, Shire has been an active member of KRPIA. After opening the South Korean branch in 2011, Takeda started off as a member of Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) and also joined KRPIA in 2013, when former President of GSK Korea President Kim Jin-ho was a chair of KRPIA. However, the company left KRPIA in 2015 and only sustained the membership at KPBMA. Takeda’s decision to rejoin KRPIA seems to have been influenced by its new drug pipelines. The company has launched an autoimmune disease treatment Kynteles (vedolizumab), a multiple myeloma treatment Ninlaro (ixazomib) and anticancer treatment Zejula (niraparib) from last year, and it has a series of other new drugs in preparation to launch. As new drug healthcare reimbursement is a controversial issue in South Korea and KRPIA is focusing on government affairs at the moment, the company could have taken a strategic action accordingly. KRPIA has various multinational pharmaceutical companies as member companies. Including a number of Japan-based companies, such as Takeda, Daiichi Sankyo, Mitsubishi Tanabe Pharma, Santen Pharmaceutical, Astellas, Kowa, Kyowa Kirin, the list of member companies also has Galderma, Sandoz, Fresenius Kabi, Fresenius Medical Care and Baxter.
- Company
- An employee at drug company earns average KRW 41M
- by Chon, Seung-Hyun Nov 24, 2020 09:02am
- Apparently, the government statics say the average annual salary of the South Korean pharmaceutical industry is 41.4 million won. It was just shy of the general industry average. Depending on the pharmaceutical companies, some had average salary gap over 10 million among their employees. A university undergraduate’s average salary started from 34.77 million won, which is 11 million won more than the high school graduates. On Nov. 19, Ministry of Employment and Labor (MOEL) disclosed the wage by industry as of June 2020 through the wage and job information system. For the second time, MOEL has presented the analysis of wage based on the employment due diligence as of June this year by job types from 2017 through 2019. Average salary in pharmaceutical companies by employment size (Unit: KRW) Source: MOEL According to the statistics, the jobs in the medical substance and pharmaceutical manufacturing industry make annually average salary of 41.4 million won. Basically, the pharmaceutical industry’s average annual salary is 1.88 million won less than the general industry’s average of 43.28 million won. However, the annual salary at pharmaceutical companies varied widely depending on the size. The employees at pharmaceutical companies with over 300 employees are making average annual salary of 48.14 million won, which is 11 million won more than employees at companies with five to 29 employees (36.79 million won). Employees at companies with 30 to 99 employees and with 100 to 299 employees are making 38.29 million won and 44.73 million won, respectively. Also the average annual salary varied depending on the education level of the employees. The average salary of employees with undergraduate degree is 47.85 million won, making 14.42 million won more than the high school graduate employees with 33.43 million won. Average salary in pharmaceutical companies for an entry level employee with less than a year employment size (Unit: KRW) Source: MOEL An entry level employee with less than a year of employment is making average of 30.45 million won a year. Specifically, the employees at pharmaceutical companies with over 300 employees are earning 36.57 million won a year, or 5.19 million won more than employees at companies with five to 29 employees (25.36 million won). An entry level employee with an undergraduate degree is earning 34.77 million won per year, whereas ones with two-year college degree or high school diploma are earning 29.72 million won and 23.42 million won, respectively. Average salary in pharmaceutical companies for an entry level employee with less than a year employment size (Unit: KRW) Source: MOEL The statistics on average salary by employment years in pharmaceutical companies found employees, who have worked over 25 years, are earning average of 64.43 million won. By third to fifth year, the salary exceeds 40 million won, and it exceeds 55.29 million won by 15th to 20th year. A male employee (45.72 million won) is making average 10 million won more than a female employee (34.17 million won) in the entire pharmaceutical industry. The salary gap seems to be big as the male employees tend to be employed longer compared to female employees.
- Company
- Daewoong succeeded in evading patent for Belkyra
- by Kim, Jin-Gu Nov 24, 2020 09:01am
- Belkyra Daewoong once again succeeded in patent evasion of 'Belkyra (Deoxycholic acid)', an injection for improving submandibular fat. The original company, Allergan, tried to defend itself through 'divisional application' but failed. According to the pharmaceutical industry on the 23rd, the Intellectual Property Trial and Appeal Board recently decided on ‘an establishment claim’ in a trial to confirm the scope of passive rights filed by Daewoong in formulation patent of Belkyra. As a result, Daewoong successfully avoided two of the three Belkyra patents. Previously, Daewoong successfully avoided Belkyra's formulation patent in June. This patent evasion is an additional patent registered by Allergan earlier this year. Daewoong's patent challenge for Belkyra began in January 2018. Daewoong has filed a trial to confirm the scope of the right to the patent of Belkyra. In June, The Intellectual Property Trial and Appeal Board filed a trial decision on an establishment claim, and Allergan abandoned the appeal, and Daewoong won on July 23rd. However, Daewoong had more things to overcome. In January and April this year, when Daewoong and Allergan's workshops were in full swing, Allergan registered two new patents of Belkyra. Allergan registered only some of the existing patents. It was part of the 'Evergreening strategy' that continues its duration through divisional applications. In the end, Daewoong had to challenge the two divisional applications. In March of this year, Daewoong filed a trial for a passive confirmation of the scope of rights to the newly registered Belkyra’s formulation patent. With this ruling, Daewoong successfully evaded two of the three Belkyra patents. There is still one patent left, but it is said that the pharmaceutical industry will avoid it. If Daewoong overcomes the remaining patent, it currently being developed will be released early. Daewoong Pharmaceutical is currently developing its own injection to improve submandibular fat under the name'DWJ211'. Since March of last year, it has entered phase III clinical trials for 150 patients at Konkuk University Hospital and Chung-Ang University Hospital. The indication is'improvement of moderate/severe submandibular fat', which is the same as Belkyra. When the development is completed, there is a possibility of being sued for patent infringement from Allergan. At this time, the trial decision is expected to be appropriately used for defense purposes. Belkyra is the only drug that has been approved by the US Food and Drug Administration (FDA) to improve submandibular fat. There are indications for moderate/severe protrusion or excessive improvement of submandibular fat in adults. It was released in Korea in early 2018.
- Company
- Will Sanofi's CHC division become an opportunity for growth?
- by Nov 24, 2020 09:00am
- Sanofi began to gain attention afterward as Sanofi started to incorporate the independent consumer healthcare (CHC) division. Sanofi declared that the CHC division became an independent corporation from last year. CEO Paul Hudson, who took office in September last year, mentioned CHC's strategy for an independent corporation in December of that year. Several speculations have been made overseas regarding the establishment of an independent CHC corporation. At the time, foreign analysts speculated that Sanofi could take options such as IPO, sale, or joint venture after establishing an independent corporation. Since the declaration of an independent corporation last year, Sanofi has not come up with a specific CHC strategy, but it seems that each country is preparing a plan for establishing a corporation and operating an organization according to a large strategy at the global level. The hopeful retirement (ERP) recently conducted by the Korean branch for employees in the CHC department is also predicted as part of this big picture. Sanofi-Aventis Korea announced the establishment of an independent CHC corporation on the 13th with the goal of September 2021. After the completion of the ERP, the company plans to go through the process of establishing a corporation. However, Sanofi dismissed the possibility of selling, stressing that even if an independent CHC corporation is established, it will go together within the group rather than sell it. Sanofi CHC division sales trend Compared to the specialty care division, which generates high sales with new drugs such as Dupixent, the CHC division has a growth rate of €1.1 billion (about ₩1.4 trillion), which is almost stagnant. In particular, in December of last year, it was also hit by the problem of collecting remaining balances. In the first quarter of 2020, it made up for the loss by raising sales of €1.3 billion (about ₩1.7 trillion), but it decreased to the level of €1 billion (about ₩1.3 trillion) due to the COVID-19 incident. At the same time, there is also the possibility of the CHC department. In particular, it is worth looking forward to growth in emerging markets. As of last year, sales in developed countries were on a decline, while in emerging markets, sales were insignificant but increased. Scale down seems inevitable. This is because management has repeatedly expressed a willingness to convert OTC sales methods to digital. In a conference call on the 30th of last month, CHC Vice President Julie Van Ongevalle mentioned maximizing digital channels and said, "I believe the CHC division has potential in digital channels." In addition, in Korea, it is expected to be operated on a smaller scale by switching to outsourced sales rather than direct sales. Sanofi said, "Not all businesses, but OTC business will be sold to third parties." In this process, conflict with the union is also expected. The Sanofi union is concerned about the coercive reduction of the size of OTC personnel in the CHC division that the company targets. In this context, it is also in this context that the company is asked for an alternative manpower changeover arrangement in case the applicants for retirement are short of the target number.
- Company
- "TNF blockers in rheumatoid arthritis is a symbol of trust"
- by Eo, Yun-Ho Nov 20, 2020 06:14am
- Professor Kim Geun-tae A tumor necrosis factor (TNF)-α inhibitor was a game changer for the rheumatoid arthritis (RA) treatment scene. An autoimmune disease RA, which causes break down in joints and bone tissues with abnormal immune reaction, has prevalence rate in female patients approximately 0.3 percent to 1 percent higher than male patients. According to South Korea’s Health Insurance Review and Assessment Service (HIRA), about 250,000 patients in South Korea are diagnosed with RA, annually. And biologic therapies were a breakthrough in the chronic RA treatment scene. The biologic therapy for RA, such as Humira (adalimumab), Enbrel (etanercept) and Remicade (infliximab) blocking TNF-α and helping to stop inflammation, targets T-cell co-stimulation or B-cell prior to the inflammatory reaction stage. And recently, the treatment options for RA have expanded with orally taken Janus kinase (JAK) inhibitors like Xeljanz (tofacitinib), Olumiant (baricitinib) and Rinvoq (upadacitinib). However, the healthcare providers’ trust in TNF-α inhibitors is sound. Kim Geun-tae, a professor at Kosin University Hospital Division of Rheumatology said, “The healthcare providers would always welcome a new selection of treatment options. There are new drugs with new mechanism of action that improves administration convenience. But to this day, I usually choose TNF-α inhibitors as a first-line therapy after prescribing methotrexate (MTX). Almost two decades of prescription experience is an asset you cannot ignore.” Professor Kim added, “It would depend on the patient’s condition, but I personally prefer Humira for the balance in safety and efficacy. Of course, other treatments are prescribed strategically as well. Depending on infection (tuberculosis and etc.), adverse reaction, and administration route, I also prescribe other TNF-α inhibitors like Enbrel and Remicade.” But there is inevitable fear of injection among patients. Especially, the user reactions on the pain from the injected TNF-α inhibitor are split. A study found the pain from Humira injection was the worst. Regarding the issue, Professor Kim explained, “Injection could be painful. The Humira brand is doing its best to improve the administration experience for the patients, such as releasing the citrate-free injection in 2017 to remove the pain-causing citrate. And now we have less patients complain about the pain thanks to the pharmaceutical companies’ efforts.” He also elaborated, “We even have to instruct the patients to not remove the syringe until all the content is injected as now they assume the injection is done before it is with the significantly improved level of pain from the new injection type.” The professor was rather concerned of the patients, who try to manage RA through bad folk remedy, instead of proper pharmaceutical therapy. “Some miss the appropriate treatment period, as they refuse to take the drug or explore for a cure in unverified folk remedy. The prognosis of RA heavily depends on the early detection and treatment. RA is a chronic inflammatory disease that requires a life-long management. To treat RA, taking anti-rheumatic drugs is crucial,” he added. Wrapping up the interview, Professor Kim stressed, “As for exercises, I would recommend stretching or yoga that increases range of motion. Although the patients should avoid strenuous exercises, working out two to four hours a week would improve disease activity and the disorder.”
- Company
- Protecting labor rights in multinational company spinoff
- by Nov 20, 2020 06:12am
- The multinational pharmaceutical companies in South Korea came under fire after they started restructuring and downsizing unilaterally and the experts are urging for the labors’ rights to participate and choose should to be secured. On Nov. 18, a member of the National Assembly Environment and Labor Committee and Democratic Party Lawmaker Yoon Joonbyeong, along with Seoul Metropolitan Council member Chu Seung-woo, convened a discussion panel regarding improving the labor environment and job security for the employees at multinational pharmaceutical companies. This marks the first time employees of multiple multinational pharmaceutical companies came together to seek legal improvement. The representatives expressed their commitment to not let their management to frequently conduct reorganization anymore, which results in job reassignment and pressure on resignation. Chair Shim Sang-nam of MSD Korea Labor Union and Professor Kwon Oh-sung of Sungshin Women’s University Department of Law respectively gave a presentation on ‘Issues with the Current Multinational Companies’ Corporate Change,’ and ‘Succession of Labor Relations for Corporate Spinoff.’ Following the presentations, a discussion panel was conducted with Professor Choi Young-woo at Korea Labor Employment Training as a speaker, and Vice-president Jin Sunmee of Korea Certified Public Labor Attorneys Association, Senior Advisor Shin Jong-hwan of MSD Korea Labor Union, CEO and Labor Attorney Kim Kyungrak of Daesang Labor Law Firm, CEO and Labor Attorney A1 Labor Law Firm, and Chair Kang Seungwook of Pfizer Pharmaceutical Korea Labor Union as panelists. Chair Shim Sang-nam said, “Recently, multinational pharmaceutical companies like Pfizer, Takeda, MSD, Roche and Sanofi had gone through reorganization. The rumor goes that when Pfizer does it, then MSD copies it and it spreads throughout the industry. And it is proving itself to be true, while the employees are suffering from job insecurity.” MSD has recently announced the list of 222 employees to be transferred to a new spinoff company Organon. Senior Advisor Shin Jong-hwan stressed, “Many of the employees transferring to Organon feel insecure and call the labor union. Because multinational companies frequently restructure the organization centering new business, the employees feel the insecurity often. So we must find legal and systematic safety net to put a brake on these situations.” Chair Kang Seungwook, who officially moved to Viatris from Pfizer Group from Nov. 16, added, “Like spinoffs in Pfizer and MSD, corporate changes that go against employees’ will happen frequently in the pharmaceutical industry. In the process, we felt the absence of legal support to protect the rights of those employees.” Labor law experts all agreed laws should protect the labors’ rights to participate and express agreement and disagreement in organization restructuring that currently the companies are making the decisions unilaterally. Companies in Germany, for instance, recognize the labors’ rights to refuse, while the laws in Japan and Austria also stipulate the companies to undergo a set of procedures for the labors to formally object based on the principle to succeed the labor relationship. Professor Kwon Oh-sung explained, “Some employees may be forced to transfer to a new company against their will, whereas some would be left behind when they wish to be transferred to new company. Guaranteeing the labors’ rights to participate in decision making is important during the process of corporate split, and we need to seek measures to guarantee the labors’ rights to choose, such as the rights to refuse and formally object.” Labor Attorney Jin Sunmee also stated, “Although a corporate split could greatly influence the employees’ job security, the current commercial law and labor relations law do not stipulate any protection. And often pharmaceutical companies let go of parts of employees by spinning off a new company dedicated to off-patent and less competitive products, which results to job insecurity and workplace discrimination.” Moreover, the attorney argued, “Based on the objective of the constitution and Labor Standards Act, the employees should be able to practice their rights to refuse transfer, when a company splits with a new business proprietor.” Also, Labor Attorney Han Man-ok highlighted, “For multinational companies that cannot create close relationship between the global headquarters and South Korean employees, there exists structural weakness that allows decision making only based on business efficiency. And also because not enough legislative bills on labor relations are passed regarding the business split, it gives off an impression that ‘companies do not have to deeply consider labor relations in South Korea, as there is no legal tools to prevent reorganization due to labor relations.’” Labor Attorney Kim Kyungrak, who organized the panel discussion, added “I personally experienced M&A twice while I was working at multinational pharmaceutical companies like MSD Korea and Allergan Korea for 15 years before I became a labor attorney, and I was even offered an early retirement program. With the corporate change becoming more frequent, we need to hold talks and raise awareness of the employees’ survival.”
- Company
- Bridge plans to establish follow-up development of BBT-877
- by Chon, Seung-Hyun Nov 20, 2020 06:11am
- Bridge Biotherapeutics announced on the 17th that it will establish a follow-up development and business strategy for BBT-877, which was recently returned from Boehringer Ingelheim, within the first half of next year. Bridge Biotherapeutics introduced research and development strategies at an online IR briefing for investors on this day. Bridge Biotherapeutics said, “The return of BBT-877 has been decided according to the internal guidelines of Boehringer Ingelheim.” Bridge Biotherapeutics IR Briefing Materials On the 9th, Boehringer Ingelheim decided to return the rights of the idiopathic pulmonary fibrosis drug BBT-877 to Bridge Biotherapeutics. BBT-877, which was technically exported in the first phase of clinical trials in July of last year, is a drug that inhibits the autotaxin enzyme responsible for fibrosis in various cell types. It is a new drug candidate developed by LegoChem and entrusted to the development of Bridge Biotherapeutics. Bridge Biotherapeutics will not return €45 million received from the technology export of BBT-877. Bridge Biotherapeutics plans to establish a follow-up development plan by reviewing additional data such as the existing developer fee for BBT-877 and the phase II clinical trial plan received from Boehringer Ingelheim. The plan is to finalize the development plan through a meeting with the US Food and Drug Administration (FDA). On this day, Bridge Biotherapeutics presented a blueprint to promote the technology transfer of BBT-401 and BBT-176, which are currently being developed. BBT-401 is a treatment for ulcerative colitis and is undergoing preclinical and phase I clinical trial, and phase II clinical trial. BBT-176, which is being developed as a treatment for non-small cell lung cancer, is currently in the clinical plan approval stage. Bridge Biotherapeutics said, "We will accelerate the clinical development of BBT-401 and BBT-176 and achieve additional global technology transfer within 2021."
