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- 2026-05-11 20:25:48
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- FDA clears Celltrion’s 2nd HIV drug manufacturing plant
- by An, Kyung-Jin Mar 18, 2020 06:34am
- On Mar. 16, Celltrion announced its HIV treatment CT-G07-manufactuing Cheongju facility has passed the U.S. Food and Drug Administration’s (FDA) on-site inspection with no violation. Prior to CT-G07’s global launch, the on-site inspection was carried out to confirm the plant’s manufacturing facility and quality control system. In January, the inspection focused on the plant’s capacity to manufacturing double-layer tablet, which was not included in the Current Good Manufacturing Practice (cGMP). As a part of ‘Global Chemical Project,’ Celltrion has developed CT-G07, an incrementally modified drug (IMD) for HIV treatment. The pharmaceutical industry suspects the new IMD would have a better marketability than Temixys, commercialized earlier in the U.S., as the drug is a triple combination drug consisting of three agents that currently popular in the global HIV treatment market. Celltrion has applied for FDA approval and World Health Organization’s (WHO) prequalification (PQ) in last May and September, respectively. The company evaluates the ‘flawless’ grade given by the FDA would leverage the company to leap for the global chemical market. The company has publicly announced the plan to commercialize and manufacture CT-G07 from April at earliest. According to Clinton Health Access Initiative (CHAI), the HIV treatment market volume has reached around 1.2 trillion won last year. The company expects to easily take over 10 percent of the market share from early on. Ultimately, it aims to surpass the market share of 20 percent. Celltrion official said, “Celltrion Pharm’s Cheongju plant is the key chemical product manufacturing facility of the group. The plant manufactures and supplies high quality drug meeting global standards and demands. With the latest FDA review, we were able to reaffirm the facility’s global level chemical product manufacturing facility and quality control capacity.”
- Company
- 2nd anti-CGRP migraine drug Ajovy seeks approval in Korea
- by Eo, Yun-Ho Mar 17, 2020 06:28am
- A second anti-calcitonin gene-related peptide (CGRP) treatment for migraine is preparing for the Korean market. According to pharmaceutical industry sources, Handok Teva has submitted approval application on CGRP targeted migraine treatment Ajovy (fremanezumab) aiming for the Ministry of Food and Drug Safety’s nod by late June. Ajovy’s migraine prevention effect has been evaluated in two Phase 3 clinical trials on patients with unbearable migraine pain affecting their daily lives. The results proved Ajovy reduces more number of days with migraine than the placebo group. When it receives the Korean government’s approval, Ajovy would compete against Lilly’s Emgality (galcanezumab) in both reimbursed and non-reimbursed drug markets. The two drugs are humanized monoclonal antibody (mAb) that binds to CGRP ligand playing a crucial role of causing migraine, and blocks its binding to the receptor. Ajovy has improved its drug compliance by offering both monthly and quarterly injection options. After winning the U.S. Food and Drug Administration’s (FDA) approval in September 2018, it also gained European Commission’s (EC) approval in just six months. Emgality has been released in the Korean market as non-reimbursed drug in last December. As none of the drug in the class has been listed for reimbursement, the competition between two drugs over the listing would get fierce. CGRP mAbs are relatively expensive drugs so the first listing standard would be limited to at least third-line treatment. However, considering patients suffering from migraine have such a low quality of life and have limited treatment options, the non-reimbursed use of the drugs would be as popular as well. Professor Chu Min Kyung of Neurology Department at Severance Hospital explained, “The pain from migraine is beyond imaginable and it significantly harms patients’ quality of life. Patients experiencing headache more than four to five days a month could expect to improve quality of life by preventive treatment. Because the condition uses hypertension and epilepsy treatments as preventive treatment at the moment, CGRP mAb would be a preferred option in the future.”
- Company
- Amid COVID-19 industry conflicted with working from home
- by Kim, Jin-Gu Mar 17, 2020 06:28am
- The pharmaceutical industry is in a dilemma of working from home. Pharmaceutical companies that have given an order to work from home to a part or all of the office are conflicted whether to continue or to stop working from home. Depending on companies, some of them have already been working remotely for over a month. But they complain it is impossible to keep working from home, because their work efficiency has plummeted. In fact, some of them have given up working from home. And if only making the decision to have salespeople resume external marketing activity was as easy. The companies still have to calculate the possible loss they would face when a confirmed case is found within. The simplest and the most certain answer to all is ‘an early end to the COVID-19 outbreak,’ but it is now a hopeful thinking as a mass infection has occurred again centering Guro-gu, Seoul. Increasing number of pharmaceutical companies are contemplating on coming back to workplace considering the number of new confirmed cases has been lowered to 110, as of 12:00 a.m., Mar. 13. ◆Switching from remote work to shortened hours or dispersed hours According the pharmaceutical industry sources on Mar. 13, the companies are setting out different tactics switch out of remote working. First, Dong-A ST and GC Pharma, where everyone works from home, have turned back into regular working hours from Mar. 9 for the in-office workers and researchers, except for the sales. But Chong Kun Dang, which also ordered all employees to work from home, has decided to extend the remote working status until this week. Companies that initially ordered the sales to work from home are also deeply conflicted by the situation. Many of them are returning to the normal working status. For instance, a Korean company that decided to have everyone work from home is considering on sending out the salespeople back to the field, except for ones assigned to Daegu, North Gyeongsang Province and Guro-gu, Seoul. And another Korean company is considering on shifting towards shortened working hours or dispersed hours, despite their earlier decision to have all sales work from home. On the other hand, most of global pharmaceutical companies have reportedly decided to continue working from home, until the outbreak subsides. An insider from a Korean company commented, “Until the early last week, the company was positively considering on stop working from home as the number of confirmed cases in Daegu and North Gyeongsang Province has been descending. But as the fear of community infection has gone up again with the surge of cases in Guro-gu, we have decided to continue work from home.” “Sales is the basics of a pharmaceutical company. Indefinitely working from home does not make sense in the business. But also, we cannot order the sales to resume visiting their accounts,” the insider added. An associate from a global company explained, “Actually, the headquarters have urged for precautions as, unlike Korea, the outbreak in Europe and the U.S. has intensified and the World Health Organization has designated the outbreak as a pandemic. The remote working would be sustained for a while.” Severance Hospital’s notice banning outside visitors. With hospitals requesting salespeople to refrain from visiting, working from home became unavoidable. ◆Why the workers cannot wait to go back to their workplaces Besides the companies’ dilemma and decision, employees working from home complain that they want to rather go back to the workplace. Their reasons vary vastly. Some say their working efficiency has plunged and some say they cannot help it with the boss’ pressure on sales performance. And some even say they are extremely fatigued by the company’s excessive workload. A salesperson from a Korean company explained, “The company is assigning almost impossible tasks as we have been working from home for a long time. Many of my colleagues say going back to work would be much better.” “Monitoring and interfering through KakaoTalk or other messenger apps have worsened over the time. What’s worse is when the supervisor thinks I’m not doing anything, when the actual workload has gotten heavier,” the salesperson added. Another Korean company’s salesperson said, “The company officially advised the sales to work from home from the get-go. But quite the opposite is happening in the field. The company may be advising working from home, but their pressure on sales performance is intense.” An in-office worker from a Korean company complained, “As we have switch to remote working without a proper preparation, most of the colleagues are frustrated. Video conference always has glitches and work reporting via email is slow on feedback. It would be much better to just go back to the office.” Another in-office working from a global company noted, “We’ve been working from home for over a month now. The working efficiency has dropped noticeably. We are holding on to it somewhat, but I have a ton of work I cannot do at home.”
- Company
- Lamisil distribution halted over 2 months inventory issue
- by Jung, Hye-Jin Mar 17, 2020 06:28am
- The distribution status of GlaxoSmithKline (GSK) Consumer Health’s anti-fungal treatment Lamisil has been unstable for a while. After the co-promotion deal with Dongwha Pharmaceutical has ended last year, GSK’s Lamisil has not been properly supplied for over two months. Although Zuellig Pharma Korea is negotiating with GSK on the Korean sales rights over Lamisil since last year, the contract signing has been long delayed. According to pharmaceutical industry and pharmacies on Mar. 13, stock of Lamisil has not been supplied since past January. Except for Lamisil, nine out of ten GSK items previously distributed by Dongwha Pharmaceutical are now taken over by Ildong Pharmaceutical from this year. Specifically Lamisil could not find its succeeding distributor for three months. Currently, Zuellig is a most likely candidate to take over the marketing license. The company has started the negotiation with GSK based on same conditions Ildong Pharmaceutical had. Although Ildong Pharmaceutical was capable of taking in all ten items to distribute, the Korean company’s Canesten Cream’s use and benefit overlapped with Lamisil. The industry initially predicted Zuellig would soon finalize the deal after Ildong Pharmaceutical inked theirs. But the companies have not announced any news, yet, regardless of the anti-fungal treatment’s top-selling season is approaching fast. Meanwhile, pharmaceutical industry experts point their fingers on the leftover stock of Lamisil from Dongwha Pharmaceutical. The former distributor has cleared out their GSK products to the regular vendors in last December. The distributor meant to minimize confusion in transaction with pharmacies in case their stocks had not been depleted before the new distributors start stocking up. But Ildong Pharmaceutical and Zuellig say plenty of stocks from Dongwha Pharmaceutical are still in the market. The global distributor would probably be burdened with return products, if Donghwa Pharmaceutical’s stock is not exhausted. The reasoning seems to be plausible as pharmacies’ inventory has been taken by Zuellig, recently. The distributor would likely to finalize the contract terms base on the inventory of Dongwha Pharmaceutical’s stock. (Source: Financial Supervisory Service, Unit: KRW 100 million) Another affecting factor seems to GSK’s low marketing margin. A multinational distributor, Zuellig has entered the Korean market with foreign capital, but its deficit has grown over the years due to aggressive sales tactics. In 2018, Zuellig’s sales have gone by 8.9 percent from the year before. Business profits and net profit have been in red for a few years now. What Zuellig needs at the moment are not just high sales made for the co-promotion deal, but also actual profit from high marketing margin. Apparently, the marketing margin of a co-promoted product by a multinational company generally tends to be lower than that from a Korean company. Predominantly, the industry experts are assuming that Zuellig trying to raise the margin rate and GSK trying to keep the original margin rate are clashing and delaying the deal signing. On Mar. 1, GSK insider on a phone call with Daily Pharm said the finalization of the deal is imminent and explained, “As soon as the deal is signed, the supply would resume normally. Right now, we are doing everything to minimize the impact on the market.” However, even after a month, the multinational company has not provided any other follow up. A distribution industry source commented, “Zuellig would not ink the deal only for the sales revenue. They are probably taking a long time fine-tuning various terms and conditions. As Lamisil stock at pharmacies is going down while summer is approaching, the companies would not take the negotiation longer.”
- Company
- Pharmaceuticals, growth rate to be cut in half
- by Eo, Yun-Ho Mar 17, 2020 06:28am
- Major National Pharmacy Sales Trend [Source: IQVIA]It was analyzed that the domestic pharmaceutical industry would be suffered hard from the aftermath of COVID-19. Drug market research firm IQVIA predicted that the growth of the Korean pharmaceutical market this year will be only 4.4%, half of the previous year due to the spread of COVID-19. This analysis compared changes found in major institutions and organizations in healthcare, including pharmaceutical companies, hospitals, pharmacies, and drug wholesalers, before and after the outbreak of COVID-19. Initially, IQVIA estimated the growth rate of the pharmaceutical market to be similar to 8.6% in 2019, but the situation changed due to the spread of COVID-19. According to IQVIA, the number of outpatient prescriptions may decrease as the number of patients visiting the hospital decreases in the aftermath of COVID-19, which in turn may reduce drug production and sales. Since the spread of COVID-19, the number of patients visiting hospitals and pharmacies in Daegu and Gyeongbuk areas has decreased significantly. Looking at each region, Daegu and Gyeongbuk accounted for about 85% of all COVID-19 confirmed patients, and the proportion of deaths was more than 90%, so the short-term impact in the region was the largest. It is estimated that the impact of COVID-19 on Daegu and Gyeongbuk sales will be 1.25 times greater than that of other regions, and as a result, it is expected that the usage of medicines in Daegu and Gyeongbuk in the first half of this year will likely be less than last year's level. Changes in over-the-counter drug sales [Source: IQVIA]In addition, as a result of questioning 300 pharmacists, the number of patients visiting pharmacies decreased by 23% compared to before the COVID-19 spread. Sales of 11 major drug wholesalers also fell by an average of 13%. Drug wholesale sales fell 8% less and 30% more. However, with the spread of COVID-19, sales of various hygiene products such as masks and hand sanitizers increased. As a result of analyzing the sales of 540 domestic pharmacies, the sales volume and proportion of masks and hand sanitizers began to increase on January 20, when the first COVID-19 confirmed in Korea. The sales volume of hygiene products, which had been faltering for a moment due to the lack of masks and the increase in the number of confirmed patients, has jumped since February 18, when the 31st confirmed patient occurred. This trend was prominent in pharmacies in Daegu. Masks and hand sanitizers accounted for less than 1% of the total sales of pharmacies in Daegu, but increased to 30% at the end of last month. It was analyzed that sales portion was expanded since the 18th of last month when the first COVID-19 confirmed patient occurred in Sincheonji Daegu Church. IQVIA said that sales of over-the-counter drugs at pharmacies, except for outpatient prescriptions, have decreased significantly since the occurrence of COVID-19, and sales of all products across all over-the-counter drugs, not specific products, have been analyzed to be attributed to a decrease in overall patient visits.
- Company
- Supect by Il-Yang Pharm reduces COVID-19 by 70%
- by Jung, Hye-Jin Mar 17, 2020 06:27am
- Research has shown that Il-Yang Pharm's 'Supect' has the effect of reducing the COVID-19. Il-Yang Pharm announced on the 13th that as a result of experimenting with COVID-19 received from the KCDC, the virus in the group using Supect decreased by 70% within 48 hours. Supect (Radotinib) by Il-Yang Pharm is a leukemia treatment agent. This study was conducted in an in vitro test method in the Biosafety Level 3 Laboratory (BSL-3) at the Biosafety Center of Korea University College of Medicine. The experimental group that used Supect for the virus and the control group that did not, were compared. As a result, the firm explained that 70% of viruses were reduced in the Supect group compared to the control group, which is superior to that of the HIV treatment 'Kaletra' and the flu treatment 'Avigan'. Result of Supect experiment Experimental results of candidate drugs for MERS treatment In addition, Il-Yang Pharm also revealed that five candidate substances that are being developed as MERS treatments reduced COVID-19 by more than 99% within 24 hours in the same experiment. candidates for MERS are IY1209, IY1471, IY1472, IY1901, and IY1209 from substances discovered through the research project of the next-generation applied ohmic 'source technology development of new and variant virus (MERS) treatment' hosted by the Korea Research Foundation under the Ministry of Science and ICT. "Supect is a commercially proven drug that can shorten the development period quickly compared to other candidates. If COVID-19 is declared a pandemic and even considers seasonal infectious diseases that come every winter, therapeutic development will be the most powerful weapon to protect humanity from disease".
- Company
- Herceptin market recovers ￦100 billion in three years
- by An, Kyung-Jin Mar 16, 2020 06:31am
- (From the left) Herzuma, Herceptin, and Sampenet Domestically developed biosimilars enter the blockbuster anti-cancer drug 'Herceptin' market. The market share of the two products 'Herzuma' and 'Sampenet' exceeded 28%. The market size of Trastuzumab that Celltrion developed as 'Herjuma' shrank with the expansion of the biosimilar market has recovered to the level before drug price cuts. According to the drug research agency IQVIA on the 11th, the market size of Trastuzumab in the fourth quarter of last year was ￦27 billion, up 19.8% from the same period last year. Last year's cumulative sales were ￦104 billion. It surpassed the record of ￦103.4 billion in 2016 before the biosimilar was released. Trastuzumab market quarterly trend in 2015-2019 (Unit: ￦100 million, Source: IQVIA) Trastuzumab is generic for Roche's targeted anticancer drug 'Herceptin'. It is prescribed for metastatic breast cancer and gastric cancer that show positive human epithelial factor receptor 2 (HER2). In Korea, after the patent expiration of the original product Herceptin, two types of biosimilar products, such as Celltrion’s 'Herzuma' and Samsung Bioepis' Sampenet, began to be sold. The original product, 'Herceptin', sold for ￦19.4 billion in the fourth quarter of last year. Herceptin's upper limit of insurance fell by 20% from ￦517,628 to ￦414,103 based on 150mg two months after Celltrion listed 'Herzuma' on the health insurance benefits list in April 2017. Since the drug price cut, it have been maintaining quarterly sales of around ￦20 billion. In principle, in the domestic drug price system, biosimilars can receive up to 70% of the original drug price before the patent expires. Starting in October 2016, 'innovative pharmaceutical companies, equivalent companies, domestic pharmaceutical companies, and products developed by companies that have entered into a joint contract between foreign companies or products that are the country's first licensed country or those produced in Korea' are guaranteed up to 80%. When the biosimilar is released, the patented expiration of the original drug will automatically lower the insurance price to 70-80%. Quarterly sales of Trastuzumab products in 2015-2019 (Unit: ￦100 million, Source: IQVIA) Biosimilar products led the recent expansion of the Trastuzumab market. Celltrion Herzuma's sales in the fourth quarter of last year were ￦6.8 billion, up 115.4% from the same period last year. Herzuma began to generate sales in earnest in the third quarter of 2017, surpassing ￦5 billion in the second quarter of last year as sales continued to rise. Last year's cumulative sales amounted to ￦23 billion, a three-fold increase from a year ago. On the other hand, Samsung Bioepis' Sampenet does not show market presence. Sampenet sold ￦800 million in the fourth quarter of last year. Last year's cumulative sales were ￦2.2 billion. Daewoong Pharmaceutical is responsible for the sale of Sampenet. Biosimilar has greatly increased its share in the Trastuzumab market within two years of starting domestic sales. In the fourth quarter of last year, the share of the two biosimilars in the Trastuzumab ingredient market expanded to 28.2%. Herzuma's market share was 25.3% and Sampenet's 2.9%. In fact, Herzuma led the expansion of the biosimilar market. 'Herzuma 150mg' was added to the reimbursed list with an upper limit of ￦372,692, which is 72% of Herceptin before patent expiration in April 2017. In February 2018, Samsung Bioepis registered an insurance premium of 'Sampenet 150mg' at ￦291,942. This is 56.4% of the price of Herceptin. Since then, in March 2018, Celltrion's insurance price was reduced by 21.7% from ￦372,692 to ￦291,942, making it the same price as Sampenet. The market size of Trastuzumab is similar to that of three years ago, but the actual usage has increased significantly considering the launch of low-cost biosimilar products and the price cuts of original products. This means that the advent of biosimilar, which has the same effect as the original medicine and is inexpensive, has a positive effect on improving patient accessibility.
- Company
- Why Ezetimibe combination drug for dyslipidemia?
- by Eo, Yun-Ho Mar 16, 2020 06:30am
- Professor Chae In-ho For some diseases, combination drugs are vastly preferred than the other. Dipeptidyl peptidase-4 inhibitor plus metformin combination for patients with diabetes, and angiotensin II receptor blocker (ARB) plus calcium channel blocker (CCB) plus alpha combination for patients with hypertension haven taken over significant part of respective overall prescription volumes. And combination drug is also on the rise for dyslipidemia treatment sector for last few years. The combination of statin and ezetimibe is the case. Despite many of specialists’ skepticism on ezetimibe, the drug has proven its catchphrase ‘the lower the LDL-C the better the benefit for cardiovascular system’ in the IMPROVE-IT trial that unveiled in 2015. Since then, the combination drug has gained popularity fast. Basically, ezetimibe-based combination drugs with either rosuvastatin or atorvastatin have shifted the market previously dominated by statin. Daily Pharm interviewed Executive Officer Chae In-ho of Korean Society of Interventional Cardiology (KSIC) (Director of Cardiology Center at Seoul National University Bundang Hospital) about the benefits of combination drugs and ezetimibe. -Do you prefer to prescribe ezetimibe-based combination drug? It would be safe to say the combination drugs have taken deep root as effective dyslipidemia treatment. For a long while, hyperlipidemia treatment was solely relying on statin and used high dosage. But nowadays, non-statin combination therapies previously marginalized have stolen the limelight again. Compared to same dose of statin, ezetimibe combination therapy has similar incidents of side effects but shows even more benefit in reducing LDL-C. When higher dose of statin is used, a patient’s LCL-C level at 100 mg/ dL would fall to 90 mg/ DL, but using ezetimibe combination the numbers fall even lower to 70 mg/ dL. -Is there any other reason why you would prefer the combination drug over the single drug? First of all, it would the convenience for sure. Administration convenience is far superior and drug compliance is also very high. Patients tend to ask a lot more questions than before when they get additional number of pills and they come prepared with basic online research. The patients are happy to hear my explanation about the combination drug not increasing the number of pills but resulting in better effect. Besides, the price of combination drugs in Korea are inexpensive than in other countries. Patients with chronic disease get sensitive about the cost, so the health insurance system is a plus factor for preferring a combination drug. -For the combination drug, there is a choice between rosuvastatin and atorvastatin. Is there a deciding factor when prescribing the combination drug? I don’t personally see a big difference. But I prefer prescribing rosuvastatin plus ezetimibe for a stronger effect. Using 20 mg of rosuvastatin and 40 mg of atorvastatin show similar level of effect, but I feel rosuvastatin lowers LDL-C better in combination. Of course, pharmaceutical companies could say otherwise. Anyway, now atorvastatin has more options with 80 mg dose added to combination option. -Is it possible to use ezetimibe combination on dyslipidemia patient as first-line therapy? Yes. For patients with high risk in acute coronary syndrome (ACS), myocardial infarction (MI) and unstable angina, a combination drug is used for an initial treatment. But for a relatively young patient with risk of arteriosclerosis, high-dose combination drug is used. As diabetic patient tend to have accelerated absorption of cholesterol, ezetimibe could demonstrate more dramatic effect. Because statin causes diabetes more frequently than ezetimibe, it would be more effective to specific patient group with high blood sugar level. Diabetes is treated not only with medication, but also with lifestyle. Cholesterol, relatively more controllable with medicine, should be managed with pharmaceutical push as much as it can. -Regardless, the 2018 dyslipidemia treatment guideline recommended ezetimibe therapy as a second-line therapy. And when the U.S. and Europe recommended LDL-C level of the mentioned groups with very high risk to be lowered to 55 mg/ dL and 40 mg/ dL, respectively, Korea recommended the level to be lowered to 70 mg/ dL. Basically, I agree with the phrase, “The lower the better.” But a guideline is merely a guideline in the end. Using the combination drug for first-line treatment means it’s targeting even more effective LDL-C reduction benefit, which coincides with the mechanism of ‘the lower the better.’ But if you’re asking whether to target 70 mg/ dL or 55 mg/ dL, it would be different case by case. I would be skeptical to prescribe higher dose or stronger drug to lower LDL-C of 80 mg/ dL in a patient with high risk, but who works out regularly and manages body weight. Probably 70 percent of clinicians in Korea and 25 percent in the U.S. would consider the guideline’s recommendation. Ultimately, it is a matter for a physician to judge and decide from their experience and expertise. Ezetimibe combination drug has diversified the choices, and it would be more frequently used as it accumulates prescription history.
- Company
- Handok tops KRW 30 bln PAH treatment market
- by Nho, Byung Chul Mar 16, 2020 06:27am
- (From left) PAH treatment Uptravi, Traclear and Opsumit by Handok Korean pharmaceutical industry is closely paying attention to Handok’s market share constantly growing in pulmonary arterial hypertension (PAH) treatment sector. In 2019, Korean PAH treatment market volume was recorded at 30.7 billion won with 20 percent bump from the previous year. In the market, Handok’s PAH line up—Traclear (6.2 billion won), Opsumit (11 billion won), Uptravi (1.6 billion won)—has taken up 61 percent of the market share generating overall 18.8 billion won together. Opsumit and Traclear are dominating 80 percent of the endothelin receptor antagonists (ERA) PAH treatment market share. And among prostacyclins, Uptravi owns 35 percent of the market share. Products in the general prostacyclin class have soared in the PAH market share. The specific class has grown 56 percent in 2019 from the previous year, where Uptravi’s volume skyrocketed by 128 percent (700 million won to 1.6 billion won). After releasing Traclear in 2006, Handok has launched follow-on drugs, Opsumit and Uptravi in 2016 and 2017, respectively, that are now successfully competing in the PAH treatment market. The company’s effort to raise awareness of PAH since 2010 by organizing a forum and various academic conferences has soundly propelled the business. PAH is a rare disease causing high blood pressure in pulmonary artery, which comes with symptoms of dyspnoea, fainting, anasarca and even the motor nerve could be seriously affected. According to overseas studies, average time of survival after diagnosis has been reported to be around two to three years, and it takes about average of 1.5 years to get diagnosed. PAH treatments are divided into three types—oral, inhalant, and injection. The oral medications are again divided into three types. Traclear (bosentan), Opsumit (macitentan), and Volibris (ambrisentan) are categorized as ERA. Pahtension (sildenafil) and Cialis (tadalafil) are phosphodiesterase type 5 inhibitor (PDE5i). And lastly Uptravi (selexipag) is prostacyclin. Most popularly prescribed PAH treatment, Opsumit has conducted two-year-long trial SERAPHIN, unprecedentedly long for oral PAH medication, and clinically confirmed the lowered risk of mortality and morbidity and reduced hospitalization rate in patients with PAH. According to the study with 742 patients with PAH, an arm administered with 10 mg of Opsumit demonstrated mortality and morbidity 45 percent lower than the placebo arm, and the arm’s death and hospitalization by PAH was reduced by 50 percent. The incidents of side effects, such as increase in hepatoxicity and peripheral edema, were on par with the placebo group, confirming outstanding safety profiled. Unlike other PAH treatment in ERA class, Opsumit has advantages of not requiring monthly hepatoxicity test, and convenience with once-daily administration. And with special case reimbursement for rare disease treatment, the treatment can be provided with various medical aid benefits. Most recently launched Uptravi is the first oral prostacyclin. Unlike other existing options, the medication works selectively on IP receptor that induces vasolidation, and it has been consolidating its position in the PAH treatment market as a combination therapy option since its release. PAH treatment trend in 2008 to 2016 analyzed by Health Insurance Review and Assessment Service (HIRA) found three-year survival in Korea is at 54 percent, which is lower than the U.S. (2006-2007) at 68 percent. As combination therapy rate in Korea is at 18 percent, far lower than 52 percent in the U.S., the figure implies promoted use of combination therapy is needed. In GRPIHON study, extended up to three years with 1,156 patients with PAH, Uptravi has confirmed reduction in mortality and morbidity. Against placebo group (80 percent already administered with ERA or PDE5i), patient group treated with Uptravi combination therapy had 40 percent lower relative risk of mortality and morbidity, showing clinical efficacy in patients who are already in treatment with other options. In Korea, insurance reimbursement is granted on both sequential double and triple combination of PAH treatments. Patients, who used to take either ERA or PDE5i monotherapy or ERA plus PDE5i double combination therapy, could receive reimbursement when combining with Uptravi. As stipulated by PAH treatment’s general reimbursement standard for early combination therapy taken in effect from last June, patients who have been administered with ERA plus PDE5i combination for over three months may receive reimbursement for taking Uptravi as third combination.
- Company
- “Lynparza now available for unmet medical needs in TNBC"
- by Eo, Yun-Ho Mar 13, 2020 06:32am
- Professor Sohn Joohyuk “Breast cancer has various treatment options.” True, but not always for all types of breast cancer. Since the release of Herceptin (trastuzumab), human epidermal growth factor receptor 2-positive (HER2+) breast cancer treatment paradigm has been shifted and follow-on targeted therapies are continuing to enter the market. The launch of Ibrance (palbociclib) has also brought new approach to hormone receptor positive (HR+) and HER2- breast cancer treatment scene. However, triple-negative breast cancer (TNBC), negative in all receptors including estrogen, progesterone and HER2, still has treatment needs unmet. For a long time, chemotherapy has been the only treatment option for TNBC. Although Roche’s targeted therapy Avastin (bevacizumab) has won the indication to treat TNBC for the first time in Korea, the treatment has not been listed for reimbursement, yet. And recently a targeted therapy option was introduced to the TNBC treatment market. AstraZeneca’s Lynparza (olaparib), first indicated to treat patients with ovarian cancer, has released tablet form and expanded its indication. Poly ADP ribose polymerase (PARP) inhibitor Lynparza has heightened the anticipation among patients with gBRCA-mutated TNBC, who have been treated with chemotherapy. Daily Pharm interviewed Professor Sohn Joohyuk of Medical Oncology Division at Severance Hospital about the effect of Lynparza. -What would be the reason behind sluggish development of TNBC treatment? Disease with clear biomarker has treatments developed accordingly, and also developing a treatment requires predictable marketability. 70 percent of breast cancer patients are HR+ patients, and 15 percent of breast cancer is HER2+. But TNBC patients only take up 15 percent of all breast cancer types. And even if a patient is categorized to have TNBC based on diagnosis of exclusion, they could be categorized again into various subtypes. With such diversity in breast cancer types, developing a treatment was surely challenging. But as most of breast cancer treatments these days are in development focusing on TNBC, we could expect to see more of new and promising findings in the future. -In the OlympiAD study, Lynparza-treated patient group demonstrated median progression-free survival (mPFS) of 7.0 months. It is arguable the difference against chemotherapy group with 4.2 months was barely noticeable, which proves the point the treatment for TNBC patient is highly difficult. Despite all, could we say the release of Lynparza is remarkable? It is apparent that TNBC itself is quite aggressive and expecting as effective treatment as HR and HER2+ treatment is not so easy due to diverse types of the cancer. The second-line therapy, after failing first-line therapy through existing anthracycline and taxane options, was limited to chemotherapy to treat TNBC. And because it was so limited that the median overall survival was at around one to 1.5 years. On the other hand, Lynparza has demonstrated significantly longer PFS in OlympiAD study, and response rate was also higher. From clinical point of view, high response rate is always considered crucial factor of consideration, so Lynparza can be viewed as a good option. -Based on the said clinical findings, Lynparza entered the market technically as a second-line treatment. Do you think it has the potential to become a first-line PARP inhibitor option? Sure. OlympiAD trial was designed to test on patients, who have been previously treated with anthracycline and taxane. The study combined patients taking first, second and third-line therapies. -Recently, immunotherapy Tecentriq (atezolizumab) has been approved as a fist-line therapy in combination with paclitaxel. As for a healthcare provider, now you are given two options. How would you utilize the options? For a patient diagnosed with BRCA mutation, I would first use PARP inhibitor on the patient who has been treated with anthracycline and taxane, as a supplementary therapy prior to a surgery. And because doctors have not reached a consensus on prescribing either immunotherapy or PARP inhibitor for TNBC patients, the effective treatment for respective patient could differ case by case. -If PD-L1 is expressed and BRCA is mutated simultaneously, would it possible to combine immunotherapy plus PARP inhibitor plus chemotherapy? At the moment, immunotherapy plus PARP inhibitor combination has an ongoing clinical study, but triple combination has not started a clinical study so it is not easy to say. -PARP inhibitor products in same class are launched one after another. Are there differences between those products? The reported clinical data between Lynparza and Talzenna (talazoparib) were not too far off. Their efficacy and safety profile could be considered on par. A candidate medicine, 'ABT-888' has unveiled meaningful clinical findings. But it is too early to talk about actually using the medicine at this point. Only because they are in a same class, it is not to say there is no difference. But the clinical data disclosed so far showed similar level of effect between Lynparza and talazoparib. -Do you agree Lynparza needs reimbursed prescription? The patients and doctors’ needs for Lynparza-like treatments have been unmet, and patients with TNBC lacked a good treatment option so far. To improve access to Lynparza, we need to both list the drug for reimbursement and improve access to BRCA mutation test. -Lastly, would you like to give us an advice on enhancing breast cancer treatment environment in Korea? To say the least, the current treatment environment has gotten much better. But it would be still helpful to build a better treatment environment by reflecting specialists’ opinions on apparent grey areas. For instance, there is a debate over the timing of using Herceptin, Kadcyla (trastuzumab emtansine), Perjeta (pertuzumab), and docetaxel. The mentioned drugs could be used after a year since the surgery as a supplementary therapy. While using trastuzumab, it is difficult to use TPH when the condition relapses or any other emergency occurs. And sometimes taxane has to be prescribed inevitably to use Kadcyla. More flexible reimbursement listing is needed to appropriate use available options. Although Korea has a wider choice of reimbursed options than in other Asian countries, the country lacks flexibility in listing reimbursement.
