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- 2026-05-15 06:55:38
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- Keytruda sales hit KRW 72.3 bln topping H1 2020
- by Chon, Seung-Hyun Aug 27, 2020 06:24am
- Apparently an immunotherapy Keytruda has made the highest sales revenue in the first half of the year. Keytruda has beaten the long-term industry leader, Lipitor. Two innovative new drugs from multinational pharmaceutical companies, Tagrisso and Spinraza have shown outstanding performances, and the sharp surge in pneumococcal pneumonia vaccine Prevenar 13 was notable as well. According to the pharmaceutical market research firm IQVIA on Aug. 24, MSD marked the highest sales in the first half of 2020 with Keytruda making 72.3 billion won. Compared to 57.2 billion won made last year, the figure leapt by 26.4 percent and placed itself on the top of the leader board. Top 10 pharmaceuticals in the first half of 2020 (Source: IQVIA) In the first quarter, Keytruda took the top spot by making 40 million won more than the dyslipidemia treatment Lipitor with 34.7 billion won. The gap between Lipitor was widened by 2.9 billion won in the second quarter as Keytruda defended the top title. Released in the Korean market in 2015, Keytruda is an immune checkpoint inhibitor that blocks PD-L1 receptor from biding with PD-1 pathway on the surface of T-cell and activates immune cells to treat the tumor cells. Immediately after the market release, Keytruda’s sales have remained around 3 billion won, but the figure grew rapidly since the second half of 2017. The demand on the drug has surged as the healthcare insurance coverage was granted from Aug. 2017 as a second-line therapy treating non-small cell lung cancer (NSCLC). Keytruda’s sales in the first quarter of 2018 surpassed 10 billion won, and it has been staying around the 30 billion won line from the second quarter last year. Keytruda quarterly sales (Unit: KRW 100 million) Source: IQVIA Pfizer’s Lipitor came in second with 69.3 billion won generated but it dropped by 4.8 percent from last year same time. Lipitor has been topping the chart since April 2015, but it stepped down to the second place from the last first quarter after four years. Meanwhile, anticancer treatment Tagrisso and rare disease treatment Spinraza continued their strong performance to this quarter. Making 51.1 billion won in the first half of this year, AstraZeneca’s Tagrisso came in fourth by growing the sales by 33.5 percent from last year. Tagrisso is a second-line treatment prescribed to NSCLC patients who developed tolerance in EGFR tyrosine kinase inhibitors (TKIs) like Iressa, Tarceva and Giotrif. The medicine is considered a third-generation treatment that overcame EGFR-TKI tolerance. After receiving healthcare reimbursement from December 2017, Tagrisso has been growing consistently. The sales in third quarter 2017 marked 2.7 billion won, but it grew by eight times in two years time. Product images of Tagrisso (left) and Spinraza Biogen’s rare disease treatment Spinraza landed itself on the ninth place by generating 38.9 billion won in the first quarter. After making 20.2 billion won in the first quarter, the treatment made 18.7 billion won in the second quarter. Spinraza has been consistently making more or less 20 billion won since it entered the market making 10.2 billion won in the second quarter last year. The rare disease treatment Spinraza is indicated to treat a genetic neuromuscular disorder called spinal muscular atrophy (SMA) that causes muscle twitching from damaged motor neurons in spinal cord and brain stem. The patient’s cognitive function stays normal, while their daily life is disrupted with weakening muscle and contracting tongue muscle. Approved by South Korean health authority in December 2017, Spinraza was listed for healthcare reimbursement after settling on a pricing of 92.35 million won per vial (5 ml) in pricing negotiation with National Health Insurance Service (NHIS). Although the eligible patient size is small, the patients have to undergo a complicated pre-review prior to the administration. Regardless of the long procedure to use, the treatment’s quarterly sales have reached 20 billion won quickly with its exceptionally high price. Product image of Prevenar 13 Meanwhile, a pneumococcal pneumonia vaccine Prevenar 13 had an abrupt exponential growth due to the novel coronavirus infection (COVID-19). Prevenar 13’s sales in the first half of 2020 skyrocketed by 70.2 percent from last year and made 36 billion won. Prevenar 13 is a pneumococcal conjugate vaccine (PCV13) that prevents infection from 13 types of pneumococcal pneumonia (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). The vaccine can be given to all age group older than 6-week-old. Chong Kun Dang is in charge of distributing the vaccine for adult in South Korea, whereas for infant and children vaccine distribution is handled by Korea Vaccine. The use of the vaccine in adults has surged sharply as many were convinced by some experts claiming the vaccine can weakened the pneumonia symptoms induced from COVID-19, although it cannot prevent the pneumonia itself.
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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.
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- 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.”
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- “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.”
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- ↓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.
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- 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.
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- Celltrion begins to develop oral Remsima following SC type
- by Kim, Jin-Gu Aug 24, 2020 06:19am
- Celltrion starts developing oral 'Remsima'. Celltrion announced on the 20th that it has signed a joint research agreement with British biotechnology company Intract Pharma. Remicade, Remsima's original drug, is a drug administered by intravenous injection.. Celltrion has already developed and commercialized Remsima SC, the first in the world, with an improved administration method in the form of SC. It is expected to become the world's first oral infliximab drug if Celltrion succeeds in development. According to Celltrion, Intract Pharma was separated from University College London in 2015. It has its own oral formulation technology that efficiently delivers protein drugs to the intestine. It has conducted joint research with various global pharmaceutical companies such as Abbvie, Janssen, and Merck. Intract Pharma is exempted from non-clinical and phase I clinical trial for oral Infliximab from the UK Medicines and Healthcare products Regulatory Agency(MHRA), and is clinically targeting inflammatory bowel disease (IBD) patients in earnest from the second half of next year, and will launch in phase IIa clinical trial. Under this contract, Celltrion will supply clinical raw materials to Intract Pharma, and Intract Pharma will develop and verify the oral Infliximab product. Celltrion has secured the right to generic exclusivity upon completion of phase II clinical trials. In addition, it has agreed to allow part of the sales to be returned as royalties even when the license is out. In addition, Celltrion will exclusively supply Infliximab for the production of commercial substances even when Intract Pharma or another pharmaceutical company that has transferred the technology successfully commercializes the product. A Celltrion official emphasized, "We started developing oral Infliximab products with high efficacy, safety and ease of use, and we will proceed with preparations for development from the clinical design stage without any problems through close cooperation."
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- United promotes phase III tx for COVID-19 in the Philippines
- by Aug 24, 2020 06:18am
- Korea United Pharmaceutical (CEO Kang Deok-young) is starting to develop a cure for COVID-19. It is Drug Repositioning of the company's Incrementally Modified Drug 'UI030'. United said on the 19th, "UI030 has confirmed the antiviral effect of up to 30 times compared to Ciclesonide in cell experiments." According to the company, UI030 is a combination of Desonide & Formoterol, an Incrementally Modified Drug developed by United for six years as an asthma treatment. AstraZeneca's treatment for asthma and chronic obstructive pulmonary disease 'Symbicort' is a salt-modifying product. It is characterized by a low risk of systemic side effects as it is an inhaled formulation that allows patients to easily administer drugs directly. Recently, in a cell experiment on human lung cells (Calu-3 cells) at the Biosafety Center, Korea University, the possibility of treating COVID-19 was discovered. UI030 confirmed the antiviral activity of 5 to 30 times that of Ciclesonide. Ciclesonide was previously found to be twice as effective as Remdesivir in an antiviral test conducted by Institut Pasteur Korea. United expects that UI030 can simultaneously exhibit antiviral and immunomodulatory effects, which are the mechanisms of treatment for COVID-19. The company is preparing application documents for approval of the phase III clinical trial protocol for the development of UI030's COVID-19 treatment. In Korea, phase I clinical trial is conducted with Asthma as an indication. When the clinical trial in the Philippines is successfully completed, it is seeking to obtain a domestic new drug license based on this. The target time for permitting is in the first half of next year.
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- Patent dispute for Promac, eventually to Supreme Court
- by Kim, Jin-Gu Aug 24, 2020 06:18am
- PromacThe patent dispute over the anti-ulcer drug, Promac (Polaprezinc) was finally concluded in the Supreme Court. According to the pharmaceutical industry on the 19th, SK Chemical, which holds a formulation patent for Promac, recently filed an appeal to the Supreme Court against Hana Pharm and Korea Prime. Earlier, on the 17th of last month, SK Chemical received a ruling against the plaintiff in a patent invalidation trial cancellation lawsuit by the Patent Court (second trial). Promac is a gastric mucosa protective agent used to improve gastric ulcers, acute gastritis, and chronic gastritis, and Polaprezinc, the active ingredient, was developed by Zeria in Japan. SK chemicals improved its marketability by developing the existing product in the form of granules into tablets in 2013. The patent held by SK Chemicals is also about converting granules into tablets. Several domestic companies have challenged this formulation patent. Hana Pharm in April 2018 and Korea Prime in November of the same year filed a request for a trial to confirm the passive scope of rights. Generic companies won in the first trial. In March 2019, a trial decision was made for Korea Prime and Hana Pharm in July of the same year. The Intellectual Property Trial and Appeal Board judged that similar formulations developed by generic companies do not infringe the patent. SK Chemical appealed to the Patent Court. However, the second trial was ended as the Patent Court sided with the generics company following the first trial. SK Chemicals is aiming for a dramatic reversal in the Supreme Court with this appeal decision. Promac is one of SK Chemical's flagship products, and according to UBIST, a drug market research institute, Promac's outpatient prescription last year amounted to ₩11.1 billion. The prescription performance was ₩6.3 billion in the first half of this year. Promac is facing tough challenges from generics regardless of SK Chemical's appeal. Korea Prime's first-trial victory received a exclusivity for generic product and launched the first generic, Prezinc at the end of last year. Prezinc produced ₩51 million in prescription results in the first half of this year. The exclusivity period ends on the 30th of this month. In addition to Prime Korea, Hana Pharm, Pharvis, Pharmedix, Hutecs, Kukje, Medix Pharm, REYON, Samsung Pharm, Wooridul, Daewoo, Medica Korea, Dong-gu Bio, Daewoong Bio, Jin Yang, Binex, Ilhwa, Dongkook Pharm, Guju Pharm, Ahngook, Daehan New Pharm, Intro Bio Pharma, Hanpoong Pharm, Mothers Pharm, Kolmar Korea, Korea Global Pharm, Jungwoo, Eden Pharma, Nexpharm, Firrson, etc. are trying to launch a generic for Promac.
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- Drug industry back on full alert as COVID-19 cases resurge
- by Aug 21, 2020 06:26am
- The pharmaceutical industry is on full alert again as the confirmed cases of novel coronavirus infection (COVID-19) is resurging rapidly around Seoul metropolitan area. Some companies have already reinitiated emergency working system with employees working in shifts or from home. The South Korean government has recently decided to toughen the social distancing measures in Seoul and Gyeonggi Province to level two. The threat of massive surge in confirmed COVID-19 cases is imminent after more than 200 cases have been confirmed in a single day. Daily confirmed case of COVID-19 reported in last seven days (Source: KCDC) The pharmaceutical industry is now in a heightened alert mode. But because many companies have implemented flexible working conditions during the first surge of COVID-19, the companies were able to take the necessary actions quickly. Centering heavily affected regions, the pharmaceutical companies are ordering the employees to work from home. Most of multinational companies order employees to work in shifts Multinational pharmaceutical companies are taking actions fast. Even before the government raised the social distancing level, most of the multinational companies have been rotating working hour shifts. The employees have been coming to the office every other day or working from home two to three days a week. But with the resurging of confirmed cases, the companies are reiterating the need of the strict measures. Due to the government’s tightened infection control measures in Seoul metropolitan area and a confirmed case reported from Seoul LS Yongsan Tower, Janssen has closed down the office until the end of the week and disinfected the area for the safety of employees. In particular, the employees working at the LS Yongsan Tower are all working from home until the end of the week. GSK Korea, also headquartering in the same building, is recommending the employees to work from home. And a biweekly schedule was given to those who have to come into the office. Lilly had their in-office employees to work from home from Aug. 18 to 19, and they are rotating their office hours from Aug. 20. Their sales people are only allowed to visit designated hospitals. Following the government’s order, Bayer has decided to work from home twice a week until the end of August, while Sanofi, Novartis, MSD and Takeda Pharmaceuticals are working from home every other day from Aug. 18. Companies like Roche, Bristol-Myers Squibb (BMS), Astellas and Pfizer have already been rotating office hour shifts or voluntarily working from home, and they plan to maintain the existing system. An associate from a multinational company commented, “The company would closely follow the reports of confirmed cases and update the working guideline accordingly to put the employees’ safety first.” Large Korean companies to work from home again Korean pharmaceutical companies have ended the order of working from home and returned to their regular working system as the social distancing has ended in last May. But with the resurge, the companies are bringing back the social distancing working system. First, Yuhan has ordered all employees to work from home, and the same order was give to in-office employees at the GC Pharma headquarters. JW Pharmaceutical is rotating two-shift to work from home. The company seems to have different shift systems in each department. Daewoong Pharmaceutical has asked employees to voluntarily work from home but to refrain from convening an in-person meeting or gathering. Dong-A ST has banned employees to come to office in regions with level-two social distancing order and refrained them from visiting hospitals. Boryung Pharmaceutical and Chong Kun Dang are still reviewing the working system as they closely watch the emergency status. An associate commented, “From various perspectives, the company is reviewing the period, type and subject of the shift in working system,” and “A guideline would be set as the situation is worsening.’ Moreover, off-line symposium and workshops, initially planned as the spread of COVID-19 seemed contained, are to be canceled. Korea United Pharm had scheduled an employee workshop from Aug. 21 to 22, but now the company is considering on cancelling it. Even if the event carries on, it would only convene less than 50 people. The workshop venue is located in Gwangju, Gyeonggi Province, where an event with over 50 people is banned. Korea United Pharm official said, “There is a possibility of canceling the event. But if not, the company would strictly follow the infection control regulations.”
