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- 2026-04-16 11:26:59
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- Statin+Ezetimibe reduces the burden of high doses Statin
- by Aug 27, 2020 06:23am
- Kim Dae-jung, a 50-year-old professor of endocrinology at Ajou University HospitalThe 'Statin + Ezetimibe' combination drug is shaking the market for hyperlipidemia treatment. In 2015, the 'IMPROVE-IT' study, which proved the low-density lipoprotein cholesterol (LDL-C) lowering effect of the combination therapy of Ezetimibe(non-statin) and Statins, targets a niche market that is concerned about side effects of high-dose Statins. Statin+Ezetimibe combination domestic market, led by 'Rosuvastatin + Ezetimibe', is growing day by day. This market, which was ₩23.8 billion in the first quarter of 2016, has expanded to ₩111.4 billion in the second quarter of 2020. The combination of Statin + Ezetimibe is also becoming a trend in the frontline medical field. Kim Dae-jung, a 50-year-old professor of endocrinology at Ajou University Hospital, said in a meeting with Dailypharm that "the trend is to use a combination of 'Statin + Ezetimibe' for preventive purposes not only for high risk of cardiovascular disease, but also for patients who need to lower LDL-C." "The combination of Statins and Ezetimibe reduces concerns about diabetes and provides metabolic benefits, which is a factor in considering this combination from the beginning." Prof. Kim also participated in a retrospective domestic cohort study of Koreans who concluded that taking a high dose of Statin for a long time increases the risk of diabetes. This study, published in the journal Cardiovascular Diabetology, an SCI-level international academic journal, was conducted in 13,698 adults aged 40 to 74 years old who were diagnosed with dyslipidemia without a history of diabetes or atherosclerotic cardiovascular disease(5,273 people in the Statin group & 5,273 people in the non-statin group), and the cumulative incidence of type II diabetes according to the annual accumulated daily dose of Statin was evaluated by follow-up method. As a result of the analysis, type II diabetes occurred in a total of 3,034 patients during the average observation period of 7.1 years, of which more than half of 1,871 patients (61.7%) occurred in the Statin group. As the duration of Statin administration was longer than 5 years, the risk of diabetes was significantly increased compared to that of the non-administered group, and the risk of diabetes incidence increased from 1.31 times to a maximum of 2.83 times compared to the non-administered group in proportion to the total cumulative dose of Statin consumed annually. ▶What is the implication of a recent study on the link between high statin doses and diabetes incidence? Long-term high doses of Statins increase the risk of diabetes. Conversely, Statins should be used as low as possible. However, in order to be effective enough to prevent cardiovascular disease, certain amount of Statin should be used. As the target LDL-C level is reached, the alternative to use less Statin is Ezetimibe combination, which is non-statin formulation In fact, there are many cases of prescribing a combination of Ezetimibe rather than a single statin drug to patients who need to use high doses of statins. Prescribing data proves this, and it seems that Ezetimibe combination is also preferred for the purpose of preventing cardiovascular disease. Even when I need to use a high dose of Statins, I often use ezetimibe complex from the beginning. ▶Are you concerned about the side effects of high doses of statins? According to the actual clinical data, the risk of developing muscle side effects such as rhabdomyolysis, which is commonly known, is rare, so it is not enough to worry. The same goes for concerns about side effects related to the liver. However, having these side effects (even if the side effects are rare) puts great stress on the doctor. The idea that I want to avoid it as much as possible makes me choose the alternative Ezetimibe combination. Concerns are higher about the occurrence of diabetes, which is cited as another side effect. In particular, high-risk groups for cardiovascular disease, who are prescribed high doses of Statin, are often highly likely to develop diabetes. Patients at high risk of diabetes may consider Ezetimibe combination from the start, as mentioned earlier. ▶Are there any other benefits of Statin+Ezetimibe? While Statins inhibit cholesterol synthesis in the liver, Ezetimibe's mechanism inhibits cholesterol absorption in the small intestine. When cholesterol is absorbed, it forms Chylomicron like triglycerides and moves into the blood, blocking the process. In other words, using Ezetimibe can reduce the absorption of not only cholesterol but also triglycerides. ▶In the area of hyperlipidemia, which used to be Statin only, combination drugs of other classes, such as diabetes and hypertension, seem to be increasingly taking up a larger proportion. This is because of the advantages of combination therapy. As with diabetes, rather than raising a certain drug to the highest dose, using one drug at an appropriate dose while using a little bit of another drug seems to be able to produce the desired effect while minimizing side effects. It is clear that the combination system is far more beneficial than using each single drug. As it is a chronic disease that must be taken for a lifetime, the number should be reduced and the dosage method should be simplified. This can increase patient compliance. ▶Research is ongoing to establish the basis for the combination therapy of 'Statin + Ezetimibe'. Recently, a study is underway in Korea to directly compare high doses of Statin and combination therapy in more than 3,000 domestic patients. You can't predict the outcome, but what if you predict the direction? Since the cardiovascular prophylactic effect is formulated according to the target LDL-C level, if the combination therapy with high-dose Statin and Ezetimibe similarly reduces the LDL-C level or reaches the target level, it will be considered similar in terms of efficacy. Furthermore, what is expected of Ezetimibe combination therapy is to reduce diabetes incidence or to show better safety data. It seems that we will have to wait for the results of the study to see if the predictions will come out as real data.
- Company
- Initiating talks on listing EBC adjuvant therapy Kadcyla
- by Eo, Yun-Ho Aug 26, 2020 06:24am
- The talks on granting healthcare reimbursement on Kadcyla as an adjuvant therapy following an early breast cancer surgery would begin. Today, South Korea’s Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee would deliberate providing the healthcare reimbursement on an antibody-drug conjugate (ADC) Kadcyla (trastuzumab emtansine), pharmaceutical industry sources reported.. The reimbursement expansion application is specifically targeting the indication as an ‘adjuvant treatment for HER2-positive early breast cancer in patients who have received a taxane plus Herceptin-based neoadjuvant treatment but have residual invasive disease.’ The expansion was requested not by the developer Roche, but by Korean Breast Cancer Society (KBCS). The medical society is demanding Kadcyla’s coverage to be expanded. Initially listed through a refund type risk sharing agreement (RSA) in August 2017, Kadcyla is indicated in HER2-positive, unresectable locally advanced or metastatic breast cancer in patients previously treated with Herceptin and taxane. Immediately after receiving the indication on early breast cancer in August last year, Roche failed in an attempt to expand the NHI coverage. However, some sees that the Cancer Deliberation Committee would unlikely to pass the expanded reimbursement on Kadcyla. Unlike other cancers, many of breast cancer treatments have been listed for reimbursement. In fact, two CDK 4/6 inhibitors—Pfizer’s Ibrance (palbociclib) and Lilly Korea’s Verzenio (abemaciclib)—have expanded their reimbursement standards. However, Kadcyla highlights the clinically proven treatment effect in early breast cancer patients having a high risk of recurrence. In the KATHERINE study, Kadcyla was used on treating a patient found with residual tumor and high risk of recurrence after completing chemotherapy. The investigational drug lowered the risk of recurrence of breast cancer or death 50 percent lower than that of the standard of care Herceptin. So far the medical need for the recurrence risk was unmet, but the treatment showed it would be possible to lower the risk. The Cancer Deliberation Committee would also focus on the fact that the breast cancer treatments listed so far have been too specified in ‘metastatic breast cancer.’ The treatment in breast cancer aims for different purposes depending on stages. The treatment strategy for metastatic cancer would be prolonging the overall survival, whereas early breast cancer would be a full recovery. Currently, the targeted therapy Herceptin (trastzumab) is the only covered adjuvant therapy following an early breast cancer surgery. Professor Sohn Joohyuk of Oncology Department at Severance Hospital said, “The healthcare reimbursement status on breast cancer treatment has significantly improved than the past. But the treatment environment would improve even further if the relevant experts’ opinions are reflected in the grey area. We need more flexible healthcare reimbursement system for a better access to treatments.”
- Policy
- Prevymis and Rekovelle PFS were newly listed
- by Kim, Jung-Ju Aug 26, 2020 06:23am
- Xarelto 2.5mg’s benefit standard will be expanded. Prevymis (Letemovir), a vaccine for preventing MSD virus from Korea, and Rekovelle (Follitropin Delta), a follicle-stimulating hormone injection by Ferring Pharmaceutical Korea, are newly applied next month, and a new reimbursement standard will be established. Pharmaceutical Reimbursement Listing Standard and Method The MOHW is pursuing the notification of 'Pharmaceutical Reimbursement Listing Standard and Method' with the aim of applying this on September 1. Benefits will be expanded to 'multivascular coronary artery patients aged 65 or older who have exceeded one year since recent myocardial infarction' and 'multivascular coronary artery patients with both coronary artery disease and peripheral artery disease'.with Xarelto 2.5mg and Aspirin combination therapy. The MOHW and the HIRA newly established and added reimbursement standards by referring to domestic and international permits, textbooks, clinical practice guidelines, clinical research literature and opinions of the society. Specifically, It is intended for adult patients with coronary artery disease or symptomatic peripheral arterial disease at a high risk of ischemic events, and is prohibited for patients with high risk of bleeding, stroke onset within 1 month, ischemic or stroke history. As Prevymis 240mg and 480mg listed, a new reimbursement standard is also established. This drug is a prophylactic treatment for cytomegalovirus infection that occurs after allogeneic hematopoietic stem cell transplantation. Subjects to be administered are cytomegalovirus (CMV)-serum positive [R+] adults who have undergone allogeneic hematopoietic stem cell transplantation (HSCT), and are patients who have been confirmed negative by serum CMV tests (both PCR and antigen) within 5 days before the start of administration. .The administration method begins on the day of transplantation and within 28 days after transplantation, and administration is possible up to 100 days after transplantation .However, if CMV disease occurs or preemptive therapy is required, the administration should be stopped .In human-derived cell lines that stimulate follicles to induce hyperovulation, Rekovelle (Follitropin Delta), a recombinant follicle-stimulating hormone injection, is scheduled to be listed next month and is newly included in the reimbursement standard .As with other follicle-stimulating hormone (FSH) injections, this drug is recognized for medical benefits within the range of 'assisted reproductive surgery benefits', but co-administration with hMG (menotrophin) cannot be recognized .The MOHW decided to apply the reimbursement standard as of the 1st of next month if there are no specific matters after checking opinions on the amendment by 6 pm on the 26th .
- Company
- “Access to Onivyde should improve for more options"
- by Aug 26, 2020 06:23am
- “Besides the findings from global clinical study on treating metastatic pancreatic cancer patients, Onivyde even offers subset analysis on Asian patients and real-world evidence (RWE) in South Korea. It is regretful the treatment has not been listed for National Health Insurance (NHI) reimbursement.” Professor Yoo Chang-hoon of Oncology Department at Seoul Asan Medical Center On Aug. 20, Professor Yoo Chang-hoon of Oncology Department at Seoul Asan Medical Center commented so, when explaining the clinical profile of Onivyde (liposomal irinotecan hydrochloride). Currently indicated as a combination therapy with 5-fluorouracil (5-FU) and Leucovorin (LV) in treating a patient with metastatic pancreatic cancer who has failed to respond in Gemcitabine-based therapy, Onivyde has accumulated meaningful clinical evidence to prove itself as an effective later-line treatment for patients who struggled with the first-line treatment. The Phase III NAPOLI-1 study conducted in 14 countries around the world provided the outcome. The study found, when Onivyde plus 5-FU/LV therapy was given to patients with metastatic pancreatic cancer who has previously received Gemcitabine-based chemotherapy, the median overall survival (mOS) was 6.1 months, which is about 1.5 times longer than 4.2 months in 5-FU/LV therapy only group. The patient group with Onivyde combination therapy demonstrated median progression-free survival (mPFS) of 3.1 months, compared to 1.5 months in the 5-FU/LV therapy only group Professor Yoo noted Onivyde would be even more effective in Asian race. After separately analyzing Asian patients from NAPOLI-1, the clinical researchers found the Onivyde combination therapy demonstrated 8.9 months of mOS and 4 months of mPFS, which was superior to the other patient groups in the study. However, the subset Asian patients using the Onivyde combination therapy marked 8.8% in objective response rate (ORR) indicating the general reduction of tumor size. The figure was lower than the other patients groups at 16.2%. Professor Yoo elaborated, “Although the Asian group had lower ORR, the most important indicators of the efficacy are OS and PFS,” and “The outstanding outcomes from these endpoints could mean Onivyde is more effective to Asian patients.” Product image of Onivyde From the safety’s perspective, Asian patient group, compared to other patient groups, had half the frequency of adverse reactions in digestive system like vomiting or diarrhea, but the their drop in white blood cell count doubled that of the other groups. Professor Yoo commented, “The decrease in white blood cell count does not significantly affect a patient’s quality of life as long as they do not have fever. Generally the toxicity was similar, but the common adverse reactions in the Asian patients seemed to not too bothersome for the patient’s quality of life.” In fact, a retrospective real-world evidence study conducted on 86 patients administered with Onivyde in South Korea had similar outcomes as the NAPOLI-1 subgroup analysis data. Nevertheless, Onivyde is still not covered by the NHI. Professor Yoo noted the patients are in agony as the NHI coverage is barely applied on the expanded second-line treatments and technically more effective options. Professor Yoo stated, “When consulting with many of the pancreatic cancer patients, we talk about second and third-line treatments a lot. Without the NHI coverage, we have to discuss about their private medical insurance,” and “It is regretful that Onivyde, despite its abundant evidences from Phase III global clinical study, Asian patient subgroup analysis, and RWE in South Korea, is still not covered by the health insurance benefit.”
- Company
- ↓generic's approval as the drug price system is implemented
- by Chon, Seung-Hyun Aug 26, 2020 06:22am
- The number of approval for generic drugs has declined for the second consecutive month. If the bioequivalence test is not performed, the new drug price system, which gives low drug prices, was implemented, and greatly reduced the number of new licenses for authorized generics. Some point out that the government's move to strengthen generic regulations has caused an unprecedented confusion as pharmaceutical companies have already installed as many generics as possible. According to the MFDS on the 13th, a total of 70 generic prescription drugs were approved last month. Following 73 in June, it fell short of 100 for the second consecutive month. The number of generic licenses recorded more than 100 for 17 consecutive months from January last year to May this year. During this period, an average of 323 new generics per month were granted. In May of last year, 560 generics were licensed in a month, and more than 200 new generics were launched every month this year. In May, 412 generics were licensed, but from June the number of licenses dropped significantly. Number of generic licenses per month (Unit: number, Source: The MFDS) Since last year, intensive licensing of generics is due to the government's move to strengthen regulations. This is because it tried to get as many generics as possible before the regulation was strengthened. .The new drug price system, which was implemented from this month, is pointed out as a factor in the surge in generic licenses .Generic products must meet both the direct bioequivalence test and the use of the registered drug substance to maintain the 53.55% upper limit price compared to the original drug before the current patent expiration .Whenever one requirement is not met, the upper limit goes down by 15% .If one of the two requirements is satisfied, the upper limit is lowered to 45.53%, and if there is no satisfaction requirement, the upper limit is lowered to 38.69% .The reorganized drug price system includes a stepped drug price system in which the upper limit is lowered as the time for registration of benefits is delayed .If more than 20 generics are listed in the specific ingredient market, the upper limit of the newly listed item will be up to 85% of the existing lowest price .It is pointed out that the Ministry of Food and Drug Safety's move to tighten regulations on permits has also encouraged the approval of a bunch of generics .In April of last year, the MFDS announced a reinforcement of regulations on joint bioequivalence test through a partial amendment to the “Regulation on Pharmaceuticals Approval, Notification and Review” .This is the content of limiting the number of consigned manufacturers to one original manufacturer .Although the reinforcement of joint bioequivalence test regulations was not initiated due to the recent recommendation of the Regulatory Reform Committee of the The Office for Government Policy Coordination, the number of applications for generic licenses increased significantly shortly after the plans to strengthen bioequivalence test regulations were revealed earlier last year .According to the MOHW, the previous drug price system is applied to products applied for benefit registration in May .Generics, which have been approved since June and applied for reimbursed registration, are said to receive low drug prices by applying the new drug price system .Even if both the bioequivalence test and the requirements for the registered drug substance are satisfied, the price of the drug is further reduced as the stepped drug price system is applied .This is the background of the sharp decline in the number of new generic licenses from June .# of authorized generics licenses to all processes per month Since June, the number of generics licensed through the entire process consignment method has decreased significantly .The number of commissioned generics licensed in June and July was 39 and 42, respectively, which was less than 20% of the average of 273 from January to May this year .Last year, a total of 3173 new generics were entered .This means that an average of 264 commissioned generics per month poured out .The proportion of authorized generics to the total number of generic licenses is also on a decline .Among the new licensed generics in June and July, the proportion of authorized generics was 53% and 60%, respectively .From January to May, authorized generics accounted for 84% of licensed generics .Last year, the proportion of authorized generics reached 82% .It is interpreted that the number of attempts to enter new markets decreased as authorized generics could no longer receive high drug prices due to the implementation of the new drug price system .As pharmaceutical companies have been intensively licensed for generics within a short period of time, the number of areas for further entry has greatly decreased .Most of the generics that pharmaceutical companies could sell before the tightening of regulations were granted .The number of generics licensed for last year is more than five times that of 741 in 2018 .Recently, pharmaceutical companies have tried to apply the previous drug price system for the last time .From January to May this year, around 300 drugs were newly listed on the reimbursed list each month .Following 558 drugs in June and 653 in July, 836 products were newly added to the list in August .That's about 2,000 in three months .It is an unprecedented generic listing in the government's regulatory reinforcement movement in the market.
- Policy
- Jardiance follow-on drugs seek approval to launch in 5 years
- by Lee, Tak-Sun Aug 25, 2020 06:14am
- A promising antidiabetic treatment, sodium-glucose co-transporter-2 (SGLT2) inhibitors are seeing their follow-on drugs emerging for an early market release after winning approval from the South Korean health authority. Due to the extended patent term, however, the new follow-on drugs’ release would have to for another two years at least. According to pharmaceutical industry sources on Aug. 24, follow-on drugs of Boehringer Ingelheim Korea’s SGLT-2 inhibiting antidiabetic treatment Jardiance (empagliflozin) has submitted an application for approval as of Aug. 12. One shares the same substance empagliflozin, and another one is empagliflozin L-proline with an extra solvate attached. SGLT-2 inhibitor impedes reabsorption of glucose in kidney, but excretes the excessive glucose through urine to prevent the spike in glucose level in blood. The medicine is known for showing low-risk in causing hypoglycemia and helping body weight control. Already over 40 Korean pharmaceutical companies have evaded Jardiance’ crystalline form patent and they are well under way to prepare an early release. But as the substance patent would be expired on Oct. 23, 2025, five more years are left until the release. Previously, Dong-A ST has failed in its attempt to nullify Jardiance’ substance patent. The latest item approval seems to be targeting the title of a first generic, as Jardiance’ post-marketing surveillance (PMS) period has ended on Aug. 11. A first generic to apply for an item approval can expect to receive preferential sales rights as well. Another SGLT-2 inhibitor, Forxiga, already has over 50 follow-on drugs approved with different solvate. They can be released to the market after Apr. 7, 2023, when the first substance patent expires. Nonetheless, Dong-A ST’s pro-drug has successfully evaded the first substance patent, and it would be launched in the market earlier than any other drugs when it gets the approval. According to pharmaceutical market research firm UBIST, the SGLT-2 inhibitor market volume in last year has reached approximately 90 billion won with a 39-percent surge from the year before. Jardiance has raised 28.2 billion won, whereas Forxiga generated 31.1 billion won in the same year.
- Company
- There is still misinformation and choice regarding MPHL
- by Eo, Yun-Ho Aug 25, 2020 06:14am
- Professor Shim Woo-young The male-type hair loss treatment'Propecia (finasteride 1mg)' was introduced in Korea, and hair loss was treated in earnest in 2000. Propecia identified the correlation between type II 5-alpha reductase and male pattern hair loss, suggested the therapeutic potential of male pattern hair loss, which was considered an incurable hereditary disease, and brought a major change in the treatment environment. Now, 20 years later, interest in hair loss treatment is growing even more. It is estimated that 14.1% of patients suffer from male pattern hair loss in Korea. In particular, unlike in the past, which was considered exclusively for middle-aged men, the number of young patients who visit hospitals for hair loss treatment is steadily increasing in recent years. In fact, about half (44%) of patients who received hair loss treatment in Korea in 2019 were in their 20s to 30s. The hair loss treatment market has also achieved explosive growth in line with this. After the launch of Propecia, the market competition was fierce as the Avodart(Dutasteride), and domestic generic drugs such as Finasteride and Dutasteride were also launched. As a result, sales of the entire domestic hair loss treatment market exceeded ₩100 billion last year. There were also unpleasant issues with a lot of interest. In recent years, as the hair loss community and online platforms such as YouTube have become active, there have been cases of patients who suffer damage with false information related to unconfirmed diseases and treatments, and there have also been cases of illegally purchasing hair loss pills through overseas direct purchases and experiencing side effects. False hype advertisements such as cosmetics and foods for which hair loss symptoms improvement or hair growth effect has not been verified are also a chronic problem that hinders the correct diagnosis and treatment of hair loss patients. Dailypharm met Shim Woo-young, professor of dermatology at Gangdong Kyunghee University Hospital, to hear about changes in hair loss treatment trends and future tasks. --As of 2020, what is the standard treatment method for male pattern hair loss and what are the latest treatment guidelines? Drug therapy is the most commonly used medical treatment method. As drugs to be taken, there are Finasteride and Dutasteride, which are mechanisms that inhibit the occurrence of DHT (dihydro-testosterone), and Minoxidil formulations are drugs that are applied directly to the scalp. Hair transplantation, in which the hair is transplanted into the hair loss site, can also be considered. In the case of transplantation, it is effective to continue drug treatment even after surgery. -You have been examining patients for 20 years, are there any differences from the past? First, compared to the past, the number of patients who visited the hospital for hair loss has increased. In particular, there are more young patients, with patients in their 20s and 30s accounting for about half of the total. As the number of young people who are relatively interested in appearance has increased, patients' willingness and aggressiveness to treat them have also increased overall. Also, as there is a lot of information online, such as portal sites and YouTube, the level of knowledge of patients about diseases and treatments is much higher than in the past. -What does the emergence of 5-alpha-reductase inhibitors such as Propecia and Avodart mean for hair loss management? In the case of male pattern hair loss, it can be said that the era of full-fledged medical treatment began with the advent of oral drug treatments. In the past, there was little recognition that hair loss was a disease, and treatment was mainly based on folk remedies. However, after the launch of Propecia in 2000, hair loss has been recognized as a disease that can be overcome with good management, and interest in treatment has also increased. -As mentioned earlier, two drugs are competing for 5-alpha-reductase inhibitors, Propecia and Avodart. You always hear the superiority and opinions are divided. -As mentioned previously, there are Propecia and Avodat for 5-alpha-reductase inhibitors, and these drugs are competing. Opinions are divided. Also, it can be said that my own know-how has been prescribed according to the situation and symptoms through sufficient consultation with the patient. However, it is important to take hair loss pills consistently. Recently, as many patients start treatment at a young age, I am paying more attention to the long-term efficacy and safety of patients. -Many men worry that 'hair loss drug = decreased sexual function' Side effects can occur. However, if they are contemplating hair loss treatment itself due to side effects, I would like to say that it is not necessary. Erectile dysfunction and decreased libido are frequently mentioned as sexual side effects of oral treatments, It is only about 1-2 out of 100. In fact, there are far fewer patients experienced at the clinic. It is also explained as a nocebo effect is said to occur when negative expectations of the patient regarding a treatment cause the treatment to have a more negative effect than it otherwise would have. It is believed that the patient received incorrect information through the Internet and such side effects appeared. In many cases, side effects disappear after sufficient explanation to the patient. Non-medical management methods such as hair loss shampoo and scalp nutrition are still prevalent. It is very unfortunate that many patients rely on non-medical management methods and get hurt if they do not work. There are cases of giving up hair loss treatment as it is. There is also a big problem for companies such as hair loss shampoo in creating this situation. Although there is no medical evidence that hair loss shampoo or scalp nutrients are effective for hair growth, they advertise as hype. This will require the regulation by government. And even hair loss patients need to be wary of accepting unconfirmed advertisements or information easily. Overseas illegal purchase of hair loss drugs is also a big issue. The Korea Consumer Agency made a presentation pointing out the dangers of this in last year. First of all, it is illegal to purchase oral hair loss treatment drugs without a prescription from a medical staff because they belong to Rx drugs. But more importantly, the patient's safety can be threatened. Taking fake medicines or unconfirmed products may cause severe hair loss or experience fatal side effects. Therefore, in order to treat alopecia, it is correct to visit a hospital and consult a specialist to find an effective treatment method. -What do you think will be the trends or key keywords of hair loss treatment in the future? 'Safety' is the top priority. The number of young patients is increasing as mentioned earlier. This means that the treatment period is prolonged. Long-term safety and effectiveness will be considered first when choosing a hair loss agent.
- Opinion
- [Reporter's view] Strategies for Trial & error/the evolution
- by An, Kyung-Jin Aug 25, 2020 06:14am
- In August, there was a lot of good news in the pharmaceutical and bio industry. Hanmi and Yuhan, leading domestic pharmaceutical companies, announced the news of the signing of a global technology transfer contract for the new drug pipeline, revealing the potential of R&D. The license agreements of domestic companies are developing. Earlier this month, Hanmi transferred the global copyright of a new bio-drug to treat non-alcoholic steatohepatitis (NASH) to MSD in the US. The scale of technology transfer is about ₩1 trillion. The down payment without obligation to return is ₩10 million, and royalties based on sales after commercialization are separately received. There is another reason that the industry gives a special meaning to this technology transfer contract. This is because it is a pipeline (HM12525A) that was returned from Janssen just a year ago, a GLP-1-based dual agonist named Efinopegdutide. The development process of Efinopegdutide was not easy. In November 2015, Janssen signed a technology transfer contract worth $915 million for diabetes/obesity indications. But the recruitment of patients was temporarily suspended in November of the following year. The trial was restarted in June of the following year, but the rights were finally returned in July of last year. At the time of copyright return, Janssen said, "As a result of analyzing two phase II clinical trials of type II diabetes patients with severe obesity, the weight loss goal was met, but the blood sugar control effect did not meet the internal standards." It can be said that it has proven enough to cure obesity. Two clinical data released afterwards showed potential as a treatment for obesity. Subjects who received the test drug showed significant weight loss after 12 weeks, and secured an efficacy and safety profile comparable to that of the blockbuster obesity treatment 'Saxenda'. Kwon Se-chang, CEO of Hanmi Pharm, pointed to 'HM12525A' as a key task at the JP Morgan Healthcare Conference earlier this year, and declared that he would develop the world's first once-a-weekly administered obesity treatment drug. Hanmi Pharm's management succeeded in regaining trust in the labscovery platform technology by signing a new technology transfer contract one year after operating the GLP-1-based dual agent rehabilitation project. It is not the end that the technology has been returned, and it is an evaluation that it has proved its R&D efforts by signing a trillion unit contract with Big Pharma after 4 years. The implications can also be found in the contract between Yuhan and Processa last week. Yuhan has transferred the global copyright of the functional gastrointestinal disease treatment candidate 'YH12852' to Biotech Processa in the United States. The total contract size is about ₩487.2 billion, and the down payment without a return obligation is $2 million. The down payment is received in full from Processa, and $4.5 million worth of shares is included in the total amount of technology exports. It is a small-scale biotech with little known contract partner, and there is no immediate cash inflow effect. 'YH12852' is a candidate substance for a synthetic new drug developed by Yuhan. In 2013, Yuhan initiated a phase I clinical trial in Korea for healthy adults, confirmed the excellent effect of improving bowel movements, and conducted a phase II clinical trial on patients. However, it has been pending for nearly two years without obtaining satisfactory results. Processa is planning to enter phase II clinical trial by meeting with the US FDA early next year. It made a turning point by handing over the new drug pipeline, which had not progressed in development since 2018, It showed that it is necessary to use selection, focus, and efficient strategies when using R&D strategies. Korean pharmaceutical companies have experienced a lot of trial and error with a lot of expectations and bitter taste. Numerous trials and errors have led to the evolution of new drug technology export strategies. It is nice that domestic pharmaceutical bio companies started to pay attention to practical interests when signing global license agreements.
- Policy
- Started to develop the generic for Norspan Patch
- by Lee, Tak-Sun Aug 25, 2020 06:11am
- The development of generic drug for 'Nospan Patch', a narcotic pain reliever that has been growing recently, has begun. Samyang Biopharm has received approval for the bioequivalence test from the Ministry of Food and Drug Safety. Northpan patch has no patents on the PMS and patent list, but there is no same active ingredient so far. On the 20th, the Ministry of Food and Drug Safety approved the bioequivalence test of Samyang Biopharm's tentatively named 'Noprepatch 10ug/h'. The test is conducted with healthy adults for bioequivalence evaluation with Norspan patch 10ug/h' of Mundipharma. It is the second time Samyang Biopharm is conducting a bioequivalence test on this formulation. The bioequivalence test was also approved in August 2019. It is interpreted that the previous test did not satisfy the validity data required for the generic license. Some analyzes indicate that it is difficult to prove bioequivalence due to the nature of the patch. Norspan patch is a pain reliever patch containing a narcotic ingredient called Buprenorphine. In Korea, the product was approved in November 2004, but the launch was conducted in April 2012 due to insurance benefits. At the time of launch, there were many views that it was not enough to target the market dominated by Janssen Korea's Durogesic D-trans patch. Durogesic D-trans patch (Fentanyl) was widely used, and The weakness is that Northpan cannot be used for cancer pains. Norspan patch is used for moderate to severe chronic pain relief that does not respond to non-narcotic analgesics. Transtec patch (Buprenorphine), which was licensed in 2017, is used to relieve cancer pain. Transtec patch has a higher content than Norspan patch. Myungmoon’s Buprein Patch, generic for Transtech Patch was approved in 2018. Although Norspan patch has no indication for cancer pain, its indication with Tramadol has expanded, and sales are now higher than Durogesic D-trans patch. As of last year's IQVIA, Norspan recorded ₩13.6 billion, and Durogesic D-trans patch recorded ₩8.4 billion. The rising trend of Norspan Patch is that Mundipharma is making progress in targeting specialized hospitals such as orthopedic clinics as well as large hospitals through joint promotions with Samil Pharmaceutical in 2017. Moreover, the lack of competing drugs for the same ingredient is an analysis that the uptrend will continue in the future. If Samyang Biopharm succeeds in developing drugs for the second generation, it is expected that high sales as a first generic will be expected.
- Policy
- Followup of drug price agreement, possible by electronically
- by Kim, Jung-Ju Aug 25, 2020 06:11am
- When the NHIS concludes a drug price negotiation with a pharmaceutical company, a legal basis will be prepared for notifying the company in writing or electronically of the details of the subsequent proceedings. The purpose of this is to increase administrative convenience so that insurance benefits work more efficiently. The MOHW announced the legislation today (21st) of a partial amendment to the 'Rules on the Standards for Medical Care Benefits of National Health Insurance' based on these contents. This revised bill was created to provide a basis for notifying applicants in writing or electronically of the matters to be reviewed by the Health Insurance Policy Deliberative Committee and the expected date and effective date of notification when a drug price negotiation is concluded to enhance the transparency of the drug price decision system. Looking at the contents, the latter part was newly established to the regulation that the drug for which the agreement was reached should be deliberated by the deliberation committee within 30 days, and whether to be eligible for medical care benefits and the maximum amount of the drug must be determined and announced. It is possible to notify the applicant in writing or electronically of the expected date of notification and the effective date of the notification." The government plans to go through an opinion inquiry for groups or individuals with opinions by October 5, and it will be applied and implemented immediately if there is no specific matter.
