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- 2025-12-27 05:14:56
- Company
- Sanofi to dismiss 3 sales reps breaching compliance
- by An, Kyung-Jin Jun 25, 2020 06:08am
- Accused of false reporting client visits, three sales reps from Sanofi-Aventis Korea may be dismissed as recommended by the headquarters. The sales department seems to be stirred by the management and commented, “The management has made a harsh decision disregarding the possibility of system error.” The sign of internal dispute is apparent as the labor union pointed out the Korean branch proceeding the headquarters’ disciplinary decision straight. According to the industry sources on June 25, Sanofi-Aventis Korea has referred two sales reps to its disciplinary committee on June 18. The committee review was conducted to verify the accusation of the sales reps falsely reporting the number of client visitation, which the headquarters said to ‘recommend dismissal.’ Another disciplinary committee review session is scheduled on June 29 for the same accusation on a different sales rep. The committee is deferring the decision on the first two for now. The level of disciplinary action would be finalized after accepting and reviewing additional explanatory evidence for a week since the disciplinary committee review. The incident began back in late last year. An insider from Sanofi says Ethics and Business Integrity (EBI) department at Korean branch, in charge of compliance affairs, received a report and called in a number of sales reps affiliated under Daejeon, Jeonju, Busan and Daegu offices to Seoul headquarters for further investigation. The reason for investigation was the unmatched information among call records (number of healthcare provider visitation by sales rep) in Centrix, highway toll payment system Hi-pass, parking receipt, and corporate card history documented from February to May of 2019. The EBI department reported three of the investigated sales reps for making ‘false calls’ as some of their Centrix call records, time and location were not matching and did not follow the initial plan. The headquarters assessed the report and officially ‘recommended dismissal’ on the three reps, which now convened the disciplinary committee. Sanofi sales department is reportedly shaken by the management’s decision. Sanofi has ordered dismissal on some sales reps for breaching the compliance code. The employees are complaining the management’s disciplinary actions are extreme and unfair as they are solely dependent on electronic records and overlooking troubles in the sales scene. An insider from Sanofi sales department noted, “Changes in planned call is always occurring depending on the paper work, team meeting, corporate training and client situation. Inputting calls into Centrix within three days causes error or inevitably mixed up time input due to limitations in the system.” The sales department explains the employees’ performance is reviewed focusing more on the frequency of product detailing, meal with client, monthly seminar and other indicators than on call records in Centrix. The insider complained, “The sales department directors do not even pay attention to the Centrix call records. Without sufficient explanatory evidence, making a harsh disciplinary decision like dismissal only based on electronic data is unjust.” The labor union in Sanofi-Aventis Korea expressed concern about the disciplinary committee and their effectiveness. Appealing to the disciplinary committee in Korean branch is merely a formality, and the headquarters’ decision is most likely to become the final decision. The head of Sanofi-Aventis Korea Labor Union, Park Young stated, “Stressing on the principle of ‘Zero Defect Zero Tolerance,’ the French headquarters has been making disciplinary decisions without fully considering the Korean employees’ circumstances. The employees are growing increasingly frustrated with the bureaucratic management by the Korean branch management and CP department, and superficial procedure taken by the disciplinary committee,” and “if their past conduct is repeated, the labor union would fight with everything to protect the union member.” In 2016, Sanofi has dismissed two sales reps for paying their team dinner with corporate card as ordered by the team manager. In 2019, a sales rep, affiliated under consumer healthcare sector handling OTC, was dismissed after being accused of deliberately returning the product late to keep incentives. Two cases fired up the criticism of unjust dismissal as the employees’ appeals were not accepted according to the French headquarters’ principle of ‘zero tolerance on breaching compliance.’ The corporate management says a detailed answer cannot be given at this point with the internal review still ongoing. A Sanofi-Aventis Korea official stated, “We are aware of the responsibility in credibility the patients, families and healthcare providers have on the company. To fully serve the social responsibility, the company would always strive to strictly follow the business ethics and compliance code.”
- Company
- Hanmi's Gugu was released in Japan
- by Chon, Seung-Hyun Jun 25, 2020 06:08am
- Hanmi's erectile dysfunction treatment 'Gugu' was released in Japan as a treatment for prostate hyperplasia. According to Hanmi on the 23rd, Sandoz began to sell Gugu 2.5mg and 5mg from all over Japan on the 18th. The Japanese product name is “Sandoz Tadalafil” (Tadalafil Tablets 2.5mg∙5mg ZA SANDOZ). Gugu released in JapanGugu is generic for Cialis, an erectile dysfunction treatment. It was approved from Ministry of Health, Labour and Welfare of Japan as a first generic for treating prostatic hyperplasia in February. Hanmi produces Tadalafil from Paltan smart plant and supplies them to Sandoz. Sandoz goes through the packaging process and conducts sales and marketing across Japan. Hanmi plans to continue close cooperation with Sandoz with the goal of securing the largest share of the Japanese prostate hyperplasia treatment market. An official from Hanmi said, “Googu has established itself as a leader in the domestic urinary treatment market based on excellent product strength, trust from medical staff, and patients. Through close cooperation with Sandoz, we will try to achieve remarkable results in new markets.”
- Company
- COVID-19 devastates outpatient prescription in April-May
- by Chon, Seung-Hyun Jun 25, 2020 06:07am
- Top pharmaceutical companies have been struggling with outpatient prescription sales for two consecutive months. The COVID-19 seems to have slowed down drug prescription for nine out of ten major pharmaceutical companies in last two months and impacted the overall prescription volume this year. On June 22, pharmaceutical market research firm UBIST found Hanmi Pharmaceutical has achieved the highest outpatient prescription sales at 271.5 billion won accumulating from this year January to May. The company made a growth of 0.1 percent from last year same time and topped the market. Regardless, the growth was rather sluggish. Major pharmaceutical companies’ cumulative outpatient prescription sales in May (Source: UBIST) Most of the major pharmaceutical companies took a severe hit with the prescription drugs compared to last year. From January to May, Chong Kun Dang made 242 billion won and came in second, but the cumulative sales were 3.0 percent lower than last year same time. Also, Pfizer Pharmaceutical Korea’s prescription sales were dipped by 6.3 percent. 12 out of top 20 companies, including Chong Kun Dang, Pfizer, Daewoong Pharmaceutical, MSD Korea, Novartis Korea, Yuhan, Dong-A ST, Daewon Pharmaceutical, Jeil Pharmaceutical, Ildong Pharmaceutical Astellas Pharma Korea and Samjin Pharmaceutical, accumulated prescription sales less than last year. Particularly, Daewoong and Ildong took a steep fall over 10 percent this year. The stagnation in this year’s prescription drug sales worsened in April and May. 18 out of top 20 companies had April and May prescription sales lower than last year. It means 90 percent of the companies failed to reach last year’s sales. Performances in those months contrasted to that of the first quarter, when most of the pharmaceutical companies performed better than last year. In the first quarter, only six out of the 20 companies—Pfizer, Daewoong, MSD, Novartis, Yuhan, Ildong, Astellas and Samjin—performed worse than last year. But the prescription sales noticeably stagnated in slow April and May. Hanmi and Chong Kun Dang, the two market leaders, recorded 8.3 percent and 9.5 percent decrease in April and May prescription sales against last year. Major pharmaceutical companies’ outpatient prescription sales in April and May combined (Source: UBIST) Hanmi’s first quarter prescription sales grew by 6.2 percent from last year’s first quarter. But it fell by 8.7 percent and 7.9 percent in April and May, respectively. Pfizer’s first quarter prescription sales this year was dropped by 4.1 percent from last year, but April and May sales were brought down further by 9.3 percent. Daewoong, MSD, Novartis, Yuhan, Daewon, Ildong and Astellas’ prescription sales fell by over two-digit in this April and May. Following the 7.0-percent fall in the first quarter, Ildong’s sales fell by 20.8 percent in April and May from previous year. The market experts analyze many of the patients with chronic disease refrained from visiting healthcare institutes and hoarded necessary drug in advance, which created a significant prescription void in April. In fact, when the number of confirmed COVID-19 cases dramatically surged, many of those patients requested for prescription lasting three to six months. On top of everything else, the experts suspect visit to healthcare providers has gone down, because postponed school semester, social distancing and keeping personal hygiene reduced the disease prevalence in infants and children. The overall outpatient prescription sales in this year’s first quarter reached 3.70 trillion won, showing 2.7-percent growth from last year at 3.60 trillion won. But the outpatient prescription sales in April and May combined was at 2.36 trillion won, sliding down 9.4 percent from last year. The prescription sales in this year’s April and May against last year plummeted by 8.7 percent and 9.4 percent, respectively. On the contrary, Celltrion and Hutecs Korea Pharmaceutical exhibited outstanding growth despite general stagnation in prescription drug sales. Surging 32.0 percent, Celltrion’s cumulative prescription sales in May reached 89.4 billion won. Celltrion continued to make striking growth of 21.0 percent in this year’s April and May against last year, after making 40.6 percent surge in the first quarter. Hutecs’s cumulative sales in May this year grew by 12.6 percent, generating 90.7 billion won. This year’s first quarter prescription sales marked 55.6 billion won increasing by 20.1 percent from last year. April and May prescription drug sales this year only grew by 2.3 percent than last year, but the company and Celltrion were the only two companies that maintained the growth.
- Company
- COVID-19's budget is being delayed in the National Assembly
- by Nho, Byung Chul Jun 24, 2020 06:14am
- With the global spread of COVID-19, vaccines and treatments are urgently needed, and the government's promised support budget plan is not in progress. Unlike the fast and full support in developed countries, there is concern that the support may be delayed and the golden time to overcome COVID-19 may be missed. As of the 23rd, 15 domestic COVID-19 related vaccines and treatments are being conducted by pharmaceutical companies and research institutes in Korea. In addition to Remdesivir which is recommended for the treatment of COVID-19 by the central clinical committee for emerging disease control, anti-viral drugs, immunotherapeutics, and preventive vaccines, which have been developed in-house, have entered clinical trials. Even though the industry suffered from COVID-19 patient loss, there are many pipelines related to COVID-19 that have not yet entered clinical trials. The industry and research institutes are doing their best because they need to succeed in developing vaccines and therapeutics that can produce and supply their own products to prevent the spread of COVID-19 in Korea and prepare for the post COVID-19 era where new infectious diseases can occur. Countries around the world are removing various regulations for the rapid release of vaccines and treatments, and investing in R&D even in the economic crisis. First of all, the United States is running an ultra-high-speed project that cuts the expected vaccine development time by half from one to a year and a half. As the government invested about 10 billion dollars in the project, US President Trump has repeatedly expressed his willingness not to spare money for vaccine development. The ‘Global Cooperation in COVID-19 Vaccine Development’, which the European Union and about 40 countries participated in, said that it will raise approximately $8.2 billion in grants for research on therapeutics and vaccines. China is also developing vaccines aiming to be completed by the fall of this year at the Chinese Academy of Sciences to take the lead in COVID-19 vaccine. President Moon Jae-in visited the Institut Pasteur Korea in Seongnam, Gyeonggi-do in April, and pledged full support by saying, "Develop the best for the treatments and vaccines." It also suggested that the government can purchase and store sufficient amounts of money even if there is no economic or commercial value in the market, so that efforts and costs in development can be compensated. This was reflected in the supplementary budget to provide 111.5 billion won for full-cycle R&D such as 'pre-clinical, clinical, and global phase III' for the early commercialization of promising candidates for therapeutics and vaccines. There were also plans for subsidies for each stage of development, including ₩9 billion for phase I, ₩24 billion for phase II and ₩15 billion for phase III. If successful in the development of vaccines and treatments, it is also essential to build infrastructure such as production facilities for rapid supply, so the budget for vaccine and treatment production facilities and process management support has been raised to ₩10 billion. However, as mentioned earlier, the budget is not passed by the National Assembly, and the industry is nervous about it. Concerns are raised that it is also a matter of time before companies that are accelerating the development of vaccines and treatments are braking the driving force for R&D. There is no commitment to support production facilities that need to secure infrastructure quickly in line with the development of vaccines and treatments. An official from the pharmaceutical industry said, "The whole world is committed to the development of COVID-19 vaccines and treatments. In Korea, even the determined budget is tied to the National Assembly." "The decision of the National Assembly is urgent."
- Company
- Penmix in trial to evade patent on fat dissolving Belkyra
- by Nho, Byung Chul Jun 24, 2020 06:14am
- An injection CDMO Penmix (CEO Park Dongkyu) succeeded in evading patent on Allergan’s under-chin fat reducing injection Belkyra (desoxycholic acid). On June 19, Intellectual Property Trial and Appeal Board validated the negative confirmation of patent scope on Belkyra’s desoxycholic acid and other pharmaceutical substance based on the salt (to be expired on Aug. 23, 2031) as requested by Penmix. Belkyra is a first injection the U.S. Food and Drug Administration (FDA) approved to treat moderate-to-severe convexity or fullness associated with submental fat in adults, and it was introduced to the Korean market in 2017. With the latest decision, Penmix has passed the first threshold of patent evasion. And if the company wins the litigation on two divisional patents owned by Allergan, it would be able to apply for the first approval after Aug. 24, 2023 when Belkyra’s post-marketing surveillance (PMS) ends. Moreover, if the Korean company wins the Belkyra patent (‘mechanism of reducing fat and related pharmaceutical patent’) invalidation trial, currently ongoing in partnership with Daewoong Pharmaceutical, Pinmex would be able to release its generic product early on May 19, 2025 before the patent expires. At the moment, the Korean fat dissolving injection market does not have any effective option besides Belkyra. Penmix and Daewoong Pharmaceutical stated, “The Korean companies are developing both the Belkyra generic and new innovative fat dissolving injection to expand the related market in Korea.” The relevant industries are keeping a close eye on Penmix and Daewoong Pharmaceutical’s patent trial results as Allergan’s Belkyra owns the exclusive indication. Currently, Jurlique is handling the distribution of Belkyra.
- Company
- Patients with Ultracet don't get benefit for anticancer drug
- by Eo, Yun-Ho Jun 23, 2020 06:21am
- There have been cases that do not meet the intention of the original insurance benefit standard in the treatment of prostate cancer. Targeted anticancer drug options such as 'Zytiga (Abiraterone acetate)' and 'Xtandi (Enzalutamide)' currently exist in adult resistant castration resistant prostate cancer (mCRPC). Moreover, since last May, the coverage has been expanded through screening benefits (Copayment 30%) for both drugs. It is said that the reimbursement is recognized if no narcotic analgesics are used, looking at the criteria for mCRPC treatment, such as Xtandi and Zytiga. The point is not 'narcotics' but 'painless or mild'. It is intended to administer anti-cancer drugs to patients who are not severe enough to be prescribed narcotic analgesics. However, there are some medications used to manage pain in mild patients, such as Ultracet (AAP/Tramadol). Ultracet is not classified as a narcotic analgesic by the MFDS, but Tramadol in Ultracet is classified as narcotic. Ultracet is similar to the pain control effect of high-dose NSAIDs (non-steroidal anti-inflammatory drugs) in medical field, but has fewer side effects and is widely prescribed. The mCRPC patient was excluded from the benefits of anticancer drugs because they were prescribed a commonly used drug. Recently, there were cases of patients excluded from the benefits due to being prescribed Ultracet on the National Petition on Cheongwadae website. The patient was diagnosed with end-stage prostate cancer and had surgery in June 2017 with bone metastasis. Since then, his cancer has spread to the lungs, but his condition has improved as the oral anticancer drug is prescribed and the prostate specific antigen (PSA) level is maintained below 0.5. However, because of Ultracet prescribed in the past, he were notified that it was no longer possible to get reimbursed, so he stopped taking the medicine. Currently, his condition has worsened, with PSA levels increasing to 5.98. Seok-Ho Kang, Public Relations Director of the KUOS, said "Ultracet is a widely prescribed pain reliever for patients with mild pain. For those who cannot receive treatment due to unreasonable reimbursement standards, it is necessary to improve the standards that are more realistic and consistent with clinical evidence."
- Company
- Immunotherapies tap on SCLC treatment area for more options
- by Eo, Yun-Ho Jun 23, 2020 06:21am
- One after another, immunotherapies are tapping into the unexplored small cell lung cancer (SCLC) treatment area. According to the pharmaceutical industry sources on June 20, AstraZeneca’s Imfinzi (duvalumab), following Tecentriq (atezolizumab) by Roche, has been indicated as a first-line treatment for SCLC by Korea’s Ministry of Food and Drug Safety (MFDS) Imfinzi’s SCLC indication was cleared in Korea for the third time in the world after the approval in Singapore and the U.S. SCLC was considered to be ‘hopeless’ for new drug as there was no treatment option other than chemotherapy for last two decades. The aggressive SCLC shows poor prognosis with five-year survival rate of just 6.5 percent, about a quarter of patients with non-small cell lung cancer. The Phase III CASPIAN study tested efficacy and safety of Imfinzi against existing standard of care in patients with SCLC from 22 countries around the world, who have not received any treatment. The study confirmed statistically significant improvement in overall survival (OS) in the arm receiving Imfinzi combined with etoposide and either carboplatin or cisplatin chemotherapy, compared to the control arm treated with six cycles of chemotherapy followed by optional Prophylactic Cranial Irradiation (PCI). The Imfinzi combination therapy reduced the risk of death by 27 percent against the standard of care, and demonstrated median OS of 13.0 months, which was 2.7 months longer than the standard of care. And other endpoints like progression free survival and objective response rate have indicated Imfinzi combination therapy shows enhanced efficacy against the standard of care. As for another immunotherapy Tecentriq, the Phase III IMpower133 study confirmed Tecentriq’s meaningful efficacy by comparing 403 patients with SCLC either treated with Tecentriq combined with chemotherapy (etoposide and ecarboplatin) or the chemotherapy alone. The study result found the patient group treated with Tecentriq combination therapy reached the medial OS of 12.3 months, whereas the chemotherapy alone reached 10.3 months. Compared to the control group, the Tecentriq combination group had 30 percent lower risk of death. Also 51.7 percent of the patients in Tecentriq combination group survived after a year, but only 38.2 percent of the chemotherapy only group survived after a year.
- Company
- Daewoong wins first patent dispute in Belkyra after 2 years
- by Kim, Jin-Gu Jun 22, 2020 06:10am
- BelkyraDaewoong has passed the first gateway for the release of generic for Belkyra (Deoxycholic acid), which targets and eliminates fat cells under the chin. Daewoong won the patent dispute that has been leading for two years with Allergan. The IPT ( Intellectual Property Trial and Appeal Board) made a trial decision on the 19th at Daewoong Pharmaceutical's passive judgment on the scope of the right to claim Belkyra's formulation patent. The patent dispute related to Belkyra was triggered in March 2018 when Daewoong Pharmaceutical filed an invalidation trial on the formulation patent. Subsequently, in April, a trial to confirm the passive scope of rights was raised against the same patent. The dispute lasted more than two years. In this process, Allergan used a “time wasting” strategy through patent splitting. In January, two new patents were registered by removing some of them from existing patents. Daewoong Pharmaceutical also challenged each of the two split patents. Penmix, a subsidiary of Kuhnil Pharmaceutical, joined here. This trial is the conclusion of the passive judgment of the scope of rights raised in 2018. The result of the invalidation trial filed in the same year has not yet been announced. However, the Patent Judge has notified that the hearing will be closed in March, so it is expected that the result of this trial will be released soon. According to the industry, Daewoong Pharmaceutical analyzed that it raised a dispute with the aim of 'preemptive defense for the development of its own products' rather than 'early launching generics through patent evasion' from the beginning. Daewoong Pharmaceutical is currently developing a submandibular fat improvement injection under the name 'DWJ211'. Since March of last year, it has entered a phase III clinical trial in 150 patients at Konkuk University Hospital and Chung-Ang University Hospital. The indication is 'improvement of moderate and severe submandibular fat', which is the same as that of Belkyra. When development is finished, Allergan may file a patent infringement lawsuit. At this time, the trial is expected to be properly used for defense purposes. Even if the development of DJW211 is torn down, Daewoong Pharmaceutical will be able to release generics after August 24, 2023. Belkyra's patent expiration date is August 23, 2031, and the PMS expiration date is August 23, 2023. However, the generic release date is delayed if Allergan appeals. Belkyra is the only subcutaneous fat injection to be approved by the U.S. Food and the FDA. Belkyra’s indications include moderate to severe protrusions in adults or excessive submandibular fat improvement. It was released in Korea in early 2018. Belkyra contains Deoxycholic acid, a 100% chemical compound that is not derived from humans or animals. Injection of this substance subcutaneously irreversibly destroys the fat cell membrane and causes new collagen production at the treatment site.
- Company
- Big 5 DC pass HIV treating two-drug regimen Dovato
- by Eo, Yun-Ho Jun 22, 2020 06:08am
- General hospitals in Korea are reviewing the prescription of GlaxoSmithKline’s (GSK) Dovato, a two-drug regimen indicated to treat HIV-1 infection. The pharmaceutical industry sources reported the drug committees (DC) at the Big Five general hospitals like Seoul National University Hospital and Severance Hospital have passed Dovato (dolutegravir/ lamivudine) after it was listed for reimbursement from early June. The healthcare reimbursement is granted for using Dovato in patients with HIV-1 infection with and without AIDS-related symptoms, who tests baseline CD4 cell count below 350/㎟, exceeds viral load of 100,000 copies /㎖, or is acknowledged by an infectious disease specialist to be prescribed with the drug. Moreover, the drug’s reimbursement would be provided for a pregnant person with HIV infection, infant born from HIV-infected mother, healthcare provider exposed to HIV infection, and spouse (partner) of a person with HIV infection for preventive purpose. In Phase III GEMINI1 and GEMINI2 trials, the drug was used to treat adult patients with HIV infection, and they confirmed the drug’s safety and antiviral effect equivalent to other triple-drug regimen (dolutegravir, tenofovir disoproxil fumarate and emtricitabine). And in TANGO trial, adult patients, who maintained viral suppression for at least six months on a tenofovir disoproxil fumarate (TAF)-containing triple-drug regimen, demonstrated a similar level of viral suppression effect after switching to the two-drug regimen. Recommended to administer a single tablet once-daily, 18,528 won per tablet Dovato would cost 555,840 won, monthly. The drug’s pricing is equal to the existing single-drug regimen option Tivicay (dolutegravir), which is at about 72 percent of the triple-drug regimen Triumeq (abacavir/ dolutegravir/ lamivudine).
- Company
- Yuyu Pharma exports FDA-approved COVID-19 test kit
- by Lee, Seok-Jun Jun 22, 2020 06:08am
- CEO Yu Wonsang of Yuyu Pharma (left) and CEO Lee Hyo-keun of SD Biosensor In partnership with SD Biosensor, Yuyu Pharma is to export COVID-19 test kit. At SD Biosensor headquarters office in Suwon on June 17, two companies signed a supply deal on real time polymerase chain reaction (RT-PCR) test kit for COVID-19. SD Biosensor’s COVID-19 test kit has received the U.S. Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) in April. As a result, USD 5.2 million worth of 300,000 kits were supplied to the U.S. Federal Emergency Management Agency (FEMA) as well. The RT-PCR kit, named 'STANDARD M nCoV Real-Time Detection Kit.,' amplifies and detects specific nucleic sequence to diagnose COVID-19 infection through human nasopharyngeal swabs and throat swab samples. SD Biosensor is one of six Korean companies that received EUA from FDA and one of seven companies Korea Centers for Disease Control and Prevention (KCDC) approved EUA for. CEO Yu Wonsang of Yuyu Pharma stated, “Using the company’s global network, the COVID-19 testing kit would prioritize export to the U.S. first and later expand out to other countries.”
