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Company
Law firms hire drug industry personnel to expand clients
by
Eo, Yun-Ho
Oct 14, 2020 06:23am
Former Director Lee Dong Uk (left) and Former Director Yoo Hee-sang Law firms in South Korea are busy scouting pharmaceutical industry specialists to attract pharmaceutical company clients. The related industry sources reported law firms like Kim & Chang, Lee & Ko, Yulchon and Shin & Kim have recruited external experts for their healthcare teams for the last month. Shin & Kim has welcomed a former director in Ministry of Health and Welfare (MOHW) and a former Deputy Minister of Health in Uzbekistan, Lee Dong Uk as a senior adviser. Joining the healthcare team in the firm, Senior Adviser Lee has served in MOHW for three decades as a director of Health Insurance Policy Bureau and a director of Healthcare Policy Bureau and led the National Health Insurance (NHI) and healthcare policies. In particular, he has been revered as the best specialist in NHI reimbursement policy like NHI drug pricing decision and adjustment and drug listing for reimbursement. Lee & Ko appointed Yoo Hee-sang, a former director of Medical Device Management Division at Ministry of Food and Drug Safety (MFDS), as a senior adviser. He used to be in charge of medical device management policy for 16 years in MFDS. His milestones were consigning public agency to review and approve low-risk medical device, compiling a safety management guideline for medical purpose mobile app and exempting business registration, introducing bill to set a separate Medical Devices Act, and exempting heart rate measuring device for sports and leisure activity. Although Lee & Ko shook hands with former Director Yoo, the firm bided farewell to Senior Consultant Byun Young-sik (former Senior Director at AstraZeneca) newly joining Kim & Chang. He began his career in the pharmaceutical industry from Janssen in 1994 and experienced more drug pricing and market access tasks for a decade in AstraZeneca. He was leading the reimbursement listing process for the third generation lung cancer targeted therapy ‘Tagrisso,’ and the first ever pharmacoeconomic evaluation-exempted drug and medullary thyroid cancer treatment, ‘Caprelsa.’ Based on his rich career, Lee & Ko scouted him in 2018. But with his new contract with Kim & Chang, Senior Consultant Byun would rub shoulders with Senior Advisor Lee Byeongil (former director of Pharmaceutical Management Department at Health Insurance Review and Assessment Service) and Senior Consultant Koh Su-kyung (former senior director at Norvatis). In the first half of the year, Yulchon recruited Associate Huh Na Eun (former Legal Counsel of Regulatory Reform and Legislation Division at MOHW), and the company welcomed Consultant Jung Hye Yeon (former Senior Director at Bristol-Myers Squibb) and Patent Attorney Kim Tae Kyung (former director of New Drug Listing Division at HIRA). They are a group of seasoned experts in drug pricing and NHI reimbursement listing. An associate from a multinational company commented, “The law firms are constantly contacting personnel who have experience in healthcare business from both government and the industry. As the firms are committed to expand business in new drug reimbursement consulting, more personnel from pharmaceutical companies would move to those firms in the future.”
Company
Daewoong's subsidiaries are all expected to turn profits
by
Oct 12, 2020 06:16am
Daewoong's eight overseas subsidiaries are expected to make a profit this year. In the first half of this year, seven have already made a surplus. It has been about 10 years since the global organization has been in full swing. Daewoong has been the most actively seeking overseas expansion among domestic pharmaceutical companies. Starting with Indonesia in 2012, it established local subsidiaries in major Asian countries such as China, Philippines, Thailand, Japan, and the United States. Overseas subsidiaries, which have been reducing losses through steady investment for 10 years, began to turn to a surplus in the first half of this year. Daewoong Infion, an Indonesian subsidiary, recorded a net profit of ₩1.2 billion in the first half of this year from a net loss of ₩1.3 billion last year. Beijing Daewoong in China also turned to a surplus of ₩200 million in the first half from a loss of ₩500 million last year. Hyun-Jin Park, head of the global business division of Daewoong, said at a meeting with Dailypharm, “Although it has suffered a deficit while building infrastructure such as local research centers and factories, it is expected that most overseas subsidiaries will turn into a surplus this year as investments are completed and local sales continue to rise.” Director Park has been in charge of planning and executing Daewoong's global business strategy for 10 years from the organization of the global headquarters in 2010 to the present. In 2019, she succeeded Jeon Seung-ho as the head of the global business division. Daewoong seeks to enter the market in a way that targets the drug and potential market needed locally. It is focusing on biopharmaceuticals in Indonesia and liquids in China. It is a strategy that goes further from exporting flagship products that are usually sold well in Korea to foreign companies. There are many difficulties in the early stages, but if the foundation is built and successful, the synergy effect is great. In fact, Daewoong has enjoyed the infrastructure benefits it has accumulated over the years in COVID-19 situation. Due to the limited number of domestic patients, clinical trials were quickly approved through overseas subsidiaries. She said that we are thinking of a R&D corporation in Europe and other places as a plan to expand overseas in the future, and Daewoong's goal is to be among the top 10 pharmaceutical companies. The following is questions & answers of Park. Hyun-Jin Park, head of the global business division of Daewoong ▶This year, overseas subsidiaries are making a surplus. There are 7 local subsidiaries that showed a surplus in the first half of the year, including Daewoong Infion, Daewoong Thailand, Beijing Daewoong, and Daewoong India. In the meantime, it took a lot of cost and time to set up a local research institute, factory, and marketing. Sales grew steadily, but the infrastructure construction cost was forced to record a deficit. Now, most of the investments have been completed and sales are increasing, making a turnaround. All eight are expected to turn to profits by the end of the year. ▶Among the countries that entered the market, Indonesia, China, and Vietnam were selected as the core. What is the reason? All three countries are rapidly growing. However, it is only possible to enter the market only if there are local production plants. There are many advantages such as bidding if it is produced locally. Daewoong Pharmaceutical has already established a manufacturing plant and is implementing a strategy to operate it like a local company, so it was determined that this strategy can be maximized. However, the ways of entering the three countries are slightly different. Indonesia and China formed joint ventures with local companies, while Vietnam chose to invest in equity. While a local company called Trapaco already had a new factory, it was better to share R&D instead of using existing resources with equity investment, rather than investing in new plant resources because of lack of R&D know-how for the products produced. Trapaco's stake may be expanded in the future depending on the company's potential, etc. Each joint venture or equity investment has advantages and disadvantages. We are choosing an appropriate method according to each country's situation. ▶Daewoong is choosing and developing its flagship drugs according to local conditions. Indonesia's biopharmaceuticals, China's digestive medicines, and Thailand's aesthetics. In general, why do you go on a difficult path without choosing a method of using drugs that are popular in Korea as your flagship products? This is because the domestic and pharmaceutical environments are often different. For example, complex medications are popular in Korea, but not in Southeast Asia such as Vietnam. There is a way to lead a combination drug in advance, but Daewoong Pharmaceutical's strategy is to analyze and develop drugs needed locally. The Chinese plant analyzes and plans medicines needed for the Chinese market and develops them at the research institute. If locally planned and responded drugs are suitable for the Korean market, reverse export is possible. Planning and research can be done according to each local situation. ▶It has been seeking global advancement for 10 years, and it is paying off recently with a turnaround. It seems that building up infrastructure and networking for a long time was not easy. Both China and Indonesia are famous for having difficult licensing. Especially in Indonesia, where it first entered the market, it suffered a lot of trial and error. The important point was to derive a model of cooperation with health authorities while expanding local research cooperation. We have presented the Indonesian government with a vision to foster Indonesia as a bio hub in Asia. In addition, although it is a for-profit company, it is also important to present parts that can win-win with each other. Therefore, it contributed socially by lowering the insurance price of Epodion in Indonesia to 55%. By providing economic support to areas where the medical environment is less favorable than in Korea, many citizens can benefit from medical care. Currently, we are continuing cooperation with UI Universitas Indonesia, the best university in Indonesia, while conducting bio research, and we are providing support for nurturing such as establishing a bio research center and hiring local personnel to provide research opportunities in Korea. Presenting this vision, it was possible to complete the process from the factory to the license within 4-5 years. Not only domestic companies that were preparing to enter Indonesia, but also local companies were surprised that the speed was very fast. ▶Was building up local networking a great help in this COVID-19 outbreak? Since the local subsidiary has a network with both health authorities and clinical CRO companies, it was possible to quickly obtain clinical approval for the treatment of COVID-19. 'DWRX2003 (Niclosamide)', which is being developed as a treatment for COVID-19, was the first to be approved in India among countries that submitted a clinical approval plan at the same time. This was due to the fact that Daewoong Infion has been building a network so that it can be considered a local company, and has been conducting several clinical trials in India for a long time. It was also able to enter clinical trials quickly in the Philippines. ▶Over the past 10 years, it has advanced into the global market with the concept of creating 'another Daewoong'. What are the plans of the global business division for the next 10 years? If the process has been focused on generics locally until now, over the next 10 years, we will develop many new drug items through research cooperation. 'Fexuprazan', which is currently undergoing examination for approval of new drugs in Korea, is trying to enter the global market through simultaneous clinical trials in Asia. By accelerating new drug programs in Asian countries, we are trying to create a virtuous cycle in which the sales value of new drugs increases. To this end, we are considering a R&D company as a local corporation to be built in the future. In the local area, I felt that the amount of information shared and the level of collaboration change depending on whether or not there is research cooperation. Although no specific plan came out, I think it would be nice to have a research company in Europe that has not yet entered the market. we are also considering establishing R&D companies in Shanghai, China. Daewoong will try to make it one of the top 10 pharmaceutical companies in major global countries in the next 10 years.
Company
Pfizer seeks for approval on NSCLC drug ‘lorlatinib’
by
Kim, Jin-Gu
Oct 12, 2020 06:15am
A product image of Pfizer’s ALK-positive NSCLC treatment lorlatinib (brand name Lorbrena) Pfizer has taken a first step to launch a non-small cell lung cancer (NSCLC) treatment ‘lorlatinib’ in the South Korean market. According to a pharmaceutical industry source on Oct. 7, Pfizer Pharmaceutical Korea has recently submitted an application to the Ministry of Food and Drug Safety (MFDS) to request an item approval on lorlatinib. After getting designated as an orphan drug in March by MFDS, the company initiated the approval application preparation in South Korea. In November last year, the product has been approved in the U.S. under the brand name Lorbrena. Lorlatinib is a latecomer to Pfizer’s anaplastic lymphoma kinase (ALK)-positive NSCLC treatment Xalkori (crizotinib). There are three generations of ALK-positive NSCLC treatments—after the launch of the first generation Xalkori, Roche’s Alecensa (alectinib), Novartis’ Zykadia (ceritinib), and Takeda’s Alunbrig (brigatinib) have emerged as the second generation drugs. Currently, Xalkori, Alecensa and Zykadia as first-line therapy and Alecensa, Zykadia and Alunbrig as second-line therapy are available to treat patients with ALK-positive NSCLC. Technically, however, there were no other treatment option for patients who have relapsed after using Xalkori as a first-line therapy and a second generation ALK-positive NSCLC treatment as a second-line therapy. Lorlatinib has received high expectation from those relapsed patients and their healthcare providers. In fact, MFDS approved of total 326 items for treatment purpose uses, and 134 cases (41 percent) were for lorlatinib. The item definitely topped the treatment purpose use approval record in this year. The clinical trials on lorlatinib disclosed so far have found the drug demonstrates meaningful level of treatment efficacy in patients who have developed tolerance to other options. Also, it was reportedly effective on patients with brain metastasis. Pfizer Pharmaceutical Korea avoided making an immediate comment about the plan after the item approval. An official from the company said, “The company would do its best to expand patients’ access to lorlatinib in South Korea.”
Company
Roche Diagnosis provides COVID-19 customized diagnostic test
by
Oct 08, 2020 06:23am
Roche Diagnostics Korea, which celebrates its 30th anniversary, has promised to provide rapid diagnostic tests in the pendemic. On the 6th, Roche Diagnostics Korea held an online press conference to commemorate the 30th anniversary of its founding, highlighting the value of diagnosis and the role of Roche Group in the situation of COVID-19. At this meeting, Hyung-ju Kim, head of Roche Diagnostics Korea, said that it has quickly provided the most suitable diagnostic method according to the progression of COVID-19." Hyung-ju Kim, head of headquarters, presenting at the press conference for the 30th anniversary of Roche Diagnosis Korea In February, when COVID-19 began to spread in Korea, the company first supplied nucleic acid extraction reagents, the core of the kit, to Korea in order to receive the Emergency Use Authorization (EUA) for a diagnostic kit that can screen patients with COVID-19. In addition, in preparation for the spread of COVID-19 around the world, it was the first to receive EUA approval from the US Food and Drug Administration (FDA) on March 12. In May, Roche Diagnostic's new antibody test 'Elecsys', which measures COVID-19 antibody in the blood and helps to identify the immune response, was additionally approved in the United States. At a time when the number of COVID-19 confirmed patients around the world increased rapidly, on-site test kits were released that can be diagnosed quickly. Most recently, in preparation for twindemic, where two viruses are simultaneously prevalent due to influenza (influenza), it has provided a field test that can simultaneously detect the flu virus and COVID-19. Currently, a screening for the COVID-19-flu simultaneous diagnosis kit is underway in Korea. Director Kim said that Roche Diagnosis is a standardized large-capacity PCR test system for the detection of flu and COVID-19 to help patients with respiratory infection symptoms receive accurate treatment. Also he added that the test system supports patients with respiratory infection symptoms so that they can receive accurate treatment, speed and medical access have been improved since nucleic acid extraction and testing can be performed in one system. He added, "In the future, we will make great efforts to quickly respond to the COVID-19 situation." In addition, Korea's rapid response system was supported, and it was selected as an exemplary case for quarantine in the world. Kwon Gye-cheol, chairman of the Korean Society for Diagnostic Laboratory Medicine, said, "We were able to actively respond from the early days of the outbreak of COVID-19 while maintaining close cooperation with the Roche Diagnosis and other related institutes, and successfully establish a quarantine model." Also he added that we hope that Roche Diagnosis and the academic community can continue joint research to respond to infectious diseases.”
Company
MSD on final stretch with Keytruda coverage expansion
by
Eo, Yun-Ho
Oct 07, 2020 06:09am
MSD Korea made the last move for the Keytruda coverage expansion. Now it is back to the government’s turn to make the decision. Related industry sources confirmed, MSD has submitted the final financial expense sharing plan to Health Insurance Review and Assessment Service (HIRA) after revising the detailed strategies regarding the reimbursement expansion of immunotherapy Keytruda (pembrolizumab) in treating patients with non-small cell lung cancer (NSCLC) as a first-line therapy. Accordingly, the Cancer Deliberation Committee would be able to revisit the matter on Oct. 14 at earliest. The next session would be Keytruda’s eighth Cancer Deliberation Committee review. If the upcoming session does not include Keytruda in the agenda, the reimbursement expansion talks would be delayed by more than a month. The Cancer Deliberation Committee deferred Keytruda’s reimbursement expansion once again on Aug. 26, claiming the expense sharing plan was insufficient. HIRA then relayed the financial plan discussed among the committee to MSD in early September and demanded a revised version. The health insurance authority actually took the version positively as it was flexible on the conflicted clause of ‘the pharmaceutical company to pay for the initial three-cycle administration cost.’ As the MSD’s global headquarters was unconvinced of the clause, the company certainly seemed like it won a wiggle room in expanding the coverage. However, the government proposed MSD to resubmit a financial plan including a new clause equivalent to the initial clause. The company immediately started revising the plan, and sent in the latest version right before the Chuseok holiday. It seems like the company has a similar clause that could replace the clause of ‘initial three-cycle administration cost payment.’ If the Cancer Committee refuses the new financial plan, Keytruda’s attempt to expand coverage would be technically over. MSD official noted regarding the issue that “The company has presented a new version of Keytruda expense sharing plan to receive reimbursement as a first-line therapy treating NSCLC, prior to the eighth Cancer Deliberation Committee session. The revised version has thoroughly reflected the recommendations made by the committee in August, and increased the company’s part of the expense sharing as a final stretch.”
Company
When will the Zyprexa lawsuit for damages be concluded?
by
Kim, Jin-Gu
Oct 07, 2020 06:09am
ZyprexaInterest is focused on whether the lawsuit for Zyprexa (Olanzapine) could be completed within this year. The range of compensation for patent infringement is determined according to the decision of the Supreme Court. If the Supreme Court sided with the original company Lilly Korea, it would be an obstacle to the early release of generics by domestic companies. ◆ Fourth year pending in Supreme Court According to the pharmaceutical industry and legal circles on the 7th, the lawsuit for damages between Lilly Korea and Hanmi filed in the Supreme Court on October 31, 2016 has been in progress on the 1438th day. Myungin’s damage claim, also 944 days have passed since it was filed on March 9, 2018. It seems that the proceedings of the lawsuit have been slow since the conclusion has not been reached for the fourth year, but the legal dispute is still going on very fiercely. Even if it is limited to the Hanmi case, there are more than 30 data submitted by the plaintiff and the defendant. Even just before this Chuseok holiday, the two sides are in a tight confrontation, submitting reference materials and answers. The Supreme Court also appears to be cautious about the decision. The opinions of interest groups and civic groups were received to understand the impact of the judgment. Opinions were submitted by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, the KRPIA, and the Pharmaceutical Association for a Healthy Society. ◆ Generic release after overcoming patents, Supreme Court's ruling overturned by 'patent infringement' The lawsuit is very complicated. The initiation was a request for a patent invalidation trial. In 2008, a trial was filed stating that Zyprexa's patent was invalid. The first and second trials interpreted the patent as invalid. Based on this ruling, Hanmi and Myungin launched generics called 'Olanza' and 'Neurozapine' in 2011. The situation got complicated as the Supreme Court overturned the ruling. Hanmi and Myungin overcame their patents and then infringed suddenly their patents. After the Supreme Court ruling, Lilly fought back. Each filed a lawsuit for damages against Hanmi and Myungin. In both cases, it was ruled to compensate the patentee for damages. Hanmi and Myungin accepted the judgment. The profits from selling generics were paid to Lilly as damages. ◆Mixed judgment by the second trial court Usually, a lawsuit for damages due to patent infringement is concluded in this way. However, Lilly Korea, not the patent holder (Lilly's headquarters), filed a lawsuit. Lilly Korea said that the drug price of Zyprexa was lowered with the release of generics, so the two companies should be compensated for the damages. In the first trial, Lilly Korea won. The court ruled in favor of some of the plaintiffs. However, the judgment was changed at the second trial. The two courts made different judgments on the case with the same contents, different from the defendant, Hanmi and Myungin. The second trial court on Hanmi did not accept Lilly Korea's claim. The Seoul High Court interpreted that Hanmi had no 'illegal intentions' because the subject of the drug price cut was the MOHW. On the other hand, the second trial court related to Myungin sided with Lilly Korea. The Patent Court judged that Myungin launched a generic by infringing the patent, knowing well that the drug price of Zyprexa would be lowered, causing damage to Lilly Korea. Accordingly, Lilly Korea and Myungin, who lost in the two cases, each filed appeals. It was October 2016. Four years later, the Supreme Court is struggling with this. ◆When Lilly wins,'strategy for early release of generics after overcoming patents' virtually lost The Supreme Court's ruling is expected to have a considerable impact on the domestic pharmaceutical industry. If the Supreme Court decides on the side of Lilly Korea, the strategy of 'early release of generics after overcoming patents' is expected to lose power. This is because the burden of generic companies for patent challenges becomes very large. In the event that a generic company is finally judged for infringement of a patent, it must compensate for damages from drug price cuts in addition to the sales revenue of the generic. There is a possibility that astronomical compensation will be charged depending on the sales volume of the original drug and the period of early generic release. It is pointed out that the generics are released only after the patent dispute is completely ended, and at this time,'early release' becomes impossible. This is because if the original company attempts a 'delay strategy' that leads the patent dispute to the Supreme Court, the release of the generic is delayed and the patent may expire while a dispute is in progress depending on circumstances. ◆Does the Supreme Court to conclude this year? As a result, the attention of the pharmaceutical industry and the legal profession is drawn to the Supreme Court, but it is likely that it is difficult to predict what kind of judgment the Supreme Court will make for the time being. One legal official said, “Unlike the first and second trials, the Supreme Court does not make public arguments except in special cases. Most of the schedule and progress of the hearing are kept secret. For this reason, it is difficult for the parties to know when the final judgment will be made.” Another legal official was rumored that the sentence was imminent last year, but in the end, the two sides are still in a firm position, and officials expect that the sentence will be postponed again to next year as the Supreme Court struggles. An official from a pharmaceutical industry said that the cost of the lawsuit itself is ₩1.5 billion for Hanmi and ₩27 million for Myungin, which is not a heavy burden on the company. However, as the Supreme Court decision will determine the direction of the early generic release strategy in the future, it is expected that there will be little impact.
Company
Next-gen flu drug Xofluza green lit in general hospitals
by
Eo, Yun-Ho
Oct 06, 2020 06:25am
The next generation influenza treatment ‘Xofluza (baloxavir)’ has been passed by major general hospitals for prescription. According to the related industry source, the Drug Committees at the ‘Big Five’ general hospitals like Seoul National University Hospital and Seoul St. Mary's Hospital green lit Xofluza, while the rest of the Big Five hospitals (Severance Hospital, Seoul Samsung Hospital and Seoul Asan Medical Center) are also processing the drug. Other major hospitals around the country, including Gangnam Severance Hospital, Gangdong Kyung Hee University Hospital, Chung-ang University Hospital, Korea University Anam Hospital, Seoul National University Bundang Hospital, Kangbuk Samsung Hospital, Kyung Hee University Hospital, and Bucheon St. Mary’s Hospital, have already landed the prescription code. The influenza treatment is still in process of seeking the health insurance coverage. When the drug is listed, the hospitals would be quick to prescribe them. The supplier Roche Korea has signed a co-marketing deal with Chong Kun Dang in last March to enter the market steady and fast. Endo-nuclease inhibiting Xofluza is a new influenza treatment, approved two decades after the launch of ‘Tamiflu (oseltamivir),’ that treats flu patients with a single dose (Tamiflu requires five-day administration). While an anti-virus can always develop tolerance, nothing but neuraminidase inhibitor is recommended for treating influenza patients at the moment. As for South Korea, the influenza immunization rate is highest in the world, but 2.26 million people have contracted influenza in 2018. And as the public interest on anti-virus drugs has been heightened amid COVID-19, the talks on listing Xofluza would likely to be processed timely. The approval on Xofluza in South Korea was based on outcomes of 'CAPSTONE-1 study' on acute influenza patient group from age 12 to 64 with no underlying disease, and 'CAPSTONE-2 study' on high-risk influenza patients aged 12 and up. The CAPSTONE-1 study with healthy adults and adolescents has found the median time to alleviation of symptoms was 26.5 hours shorter in the Xofluza-administered patient group, compared to the placebo group. Xofulza also demonstrated comparatively faster time of viral shedding. It took 24.0 hours for Xofluza to halve the patients found with the virus, which was significantly shorter than the placebo group (96.0 hours, about four days) and Tamiflu group (72.0 hours, about three days). During the CAPSTONE-2 study with high-risk influenza patient groups including senior and chronic disease patients, the high-risk patient group treated with Xofluza demonstrated median symptom alleviation time of 73.2 hours, which was about 29 hours shorter than placebo group (102.3 hours). In the same study, Xofluza halved the viral shedding in 48.0 hours, improved by approximately 50 percent than placebo (96.0 hours) and oseltamivir (96.0 hours). Professor Lee Jae-gab of Hallym University Medical Center Infectious Disease Department commented, “Besides the advantage of convenient one-dose oral administration, Xofluza is expected to be used for various indications as it has a different mechanism of action compared to other existing options”.
Company
Mundipharma Korea appoints Hun Choi as the new CEO
by
An, Kyung-Jin
Oct 06, 2020 06:24am
Hun Choi, new CEO of Mundipharma Korea Mundipharma announced on the 5th that it had appointed Hun Choi (46 yrs old), Managing Director, as the new CEO as of October 1. He graduated from Korea University Department of Chemistry and entered the pharmaceutical industry when he joined Novartis Korea in 2001. He served as a brand manager and sales manager, starting with a salesperson at the anticancer drug division. Since recruiting as head of the anticancer drug division of Mundipharma in 2012, he has served as a managing director of the Ethical division, including the pain division, respiratory division, and medical device division. The company said that the reason for choosing the new CEO Choi is because of its differentiated marketing strategy and leadership. He has been leading the company's sales growth so far, and is evaluated as the right person to lead a successful business even in an environment where uncertainty has increased due to the aftermath of COVID-19. Hun Choi said, "We will lead the company's growth through reorganization of our existing flagship business and new customized strategies. We will play a role as a value accelerator that raises our position as a global big pharma while leading the New Normal of the pharmaceutical industry." Former CEO Lee Myung-se, who led Mundipharma Korea for the past four years, recently moved to Shaperon, a new drug development company.
Company
Samsung Pharm won second trial with Samsung Electronics
by
Kim, Jin-Gu
Oct 06, 2020 06:24am
Samsung Pharm won the second round of the trademark dispute with Samsung Electronics over the name of 'Samsung'. Like the first trial, the second trial court admitted that Samsung Pharm had used the name Samsung for a longer time. Corporate CI of Samsung Pharm & Samsung Group (Data: the KIPO) The Patent Court of Korea ruled against the plaintiff in a lawsuit for invalidation of trademark registration filed by Samsung Electronics against Samsung Pharm on the 24th. Like the first trial, the Patent Court of Korea sided with Samsung Pharm. The issue was that as Samsung Group's 'Samsung' is a more well-known and well-known trademark to the public, Samsung Electronics argued that the trademark newly registered by Samsung Pharmaceutical in 2015 should be invalidated. Accordingly, the first trial sided with Samsung Pharm. The point of the trial decision is that Samsung Pharm has been using the name ‘Samsung’ for a longer time than Samsung Electronics. ◆1929 vs 1938, "Samsung Pharm precedes Samsung Chamber of Commerce" Samsung Pharm started with 'Samsung Pharmaceutical', established in August 1929. Then, in 1963, it changed its name to 'Samsung Pharmaceutical Industry Co., Ltd.'. In July 2014, the company changed its name again to the current 'Samsung Pharmaceutical Co., Ltd.', and in December of that year, 'Samsung Pharmaceutical Healthcare Co., Ltd.', a health functional food manufacturer, was established. The Patent Tribunal explained that "Samsung Pharmaceutical was established before the Samsung Group, and the abbreviation of Samsung Pharmaceutical has been recognized among domestic general consumers and traders as they have been using the trademark for over 90 years." On the other hand, in the case of Samsung Electronics, it was established in 1938 by 'Samsung Chamber of Commerce'. It means that Samsung Pharm was established nine years before Samsung Electronics. The Intellectual Property Trial and Appeal Board explained that Samsung Pharm was established before the Samsung Group, and the abbreviation of Samsung Pharm has been recognized among domestic general consumers and traders as they have been using the trademark for over 90 years." Regarding the reputation of the trademark, "Samsung Group's pharmaceutical business will be recognized by general consumers as 'Samsung Bio' or 'Samsung Biologics'. He judged that it will be recognized as a different concept. In the case of the second trial, the ruling has not yet been disclosed, but it is said that the ruling was generally made with the same purpose as that of the first trial. ◆Samsung Pharm succeeded in defending all three brands of the first and second trials There are a total of three trademark rights that have problems. There are two 'Samsung Pharm since 1929' and one 'Samsung Pharm Healthcare' with slightly different designs. Samsung Pharm applied for three trademarks in March 2015. It was an application to protect the brand of Samsung Pharm Healthcare, a subsidiary established in December of the previous year. At the same time as the filing, the Samsung Group filed an objection. The KIPO accepted the objection and rejected the registration. In January 2016, Samsung Pharm filed a trial requesting that the decision to reject it be canceled, and the KIPO accepted Samsung Pharm's argument. After twists and turns, three trademarks of Samsung Pharmaceutical were officially registered. Then, this time, Samsung Electronics insisted on the invalidation of the trademark. However, Samsung Pharm succeeded in winning the trademark right as the KIPO and the Intellectual Property Trial and Appeal Board did not accept Samsung Electronics' claims. It has not yet been decided whether Samsung Electronics will appeal to the Supreme Court over the results of the second trial.
Company
Daewoong promotes the development of injectable hair loss tx
by
Nho, Byung Chul
Oct 06, 2020 06:23am
Daewoong is developing long-lasting hair loss treatments for male in earnest through open innovation that introduces promising external technologies. Daewoong (CEO Seng-Ho Jeon) signed a joint development contract with Inventage lab (CEO Ju Hee Kim), a drug delivery system platform venture company, on the 25th, and is conducting joint research, development and commercialization of long-lasting hair loss treatment drugs (IVL3001, IVL3002) owned by Inventage Lab. IVL3001 & IVL3002 jointly developed by Daewoong as a pipeline are injection formulations administered once every 1 or 3 months. Inventage Lab's drug delivery system (DDS) platform technology, IVL-PPF Microsphere® (IVL-Precision Particle Fabrication Microsphere), is equipped with hair loss treatment for male. Finasteride is one of the most proven hair loss treatment ingredients approved by the US Food and Drug Administration (FDA), and has proven its efficacy and safety in preventing hair loss and is widely used. The existing oral formulation of hair loss treatment for male should be taken once a day. However, long-lasting injections are expected to improve patient compliance, improve hair loss treatment, and reduce the likelihood of side effects by minimizing the dose of drugs for the same efficacy. IVL3001 (1 month long-lasting male pattern hair loss treatment) is scheduled to be released in 2024 with a non-clinical study scheduled to be conducted in early 2021, and IVL3002 (3-month-lasting male pattern hair loss treatment) is currently in non-clinical studies. CEO Seng-Ho Jeon said, “Daewoong has a variety of R&D pipelines such as anticancer drugs, CNS, diabetes, and obesity based on long-term continuous injection production and research experience over the past 20 years.” and he added that it plans to accelerate the development of long-lasting hair loss treatments for male to advance into overseas markets based on Daewoong's excellent R&D capabilities and commercialization know-how. Ju Hee Kim, CEO of Inventage Lab said, “It is a very valuable achievement to jointly develop Inventage Lab's long-lasting drug, which is developing innovative new platform technology in this field, with Daewoong, which has development expertise and sales network as a leader in domestic long-lasting injections, and we will do our best to provide better treatment options to 10 million hair loss patients in Korea through close cooperation with Daewoong and to make it a commercially successful drug in the global market.”
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