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- 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.”
- Company
- Choline alfoscerate coverage reduction order suspended again
- by Chon, Seung-Hyun Oct 05, 2020 06:20am
- The court has once again approved to halt the administrative order on the cognitive enhancer ‘choline alfoscerate.’ Previously, the court has decided to suspend the order until the final ruling of the litigation, but another litigation case added 30 days to the already-approved order suspension. According to the industry sources on Oct. 28, the Seoul Administrative Court has decided to withhold the effect of partially revised health insurance reimbursement standard the pharmaceutical companies filed litigation against on Oct. 25, regarding the choline alfoscerate coverage reduction, for 30 days from the day the litigation is concluded. Represented by the law firm Lee & Ko, 39 pharmaceutical companies and one individual, including Daewoong Bio, has requested the order suspension. On Sept. 26, the Ministry of Health and Welfare (MOHW) issued a revised notice on the reimbursement standard, which stipulated adjustment of choline alfoscerate coverage. From this month and on, the government’s new reimbursement standard was supposed to raise the patient copayment rate from 30 percent to 80 percent, if a patient who has not been diagnosed with dementia were to use a choline alfoscerate drug. The court ruled, “Halting the administrative order on choline alfoscerate does not seem to significantly affect the public welfare.” The court also pointed out the patients could continue to use choline alfoscerate, regardless of the burdening copayment rate, or give up on the drug use due to reduced healthcare benefit on the drug. Moreover, the court judged the coverage adjustment on choline alfoscerate with insufficient clinical evidence could bring a grave impact on the related market as it would defame the credibility and reputation of the drug and the companies. Currently, two litigation cases against the administrative order on choline alfoscerate are in process. The law firm Shin & Kim is representing 39 companies and eight individuals including Chong Kun Dang, and the law firm Lee & Ko is representing 39 companies and one individual. Shin & Kim and Lee & Ko have filed the litigations on Sept. 27, immediately after the ministry issued the notice. The order suspension request made by Shin & Kim has been approved until the day of the final ruling. And now, the request by Lee & Ko has been accepted as well. The two cases do not conflict issues on respective order suspension. Meanwhile, MOHW has reportedly filed an appeal on the Shin & Kim case.
- Company
- Merged BMS-Celgene to offer ERP after all
- by Eo, Yun-Ho Oct 05, 2020 06:20am
- Initially merged with almost no downsizing, Bristol-Myers Squibb (BMS) and Celgene have ultimately decided to slim down the organization in South Korea. According to the pharmaceutical industry sources, BMS Korea has recently decided to issue the Early Retirement Program (ERP) as a result of acquiring Celgene. The staff reduction would focus on marketing and sales, which would also include executive-level layoffs. The compensation would be severance pay worth additional eight months on doubled service years, which would add up to maximum 48 months (standard pay) plus more premium. The offer is considered one of a top-level ERP condition ever offered by a multinational pharmaceutical company in South Korea. In last March, BMS has announced newly formed divisions and new head personnel for the Business Unit (BU). At the time, the multinational company integrated the Oncology and Hematology Departments. Although some employees with overlapping positions left the company, but official downsizing did not take a place. Nevertheless, the delay in immunotherapy Opdivo (nivolumab) coverage expansion, sales stagnation and pricing reduction and generic launch of off-patent Eliquis (apixaban) seemed to have affected the decision to provide ERP. In January last year, BMS has decided to acquire Celgene for USD 74 billion (86.40 trillion won). The Celgene acquisition was processed with cash and stock transaction, and the legal process is still in progress at the moment. Through the acquisition, BMS has also obtained anticancer therapy Revlimid, and the next-generation immune CAR-T cell therapy option, taken over from a deal with Juno Therapeutics
- Company
- Ildong is accelerating the development of Lasmiditan
- by Kim, Jin-Gu Sep 29, 2020 06:20am
- Ildong’s Headquarters Ildong is accelerating the development of a new class of migraine treatment 'Lasmiditan'. A large-scale phase III clinical trial is in progress, close to 300 as a bridged clinical trial, and it is confirmed that the registration of subjects has recently been completed. According to the pharmaceutical industry on the 25th, Ildong recently completed registration as a subject for Lasmiditan-related bridging clinical trial. Ildong was approved for phase III clinical trial from the MFDS in December of last year, and recruited subjects from 13 institutions including Seoul National University Hospital and Nowon Eulji Medical Center. The number of people participating in the bridging clinical trial reached 288. This is unusual considering the fact that normal bridging clinical trials are conducted in units of dozens of people. This explains that Ildong is working hard on the development of Lasmiditan. Lasmiditan is a new class of migraine medication that was approved by the US Food and Drug Administration (FDA) in October last year. As a treatment for acute migraine headaches, it is receiving great attention because it is a new drug that has been released in 20 years. In the United States, Reyvow by Eli Lilly was approved. The domestic copyright is owned by Ildong. Ildong signed a contract with the original developer, CoLucid, in 2013, and acquired the copyrights in eight ASEAN countries, including Korea. It is the first and only therapeutic agent that acts on the serotonin (5-HT)1F receptor. Previously, there were Triptan-based treatments, but there are cardiovascular side effects. But Lasmiditan selectively acts on serotonin receptors, so there is no cardiovascular side effects due to vasoconstriction. Ildong plans to complete phase III clinical trials by the first half of next year and apply for NDA. The launch is likely to be done in 2022. An official of Ildong said, “Generally, only about phase I is performed for bridging clinical trials, but in the case of Lasmiditan, due to the nature of a migraine headache, it is necessary to closely examine the efficacy and safety, so not only phase I but also phase III is carried out on a large scale.” He said that the drug's value and reliability will be greater if it undergoes large-scale phase III clinical trials.
- Company
- Korean rare disease drug Hunterase market share surges
- by An, Kyung-Jin Sep 29, 2020 06:20am
- Product image of Hunterase Developed with South Korean-made rare disease treating technology, Hunterase (idursulfase-β) continues to top the market. The treatment’s market share gap with Elaprase (idursulfase) that used to dominate the Hunter syndrome market has tripled as Hunterase maintains market share of over 70 percent. While the treatment is generating significant sales in Central America and North Africa, its commercial value is to grow even further as it prepares for the Chinese and Japanese markets. A pharmaceutical market research firm IQVIA reported on Sept. 24, GC Pharma’s Hunterase has generated 8.8 billion won in the second quarter of the year. The sales in first half of the year accumulated to 17.6 billion won, taking up 72.3 percent of the market. Although the figure went down by 0.5 percent compared to 17.7 billion won last year same time, the treatment has been dominating the market with the sales still tripling the competitor’s. In the same time, Sanofi Genzyme’s Elaprase has only made 6.7 billion won. In 2008, GC Pharma has licensed in the technology from Samsung Medical Center Professor Jin Dong Kyu and co-developed Hunterase to treat patients with Hunter syndrome. After Ministry of Food and Drug Safety (MFDS) green lighting the drug in 2012, the Korean company successfully commercialized the world’s second Hunter syndrome treatment, following after Sanofi Genzyme’s Elaprase. Hunter syndrome is a rare, inherited disorder, diagnosed roughly in one out of 100,000 to 150,000. Caused by deficiency of an enzyme called idursulfase, the disease has poor prognosis as patients express skeletal abnormality, cognitive impairment other unpredictable symptoms when not treated in adequate timing and have life-expectancy of around 15 years. There are about 70 to 80 cases reported in South Korea. Quarterly market share of two Hunter syndrome treatments in Korea (Unit: %) Source: IQVIA Launched in 2008, Elaprase was the only prescription treatment for treating Hunter syndrome accessible in South Korea, up until Hunterase was released. Although it used to generate 7 billion won per quarter, Elaprase’s quarterly sales have plunged to around 3 billion won ever since Hunterase entered the market in the third quarter of 2012. The global drug has raised 3.4 billion won in the second quarter taking up the market share of 28 percent. Basically, the two-thirds of the market were handed to Hunterase. Hunterase’s market presence has been consistently growing since it was released. According to IQVIA’s data, the sum of two Hunter syndrome treatments in last year’s second quarter marked 12.2 billion won, which has gone up by 17.1 percent from the second quarter of 2016. When Elaprase’s sales were stagnating for last four years, Hunterase has been pushing the market expansion. The Korean drug’s maximum price with coverage is 2,254,200 won, which is about 17.6 percent lower than Elaprase (2,651,616 won). As the follow-on drug was offered with lower pricing, the Hunter syndrome treatment market has been expanded and the rare disease patients’ access to treatment was improved. Currently, Hunterase is indicated to be administered 0.5 mg per kilogram of patient’s body weight once-weekly. For instance, a child weighing 36 kg would need to pay 6,762,600 won to receive 18 mg per dose. In a year, the number would add up to 351.66 million won. Because the number of competitors is low with limited number of patients, the companies are expecting high profit for providing life-long doses of the needed enzyme. Hunterase’s quarterly sales in domestic and overseas markets (Unit: KRW 100 million) Source: GC Pharma Also, Hunterase has been performing well in the overseas markets as well. GC Pharma says Hunterase’s export in the first half of the year reached 5.2 billion won, which was 35.4 percent of the overall sales. The drug’s export of 20.3 billion in last year surpassed the domestic sales of 18.7 billion won for the first time. At the moment, GC Pharma supplies Hunterase to markets in Central America and North Africa, and it has been improving the drug’s commercial value by lately entering other global markets. Early this month, GC Pharma won an approval by China’s National Medical Products Administration (NMPA) for Hunterase. Care Pharma Hong Kong, a rare disease treatment specializing offshoot of Canbridge Pharmaceuticals, licensed out the development and commercialization exclusivity in China, Taiwan, Hong Kong and Macao regions and successfully passed the Chinese pharmaceutical authority after 20 months since the partnership deal in January last year. The Korean company estimates there are 3,000 Hunter syndrome patients in China. The drug is expected to significantly leverage the international sales as it was approved as the first Hunter syndrome treatment in China with a sizable market. Soon, the drug would be knocking on the Japanese market as well. GC Pharma’s partner, Clinigen K.K. has submitted a New Drug Application in last March to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for their approval review on Hunterase Intracerebroventricular (ICV). Hunterase ICV is administered to the brain directly to deliver the medicine to cerebral ventricles. The specific administration route can overcome the limitation of other intravenous injection that cannot improve the cognitive improvement as the medicine fails to permeate through the blood-brain barrier (BBB). The global Hunter syndrome treatment market only has a handful of competitors. The limited size of the rare disease patients would ultimately hinder the domestic market expansion, but Hunterase is strategizing to rather consistently grow its global market presence in new overseas markets.
- Company
- Pfizer Korea launches Cresemba in Korea
- by Eo, Yun-Ho Sep 28, 2020 06:20am
- Pfizer Korea launched Cresemba (Isavuconazole), an invasive fungal infection treatment in Korea. Cresemba is an antifungal drug approved for the treatment of invasive aspergillosis in adults over 18 years of age and invasive mucormycosis, which is not suitable for administration of Amphotericin B in adults over 18 years of age, and obtained marketing permission. Cresemba has a broad antifungal spectrum, so it can treat both invasive aspergillosis and invasive mucormycosis, and is the only Azole-based antifungal agent in Korea with indications for invasive mucormycosis. In addition to the launch of Cresemba in Korea, Pfizer launched a campaign to raise awareness of diseases related to fungal infections with executives and employees in celebration of World Fungal Infection Awareness Week. It has been designated by the Centers for Disease Control and Prevention (CDC) to save more patients' lives by reducing delays in diagnosis and treatment by raising awareness of these fungal infections. Company officials hope that the launch of Cresemba in Korea will improve access to treatment in patients with invasive fungal infections, whose treatment options have been limited, and will continue to do their best to provide innovative treatment options to patients suffering from fatal fungal infections. Cresemba obtained approval from the US FDA in March 2015. Cresemba is a drug jointly developed by Basilea in Switzerland and Astellas in Japan, and Pfizer holds the right to sell in the EU and the Asian-Pacific region, including Korea. Astellas has been approved in the United States and Japan. This drug was found to have a lower mortality rate than Voriconazole (Vfend) in a clinical trial in 516 patients with invasive aspergillosis. The mortality rate of all causes at 42 days in the entire group was 18.6% (48/258 patients) in the Isavuconazole group and 20.2% (52/258 patients) in the Voriconazole group.
