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- Product
- The supply of Tylenol suspension has been postponed again
- by Kim JiEun May 25, 2022 05:47am
- The sale of children's Tylenol suspension will be extended further. The supplier originally promised to supply it in June, but it seems that it will not be available until August, two months later. Johnson & Johnson Korea recently sent an official letter to drug distributors on the "Delay Notice on the Supply Schedule of Children's Tylenol Suspension 500ml." As of January 3, children's Tylenol suspension 500ml was distributed from Janssen Korea to Johnson & Johnson Korea, and the vendor was changed. In this official letter, the company said, "The supply schedule of children's Tylenol suspension 500ml products will be delayed from June to August due to internal circumstances," and added, "We will do our best to provide stable products." Earlier this month, the government also decided to urgently introduce Tylenol suspension and tablets distributed in Australia due to the prolonged sale of children's antipyretic analgesics containing acetaminophen. Tylenol suspension 50ml for children was scheduled to be supplied from this month, and Tylenol 500mg tablet from June through wholesalers nationwide. As of last week, Australian children's Tylenol suspension 50ml began to be distributed to pharmacies, but this is also not easy to order. Currently, 100, 500, 200ml of Tylenol suspension is on sale at drug store, It has been confirmed that only Tylenol suspension 200ml can be ordered in small quantities. In most pharmacies, consumers' perception has changed to some extent compared to the early Tylenol crisis, so the number of cases of explaining and selling generics for Tylenol has increased. A pharmacist in Seoul said, "Since there are many products from domestic pharmaceutical companies, I understand and purchase them when I explain them to mothers these days," adding, "As even orders are not easy for years, I have virtually given up ordering them these days." In the case of Australian Tylenol suspension, caution is required when instructing drugs at pharmacies as the dose per dose is unknown due to the difference in the concentration of active ingredients compared to domestic products. For ages 7 to 8, 10ml of existing Tylenol suspension, 7.5ml of Australian Tylenol, 15ml of existing Tylenol and 11ml of Australian Tylenol are recommended. At the age of 12, 20ml of existing Tylenol suspension and 12.5ml of Australian Tylenol suspension are recommended doses.
- Policy
- Xarelto's generic 15 items have been revoked
- by Lee, Hye-Kyung May 25, 2022 05:47am
- The MFDS canceled the item license of Rivaroxaban-based products, which were sold before the expiration date of the registered patent right as of the 27th. The cancelled product is Rixa 10mg, 15mg, 20mg, Wirelto 10mg, 15mg, 20mg, Jabaroxa 10mg, 15mg, 20mg Xarel-Q 10mg, 15mg, 20mg Xarelivan 10mg, 15mg, 20mg. The composition patent of the original Bayer Xarelto is until November 2024, and the material patent ended in October last year. However, it was confirmed that five pharmaceutical companies distributed generics to wholesalers before Xarelto's patent expired on October 3 last year, and the cancellation of the item license was decided this time. The reason was that generic products were distributed to wholesalers before the expiration of Xarelto's patent (October 3, 2021). According to Article 76(1)5-8 of the Pharmaceutical Affairs Act, "If a person who applied for an item permit or permission to change a registered patent right to sell it after the expiration of the period sells the drug" is subject to cancellation and suspension. The items that were decided to cancel the item license were reportedly distributed to some wholesalers first for distribution purposes after October 13 last year. Xarelto's outpatient prescription (UBIST) performance reached 59.6 billion won last year.
- Opinion
- [Reporter’s view] What was gained and lost with COVID R&D
- by Kim, Jin-Gu May 25, 2022 05:47am
- Literally, the companies have played it out to the end. By the companies, this reporter is referring to the developers of COVID-19 treatments and vaccines. Just 2 years ago, the developers had received the investors’ utmost interest. Stock prices soared when news broke out that a company is developing COVID-19 treatments or vaccines. The domestic stock market had been in a boom then, and every day, press releases on related news poured in. Some companies had even made malicious attempts to ride the investment boom. Many new treatments and vaccines were released in the past 2 years, but many of the companies that attempted to develop COVID-19 treatments and vaccines have also waved the white flag. In the case of the other companies still continuing on their R&D journey, their motive and drive have weakened significantly. Skepticism prevails over how many of these companies will continue to carry out their COVID-19 R&Ds to the end. The investors’ interest has also dropped sharply. They are no longer interested in whether the companies applied to initiate clinical trials, completed patient enrollment, or saw positive interim results. The stock prices of the companies that dangerously soared 2 years ago are making their way back. The COVID-19 R&D companies have both gained and lost much during the past 2 years. One gain is that the companies were able to imprint their names into the investors’ minds amid fierce competition. Also, the companies accumulated practical experience deriving candidate substances and conducting clinical trials in an emergency situation like the pandemic. Some companies also secured considerable cashable assets by selling their shares when their stock prices rose. On the other hand, many of these companies are losing their investors' interest and trust in return. In particular, the declining investor trust seems to be adding weight to the bubble theory in the pharmaceutical and bio industry. KRXHLTH, which represents the stock price of the pharmaceutical and bio-industry in Korea, has returned exactly to the level it had been before the pandemic. KRXHLTH rose 89.3% from 2915.31 at the start of 2020 to 5517.31 at the end of 2020 but then has been steadily declining to return to the pre-COVID-19 level of 2916.62 (as of May 20th). Among the 17 industry sectors that make up the KRX sector, the decline compared to the end of 2020 has been the largest in Healthcare. Now, there is rising concern that KRXHLTH may become lower than even before the COVID-19 outbreak. It is not about applauding the companies that have succeeded and criticizing those that failed to develop COVID-19 treatments and vaccines. It is more about asking the conscience of the companies that have carried out massive promotions about their development of COVID-19 treatments and vaccines. What did you truly gain, and what have you lost?
- Policy
- GSK meningococcal vaccine Bexero PFS was approved in Korea
- by Lee, Hye-Kyung May 25, 2022 05:47am
- The MFDS recently approved the item permission of Bexero PFS applied by GlaxoSmithKline (GSK). Bexero PFS is used to prevent invasive meningitis disease by Neisseria meningitidis B group at least 2 months of age. The safety and effectiveness of this vaccine in infants under 8 weeks of age have not been established. This vaccine injects deeply into the muscles. It is recommended to inoculate infants under 12 months of age to the outside of the thigh and to the upper arm deltoid area for those older than that. If inoculated at the same time as other vaccines, the injection site is different. Bexero PFS should not be intravenously, subcutaneous, or intradermally injected, nor should it be mixed in the same syringe as other vaccines. Bexero PFS is the only vaccine approved in Europe in 2016 to prevent type B meningitis and is a drug obtained by GSK through asset exchange with Novartis in 2015. The vaccination purpose of this vaccine is to prevent invasive meningococcal disease (IMD) by promoting antibody production that recognizes the vaccine antigens NHBA, NadA, fHbp, and PorAP1.4 (immune dominant antigen present in OMV components). In approximately 1000 meningococcal B group isolates collected in 5 European countries from 2007 to 2008, between 73 and 87% of meningococcal B group isolates, depending on the country of origin, showed MATS antigen profiles prevented by this vaccine. Phase 3 clinical trials showed that the vaccine was inoculated twice every two months for complement deficiencies (40 patients) aged 2 to 17, asymptomatic or spleen impaired patients (107), and healthy subjects (85) of the same age, with 87% and 97% for fHbp antigens, 95% and 100% for PorA P1.4 antigens, and 73% and 94% for NHBA. In the UK in September 2015, Bexsero PFS was introduced as NIP with a schedule of two additional inoculations (two months of age and four months of age) to infants.
- Company
- Yuhan Leclaza's first-quarter sales were 3.2 billion won
- by Chon, Seung-Hyun May 24, 2022 05:55am
- Yuhan's new anticancer drug Leclaza posted sales of 3 billion won in the first quarter. It has continued to rise since it entered the domestic market in earnest in the second half of last year. It is expected to surpass 10 billion won in annual sales for the first time among new anti-cancer drugs developed in Korea. According to IQVIA, on the 23rd, Leclaza recorded 3.2 billion won in sales in the first quarter. Leclaza is a non-small cell lung cancer treatment approved as the 31st new drug developed in Korea in January last year. Patients with local progressive or metastatic non-small cell lung cancer who developed T790M resistance after administration of the first and second generation epithelial cell growth factor receptor (EGFR) tyrosin kinase inhibitor (TKI) are eligible for administration. It acts as a mechanism to suppress the proliferation and growth of lung cancer cells by interfering with the signal transmission involved in lung cancer cell growth. Leclaza made its market debut in July last year with the listing of health insurance benefits. Leclaza made 4.1 billion won in sales in the second half of last year alone. The first sales of 1.5 billion won occurred in the third quarter of last year and 2.6 billion won worth of sales were sold in the fourth quarter. Cumulative sales have been estimated at 7.3 billion won since the third quarter of last year. Since anticancer drugs usually used in large medical institutions can be prescribed after the passage of the drug committee, it takes a considerable amount of time for sales to occur at the beginning of the release. Leclaza can be prescribed at more than 30 medical institutions, including Seoul National University Hospital, Sinchon Severance Hospital, Samsung Medical Center, and Asan Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Hwasun Chonnam National University Hospital, Chilgok Kyungpook National University Hospital, and Pusan National University Hospital. At this rate, it seems likely that annual sales will surpass 10 billion won in the second year of its release. None of the new anticancer drugs developed by domestic pharmaceutical companies has yet exceeded 10 billion won in annual sales. Domestic developed anticancer drugs licensed before Leclaza include Supect of Ilyang Pharmaceutical, Chong Kun Dang's Camtobell, Samsung's Riavax, and Hanmi's Oilta. Among them, Supect recorded 7.4 billion won in sales last year. Sales in the first quarter of this year are 1.9 billion won. Supect, which was approved as the 18th new drug developed in Korea in January 2012, is a drug used as a treatment for chronic myeloid leukemia. However, compared to the anticancer drugs of multinational pharmaceutical companies used for similar purposes to Leclaza, there are hurdles to overcome in the future. EGFR targeted anticancer drugs approved for use in Korea before the release of Leclaza include Iressa and Tarceva, the first-generation drugs, Giotrip and Vizimpro, and Tagrisso. Tagrisso posted 26.4 billion won in sales in the first quarter, up 8.0% from a year earlier. Tagrisso is a secondary treatment prescribed for non-small cell lung cancer (NSCLC) patients who developed resistance after administration of existing EGFR tyrosin kinase (TKI), such as Iressa, Tarceva, and Giotrif. It is called the same third-generation drug as Leclaza in that it overcomes the resistance of existing EGFR-TKI. Tagrisso, which received domestic permission in 2016, saw its sales increase significantly after applying health insurance benefits in December 2017. Tagrisso surpassed 10 billion won in sales in the third quarter of 2018 and has been recording 20 billion won in sales since the second quarter of 2019. It recorded sales of about 100 billion won for two consecutive years in 2020 and last year. Beringer Ingelheim's Geotrip, which is classified as a second-generation EGFR target anticancer drug, recorded 5.8 billion won in sales in the first quarter, up 13.2% from the previous year. Iressa and Tarceva, the first-generation drugs, showed sales of 3.4 billion won and 1 billion won in the first quarter, respectively. Yuhan Corporation has secured a total of $150 million in technology fees with Leclaza. Yuhan Corporation exported Leclaza to Janssen Biotech in November 2018. At this time, he received a deposit of $50 million without obligation to return it. Yuhan Corporation received $35 million in milestone from Janssen in April 2020. Janssen paid additional milestones to Yuhan Corporation when he began clinical trials of combination therapy with Amivantamab and Leclaza at the time. In November 2020, Janssen paid an additional $65 million to Yuhan Corporation when it began recruiting subjects for this clinical trial.
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