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- 2026-03-19 01:38:07
- Company
- GC Pharma has signed a contract to supply Pfizer's Rapamune
- by Jul 06, 2020 06:15am
- GC Pharma is launching a sale of Rapamune (Sirolimus), an immunosuppressive agent of Pfizer Korea. PfizerAccording to the distribution industry on the 3rd, GC Pharma signed a supply contract with Pfizer Korea for supply of Rapamune 0.5·1·2mg on the 19th of last month and began selling on the 1st of this month. Rapamune is an immunosuppressive drug released by Pfizer Korea with a domestic license in March 2006. It is used to prevent long-term rejection of patients with kidney disease and to treat patients with lymphangioleiomyomatosis (LAM). Rapamune's annual prescription amount is low at ₩2 billion. According to IQVIA, the annual sales from 2015 to 2019 were ₩2.4 billion. In the case of Rapamune 1 & 2mg, the drug price is expected to drop slightly from this year, and sales are expected to fall further. As a result, Rapamune has not released generics for 5 years after the patent expires in 2013. Only in August 2018, Chong Kun Dang was the first Korean pharmaceutical company to receive a generic named Raparobell. The generic got listed this year. With the drug price cut and generics, the impact of GC Pharma's sales of Rapamune is expected to be minimal. Nevertheless, the reason for choosing Rapamune is considered to reflect the company's willingness to empower the rare disease field. GC Pharma has a rare disease team and provides treatment for many rare diseases such as Hunter syndrome, hemophilia, and Fabry disease. An official in the pharmaceutical industry said, "As GC Pharma is focusing on the rare disease field, it seems to be a choice to increase the market influence by expanding the related pharmaceutical items rather than sales."
- Company
- Hanmi appealed patent lawsuit of Galvus
- by Kim, Jin-Gu Jul 06, 2020 06:14am
- GalvusAs soon as the Patent Judge sidede with the original company in the patent dispute of Galvus (Vildagliptin), a DPP-4 inhibitor-based diabetes treatment agent, Hanmi immediately announced its appeal. An official from Hanmi said in a call with Dailypharm on the 2nd, "We will appeal immediately and receive a trial for the scope of the patent once again." Earlier, on the 1st, the Intellectual Property Trial And Appeal Board made a decision to raise the hand of the original company in the patent dispute surrounding Galvus. The patent dispute was triggered when Hanmi and Korea United Pharm filed a claim against Novartis to confirm the passive scope of rights. About this trial, Hanmi evaluated that it was a meaningful patent challenge to overcome the high patent barrier of multinational pharmaceutical companies. Hanmi Pharm attempted a new patent evasion strategy to develop Galvus’ generic. Based on four indications (1, 2, 4, and 5 indications) except for one of the five indications applied to Galvus, the marketing authorisation of the MFDS was recently obtained. Galvus 5 indications of Galvus. Hanmi has obtained the marketing authorisation from the MFDS based on the four indications except for the third indication. However, the Intellectual Property Trial And Appeal Board ruled that four indications in addition to one indication excluded by Hanmi have an extended patent. It was the intention that the five indications correspond to a treatment regimen belonging to the same disease group (type II DM). Accordingly, Hanmi decided to appeal immediately and decide the patent court. Separately, Hanmi won the trial of invalidation of the extension of the duration of the patent for a substance at the existing patent tribunal. It was decided that the extended patent period of 187 days was invalid. Novartis appealed to the patent court. The second trial is scheduled for August 13th. An official from Hanmi said, “We expect that Hanmi's action will stimulate the drastic patent challenge of domestic pharmaceutical companies against multinational pharmaceutical companies. we will go to the strong pharmaceutical country based on our own innovation strategy.”
- Company
- Hanmi loses first trial in patent dispute over Galvus
- by Kim, Jin-Gu Jul 06, 2020 06:14am
- GalvusNovartis won the patent dispute between Hanmi and Novartis over the DPP-4 inhibitor-based diabetes treatment agent Galvus (Vildagliptin). The Intellectual Property Trial And Appeal Board made a decision to dismiss the passive right scope verification trial requested by Hanmi on the 1st. Hanmi has filed a total of eight trials for Galvus patent, but the Board has dismissed it. On the same day, Korea United Pharm also lost. It is expected that the trial will have a significant impact on Novartis' application to the Seoul Central District Court for a prohibition of sales disposition, a lawsuit for patent infringement claim, and a lawsuit to cancel an item license. ◆Hanmi's new strategy, Patent challenge by dividing indications In July 2018, Hanmi filed a judgment against Novartis to confirm the passive scope of rights for Galvus and Galvusmet's material patents. In the following year, Hanmi applied for permission of Vildagle, salt-changing generic for Galvus. Hanmi applied for a product license except one of the five indications of the original drug, Galvus. It was Hanmi's new patent avoidance strategy. Hanmi unveiled the logic that Novartis' patent is limited to only 3 out of 1-5 indications applied to Galvus. The indication is said that it is used dual oral therapy in combination with Metformin, Sulfonylurea, thiazolidinedione in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy. Galvus In other words, Hanmi asserted that since the validity of Galvus’ patent right only affects the indication #3 and not the rest of indication #1, #2, #4, and #5, Vildagle also does not infringe patent of Galvus. Novartis refuted this. In fact, the claims of Hanmi made an unreasonable demand because indications were included in the same scope (type II DMtreatment). The MFDS approved the application for Hanmi in January this year. In April, insurance benefits were decided. However, Hanmi has not yet released the product. As the Intellectual Property Trial And Appeal Board decided to take Novartis side on the 1st, the challenge of Hanmi has been put on hold. Vildagle's release schedule has been postponed indefinitely. ◆Dutasteride was applied, but why is it not Vildagliptin This patent dispute is of great interest in the industry. It is because expectations are raising whether the challenge of Hanmi will be a new path to generic's patent evasion strategy. It is said that Hanmi got a hint from patent dispute of Dutasteride in 2015. Patent dispute of Dutasteride was similar to Galvus, but proceeded with another issue. At that time, Generic company claimed that the patent for the substance was extended because original company's Dutasteride (Brand name: Avodart) was limited to the permission for prostate hyperplasia. In other words, it was argued that the patent right has no effect in the case of 'hair loss', another indication of Dutasteride. Based on these claims, the MFDS approved it because Generic company applied only one indication for hair loss. The generic company won the patent dispute. The Intellectual Property Trial And Appeal Board judged that the effective right of Dutasteride patent was limited to prostate hyperplasia and did not affect hair loss. Generic succeeded in launching a hair loss indication and before the patent expired. ◆Pharmaceutical industry expects new patent avoidance strategy The Judge's decision has not been released. However, in the industry, it is persuasive to argue that the case of Dutasteride and Galvus is different. In the case of the Dutasteride dispute, the indications of prostatic hyperplasia and hair loss are markedly different, whereas the Galvus dispute is virtually the same indication and cannot be regarded as the same case. Generic companies was expecting the result. A domestic patent official said, "It is true that we thought about whether to challenge patent evasion in the same way as Hanmi, but the possibility of success did not seem so high, so we were waiting for the result of this dispute." He added that there is no plan to file a referee with this strategy, the Intellectual Property Trial And Appeal Board did not accept the claim that it should judge the identity of medical use based on the individual indication. Another official in the pharmaceutical industry said, "If Hanmi leads the case with an appeal, it is unlikely that the trial will be overturned." The trial is expected to have a significant impact on other lawsuits between Novartis and Hanmi. Three related lawsuits are in progress. Novartis has filed a lawsuit against the Seoul Central District Court for infringement and prohibition of sale and filed a lawsuit against the Seoul Administrative Court to cancel the item permission, which is the main lawsuit of the provisional injunction. Three cases are currently pending. If the court accepts the provisional disposition, it is expected that Vildagle will not be available for the time being.
- Company
- AML treatment Rydapt can be prescribed in general hospitals
- by Eo, Yun-Ho Jul 03, 2020 06:18am
- Novartis' new acute myelogenous leukemia drug 'Rydapt' can be prescribed in general hospitals. According to the related industry, acute myeloid leukemia (AML) treatment, Rydapt (Midostaurin) has passed the pharmaceutical committee (DC, drug commitee) of Big 5 Hospitals, such as Seoul National University Hospital and AMC. It was approved as an orphan drug in Korea last year as a FLT3 inhibitor and can be prescribed for ▲combination of high-dose Cytarabine with standard Cytarabine or Daunorubicin induction therapy for new AML patients with positive FLT3 mutation ▲Aggressive systemic mastocytosis, systemic mastocytosis with hematologic neoplasm, mast cell leukemia. FLT3 inhibitors are also well known as 'HM43239', Hanmi’s candidate. The effectiveness of Rydapt has been demonstrated through ATIFY studies. The study was the largest of all clinical trials involving 3,277 AML patients with specific gene mutations. Patients treated with Rydapt in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy experienced significant improvement in overall survival (OS) with a 22% reduction in the risk of death compared with chemotherapy plus placebo. In patients in the Rydapt arm, OS was 74.7 months vs. 25.6 months in the placebo arm. AML is the most common form of leukemia, accounting for about 65% of adult acute leukemias. The incidence increases with age. AML is primarily treated by administering 2 to 3 drugs such as Anthracycline in combination. The problem is that after the first chemotherapy, up to 50% of cases of recurrence of leukemia cells fall below 5%, even if the degree of 'complete remission' reaches 50 to 70%. Official from Society of Hematology said, “It is important to reduce the number of cancer cells in the early stages of AML. We are looking forward to the emergence of an option that can be prescribed to patients who are not able to apply induction techniques, which is an important issue.”
- Company
- Lee Heeseung to oversee MA-GA-PR at MSD Korea
- by Eo, Yun-Ho Jul 02, 2020 06:09am
- A former senior director at Novartis Korea, Lee Heeseung is to be appointed as a leader of the External Affairs department at MSD Korea. According to the pharmaceutical industry sources told the latest personnel decision by MSD Korea. Lee Heeseung would take over the position of External Affairs Lead from July 15. Three teams including Market Access (MA), Government Affairs (GA), and Public Relations (PR) are operating under the umbrella of the External Affairs department at MSD Korea. The soon-to-be Lead would oversee all three teams. Lead Kim So Eun, who has been in charge of the External Affairs so far, is newly appointed as a Translation Leader for MSD spin-off Organon. A new CEO would be appointed for the full-fledged spin-off company. MSD Korea insiders are speculating the latest personnel decision was made to appoint Kim as the CEO of Organon Korea. Lee Heeseung started her career from a PR agency Edelman Korea and joined Novartis Korea in 2016 managing the PR operation. In 2019, she worked at Visa Korea to manage marketing in Korea and Mongolia.
- Company
- Nicetile's Rx has decreased by 40% over the past year
- by Chon, Seung-Hyun Jul 02, 2020 06:08am
- Sales of 'Acetyl-L-Carnitine (ALC)', a brain function improving agent, fell sharply. As a result of clinical re-evaluation, the market size has decreased by 40% in one year as indications have been reduced. The market for 'Choline alfoscerate', which is predicted for clinical re-evaluation, is also expected to change depending on the results. According to UBIST, a pharmaceutical research institute on the 28th, the outpatient prescription amount of ALC in the first quarter was ₩11.7 billion, a 37.9% decrease from the same period last year. Dong-A ST's ALC, generic for Nicetile, is approved for use in 'primary degenerative diseases' or 'secondary degenerative diseases caused by cerebrovascular diseases'. However, as a result of the clinical reevaluation ordered by the MFDS in 2015, the indication was deleted in July as it was unable to prove the efficacy of the 'primary degenerative disease'. Quarterly Rx amounts of ALC (Unit: ₩1 million, Source: UBIST) Acetyl-L-Carnitine (ALC) formulations have steadily formed a market size of nearly ₩20 billion every quarter. In the first quarter and the second quarter of last year, the prescription results were ₩18.9 billion and ₩17.9 billion respectively. However, the scale of prescriptions has dropped significantly since the reduction of indications. In the third quarter of last year, it fell 26.8% from the previous year to ₩13.5 billion, and in the fourth quarter of last year, it decreased by 38.0% compared to the previous year to ₩12.1 billion. This year, This trend has accelerated. It is analyzed that the prescription avoidance phenomenon has spread due to the reduction in indications according to the reevaluation results. The market for ALC products has been slower since the recent spread of COVID-19. In April and May last year, the prescription amounts of ALC were recorded at ₩6.5 billion and ₩6.4 billion, respectively. The ALC based products had a large reduction in prescription sales amount. Major ALC outpatients prescription amount (Unit: ₩ 1 million, %, Source: UBIST) Hanmi's 'Carnitil', which is currently in the top position in the market, has a 32.8% decrease in prescription performance in the first quarter to ₩3.7 billion. Dong-A ST's 'Nicetile ' decreased 29.4% from ₩2.7 billion in the first quarter of last year to ₩1.9 billion in the first quarter of this year. Daewoong Bio, Samik, and Myungmoon, all of which have the highest prescriptions, have significantly reduced their prescription amounts from last year. As a result of re-evaluation of the Choline alfoscerate, which has recently been decided on a clinical re-evaluation policy, such as Acetyl-L-Carnitine, it is predicted that prescription reduction will be inevitable if some indications are deleted. Choline alfoscerate is a drug that has three indications: ▲secondary symptoms due to cerebrovascular defects and degenerative or degenerative cerebral stromal psychological syndrome ▲emotional and behavioral changes ▲senile pseudoplastic depression. It recorded a total of ₩352.5 billion in prescriptions last year, and has established itself as a new source of revenue for pharmaceutical companies. The MFDS approved an item renewal for Choline alfoscerate in 2018, but announced that it would conduct a clinical re-evaluation of Choline alfoscerate on the 23rd as the efficacy controversy continued. The MFDS ordered 255 items from 134 companies to submit domestic clinical trial results. When conducting a clinical trial, it was instructed to submit IND by December 23.
- Company
- European license for Avastin biosimilar is imminent.
- by Chon, Seung-Hyun Jul 01, 2020 05:55am
- Samsungbioepis Samsung Bioepis said on the 28th (local time) that it received a positive opinion on the approval of ‘Avastin biosimilar, Aybintio' from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). It received positive feedback from the CHMP about 11 months after the launch of EMA's marketing authorization review in July last year. As a result, Samsung Bioepis expected that it would be able to obtain an official sales license after a final review by the European Commission (EC), which usually takes 2-3 months. Avastin, the original for Aybintio, is a treatment for tumor diseases sold by Roche, Switzerland. In Europe, it has indications such as metastatic colorectal cancer, non-small cell lung cancer, and metastatic breast cancer. Avastin's global market sales last year amounted to about ₩8.5 trillion, of which Europe accounts for about a quarter. Amgen’s and Pfizer’s Avastin biosimilars are currently licensed by the United States and Europe. Among Korean companies, Celltrion is conducting Phase III clinical trials of Avastin Biosimilar. Samsung Bioepis announced the results of Phase III clinical trials of Aybintio at the regular conference of the European Society for Medical Oncology in Barcelona, Spain last September. Aybintio proved the equivalence of risk ratio of best ORR2 to the original drug through a study of a total of 763 non-small cell lung cancer patients. Aybintio is the fifth biosimilar product from Samsung Bioepis. In November of last year, the U.S. Food and Drug Administration (FDA) launched an approval test. Samsung Bioepis currently treats anti-cancer drugs such as 'Benepali' (Enbrel biosimilar), 'Imraldi' (Humira biosimilar), 'Flixabi' (Remicade biosimilar), and ‘Ontruzant' (Herceptin biosimilar) in Europe. "The company's R&D capability has been proven once again, and it has opened up the possibility of further expanding the treatment benefits of cancer patients through high-quality biopharmaceuticals," said Koh Seung-han, president of Samsung Bioepis.
- Company
- Complaint against the plan to reduce benefits of α-GPC
- by Chon, Seung-Hyun Jun 30, 2020 06:11am
- Pharmaceutical companies agreed to file a complaint against the government's plan to reduce the reimbursement of Choline alfoscerate. It is suggested that the co-payment rate be lowered for reasons such as high cognitive impairment and brain-related diseases with high prescription rates. According to the industry on the 29th, more than 100 executives from pharmaceutical companies with Choline alfoscerate had an emergency meeting on that day and sought a response strategy to the government's policy to reduce the benefit. Gliatamin byDaewoong Bio & Gliatilin by Chong Kun Dang At the meeting, which was conducted by online video conference, it was agreed that an appeal would be needed to reduce the coverage of Choline alfoscerate. The HIRA held the Pharmaceutical Benefits Advisory Committee on the 11th to deliberate the appropriateness of the choline alfoscerate formulation, and then decided positive list system according to efficacy and effectiveness. Choline alfoscerate is a drug that has three indications: ▲secondary symptoms and degenerative or degenerative cerebral stromal psychological syndrome ▲emotional and behavioral changes ▲senile pseudodepression. When a patient diagnosed with dementia uses this drug for the purpose of improving symptoms such as cognitive impairment, the copayment rate of 30% is maintained as before. However, dementia patients only pay 10% copayment. However, if a patient who has not been diagnosed with dementia is prescribed a Choline alfoscerate product, it increases from 30% to 80%. The prescription performance of choline alfoscerate last year was ₩352.5 billion. Among them, the diagnosis of dementia patients whose benefits are maintained as in the past was only ₩60 billion, only 17% of the total. More than 80% of the prescriptions for Choline alfoscerate drugs increase the patient's drug burden by 2.7%. Pharmaceutical companies shared a strategy to lead to a downward adjustment of the co-payment rate through appeals against areas where the drug cost burden rate will increase to 80%. To this end, it was reported that each area discussed the need for a response strategy that provides a basis for refuting the health authorities' decision. In the near future, the HIRA will notify pharmaceutical companies of the conversion of Choline alfoscerate formulations to a positive list system determined by the Pharmaceutical Benefits Advisory Committee. In response, pharmaceutical companies can appeal only once. In addition to dementia for which an increase in the co-payment rate has been announced, the strategy of pharmaceutical companies is to actively lead to a downward adjustment of the co-payment rate in the areas of mild cognitive impairment and other brain-related diseases in 'Secondary symptoms and degenerative or degenerative brain-based psychotic syndrome due to cerebrovascular defects'. The health authorities decided to re-evaluate the Choline alfoscerate product, taking into account its clinical usefulness, cost effectiveness, and social needs. However, pharmaceutical companies believe that in the case of mild cognitive impairment and other brain-related diseases, the 30% of copayment should be applied or lowered to 50%. There are not many drugs to replace for mild cognitive impairment and brain-related diseases of Choline alfoscerate and they said that it is unfair to increase the copayment rate under high social demand. In the case of mild cognitive impairment and brain-related diseases, which are serious diseases, it has been reported that despite the clinical usefulness, patients may be deprived of treatment opportunities if their drug burden increases. Pharmaceutical companies believe that mild cognitive impairment may increase the risk of dementia in the future, so treatment through drug administration is important. Studies have been reported that Choline alfoscerate is effective in mild cognitive impairment and brain-related disorders, but it has been reported that it has not been reflected in the re-evaluation of reimbursement. Last year, in mild cognitive impairment and other brain-related diseases, Choline alfoscerate formulations showed prescription performances of ₩252.8 billion, more than 70% of the total prescription amount. The pharmaceutical company believes that the positive list system of Choline alfoscerate formulations is confirmed, which can lead to a reduction in prescriptions if the patient's drug burden increases. The meeting did not discuss the clinical re-evaluation of Choline alfoscerate formulation recently announced by the MFDS. On the 23rd, the MFDS ordered 255 items from 134 companies to submit domestic clinical trial results. It was instructed to submit a clinical trial plan by December 23 if a clinical trial is conducted.
- Company
- Spravato, a nasal spray for TRD entered the domestic market
- by Eo, Yun-Ho Jun 30, 2020 06:09am
- Spravato is the first nasal spray medication, taken along with an oral antidepressant, for adults with treatment-resistant depression (TRD) and it enters the domestic market. According to the related industry, Janssen’s Spravato nazal spray (Esketamine HCl) as a treatment for moderate to severe major depressive disorder (treatment-resistant depression) in adults who do not adequately respond to at least two different oral antidepressants from the MFDS on the 23rd has been approved for oral antidepressant use in combination. Treatment-resistant depression refers to a case in which patients who are currently suffering from major depressive disorder (MDD) have taken two or more other antidepressants at appropriate doses for a sufficient period of time, but do not improve their symptoms due to inadequate response. In general, it is estimated that about one-third of patients with depressive disorder correspond to treatment-resistant depression. Spravato is a new mechanism of nasal spray treatment that first appeared in the field of treatment-resistant depression and 30 years in the major depressive disorder. The main component of Spravato, Esketamine, improves the symptoms of depression by regulating the activity of glutamic acid receptors called NMDA receptors in the brain to restore synaptic connections and increase neurotrophic signaling. The efficacy of the drug has been demonstrated in a phase III clinical trial consisting of short-term and long-term clinical trials in more than 1700 adult patients with treatment-resistant depression. In a short-term clinical trial of treatment-resistant depression between 18 and under 65 years of age, the combined group of patients with Spravato and oral antidepressants showed a decrease of 19.8 points on the Montgomery-Asberg Depression Assessment Scale (MADRS) over a 4-week treatment period. On the other hand, the group of patients receiving placebo and oral antidepressants in combination showed a decrease of 15.8 points, and statistically, it was confirmed that the symptoms of the group of patients receiving combination of Spravato and oral antidepressants were improved. In a long-term clinical study, patients who had stable remission by using Spravato and oral antidepressants were found to have a 51% reduction in the likelihood of recurrence of depressive symptoms compared to those who received placebo and oral antidepressants. Deok-in Jeon, Chairman of the Korean Society for Affective Disorders, said, "Resistant depression, which has a longer duration of disease and more severe symptoms than normal depression, causes serious pain to patients and their caregivers. Approval of Spravato is an innovative treatment option for new mechanisms in the field of depression that have not had new drugs in the past decades."
- Company
- Prevymis by MSD is noted whether it is listed
- by Eo, Yun-Ho Jun 29, 2020 06:13am
- It is noteworthy whether the coverage for prevention of cytomegalovirus, infection in allogeneic hematopoietic stem cell transplant patients will be expanded. According to related industries, 'Prevymis (Letermovir)', a preventive treatment for cytomegalovirus (CMV) infection in allogeneic hematopoietic stem cell transplant patients, which passed the Pharmaceutical Benefits Advisory Committee of the HIRA last month, will enter into drug price negotiations with the NHIS. It is interpreted that the evaluation of the adequacy of Prevymis is clinically useful and cost effective compared to the case which is not prevented. This is similar to the government's policy to strengthen health insurance coverage. Allogeneic hematopoietic stem cell transplantation is essential for the treatment of severe hematologic cancer patients such as acute myelogenous leukemia and acute lymphocytic leukemia The government has increased the age limit for the payment of hematopoietic stem cell transplants from under 65 to under 70 in 2019 as a policy to strengthen health insurance coverage. Efforts have been made to revitalize transplants and reduce costs, including recognizing primary allograft as a nursing care benefit. When cytomegalovirus (CMV) is reactivated in patients with hematopoietic stem cell transplantation, diseases such as pneumonia, hepatitis, myocarditis, gastroenteritis, and encephalitis develop. Even if the level of CMV is low, it has an effect on mortality. In the case of hematopoietic stem cell transplantation patients with CMV infection, there is a report that the mortality rate during initial hospitalization is 3.5 times higher than that of non-infected patients, and the risk of death is 2.6 times higher in patients with CMV viremia at the early stage of transplantation (within 60 days). However, CMV treatment in allogeneic hematopoietic stem cell transplantation patients is currently relying on pre-emptive administration of antiviral agents when the concentration of virus in the blood exceeds a certain level. Sung-Soo Yoon (SNU), Chairman of the Korean Society of Hematology said, "The limitations of current preemptive treatments that can only be started after the CMV blood level reaches the threshold are clear. In particular, the demand for treatment sites for Prevymis is increasing, as it is an important drug treatment option for survival of high-risk patients.." Prevymis clinically demonstrated the inhibition of CMV reactivation and the reduction of mortality. Also, no adverse reactions related to myelotoxicity and nephrotoxicity occurred. Previmis is recommended as a prophylactic agent for allogeneic hematopoietic stem cell transplant patients with CMV seropositivity in the 2019 guidelines of the National Comprehensive Cancer Network (NCCN) and the European Conference on Infections on Leukemia (ECIL).
