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- 2026-04-12 18:23:58
- Company
- SK Biopharm targets US sales of Xcopri
- by Kim, Jin-Gu Mar 25, 2022 05:48am
- SK Biopharm announced that it will double U.S. sales of Cenobamate (Xcopri) this year. Cho Jung-woo, CEO of SK Biopharm, presented this year's goal at an online press conference on the 24th. SK Biopharm generated 78.2 billion won in sales from Cenobamate in the U.S. last year. Sales have more than increased seven times compared to 10.6 billion won in 2020, the first year of its launch. SK Biopharm plans to double its sales to 160 billion won this year. New marketing plan has been drawn up this year. First of all, the government plans to double the annual number of prescriptions from 90,000 last year to about 90,000 this year. If the company focused on increasing the new prescription rate of doctors who mainly deal with CNS diseases until last year, it plans to expand marketing to target various doctors from this year. It plans to focus on raising awareness of SK Biopharm and Cenobamate in the epilepsy treatment market. It has set a goal to achieve No. 1 recognition of products and companies in the epilepsy treatment market within this year. CEO Cho Jung-woo said, "Cenobamate is growing into a top tier in the U.S. epilepsy treatment market. Considering that patents for major competitors will expire next year, it will be able to establish itself as the only new drug for epilepsy. We will expand face-to-face sales and marketing to double sales in the U.S.," adding, "In the U.S., quarantine guidelines have been eased until the stage of taking off masks." In the second half of this year, face-to-face activities are expected to recover to around 90%." He added, "We will improve awareness of diseases through TV advertisements and SNS marketing, and increase brand awareness of companies and products."
- Policy
- Yoon’s transition team prepares for digital platform govnt
- by Lee, Jeong-Hwan Mar 25, 2022 05:48am
- President-elect Suk-Yeol Yoon’s presidential transition committee announced a policy with the state-led public prescription system in mind. In the process of announcing the creation of a task force (TF) to bring the digital platform government into reality, the committee made a remark that it would be possible that the TF will establish a one-stop hospital treatment and prescription to pharmacy dispensing system. In the transition committee’s press conference that was held at Samcheong-dong, Seoul on the 23rd, the committee announced the creation of a Digital Platform task force (TF). The digital platform government was Yoon’s administration’s pledge to improve administrative efficiency by expanding cooperation between ministries as a state administration system that focuses on digital transformation, artificial intelligence (AI), and big data utilization. The committee’s goal is to ultimately reduce and simplify the steps in the administrative service through data integration by fully disclosing and linking public data owned by government ministries, in principle. The committee said that a site that allows a one-stop, paperless process from hospital treatment and prescription to dispensing in pharmacies needs to be prepared as one case of the digital platform government. This was a statement that can directly affect the establishment of the government-led public prescription system. The Korean Pharmaceutical Association had proposed the establishment of a public prescription issuance system to policy head Hee-Ryoung Won and the healthcare policy promotion director Jeong-Sook Seo during a policy roundtable that was held with Yoon’s policy coordination team last month. Il-Hee Won, senior deputy spokesperson of the transition committee, said, “the TF will consist of 10 members, with the Planning and Coordination Division holding the key and the Science and Technology Education Division and the Political Affairs and Judicial Administration Division working together with private ICT experts. The data is ultimately the public’s asset, therefore it needs to be given back to the people.” Deputy spokesperson Won added, “For example, you now need to receive treatment at a hospital and submit prescriptions to a pharmacy to receive medication. In order for this to become a paperless process, data must be shared, linked, and integrated. We are planning to establish a one-stop, one-site service so that these documents can be issued online." In addition, he said, “If the current government’s system ended at linking the ministries together, the digital platform government pursued by the new government will achieve integration of the ministries We will remove the barriers between ministries and open and release the data to the public, the rightful owners of the data.”
- Policy
- Corona tx Largevrio has been urgently approved
- by Lee, Hye-Kyung Mar 24, 2022 05:54am
- The MFDS (Director Kim Kang-rip) announced on the 23rd that it has decided on the EUA of Largevrio developed by Merck and imported by MSD Korea. Largevrio can be used in patients with severe liver and kidney disorders who are difficult to use injection-type treatments, and patients who cannot take Paxlovid, a conventional PO treatment, for taking certain ingredient drugs. Largevrio, which is inserted instead of RNA in the process of replicating the COVID-19 virus as an RNA-like substance, can be taken twice (every 12 hours) for five days, 800 mg (200 mg x 4 capsules) a day. It should be administered as soon as possible within five days after being diagnosed positive for COVID-19, and mild symptoms with a high risk of developing severe corona due to age and underlying diseases. It targets adult patients with moderate symptoms. Pregnant women or children and adolescents under the age of 18 are prohibited from taking them. On November 17 last year, the KDCA requested Lagevrio's EUA to the MFDS, and the MFDS decided after deliberation by the Public Health Crisis Response Medical Product Safety and Supply Committee. As a result of consultation with external experts (11 people) in various fields such as infectious medicine, toxicology, and virology, it was agreed that the need for emergency use approval of Lagevrio was recognized considering the results of non-clinical and clinical tests and the COVID-19 pandemic in Korea. Considering the results of reviewing animal test data and clinical test data, it was recommended to partially restrict the target patient group, such as not administering it to pregnant women and children and adolescents under the age of 18. The Public Health Crisis Response Medical Product Safety and Supply Committee also acknowledged the validity of emergency use approval by comprehensively considering expert advice, the increase in COVID-19 confirmed patients in Korea, access to treatment for patients who cannot use existing treatments, and medical staff's options. The MFDS will strengthen the collection of side effect information and additional safety use measures in the process of using Largevrio. It has established a system that allows domestic importers to actively collect and report domestic and foreign safety information, and allows medical experts and patients (family members) to report side effects over the phone or online.The government will continue to analyze and evaluate domestic and foreign safety information to promptly take necessary safety measures such as guidance, suspension of use, and recovery of serious side effects, and to evaluate causality and compensate for them. Side effects that occurred after using Lagevrio can be reported to drugsafe.or.kr, and side effects can be reported directly by phone (1644-6223) or related consultations can be made. It is a DUR used by medical experts for prescription and preparation that it cannot be used for pregnant women and children and adolescents under the age of 18, and plans to provide cautionary information on women, men and lactating women planning to get pregnant. In cooperation with the MOHW, the KDCA, and the Korean Pharmaceutical Association, guide patients (guardians) using Largevrio for safe use will be provided, and thoroughly managed not to be prescribed and administered to excluded patients, such as pregnant women and children and adolescents under 18.
- Opinion
- [Reporter’s View] Specific healthcare plans are required
- by Lee, Jeong-Hwan Mar 24, 2022 05:54am
- President-elect Suk-Yeol Yoon’s transition committee has officially started working. Due to the COVID-19 pandemic, Yoon’s transition committee has opted to separately establish a special committee for COVID-19 response and operate the healthcare sector through the subcommittee for social affairs, welfare and culture. Therefore, policies on COVID-19 control, domestic health, and welfare, as well as pharmaceutical and bio-industry will be jointly established by the special COVID-19 committee and the social affairs, welfare, and culture. subcommittee. After the 20th presidential election ended with Yoon’s victory, the domestic healthcare and pharmaceutical-bio industry officials keenly eyed the composition and direction taken by Yoon’s transition committee, as it would become the basis of the next administration. The policy guidelines that the special COVID-19 committee and the social affairs, welfare, and culture subcommittee establish will greatly affect the direction of work of those in the industry. The return of the transition committee is special in that it is the first committee of its form in 10 years and that it works to identify the organization and function of the government and sets a policy base for the new government. Therefore, the committee needs to prepare specific measures and plans for funding to realize the pledges that were made by Yoon. The committees would need to design a more detailed action plan that goes beyond the implementation plan and fiscal measures that Yoon had set as a candidate to promote policies that minimize uncertainty. The direction Yoon takes to implement his pledge acts as an important reference point for pharmaceutical companies in Korea and abroad in developing new drugs and devising business strategies. The healthcare, pharmaceutical, and legal community all began to revisit Yoon's healthcare pledges while working to identify the transition committee’s direction of work in realizing Yoon’s pledges. In addition, government affairs officials in every industry are also starting to work under the table to lead the policy operation direction of the next government to their benefit. Therefore, the responsibility of the transition committee to devise a specific implementation plan for the inauguration of the next government has also grown. Yoon had defined the current government's COVID-19 response measures as a failure and said that he will implement completely different disease control and prevention measures within 100 days of taking office. Along with bold investments to promote the domestic biopharmaceutical industry, Yoon had pledged to prepare various mechanisms to strengthen patient access to relatively expensive innovative new drugs. Based on the expansion of government R&D in the fields of vaccines, treatments, and advanced medical care, Yoon had also pledged to establish a Pharma-Bio Innovation Committee directly under the Prime Minister and promised to strengthen NHI coverage for disease, establish a separate severe disease fund, and industrialize non-face-to-face treatment. Yoon’s transition committee needs to speed up its drawing up a concrete blueprint to bring the promised health care and biopharmaceutical pledges into reality. Yoon’s fulfillment of his pledges will directly translate to the policy management score of the next government. When and how the science-based COVID-19 management and control system, government R&D support for vaccine sovereignty and the establishment of the global vaccine hub, the establishment of a pharma-bio committee, and fostering key talents in the pharmaceutical and bio-industry, and job creation will be implemented or realized in the pharmaceutical and bio sector will be reflected in Yoon’s grades. The committee will receive reports from each ministry until the 29th and then select the final list of tasks for the new administration for a public announcement in early May. With the kick-off of the transition committee, Yoon’s administration has put to the test its ability to fulfill its pledges and manage state affairs. Since his victory to the kick-off of the transition committee, Yoon had repeatedly stated that he “will not hide behind the public and staff, and will communicate sincerely with the public.” Therefore, expectations rise for the transition committee and on how it will present a clear vision to change and develop the paradigm of the healthcare and pharmaceutical, and bio-industry.
- Policy
- Ahn to tap on “domestic production of Paxlovid generic”
- by Lee, Jeong-Hwan Mar 24, 2022 05:54am
- Transition Committee Chair Cheol-Soo Ahn (Source: National Assembly Picture Corp) President-elect Suk-Yeol Yoon’s transition committee is pursuing the manufacture of a generic version of the oral COVID-19 treatment, Paxlovid. The government plans to ask Pfizer whether it would be possible to produce generic copies of Paxlovid in exchange for royalties. At a press conference of the transition team that was held in Samcheong-dong Seoul on the 22nd, transition committee chair Cheol-Soo Ahn said, “Although it is unprecedented, there is a need to review the possibility of domestically manufacturing generic COVID-19 pills by making a deal with pharmaceutical companies for their patents in exchange for a royalty." Such a decision is interpreted as one of the changes that Chairman Ahn is preparing after criticizing the current government's COVID-19 measures as political and announcing policy reorganization for scientific quarantine at a meeting of the Special Committee for the Emergency Response to COVID-19 the day before (21st). Ahn said, “We are experiencing a severe shortage of Paxlovid and other oral COVID-19 treatments, and may completely run out of stock by April. So we need to do our best to secure oral pills to minimize those who die due to lack of treatments.” Ahn also announced his idea of conducting a public survey to investigate the rate of positive antibodies in the general public. Ahn said, “Although the confirmed cases amount to 300,000 cases a day, we estimate that the actual number of those infected is around twice that due to those who are unaware of their condition or uncounted for in the statistics. If we regularly investigate the positive rates among the general public, we can better grasp how much of the public was infected and is recovering, based on which we can establish a more accurate quarantine policy by age and region.” Regarding vaccinations and the vaccine pass system, Ahn believes it is appropriate to maintain the current measures as is, and that it is reasonable to allow people to decide upon themselves to receive vaccinations Ahn said, “although vaccinations are not mandatory even now, we all saw consensus on the fact that it should be left to the decision of individuals and parents. Some have also discussed the use of vaccine passes, but the passes have already been discontinued by the present administration, and we believe it is no longer necessary.” Meanwhile, Ahn presented 7 recommendations regarding the COVID-19 response to the government that included: ▲ Face-to-face treatment at local clinics ▲ Fast track treatment of high-risk confirmed patients ▲ Transparent disclosure of vaccine’s side effects and confirmed patient data ▲ Voluntary vaccination for 5-11 years old ▲ Procurement of oral COVID-19 treatments ▲ Extension of small business loans and deferment.
- Policy
- The price of Biktarvy will be lowered next month through PVA
- by Lee, Jeong-Hwan Mar 24, 2022 05:54am
- Gilead Science Korea's HIV treatment drug Biktarvy will be reduced by signing PVA negotiations. The price will be adjusted from 24,631 won to 23,900 won and the new drug price is expected to take effect from April 1. According to the industry on the 21st, the MOHW is pushing for a "revision of the drug benefit list and upper limit table" with such contents. The PVA adjustment item, Biktarvy, is a new drug registered as a drug negotiation, up more than 30% from the expected amount of drug negotiations, making it the subject of negotiations. The company and the NHIS will negotiate drug prices to agree on a reduction rate within up to 10% below the current upper limit. Biktarvy is leading the HIV treatment market with annual sales exceeding 10 trillion won last year. Biktarvy's price will be applied in April based on the results of PVA negotiations.
- Company
- Why Vemlidy's patent dispute took 3 years to win the 1st tri
- by Kim, Jin-Gu Mar 24, 2022 05:54am
- Generics, which challenged the patent of Gilead Science's hepatitis B treatment Vemlidy (Tenofovir Alafenamide HemiFumarate), won the first trial in about three years. According to the pharmaceutical industry on the 21st, Intellectual Property recently made a "claim establishment" trial on the passive scope of the Vemliddy salt patent filed by Dong-A ST, Daewoong Pharmaceutical, and Chong Kun Dang against Gilead. The patent expires in August 2032. Pharmaceutical companies that won the first trial have been qualified to release generic products after September, when Vemlidy's PMS period expires. Attention is drawn to this by the referee. Dong-A ST and others requested a trial in December 2018. It took more than three years for the decision to be reached. Generics usually apply for a "priority trial" at the same time when requesting a trial, so it is unusual for the decision to take three years. ◆The conclusion was reached 3 years after the request for trial The pharmaceutical industry explains that Vemlidy's remaining PMS expiration period had a decisive impact on the prolonged dispute. Vemlidy's PMS expires on September 12. As of December 2018, when generics requested a trial, Vemlidy's PMS expiration date was about three years and nine months away. However, Intellectual Property did not immediately look into the incident. This is due to Intellectual Property's regulations on preferential trials. Article 31 of the Administrative Rules of Intellectual Property's "Patent Trial Handling" stipulates that the claimant's application for a priority trial must be judged before other cases.This regulation stipulates that "the trial case for patent rights related to drugs whose expiration date of the retrial period is one year after the date of application for priority trial is excluded." When generics filed a patent trial in 2018, Vemlidy's PMS did not expire within a year, so it was excluded from the priority trial, and only recently, when the PMS expiration date was within a year. An official from the pharmaceutical industry explained, "With the implementation of the patent-approval linkage system, there have been more requests for patent trials by generics to accept generic for exclusivity, and I understand that Intellectual Property has set these regulations to prioritize." He said, "Under this regulation, hearings have not been conducted for a while since the request for a trial, but only recently have the Patent Tribunal begun to look into the case," adding, "The rest of the Vemlidy salt patents that have yet to be concluded are expected to come out soon." Vemliddy is another hepatitis B drug from Gilead, generic for Viread. The active ingredient is Tenofovir Disoproxil Fumarate, but Gilead has newly developed the drug in pro-drug form. This improved drug resistance and kidney toxicity side effects. Vemlidy is rapidly replacing existing Viread in the hepatitis B treatment market. According to IQVIA, pharmaceutical market research firm, Vemlidy's sales surged in four years from 500 million won in 2017 to 28 billion won last year, the first year of its launch. During the same period, Viread's sales fell nearly half from 129.3 billion won to 63.1 billion won.
- Policy
- EUA of Lagevrio imminent…interest focused on its treatment
- by Lee, Jeong-Hwan Mar 23, 2022 05:51am
- Whether the US company Merck (MSD)’s oral COVID-19 treatment Lagevrio (molnupiravir) will settle in Korea as an alternative to Paxlovid (nirmatrelvir, ritonavir) is gaining attention. The company had applied for the emergency use authorization of molnupiravir to the Ministry of Food and Drug Safety in November last year but has not been granted EUA as of yet. On the reason for the delay, some had evaluated that the delay was due to the lower efficacy of Lagevrio, whose rate of preventing hospitalization and deaths is 30% as compared to the 88% demonstrated by Paxlovid. The MFDS had announced that it will decide upon Lagevrio’s EUA by 24th at the latest. However, as the disease control and prevention authorities had already announced that it will bring in 100,000 courses of Lagevrio within the week, the prevailing view is that Lagevrio will be granted EUA. Lagevrio is an RSA analog containing molnupiravir that induces virus deaths by being inserted in the place of the normal ribonucleic acid needed in the viral replication process. Four 200mg capsules (800mg) of Lagevrio are to be taken twice a day for 5 days, totaling up to 40 capsules. As for the period of administration, the drug is used in patients with mild symptoms of COVID-19, within 5 days of symptom onset. The FDA had announced in December last year that Lagevrio’s rate of preventing hospitalization and deaths was 30%. The drug is contraindicated in pregnant women, and some leukemia treatments are known to cause drug-drug interactions. In the current situation, whether Lagevrio can show practical effect in treating COVID-19 as a substitute to Paxlovid in the case of its shortage is gaining attention. The authorities believe that Lagevrio can be useful as Paxrovid, which is currently used in patients of all ages over 60, the immunocompromised, and those over 40 with underlying diseases, has many contraindications and is difficult to use in patients with impaired renal and liver function. Eun-Kyeong Jeong, the commissioner of the Korea Disease Control and Prevention Agency (KDCA), had said, “The National Infectious Disease clinical committee had discussed on the need to introduce Lagevrio in patients that are ineligible for Paxlovid. The WHO had also authorized limited use of Lagevrio in patients who cannot be prescribed Paxlovid.” Although Lagevrio’s prevention rate of hospitalization and deaths is at 73% that of Paxlovid,’ the need for its introduction has been growing due to the upsurge of new confirmed COVID-19 cases and the strict conditions required for Paxlovid’s administration. The need for an alternative to Paxlovid has been increasing with the rising demand for oral tablets due to the upsurge of new COVID-19 cases in the medical field. In particular, compared to Lagevrio, which is only contraindicated in pregnant women, and some leukemia treatments, the use of Paxlovid is much more restricted. Paxlovid in patients with severe renal, liver impairment, and not allowed for use with 23 medicinal products including hypertension drugs, analgesics, angina drugs, arrhythmia drugs, gout drugs, sedatives, anticancer drugs, anticonvulsants, and some antifungal drugs. The fact that one of the main ingredients of Paxlovid, ritonavir, has many contraindications and drug-drug interaction has affected the change in attitude towards Lagevrio. As a result, after the Ministry of Food and Drug Safety decides on the emergency use of Lagevrio, how the drug will be used is expected to be determined according to the trend of new COVID-19 patient development and the prescription and medication status of Paxrovid. Whether Lagevrio can broaden the range of options for patients who cannot take Paxlovid is also expected to affect the response of confirmed COVID-19 patients in the medical field. The government has already signed an advance purchase agreement for 242,000 courses of Lagevrio.
- Opinion
- [Reporter's view] Our attitude toward personalized txs
- by Eo, Yun-Ho Mar 23, 2022 05:51am
- These drugs such as HER2, ALK, EGFR, and ROS1 are keywords that appear more frequently in recent articles related to anticancer drugs Effective treatments for patients vary depending on what genetic mutations the patient has. Starting with treatment HER2, ALK, EGFR, etc., which show excellence in patients in certain conditions, drugs targeting gene mutations such as ROS, NTRK, and RET are now emerging. Advances in precision medicine now herald a shift in prescription standards for drugs from disease to genetic. The era of customized medical care has arrived. Can the Korean system handle these drugs that are effective if genetic mutations are identified regardless of cancer species? It is not easy to expand salaries for target anticancer drugs and cancer immunotherapy that have already been registered. Although drug prices are expensive, valuation should be carried out again as the use increases. This is also the basis for supporting health insurance system. One of the characteristics of these new drugs is that the number of patients corresponding is very small. In other words, there are not many subjects who can prescribe new drugs. The rare type of patient is less than 1%, and the diagnostic efficiency is less than 200. Moreover, doctors explain that this type of patient does not work well with typical standard treatment (existing drugs). The time has come to think about benefit track based on precision medicine. It does not seem to ignore our system, but it seems necessary to prepare a situation-appropriate benefit screening standard for the benefits of treatments regardless of cancer. One more goal of precision medicine is to realize personalized treatment for patients. For customized treatment, tests that can apply the latest research are essential. To this end, it is time to reconsider whether it is necessary to expand essential genes for patient treatment, and to consider improving NGS-based panel tests.
- Company
- Samsung Bioepis makes ₩847 billion expanding overseas
- by Chon, Seung-Hyun Mar 23, 2022 05:51am
- Samsung Bioepis made a new sales record last year. With the global expansion of its biosimilars well on track, the company had made over ₩800 billion last year. According to the Korea Financial Supervisory Service, Samsung Bioepis’s sales recorded ₩847 billion last year, a 9.0% increase from the previous year. This is the largest record ever since the company was established in 2012. Sales have increased 129.7% in just 3 years from ₩368.7 billion in 2018, and have been breaking its sales record ever since. Annual Sales of Samsung Bioepis (Unit: million won, Data: Financial Supervisory Service) After recording ₩765.9 billion in sales in 2019, the company’s growth rate had fallen to 1.5% the next year. The reduced growth has been due to the temporary market contraction that occurred in the early stages of the COVID-19 crisis. The company’s quarterly performance had then showed ups and downs with preorders from hospitals and wholesalers in Europe to secure a supply. However, the company’s recovered growth last year was driven by the increased sales of biosimilars in the US and Europe. Samsung Bioepis’ sales are mostly generated by overseas sales of biosimilars that were developed by the company. Samsung Bioepis had succeeded in commercializing biosimilars of 6 products - Enbrel, Remicade, Herceptin, Humira, Avastin, and Lucentis. All 6 products were approved in Europe, and 5 products less the Avastin biosimilar achieved marketing authorization in the US. The five biosimilars from the company had recorded $1,255,100,000 (approx. ₩1.5 trillion) in overseas sales last year. This is an 11% increase and a new record from the $1,125,800,000 it made in 2020. Samsung Bioepis’ biosimilar is sold abroad by its partners Biogen and Organon. Biogen sells the company’s biosimilars of Enbrel, Remicade, Humira for autoimmune diseases in Europe. Organon sells the mentioned products in countries other than Europe and Korea, and the Remicade biosimilar in the US. Organon is also in charge of overseas sales of Samsung’s two anticancer drugs, the biosimilars of Herceptin and Avastin. Last year, Biogen’s sales of Samsung Bioepis’ biosimilars recorded $831,100,000 (approx. ₩1 trillion), which was a 4% increase from the previous year. Organon’s sales of Bioepis’ products also increased 28% from the previous year to record $424,000,000 (approx. ₩500 billion). Also, the approval of the biosimilars abroad has added new milestones. In August last year, the company’s Lucentis biosimilar ‘Byooviz’ that it developed received marketing authorization from the European Commission (EC) and the U.S. Food and Drug Administration (FDA) a month later. Samsung Bioepis will be converted into a wholly-owned subsidiary of Samsung Biologics. At the time of its establishment, Samsung Bioepis was established as a joint venture between Samsung Biologics and Biogen. Samsung Bioepis was launched in February 2012 with a capital of ₩164.7 billion, and Biogen initially invested 15% of the capital, 24.7 billion won. With Biogen only partially participating in the paid-in capital increase, its share fell to 5.4% in 2017. In 2018, Biogen had exercised its call option over Samsung Epis and increased its shares to 50%. Previously, the company had signed a call option agreement under which the company may acquire ‘50% less 1 share’ of Bioepis’s stock by June 29th, 2018. And upon the date of expiry, Biogen decided to acquire the stocks. In June 2018, the company acquired 9,226,068 of the 19,567,921 shares of Bioepis that were owned by Samsung Biologics for $700 million (₩748.6 billion). In January, Samsung Biologics decided to acquire 10,341,852 shares (50% stake) of Samsung Bioepis that was owned by Biogen for ₩2.765 trillion. Samsung Biologics plans to pay the remaining amount of the acquisition price in installments over the next two years. After the acquisition, Samsung Biologics will own 100% of Samsung Bioepis’s shares.
