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- 2026-05-19 23:42:13
- Company
- The FDA's final decision on Rolontis remains
- by An, Kyung-Jin Jun 01, 2021 06:11am
- View of Hanmi The FDA's due diligence on the domestic manufacturing facilities of Rolontis, a drug that Hanmi exported technology, has entered the final stage. The final process for obtaining final FDA approval has been completed as scheduled. Hanmi's partner Spectrum is rushing to prepare to enter the U.S. market worth about ₩3 trillion in preparation for FDA approval within this year. According to an industry on the 1st, FDA pre-approval inspection of Hanmi's Pyeongtaek Bio Plant, which produces undiluted liquid of Rolontis (Eflapegrastim), is underway. The schedule, which was scheduled from the end of last month to the beginning of this month, is progressing smoothly. "We cannot reveal the specific schedule," a source at Hanmi said. The FDA's due diligence has been carried out as scheduled. The due diligence of the Pyeongtaek Bio Plant is the final step for Rolontis' FDA sales license. "Rolontis' remaining procedures related to BLA have been completed," said Spectrum Pharmaceuticals, a U.S. partner of Hanmi. In the aftermath of COVID-19 infection, we were forced to proceed with due diligence at the Pyeongtaek plant," he said, stressing several times that final approval is possible once due diligence is completed." Rolontis is up to the FDA's decision. It is predicted that it will be able to obtain FDA's permission as early as this year. "If there was a problem with the clinical data, the FDA would have sent a CRL in October last year after completing the review of Rolontis," said Joe Turgeon, CEO of Spectrum Pharmaceuticals. "I'm confident that the rest of the process was fine. We are looking forward to FDA approval." Rolontis is a bio-new drug that Hanmi Pharmaceutical Co. transferred to Spectrum in Spectrum in 2012. Cancer patients subject to myelosuppressive chemotherapy are administered for treatment or prevention of neutrophilia. It is a family of "G-CSF" (grain globular stimulators) that stimulates granulocytes to increase the number of neutrophils, similar to Amgen's blockbuster drug "Neulasta" (Pegfilgrastim). If "Rolontis" receives FDA's final approval, Hanmi will release its first bio drug to the U.S. market that combines Labscovery platform technology that increases the duration of bio-medicine in the body. Given that Pyeongtaek Bio Plant has passed the FDA's strict due diligence standards, it can also enjoy the achievement of recognizing biopharmaceutical manufacturing technology. It is estimated that long-term G-CSF markets in the U.S. are worth ₩3 trillion. Amgen's "Neulasta" accounts for about 70%, Mylan's "Fulphila" and Coherus' "Udenyca" account for the remaining 30%. Spectrum has been conducting new global clinical trials since March last year, apart from "Rolontis" licensed clinical trials. It is a study that administers Rolontis on the day of myelosuppressive chemotherapy (Docetaxel+Cyclophosphamide). Existing treatments in the G-CSF family are difficult to administer on the same day as anti-cancer drugs, so patients have to be hospitalized or visit the hospital again the next day. Spectrum is conducting a reaction evaluation by administering Rolontis for 30 minutes, 3 hours, and 5 hours after chemotherapy to ease this hassle. Its strategy is to secure differentiation from competitive drugs by maximizing convenience of patients. Spectrum's management team said at a recent conference call, "Patients' enrollment on the same day of Rolontis is going smoothly. We expect to be able to announce research results by the end of this year. It will serve as data that can differentiate itself from competitive drugs after market release." Hanmi did not disclose specific terms of the contract regarding the transfer of Rolontis technology at the time of the initial contract with Spectrum. However, it is possible to estimate the size of the contract through a report submitted by Spectrum to the U.S. securities and exchange commission (SEC). Spectrum agreed that "If Rolontis obtains FDA's final sales license, Spectrum will pay Hanmi $10 million (about ₩1.9 billion) in technical fees." After its release, it pays an additional percentage of royalties each year depending on net sales.
- Policy
- Comparing Cellid with Janssen·AZ… SK Bio with Novavax
- by Lee, Tak-Sun Jun 01, 2021 06:11am
- With the Ministry of Food and Drug Safety announcing lowered standards for conducting Phase III clinical trials to promote the development of domestically developed COVID-19 vaccines, commercialization of Korean COVID-19 vaccines is likely to happen sooner than expected. In particular, domestic vaccines that were not able to enter the Phase III stage may be able to enter the market early by conducting comparative effectiveness clinical trials with previously approved products. On the 31st, the MFDS released the “Standard Draft for Covid-19 Vaccine Clinical Investigation Plans" on the 31st. In particular, the draft allows comparative clinical trials (phase 3) with previously approved vaccines. On the 31st, the MFDS released the “Standard Guideline for Covid-19 Vaccine Clinical Trial Plans.” In particular, the guideline allows comparative clinical trials (phase 3) with previously approved vaccines. Until now, clinical trials of COVID-19 vaccines had to demonstrate its efficacy compared to placebo. In the WHO guidelines, the efficacy of the investigational drug is compared with placebo in 150 subjects diagnosed with COVID-19. For example, if 15 out of the 150 patients received the investigational drug and the others received the placebo, the drug’s effect becomes 90%. AstraZeneca, Pfizer, Moderna, and Janssen’s vaccine were all approved through this method. However, issues that administering placebos to patients is ethically wrong as COVID-19 vaccines that are already commercialized do exist, and that an excessive amount of time and money is spent on the developer’s part when conducting placebo studies have been raised. According to MFDS, to conduct a Phase III trial in a country with a COVID-19 incidence rate of 0.4%~1.2%, a minimum of 20,372 to a maximum of 60,112 subjects is needed. However, the guideline presented by MFDS for comparative effectiveness clinical trials only requires an administration record for a minimum of 4,000 subjects. The comparative clinical trial would need to demonstrate that the vaccine is non-inferior or superior to the comparator drug (commercialized drug) at week 4 after vaccination through comparison of their neutralizing antibodies. However, for the safety review, at least 4,000 subjects (≥3,000 in the test group, 1,000≥ in the control group) will need to be enrolled in the trial. MFDS announced that by cohort, approximately 20% of the subjects should be 65 years or older and that over 5,000 participants should initially register for the trial in consideration of the 20% dropout rate. The comparator vaccine should be an item approved in Korea and be produced using the same platform. Currently, 5 domestic pharmaceutical companies have been conducting clinical trials on domestic COVID-19 vaccines. Cellid’s vaccine is being developed using a viral vector platform, SK Biosceincec and EuBiologics are basing their vaccine on a recombinant vaccine platform, and Genexine and GeneOne Life Science are using a DNA vaccine platform to develop the vaccines. The companies have not completed their Phase II trials yet. To be approved to progress to Phase III trials, the companies would need to first submit the results of their Phase II trial and be verified on the dosage and regimen. Under the new guidelines, by platform, Cellid will be able to conduct a comparative effectiveness clinical trial with Janssens or AZ’s vaccine. SK Bioscience and EuBiologics will be able to conduct the trial with Novavx’s vaccine. However, as only items that are approved in Korea may be used as comparators, the Novavax vaccine, which has not been approved in Korea yet, would not be immediately available for use as a comparator. Genexine’s DNA vaccine will not be eligible for the comparative effectiveness clinical trial as there is no DNA platform vaccine currently approved in the world. Therefore, Genexine would need to conduct its Phase III trial in the traditional way. Genexine plans to conduct its Phase III trial in Indonesia and other countries. The comparative effectiveness clinical trials may be conducted in a multinational manner. However, the proportion of domestic subjects must exceed 10%. An MFDS official said, “the long-term safety and immunogenicity data of vaccines are analyzed even after approval. Products approved by MFDS may be used for inoculation purposes in Korea.”
- Company
- 3-way race between ultra-expensive new orphan drugs to start
- by Jun 01, 2021 06:11am
- With Novartis’s gene therapy ‘Zolgensma’ approved, 3 new drugs have been introduced into the Korean spinal muscular atrophy (SMA) market, a market that previously had virtually no treatment available. The introduction of 3 new drugs in just 3 years marked the start of a full 3-way race between the new SMA treatments in Korea. In the U.S. where the race had already started, Spinraza’s share in the market has been decreasing. As to whether the situation would be the same in Korea is gathering attention. The Ministry of Food and Drug Safety (MFDS) has approved Novartis’ ‘Zolgensma (onasemnogene abeparvovec-xioi)’ as the second advanced biological product in Korea. Zolgensma can be used in SMA patients with a double allelic mutation in the SMN1 gene who have been ▲ clinically diagnosed as SMA Type 1 or ▲ has three or fewer copies of the SMN2 gene. Zolgensma’s different mechanism of action works as a strength over to Spinraza or Evrysdi SMA is a serious rare disease in which muscles gradually degenerate as motor nerves are damaged due to a gene defect in the survival motor neuron 1 (SMN1) gene. One out of every 10,000 infants around the world are diagnosed with SMA, and in Korea, around 30 patients (per 300,000 infants) are diagnosed with SMA every year. The severity of SMA is deeply associated with the number of copies of the “backup” SMN2 gene. The SMN2 gene may produce and compensate at most 10% of the SMN protein unable to be produced by SMN1. Patients with Type 1 SMA that have only 1-2 SMN2 copy genes may experience 95% loss of their motor neurons, and 90% of the patients die before reaching age 2. In Korea, there had been no SMA treatment available until 2017. Biogen’s ‘Spinraza’ was the first to be approved in December 2017, opening up a new treatment paradigm. 자료: 각사 Spinraza is an RNA-based treatment. It is an antisense oligonucleotide splicing modulator that promotes protein production by binding to the pre-mRNA sequence of the SMN protein produced by SMN2. After Spinraza, Roche also received approval for its RNA-based treatment, ‘Evrysdi.’ Unlike Spinraza, which is an injection formulation, Evrysdi is an oral formulation and is cheaper. However, this oral drug needs to be taken every day. Evrysdi has not yet been released in the Korean market. Zolgensma’s mechanism of action is completely different from the two drugs that were previously approved. Unlike Spinraza and Evrysdi, which use the “backup” SMN2 gene to increase the production of proteins, Zogensma completely replaces the function of the missing SMN1 gene to produce SMN proteins. When the replacement, made with a recombinant AAV adeno-associated virus (AAV9), is given to an infant by intravenous infusion, it works as an SMN1 gene and produces proteins. It is also called a 'dream cure' as patients can expect to be completely cured with just a single treatment. As a “one-shot treatment,’ the cost of the drug is also ultra-expensive. The cost of a single Zolgensma infusion costs 2.5 billion won. This is 25 times higher than the cost of Spinraza. However, Novartis explains that the cost-effectiveness of Zolgensma is quite high considering that Spinraza or Evrysdi would cost 0.3-0.5 billion won every year. Spinraza’s sales falter and Evrysdi strong in the U.S…. how about Korea? The SMA market in Korea is currently dominated by Spinraza. Based on IQVIA, Spinraza sold 72 billion won in sales last year. However, with the entry of Zolgensma and the yet-to-be-introduced Evrysdi, the market dominion in Korea is expected to change. Changes in the U.S. SMA market that is already in the 3-way race, can be used as a reference to predict the future of the Korean market. In the U.S. Spinraza’s sales have been showing a decline with the introduction of Zolgensma and Evrysdi. After selling 233 million dollars (approx. 257.3 billion Korean won) in Q1 2019, its sales had started falling from Q2 2020. The sales fell to under 200 million dollars in Q3 2020 to record 183 million dollars (approx. 202.1 billion won), then to 149 million dollars (approx. 164.5 billion won) in Q1 last year. This was a 36% decline in sales over the past 2 years. On the other hand, Zolgensma’s sales have shown a similar record every quarter since its introduction, since Zolgensma is a one-shot treatment that does not accumulate patients. After recording 150 million dollars (165.6 billion won) in Q3 2019 when it started to be prescribed in earnest, its sales have stayed steady in the 100 million to 130 million dollar range (143.5 billion won) every quarter. Evrysdi, which was introduced last in the U.S. market, has been relatively rapidly gaining its share compared to the other two competitors. After receiving approval in August 2020, Evrysdi sold 9 million dollars (9.9 billion won) in Q3 of the same year, which increased to 51 million dollars (56.3 billion won) in Q4, then to 87 million dollars (96.1 billion won) in Q1 this year. It may have had the lowest sales record, but its sales growth is the fastest among the three products. Based on the trend, U.S. experts expect Evrysdi to record the highest sales in 2026 based on its low-cost and oral formulation. Of course, the U.S.’s case may not apply 100% to Korea, as the Korean market is most strongly influenced by whether the drug is reimbursed as well as the reimbursement criteria. However, Spinraza’s sole lead in the Korean market is expected to continue for the time being, until reimbursement is approved for Evrysdi and Zolgensma. Also, there is criticism that the current insurance policy structure makes it difficult to accommodate ultra-expensive drugs like Zolgensma. The various clinical trials ongoing with Spinraza are also a variable. Spinraza has been conducting various clinical trials to maintain its lead in the SMA market; one of which is on asymptomatic infants. This study investigates whether administering Spinraza in advance to infants that have been genetically diagnosed with SMA helps to maintain a normal level of motor function in the patients. If Spinraza is approved for the indication to treat infants with confirmed SMN1 gene defect or mutation prior to diagnosis, Spinraza will be available at the very front-end, before any other treatment. In addition, Biogen has started more aggressive trials as well. The Phase IV RESPOND trial studies the benefit of switching to Spinraza in patients who showed a suboptimal clinical response to Zolgensma. Biogen identified cases of some patients who received Zolgensma but were insufficiently treated and found that switching to Spinraza may bring additional benefits to these patients. A long-term follow-up study showed that 4 out of 10 patients that had previously received Zolgensma have switched to Spinraza to continue their treatment.
- Company
- Astellas notified distributors, Betmiga cannot be returned
- by Kim, Jin-Gu Jun 01, 2021 06:11am
- BetmigaConfusion in pharmacies is expected to continue for a while over the lowering of the drug Betmiga (Mirabegron), an irritable bladder treatment. The pharmaceutical industry and the outpatient pharmacies predict that it will take at least a year for the drug price to be finalized. According to the pharmaceutical industry and pharmacies on the 28th, Astellas Pharma Korea Betmiga PR will be lowered from the 1st of next month. This is because Chong Kun Dang and Hanmi Pharmaceutical succeeded in overcoming patents and released generic. The MOHW has announced that it will lower the upper limit of the original Betmiga from June 1 following the release of generic drugs. However, it is highly likely that Betmiga's drug prices will not be reduced. Astellas disobeyed the second trial's ruling, and the case went to the Supreme Court. Astellas lost the second trial of Betmiga's use-and-crystal patent dispute with 11 companies, including Hanmi, on January 22 this year. Astellas filed an appeal with the Supreme Court on March 3. At the same time, it is said that it filed an injunction with the administrative court to suspend the execution of the drug price notice. Since the related case has not yet been finalized, it is a request to postpone administrative disposition until the Supreme Court ruling is made. This is why Astellas notified distributors of "nonreturnable" and "non-settle balance" by saying, "There is no reduction in drug prices in June." In fact, the same thing happened earlier in the patent dispute surrounding Eliquis. BMS, the original company, maintained an insurance upper limit of ₩1,185 per party by dragging the case to the second trial and applying for an execution suspension of drug prices at the same time, even though generic was released after the first trial was lost. When the second trial was lost, the MOHW warned of a drug price cut, but the BMS applied for an execution suspension of the drug price cut as it dragged the case back to the third trial and eventually the insurance upper limit price was maintained. The case was overturned in the third trial and eventually BMS succeeded in delaying the drug reduction until September 2024. It took about two years for the final sentence (April 8, 2021) to be made after the third trial was held in the Eliquis case (May 3, 2019). Considering this, the pharmaceutical industry and pharmacies predict that it will take at least a year to reach a final conclusion on the reduction of Betmiga prices. Unlike the first and second trials, the Supreme Court does not disclose the date of the sentence to the public. This explains that the company's non-returnable measures and the pharmacy's confusion over them will continue for more than a year. However, there is a possibility that the conclusion may be unusually early. The Supreme Court will decide within four months whether to deal with the case in earnest from the second trial. This is called the discontinuity of trials period, and if the Supreme Court judges that the hearing is unnecessary, the second trial will be finalized before October. "Astellas submitted a statement of grounds of the final civil application," a pharmaceutical industry source said. "We expect a new claim to be made in the Supreme Court, which is different from the second trial," he said. "We believe that the possibility of disccontinuity of trials is low at the moment." For Bayer's new oral anticoagulant Xarelto (Rivaroxaban), the situation is different from that of Betmiga. Bayer is also said to have applied for suspension of execution in the government's disposition to lower drug prices because the lawsuit has not been completed. However, Bayer was defeated in the Supreme Court in December last year. The Supreme Court dismissed Bayer's appeal and sent it back to the Patent Court. Xarelto's prices are likely to remain until the Patent Court has reached the conclusion of the remand trial. In general, the period of judgment is shorter than that of the Supreme Court for destruction and repatriation. This means that the chaos in the pharmacy disappears more than in the case of Betmiga.
- Company
- Beovu can be prescribed at general hospitals
- by Eo, Yun-Ho Jun 01, 2021 06:11am
- AMD treatment Beovu became available in general hospitals with insurance coverage. According to related industries, Novartis Korea's Beovu (Brolucizumab), which has been registered since April, passed drug committees of more than 30 medical institutions including Seoul National University Hospital and Sinchon Severance Hospital. Wet AMD treatment Beovu, in combination with VEGF-A, is a mechanism that inhibits neovascular expression and retinal effusion, administered once a month for the first three months and once every three months. Beovu's efficacy has been demonstrated through two three-phase clinical trials HAWK and HARRIER studies compared to Eylea (Afribercept). Clinical studies of 1,817 patients with macular degeneration related to the age of 50 and older demonstrated noninferiority compared to controls at 1 year (48 weeks) in BCVA (Best-Corrected Visual Acidity) changes, the primary evaluation index. Beovu also demonstrated that the proportion of patients with improved maximum corrective vision (BCVA), which is a secondary evaluation index, by more than 15 letters, was also non-equivalent compared to the control group at week 48. (HAWK study: 34% Beovu group, 25% Eylea group; HARRIER study: 29% Beovu group, 30% Aflibercept group) Furthermore, patients with intra-retinal fluid (IRF)/sub-retinal fluid (SRF) were also significantly lower in the Beovu group, showing superior improvement over controls. Kang Se-woong, an ophthalmologist at Samsung Medical Center, said, "AMD is a disease that can be blind within two years without proper treatment and requires active and effective treatment from the beginning. "Beovu, which is effective not only in improving vision but also in improving the retina, which causes direct degeneration of the macula, will be covered by insurance benefits and will be able to provide patients with effective treatment options." "In particular, as Beovu allows us to maintain a longer, three-month treatment interval than conventional treatment, it is expected that the burden of treatment and the possibility of discontinuation of treatment will be reduced in AMD, where continuous treatment is important," he added. AMD, one of the top three causes of blindness in the elderly population aged 65 and older, is a disease in which vision is degraded due to the metamorphosis of the macular region in charge of vision. Macular degeneration is caused by structural changes and damage to the retina and macula by leaking effluent or blood from abnormally produced blood vessels (new blood vessels). As it is a disease that causes vision loss and blindness, the main treatment goal of Neovascular (Wet) Age-Related Macular Degeneration is focused on improving vision, and anatomical changes should also be considered for effective treatment.
- Company
- Pacenra(Fasenra) can be prescribed at the general hospitals
- by Eo, Yun-Ho May 31, 2021 06:02am
- The severe asthma treatment "Pacenra" is available at general hospitals. According to related industries, Pacenra (or Fasenra, Benralizumab) of Astra Zeneca Korea has passed drug committee (DC) of medical institutions such as Samsung Medical Center, Seoul National University Hospital, Seoul National University Bundang Hospital , Ajou University Hospital, and Wonju Severance Christain Hospital. Pacenra is approved for use as an additional treatment in adult patients with severe anaerobic asthma if it is not properly controlled by conventional treatment, and is then administered once every four weeks for the first three months. One of the reason for asthma management is to reduce the risk of asthma deterioration. Pacenra is an anti-eosinophil, humanised afucosylated, monoclonal antibody (IgG1, kappa). It binds to the alpha subunit of the human interleukin-5 receptor (IL-5Rα) with high affinity and specificity. The IL-5 receptor is specifically expressed on the surface of eosinophils and basophils. The absence of fucose in the Fc domain of benralizumab results in high affinity for FcɣRIII receptors on immune effectors cells such as natural killer (NK) cells. This leads to apoptosis of eosinophils and basophils through enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), which reduces eosinophilic inflammation. According to the SIROCCO study of 1,205 patients with severe asthma worldwide, including 122 Korean patients, the annual asthma exacerbation rate compared to placebo was reduced to 45% in once-four weeks and 51% in once-eight weeks. In addition, another clinical CALIMA study confirmed that the annual asthma exacerbation rate compared to placebo decreased by 36% in the once-in-a-week group and 28% in the once-in-eight-week group, significantly reducing the annual asthma exacerbation rate in the placebo group. In both studies, the change in FEV1 (1-second forcing capability) compared to baseline was measured, and consistent improvement over placebo was shown. In order to evaluate the long-term safety and efficacy of Pasenra in patients with severe anacid, there was no significant difference compared to placebo in the SIROCCO study and BORA study, a 56-week safety assessment extension study of 1926 patients participating in CALIMA study. Asthma, meanwhile, is associated with an unexpectedly high mortality rate. The death rate of hospitalized patients due to asthma is about one-third, and the cost of asthma-related patients requiring emergency treatment or hospitalization accounts for more than 80% of the total asthma-related costs. In particular, eosinophilic inflamination is present in 50% of asthma patients, which can cause poor lung function, worsening asthma, and increased exacerbation rates. Despite proper ICS therapy, patients with eosinophilic inflamination asthma with high levels of eosinophil are often not managed by conventional therapy such as ICS-LABA therapy, which is life-threatening due to pain caused by symptoms and frequent deterioration of diseases.
- Policy
- Objections to post-marketing premium reevaluation submitted
- by Lee, Hye-Kyung May 31, 2021 06:02am
- The Health Insurance Review & Assessment Service’s reevaluations of premiums applied to listed drugs are being finalized. On the 28th, HIRA held a post-marketing drug management subcommittee meeting to finalize its decision on the items for which the premiums would be terminated (products for price ceiling recalculation) according to the reorganized drug premium pricing system. 가산재평가 기준 The subcommittee meeting was held to review items that companies submitted objections to, among candidates for reevaluation that was first selected at the Drug Reimbursement Evaluation Committee’s meeting on April 8th. The specific number of items that would undergo re-evaluation will be disclosed after the DREC meeting on the 3rd of next month. HIRA had announced that companies submitted objections to 180 items among the 500 that were first selected during the submission period. After the next DREC meeting, the National Health Insurance Service will conduct a drug pricing negotiation for 60 days under the order of the Minister of Health and Welfare, then implement the notice around August or September after passing the Health Insurance Policy Deliberative Committee meeting. The premium re-evaluation was modified according to the ‘Rules on Criteria for Medical Care Benefits of the National Health Insurance’ and ‘Standards for Decisions and Adjustments for Drugs' that were announced by the Ministry of Food and Drug Safety on November 9th of last year. The rules were modified so that premiums applied to drugs that fall under the following criteria may be terminated after deliberation by DREC: ▲ a biologic that had been applied a premium for 1-2 years that is being manufactured by 4 or more companies; ▲when the premium was applied for 3-5 years; and ▲When the premium was applied for over 5 years HIRA has been receiving data submissions from pharmaceutical companies since January this year to finalize the items subject to reevaluation. In the process, premiums for drugs that had been applied for over 5 years were terminated. For drugs that were applied premiums over 3 years but less than 5 years, the authorities decided to maintain the premium if the drug satisfied at least one of the following criteria: ▲the non-existence of alternative drugs ▲clinical necessity ▲superiority in additional costs incurred ▲listing status of same ingredient drugs ▲IMD (Incrementally modified drug)
- Policy
- Leukemia treatment ‘Venclexta’ to be reimbursed
- by Lee, Hye-Kyung May 31, 2021 06:02am
- ‘Venclexta (venetoclax)’ in combination with ‘MabThera (rituximab)’ will be reimbursed as second-line treatment for patients with chronic lymphocytic leukemia. The Health Insurance Review and Assessment Service (HIRA) has been conducting an opinion inquiry on its proposed revision of the ‘Notices required according to drugs prescribed and administered to cancer patients.’ If no objections are raised during this period, the revision will be applied and enforced from June 7th. Venclexta was approved in combination with rituximab for ‘adult patients with chronic lymphocytic leukemia (CLL) who had at least one prior treatment.’ HIRA reviewed the reimbursement expansion based on information from textbooks, guidelines, and clinical papers. As a result, the combination’s clinical efficacy was demonstrated in the randomly assigned, open-label, Phase III MURANO trial through progression-free survival (PFS), etc., in adult patients with relapsed or refractory chronic lymphocytic leukemia. In addition, the interval required for response evaluation of Afinitor (everolimus), a treatment for central nervous system cancer, was extended. Under general principles, the response of patients with solid cancers and malignant lymphoma should be evaluated every 2-3 cycles or 2-3 months. However, a request had been filed to extend the evaluation interval for Afinitor in tuberous sclerosis complex (TSC) patients who are in need of therapeutic interventions but have a brain tumor called subependymal giant cell astrocytoma (SEGA), in which the tumor cannot be removed completely by surgery. HIRA's textbook review showed that the interval should be 3-6 months for the first 3-5 years, followed by at least once a year. The U.K. guidelines also recommend patients to check responses in 1-3 years if they are asymptomatic, and more frequently so if they have symptoms. Considering the evidence that shows that the imaging tests may be conducted in an interval of 1 year at maximum, HIRA decided to recognize the 3 to 12 month interval as the response evaluation interval for Afinitor depending on the patient's condition.
- Company
- Sales of Gaviscon and Strepsil continue to be sluggish
- by Kim, Jin-Gu May 31, 2021 06:01am
- Gaviscon & StrepsilsSales of Gaviscon and Strepsils have been sluggish for five years since Reckitt's boycott. It is shown that sales of two products decreased by 46% and 74% respectively in first quarter compared to before boycotting. Competitive items are found to benefit from the long-term sluggishness of the two products. According to IQVIA, a pharmaceutical market research company, Strepsil's sales in first quarter of last year were ₩600 million. The figure is down 74% from ₩2.2 billion in the first quarter of 2016, just before the boycott of the entire Reckitt product began in earnest. The boycott of Reckitt products began in earnest after the second quarter of 2016. At that time, the humidifier disinfectant incident caused a lot of controversy, and as public opinion deteriorated sharply, it spread to a boycott of the entire product. The company changed its name from Oxy Reckitt to Reckitt, but it was not enough. Strepsils was ranked first in the sore throat treatment market with quarterly sales of about ₩2 billion before the boycott. However, since the boycott began in earnest, it has only generated ₩600 million to ₩1.2 billion in sales so far. Competing products are enjoying reflective benefits due to Strepsil's sluggishness. The representative product is Boryung's Younggaksan. Immediately after the boycott, it beat Strepsils and became the No. 1 item in the market. Its quarterly sales are about ₩2 billion. Since the fourth quarter of last year, sales have risen significantly on the basis of COVID-19 prevention issues. Its sales in fourth quarter of last year are ₩3.5 billion and its sales in first quarter of this year are ₩4 billion. In the case of Gaviscon, the company generated ₩2.3 billion in sales in the first quarter of 2016, just before the boycott began, but has since maintained sales of around ₩1 billion. Its sales in first quarter of this year are ₩1.2 billion. In five years, it has fallen by 46%. Gaviscon's rival, Yuhan's Almagel, has seen a modest rise in sales since the boycott. Its first quarter sales were ₩3.2 billion and it was the highest ever. Another competitor, Boryung's Gelfos, had sales similar overall to those before the start of the Gaviscon boycott. Its first quarter of this year's sales were about ₩2.4 billion. Analysts say that the sluggish sales of Gaviscon & Strepsils are due to the company's passive advertising and marketing activities. In fact, Reckitt Benckiser had been actively advertising and marketing both products before the boycott began. According to the KFAA's Advertising Information Center statistics, Reckitt Benckiser was included in the top 100 advertisers, spending ₩2.2 billion as of January 2016, but has disappeared since 2017.
- Company
- Keytruda, passed the committee except for lung cancer
- by Eo, Yun-Ho May 31, 2021 06:01am
- According to the industry, yesterday (26th) the HIRA's Cancer Drugs Benefit Appraisal Committee recognized the appropriateness of immuno-cancer drug Keytruda (Pembrolizumab)'s ▲ bladder cancer 2nd or higher ▲ typical Hodgkin lymphoma solo therapy that recurred after 3rd treatment. In fact, NSCLC, Non-small Cell Lung Cancer's indication of primary solo and combined therapy failed to pass the Cancer Drugs Benefit Appraisal Committee on the eighth challenge. This is likely to make it virtually difficult to expand the benefit of Keytruda's indications of lung cancer. It has been discussing the benefit expansion since September 2017. It's been almost four years now. The biggest challenge at the time was the "burden of pharmaceutical companies for the initial third cycle of medication," which the government presented as a condition for expanding the benefit to pharmaceutical companies with immuno-cancer drugs. Roche, a company with "Tecentriq(Atezolizumab)" which was generic at the time, accepted the proposal, and failed to accept two types of PD-1 inhibitors, including Keytruda and "Opdivo(Nivolumab)." The MSD then repeatedly proposed and revised compromises. The final discussion was in August last year. At that time, the Cancer Drugs Benefit Application Committee held off because it believed there was a lack of compromise. The HIRA then resubmitted the financial contributions discussed at the Cancer Drugs Benefit Appraisal Committee to MSD in September of the same year, demanding a revision. MSD submitted the revised bill a month later and handed it over to the Cancer Drugs Benefit Appraisal Committee for discussion. Eventually, the introduction of the Cancer Drugs Benefit Appraisal Committee was delayed, and the MSD persuaded the government directly by the new CEO Kevin Peters, but the answer was NO. There may be a reason, but even the failure of third-generation EGFR TKI 'Tagrisso' (Osimertinib) and Keytruda in April, the expansion of the benefits of the first treatment for lung cancer is facing difficulties.
