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- 2026-03-19 04:10:02
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- Listed ovarian anticancer Zejula applies for new indications
- by Eo, Yun-Ho Mar 23, 2020 06:28am
- PARP inhibitor Zejula Anticancer treatment Zejula, listed for pharmaceutical reimbursement last year, is now preparing for expanded label. According to related industry on Mar. 23, Takeda Pharmaceuticals Korea has recently submitted an application to expand reimbursement on DNA repairing Poly ADP-ribose Polymerase (PARP) inhibitor Zejula (niraparib). The anticancer treatment is targeting two additional indications; monotherapy for the maintenance treatment of BRCA-negative patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy; and monotherapy to treat relapsed ovarian cancer after receiving third or later-line chemotherapy. Zejula is the first PARP inhibitor, used regardless of BRCA, indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian (fallopian tube or primary peritoneal cancer), who are in response (complete or partial) to platinum-based chemotherapy in Korea last March. Although it was listed for reimbursement last December, the first reimbursement standard is limited to patients with BRCA mutation. However, in major clinical studies, Zejula has demonstrated outstanding improvement on median Progression-Free Survival (mPFS) against placebo. For the fourth-line treatment indication was based on mutlicenter, open-label QUADRA study in adult patients with ovarian cancer, who have received third or later-line treatment. During the clinical study, Zejula demonstrated clinical efficacy with an object response rate (ORR), a primary efficacy endpoint. The patient group with platinum-sensitive homologous repair deficiency (HRD) demonstrated ORR of 24 percent, where as BRCA-positive platinum-sensitive group, BRCA-positive platinum-resistant group and BRCA-positive platinum-refractory group recorded ORR of 39 percent, 29 percent and 19 percent, respectively. And median duration of response (mDOR), a secondary efficacy endpoint, of Zejula was 8.3 months for platinum-sensitive HRD patient group. The study concluded the treatment’s safety profile can be adequately managed with adjusted dosage. Zejula was listed for reimbursement at a price of 76,400 won. The Korean health authority evaluated the treatment is more cost-efficient than AstraZeneca’s Lynparza (olaparib). But because Lynparza was listed with risk sharing agreement (RSA) and pharmacoeconomic evaluation-exemption track, the identical expenditure cap RSA was applied on Zejula as well.
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- Chong Kun Dang co-market Xofluza with Roche
- by Chon, Seung-Hyun Mar 23, 2020 06:27am
- Chong Kun Dang announced on the 19th that it recently signed a joint sales contract with Roche Korea for domestic distribution of the influenza treatment drug 'Xofluza'. Xofluza by RocheRoche Korea and Chong Kun Dang jointly handle marketing and sales of Xofluza, and Chong Kun Dang is responsible for distribution. Xofluza is a drug used to treat influenza virus A/B infection in adolescents and adults over 12 years of age. This product has attracted attention as a new antiviral drug with a new mechanism of action developed after about 20 years since Tamiflu. Unlike conventional oral influenza treatments, which had to be administered for 5 days, Xofluza improved medication convenience so that it could be treated with only one dose. After taking it, it is evaluated that the symptom relief rate is fast and the time to stop the influenza virus detection is shortened. Nic Horridge, President of Roche Korea, said, "Xofluza is an influenza treatment with a new mechanism of action that suppresses the replication of influenza viruses. It has the convenience of a single dose. In cooperation with Chong Kun Dang, who has expertise in sales and marketing, we will present solutions to treatment areas that the existing antiviral drugs have not met and contribute to the promotion of public health”. President Young-ju Kim of Chong Kun Dang said, “We have continued to cooperate with Roche Korea in 2012 by jointly selling Tamiflu for the treatment of influenza. It is expected that this agreement will further strengthen cooperation between the two companies and show synergy”.
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- Daewoong vs Allergan, patent dispute for two years
- by Kim, Jin-Gu Mar 20, 2020 06:25am
- Belkyra (double-chin reduction treatment)The patent dispute between Daewoong Pharmaceutical and Allergan surrounding double-chin reduction treatment 'Belkyra' has not been concluded for the second year. According to the pharmaceutical industry on the 19th, the dispute began in March 2018, two years ago. Daewoong Pharmaceutical filed an invalidation trial of patents for Belkyra against Allergan. In April, the next month, a defensive confirmation trial for the scope of rights was filed. However, even after two years, the referee hasn't even reached a first-final conclusion. It is the consistent evaluation of industry officials that it is unusual, considering the fact that if a normal patent dispute is short, the conclusion can be reached in four months. That doesn't mean that the fights between the two sides are very intense. Of the two referees, only one oral hearing was conducted recently at the invalidation trial. There has not been a full-fledged dispute in a defensive confirmation trial for the scope of rights. In the industry, it is interpreted that the respondent, Allergan, is using a 'time-wasting' strategy. So far, the evaluation that the strategy has worked is dominant. In a defensive confirmation trial for the scope of rights, Allergan submitted 'application for designated period extension' four times over two years. The judges accepted it. In the invalidation trial, Allergan made the same attempt three times. Allergan's time-wasting strategy is also confirmed in the divisional patent application. Allergan registered a new patent of Belkyra on January 9 this year. Some of the existing patents were divided and registered as new patents. It was part of the 'Evergreening strategy' that continues its existence through the split registration. In the patent trial and patent registration, the time-wasting strategy is developed in two tracks. Eventually, Daewoong Pharmaceutical presented a new challenge to the split patent. Daewoong Pharmaceutical raised a judgment to confirm the passive scope of rights. in the new Belkyra formulation patent on the 17th. In conclusion, there are three patent disputes between Daewoong Pharmaceutical and Allergan in Belkyra. The key is the invalidation trial. It is expected that the rest of the judgment will be decided in a similar way depending on the conclusion of the Judge by the Patent Judge. In the industry, the invalidation trial is expected to proceed in earnest. Actually, the Patent Judge showed the will to continue the hearing by changing and designating the judge on the 4th of this month. It is said that oral hearing has also been recently conducted. An official from the pharmaceutical industry said, "It is judged that an active time-wasting strategy was effective in defending the patent strategy (Allergan).However, considering that the oral hearing has recently been held, it is expected that the referee, who has drawn for over 2 years, will accelerate".
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- Salespersons got worked up about pharmacy’s poor sales
- by Jung, Hye-Jin Mar 19, 2020 06:26am
- Pharmaceutical industry sales managers are also suffering from the economic downturn in the medical institution caused by the aftermath of COVID-19. This is due to the fact that some retail pharmacies refuse to pay monthly payments to pharmaceutical salesmen due to a decrease in prescriptions. Even at the end of February, quite a few managers had trouble collecting the bills. However, with the prolonged COVID-19 situation, there are not a few pharmacies that already have difficulty making payments in March, so pharmaceutical companies are suffering in silence. According to the pharmaceutical industry on the 18th, there are quite a few pharmacies that will delay drug payments to pharmaceutical companies due to sluggish sales. In particular, pharmacy managers not only provide product descriptions, but also discuss the details about pharmacy matters and help pharmacists and pharmacy staff, and even after COVID-19 , the main job changed from general medicine promotion to procurement and sales of masks. The biggest concern for pharmaceutical pharmacy managers right now is collection in March. It is known that a number of pharmacies are notifying that it will be difficult to make payments in March. In fact, it is known that the average prescription received in March has been reduced to less than 100 prescriptions/day in one ophthalmology center around Seoul. It is a prescription that came out in close to 300 cases/day in the same month last year. Another pharmacy located in Seoul, also said that prescriptions per day plummeted from 250 to 100 cases per day. Although it varies by region and condition, most pharmacies are suffering from a decrease in patient sales and a drop in prescription sales due to COVID-19. “We had a hard time collecting pharmacies in the last week, even last month when the COVID-19 issue began to take off”, said one pharmaceutical company representative. "Some employees delayed the payment of pharmaceutical companies because of difficulties in pharmacies, so it was said that they gave up about half of their pharmacies". As a result of summing up the prescription trends of the pharmacies he was charge of, the representative said that the decrease in sales was a general phenomenon in the pharmacy. In particular, pharmacies with more than half the number of prescriptions reduced are noticeable. "It's hard to whinge about this situation even worse at a pharmacy," said a representative in charge. Many pharmaceutical companies are working from home, but even this is far from Salespersons. Prior to the sale of public masks, pharmacies requested more masks, so some sales representatives lined up in front of markets and household goods stores to obtain masks. Since the pharmacy started selling public masks, there are a number of pharmaceutical companies in charge of mask packaging, social security number identification, and mask sales.
- Company
- Samsung Biologics, CDO for alzheimer's treatment
- by Lee, Seok-Jun Mar 19, 2020 06:26am
- Samsung Biologics announced on the 17th that it has signed a CDO(Contract Development Organization) partnership with Aprinoia, a Taiwanese company that is developing Alzheimer's treatment. Aprinoia is a Taiwanese bio-venture with specialized technology in developing medical equipment and therapeutics for the diagnosis of degenerative neurological diseases. It is considered a leader in the development of 'tau protein' target antibodies that have been identified as a key cause of Alzheimer's. Samsung Biologics signed a contract to develop a candidate cell line for Aprinoia’s Alzheimer treatment, and provide development services ranging from process development, clinical sample production, and clinical trial planning (IND) submission. In addition to Aprinoia, Samsung Biologics is also undertaking contracts with more than 20 Chinese customers. To date, Samsung Biologics has conducted a total of 48 CDO projects, supporting bioventure drug development and globalization, including clinical trial approval applications and license out support.
- Company
- Pharmaceutical industry focuses on Kyung-Hae Lee from GSK
- by Eo, Yun-Ho Mar 18, 2020 06:35am
- Candidate Kyung-Hae LeePersonnel from executives of multinational pharmaceutical companies is on the list of proportional representative candidates for the United Future Party, attracting the attention of the industry. Kyung-Hae Lee(52) is the current vice president of BioGraphene and has been working in the Foreign Cooperation Department of GlaxoSmithKline (GSK) from 2011 to 2018. The Future Korea Party, the United Future Party’s satellite party, tentatively confirmed the list of candidates for the general election on April 15 and the order number on the 16th. This is the 13th which is rated as the right to win, among the 7 pharmacists who applied for a candidate for proportional representation. She graduated from the Department of Chemistry at Dongguk University and from Sungkyunkwan University School of Pharmacy. She has experience in teaching general chemistry and organic chemistry at the Department of Chemistry at Dongguk University. Prior to joining GSK, She also worked as a policy adviser to former National Assembly member, Eunhee Bae who is now deceased. When she worked for GSK, Kyung-Hae Lee was primarily responsible for expanding the benefits of premium vaccines such as the pneumococcal vaccine 'Synflorix' and the cervical cancer vaccine 'Cervarix'. All of these vaccines are currently included in the National Immunization Program (NIP). In addition, her husband, Won-dong Jeong (53), was the executive officer of Senior Secretary to the President for Political Affairs of Cheongwadae, and is currently a member of the Korea Exchange. Expert committee member Jeong is said to have played a strong role in helping Lee start the political campaign. An official from a multinational pharmaceutical company who worked at GSK said that he was cheering for the new starter by saying that Kyung-Hae Lee had been a good-natured and sincere person since she worked at a pharmaceutical company. Meanwhile, on the list of proportional representatives, Sang-Hyuk Bang (53), a full-time vice-chairman of the Korean Medical Association, was given the number 20 of the elections.
- Company
- 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.”
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- 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.”
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- 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.”
