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- 2026-05-14 01:01:05
- Policy
- Paxlovid is contraindicated with other concomitant meds
- by Lee, Tak-Sun Sep 13, 2022 05:51am
- PaxlovidPiroxicam was excluded from the list among drugs that should not be taken with Paxlovid, an oral COVID-19 treatment. As a result, the number of combination contraindications has decreased to 16, but there are many contraindications, making it difficult for patients with chronic diseases who take drugs every day to take Piroxicam. The HIRA announced on the 5th that it will delete the Piroxicam-containing drug among the concomitant of the drug Paxlovid (Nirmatrelvir+Ritonavi) and Pfizer Pharmaceutical, which were approved for emergency use in COVID-19. Piroxicam is a nonsteroidal anti-inflammatory drug and] is used to relieve inflammation such as arthritis. Until now, Piroxicam has been one of the 17 contraindicated drugs for Paxlovid. This drug should not be taken with Paxlovid due to severe respiratory inhibition or hematological abnormalities. The KDCA last week ordered related ministries to exclude Piroxicam from contraindicated drugs according to overseas safety information, which is believed to have been reflected by the Ministry of Food and Drug Safety and the HIRA in the DUR. Although Piroxicam is excluded, Paxlovid is contraindicated with drugs which are Amiodarone, Ergotamine, Pimozide, Sildenafil, Simvastatin, Flecainide, Lovastatin, Alfuzosin, Pethidine, Ranolazine, Dronedarone, Colchicine, Clozapine, Triazolam, Propafenone, Methylergonovine.
- InterView
- “Will rise independently as Organon in the industry”
- by Eo, Yun-Ho Sep 08, 2022 05:59am
- So Eun Kim, Managing Director of Organon Korea Spin-offs, which are made for various reasons in various circumstances, bring out various positive and negative issues in the process. Organon’s course of the spin-off was also quite eventful. However, the company quickly straightened its affairs after completing the spin-off and being reborn as an independent organization in June last year. Organon was established in 1923 in Netherland and had become part of MSD. In 10 years since then, the company again was separated from MSD and reborn as Organon. Utilizing the power of its existing legacy brand, the company heralded its new leap into a pharmaceutical company specializing in biosimilar and women’s health. Dailpharm met with So Eun Kim (51), the founding Managing Director of Organon Korea, to hear about the company’s vision and value. -A year has already passed since the establishment of Organon Korea. Has the company undergone many changes? During the past year, the company had made efforts -small and large – to lay the foundation to realize our women's health vision. Above all, we were able to achieve organizational stability, and in terms of business, Global Organon has earned the trust of its investors by making a stable start from the first year. Organon Korea made a 4% YoY growth in the first year of the spin-off, expanding its product influence. -There must have been difficulties as well. One of the things our employees had the most trouble with was meeting with various healthcare professionals who were unfamiliar with our name, ‘Organon.’ The heightened COVID-19 situation had further rendered sales activities and external meetings with partners and stakeholders difficult. Therefore, we focused on utilizing digital channels in communicating with healthcare professionals. One main example of this is ‘Organon Connect,’ a portal site we prepared for HCPs. Korea was the first among all Organon subsidiaries globally to launch the portal and had launched it upon the establishment of the company. Through the system, we have continued to hold symposiums during the pandemic. -In addition to your existing items, what other products are you preparing for your goal to become a women’s health pharmaceutical company? Organon has signed agreements for 6 solutions in the field of women’s health where unmet needs remain. In the case of our solution for postpartum hemorrhage, the solution has been approved by the FDA and is being sold in the US. XACIATO, the bacterial vaginosis treatment, has been granted accelerated approval by the FDA. We are preparing to introduce these treatments to Korea as soon as possible, through market analysis in Korea. Clinical trials or preclinical trials on solutions for premature birth, endometriosis, breast cancer, contraception, etc. are also being completed. We are preparing to launch the products in development according to their development stage. Also, the contraception, infertility, childbirth, and postmenstrual treatments that we already own have much potential in the Korean market. Although the company was unable to pay sufficient attention to these products but based on Organon Korea’s vision, we plan to make the most of the opportunities owned by each and every product. -With so many of your women's health products in development, it seems like not many products are readily available for introduction to Korea. In this sense, the company would have to focus on its chronic disease area. What kind of efforts and attempts have you made to increase your influence in women’s health in Korea? Well, we expect that Korea will be able to participate in various stages of applicable clinical trials of the various products in development, and is preparing plans for such trials. Also, for the FDA-approved products, we are working to quickly introduce them to Korea. The chronic disease business accounts for over 90% of Organon Korea’s business. This field will be our main business for the few years to come, during which we will be making efforts to expand our portfolio and share in women’s health. -has the labor-management issues that you experienced in the course of your spin-off been resolved? Many of the concerns and anxiety held by our executives and employees with regard to the spin-off have been resolved. At the time of the spin-off, we focused on listening and communicating with our executives and employees about their various concerns and received consent from each through discussion with the union. After the spin-off, we worked to relay the direction of the company and build solidarity among our executives and employees. We are regularly communicating with the union every week, and are holding a labor-management council to listen to the opinions and answer questions held by the employees, facilitating smooth communication between the union, executives & employees, and the company. For your reference, only a very few employees left the company due to the spin-off. -What are your future ambitions? Based on Organon’s global ESG reporting standards, we believe we need to find areas where Organon can contribute to Korean society and increase our influence in Korea. Building on the vision and confidence we have today, we plan to grow together with our executives and staff and strive to lay the foundation for bigger dreams, toward our vision of women's health.
- Company
- Unilateral voluntary retirement
- by Sep 08, 2022 05:59am
- The GSK labor union of Korea has taken legal action, insisting on the management's unilateral voluntary retirement. The company is not taking any action, but the inside is "like the calm before the storm" as legal battles are predicted. Novartis Korea, where voluntary retirement is being carried out relatively quietly, is also nervous until the end. According to the pharmaceutical industry on the 8th, NPU's GSK branch recently filed an application with the Seoul Western Office of the Ministry of Employment and Labor and the Seoul Regional Labor Committee to file a petition for violation of the collective agreement and relieve unfair labor practices. It is claimed that the management violated the collective agreement and unilaterally proceeded with voluntary retirement. The union said, "According to Article 21 of the Korea Unification Association, in principle, it is necessary to agree with the union when the reduction is carried out due to unavoidable management circumstances. However, without any prior discussion, the management notified the union 30 minutes before the decision to reduce the number of employees and abruptly announced the voluntary retirement." Since then, they have pushed ahead with one-on-one meetings with employees, and they are putting psychological pressure on early applicants within a week by applying additional payment conditions. A union official added, "The decision is to make a legal judgment on HR's unfair labor practices and violations." It is reported that the management has not taken any action since the deadline for applications for voluntary retirement at the end of last month. Although the applicant did not meet the company's standards, there was no pressure or encouragement to meet the number of people. It is reported that there is no special response to the legal lawsuit filed by the union. Novartis Korea is better than this situation, a day before the deadline for voluntary retirement. Unlike GSK Korea, it has been consulted with the union and is found not to be coercive. Novartis Korea, the applicant union official said, " voluntary retirement and to understand the accurate number of people are. But the company's voluntary retirement is to think, how much remains to be part of what to do " said it would not.
- Policy
- Approval of Boryung’s new SCLC drug Zepzelca imminent
- by Lee, Hye-Kyung Sep 08, 2022 05:58am
- Boryung Pharmaceutical’s new drug for small-cell lung cancer (SCLC), 'Zepzelca inj, (lurbinectedin) is soon to be granted marketing approval in Korea. Currently, Hycamtin inj (topotecan)’ and ‘Camtobell Inj (belotecan)’ are approved for second-line use in Korea. According to industry sources on the 7th, the Ministry of Food and Drug Safety recently completed the safety and efficacy review for Zepzelca recently. With the safety and efficacy review complete for the drug, it is highly likely that Zepzelca will be approved soon if no variables arise. Zepzelca is an anticancer drug for which Boryung owns exclusive rights to development and sales in Korea. After signing a technology introduction agreement with the Spanish pharmaceutical company Pharmamar in 2017, the company has been coordinating the period for its domestic introduction after the drug received FDA marketing approval on June 15th, 2020. The FDA approved Zepzelca for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Zepzelca 3.2 mg/m2 is administered as a 60-minute infusion every 21 days, and treatment is continued until disease progression or unacceptable toxicity. The drug may be administered in an outpatient setting when appropriate, and the 21-day administration schedule has the advantage of reducing the time required for treatment in the hospital compared to its other options.
- Company
- Sales of immuno-cancer drugs exceeded 200 billion won
- by Sep 08, 2022 05:58am
- In the first half of this year, the domestic immune anticancer drug market surpassed 200 billion won. In particular, Opdivo's performance, which showed his endurance, was remarkable. Opdivo sales increased 41% from the previous year, surpassing 50 billion won in half-year sales. According to IQVIA, a pharmaceutical market research firm, the size of the domestic immuno-cancer drug market in the first half of this year was 215.8 billion won, up 17.2% from 184.1 billion won a year earlier. The drug leading this market is MSD's Keytruda, which has the most indications. Keytruda posted 94.4 billion won in sales in the first half of this year, up 1.2% from the previous year. Sales seemed to be decreasing from the same period last year due to drug price cuts in the first quarter, but it turned upward again as benefits expanded in the second quarter, including primary treatment for non-small cell lung cancer. Currently, there are 15 cancers that can use Keytruda, including lung cancer, head and neck cancer, Hodgkin lymphoma, urinary epithelial cancer (Bladder cancer), esophageal cancer, melanoma, renal cell cancer, endometrial cancer, gastric cancer, small intestine cancer, ovarian cancer, pancreatic cancer, biliary cancer, colorectal cancer, and triple negative breast cancer. ◆Opdivo, which shows its endurance, surpasses 50 billion won in semi-annual prescriptions What stands out is Opdivo's rise. Opdivo sales in the first half of the year were 51.3 billion won, up 40.5% from 36.5 billion won a year earlier. The gap with Keytruda, which nearly tripled, has less than doubled. The market share of immuno-cancer drugs has also changed due to higher growth than Keytruda. Unlike last year, when Keytruda monopolized half of the total market, its share of Opdivo rose to 24% this year, reducing its share of Keytruda to 44%. Opdivo, developed by Ono and BMS, is an immuno-cancer drug licensed in Korea at the same time as Keytruda in 2015. It recorded sales similar to Keytruda until 2017, but the gap widened since 2018. This is because it has been relatively slow to expand indications and benefits compared to Keytruda, which aggressively increased indications. For this reason, Opdivo sales seemed to slow down between 2019 and 2020, but began to rise again from the end of last year. Opdivo, which stayed at 10 billion won for seven consecutive quarters from the fourth quarter of 2019, surpassed 20 billion won for the first time in the third quarter of last year. In the first and second quarters of this year, it settled in the mid-20 billion range with 25.1 billion won and 26.2 billion won, respectively. Opivo is expected to continue its upward trend as stomach cancer benefits are expected for the first time in an immuno-cancer drug. In June, the HIRA set Opdivo's standard for first-line gastric cancer treatment. Opdivo succeeded in re-challenging in about four months after suffering once in February. When the expansion process is completed, patients with HER2-negative stomach cancer will be able to use new drugs at low prices. HER2 negative gastric cancer patients account for nearly 90% of all patients, and there are no drugs other than Opdivo in the first treatment, so if it is expanded, it is expected to have a significant impact on sales. Yervoy, considered Opdivo's partner, also saw sales increase. Yervoy, which was only 1.3 billion won in the first half of last year, jumped to 6.1 billion won this year. Yervoy, the first immuno-cancer drug in Korea in the CTLA-4 family, is not well selected alone due to its limited effect and relatively high side effects. Instead, there is a combination therapy with Opdivo. Earlier this year, a combination therapy with Opdivo added a metastatic direct bowel cancer indication. ◆↑ 23% of Tecentriq & growth of Impinzi Roche Tecentriq and AstraZeneca Impinzi, generics of immuno-cancer drugs, are also steadily increasing their sales. It is Tecentriq which is showing greater performance. Tecentriq increased 22.6% year-on-year to 37.6 billion won in the first half of the year. During the same period, Impinzi increased 19.1% from 22.2 billion won to 26.4 billion won. Tecentriq succeeded in paying liver cancer for the first time among immuno-cancer drugs in April. The combination of Tecentriq and the targeted anticancer drug Avastin has become a standard treatment for liver cancer with excellent data beyond existing drugs. Analysts say that Tecentriq will gain momentum in expanding sales as it is prescribed for liver cancer in earnest. Impinzi is growing at a relatively slow pace this year with no special news. After surpassing 10 billion won for the first time in the first quarter of last year, quarterly sales remained in the early 10 billion range. Impinzi continues clinical trials in biliary tract cancer and liver cancer to expand further indications. Merck's Bavencio posted only 100 million won in sales in the first half of the year.
- Company
- Zolgensma, which is the same price as an apartment
- by Moon, sung-ho Sep 08, 2022 05:58am
- With ultra-high-priced treatments from global pharmaceutical companies newly entering the benefit range this year, human "risk management" is emerging as an issue at clinical sites. Since the treatment is so expensive, "risk" management issues such as damage and loss that may occur during administration are acting as a key issue. #Kymriah, the CAR-T treatment of Novartis Korea, which entered the benefit range this year, and Zolgensma, the treatment of Spinal Muscular Atrophy (SMA), are representative. According to the pharmaceutical industry and the medical community, Novartis Kymriah Korea has been applied as a health insurance benefit since April, and it has been confirmed that it has been administered not only at university hospitals in the Seoul metropolitan area but also at university hospitals in provincial areas. Zolgensma, who has newly entered the health insurance benefit zone since August, has passed the Drug Committee (DC) of major Big 5 hospitals, including Seoul National University Hospital and Seoul Asan Hospital, and is preparing to administer patients in earnest. As expensive treatments, which cost hundreds of millions of won alone, are administered in earnest at the clinical site, "risk management" that may occur is emerging as a key issue. For example, the question is who will be responsible for the damage or loss of the treatment in the process of handling patients with expensive treatments. This is because the price of the treatment is expensive, so both hospitals and pharmaceutical companies can be burdened depending on where they are responsible. Moreover, in Korea, it is recognized as a bigger problem because there is no insurance system that can be called a safety device in preparation for the human risk of such expensive treatments. However, there is a difference if Kymriah and Zolgensma are directly compared in terms of risk management. First of all, Kymriah, which entered the benefit range, is a pair due to the nature of the treatment, that is, a system that prepares two treatments in case of an emergency. An official from Novartis said, "In the case of Kymriah, due to the nature of the treatment, two treatments are prepared in case of an emergency." He explained the background, "As we make a treatment with T cells collected from the patient's blood, we can make two treatments with the same sauce." Kymriah reached up to 500 million won in the United States for a single administration, but in Korea, the patient's burden was lowered to up to 5.98 million won as it was set at 360.4 million won through drug price negotiations. Against this background, Um Ki-sung, a professor of blood medicine at Seoul St. Mary's Hospital, said, "In the process of introducing Kymriah, Novartis said that he would not receive drug costs if it was not actually administered, regardless of who did it wrong." Professor Um Ki-sung explained, "If a patient receives a lot of chemotherapy during the three-week administration, lymphocytes may not be extracted or cells may not come out." Professor Um said, "This means that pharmaceutical companies will not take issue with this and will only receive the drug price when the administration is completed." The problem is Zolgensma, which domestic drug price has been set at nearly 2 billion won. This is because the characteristics are different from Kymriah itself and there is no insurance system to prepare for risks that may occur during the administration process. In particular, in the case of Zolgensma, it is also worrisome that it differs from Kymriah in that the process is different, such as putting genes in vectors and transporting them so that they do not die. For this reason, there are opinions among large hospitals that are concerned about this. On top of that, Evrysdi, which is considering salaries as SMA treatments following Zolgensma, is also said to have to come up with a safety device for human risk. In this regard, the HIRA, which is considering benefits, reportedly asked pharmaceutical company Roche to come up with a plan. As Evrysdi is an oral drug, it means that safety devices should be prepared to prevent risk of patient loss. This is because Evrysdi will not have a high drug price compared to Zolgensma and Spinraza, but it is widely expected that it will be set as a burdensome drug price for patients. Novartis is in a position to discuss the plan with hospitals as it is scheduled to be administered in earnest according to the application of Zolgensma benefits. "Since it is an expensive treatment, it is not easy for hospitals and pharmaceutical companies to pay for it," a Novartis official said. "In the near future, Seoul National University Hospital is discussing how to manage risks and has been partially coordinated." "I think we will need to continue discussions in the future," he explained. He said, "I checked the insurance company in terms of human risk safety, but there is no insurance company that covers it." He added, "There is no internal determination of responsibility at the moment, but since it is the first time, we have to continue to discuss it in the future.".
- Policy
- MOHW to provide premium pricing support for innovative drugs
- by Lee, Jeong-Hwan Sep 07, 2022 05:52am
- The Korean government has emphasized the need to enact subordinate statutes to give preferential treatment to new drugs manufactured by Korea Innovative Pharmaceutical Companies and promises to prepare policy support. This announcement reflects the authorities’ determination to find a way to provide preferential treatment for drug prices based on the “Research service for the preparation of subordinate statutes for preferential pricing of drugs developed by Korea Innovative Pharmaceutical Companies that correspond to the international trade order.” However, the government had also expressed practical difficulties in its implementation, as providing pricing support for specific pharmaceutical companies, despite its legal basis, can lead to trade conflict. On the 6th, MOHW answered so to the written inquiry submitted by the People Power Party member Jong-Sung Lee regarding the preferential pricing of drugs developed by Korea Innovative Pharmaceutical Companies. NA member Lee inquired on the reason why no actual support is being provided for such companies despite legal grounds provided under the Special Act On Fostering and Support of Pharmaceutical Industry, and the MOHW’s opinion on the need for subordinate statutes to support the legal grounds. To the inquiry, the MOHW answered that although a clause for providing pricing premiums to Korea Innovative Pharmaceutical Companies does exist, the authorities must exercise caution in providing support to specific companies as this can lead to international trade conflict under international trade laws. If the final supports implemented under the act are concentrated on Korean companies, other countries may file a complaint under the WTO subsidy agreement, etc. In particular, the ‘Premium drug pricing system for global innovative new drugs’ that had been announced on July 7th, 2016, to provide preferential treatment for drugs developed by such companies, had been deleted in December 2018 as a discriminatory factor as a result of negotiations on amendments and modifications of the US-Korea (KORUS FTA). Despite such realistic difficulties, the MOHW expressed its will to enact subordinate statutes for the preferential drug pricing clause of the Special Act On Fostering and Support of the Pharmaceutical Industry. In addition, the MFDS said it will prepare measures for policy support that aligns with the international trade order and does not trigger trade conflict. The MOHW said, “We agree on the need to enact subordinate statutes to foster the Korean biohealth industry. However, the matter needs to be approached in comprehensive consideration of its impact on the domestic pharmaceutical industry, its compliance with the international trade order, its fiscal impact on NHI finances, etc.." It added, “We will also contemplate preparing policy measures for preferential pricing of new drugs manufactured by Korea Innovative Pharmaceutical Companies. And examine various angles to prepare drug pricing support that complies with the international trade order. The authorities also announced their operation plan for the Roadmap on supporting homegrown new drugs. The MOHW explained, “The government will support the full cycle of new drug R&D processes, investing ₩2.2 trillion through the pan-government National New Drug Development Project (2021-2030). With the support, we will start introducing a smart clinical trial system in 2022 to establish an environment for large-scale clinical trials and new drug development.” "We are also reviewing preparing measures to support continous new drug development for pharmaceutical companies by establishing large-scale funds in the pharma and bio industry."
- Policy
- What's patient-centered safety in the biopharmaceutical era?
- by Lee, Hye-Kyung Sep 07, 2022 05:52am
- Along with the application of the world's first CAR-T cell therapy Kymriah and Zolgensma, an alternative treatment for spinal proximal phagocytosis (SMA), the biopharmaceutical era has opened in Korea. Controversy over safety and accessibility has not yet been resolved in the process of innovative biopharmaceuticals being developed and used to treat patients. Seo Kyung-won, director of NIFDS, who attended the debate, said, "It seems to be the first session related to patient safety during the 8th session of the GBC," adding, "Thinking about how and at what point patients' opinions should be contained should begin from now on." Director Seo said, "Although it was not actually implemented due to the spread of COVID-19, we wanted to provide a place to listen to the stories of patients who participated in clinical trials of anticancer drugs developed in Korea at expert meetings such as the Central Pharmaceutical Review Committee." Director Seo expressed his willingness to directly hold the patient's opinion, saying, "It is a task I really want to do in the future." What is the controversy over biopharmaceutical safety and accessibility? Lee Hyung-ki, a clinical pharmacology professor at Seoul National University Hospital who was in charge of the topic presentation, pointed out safety problems such as unexpected side effects in clinical trials on patients due to the nature of biopharmaceuticals. Professor Lee said, "A skin injection reaction that did not occur in a preclinical trial of an innovative biopharmaceutical company in Korea occurred in a clinical trial of a patient," adding, "Biopharmaceuticals have unexpected problems, and the safety of long-term administration has not been clinically confirmed." Professor Lee's opinion is that as more innovative biopharmaceuticals have been developed and used to treat patients, the issue of safety should not be underestimated after approval. Regarding biopharmaceutical safety, the industry showed a slightly different idea. Choi In-hwa, executive director of Roche Korea, said, "Stability is under follow-up management such as management and post-marketing management to carefully review data when the Ministry of Food and Drug Safety approves products." Executive Director Choi said, "There are drugs that have been approved in foreign countries, but have not been approved in Korea, and in some cases, benefits are applied after two to three years of approval due to complicated benefit processes." Executive Director Choi said, "We have no choice but to be upset from the perspective of patients who are threatened with rare and incurable diseases or lives." Choi added, "There are products from the introduction of innovative new drugs such as rapid approval system, rare disease designation system, permit-drug link system, rare disease law, RSA, and PE exemption, but improvement is needed because there are not enough systems that reflect patient opinions." Critics of drug accessibility were also pointed out by patient groups. Lee Eun-young, director of the Korean Association of Patient Organizations, said, "The right to access drugs should start with permission." She noted, "Kymriah took more than a year to get approval from the Ministry of Food and Drug Safety after FDA approval, and it took 13 months to register benefits." Director Lee said, "Quick permission and benefit registration are important issues," adding, "The Yoon Seok-yeol government will be established and the Ministry of Health and Welfare will carry out pilot projects and main projects so that approval and drug price negotiations can be carried out at the same time for rapid registration." An important phrase here is the establishment of a cooperative relationship with the Ministry of Food and Drug Safety. Director Lee said, "If the Ministry of Food and Drug Safety does not grant prompt permission, rapid registration is useless," adding, "If a pharmaceutical company applies for an item permission, the Ministry of Food and Drug Safety must approve it and then go through the HIRA and the NHIS procedures." At this time, he emphasized that "the accessibility of new drugs will be stabilized only when patients are centered, and it will be a patient-centered policy that the Ministry of Food and Drug Safety is talking about." The association also agreed that the Ministry of Food and Drug Safety's patient-centered policy can be realized only when patients have access to new drugs. Park Jung-tae, vice chairman of the Korea Biopharmaceutical Association, said, "In foreign cases, patient safety is reflected in the policy," adding, "It is important to secure therapeutic access to patients by opening the way for active participation in regulatory science." The Ministry of Food and Drug Safety also expressed a consensus on this point, but explained why it is practically difficult. Jung Hyun-chul, head of the Ministry of Food and Drug Safety's bio-policy department, said, "The keywords of today's debate are the same as rapid screening and rapid approval," adding, "With the introduction of the Breakthrough Designation system in the U.S. in 2015, Korea also enacted the Breakthrough Drug Development Promotion Act the following year, but it was scrapped." The scrapped bill calls for introducing an occasional review to review the results of each product development process even before applying for permission to boost the development of miracle drugs and shorten the approval period. It also includes the basis for the conditional permission system, such as priority screening before other drugs so that innovative drugs can be supplied to terminal cancer patients in a timely manner, submitting clinical trial data that can confirm the effectiveness of the drug, or prescribing only specific trained medical personnel. "Because rapid approval and screening are really necessary for high-tech biopharmaceuticals, the 2019 Advanced Biopharmaceutical Act was passed, and a bill related to drugs responding to the public health crisis was prepared due to the spread of COVID-19 in 2020," said Jeong. He said, "As it requires a lot of manpower as well as the burden of reviewers, recruitment of manpower should be done." There was also an explanation for the approval of the therapeutic purpose of overseas clinical trial drugs currently being promoted. "Overseas clinical trial drugs are expected to be used for a small number of patients," Jeong said. "The problem is that there should be a great burden as the KFDA judges have to proceed with permission only with doctor's medical certificates and opinions without seeing any non-clinical data and quality data."
- Company
- Godex’s price to be cut further under PVA
- by Nho, Byung Chul Sep 07, 2022 05:52am
- Celltrion Pharm’s liver disease treatment Godex cap. is experiencing ‘double trouble,’ being subject to Price-Volume Agreement negotiations after reimbursement reevaluations. According to industry sources, Godex’s price will be cut by ₩15 per capsule (4% reduction) from ₩371 to ₩356 as of the 1st of this month. Until now, Godex’s price had been discounted 11 times, from ₩434 in 2009 to ₩433 in 2011, to ₩431 in March 2016, to ₩422 in December 2016, to ₩422 in February 2017, to ₩413 in November 2017, to ₩402 in 2018, to ₩388 in 2019, to ₩376 in 2020, to ₩371 in 2021, to finally reach ₩356 in September this year. Godex, which was approved in Korea in 2000, is a combination of Biphenyldimethyldicarboxylate (main ingredient), Cyanocobalamin, Adenine Hcl, Carnitine Orotate, Pyridoxine Hcl, and antitoxic liver extract. Although its patent had become expired due to difficulty demonstrating bioequivalence, no generics have been released as of yet. The drug, which had enjoyed exclusivity in the market over the past 23 years due to this reason, is under adjustments after filing an appeal after the Health Insurance Reimbursement and Assessment Service failed to recognize the adequacy of its reimbursement during reevaluations, and its course of direction will be decided upon soon. In addition to the rise of such situational variables, Godex also became subject to management under the Price-Volume Agreement system and was cut ₩15 per capsule, hampering the product’s external growth. Even excluding the potential threat of reimbursement reevaluations, Godex will incur a ₩2.4 (4%) drop in annual sales from its current ₩60 billion in annual sales. Meanwhile, the PVA system was implemented with the positive-listing system to improve drug price management and encourage appropriate use of NHI finances. The PVA system discounts a drug’s price by up to 10% through negotiations between the pharmaceutical company and NHIS for products whose use volume had exceeded a certain rate. The system is largely categorized into those applied to new drugs and generic drugs, as ▲Type A (new drug); ▲Type B (new drug); ▲Type C (drugs and generics listed without negotiations). Type A applies to cases where the volume of the estimated claims exceeds the volume negotiated with the NHIS by over 30%. Type B applies to claims volume increases by ① over 60% from the previous year, or by ② over 10% and exceeds ₩5 billion for drugs in the same therapeutic class for which the maximum volume had already been adjusted according to type A. Drugs fall under Type C when claims of products in the same therapeutic class ① increase by over 60% from the volume of claims filed in the previous year, or ② has increased over 10% but the increased volume exceeds ₩5 billion and does not fall under PVA Type A or Type B. However, drugs with an annual claims volume less than ₩1.5 billion, whose ceiling price is less than the arithmetic average of other same-ingredient drugs, and Drug Shortage Prevention Program drugs are not subject to PVA.
- Company
- Poziotinib responds 100% to pts with lung cancer mutations
- by Sep 07, 2022 05:52am
- Poziotinib, a new lung cancer drug exported by Hanmi Pharmaceutical, was found to have a significant effect on the G778 mutation, which is common in patients with HER2 Exxon20 insertion mutation. As a result of ZENITH20 clinical subanalysis, 12 patients showed 100% response, and PFS was also longer than other HER2 Exxon20 mutants. In particular, when Poziotinib was first used, the PFS reached 9.8 months. ESMO pre-released a draft of clinical studies scheduled to be announced ahead of the opening of the academic conference on the 5th (local time). Further analysis results of ZENITH20 clinical trials conducted by Hanmi Pharmaceutical partner Spectrum Pharmaceuticals were also published. Poziotinib is a pan-HER2 anticancer drug that Hanmi Pharmaceutical transferred technology to the spectrum in 2015. Spectrum has taken over the right to develop and commercialize Poziotinib in countries around the world except Korea and China. At the end of last year, Spectrum filed an application for Poziotinib's permission with the U.S. Food and Drug Administration (FDA) based on the results of the cohort 2 study among the ZENITH20 Global Phase 2. The official review process will begin in February and an advisory committee will be held this month. The data released this time is the result of confirming the effect of Poziotinib in the patient group with the G778 mutation among subtypes of non-small cell lung cancer with HER2 Exxon20 insertion mutation. According to the spectrum, the G778 mutation is one of the most common submutants found in 9-19% of patients with HER2 Exxon20 insertion mutation. Of the 170 patients who participated in the ZENITH20 study, a total of 14 patients showed G778 mutations among non-small cell lung cancer patients with HER2 Exxon20 insertion mutations. They were included in cohort 2 and cohort 4, respectively. Cohort 2 is for patients with past treatment experience, and Poziotinib 16mg was administered (QD) per day. Cohort 4 administered one pill a day of Poziotinib 16mg or two tablets a day (BID) of 8mg to patients with no history of treatment. As a result of analyzing 12 people who can be evaluated out of 14, all of them (100%) showed PR, and the DoR median value was 5.5 months. The median PFS was 7.8 months. In particular, in the case of cohort 4 consisting of patients with no treatment experience, the median PFS value reached 9.8 months, which was superior to the group of patients without G778 mutation. The PFS of the patient group without G778 mutation was 5.5 months in cohort and 45.6 months in cohort. Side effect profiles were similar to existing TKI ratings. Spectrum commented, "No treatment experience or Poziotinib was effective in G778."
