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Company
Eisai strengthened Pariet's sales, collaborated with Yuhan
by
Nov 06, 2020 06:25am
Eisai strengthened the collaboration of Pariet (Rabeprazole) with a domestic company of PPI. The joint sales were expanded to Pariet 10·20mg following low-dose Pariet 5mg. According to the pharmaceutical industry on the 3rd, Yuhan recently signed a joint sale contract with Eisai for Pariet 10·20mg, and started supplying the product from this month. Yuhan will focus on hospitals and clinics, and co-promotions will be held by the two companies in general and university hospitals. Eisai signed a partnership with Yuhan earlier this year to sell low-dose Pariet 5mg. This is the first co-promotion with a domestic company. After that, the two companies expanded the contract to Pariet 10·20mg. Pariet is a representative PPI product developed by Eisai and launched in Korea in 2000. At that time, it was leading the PPI market with a high market share, but performance has slowed in recent years due to intensifying competition such as PPI formulations and generics. Based on UBIST, Pariet's outpatient prescriptions amounted to ₩6.3 billion in 2015, ₩8 billion in 2016, and ₩12.4 billion in 2017, showing a double-digit growth rate from the previous year. The stagnation of earnings began in 2018. In 2018, it reached ₩13 billion, an increase of only 5.2% from the previous year, and in 2019, it increased slightly to ₩13.3 billion. This year, the aftermath of COVID-19 was added. Until the third quarter, the cumulative prescription amount was ₩7.9 billion, down about 20% from the same period last year. Eisai, which had sold exclusively after ending the joint sales contract with Janssen in 2015, launched aggressive marketing to increase sales. After strengthening the Pariet lineup last year, it signed a co-promotion contract with Yuhan this year. Pariet 5mg introduced in Korea in September of last year. Pariet 5mg is the lowest dose among PPI and released in Korea. Low-dose Pariet is receiving a positive response from medical staff who prescribe long-term prescriptions. An official from Eisai said, "As Yuhan's strong sales power was added, it was determined that the synergy effect was clear." He also explained, "The marketing was not active due to COVID-19 incident right after the contract, but sales of Pariet will be expanded."
Company
Lilly implements ERP for the sales department
by
Nov 05, 2020 11:03am
On the 4th, Lilly Korea announced the implementation of ERP to all employees of the sales department. It is known that the ERP compensation condition adds 8 months to twice the number of years of service, and provides annual consolation money. Although the exact size is undecided, it is intended for all employees of the sales organization, including non-core sectors. About 100 employees in the sales department of Lilly Korea. The background of this ERP is part of the reorganization that is going on at the global level. An official from Lilly Korea explained, "We want to improve the business model at Lilly," and "Lilly Korea's ERP will also be carried out as part of this." This Early Retirement is about 3 years since the small ERP in 2017. Earlier, Lilly implemented ERP in 2014 and 2015 as well. Some say that a large-scale ERP will take place this year, centering on the sales department in charge of non-core products. In response, Lilly Korea said, "We are receiving voluntary early retirement applications not from all sales departments."
Company
Zuellig Pharma union reports company’s abusive practice
by
An, Kyung-Jin
Nov 05, 2020 06:41am
The Zuellig Pharma Solutions Service Korea Chapter is protesting in front of the president’s residence (Source: Korea Democratic Pharmaceutical Union) The management and labor union dispute in Zuellig Pharma Korea’s subsidiary Zuellig Pharma Solutions Service Korea seems to be intensifying fast. According to the pharmaceutical industry sources on Nov. 3, Korea Democratic Pharmaceutical Union has recently reported Zuellig Pharma Solutions Service Korea management for their unfair labor practices on three members of the company’s labor union to the Western Seoul District Office of Ministry of Employment and Labor (MOEL). The Democratic Union accused the management assigned the three labor union members on an in-between job waiting list, when the salary negotiation between the management and the labor union did not follow through. The Democratic Union stated Zuellig Pharma Solutions Service Korea and the Zuellig Pharma Solutions Service Korea Labor Union Chapter had eight sessions of salary negotiation for 2020, but they could not reach an agreement. The union claims the management assigned Chief Yang Hee-Jin of the Zuellig Pharma Solutions Service Korea Chapter on an employment waiting list on Oct. 15, when the Chapter requested the Seoul Labor Relations Commission to arbitrate the negotiation and showed possibility of a strike. The Zuellig Pharma Solutions Service Korea Chapter insider noted, “When the negotiation fell through and the arbitration began immediately, the Chapter chief was suddenly removed from the previous position. The management has not disclosed a detailed reason, other than a report of workplace bullying.” The Democratic Labor Union Zuellig Pharma Solutions Service Korea Chapter has earned the right to strike on Oct 26, as the Seoul Labor Relations Commission decided to halt the arbitration. However, the company management again assigned a director and a member of the Chapter on the waiting list. In just about two weeks, three members of the labor union were removed from their original positions. Legal Director General Cho Guk-Hyun of the Democratic Pharmaceutical Union said, “The Article 97 of the negotiated agreement signed by both the company and the Union in last May states the Union and the management must jointly form an investigation council and conduct an audit on the workplace bullying. Any penalty or personnel transfer made during the period of strike is a violation of the Paragraph 2 of the Article 117.” The director general pointed out the company management was abusing the Article 76-2 of the Labor Standard Act on workplace bullying ban to oppress the labor union. Regarding the issue, the company management has not issued any official statement. Zuellig Pharma Solutions Service Korea is a global marketing agency that provides healthcare communication service as a subsidiary of Zuellig Pharma. Its labor union, formed in March last year, joined the Korea Democratic Pharmaceutical Union as a new chapter. Beyond the legal dispute, the labor union is also taking an organized action. In the afternoon of Oct. 30, all members of the Chapter went on a strike, which would continue with the second strike from Nov. 2 through 13. From the morning of Nov. 3, the union member began protesting in front of the residence of Zuellig Pharma Korea President Erwan Vilfeu, who is technically overseeing Zuellig Pharma Solutions Service Korea as well. An insider from the Zuellig Pharma Solutions Service Korea Chapter stated, “Backed by a major law firm, the management is overtly oppressing the labor union with abnormal procedure that violates the Labor Relations Act and the agreement. Their illegal practice would be uncovered soon. We would fight until the laborers working normally and earnestly are rightfully recognized by the company.”
Company
Gilead, registered 6 patents for Remdesivir in Korea
by
Kim, Jin-Gu
Nov 05, 2020 06:40am
Remdesivir It is confirmed that Gilead recently registered a patent related to Remdesivir (Veklury) in Korea. Remdesivir is currently the only drug approved for the treatment of COVID-19. In Korea, it was supplied in earnest from last July. According to the MFDS and the KIPO on the 3rd, Gilead registered six patents related to Remdesivir in the domestic patent catalog at the end of last month. There are two material patents, composition patents, and application patents. Two '1'-substituted carba-nucleoside analogs' for antiviral therapy expiring on April 22, 2029, two'methods and compounds for treating Paramyxoviridae virus infection' expiring on July 22, 2023, Two cases of'How to Treat Filoviridae Virus Infection' that expire on October 29, 2035, and so on. However, it is confirmed that a patent for use limited to the treatment of the Corona 19 virus has not been registered. In Korea, this patent right was registered in 2016 (material patent) and 2018 (composition patent and use patent). However, the'non-exclusive licensee registration' was not done because the drug was not introduced in Korea. Non-exclusive licensee means the subject and qualification to exclusively exercise overseas (head office) patent rights in Korea. In this case,'Gilead' is the case. In other words, after the Corona 19 epidemic, Remdesivir was introduced in Korea by Gilead, and Gilead was registered as a non-exclusive licensee at the end of last month. In August, an opinion was raised to urge the'forced implementation' of the Remdesivir patent mainly by civic groups. It was argued that the government should force the production of generics before the expiration of patents in national crises such as the public health crisis. At that time, eight civic groups, including the Pharmacy Society, Health Department Alternatives, and Participation Solidarity for a healthy society, issued a statement and raised their voice saying, "The government should immediately produce a cure for Corona 19 without noticing anyone." They argued that "the dosage of treatment depends on the amount of supply rather than medical considerations, which is why Gilead is monopolizing the supply of Remdesivir," and argued that "the government should issue a mandatory patent enforcement of Remdesivir right now and expand the treatment production facilities." In response to these arguments, the government has indicated'the possibility of review', but has not come out in earnest. As of 16:00 on October 30th, there were 715 confirmed patients using Remdesivir in 64 hospitals.
Company
MSD Korea appoints Seongpil Kim as executive director
by
Nov 05, 2020 06:40am
Kim Seong-pil (left), new executive director of MSD Korea anticancer drug division, Jae-yeon Choi, new CEO of Taiwan MSD (right) MSD Korea (CEO Kevin Peters) announced on the 1st that it had appointed Kim Seong-pil (43 years old), executive director of the anticancer drug division. In December 2018, the new executive director of Seongpil Kim joined MSD Korea as the 'Commercial Operations Lead', which led to double-digit growth. He has also contributed significantly to the implementation of the biomarker strategy so that the company's anticancer drug portfolio can be used for patients in need. Prior to joining MSD Korea, he served as CEO at Elanco. Prior to that, he managed the sales of the anticancer drug division, the cardiovascular division, and the diabetes division at Lilly Korea. He graduated from Korea University Department of Business Administration and obtained an MBA from Northwestern University's Kellogg School of Business. Managing Director Seong-pil Kim said, "MSD's anticancer drug business unit gathered employees with extraordinary passion and vision to lay the foundation for MSD to grow into a leading company in the anticancer drug field in a short time." He said, "Based on our excellent organizational capabilities, we will continue to position ourselves as a business unit that can contribute to Korean medical staff and cancer patients." On the other hand, Choi Jae-yeon (47 years old), managing director of MSD Korea's anticancer drug division until recently, led the business growth and organizational innovation of the division, and was recognized for the achievement of making the company a leading company in the field of anticancer drugs. This is the first time a Korean has been elected as the CEO of MSD. Jae-yeon Choi, the new representative of Taiwan MSD, joined MSD Korea in 2017 and led external cooperation departments such as market access, rental, communication, etc. Prior to joining MSD Korea, she oversaw the marketing team and anticancer drug division of Lilly Korea, leading product and portfolio strategy and digital marketing. She majored in French from Hankuk University of Foreign Studies and obtained an MBA from Northwestern University's Kellogg School of Business.
Company
Multinational companies rush to appoint new CEOs
by
Eo, Yun-Ho
Nov 05, 2020 06:40am
(From left) CEO Kim Younhee, Choi Ho-jin and Kim So-eun Multiple Korean subsidiaries of multinational pharmaceutical companies are reporting their news of newly appointed top executives. Just in the latter half of the year, six companies have welcomed their new leaders. According to pharmaceutical industry sources, Sanofi Pasteur Korea, Galderma Korea, Ono Pharma Korea, MSD Korea, Organon Korea and GlaxoSmithKline (GSK) Korea eighter elected or nominated new CEOs. Apparently, South Korean CEOs were appointed at Galderma Korea, Ono Pharma Korea and Organon Korea. Since October, Galderma Korea elected CEO Kim Younhee, a new Korean CEO after two years. Former CEO Rene Wipperich, elected after former CEO Park Heung Bum, was transferred to Swiss office after serving two years in South Korea since September 2018. Ono Pharma Korea welcomed a new leader only after a year as former CEO Yang Min-yeol retired. A South Korean would continue to oversee the multinational company as former Vice-president Choi Ho-jin is taking over the position. Prior to CEO Yang’s appointment, former CEO Takashi Kishi used to manage the company. Along with CEO Choi’s personnel news, Ono Pharma is resuming its process to seek reimbursement and expand indication on immunotherapy Opdivo that the industry once evaluated the company’s attempt to be sluggish. Split from MSD, Organon has nominated the current South Korean External Affairs Lead, Kim So-eun, as a new CEO. Kim would lead the company from February next year. While former CEO Avi BenShoshan has been promoted to take a position at the headquarters, MSD Korea nominated Kevin Peters, from the Thai office, as a new CEO. (From left) CEO Kevin Peters and Pascal Robin Regarding the Organon spin-off, MSD’s Korea labor union and the management are in dispute. The new CEOs would have to face the imminent issue and urgently take actions to successfully complete the corporate reorganization procedure. Besides MSD Korea, Sanofi Pasteur Korea and GSK Korea are also maintaining the non-Korean leadership. In last August, Pascal Robin stepped in as a new CEO of Sanofi Pasteur Korea. The position was vacant for a couple of months, as former CEO Baptiste de Claren resigned last June. GSK Korea is bidding farewell to current CEO Julien Samson by the end of the month for him to take his position at the headquarters. Robert Kempton, a vice-president from the U.S. North Carolina office, is now nominated as a new CEO at the Korean office. Leading the South Korean branch since February 2018, Samson was the first foreigner CEO of the office. Previously, CEO Hong Yoo-seok was elected in 2014 as a successor of former CEO Kim Jin-Ho, who led the company from the time of GlaxoWellcome. Hong later nominated Samson as a next CEO, when he was promoted to lead the pharmaceutical business unit (therapeutics and vaccines) at GSK Canada in 2018.
Company
Soliris competitor Roche’s Enspryng readies for South Korea
by
Eo, Yun-Ho
Nov 04, 2020 06:09am
Apparently, Enspryng, a Soliris (eculizumab) competitor, is making a move to enter the South Korean market. The pharmaceutical industry sources reported Roche Korea has recently submitted an approval application on a neuromyelitis optica spectrum disorder (NMOSD) treatment Enspryng (satralizumab) to the Ministry of Food and Drug Safety (MFDS). The final decision on the approval would be made in the first half of next year. Previously, the drug was designated as a rare disease drug. When Enspryng is released to the market, Soliris developed by Alexion and supplied to the Korean market by Handok would be the sole competitor of the drug. However, Enspryng is expected to dominate the NMOSD therapeutic area, as Soliris is only indicated to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) in South Korea. Currently in the U.S. market, Enspryng and Soliris are in competition, where Enspryng is highlighted with comparatively inexpensive price. In June last year in the U.S., Alexion was able to expand Soliris’ indication to treat NMOSD, but the company has not taken a related action in the South Korean market. Enspryng’s efficacy was confirmed in SAkuraStar and SAkuraSky studies with Aquaporin-4 (AQP4) antibody-positive adult patients. In the SAkuraStar monotherapy study’s AQP4 antibody-positive group, 76.5 percent of Enspryng-treated patients were relapse-free at 96 weeks, compared to 41.1 percent with placebo. In the SAkuraSky study, which evaluated Enspryng when used concurrently with baseline immunosuppressant therapy, 91.1 percent of Enspryng-treated AQP4 antibody-positive subgroup patients were relapse-free at 96 weeks, compared to 56.8 percent with placebo. NMOSD is a rare, lifelong and debilitating autoimmune disease of the central nervous system that primarily damages the optic nerves and spinal cord, causing blindness, muscle weakness and paralysis. The autoantibody destroying the function of AQP4 on nerve cell is the main cause of the disease. Without a specialized treatment available to date, patients are typically prescribed with high dose of steroid, and the patients with severe level of condition either use immunoglobulin as a blood product or undergo plasmapheresis.
Company
AstraZeneca objected to the second judgment of Forxiga
by
Kim, Jin-Gu
Nov 04, 2020 06:08am
Forxiga AstraZeneca lost the second trial of Forxiga's material patent. And AstraZeneca announced that it would appeal to the Supreme Court. AstraZeneca said in a separate statement on the 30th that it disobeyed the judgment of the Patent Court of Korea on the 29th. The Patent Court of Korea sided with 19 companies including Kukje Pharma in a lawsuit related to Forxiga substance patents on the 29th. AstraZeneca said that the criteria for judging the progressiveness of optional inventions are too strict in Korea. AstraZeneca argues that the criteria for judging the progressiveness of optional inventions currently applied by the courts were established by the Supreme Court rulings in the late 1990s and early 2000s, and that the criteria do not meet international standards. AstraZeneca said, "There is a possibility that Eliquis' substance patent, which is pending in the Supreme Court, has recently been referred to the entire consensus, and a new standard for judging the progressiveness of the optional invention is proposed." It criticized, "Even so, we are sorry for the patent court ruling that was made without confirming this case." AstraZeneca said, "No one will be willing to invest in the Korean pharmaceutical industry unless the protection of substance patents is faithfully implemented in Korea." And it also stressed, "We hope that excellent patents in the pharmaceutical field will receive reasonable protection." There are a total of two Forxiga material patents. One expires on April 7, 2023, and the other expires on January 8, 2024. The ruling, which was won by 19 generic companies, concerns a patent that expires in 2024. In the case of the patent expiring in 2023, Dong-A ST is the only one who won the first trial with the “Pro-drug” strategy.
Company
Opdivo resumes indication expansion in NSCLC as first-line
by
Eo, Yun-Ho
Nov 03, 2020 05:58am
The pharmaceutical industry sources reported Ono Pharmaceutical and Bristol Myers Squibb (BMS) have recently submitted an application to expand indication on a programmed death-1 (PD-1) immune checkpoint inhibitor Opdivo (nivolumab) in combination with a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) immune checkpoint inhibitor Yervoy (ipilimumab) to treat patients with non-small cell lung cancer (NSCLC) as a first-line treatment. In last May, the U.S. Food and Drug Administration (FDA) has approved Opdivo plus Yervoy combination as a first-line therapy on NSCLC patients with programmed death-ligand 1 (PD-L1) expression over 1 percent. Also the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted an approval recommendation on the combination therapy as well. The Phase 3 CheckMate-9LA study confirmed the efficacy of the Opdivo plus Yervoy combination treating patients with NSCLC as a first-line treatment. CheckMate-9LA is an open-label, multi-center, randomized Phase 3 trial that evaluated Opdivo plus Yervoy combined with two cycles of chemotherapy, compared to chemotherapy alone, as a first-line treatment in patients with metastatic NSCLC regardless of PD-L1 expression and histology. In the study, study, the combination of Opdivo plus Yervoy plus two cycles of chemotherapy resulted in superior overall survival (OS), progression-free survival (PFS) and overall response rate (ORR), and met primary and secondary endpoints. An interim analysis following up the patients at least for 8.1 months found that the Opdivo plus Yervoy combined with two cycles of chemotherapy reduced the risk of death by 31 percent, compared to chemotherapy alone. Moreover, a longer follow-up of at least 12.7 months was able to verify the median OS of the Opdivo plus Yervoy combined with two cycles of chemotherapy marking 15.6 months, which continued to improve OS than the chemotherapy alone at 10.9 months. In the same extended follow-up, the combination therapy demonstrated improved OS regardless of PD-L1 expression. And in patient group with PD-L1 expression less than 1 percent, the risk of death was reduced by 38 percent, when the risk was reduced by 36 percent in patient group with over 1 percent expression. Comparing the combination therapy against the chemotherapy alone, the one-year PFS rate was at 33 percent and 17 percent, respectively, whereas their ORR were at 38 percent and 25 percent, respectively. In South Korea, Opdivo in combination with Yervoy, indicated to treat patients with renal cell carcinoma, is in process of seeking the healthcare reimbursement listing. In last June, the Cancer Deliberation Committee has passed the combination therapy.
Company
Roche: Fast listing was all about improving patient access
by
Eo, Yun-Ho
Nov 02, 2020 06:13am
President Nic Horridge An anticancer treatment specializing pharmaceutical company, Roche has been viewed to stand relatively “aloof” from seeking the health insurance reimbursement. But now Roche seems to be picking up its speed. Their last two years have been different; the company successfully expanded the reimbursement on targeted therapy Alecensa in anaplastic lymphoma kinase (ALK) lung cancer as a first-line therapy, immunotherapy Tecentriq in lung cancer as a second-line therapy after listing in urothelial carcinoma, and targeted therapy Perjeta in early stage of breast cancer. Also the multinational company is under review for expanding the reimbursement on Tecentriq as a first immunotherapy in triple-negative breast cancer (TNBC), and antibody-drug conjugate (ADC) Kadcyla in breast cancer as a maintenance therapy, as well as for receiving reimbursement on a new flu drug Xofluza. President Nic Horridge at Roche Korea is in the center of such dynamic change. Appointed as a president of Roche Korea in October 2018, Horridge once said “We prioritize in the patients’ access to treatment more than anything else.” Daily Pharm interviewed President Nic Horridge about his perspective on the changed Roche and the prospects. -Soon, it would be two years since you took the position. And Roche’s products are receiving the reimbursements fast, which is a positive change in the company. It is gratifying for the public to notice the accelerated speed in the reimbursement listing process. Many may think of drug approval, when talking of pharmaceutical accessibility. But the healthcare reimbursement is crucial to secure the practical access to the treatments. We are proud of Roche’s close engagement with the South Korean government. The fact that the company’s products are meeting the government’s level of pharmaceutical value to win the reimbursements fast means significant to the company. Regarding the topic, I would like to express my gratitude to our staffs at Roche. Personally, this is one of the proudest parts of my career in South Korea—improving the Korean patients’ access to new drug. Specifically, Kadcyla and Perjeta are attempting various tactics to achieve complete recovery. In the lung cancer treatment area, Tecentriq and Alecensa contributing to the patients’ treatment benefit is also an outstanding performance. -What was your impression on the National Health Insurance (NHI) benefit system, and what do you think is the changes it needs? To be honest, my first impression of the South Korean reimbursement scene was that ‘it is not that easy.’ But a government trying to take the most value out of pharmaceutical purchasing cost is common in every country, so it does not necessarily make the Korean government too special or difficult. The upside of Korea is that the general review and decision making process are thorough, which makes it clear for the pharmaceutical companies to see what should be done and proven to list the drugs in the market. The system seems to clarify which evidence should be provided to reflect the needs of the healthcare providers and patients and to prove the value of the drug. And it even suggests which role should a company play as the government’s partner. Regardless, the time taken for the reimbursement listing in South Korea is relatively longer than other countries with similar regulatory environment. -Roche has been fruitful in the breast cancer therapeutic area, and its presence in the market seems to be outstanding. But with new immunotherapy line-ups, the company seems to have expanded to other cancer areas. Is there any challenge in the sales and marketing? This is the part we have been deeply contemplating about. And this applies not only to anticancer treatment fields, but also in other fields as well. To tackle the issue, we need to first study the issue the consumers have and then try to provide fitting solution. To do so properly, we need to push up our work efficiency, and take an agile stance on resource utilization. -Avastin, with its patent term coming to expire soon, is actually having its second golden age. While it is considered as the best combination drug for both targeted therapy and immunotherapy, we assume the health authority’s pressure to bring down the pricing would get greater. For any drug, patent term expiration is inevitable. This is the reason why Roche cannot cease to pursue innovation and annually invest USD 12 billion, or 20 percent of the entire sales from the group, to develop new drugs. The healthcare providers and patients would continue to look for Avastin, and the company would also continue to provide support for the market in an environment we can adequately provide such support. As Avastin has been recently studied to create remarkable synergy effect in combination with an immunotherapy, we plan to provide support regardless of the types of the cancer. But the weight of the innovation would be on Tecentriq than on Avastin. -Many news reporters were surprised to find out Tecentriq winning the NHI reimbursement. The South Korean government proposed pharmaceutical companies to cover the initial administration cost, and Roche was the only company with an immunotherapy option to accept the deal. Was there any regret in the decision? We are exhilarated to expand the patients’ access to Tecentriq with the company’s decision. Even if we turn back the time, we would make the exact same decision. It was a positive experience considering how we shared constructive talks with the government. -Roche’s reputation as a market leader in the anticancer treatment scene has been lately challenged as other companies are leading the immunotherapy competition and other anticancer businesses. What is your plan to maintain that title? Roche has the richest pipeline among the healthcare industry. There are 20 candidate medicines in late development phase, scheduled to be released in about five years. In South Korea, the company would continuously expand Tecentriq’s reimbursement in treating lung cancer and liver cancer, and pursue reimbursement on Kadcyla in treating early stage of breast cancer. Meanwhile, a neurotrophic tropomyosin receptor kinase (NTRK) gene targeted therapy Rozlytrek was recently approved. With the drug targeting a specific biomarker regardless of the types of cancer, the company is determined to continuously improve patients’ access to treatment.
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