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- 2025-12-27 08:44:35
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- “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.
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- Vibramycin & Cefdana are out of stock
- by Jung, Hye-Jin Mar 13, 2020 06:30am
- Some of rescription medicines are sold out. In particular, since Vibramycin-N sold out 500 tablets units in 2018, it is expected that units of 100 tablets will be out of stock, which will cause inconvenience to the prescription site. According to the distribution industry on the 11th, the re-supply of both 100 tablets unit and 500 tablets unit of Pfizer’s Vibramycin 100mg has been delayed. Pfizer Pharmaceuticals delayed the re-supply time from January to May of this year. The reason for the supply delay is the production schedule of the manufacturer. Vibramycin 500 tablets units have been delayed in re-supply since 2018. As the 500 tablets units were sold out, it seems that the supply and demand of 100 tablets units have been unbalanced since November 2018. Both 100 units and 500 tablets units are currently out of stock. The supply of 100 tablets units of Daewoong Bio's antibacterial drug 'Cefdana' are also insufficient. Daewoong Bio asked hospitals and pharmacies to order 30 tablets units. Packaging of 100 tablets will be released after April 20th. Korea Pfizer's hypertension treatment, Nitropress 2ml/vial type is also out of stock. It is expected to be available again later this month. The supply of 10mg, 30mg, 50mg, and 60mg of Bisphentin CR cap, a central nervous system stimulant of Mundipharma, was temporarily discontinued. This is due to the export license delay for original developers in Canada, and supply is expected to resume after April 21st. Some prescription drugs and some OTC were discontinued. The decision was made to discontinue 10 bottles units of Pocral Syrup 10ml, by Hanlim’s psychotropic drug, Hanlim announced that supply was discontinued after the final arrival in the second week of April due to difficulties in maintaining product production by consignment company, Kolmar’s situation, consignment company. Pocral syrup 10ml units were released in June 2018 upon the request of many hospitals. However, the leak problem occurred again in the bottle and lid joint, and the company tried to improve it by changing the glass bottle specification and investing in nozzle equipment, but the problem was not resolved, so the decision was made to discontinue production. Samil Pharmaceutical's disinfectant 'Potadin Surgical Scrub' 7.5% 4L packaging is also discontinued. It is a generic drug for Povidone-Iodine solution. Pharmbio Korea announced that there is no plan to re-supply RIBON 150mg 1 tablet units, an osteoporosis treatment.
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- The Thai government has eased regulations on fillers
- by Kim, Jin-Gu Mar 13, 2020 06:30am
- Export of Hyaluronic acid filler to Thailand becomes easy. This is due to the Thai government's classification of hyaluronic acid fillers as medical devices, not pharmaceuticals, in Thailand starting tomorrow (11th). It is expected that domestic companies' entry into Thailand will accelerate as related certification requirements ease. According to KOTRA (Korea Trade-Investment Promotion Agency) on the 11th, Thailand will change the supervision of Hyaluronic acid fillers from the current FDA's Drug Management Bureau to the Medical Device Management Bureau. The classification of products is changed to 'Licensed Medical Devices' from 'Risk or Specially Managed Drugs among Drugs'. According to the Thai medical device classification, licensed medical devices include contact lenses, disposable syringes, surgical gloves, condoms, and HIV diagnostic devices. However, it is limited to products intended for skin treatment. Fillers used in addition to skin, such as knee pain treatment, are classified as pharmaceuticals as in the past. Hyaluronic acid filler's export certification requirements will likely ease as the classification system is changed. In the case of pharmaceuticals, certification requirements for safety and effectiveness were more difficult than medical devices. To export drugs to Thailand, A license to manufacture, import, and sell drugs from the Thai FDA must be obtained, and separately, Certification from the Food and Drug Administration for individual drugs must be obtained, too. At this time, documents such as the results of the non-clinical and clinical tests, chemical composition, manufacturing formula, quality control, and labeling should be submitted. In the case of medical devices, it is the same to obtain manufacturing, import, and sales licenses. However, the required documents are the application for permission, the sales certificate proved by the producing country, and documents related to side effects. As of 2018, a total of 35,018 cosmetic non-surgery methods in Thailand were counted. The proportion of Hyaluronic acid filler treatment is 27.1%, the second after Botulinum toxin treatment (58.7%). Hyaluronic Acid Filler Import Trend in Thailand as of 2019 (Data: KOTRA)Last year, Thailand's imports of Hyaluronic acid fillers amounted to $255.3 million. The share of French fillers is the highest at 25.7%. It is said that some brands from France, Sweden and Canada have a high share. Korea's share is 6.5%, ranking seventh. The amount is $16.69 million. An official from Kotra predicted that the change in the classification system would be particularly beneficial for Korean pharmaceutical companies. An official of KOTRA explained, "To date, the market of Hyaluronic acid filler in Thailand has a very high share of brands in some countries such as France and Sweden". He said, “But this change would make it easier for Korea to export to Thailand, Especially, it is expected to act advantageously for entry of Korean products with excellent quality and competitive prices”. He said, "Europe and Canada do not have an FTA with Thailand, so they have to pay 30% of the general import taxes, but in Korea, the Korea-ASEAN FTA Agreement is applicable so that they can enter the Thai market without taxes". Among domestic pharmaceutical companies, Medytox, Daehan New Pharm, Yooyoung pharmaceutical, Dongkook, and Hugel have been confirmed to have entered or are entering the Thai filler market.
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- Bukwang “Levovir as effective as Kaletra on COVID-19”
- by Lee, Seok-Jun Mar 13, 2020 06:30am
- On Mar. 10, Bukwang Pharmaceutical announced its new treatment for hepatitis B Levovir (clevudine) has demonstrated treament effect on par with HIV drug Kaletra, also used to treat COVID-19. According to the Korean company, Levovir has been tested in vitro on virus extracted from Korean COVID-19 patient’s samples. Kaletra’s active pharmaceutical ingredient was used as positive control group. In plaque reduction neutralization test and real-time PCR, Levovir showed similar level of treatment effect with Kaletra. Clevudine is antiviral agent developed by Bukwang Pharmaceutical. The drug was released as a fourth hepatitis B virus treatment in the world and first in Asia. As a nucleoside analogue, clevudine has a mechanism to inhibit replication of virus DNA. Bukwang Pharmaceutical official said, “Based on the findings, the company would discuss with Ministry of Food and Drug Safety about further development plan like follow-up clinical trial.”
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- Venclexta will be prescribed in major hospitals soon
- by Eo, Yun-Ho Mar 12, 2020 06:07am
- Venclaxta, which is ready for insurance benefits, will be prescribed at a general hospital soon. According to the related industry, Abbvie's Chronic Lymphocytic Leukemia (CLL) treatment, Venclexta (Venetoclax), passed DC (drug committee) of 5 big major Hospitals such as Seoul National University Hospital, Seoul St. Mary's Hospital, Severance Hospital, and Asan Medical Center. This drug is the first and only oral inhibitor of B-cell lymphoma-2 (BCL-2) in Korea. Recently, it concluded a drug price negotiation with the NHIS and is expected to be presented to the Health Insurance Policy Deliberative Committee. Reimbursed prescriptions will be available as early as April. Venclexta inhibits excessive expression of BCL-2 protein, which inhibits apoptosis in chronic lymphocytic leukemia, in which lymphocytes in the blood are significantly increased. It selectively binds to the BCL-2 protein and inhibits its function to induce apoptosis, a new mechanism of treatment that prevents cancer cells from proliferating and worsening abnormally. Authorization is based on the results of the M14-032 study for phase II clinical trial to evaluate the efficacy in patients with chronic lymphocytic leukemia who have a history of treatment with Imbruvica (Ibrutinib) or Zydelig (Idelalisib). As a result, the overall response rate (ORR) of 127 Venclexta-treated patients was 70%. According to the latest results, the number of leukemia cells remaining in the peripheral blood or bone marrow analyzed the patient group with a minimal residual disease (MRD), which is an indicator of the remission and risk of recurrence. In patients without disease, the median progression-free survival (PFS) was more than 2 years (24.7 months). Jin-seok Kim, professor of hematology at Severance Hospital, said, "The introduction of Venclexta has opened the way for patients who are old or have failed or relapsed to continue treatment".
- Company
- “No changes in safety and efficacy of montelukast”
- by Kim, Jin-Gu Mar 12, 2020 06:07am
- Medical academics argue there is “no change in safety and efficacy of montelukast,” currently controversial with safety risk. Professor Kim Chang Geun (Director of Inje Uniersity Sanggye Paik Hospital the Asthma and Allergies Center and President of Pneumonia and Respiratory Diseases Study Group at Korean Academy of Pediatric Allergy and Respiratory Disease) Director Kim Chang Geun of Inje Uniersity Sanggye Paik Hospital the Asthma and Allergies Center spoke on Mar. 9 at a roundtable with press. The President of Pneumonia and Respiratory Diseases Study Group at Korean Academy of Pediatric Allergy and Respiratory Disease (KAPARD), Director Kim stressed “The neuropsychiatric event from montelukast has been labeled on the drugs since 2008, which the prescribers are already aware of.” On Mar. 4, the U.S. Food and Drug Administration (FDA) has announced it would require Boxed Warning on montelukast products, including Singulair and generics. The U.S. health authority took the action after learning many healthcare providers, patients and caregivers are unaware of mental health side effect, such as anxiety, depression, sleep disorder and suicidal thoughts. FDA also recommended the drug would be used for “only patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies.” Montelukast is vastly used for patients with asthma and allergy. The used volumes in Korea and Japan are particularly high. Although the alternative options advised by FDA are inhaled steroid and antihistaminic medicines, Professor Kim Chang Geun explains the use of those options would highly unlikely in Korea. Following is his answers to interview questions. -How are patients and caregivers reacting to the news? “A patient asked about the warning and if it would be okay to use it. I answered there is no specific change to the drug’s state of safety or efficacy. The said side effects are not newly discovered. Rather, the medications have been used for over two decades. I reminded the patient to read about the listed side effects carefully.” -Please explain how has treatment for allergic rhinitis been prescribed so far “Montelukast was the go-to medicine. Depending on the symptoms, other medicines were added. Antihistaminic agent was prescribed for serious sneezing, and steroid was prescribed for serious nasal congestion. And if the allergic antigen was clear, then immunotherapy was provided as well.” -Basically, the FDA’s announcement recommended montelukast as a second-line treatment for mild case of allergic rhinitis. Could it affect the trend of prescription on mild case of allergic rhinitis? “The FDA announcement could be summarized to two points; think twice before prescribing the medication to patients with asthma and select other alternative for patients with mild allergic rhinitis. The key is prescription for rhinitis. FDA mentioned three medicines for alternative options—antihistaminic agent, inhaled steroid, and immunotherapy. “Personally, the tendency of my prescription would not change. We do not have that many options to choose from. Patients and caregivers are highly resistant to inhaled steroid in Korea. Healthcare providers also tend to steer away from it, because we are aware of even worse side effects. Antihistaminic medicines are hardly a treatment. And immunotherapy is for limited use only.” -How about leukotriene receptor antagonist instead of montelukast? “Pranlukast would be an option. But it hasn’t got the U.S. FDA approval, yet. Developed from Japan, the medicine is used in Japan, Korea, China, Turkey and Mexico, as far as I know. I heard of zileuton and zafirlukast. But technically, they have not been used at clinical scenes.” -Considering the medicine is indicated to treat pediatric patients over age one, should the parents with young patient worry more about it? “Along with the official statement, FDA has attached a related research result. It compared side effect prevalence between montelukast and inhaled steroid used to treat patients over six. The result is that there is not much difference found between those two. It is not easy to evaluate patients aged one to five. But, with my 20 years of experience in the clinical scene, I have not found such side effect.” -What do you make of the FDA’s decision? “I’m not trying to defend the medication. But what I can assure is that it does not mean a new side effect has been reported. The point of the action was to highlight the neuropsychiatric side effect, labeled since 2008 to be exact, for healthcare professionals and patients to be aware of it. There is no change in the medication’s safety or efficacy. The clinical professionals are well-aware of the side effects. I assume the medication could be used without a problem, as it has been to this date. “Moreover, FDA said the cause and effect has not been clarified, yet. It only stated such case has been reported. So a patient suffering from neuropsychiatric side effect has used montelukast, but it wasn’t the only prescribed medication. It could have been the steroidal medication that caused the event. The disease itself tends to affect mental health as well. Regardless of the prescription, patients complain of anxiety and depression.”
- Company
- Household brand pain reliever Geworin price goes up
- by Jung, Hye-Jin Mar 12, 2020 06:03am
- Household brand pain reliever Geworin’s price would be raised by 8 percent to 9 percent around March or April. According to pharmacy and pharmaceutical distributor sources, Samjin Pharm has decided to adjust supply price of Geworin after contemplating on it for months. In this week, the company would officially notify the decision to wholesale distributors and pharmacies. The increase in Geworin’s price is first in four years. In February 2016, Samjin Pharm pushed up Geworin’s pharmacy supply price by 15 percent. The price was increased in 2007 before. Regardless, pharmaceutical distribution industry has been anticipating the price increase. Majority of popular brand pain relievers have raised their prices last year, and made Geworin’s supply price surge predictable. Prices of Janssen Korea’s Tylenol and Chong Kun Dang’s Penzal-Q have gone up last year, and Daewoong Pharmaceutical’s EZN 6 joined the club in January. Including Geworin, four popular brands of pain relievers have raised their supply prices in nine months from last June to this month. Janssen Korea took the lead in the series of price increase. The global company announced in last May that prices of all Tylenol items except for the ER tablet would be raised from last July. Janssen Korea followed through with the announcement and the increase rate was not insignificant. The price of Tylenol 500 mg, Tylenol Cold-S, Tylenol Suspension, Tylenol Chewable, and Women’s Tylenol were raised by 18.6 percent, 25 percent, 18.6 percent, 18.6 percent and 14.9 percent, respectively. Also in 2017, Janssen Korea has raised the supply price of Tylenol Cold-S and Chewable by 14.8 percent and 14.2 percent, respectively. It seems the market leader Tylenol has affected the follow-on drugs’ price inflation. A few days after Janssen’s announcement, Chong Kun Dang followed up with an announcement to raise the supply price of Penzal-Q as of June 1. And Daewoong Pharmaceutical also raised the price of EZN 6 from February. The price of EZN 6 series (Any, Eve, Pro, Strong and Ace) has been raised by 8 percent. All companies explained the common reason behind the price bump is ‘reflecting production price increase due to increased raw material price.’ Considering the reason, Samjin Pharmaceutical took its time to adjust the price longer than other companies. So why are these pharmaceutical companies raising the pain reliever drug prices? Sources analyze respective companies’ assertive advertisement campaigns have heightened the intense market competition. Specifically, TV ads tremendously bump up the marketing cost and eventually cause surge in supply price. The fact that among top selling pain relievers—Tylenol, Geworin, Maxibupen, EZN 6, Tak-sen, Carol and Penzal—ones without high-cost TV ads are not planning to raise their price supports the claim. A pharmaceutical industry insider explained, “Pain reliever market is saturated as consumer accessibility is high. Their prices seem to go up often due to high marketing activities to expand market share.”
- Company
- Next-gen insulin medications approved for pediatric patients
- by Eo, Yun-Ho Mar 11, 2020 06:27am
- Next generation insulin medications are actively seeking for expanded indication to treat children and adolescents. Novo Nordisk’s rapid-acting insulin Fiasp FlexTouch (insulin aspart) has recently won indication to treat to children aged under two and adolescents. Fiasp is a next-generation fast-acting mealtime insulin injection that controls high blood sugar effectively and safely. The injection features the addition of vitamin B3 (niacinamide) and L-arginine amino acid to increase the speed of initial insulin absorption and to double the mealtime onset of appearance in the bloodstream. Fiasp has previously won pediatric indication from EU and the U.S. Food and Drug Administration (FDA). The indication expansion was based on the outcomes of ONSET7 trial in 777 children and adolescent with type 1 diabetes. As a result, Fiasp demonstrated effect of hemoglobin A1C control non-inferior against other existing fast-acting insulin ‘NovoRapid,’ and showed no other safety risks. The U.S. FDA also additionally indicated Sanofi-Aventis’ long-acting insulin Toujeo (genetic recombinant insulin glargine) to treat children over six and adolescent with type 1 and type 2 diabetes. Toujeo also successfully received approval on the expanded indication in Europe last October. The new approval was based on the outcomes of EDITION JUNIOR clinical trial. The EDITION JUNIOR trial was conducted with 453 children and adolescents aged between six to 17 with type 1 diabetes, who have been treated for at least a year and showed hemoglobin A1C ranging from 7.5 percent to 11.0 percent at screening. Patients were randomly assigned to either Toujeo or Gla-100 group, and administered the treatment before generic mealtimes. In the end, Toujeo reached the primary endpoint. At week 26, the Toujeo patient group against Gla-100 group demonstrated non-inferior reduction rate of A1C. Korean Diabetes Association official said, “As next generation insulin has resolved the low blood sugar level issues and significantly improved hypoglycemic effect, it would be a helpful treatment option for children and adolescents with diabetes.”
- Company
- Celltrion, apply for European license for CT-P17
- by An, Kyung-Jin Mar 11, 2020 06:27am
- HumiraCelltrion is the first in the Humira (Adalimumab) market for its global sales of ₩20 billion. Celltrion announced on the 9th that it has completed application for Humira biosimilar 'CT-P17' to the European Medicines Agency (EMA) on the 6th (local time). Humira, the original drug of CT-P17, is the most sold blockbuster product in the global market. According to Abbvie, the original developer, the company recorded global sales of $19.17 billion last year. Humira's bio patents expired in October 2018, and it is competing with Samsung Bioepis’ Imraldi, Amgen’s Amgevita, Hyrimoz by Sandoz and Mylan·Fujifilm’s Hulio. Humira's European sales declined 31.1% last year due to the price-competitive release of biosimilars. If Celltrion is going to sell its CT-P17 in Europe one year later, it will have to overcome the limitation of generic drug. Celltrion's differentiation strategy is that CT-P17 is the first high concentration formulation of Adalimumab-based biosimilars. The patient's convenience is maximized by reducing the dose by half compared to conventional biosimilar products. Another advantage is that it eliminates citrate, which can cause pain when injecting. Celltrion is demonstrating its influence in the market of TNF-α inhibitors with its first product globally, 'Remsima'. According to IQVIA's global market research institute, 'Remsima' surpassed original products with 59% market share in the third quarter of last year. Following the recent release of the subcutaneous injection type, Remsima SC in Germany and the UK, it plans to Expand Autoimmune Disease Therapeutics Portfolio through commercialization of Humira's biosimilar 'CT-P17'. An official at the Celltrion company said that it is preparing to expand the market for TNF-α inhibitors by completing the application of CT-P17's EMA license following Remsima SC, which received EMA sales license in November last year and we will do our best for the early launch of CT-P17 which has differentiated product from the existing Humira Biosimilar.
- Company
- Drug industry's ‘Corona Blue,’ “We miss our mundane life"
- by Chon, Seung-Hyun Mar 11, 2020 06:27am
- “Life with COVID-19” 50 days have passed since the 2019 novel coronavirus (COVID-19) started infecting Korea. COVID-19 has consumed the whole of Korea in merely 20 days after 31st patient was confirmed with infection on last Feb. 19. As of last Sunday 4 p.m., 7,313 people were confirmed with COVID-19 in Korea. As the COVID-19 outbreak has been lingering longer than expected, a new term, ‘Corona Blue,’ has emerged. Apparently, it means the symptom of feeling depressed or lethargic from COVID-19 outbreak changing the lifestyle. The outbreak also entirely changed the pharmaceutical industry workers’ lives. The commuting route has been simplified to home and office. To avoid infection, salespeople started working from home at early stage as they usually visit number of healthcare institutes. Most of office employees are also working from home or visit offices only when needed. Chats between colleagues are almost non-existent. Meetings with vendors and clients are avoided as much as possible. This is a scope into the lives of pharmaceutical industry experiencing small and big changes amid COVID-19 outbreak. ▶Sales Director of 11 years “Working from home but still restless” Director Kim working at Sales Division in a Korean pharmaceutical company starts his day from home. When the number of confirmed COVID-19 patients surpassed a thousand on Feb. 26, all salespeople were ordered to stay put and work from home. “I’m all up for not commuting…” But will they me for plummeted sales? Although working from home is convenient without the hustle and bustle of public transportation, Kim is getting anxious day by day with the company pressuring on the sales performance. He worries greatly of prescription rate dropping as he stopped visiting his clients. But then again, visiting a healthcare institute is also terrifying. If Kim contracts COVID-19 while visiting hospitals and clinics, all of them would have to close temporarily. The damage is unfathomable. His company could be reproached for not managing a salesperson properly. The company seems to be encouraging sales activity through online or social media channels, but it is not as effective. Pressured by the boss ordering him to thoroughly manage his accounts, Director Kim visits a hospital despite he is supposedly working from home. Meeting the director of hospital was easy with far less patients visiting, but the director asked him “to refrain from visiting hospital for a while with the outbreak.” ▶Veteran pharmacy salesperson Senior Director Cho ”Cannot even visit pharmacy with a long line of customers buying masks” Senior Director Cho is a veteran salesperson with 18 years of experience in pharmacy sales. He has never struggled with sales like this before. Judging that pharmacy would be less exposed to the risk of infection, Cho prefers to visit pharmacy than hospitals or clinics. And because of unique quality of pharmacy sales, he has much to handle at pharmacies. “If I line up, could I please have a chat with the pharmacist?” However, an ordinary sales activity is impossible as every pharmacy is in chaos selling masks. Cho was exhausted for a while as pharmacists requested him to get supply of masks. As pharmacists asked him not visit last month, he missed out on a month-worth of due and did not meet his target payment. It is not easy to even talk about his products lately, when the pharmacists vent their tremendous stress. Pharmacists are deeply worried about the plunging number of prescription from neighboring healthcare institutes. They are tensed up about managing customers lining up from early morning to buy masks and dealing with the complicated procedure of supplying government-issued masks. Although Cho wants to ask about the sales of a newly released product that the neighboring hospital has started prescribing, he can barely step into the pharmacy with a long line of crowd waiting outside to purchase a mask. ▶Factory workers “Contracting the virus means substantial loss to the company” Manager Ahn, in charge of production management at a pharmaceutical manufacturing factory, dreads to go to work these days. As for factory employees like himself, working from home is a distant story. If any one of the employees is confirmed with COVID-19, then all manufacturing has to be stop for disinfection while the factory is closed for days. One confirmed case in the factory could cause a massive loss for the company. Manager Ahn is always on pins and needles in case one of the employees is infected. “It could’ve been us…” His heart dropped when he heard an employee at a pharmaceutical company’s R&D facility was reportedly confirmed with COVID-19 infection. Manager Ahn checks COVID-19 infection among the employees around the clock. Some managers ask employees of who they met the day before. Infrared thermometers have been installed around the facility, and employees’ body temperatures are checked constantly. As some managers are threatening the employees to not contract COVID-19, colleagues are avoiding close encounters. It is even more depressing to hear the news of nearby kimchi stew place he frequently visited is now not serving the lunch menu. ▶Senior Manager Suh at Government Affairs Team "Bioequivalence test and overseas on-site inspection all suspended " Senior Manager Suh at Government Affairs Team of a Korean pharmaceutical company has been extremely stressed out. The company is in emergency state as a healthcare institute supposed to execute bioequivalence test for the company’s generic product has informed it would suspend all face-to-face meetings for next two weeks. “Calling MFDS is more difficult than buying a mask” To prepare for the revised drug pricing system coming in effect from July, Senior Director Suh has fully scheduled bioequivalence tests to be done before. Suh fears the unexpected break would get longer with the prolonged COVID-19 outbreak. Suh keeps on tossing and turning at night thinking about how generic drug business strategy would be affected, as well as about failing to defend the current pricing of already released generics. The senior manager is tempted to call and ask about the situation to Ministry of Health and Welfare (MOHW) and Ministry of Food and Drug Safety (MFDS), but it is not that easy with the government bodies responding to the outbreak like managing government-issued masks. Since the virus has been spreading, pharmaceutical approval procedure has slowed as well. Companies have gone the distance to sign marketing deals for Korea with overseas companies, but MFDS is hesitant to conduct overseas on-site inspection. Actually, the overall approval procedures are halted with many of foreign countries closing their doors on Korean travelers. It is now even more frustrating as the office employees have been given an order to work from home. Meeting up with vendors and teammates would unlikely to happen from now on. ▶Director Chung from Personnel "Hiring a new employee is like guerilla tactic” Director Chung from a new biopharmaceutical company’s Human Resources Team just spent a hectic week. Concerned of unwanted break in business operation from an employee contracting COVID-19, the team has proactively coming into office in rotation to minimize the infection risk. But the whole team was in a panic mode as an employee, who has recently returned from an overseas business trip, had cold-like symptoms. “First time convening a video conference…” It’s time for lunch when everyone is finally online Ordering the team members to self-quarantine has almost pulled the plug on the company’s operation. As the team never had sufficient number of employees, the team was complaining about the workload surged from covering for the self-quarantined employee. Although the team tried online video conference call but it was a sluggish process with not everyone familiar with the system. The situation worsened around Feb. 26, when the number of confirmed cases in Korea exceeded one thousand. A day before the interview session with prospective employees, the company has decided to push down the date by a week during an emergency meeting. Chung had to individually contact the interviewee and explained the situation apologetically. The situation has not gotten any better, yet. Big companies could simply postpone the recruitment, but Chung’s company is relentlessly requesting for additional employee. The director could not help it but to schedule an online video interview. And as the interview date approached, Chung is getting restless for any technical difficulties during the interview. ▶PM Lee at a global pharmaceutical company “I miss the days I went to the office” Project Manager Lee working with Marketing Division at a multinational pharmaceutical company is getting depressed growingly after working from home for about a month. Productivity seems to falter as most of the meetings are conducted through social media. And marketing activity is out of the question as various academic conferences and seminars are canceled. A regular marketing meeting convened with Korean company for the co-marketed product has been postponed indefinitely. While the first quarter of the year is already ending, the marketing team did not even get to initiate the ambitious promotional strategy targeting medical doctors and pharmacists. “I miss my mundane life at work” It feels as if the company is watching Lee, when working from home on a laptop with security program installed. And it is upsetting when the boss accuses him of not working, while he actually worked even more than usual. PM Lee is even hesitant to go out to a nearby café for a cup of coffee. Working at the office with temperature check after a crowded metro commute might feel better at this point. Is it because of the stagnating performance? The executives seem to nag more than usual. In a group chat, criticisms and orders are given ceaselessly. “Nagging might even sound better in person. I’ve never thought that I would miss the mundane life so much. Hopefully, the outbreak would be contained soon so I can go out and enjoy a nice refreshing glass of beer with my colleagues.”
