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- 2025-12-25 20:53:46
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- Prolonged Galvus patent dispute… results to come next year?
- by Kim, Jin-Gu Jul 19, 2021 05:56am
- The patent dispute surrounding Novartis’ anti-diabetic DPP-4 inhibitor ‘Galvus (vildagliptin)’ may be prolonged and not be concluded within this year. With the substance patent of the said product to expire in March of next year, the benefits of early release will disappear for generic companies if the ruling comes after then. However, generic companies plan to continue the legal dispute to the end in consideration of the impact this case will have on future pharmaceutical patent strategies set by the industry in general. ◆4 years of legal dispute over invalidation of the extended period for a substance patent deepens Supreme Court’s concerns Pic of Galvus1According to the pharmaceutical industry, the legal dispute between the original drugmaker Novartis and generic companies centered around Ahn-Gook Pharmaceutical is ongoing for 4 years now. The case is currently pending in the Supreme Court. In November last year, Novartis filed an appeal to the Supreme Court despite the partial win it received in the second trial. The period for the dismissal of appeal to the Supreme Court had passed, and the Supreme Court will now officially review the legal dispute. However, negative prospects on whether the Supreme Court will make a final decision soon are being raised, as the court will have to carefully examine this new type of legal dispute that had not existed in the past. A legal official said, “Many legal suits to invalidate the extended period of substance patents for pharmaceuticals had been filed; however, the claims had never been recognized in the first or second trial. The Galvus case was the first ruling by the court that accepted the invalidation claim to shorten the extended term of a patent.” “Due to these issues that require careful consideration, the Supreme Court seems to be seriously contemplating on the case. Even the parties in dispute will not be able to predict the date of the Supreme Court's ruling, and there is a possibility that a final decision will not be reached within this year," he added. ◆Despite substance patent expiry in March 2022, generic companies are 'in for the whole fight' The key is whether the Supreme Court will make its ruling before March 4th of next year. March 4th is the date when the substance patent for Galvus expires. If the court’s ruling comes after May 4th, the generic companies will not be able to reap the benefits of overcoming Galvus’s patent or from the early release of its generic. According to UBIST, Galvus and Galvusmet sold 8.1 billion and 36.4 billion won in outpatient prescriptions last year. If the ruling comes after March, the generic companies will lose the opportunity to acquire the right to exclusive marketing approval of their generic in the prescription market that amounts to 40 billion won per year. Despite the risks, the generic companies plan to fight the full battle, as the results of this legal dispute may set a new milestone for generic companies in establishing patent strategies for generics in the future. If the generic companies succeed in invalidating even just one day of the extended patent term, this will may start a series of challenges on substance patents of original drugs, an area that had been considered impregnable. ◆187 days vs 55 days vs 0 days… What will the Supreme court’s judgment be? The Supreme Court‘s ruling is expected to be one of the three – recognizing the ‘187 days invalid’ by accepting the ruling of the first trial; recognizing the ’55 days invalid’ by accepting the ruling of the second trial, or accepting Novartis’ claim and not recognizing any part of the term invalid. The conflict began 4 years ago in July 2018 when Ahn-Gook Pharmaceutical requested a trial claiming that part of the term extended for the substance patent of Galvus is invalid. Hanmi Pharmaceutical later joined in the fight. Patent rights are usually protected for 20 years from the filing date. For pharmaceutical products, the time taken for clinical trials and regulatory approval is added to the protection term. Depending on the recognized period, patent protection for a drug can last 21 years or even 22 years. The same applied to Novartis when applying for Galvus’s patent in Korea. The company requested the patent term for Galvus to be extended to make up for the time spent on clinical trials and for the regulatory review by the Ministry of Food and Drugs Safety. The Korean Intellectual Property Office accepted the request and extended the term by 2 years, 2 months, and 23 days (1068 days). Ahn-Gook Pharmaceutical claimed that the 187 days of the extended term for Galvus’s substance patent was invalid. IPTAB accepted Ahn-Gook claim and ruled the 187 days invalid. Novartis appealed, and the case went to the hands of the Patent Court of Korea. Intellectual Property Trial and Appeal Board had overturned the first instance judgment to take Novartis’ side. However, the court ruled that only 55 of the 187 days are invalid. As a result, Ahn-Gook did lose the suit but reaped the rewards. As a result, Novartis once again appealed, and the case is not being reviewed by the Supreme Court.
- Company
- Emtuen became the largest shareholder of SillaJen
- by An, Kyung-Jin Jul 19, 2021 05:56am
- SillaJen said that Emtuen paid ￦60 billion for 18.75 million shares. Emtuen will become SillaJen's new largest shareholder starting with the payment, seeking to normalize its management and strengthen its expertise in bio-industry companies. On the 13th of next month, SillaJen will hold an extraordinary shareholders' meeting at the Korea Broadcasting Center in Yangcheon-gu, Seoul and appoint new board members. According to SillaJen, the new board consists of people who can normalize management and develop bio expertise. GreenFireBio.LLC personnel, a U.S. drug development company with Emtuen as the largest shareholder, are also expected to join the board of directors of SillaJen. "We will do our best to become a pioneer in the bio industry as well as responsible management as the new largest shareholder," an Emtuen official said. "We will make efforts to establish a virtuous cycle model for the bio industry that leads to Emtuen, Sillazen and GFB." "With capital and expertise, Emtuen is truly pleased to be the new largest shareholder," said SillaJen. "We will do our best in research and development as SillaJen is able to make a new leap forward." Emtuen sets the entire new shares to lock-up period for three years to advocate responsible management as the largest shareholder and guarantee minority shareholders rights.
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- ↑38% of drug exports in the first half
- by Kim, Jin-Gu Jul 19, 2021 05:56am
- In the first half of the year, Korea's pharmaceutical exports recorded about ￦4.5 trillion. There is a possibility that it will surpass ￦10 trillion within this year. In particular, exports of medicines to Germany have increased significantly. In the first half of this year alone, more than ￦1.5 trillion was exported to Germany. Germany's share of domestic pharmaceutical exports exceeded one-third of the total. According to the Korea Customs Service on the 15th, Korea's pharmaceutical exports in the first half of this year are estimated at $3,915.86 million. The figure rose 38% from $2843 million in the first half of last year. Due to the prolonged corona crisis, it is observed that it is consistently performing well in drug exports. Semi-annual drug exports were in the mid- to late $1 billion by the second half of 2019, but have been in the middle of more than $2 billion since the first half of last year when the corona crisis began in earnest. In the first half of the year, imports of drugs amounted to $3.989 billion. The trade balance of drugs, which deducted imports from exports, was $6.92 million. It turned from a deficit of $847.22 million in the first half of last year to a surplus. This is the second consecutive surplus since second half of last year. Attention is focusing on whether it will change its record-high export performance recorded last year. Semi-annual drug exports since 2017 (Unit: $billion, Korea Customs Service) Total exports of drugs last year amounted to $6.89355 billion, the highest ever. In particular, more than $4 billion was concentrated in the second half of the year. Assuming that it will produce export performance similar to last year in second half of this year, it is predicted that it will be able to surpass ￦10 trillion by end of this year. Top 10 countries in drug exports in the first half of 2020 and the first half of 2021 (Unit: $billion, Korea Customs Service) By country, exports of medicines to Germany were high. In the first half of the year, $1.352.63 billion of medicines were exported to Germany. It accounted for more than one-third (34%) of domestic pharmaceutical exports. Last year, exports to Germany accounted for 22%. Exports of drugs to the United States, the largest exporter of drugs, have declined significantly. It was $46.72 million in the first half of last year, but fell 32% to $274.83 million in the first half of this year. Exports to Japan rose 30% ($168.23 million → $219.38 million dollars), the Netherlands 345% ($45.1 million → $288 million), and China 14% ($119.27 million → $136.47 million). Exports to Turkey fell 54% ( $327.31 million → $149.83 million), while Brazil also fell 9% ( $96.37 million → $87.32 million).
- Company
- Onivyde is expected to be eligible for insurance coverage
- by Eo, Yun-Ho Jul 16, 2021 05:54am
- The new pancreatic cancer drug Onivyde is expected to be listed on the insurance benefit. According to the industry, Servier recently concluded a negotiation with the NHIS for the listing of Onivyde(Irinotecan HCl). As a result, it is expected that new insurance benefits will be available in pancreatic cancer treatment. Onivyde is eligible for the benefit if it passes the final procedure, the Health Insurance Policy Committee. It is the first achievement in about four years since domestic approval was made in August 2017. The drug has passed the DC of major medical institutions, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medical Center, and Sinchon Severance Hospital. Combination of Onivyde and 5-FU/LV are available for patients who fail primary treatment based on Gemcitabine. Through a global NAPOLI-1 study, Onivyde significantly improved treatment performance by combining with the existing secondary treatment option 5-FU/LV in patients who failed Gemcitabine based primary treatment. It has become a reminder of the importance of sequential treatment strategies in treating metastatic pancreatic cancer. If Gemcitabine-based chemotherapy is used as a secondary chemotherapy for metastatic pancreatic cancer, it is the only treatment recommended by NCCN to be Category 1. Onivyde was approved by the Food and Drug Administration (FDA) in October 2015. Since then, Baxalta has acquired permission in Europe in October last year, and Shire has taken over development and sales rights in the global market except for the United States and Taiwan. Servier took over Shire's anti-cancer drug division and was granted permission from 2019.
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- SMA tx Evrysdi has been applied for insurance benefits
- by Jul 16, 2021 05:54am
- Roche's Evrysdi, the second treatment for spinal muscular atrophy (SMA) in Korea, began the process of registering insurance benefits eight months after approval. According to the pharmaceutical industry on the 15th, Roche Korea applied to the HIRA earlier this month for the registration of the oral SMA treatment Evrysdi(Risdiplam). Evrysdi is the second domestically licensed treatment for spinal muscular dystrophy after Biogen's Spinraza. Although it was approved in November of last year, it has not been officially released in markets yet. A third treatment for spinal muscular dystrophy, Novartis' Zolgensma, has been approved. Novartis completed the application last month using the evaluation linkage system. Evrysdi was approved first, but Zolgensma's reimbursement was faster. Evrysdi is expected to be easy to register because it is cheaper than the previously listed Spinraza. Zolgensma are most expensive, so there are many concerns about which pay model to apply. Spinraza was also not easy to register at a high cost of nearly ₩100 million per vial at the time of the process. It took months before it was presented to the Pharmaceutical Benefits Advisory Committee. The final price of Spinraza is ₩9,2359,131. It costs ₩554.15 million per person in the first year, and ₩277.07 million from the following year. Patient's copayment is 10% of the total cost. Since Spinraza, which is already more expensive, has been reimbursed, it is not difficult to register if Evrysdi's drug price negotiation goes well. Evrysdi is also likely to follow the Expenditure Cap (RSA) applied to Spinraza. Zolgensma is a "one-shot treatment" that is only taken once in a lifetime, but the price is about ₩2.5 billion (based on the U.S.), the most expensive drug in Korea. The government and the company are considering ways to reduce the financial burden of health insurance. The company proposed a value-based RSA. The government are reviewing the Amortized Payment model. However, the only drug listed as Value-based RSA is "Evoltra," an acute lymphocytic leukemia treatment, and the Amortized Payment model is a new model that is attempted for the first time. It is expected to take some time to set detailed items such as standards and evaluation methods. Meanwhile, Evrysdi met the criteria for 'sitting without help' in BSID-III 12 months after treatment in the FIREFISH clinical trial of 41 infants from 2.2 to 6.9 months of age. 88% of patients on Evrysdi over two years survived without respirators for two years. In addition, the SUNFISH study of 180 patients aged 2-25 demonstrated improvement in motor function evaluation scale MFM-32 of Evrysdi in the 12th month of treatment.
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- Novartis most challenged for its patents, followed by Pfizer
- by Kim, Jin-Gu Jul 16, 2021 05:54am
- Among pharmaceutical companies, Novartis was found to have received the most amount of patent challenges since 2016. Over the past five and a half years, 33 generic companies had filed a total of 121 patent suits against Novartis' 15 patents on 8 products. In addition to Novartis, generic companies also targeted Pfizer, Boehringer Ingeheim, Astellas, and AstraZeneca. The same went for domestic companies. United Pharma, Alvogen Korea, Boryung Pharmaceutical, and Chong Kun Dang were also challenged on their patents by generic companies. ◆Generic companies challenge patents of 8 Novartis products On the 13th, Dailypharm’s tally of patent challenges in the biopharmaceutical sector since 2016 showed that Novartis has received the most challenges from generic companies. Generic companies had challenged 15 patents of 8 drugs owned by Novartis. A total of 121 requests for appeal and trial were filed by the companies against Novartis. In the same period, the total number of appeals and trials claimed (scope of right + invalidation suits) amounted to 1,042. In other words, 1.2 cases in every 10 patent suits filed had targeted Novartis. The 8 products that received patent challenges were;▲heart failure treatment ‘Entresto’; ▲DPP-4 inhibitor antidiabetic ‘Galvus’; ▲Breast cancer treatment ’Afinitor’; ▲ glaucoma treatment ‘Simbrinza eye drops’; ▲ conjunctivitis treatment ‘Pazeo eye drops’; ▲ COPD treatment ‘Xoterna’; ▲ chronic iron overload treatment ‘Exjade FCT’; and ▲ immunosuppressant ‘Certican’ The interesting point is that only 2 of the drugs among those in legal dispute are blockbuster drugs that bring over ₩10 billion in annual sales. According to the pharmaceutical market research institution IQVIA, only Entresto (₩21.7 billion) and Afinitor (₩14.9 billion) recorded over ₩10 billion in sales among the 8 Novartis products. The other products, Exjade (₩8.5 billion), Galvus (₩7.3 billion), Certican (₩6.9 billion), Xoterna (₩6.2 billion), Pazeo (₩4.1 billion), and Simbrinza (₩2 billion) all recorded less than ₩10 billion in annual sales. The analysis is that generic companies are now actively seeking patents not only for the well-sold large items but also for small and medium-sized sales items. Five or fewer generic companies have requested a judgment for each of the products that sold less than ₩10 billion. Also, Novartis targeted the most is because the company has that many patents. As of the 12th, Novartis has 151 patents (on 69 drugs) listed on Korea’s patent list. This is the most amount of patents registered among domestic and multinational pharmaceutical companies combined. In other words, despite the aggressive patent challenges filed by generic companies over the past 5 and a half years, Novartis has kept over 80% of its patents safe and sound. ◆Followed by Pfizer with 106 patent cases > Boehringer Ingelheim with 95 cases > Astellas with 89 cases The runner-up was Pfizer. Pfizer received the second-most amount of patent challenges after Novartis since 2016. A total of 106 patent trials were filed on 8 patents of 6 drugs. Pfizer's sedative ‘Precedex,’ the pneumococcal vaccine ‘Prevenar 13,’ smoking-cessation treatment ‘Champix,’ antidepressant ‘Prestiq,’ JAK inhibitor immunology drug ‘Xeljanz,’ and neuropathic pain treatment ‘Lyrica’ were the targets. The 4 products other than Precedex and Pristiq were blockbusters that raised over ₩20 billion in sales last year. Also, Boehringer Ingelheim (95 cases), Astellas (89 cases), and AstraZeneca (80 cases) received patent challenges from generic companies. Boehringer Ingelheim received patent challenge for its SGLT-2 inhibitor diabetes treatment ‘Jardiance,’ NOAC ‘Pradaxa,’ and Parkinson’s disease treatment ‘Mirapex.’ Astellas was challenged for its patents on its OAB treatment ‘Betmiga' and immunosuppressant ‘Advagraf.’ AstraZenca’s SGLT-2 inhibitor ‘Forxiga’ also was a target of focus for patent challenges. Among domestic companies, United Pharma, Alvogen Korea, Boryung Pharmaceuticals, Dong-A ST, and Chong Kun Dang were also actively targeted for their patents. In the case of United Pharma, 4 patents on its gastrointestinal symptom treatment ‘Gastiin CR,’ antiplatelet drug ‘Cilostan CR,’ and expectorant ‘Levotics CR,’ were targeted by generic companies. A total of 28 pharmaceutical companies had filed 80 patent trials. Alvogen Korea was challenged by 50 pharmaceutical companies for one single drug - its antithrombotic drug ‘Sarpodipil SR.’ Also, 44 generic companies challenged Boryung Pharmaceuticals 'patent on its antihypertensive combination drug ‘Dukarb.’ Dong-A ST also was challenged by 31 generic companies on its gastritis drug ‘Stillen 2X.’ Chong Kun Dang was challenged for the patent of two of its drugs – its GERD treatment ‘Eso Duo’ and its antihypertensive combination ‘Telminuvo.’ The patents held by domestic companies that the by generic companies targeted are all Incrementally Modified Drugs (IMDs). In other words, the drugs do not separately hold a substance patent and are therefore relatively easy to target. The analysis is that the patent challenges focused on IMDs as most were well-sold products that brought over ₩10 billion a year.
- Company
- Xospata is approved as a targeted anti-cancer drug
- by Eo, Yun-Ho Jul 15, 2021 07:06pm
- The emergence of FLT3 targeted anticancer drugs is also causing new changes in the area of acute myeloid leukemia, which lacked treatment options. Chronic Myeloid Leukemia (CML), which was considered incurable, has benefited many patients from the commercialization of the targeted anti-cancer drug Glivec(Imatinib), but Acute Myeloid Leukemia (AML) has relied on next-generation chemotherapy, despite being a life-threatening serious condition. Astellas' FLT3 target anti-cancer drug "Xospata ( Gilteritinib fumarate)" has been approved by the MFDS as the first FLT3mut+ recurrence or nonresponsive AML target treatment. AMLs are identified by individual chromosomes or genetic mutations. Guidelines published by the U.S. NCCN and the European ELN classify patients with FLT3-ITD mutations or TP53 mutations as the highest risk group. Xospata is a drug that targets both FLT3-ITD, FLT3-TKD, and FLT3-TKD mutations, which can be treated at home without frequent visits to hospitals. It also showed higher effectiveness and safety compared to conventional chemotherapy. It obtained permission from the U.S. FDA, Ministry of Health, Labor and Welfare of Japan in 2018 and the European EMA in 2019, and was also classified as Category 1, the highest recommended class for treating relapsing or nonresponsive AML patients with FLT3 mutations. It has recently been approved by Asian countries such as China and Singapore. Since its approval in March last year, it has passed the DC of major hospitals in Korea, including Seoul National University Hospital, Seoul St. Mary's Hospital, and Samsung Medical Center, and is under review at other general hospitals. It passed the HIRA's Cancer Drugs Benefit Appraisal Committee in February. Medical staff are also looking forward to it. Kim Hee-je, a professor of hematology at Seoul St. Mary's Hospital, said, "With Xospata's permission in Korea, patients can relieve their anxiety." "Of course, there is still a cost problem, but we expect it to become a standardized treatment as soon as possible after the salary is registered." "In FLT3mut+ R/RAML patients, the prognosis is poor and the disease can worsen rapidly, so it is important to provide proper treatment quickly. "That's why Xospata is being prescribed even though it's non-reimbursement." In May, the Korea Alliance of Patients organization delivered its opinion on the rapid benefits of new drugs, including Xospata, at a meeting with the MOHW' insurance and medicine department. "It is very unfortunate that AMLs are rapidly deteriorating and cannot be applied with already licensed treatments," said an official at the Korea Alliance of Patients organization. "We are also making efforts to ensure that the treatment can be used quickly for patients who need the only new medicine."
- Company
- Keytruda overcomes its 4-year hurdle, with Tecentriq
- by Eo, Yun-Ho Jul 15, 2021 06:30am
- The immunotherapy ‘Keytruda’ finally overcame one giant hurdle for its reimbursement, with ‘Tecentriq.’ According to industry sources, the PD-1 inhibitors – MSD Korea’s ‘Ketyruda (pembrolizumab) and Roche Korea’s ‘Tecentriq (atezolizumab)’ – passed deliberations by the Health Insurance Review & Assessment Service’s Cancer Drug Review Committee for its first-line indication for non-small cell lung cancer (NSCLC) yesterday (14th). However, differences exist between the criteria under which the two drugs gained the nod. Keytruda’s is for monotherapy and in combination with chemotherapy for patients with a PD-L1 expression rate of 50% or higher, and Tecentriq’s is as monotherapy for those with a PD-L1 expression rate and PD-L1 stained tumor-infiltrating immune cells (IC) covering 10% or more of the tumor area. Regardless of the specifics, the introduction of a cancer immunotherapy option in first-line NSCLC is reassuring news. The last move made by MSD Korea, which waited nearly 4 years for reimbursement of Keytruda in NSCLC, seems to have finally paid off. However, Keytruda’s nod comes with a condition attached. The Cancer Drug Review Committee again mentioned the equity of Keytruda and Tecentriq and requested additional modifications to be made to Keytruda's cost-sharing plan. This indicates that the drug pricing negotiations with the Pharmaceutical Benefits Appraisal Committee or the National Health Insurance Service will act as a variable in discussing Keytruda's benefit expansion to the lung cancer indication. Keytruda’s benefit expansion has been discussed for almost 4 years since September 2017. Among the many barriers, the biggest unresolved issue was the condition presented by the government to all pharmaceutical companies with cancer immunotherapies – requesting the company to ‘cover the initial 3 cycles’ worth of administration cost’ Roche, which owned the then-latecomer ‘Tecentriq,’ was the only company to accept the government’s proposal then, and 2 types of PD-1 inhibitors – Keytruda and ‘Opdivo(nivolumab)’ were unable to accept the offer. Since then, MSD had repeatedly proposed compromises and revisions to the government. The last discussion was held in August last year, during which the decision for the drug was put on hold as the committee believed that MSD Korea’s proposal lacked compromise on the company’s part. In September of the same year, HIRA handed the proposal back to MSD Korea and requested a re-revision. A month later, MSD submitted a re-revised proposal, which the reimbursement standard sub-committee meeting discussed but to no avail. The agenda was push back and not deliberated at the Cancer Drug Review Committee meeting. This time, with MSD Korea’s new managing director Kevin Peters personally attending to persuade the government, finally, the long-awaited “YES” came from the Cancer Drug Review Committee. Meanwhile, Keytruda was first listed for insurance benefits in August 2017 through the mixed refund and expenditure cap type of the Risk Sharing Agreement (RSA) with a PD-L1 expression rate standard.
- Company
- Will Rivoceranib+Iressa really be a game changer ?
- by Jul 14, 2021 06:26pm
- Can Rivoceranib+Iressa therapy really be a game changer? This is the title of the press release distributed by HLB on the 9th. "We have confirmed high synergy with the first-generation blockbuster EGFR TKI drug in phase 3 clinical trials," HLB said. "We expect a next-generation treatment due to a complete improvement in one person and PFS." Rivoceranib (Aptinib) is a targeted anticancer drug targeting endothelial cell growth factor receptor 2 (VEGFR-2), which plays an important role in the tumor development process. It is a plan that combines this with Iressa (Gefitinib), a first-generation EGFR target anti-cancer drug, to create synergy in treatment. The combination of the two drugs is positive. In fact, other VEGFR2 inhibitors "Cyramza" and first-generation EGFR TKI "Tarceva" combined therapy were approved as the first treatment for EGFR mutation non-small cell lung cancer in the U.S. last year. Let's take a look at the phase III results recently published by developer Jiangsu Hengrui Medicine in the Journal of Thoracic Oncology, a journal of the World Lung Cancer Society. This study compares Rivoceranib and Iressa combinations with Iressa sole therapy (Iressa+placebo) in patients with EGFR-positive non-small cell lung cancer who have not received existing chemotherapy. EGFR Exxon 19 defect or Exxon 21 L848R variant were deployed one-on-one in both counties. The primary validity indicators are PFSs evaluated by the IRRC, which consists of radiologists, and secondary validity indicators include clinical evaluation PFSs, overall survival periods (OS), and quality of life (QoL). In the study registered by 313 people, the primary variable, the median progressive survival period (mPFS), was approximately 3.5 months longer than 13.7 months for the combined group and 10.2 months for the single group (HR 0.71, p=0.0189). The 12-month PFS was 53.4% to 35.6%. OS data is immature at the time of analysis. CR was observed in one person. Grade 3 or higher adverse reactions were higher in the Rivoceranib group, with high blood pressure (46.5%), proteinuria (17.8%), and higher serum ALT in the control group (10.3%), and higher AST (3.2%), but there were no statistical changes in the quality of life between the two groups. It is true that the combination of Rivoceranib and Iressa therapy in phase 3 demonstrates the significance of effectiveness over Iressa alone therapy. However, considering the results of Tagrisso (Osimertinib), a third-generation targeted drug, which is currently a global standard for treating EGFR-positive non-small cell lung cancer, or Cyramza+Tarceva, the same mechanism, the results are somewhat insufficient to become a "game changer." Although clinical designs and patients are different, let's refer to the results of FLAURA study, which served as the basis for Tagrisso's acquisition of primary indications. Tagrisso compared Iressa and Tarceva, the first-generation drugs at the time, to patients with EGFR-positive non-small cell lung cancer who have no experience in chemotherapy. mPFS had 18.9 months for Tagrisso and 10.2 months for control (HR 0.46 and p
- Company
- Bavencio can be prescribed in general hospitals
- by Eo, Yun-Ho Jul 14, 2021 06:03am
- Merck and Pfizer’s immunotherapy ‘Bavencio’ can now be prescribed at general hospitals. According to industry sources, the PD-L1 inhibitor Bavencio (avelumab) passed the Drug Committees (DCs) of the Big-5s general hospitals in Korea - Seoul National University Hospital (SNUH), Asan Medical Center (AMC), Seoul St. Mary’s Hospital, Samsung Medical Center (SMC), and Severance Hospital – as well as other major medical institutions in the nation including Inje University Seoul Paik Hospital, Ajou University Hospital, Ewha Womens University Hospital, Wonkwang University Hospital, Wonju Severance Christian Hospital, Chosun University Hospital, and Inje University Haeundae Paik Hospital. Bavencio, the 6th cancer immunotherapy and the 3rd PD-L1 inhibitor to be approved after Tecentriq (atezolizumab) and Imfinzi (durvalumab), was first approved in Korea in March 2019 to treat the rare condition, Merkel cell carcinoma (MCC), then listed for insurance benefit under the RSA (Risk Sharing Agreement) scheme for the same indication in September last year. In Part A of the EMR100070-003 study that was conducted on patients with MCC whose disease had progressed on or after chemotherapy, the objective response rate (ORR) of those treated with Bavencio inj. as monotherapy was 33.0%. 11% of patients experienced a complete response and 22% of patients experienced a partial response. At the time of analysis, tumor responses were durable, with 93% of responses lasting at least 6 months and 71% of responses lasting at least 12 months. Also, interim analysis results in Part B of the study showed that the ORR in this patient group was 39.7%, with 13.8% of patients experiencing a complete response and 25.9% experiencing a partial response However, the company has been facing difficulties in expanding Bavencio's indication. Since December last year, the benefit approval is being delayed due to negative evaluations made on the efficacy of Bavencio for renal cell carcinoma by the Central Pharmaceutical Affairs Council. The council pointed to the overall survival (OS) data of the drug as the key cause. Also, recently, Bavencio’s indication as a first-line maintenance therapy for urothelial cancer that has been approved by the U.S. FDA was rejected in the U.K by NICE. NICE recognized the drug’s value in addressing the unmet need that exists in the population up for review but raised the question on its cost-effectiveness.
