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- Pharma companies speed up delivery of urology combo drugs
- by Kim, Jin-Gu Sep 13, 2021 05:56am
- Korean pharmaceutical companies have been rushing to develop combination treatments for various urologic diseases, such as those for prostatic hypertrophy+erectile dysfunction or benign prostatic hyperplasia+overactive bladder. Many patients with urogenital disorders suffer various conditions at once, including enlarged prostate, erectile dysfunction, overactive bladder, etc. The market size for the single-therapy agents that treat each separate condition is considerable. With no other combination therapy than Hanmi’s ‘Gugutams’ authorized in Korea, the industry’s interest in the combo drug market has been rising. Pic of Hanmi Pharm As of the 13th, the only drug approved as a combination therapy for hypertrophy+erectile dysfunction in Korea by the Ministry of Food and Drug Safety is Hanmi Pharmaceutical's ‘Gugutams.’ Gugutams is a combination of the prostate treatment ‘tamsulosin’ and erectile dysfunction treatment ‘tadalafil.’ At the time of its release in 2016, Gugutam’s performance did not meet expectations, due to low awareness of the urogenital disease in general. However, with increased awareness, the product became a steady seller, reaching ₩2.1 billion in sales last year. On this, Dongkook Pharmaceutical and Yuyu Pharma have jumped in to compete in the combination treatment market for benign prostatic hyperplasia+erectile dysfunction that combines tadalafil with ‘dutasteride,’ which is another ingredient used for benign prostatic hyperplasia. No combination treatment has yet been approved for this combination in Korea. Dongkook Pharmaceutical has started Phase III clinical trials on its dutasteride+tadalfil combo, ‘DKF-313,’ earlier this month at the Seoul Asan Medical Center. The company expects the Phase III trials to be complete by the end of next year. Yuyu Pharma is also developing a combination therapy using the same two ingredients. The company received approval for the Phase III trial in 2018, however, before starting the Phase III trial, a need to change the formulation was raised, and the company decided to start over from Phase I. Also, the development of combination treatments for benign prostatic hyperplasia+overactive bladder is actively underway. KyungDong Pharm and Dongkoo Bio&Pharma are competing to develop the combo treatment. In March this year, KyungDong Pharm received approval to start Phase III trials for its ‘KDF1905,’ which combines the benign prostatic treatment tamsulosin with overactive bladder treatment ‘mirabegron.’ Dongkoo Bio&Pharma had also previously received approval for the Phase III trial of its tamsulosin+mirabegron combination in January last year. Ildong Pharmaceutical and Jeil Pharmaceutical had also developed combinations using tamsulosin and another overactive bladder treatment ‘solifenacin.’ The two companies have completed Phase III trials for their combinations. However, Ildong Pharmaceutical decided to discontinue the development of its drug last year. Jeil Pharmaceutical had not applied for the marketing authorization of its drug for over 2 years since the completion of its Phase III trial. Also, CTC Bio’s development of its combination treatment for premature ejaculation+ erectile dysfunction is in its final stages. It is a combination of the premature ejaculation treatment ‘clomipramine’ and the erectile dysfunction treatment sildenafil. The company plans to apply for marketing authorization of its combination drug after completing its Phase III trial within this year.
- Company
- Jardiance marks new milestone in heart failure treatment
- by Whang, byung-woo Sep 13, 2021 05:55am
- With the SGLT-2 inhibitor, Jardiance (empagliflozin), proving its efficacy in heart failure with preserved ejection fraction (HFpEF), on how it will affect the domestic prescription market for heart failure is gaining attention. As another SGLT-2 inhibitor, Forxiga (dapagliflozin), was the first to receive approval for heart failure with reduced ejection fraction (HFrEF) indication, whether Jardiance’s study results could become the solid blow that could overturn the drugs' positions is gaining industry interest. The competition among SGLT-2is that are expanding their indications from their existing diabetes indications to heart failure as well as chronic diseases is also a special point of interest. The full results of the EMPEROR-Preserved clinical trial that demonstrated Jardiance’s effect on heart failure were presented recently at the ESC Congress 2021. The study showed a 21% reduction in the relative risk of cardiovascular death or hospitalization using Jardiance in HFpEF patients with or without diabetes compared to placebo, meeting its composite primary outcome. Also, in the analysis of its major secondary endpoint, Jardiance reduced the relative risk of first and recurrent heart failure hospitalization by 27%, and significantly delayed kidney function decline. On this, Jung-Woo Son, Professor of Cardiology at Wonju Severance Hospital, said, “It is encouraging that a treatment had been able to meet its primary outcome in HFpEF, in the midst of all other trials failing development for the condition. The outcomes with regards to cardiovascular deaths were a little disappointing, but the results showed enough benefit in other areas.” Dong-Ju Choi, President of the Korean Society of Heart Failure who participated as the head coordinator in the trial, stressed that the study reflected Korea’s heart failure treatment environment as 13 Korean medical institutions participated in EMPEROR-Preserved trial. With such strengths, the sentiment in the field is that there is no reason not to prescribe Jardiance after its approval as the clinical benefits are clear. However, how the prescription patterns will change will need to be observed in comparison to Forxiga, which was approved for HFrEF. A cardiology professor from a tertiary hospital in Korea who requested animosity said, “The good performance shown by Forxiga and Jardiance, has even raised discussions on their class effect. Since we have already been using Forxiga for HFrEF, doctors will be preferring Forxiga for the time being, however, there is a possibility that Jardiance will attract attention due to its versatility.” In particular, the professor predicted prescription of Jardiance would increase for patients whose diagnosis between HFrEF and HFpEF is unclear. He said, “There are heart failure patients who belong in the range between HFrEF and HFpEF, and Jardiance will have an advantage in preoccupying this market as it has presented results for both HFrEF and HFpEF. However, I know Forxiga is also conducting studies to cover the relevant areas, so on how the results will be remain to be seen.” As such, the majority of the HCPs in Korea are positive about the performance and expandability of SGLT-2is in heart failure. Therefore, the only barrier is in the drugs' progress in receiving approval and reimbursement. Forxiga is currently approved for HFrEF but is not reimbursed yet. And Jardiance is aiming to gain approval for its HFpEF indication based on its EMPEROR-Reduced trial within this year. Some industry experts have cautiously anticipated that the two drugs may be concurrently approved for reimbursement after Jardiance is approved for its HFpEF indication. Also, Boehringer Ingelheim and Lilly plan to submit the HFpEF results from their clinical trial to regulatory authorities within the year, but considering the domestic situation in which approval for drugs is processed only after FDA approval, it is unclear whether the drug will immediately be approved for prescriptions. Another variable that exists is Entresto. Novartis has applied for approval to expand the drug’s indication to the HFpEF indication.
- Company
- Key 3 mRNA vaccine techs are not Moderna's nor Pfizer's
- by Kim, Jin-Gu Sep 10, 2021 05:58am
- The three key technologies required for developing mRNA vaccines were revealed. These are technologies related to antigen optimization, mRNA syntehsis·modification, and manufacture of lipid nanoparticles (LNP) that correspond to steps 1, 2, and 4 of the 5-step vaccine manufacturing process. The explanation was that a biopharmaceutical company aiming to develop COVID-19 vaccines or anticancer treatments using mRNA must secure the technologies mentioned above. Even Pfizer and Modera, which produce the mRNA COVID-19 vaccines, are said to have secured patents related to the abovementioned technology through a licensing agreement. On the 8th, the Korean Intellectual Property Office (KIPO) published an ‘mRNA Vaccine Patent Analysis Report' and introduced the key technologies required for the production of mRNA vaccines. According to the report, a total of 691 mRNA vaccine-related patent applications have been filed globally. Moderna had filed for the most with 211, followed by CureVac’s 108, TranslateBio’s 67, Pfizer·BioNTech’s 60, and GSK’s 25 applications. However, the report showed that the core patent required for the production of mRNA vaccines is not owned by Pfizer nor Moderna. mRNA vaccines are produced in five steps: ▲antigen optimization ▲mRNA synthesis and modification ▲ Separation & Purification ▲LNP production ▲formulation. Among these, technologies for antigen optimization, mRNA synthesis and modification, and LNP production are the key technologies required for vaccine production. Map of COVID-19 mRNA vaccine technology relationships between companies (Source: KIPO) The technology for antigen optimization is owned by the US National Institute of Health (NIH). NIH had applied for 3 patents on ‘COVID-19 spike protein antigens,’ and one of the three has been registered in the US. Companies that develop mRNA COVID-19 vaccines like Pfizer·BioNTech, Sanofi, and GSK have signed licensing agreements with the NIH for the relevant patent. It is not confirmed whether Moderna, which had jointly developed a COVID-19 vaccine with NIH, had signed a licensing agreement for the said patent. In mRNA syntehsis·modification, patents on the ‘modified nucleic acid’ is key. Cellscript owns the patent on ‘the method reducing immunogenicity using pseudouridine.’ The patent, which had previously been owned by the University of Pennsylvania, was transferred to Cellscript. Moderna and BioNTech secured the technology through a licensing agreement with Cellscript. Two companies have the key technology related to lipid nanoparticles as patents- ‘Arbutus’ and ‘Acuitas.’ Arbutus owns multiple patents on “lipid-nucleic acid particle composition containing cationic lipids,’ and Acuitas owns multiple patents related to ‘lipid-nucleic acid particles containing cationic lipids and PEG-Lipid.’ Both play a vital role in the manufacturing of lipid nanoparticles. Pfizer·BioNTech had signed a license agreement with both companies to secure the technology. On the other hand, Moderna only signed a license agreement with Acuitas Therapeutics and is in a patent dispute with Arbutus in the US and Europe with regards to the technology. KIPO said, “Korean pharmaceutical companies and research institutions wishing to develop mRNA vaccines would need to acquire or evade the license of these patents. However, only 17% of the 691 patents related to mRNA are registered in Korea, therefore, Korean mRNA vaccine developers are less likely to get embroiled in patent dispute compared to those in the US or Europe.”
- Company
- Medytox’s American dream falters with returned botox rights
- by Kim, Jin-Gu Sep 09, 2021 05:55am
- Medytox’s plans to overcome the license revocation in Korea by entering the US market, have come to a halt with AbbVie, which had been conducting global trials for the new botulinum toxin candidate 'MT10109L,’ returning its rights to Medytox. ◆A technology export agreement worth up to ₩400 billion was returned in 8 years On the 8th, Medytox announced that AbbVie has returned the rights concerning MT10109L, an improved botulinum toxin candidate, to its company. The right was returned in 8 years since the technology export. Medytox had signed a licensing-out agreement for its botulinum toxin candidate in 2013 to Allergan (now AbbVie) and handed over the global development and sales right of its product in all countries around the world than Korea and Japan. The agreement including the signing fee and milestone was worth $362 million (₩390 billion) The returned rights by themselves are not bad news to Medytox, as the company has no obligations to return the $100 million (₩120 billion) that it received during the term of the contract. The company had received $65 million upon signing the agreement, and an additional $35 million milestone. company However, the returned rights could be a serious blow considering Medytox’s current circumstances. Medotx’s 6 botulinum toxin products are all on the verge of license revocations. The Ministry of Food and Drug Safety had ordered the disposition to suspend sales and cancel licenses of Medytoxin 50·100·150·200, as well as Coretox, and Innotox. The court accepted Medytox’s request to suspend the execution of the administrative order, however, the MFDS’s disposition served as a major negative factor on Medytox. Medytox earned ₩140.8 billion last year, which was a 32% decrease from the previous year. To Medytox, MT10109L was the key substance that could save the company from the looming crisis. The plan was for MT10109L to enter the US market through AbbVie to overcome the crisis of license revocation in Korea. In addition, the company had planned to use the FDA approval as momentum to receive authorization for MT10109L as a new product. Until earlier this year, the plan seemed to be in smooth progress. AbbVie had started 4 global Phase III trials on a total of 1,308 subjects in December 2018. The trials were completed in March this year. The industry had expected AbbVie to submit a Biologics License Application (BLA) to the US FDA within this year. However, contrary to industry belief, AbbVie suddenly returned its rights to Medytox., putting a stop to Medytox’s plans to enter the US market. ◆Why did AbbVie return the rights after completing Phase III trials? The industry has been speculating on two reasons as to why the company had returned the rights to MT10109L after completing Phase III trials. One is the possibility of trial failure. The results of the Phase III trial may not have been satisfactory, which led to the return of rights of MT10109L to Medytox. The other is the poor relationship it has with Daewoong Pharmaceuticals. In May, Daewoong Pharmaceuticals had submitted an investigation request into MT10109L claiming that its data has been manipulated. Its argument was that MT10109L is the same product as the Innotox that was revoked in Korea, and that Innotox’s data was found to be manipulated during the MFDS investigation. On this, Medytox had refuted the claim, saying that MT10109L is a new botulinum toxin formulation and a clearly different product from Innotox. Innotox is a domestically sold pharmaceutical that complies with the MFDS regulations, however, MT10109L is a product designed for approval in the US and Europe, and is manufactured and produced in compliance with the regulations in those countries. An industry official said, “AbbVie may have determined MT10109L the same substance as Innotox. And even if the company decided the two were not the same, the FDA’s move to launch an investigation into the drug may have been a burden.” Medytox plans to soon decide whether to apply for authorization of the retrieved MT10109L in the US. A company official explained that although the rights were returned from AbbVie, the possibility of applying for approval remains as the development of the product has not been aborted. An official from Medytox said, “We have received the full clinical data from Abbvie. We will be reviewing entry into the global market while conducting data analysis. We have not decided whether to directly apply for approval or seek a new partner. It’s all being reviewed internally.”
- Company
- Genome & Co acquires US firm to enter CDMO business
- by An, Kyung-Jin Sep 09, 2021 05:55am
- The KOSDAQ listed Genome & Company has acquired a manufacturing facility in the US to enter the microbiome contract development and manufacturing organization (CDMO) business. Through the acquire, the company aims to rise to a leader in both R&D and production in the microbiome market, a field with high growth potential. On the 8th, Genome & Company announced that it had acquired 966,502 shares of List Labs in the US in cash. This is equivalent to 27.17% of the company’s net worth. To internalize the production of microbiome treatment and diversify the company’s business, Genome & Company acquired 60% of List Lab’s shares and became the major shareholder of List Labs Genome & Company is a biotech company that specializes in new drug development. It was listed on KOSDAQ in December last year. The company has been using microbiomes to develop immunotherapy drugs for cancer and treatment for autism, as well as new antibody therapies. List Lab is a specialized CDMO business with 43 years of history. It owns a 2498m² sized FDA cGMP certified facility in San Jose, California that produces consigned microbiomes and biotoxins. The company had accrued an average of $9.7 million in sales annually. The company’s operation of 7 independent manufacturing spaces within the facility was positively reviewed as it allows separate production of aerobic and anaerobic microbiome-based drugs. List Labs’ manufacturing facility (Source: Genome & Company) Genome & Company’s management held an online discussion session to explain the company’s mid-to-long term vision regarding its entry into the new business area. By incorporating List Labs as the company’s subsidiary, the company aims to internalize the production of its self-developed microbiome pipeline and more stably operate clinical trials. Even after acquiring the management rights, the management said that List Lab will maintain its independent operations but expand new production facilities to increase the size of the business. The company plans to become a global microbiome CDMO leader by expanding its business area from the existing model that focused on early-phase clinical trials to late-phase clinical trials and consignment production for commercial use. The company also mentioned that it is considering listing Lists Lab on NASDAQ or other markets after the global CDMO business is in place. Microbiomes refer to a community of microorganisms. With increasing interest and attempts to affect the creation of the microbial environment for use in rare disease and cancer treatment, the microbiome industry has emerged into a blue ocean in the field of new drug development. Genome & Company expects the demand for production capacity to rise steadily in line with the continued rapid growth of the microbiome treatment market. According to the Ministry of Food and Drug Safety data, 204 microbiome treatments are currently being developed worldwide. The market size is expected to increase approximately 167 times, from $56.3 million(₩62.4 billion) in 2018 to $9.38 billion (₩10.87 trillion) in 2024. Jisoo Pae, CEO of Genome & Company who attended the session said, “Success of a microbiome-based new drug development depends on its prompt release and market preoccupation. I believe securing a CDMO will become an important factor for success in the microbiome market," He also expressed his expectations that the company’s entry into the microbiome CDMO business will add a new profit model to the company, increasing the speed of new drug development, and ultimately push the company up to a ‘first-mover’ in the global microbiome industry. Genome & Company’s microbiome CDMO project plan (Source: Genome & Company) The management had stressed that the ₩30 billion paid out in the acquisition process was 100% self-funded. The company does not plan to receive investment from external institutional investors nor intend to issue new shares. Pae emphasized, “The few media reports that Genome & Company plans to make paid-in capital increases because of the acquisition are not true. However, we may need to attract investment to expand the factory in the U.S. However, we will be attracting investments around List Labs and the U.S. subsidiary, therefore the HQ’s equity will not be affected or diluted in any way.”
- Company
- Leclaza can be prescribed at general hospitals
- by An, Kyung-Jin Sep 09, 2021 05:54am
- Leclaza Leclaza(Lazertinib Mesylate Monohydrate), a new domestic drug, is targeting the domestic lung cancer treatment market. As more than 30 major medical institutions nationwide were able to prescribe in about eight months of domestic permission, it has entered the domestic market competition, which forms 150 billion won a year. According to the industry on the 6th, Yuhan's Leclaza passed the drug committee of more than 30 medical institutions within two months of the launch of the benefit. It can be prescribed at Seoul National University Hospital, Sinchon Severance Hospital, Samsung Medical Center, and Asan Medical Center, as well as upper-level general hospitals called "Big 4," National Cancer Center, Bundang Seoul National University Hospital, Seoul St. Mary's Hospital, Hwasun Chonnam National University Hospital, Chilgok Kyungpook National University Hospital, and Pusan National University Hospital. Leclaza became the 31st new drug to be developed in Korea with conditional approval from the MFDS on January 18 this year. Patients with T790M-resistant local progressive or metastatic non-small cell lung cancer such as Iressa (Gefitinib), Tarceva(Erlotinib HCl), and Giotrif (Afatinib Dimaleate) are subject to administration. It is a mechanism that inhibits the proliferation and growth of lung cancer cells by interfering with signaling involved in lung cancer cell growth. Yuhan released it on July 1. and applied for insurance registration on December 30 last year before the item license using the "Drug Approval-Patent Linkage System," and achieved high-speed registration 165 days after the license. Despite its therapeutic effectiveness and safety comparable to AstraZeneca's Tagrisso (Osimertinib Mesylate), which acts as the same mechanism, it was recognized for its adequacy by offering low drug prices. Academic organizations consisting of clinical specialists such as the Korean Cancer Study Group, The Korean Cancer Association, Korean Society of Medical Oncology, and Korean Association for Long Cancer also showed similar efficacy and safety to Tagrisso and had a low risk of heart toxicity. It will be a new treatment alternative for patients with local progressive and metastatic non-small cell lung cancer with EGFR T790M mutations." EGFR mutation is a very common type of mutation observed in 30-40% of non-small cell lung cancers that account for 80-85% of lung cancer, occurring between exon No. 18 and 21. It is known to be more prevalent in Asians. EGFR-TKI, which can be prescribed in Korea until the release of Leclaza, is the first-generation drugs Iressa and Tarceva, Giotrif, Vizimpro, and Tagriso. According to IQVIA, a pharmaceutical research institute, five EGFR-TKI types formed a market worth 74.3 billion won in the first half of this year. Tagrisso, classified as a third-generation drug like Leclaza, accounts for 70% of the total market with 52 billion won in sales. Based on the recommended daily dose, Leclaza's insurance upper limit is about 206,900 won. It is about 10,000 won cheaper than Tagrisso (217,782 won). An official from Yuhan said, "We are happy for Leclaza to pass the DC of major university hospitals and general hospitals nationwide at the same time as insurance benefits.With the start of Leclaza prescription in July, positive treatment effects are being derived from the treatment site." He said, "If more medical institutions can prescribe within this year, we will contribute to improving the unmet medical needs of cancer patients in Korea."
- Company
- Alunbrig proves the effectiveness of epilepsy patients
- by Sep 09, 2021 05:54am
- Competition is fierce for the first standard treatment as the second and third generation drugs, which are next-generation drugs, appear one after another in the ALK-positive non-small cell lung cancer treatment market. Target anticancer drugs targeting ALK mutations include the first generation Xalkori (Crizotinib), the second generation Zykadia (Ceritinib), "Alecensa (Alectinib HCl), and the third generation Lorviqua (Lorlatinib). A generational shift is taking place in Xalkori, which has long been the first standard treatment. Except for Lorviqua, which still has only secondary treatment indications, Roche's Alecensa and Takeda's Alunbrig are the most fiercely competitive drugs in Korea. Both are second-generation drugs and are similar, showing excellent effects on patients with brain metastasis. Alunbrig, which was released relatively late, has different convenience and tolerability from Alecensa. Dr. Ross Camidge ( University of Colorado Cancer Center), who participated in the Alunbrig online media session held by Takeda Pharmaceutical Korea on the 3rd, showed similar results that he was superior to Xalkori through phase 3 clinical trials of Alunbrig and Alecensa. This is also the case in patients with epilepsy, he said. The secondary factors Dr. Ross Camidge refers to convenience, safety, tolerability, and cost. In this respect, he said Alunbrig is a good drug to choose from as the primary treatment. Looking at the convenience, Alcensa needs to be taken 8 capsules a day and Alunbrig needs to be taken only once a day (two tablets a day in some countries). In terms of quality of life, Alunbrig maintains a high quality of life for a long time. Dr. Ross Camidge explained, "In Alunbrig clinical trials, the time point at which the Crizotinib group recorded a lower quality of life than Alunbrig was faster than expected." Early-Onset Pulmonary Events (EOPE) were also concluded to improve when the drug was stopped for a while and then taken again. Referring to this, Dr. Ross Camidge added, "If you are worried about lung abnormalities, you will not take 90mg for seven days from the beginning, but 30, 60, and 90mg for three days each, and the method of slowly increasing will be effective." Lorviqua, a third-generation drug, was diagnosed with great side effects. He said, "The PFS risk ratio of Lorviqua's phase 3 CROWN study shows the best number among existing treatments," but added, "However, there are significant side effects, with about 80% of patients taking additional drugs with cholesterol levels, and half suffer from central nervous system functional problems. Even when looking at the quality of life data, the quality of life deterioration patterns of Lorlatinib and the control group (Crizotinib) overlap considerably, he said. For this reason, controversy still persists over whether Lorviqua should be viewed as a primary treatment option. Dr. Ross Camidge said, "Personally, Lorviqua is better to be used in secondary or higher treatment situations," adding, "In particular, ALK-positive lung cancer means that there is no need to use highly toxic drugs from the beginning of treatment." He said, "If we have to use Lorlatinib as a secondary drug like Korea, we will choose Alunbrig, which has better convenience and resistance, rather than Alecensa, as the primary treatment."
- Company
- It would have been a big trouble if no improvement
- by Chon, Seung-Hyun Sep 08, 2021 06:07am
- Pharmaceutical companies are actively working on transferring drug copyrights. As drug prices of transfer and transfer drugs are allowed, the transfer of permission rights due to mergers and acquisitions or corporate separation is speeding up. It is trying to enter the new generic market by receiving expensive products from other companies. According to the MOHW on the 7th, Celltrion's Actos 15mg will be newly listed on the health insurance benefit list at 626 won starting this month. The copyright of Actos 15mg will be changed to Celltrionl. Takeda Korea's Actos 15mg was removed from the list. It is a follow-up measure to Celltrion's acquisition of Takeda's drugs. Celltrion acquired Takeda's primary care division in the Asia-Pacific region for $278 million in June last year. Takeda has all rights to patents, trademarks, and sales of 18 pharmaceutical products sold in Korea, Thailand, Taiwan, Hong Kong, Macau, the Philippines, Singapore, Malaysia, and Australia. In Korea, Celltrion will take over the rights of Takeda products acquired by Celltrion. Celltrion is in the stage of completing the transfer of rights in Korea through the procedure of changing permission rights and registering drugs. The price of Actos 15mg remains the same as the previous drug price of 626 won. The previous upper limit of 626 won was maintained as the drug price succession rule was newly established in January. If the right to Actos 15mg was changed last year, drug prices are likely to have fallen significantly. Due to the reorganization of the drug price system in July last year, the drug price system was implemented, where the drug price fell as the registration time was delayed. If there are more than 20 identical registered products, generic will have a 15% lower drug price. At this time, the transfer drug was listed at the lowest price among the same products due to the application of the step-type drug price system. If the drug license is changed, it goes through a procedure of deleting and re-registration. Even if it was a previously registered product, it was inevitable to apply a step-type drug price system. When the pharmaceutical industry pointed out that it was unfair to register transferred drugs in the same way as newly registered products, the MOHW accepted the improvement of the system improvement. With the revision of the regulations, Actos was able to maintain the previous drug price of 626 won. Singulair Chewable 4mg of Organon Korea has been listed at 693 won since this month. As the license was changed to Organon, a new corporation spun off from MSD Korea, it was newly listed on the health insurance benefit list. The 4mg Singular Chewable has 59 identical products listed. If 4mg of Singular Chewable is recognized as a newly registered product, it cannot exceed 322 won. As drug prices were allowed to succeed, drug prices avoided falling below half. Organon's Vytorin 10/10 and Vytorin 10/20 were listed at 782 won and 1,093 won, respectively. Vytorin 10/10 and Vytorin 10/20 each have 48 generics listed, so new licensed products are subject to the step-type drug price system. If Vytorin 10/10 is applied as a newly registered product, it cannot exceed 481 won. However, due to the improvement of the system, the previous drug price was applied as it was.
- Company
- Tagrisso has established itself as an EGFR treatment
- by Sep 07, 2021 05:53am
- Lung cancer is the No. 1 cancer death rate among Koreans, but treatment is greatly evolving, with the 5-year survival rate more than tripling over 20 years. What had a significant impact on this was the EGFR target treatment. Targeted treatments targeting EGFR mutations have dramatically improved the overall survival period of patients. Among them, the third generation 'Tagrisso (Osimertinib)' has clearly established itself as a standard treatment for non-small cell lung cancer with current EGFR mutations. Tagrisso is a third-generation EGFR-TKI that inhibits both EGFR variations and T790M variations represented by L858R and exon 19 deficiencies. It is the only third-generation EGFR-TKI that has shown a full survival period of more than three years, which is excellent for patients with brain metastasis. AstraZeneca succeeded in the first generation of Iressa and the third generation of Tagrisso. Tagrisso's global sales reached $4.33 billion as of last year, becoming the first blockbuster drug in five years. Ironically, Tagrisso is going through all sorts of ups and downs in Korea. It's been a problem since the first registration. Since its first rapid approval in the United States in November 2015, Tagrisso has been the fifth in the world to obtain an item permit in Korea. At that time, Olita, the same third generation, was released in Korea. Tagrisso was the only third-generation drug in the world, but competed with Olita in Korea. Tagrisso was "too expensive" for the government, compared to Olita, which offered relatively low prices. In November 2016, the HIRA declared Tagrisso as a non-reimbursement drug, equivalent to the economic evaluation exception scheme. It passed the committee after three challenges, but negotiations with the NHIS were not easy. It was first listed as a secondary treatment in December 2017. Olita's development was suspended due to safety issues, and Tagrisso's quarterly sales jumped from ₩3 billion to ₩10 billion based on IQVIA. However, the Asian subanalysis data of the 2019 FLAURA 3-phase study became a problem. FLAURA is a global clinical trial that identifies Tagrisso's efficacy and safety as a primary treatment. Overall clinical results demonstrated improvement over first-generation drugs with a total survival period of 38.6 months. The problem was the result of a sub-analysis that only Asians did separately. The risk ratio (HR) of the Asian subgroup is 0.995, which is virtually no difference from the control group based on 1. AstraZeneca also submitted FLAURA China data for Chinese to reaffirm its effectiveness in Asians, but failed to pass the Cancer Drugs Benefit Appraisal Committee. Two years have passed since the first treatment indication was added, but conditions have no longer evolved since December 2017. Tagrisso's sales are steadily increasing. According to IQVIA, Tagrisso's annual sales reached ₩59.4 billion in 2018 and ₩79.2 billion in 2019. Last year, its annual sales surpassed ₩100 billion for the first time with ₩106.5 billion. It has become a global primary standard treatment. This year, Tagrisso's situation is not so good. First of all, after Olita, Yuhan's Leclaza is the second competitive drug. The UK, which was passive in primary care benefits due to its high cost, also recognized Tagrisso as primary standard treatment last year and applied the benefits. Currently, 44 countries around the world, including the United States, Britain, Germany, France, Italy and Japan, recognize Tagrisso as a primary treatment. Despite the controversy over the Asian OS, major Asian countries recognize Tagrisso as a primary treatment. Tagrisso is also applied as the first benefit in major Asian countries such as Japan, China, Taiwan and Singapore. After all, Tagrisso's benefit is an irresistible global trend. However, as two years have passed, complaints from patients are growing. It is noteworthy whether Tagrisso will be able to cross the high barrier of salary expansion amid changes in global treatment flow and demands from patients.
- Company
- Downfall of Cialis·Viagra…market taken over by generics
- by Chon, Seung-Hyun Sep 06, 2021 05:59am
- ‘Viagra,’ which had once held a commanding lead over the erectile dysfunction treatment market, is having trouble making a comeback. After being taken over by domestic generics Palpal,’ and ‘Sendom,’ it had also been outrun by another local generic, ‘Gugu.’ Lilly’s Cialis is also having trouble making a comeback due to generic competition. According to the pharmaceutical research institution IQVIA, the oral erectile dysfunction treatment market in Q2 marked ₩29.5 billion, showing a 48% YOY increase. Also, this was a 3.1% increase from the previous quarter. The erectile dysfunction treatment market had seen a reduction in sales in Q1 and Q2 of last year and had only started making a recovery since the second half of last year. In 1H last year, the reduced number of patients’ hospital visits as well as restrictions in sales and marketing due to the spread of COVID-19 had slowed down sales, but the market recovered to the previous year's level from the second half of the year. Generics from domestic companies are showing increasing influence over the market. Hanmi Pharm’s Viagra generic Palpal sold ₩5 billion in Q2, solidifying its lead in the market. Palpal’s sales had fallen 4.4% YOY, but still had a far lead over the runner-up by that makes around ₩2 billion in quarterly sales. Palpal, which was released immediately after Viagra’s patent expiry in 2012, had surpassed Viagra’s sales in Q2 2013 and Cialis’s sales in Q4 2015, then has been holding the lead in the erectile dysfunction treatment market for 6 years. Chong Kun Dang’s Cialis generic Cendom kept its 2nd place by selling ₩2.7 billion in Q2, a 5.6% YOY increase. Cendom, which was released after Cialis’s patent expired in September 2015, gradually increased its share in the market to surpass its original Cialis in Q4 2017 and Viagra in Q4 2018 and reach second place in the overall erectile dysfunction treatment market. Hanmi Pharm’s Cialis generic Gugu also marked 3rd place for the first time since its release. Gugu sold ₩2.2 billion in Q2, making a 9.5% YOY increase. Gugu’s sales had surpassed Cialis in Q2 2019 and Viagra for the first time in this term. On the other hand, originals from multinational pharmaceutical companies had not shared such positive performance in sales. Viatris Korea’s Viagra sold ₩2.1 billion in Q2 and increased 1.0% YOY, but still gave way to Gugu and lost its 3rd place in the market. This was the first time Viagra had ranked 4th in the erectile dysfunction treatment market. Viagra lost its lead in 2013 to Palpal, then became 3rd place in 2018 being outrun by Cendom. Since then, the product had stayed in its place for 2 years but then was surpassed by Gugu this year. Viagra, which had once represented the erectile dysfunction treatment market, is now selling less than half of what Palpal sells. Sales of Lilly’s Cialis also fell 6.5% YOY to mark ₩1.5 billion in Q2. The drug had held a strong lead in the market for 3 years, from Q3 2012 to Q3 2015, but had to hand over the lead in the domestic erectile dysfunction treatment market to Hanmi’s Palpal upon patent expiry. Since then, Pfizer's Viagra and Chong Kun Dang’s Cendom had sequentially exceeded Cialis’s sales. In 2018, Lilly had signed an agreement with its former sales partner, Handok, for the domestic distribution, marketing, and sales of Cialis, but saw no recovery in sales.
