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- 2025-12-25 15:34:14
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- Hanmi & Ahn-Gook finally won the Galvus patent dispute
- by Kim, Jin-Gu Nov 01, 2021 05:55am
- The Supreme Court sided with Generic companies in a patent dispute over Galvus (Vildagliptin), a DPP-4 inhibitor-based diabetes treatment. On the morning of the 28th, the Supreme Court dismissed Novartis' appeal against Ahn-Gook Pharmaceutical and Hanmi Pharmaceutical to invalidate the extension of the patent duration. There is a problem with the reason for the appeal claimed by Novartis. Generics succeeded in invalidating 55 days of the material patent duration. Ahn-Gook and Hanmi Pharmaceutical began early launch of generics for Galvus in accordance with the ruling. Generic is likely to be released early next year. The issue of this case is which period of the "extended duration" of the drug substance patent will be considered invalid. So far, there has never been a case in which generic has overcome the extended duration of drug substance patents against the original company. Ahn-Gook claimed that "187 days" out of the 1,068 days of Galvus' extended material patent duration was invalid. On top of that, Hanmi also requested an extension invalidation trial. Ahn-Gook won the first trial. Intellectual Property Trial and Appeal Board sided with Ahn-Gook and said 187 days were invalid. Ahn-Gook was qualified to release the generic 187 days earlier. Novartis won some of the second trials. The patent court ruled that only 55 days out of 187 days were invalid. Novartis once again objected and filed an appeal to the Supreme Court. Novartis argued that it could not be considered invalid.
- Company
- Qtern will be released in Korea after 4 years of approval
- by Eo, Yun-Ho Oct 29, 2021 05:53am
- The DPP-4 inhibitor and SGLT-2 inhibitor diabetes complex Qtern will be released four years after approval in Korea. According to related industries, AstraZeneca Korea will start promotional activities for Qtern, a product that combines Onglyza and Forxiga, on the 1st of next month (November). Qtern was approved in Korea in March 2017, but its launch in Korea was delayed as the problem of insurance benefits for diabetes combined therapy was not resolved. However, a change in the market is expected as insurance authorities have recently discussed recognizing the combined benefits of SGLT-2 inhibitors. A meeting of diabetes experts convened by the HIRA integrated the benefits of a combination of DPP-4 inhibitors and SGLT-inhibitors. The reason for the decision to release Qtern is also believed to have reflected this. Currently, in addition to Qtern, combinations of DPP-4 inhibitors and SGLT-2 inhibitors are licensed in Korea, Beringer Ingelheim's Esglito and MSD's Sitagliptin+Ertugliflozin. It has been confirmed that they are also preparing to launch as the benefit issue has been resolved. On the 25th, GC Pharma's GC2123A received approval from the MFDS for a biological equivalence test plan. The active ingredient of this product candidate is known as the same ingredient drug Empagliflozin+Linagliptin. In addition, Dongkoo Bio applied for permission for a combination drug of Januvia (Sitagliptin) and Forxiga in March. LG Chem is conducting commercialization clinical trials for Zemiglo and SGLT-2 inhibitors, while Aju is conducting commercialization clinical trials for a combination drug of Jardiance and Forxiga. Meanwhile, the PMS period of the DPP-4 inhibitor and SGLT-2 inhibitor combination is now less than two years away. The PMS period ends in March 2023. Since March 2023, news of generic development has continued as it is possible to apply for a generic license.
- Company
- Bayer’s ‘Nubeqa’ can be prescribed at general hospitals
- by Eo, Yun-Ho Oct 28, 2021 05:59am
- The new prostate cancer drug ‘Nubeqa’’ can now be prescribed at general hospitals in Korea. According to industry sources, Bayer’s oral androgen receptor inhibitor for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC), ‘Nubeqa (larotrectinib)’ has recently passed the review of drug committees (DC) in three major hospitals - the Samsung Medical Center, Asan Medical Center, and Gangnam Severance Hospital. Nubeqa is an androgen receptor inhibitor with a distinct chemical structure that binds to the receptor and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. The drug was approved based on the Phase III ARAMIS study that assessed the safety and efficacy of Nubeqa in combination with androgen deprivation therapy (ADT) compared to ADT alone. Study results demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS) in Nubeqa +ADT, with a median of 40.4 months, compared to the 18.4 months for placebo+ADT. Also, Nubeqa+ADT reduced the risk of death by 31%. Also, the full overall survival (OS) results from the pre-specified final OS analysis of the Phase III ARAMIS trial were published in the New England Journal of Medicine (NEJM) on the 9th. Results showed that Nubeqa+ADT showed a statistically significant improvement in OS compared to placebo plus ADT, with a 31% reduction in risk of death. The results hold significance as the OS improvement was achieved despite 55% of patients that taking placebo received subsequent Nubeqa or other life-prolonging therapy after the trial was unblinded at data cut-off for final analysis (November 15, 2019). Meanwhile, Nubeqa has not been added to the insurance benefit list yet. The drug has been determined inappropriate for reimbursement by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee in February, and the company has supplemented the data and is again undergoing the listing process.
- Company
- “Prolia·Evenity drives the osteoporosis treatment market”
- by Oct 28, 2021 05:59am
- Amgen has long been considered the company that has changed the osteoporosis treatment paradigm with potent new drugs. After sweeping over the osteoporosis treatment market with ‘Prolia (denosumab),’ a bone resorption inhibitor, the company then presented a new treatment strategy with ‘Evenity (romosozumab),’ a bone builder with a dual mechanism of action that increases bone formation and inhibits bone resorption. The sequential therapy strategy of using Evenity then Prolia is regarded as the top-priority treatment option in patients at very high risk of fractures. Prolia recorded 75 billion won (based on IQVIA) in domestic sales in just 4 years after its release, and Evenity, which has been rapidly approved for reimbursement, is also settling well in the market. Behind such great success are the hidden efforts of three Amgen Korea’s three PMs in charge of marketing Amgen’s osteoporosis treatments. The PMs Yoochae Park, Ga-eul Lee, and Saim Shin, who have an average of 10 years of experience in the industry, work to make known the importance of treatment to those at high risk of osteoporosis that were left unattended while introducing the effect and treatment strategy of Prolia and Evenity to HCPs. Dailypharm met with the three Amgen Korea PMs that have been driving the growth of Prolia and Evenity to hear about the marketing strategies of the two products and the changing paradigm in osteoporosis treatment. (From the left) PMs Yoochae Park, Ga-eul Lee, Saim Shin in charge of Amgen’s osteoporosis treatments -Could you tell us about your roles in marketing Amgen’s osteoporosis treatments? PM Yoochae Park (hereinafter “Park”)= I joined the marketing team as a PM for Prolia in Januarya last year. My main tasks include strategy establishment, planning, and material production to strengthen Prolia's position as a market leader in osteoporosis treatment. PM Saim Shin (hereinafter “Shin”)= I joined Amgen ahead of Prolia’s launch in 2016 and worked at its sales team until 2019 when I started to work as a PM for Prolia. I am mainly responsible for overall branding activities such as the development of Prolia messages as well as HCP support activities such as symposiums and webinars. PM Ga-eul Lee (Hereinafter “Lee”)=I am a PM for Evenity. I joined Amgen in March last year and prepared for and executed the non-reimbursed launch of Evenity. My marketing activities are similar to those done by the Prolia team, but more focused on branding activities such as message development and market positioning to promote Evenity, as Evenity is still in the early stages of its launch. -Prolia holds a solid position in the osteoporosis treatment market, recording an annual sales of 75 billion won in Korea. What factors do you believe contributed to Prolia's rapid growth? Shin=In the past, an unmet need among HCPs had existed as there had been insufficient clinical grounds to support the need for long-term treatment in osteoporosis. In other words, treatment efficacy, such as the continued reduction in risk of fractures and continuous increase in bone density from long-term treatment, were not established for the long-term treatment. The long-term data of Prolia in the 10-year FREEDOM clinical study demonstrated the drug’s effect in improving bone density and reducing the risk of fractures. The longer-term between treatments, with a single shot every 6 months, had also improved convenience in administration in patients, allowing them to more realistically receive long-term treatments. Such characteristics that differentiated Prolia from other existing treatments for HCPs and patients were the biggest factor that pushed the growth of Prolia. Park=We were able to directly see the patients’ bone health and density improve after being prescribed Prolia. The HCPs prescription experience and trust in our product has allowed for the continuous growth of Prolia. -With Evenity recently approved for reimbursement, there must be a lot on your plate. What are you most focused on for Evenity? There must be some regrets due to the somewhat limited conditions for Evenity’s reimbursement. Lee=The most important activity for us now is to position Evenity to be used as a first-line treatment after fractures. In this regard, we are focusing more on expanding the market for anabolic agents so that patients who have already experienced fractures can prevent additional fractures. Our focus is on delivering the personalized treatment message to more very-high-risk patients so that they can receive the appropriate treatment to prevent osteoporosis fractures, rather than is limited reimbursement -How have HCPs in the field responded to Prolia-Evenity? Shin=The most difficult issue that the HCPs had faced was that patients were unable to receive continuous treatment despite the HCP’s strong will for their treatment. However, the doctors have acknowledged that continued osteoporosis treatment became a lot easier with the introduction of the once-every-6-months injection, Prolia. According to research, the reduction in fracture risk is lessened if the patients miss 1 of the 2 osteoporosis treatments. In this sense, the high medication adherence in Prolia is a great advantage Lee=With expectations also high for Evenity overseas, HCPs in Korea have shown much interest in the therapeutic benefits of Evenity. In this sense, the most feedback I receive is about how much the HCPs expect a good effect. In addition, the continuous treatment rate of Evenity in HCPs who have previous prescription experience has been maintained high. Also, we were able to confirm successful treatment cases where patients were able to act and return to daily life without protective gear only 3-4 months after receiving surgery for their fractures. -Were there any difficulties in switching the previous face-to-face marketing methods to online due to COVId-19? Shin=At first, digitalizing all marketing directions came as a great burden. All the pharmaceutical companies had launched similar online marketing activities in the same period, and we paid special attention to the online materials that we prepare to increase the mail check rate and the number of webinar viewers. As a result, we have hosted the 24th webcast symposium for osteoporosis experts this year, which has been running for 4 years now. An average of 500 HCPs accessed the symposium live in real-time. It was a difficult but rewarding year in which our symposium was recognized for its quality lectures that address the questions made by HCPs on Prolia and Evenity. Park=Switching all our work to online had increased our load, and also brought concern whether the messages that need to be effectively delivered to the HCPs are being sent one-way. In the field, many HCPs seem to have a positive view of online marketing activities. The HCPs immediately check the material online and request additional material, if necessary. We have been better utilizing the advantages of online communication than our initial concerns, and our message and the advantages of our product are being well delivered online. Lee=Evenity was approved for reimbursement after the COVID-19 pandemic, and the launch symposium for the drug was held as a hybrid event, increasing the need for marketing activities in the online environment. Therefore we considered various measures to organically utilize the brochures, emails, and iPad contents on and offline. Due to our continued efforts, we saw high viewer numbers and e-mail checks from HCPs from the start of the launch.
- Company
- Samsung BioLogics' sales surpassed ₩1 trillion
- by Chon, Seung-Hyun Oct 28, 2021 05:58am
- View of Samsung BioLogics Plant 3Samsung BioLogics surpassed 1 trillion won in sales in three quarters. Sales exceeded 1 trillion won in nine years after its establishment last year, and it showed a steeper rise this year. Samsung Biologics announced on the 26th that its operating profit as of the third quarter was 167.4 billion won, up 196.12% from a year earlier. Sales amounted to 408.5 billion won, up 104.02% from the previous year. Both sales and operating profit are the largest ever. It broke new records of sales (412.2 billion won) and operating profit (166.8 billion won) set in the second quarter again in one quarter. Samsung Biologics' cumulative sales in the third quarter amounted to 1.1237 trillion won, up 42.34% from the previous year. Founded in 2010, Samsung Biologics recorded sales of 1.1648 trillion won last year, exceeding 1 trillion won for the first time in nine years. This year, it surpassed 1 trillion won for the second consecutive year in three quarters. The company's cumulative operating profit in the third quarter was 408.5 billion won, up 104.02% from a year earlier. The operating profit ratio to sales reached 36.4%. The company explained, "In the third quarter, sales increased 64% year-on-year due to the rise in the utilization rate of the third plant due to the performance of new product orders, and operating profit increased significantly due to the operating leverage effect of the third plant operation rate." Samsung Biologics is currently operating three biopharmaceutical plants. As the world's largest (180,000 liters) three plants as a single factory were in full operation in October 2018, the volume of consignment contracts is also soaring. Samsung Biologics signed consignment production contracts with global pharmaceutical companies such as Roche and MSD in the third quarter of this year alone, surpassing $7.1 billion in cumulative orders. Samsung Biologics is building its fourth plant with the aim of operating it in 2023. The fourth plant is the largest ever with 256,000 liters of production. When the fourth plant is in operation, Samsung Biologics will secure a total of 618,000 liters of production facilities along with its third plant (3,000 liters of first plant, 152,000 liters of second plant, and 180,000 liters of third plant).
- Company
- 'Vyndamax' fails reimbursement listing once again
- by Eo, Yun-Ho Oct 27, 2021 05:49am
- The new transthyretin amyloid cardiomyopathy (ATTR-CM) drug, 'Vyndamax,’ is suffering hardships in its process of being listed for insurance benefit. According to industry sources, the application Pfizer Korea submitted for the reimbursement of its new ATTR-CM drug, Vyndamax (tafamidis 61mg), was unable to pass the insurance benefit standard subcommittee. After the company failed to receive designation as an essential drug earlier this year, the company had applied for reimbursement once again through the Risk Sharing Agreement (RSA) scheme. Being deemed inappropriate after submitting data for PE evaluation, reimbursement of Vyndamax is facing difficulties. The problem is that this delay in reimbursement is affecting the patients. ATTR-CM is a fatal condition with a poor treatment outcome due to a lack of specific treatment and is often mistaken for simple heart failure. If not treated properly, patients with ATTR-CM have a survival period of only 2 to 3.5 years. Vyndamax is the only drug that demonstrated its survival benefit in ATTR-CM (ATTR amyloidosis with cardiomyopathy) and is virtually the only drug available as there are no alternatives. The subcommittee’s decision left much room for disappointment as experts have submitted a consistent opinion on the clinical benefit of Vyndamax at the government’s inquiry on the need to apply reimbursement to Vyndamax. Usually, another reason would have to exist for a drug that demonstrated clinical efficacy, has no alternative, and received a positive opinion from the academic society to not pass the insurance benefit standard subcommittee, and for Vyndamax, the reason is assumed to be its fiscal impact. However, separate subcommittees such as the economic evaluation subcommittee and the fiscal impact subcommittee do exist to assess the economic feasibility and fiscal impact of a drug. Therefore, the industry has been voicing complaints about the redundancy of the subcommittee reviews, by the insurance benefit standard subcommittee that is in charge of reviewing the insurance benefit standards conducting assessments on a drug’s fiscal impact. Jungwoo Son, Professor of Cardiology at Wonju Severance Christian Hospital said, “Early diagnosis and continued treatment is important for patients with the progressive ATTR-CM disease. Last year, the domestic ATTR-CM treatment environment has made rapid progress with the approval of Vyndamax, the only drug that provides practical survival benefit to ATTR-CM patients, however, the continued non-reimbursement of the drug has brought on the unfortunate situation where patients cannot start treatment even after being diagnosed.” Son stressed, “The insurance reimbursement system needs to be operated in a flexible manner for drugs like Vyndamax that has clear clinical benefit and no alternatives in consideration of the characteristics of rare diseases so that the patients’ right to treatment is not obscured by economic logic.”
- Company
- The supply of 8 GSK vaccines will be suspended until Feb
- by Oct 27, 2021 05:49am
- The supply of eight GSK vaccines, including Rotarix, is temporarily suspended, which is expected to disrupt the inoculation schedule. According to the pharmaceutical industry on the 26th, GSK announced a temporary suspension of supply of its vaccines to clinics and hospitals. Discontinued vaccines are ▲Rotarix (Human Rotavirus Live Attenuated), ▲Synflorix (Pneumococcal Vaccine), ▲Menveo, ▲Havrix, ▲Priorix (MMR Vaccine), ▲Boostrix (Tdap Vaccine), and▲Infanrix-IPV, IPV/Hib(DTaP vaccine). GSK said, "Some errors were found in the process of checking the registration details of its vaccines supplied to Korea, so we stopped importing and shipping additional products altogether." And GSK added, "This is a documentary error that does not affect product safety, quality, characteristics, purity, and efficacy, but this measure is expected to disrupt supply." Vaccines suspended from shipment are expected to be released by February next year. All products except Rotarix are included in the NIP. Most alternative generics exist, but some are multiple doses vaccinations and cross-vaccination with other products is not recommended, which is expected to disrupt the inoculation schedule.
- Company
- Celltrion's self-test kit has been approved for EUA
- by Chon, Seung-Hyun Oct 27, 2021 05:49am
- Celltrion announced on the 25th that the COVID-19 antigen rapid self-test kit DiaTrust COVID-19 Ag Home Test, jointly developed with Humasis recently acquired Emergency Use Authorization from the U.S. Food and Drug Administration (FDA). Celltrion received the EUA of Celltrion DiaTrust™ COVID-19 Ag Rapid Test for Professionals from the FDA in April, and the rapid self-test kit was also approved this time. The DiaTrust Home Test conducted clinical trials on 490 patients with COVID-19 symptoms in the United States from March to July, and showed 86.7% and 99.8% accuracy in sensitivity and specificity, respectively. Third-party products that have already been approved by the FDA and are in circulation in the U.S. require consecutive tests that require at least two tests regardless of symptoms. The company explains that this product requires the same continuous itest for asymptomatic patients, but for symptomatic patients, it is possible to check for infection with just one test. This product is available for those aged 14 or older and can be purchased online or offline without a separate prescription. Celltrion is planning to supply DiaTrust Home Test in the U.S. through its subsidiary Celltrion USA. For rapid supply, last-minute consultations are underway with local governments, online distributors, and offline distributors. The home test kits are handled by Humasis, a co-developer. Celltrion won a contract from DLA in the U.S. last month to supply DiaTrust for experts worth up to 738.2 billion won. An official from Celltrion said, "This EUA is based on the high reliability of Celltrion diagnostic kit products, and we will make efforts to prevent the spread of COVID-19 through early supply of products."
- Company
- Sales of choline alfoscerate rise despite controversy
- by Chon, Seung-Hyun Oct 26, 2021 05:53am
- Sales of brain function enhancer ‘choline alfoscerate’ are on the rise in the prescription drug market. The drug recorded growth for 3 consecutive quarters despite controversy over its efficacy, reduced scope of reimbursement, and the restitution of insurance benefits. Also, with many CA products withdrawing from the market after giving up clinical re-evaluations, the market dominion has fluctuated. According to the market research institution on the 25th, the outpatient prescriptions in Q3 recorded ₩127.3 billion. This was a 5.4% decrease YOY, however, also a 3-quarter consecutive rise from the ₩116.7 billion in Q4 last year. The cumulative prescription of choline alfoscerate products was ₩368.7 billion by Q3 this year, which was a 2.3% increase from the previous year. Choline alfoscerate is currently approved for the following three indications: ▲ Secondary symptom caused by cerebrovascular defects or degenerative brain-organic psychiatric syndrome by cerebrovascular deficiency; ▲ Emotional and behavioral change; and▲ Senile pseudo depression.’ Despite the recent flood of issues from clinical reevaluations, reduced scope of reimbursement, and negotiations for restitution of insurance benefits, sales of choline alfoscerate have stayed strong in the prescription market. The amount of choline alfoscerate prescriptions in Q3 nearly doubled from Q3 2017, 4 years ago. The safety and efficacy of choline alfoscerate are currently on the testbed, and the governments’ pressure to reduce the drug's insurance benefits is still ongoing. Choline alfoscerate became the first subject of the unprecedented restitution negotiations. At the end of last year, the Ministry of Health and Welfare ordered the National Health Insurance Service to sign an insurance benefits agreement ‘to return the prescription amount if the clinical trial fails.’ 8 months after the negotiation order, the companies have comprehensively agreed on the restitution rate of 20%. What is noteworthy is that the overall market size showed growth even though some of the choline alfoscerate products withdrew from the market after giving up re-evaluations. The MFDS had first ordered clinical re-evaluations to 134 companies, and 57, less than half, of the companies received approval for their clinical reevaluations. In other words, 77 companies have given up reevaluations and decided to withdraw from the market. Some of the companies have officially withdrawn from the market by voluntarily withdrawing their licenses. The interpretation is that these products were replaced by other choline alfoscerate products. The market dominion for each product had also been fluctuating. Some products showed a sudden surge in sales by absorbing prescriptions of products that withdrew from the market. Sales from market leaders, Daewoong Bio and Chong Kun Dang, recorded sales at a similar level to previous years. Sales of Daewoong Bio’s Gliatamine fell 1.6% from the previous year to record ₩28.1 billion in Q3, and Chong Kun Dang’s Gliatilin recorded ₩23.4 billion, a 3.3% decrease from Q3 of the previous year. Mid-sized pharmaceutical companies including Korea Prime Pharm, Hutecs Korea Pharmaceutical, Dongkoo&Pharma, HLB Pharma showed high growth.
- Company
- Merck will actively support Korea to become one of the top 5
- by Oct 26, 2021 05:53am
- Korea M Lab Collaboration CenterM Lab has promised to actively invest and expand cooperation with domestic companies to expand its capabilities in Korean vaccine production and bio-process. In an online press conference hosted to commemorate the 5th anniversary of its establishment on the 21st, M Lab said, "We will support Korea to leap into one of the top five global vaccine production powerhouses." M Lab explores pharmaceutical bio companies' ideas for developing new drugs and provides solutions to solve important process development and production problems. It is located in eight countries around the world, including the United States, France, China, and Singapore, and was located in Songdo, Incheon in 2016. Merck Life Sciences invested a total of 10 million euros (about 12 billion won) for the 1865㎡ M Lab Center. M Lab supports professional education and skills in a wide range of fields, including drug development, manufacturing, and guarantee. Non-GMP research facilities allow customers to improve their R&D processes through the M Lab simulation system without being affected by the actual production line. M Lab has provided more than 540 customized training programs over five years and has helped practice more than 240 state-of-the-art facilities. It has formed a technology strategy partnership with more than 100 domestic pharmaceutical bio companies such as Samsung Biologics, Chong Kun Dang, and SK Bioscience. As large-scale biopharmaceutical production facilities have been established in Korea over the past decade and the need for vaccine and cell gene therapy has been increasing, M Lab also plans to expand cooperation in this field. Kim Yong-seok, general manager of process solution business, said, "Global is also paying attention to the growth potential of the Korean biotech industry. In particular, we expect biopharmaceutical production facilities to achieve the largest growth after the U.S. and China, he explained. He said, "In the past, we mainly collaborated with large pharmaceutical companies, but in the future, we will also cooperate with growing bio ventures to contribute to the construction of Korea's bio-eco system." In particular, bio ventures are rich in R&D ideas, but they are having difficulty in concrete demonstration methods. M Lab predicts that it will be able to educate them on scale-up technologies necessary in the initial process development and commercialization process and provide services for development optimization. It also expressed its intention to actively contribute to Korea's leap into the world's top five vaccine producers. Merck is also affiliated with a consultative body of vaccine companies composed of the Korean government and domestic pharmaceutical bio companies. It is determined to invest to support vaccine production and expand bio-processing capabilities. The domestic pharmaceutical bio industry has grown rapidly for 10 years, but it is difficult to recruit talent. The government, Incheon, and Yonsei University are establishing a K-NIBRT consortium to foster professionals in the vaccine and bio sectors. Merck will also participate in the consortium to support training programs and dispatch of experts. On November 4, the "Virtual M Lab Open House" will be held to guide bio-process education, job consulting, and recruitment information for college students majoring in life science. As national expectations for the biopharmaceutical industry grow after the COVID-19 incident, we will contribute to the growth of the industry by providing customized solutions and services through M Lab and sharing expertise and know-how, he said. "We will establish ourselves as a win-win partner that grows together through collaboration with Korea, which has unlimited potential," he said.
