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- 2026-04-17 19:19:01
- Policy
- Forxiga, solvate modifier applied for the first permit
- by Lee, Tak-Sun Dec 05, 2019 06:22am
- Diabetes treatment, Forxiga by AstrazenecaDomestic pharmaceutical companies have developed a solvate modified drug for the SGLT-2 inhibitory diabetic drug Forxiga (Dapagliflozin, AstraZeneca Korea) and has entered into the application process. Once approved, the market sale will be available from April 8 2023, when material patents will be terminated. According to the MFDS on 3rd, the first approval application for Forxiga's solvate modified drug was received on 26th, and the patent holder, Astrazeneca was notified according to the licensed patent linkage system. The formulations requested for approval are Dapagliflozin L-proline and Dapagliflozin citric acid. The solvate is different from the Dapagliflozin propanediol hydrate of Forxiga. In the meantime, Korean pharmaceutical companies have been trying to avoid patents by changing solvates. In particular, the efforts were made to advance the release date by avoiding the extended period of 917 days for material patents. However, the plan was out of order with the ruling that salt-modifying drugs could not circumvent material patents with extended duration. Pharmaceutical companies, except for material patents, have challenged to follow-up patents (substance 2, formulation) and received an invalid or evasion decision this year. As a result, after April 7 2023, when the patent of substance is terminated, it will be possible to market the late drug. The initial license applicants are unknown, but as many companies have been patent-challenged, concurrent licensed products are expected to be poured out through commissions. Forxiga, used for the treatment of type 2 diabetes, is the first drug to be developed as an SGLT-T inhibitor. SGLT-2 inhibitors have a mechanism that lowers blood sugar by inhibiting glucose resorption in the kidneys, thereby promoting the release of glucose through urine. Insulin-independent mechanism of action is not affected by beta cell dysfunction and insulin resistance, so it can be used in combination with existing oral hypoglycemic agents. In particular, releasing sugar through the urine has the effect of weight loss. In some cases, it is known as diabetes medication that lose weight. Because of these advantages, Forxiga is leading the new trend in the diabetic market with outpatient prescription of ₩27.4 billion last year. Currently, SGLT-2 inhibitors include Forxiga, Suglat, Jardiance, and Steglatro, all of which are new drugs. Generic drugs are blocked from market sales due to original patents.
- Opinion
- Both to blame of the rising Pharmaceuticals & Korea
- by Eo, Yun-Ho Dec 05, 2019 06:16am
- The pharmaceutical industry is a high value-added industry and Korea is now more interested in new drugs than ever before. As interest has increased, the names of pharmaceutical companies that have reported news such as clinical failures, discontinuations, or controversy about efficacy are very popular on the Internet. It is possible. Samsung and Celltrion's biosimilars are being recognized in the US and Europe, and the government is drawing blueprints for preferential treatment of new drug prices under the development policy of the pharmaceutical industry. But it should be clear. If success is easy, it is not a new drug in the first place. According to the analysis of 9,985 data performed or in progress by the US Food and Drug Administration (FDA) for 10 years from 2006 to 2015, the success rate of the phase I was 63.2%, the phase II was 30.7%, the phase III is 58.1%. If we calculate this and estimate the probability that a new drug will be commercialized, it is only 9.6%. Stopping development and failing clinical trials are strange not to happen. However, there is a herd effect and both to blame. It is also true that many pharmaceutical companies aimed at a bandwagon effect like striking while the iron is hot. The clinical entry and completion data of the developed materials and indiscriminately presented data of the development materials, which are distributed indiscriminately without any explanation of what the drug is, aims only at investor psychology. 'Excellent efficacy compared to OOO drugs', 'It is the first XXX cancer drug', 'Secured cardiovascular safety’. It is attractive but shows no evidence. As a result of how many patients were studied and how long the study was conducted, it is not known how the difference was shown in terms of efficacy and safety compared to the comparison group. There is even a case where a comment from a company official called 'Good Medicine' is all about the medicine. story of domestic drug development is encouraging. It should be duly evaluated. This is no time to care of IR (Investor Relations). Shouldn't the stigma of playing with stocks be free itself from restraints of rebates?
- Policy
- HIRA unveils listed drug reevaluation guideline
- by Kim, Jung-Ju Dec 05, 2019 06:14am
- Chief Park Eun-Young of Pharmaceutical Evaluation Improvement Team at HIRAThe government unveiled the details of the post-marketing reevaluation criteria and procedure of reimbursed drug. The scope of listed drug reevaluation mainly centers expensive drug items, such as anticancer and rare disease treatments, covered by insurance benefit despite their uncertainty in clinical efficacy. The evaluation borrows the previous reimbursed drug list adjustment procedure, but the criteria are to be set in more intricately to cover different kinds of pharmaceutical benefit provided now. Health Insurance Review and Assessment Service’ (HIRA) Chief Park Eun-Young of Pharmaceutical Evaluation Improvement Team under Pharmaceutical Department presented a post-marketing reevaluation plan on listed drug at a public hearing convened for the topic on Dec. 3 at the Ferrum Tower, Seoul. For the reevaluation, applicable items are to be selected from the pool of high-cost drugs treating cancer and rare disease with uncertainty in clinical efficacy. The selection procedure would take account of item’s insurance listing status in foreign countries, usage frequency, insurance billing ratio, namely pharmaceutical expenditure increase rate and billing amount. Also levels of pharmaceutical and medical importance and social interest could also affect the procedure. Initially selected list of drugs would then be evaluated by published literature, such as textbooks, guidelines and clinical literatures. Basically, the structure of the listed-drug post-evaluation is to follow the footsteps of the Moon Jae-in Care. Evaluation model the government used for adjusting reimbursed drug list from 2007 to 2011 ◆ Updating listed drug post-evaluation from 12 years back: Evaluation on clinical efficacy was a key evaluation model in the previous reimbursed drug list adjustment. Enforced from 2007 to 2011, the list adjustment procedure also made decisions on reimbursement listing cancellation or restriction based on literature review of related textbooks and guidelines, and verification of medically essential substances. The Level A clinical efficacy evaluation indicated an item is “clinically effective”, as long as it met at least one of criteria, including Health Technology Assessment (HTA), World Health Organization (WHO) Model List of Essential Medicines (EML), shortage prevention drug, orphan drug, basic parenteral solution, and other essential drug. Whereas, Level B evaluation indicated an item as “clinically effective” when it met all three criteria of confirming essential medicine recommendation by related academics, recognition by related committees, and usage status in foreign countries. In the past, the Korean government used to refer to the U.S. the U.K., France, Italy, Japan, Germany and Switzerland, also known as A7, for the status of reimbursement listing. For the evaluation, an item had to be listed in more than two countries from the list. A new drug developed from Korea or in Asia was considered ‘listed in two or more A7 countries.’ And now the government plans to apply the past experience in the reimbursed drug list adjustment procedure on to the new listed drug post-management. Considering the diversified pharmaceutical benefits since then, the new post-management system is expected to be segmentalized and tightened even more. New reimbursed drug post-marketing evaluation procedure model ◆ Evaluation details: From the overall list of reimbursed drug items, anticancer therapy, rare disease treatment and items with uncertainty in clinical efficacy would be selected as subjects for the evaluation. Further selection criteria consist of substances requiring clinical efficacy validation by reevaluating effectiveness, requiring tightened management due to change in population structure and increased usage volume, and requiring Post-marketing Drug Reevaluation Subcommittee’s evaluation considering impacts on the society and other healthcare issues. After the first phase of selection, HIRA would review foreign countries’ approval and reimbursement listing status on the subjects. Besides the list of seven foreign countries used for the past reimbursed drug list adjustment, Canada is newly added. Moreover, drug reimbursement billing amount, increased rate claims, billing frequency and its ratio are to be reviewed all around. Other factors like levels of pharmaceutical and medical importance and social interest would be added as the evaluation criteria. HIRA would then evaluate the filtered subjects with evenly chosen clinical literatures, such as related textbook, guidelines and HTA reports. The agency explained alternative treatment options and special property of substances would be considered as well. When choosing the textbooks and guidelines for the review, HIRA would extensively consider literature’s evidence basis, popularity, expertise, validity, publication period, language, and recognition based on academic society’s evidence evaluation. Currently, the government and HIRA have not finalized the detailed list of literatures, such as basic list of textbooks from major search database, list of basic guideline from foreign guideline search database, government-related or not-for-profit performance assessment report, and list of published Cochran Reviews and HTA report. In addition, HIRA is contemplating on taking account of substance demand from related academic societies, alternative feasibility based on available option with equivalent or different mechanisms, and special property of substance. Restrictive use for pediatric patient, treatment for special patients with HIV-like conditions, and emergent medicine are categorized as special property of substance. Clinical efficacy reevaluation procedure ◆ Procedure of clinical efficacy reevaluation: The government and HIRA are planning to select subject items with administrative review, Post-marketing Drug Reevaluation Subcommittee, and Drug Reimbursement Evaluation Committee (DREC), in the said order. The literature-based evaluation would follow the selection, and then the government agency is to officially notify respective pharmaceutical companies. The reevaluation can be repeated from the top, if need be, and the result is finalized after the second around. The government plans to subdivide the reevaluation procedure into finance-based and performance-based post-marketing evaluation, and further enhance the reevaluation procedure. Prospective plan for the reevaluation system
- InterView
- The key to drug development is not just safety and efficacy
- by Jung, Hye-Jin Dec 05, 2019 06:12am
- 박영준 대표“In short, it is an area that is easy to miss even though it is important enough to be the core of new drug development. Most of the domestic companies that have applied for a permit with the US FDA or the European EMA are asked to submit additional data. As more and more pharmaceutical companies are attempting to penetrate overseas, Korean companies are also beginning to recognize the importance of quality data”. The reporter met with Park Young-jun, Ph.D. (55, Seoul National University) who is a professor of Ajou University, to hear about CosmaxIMD, IMDpharm joins a venture founded by CosmaxPharma. However, Professor Park emphasized the importance of Chemistry, Manufacturing and Controls (CMC) in the new drug development process. Professor Park has been developing medicine at pharmaceutical companies since graduating from pharmacy. After 17 years as head of product development at Yuhan Research Institute, he worked as research director at Samil Pharmaceuticals and CJ Healthcare. Korea's No. 30 new drug 'K-Cap' is a product that he developed as a CJ research director.Professor Park then set up a new drug research institute. IMDfarm stands for 'Innovative Medicine & Drug Delivery'. ◆Overlooking the importance of CMC to ensure 'quality of material' IMDpharm is a company researching new innovative new drugs, ▲At the same time as developing new innovative medicine for intractable diseases, ▲Improving absorption of poorly soluble drug solubilization, a pharmaceutical formulation technology ▲Sustained Release Drugs ▲Persistent Injectable Technology ▲Disease Targeted Nanoparticle Technology ▲ It is a company that develops convergent new drugs by holding technologies in various formulations such as eye drops and external preparation technologies and applying them to new drugs. However, at present, IMDpharm's cash cow is quality management, or CMC, which is an essential element in the process of leading clinical trials. Venture companies that are engaged in new drug development are the main customers of IMD Pharm CMC service. According to Professor Park, there is no company in Korea that offers a full range of CMC services from nonclinical to clinical. Most of the nation's top pharmaceutical and venture companies, which spend ₩billions on new drug development, use CMC companies in China or India. This is the result of the CMC not receiving attention in the domestic pharmaceutical industry. But the mood has changed recently. This is because CMC, the quality control of the substance, is considered as important as the efficacy and safety of the drug. "The first thing to notice when developing a new drug is the effectiveness, because any substance has a 'pharmacological effect' to get started. The next thing to notice is safety. It is marketable as a drug, 'Quality Control' covers the whole process, from the beginning to the end, demonstrating that all experiments and tests are made of the same substance and keeping this process as records and data". A typical case is 'Rolontis' by Hanmi Pharmaceuticals, . In March, the US FDA requested additional data from Hanmi Pharmaceuticals for marketing approval, which is CMC data. Overseas, the quality control of substances has already been considered important, and more quality control data are required for companies attempting to obtain a marketing license. Professor Park said, "The reason we have to conduct CMC thoroughly from the beginning of new drug development is that we can't do the same clinical trial again." "Even if you already have finished the clinical trial and submitted the results, if you should prove that you have tested all the animals and humans with the same substances and without impurities, can companies that haven't left their data back in time?" "CMC is important for finished products as well as new drugs, increased impurity risk " "Controversial impurity management is also an important part of CMC. With the development of analytical techniques and tightening impurity regulations, this poses a greater risk for pharmaceutical companies. CMC will become even more important throughout the production and distribution of finished products, and Valsartan, Ranitidine, and Nizatidine are all about this. " In this atmosphere, IMDpharm has recently expanded its business. Established in 2016 and started full-fledged business from 2017, the company expanded non-clinical CMC to clinical CMC from August. In September, the company established a joint venture with CosmaxPharma. Cosmax Pharma, which has a finished mass production facility, produces the formulation developed by IMDpharm. “CosmaxPharma and IMDpharm have combined to provide full-service services for CMC, and this year, non-clinical and clinical CRO, Dt & CRO (DTI & CRO), will join us to ensure the safety of materials at all stages of drug development, from non-clinical and clinical. The ultimate goal is to increase the success rate of new drug development for domestic companies”. Professor Park would like to help create a new drug development foundation so that all the processes and technologies necessary for drug development can be solved in Korea".
- Opinion
- [Column] Legal disputes over rebate penalty reducing price
- by Lee, Hye-Kyung Dec 05, 2019 06:12am
- This year would be a year to remember as various issues regarding drug pricing broke out, such as ‘lump-sum price reduction on single-use eye drops’, ‘revised generic pricing system’, and ‘litigation against pricing reduction penalty for providing rebate’. Currently the drug pricing system is geared towards paradigm shift, starting with abolished ‘same substance same pricing’ policy. Pharmaceutical companies would be helpless but to seek for other survival tactics in the coming year while the drug pricing ecosystem changes. There are many issues to be talked about regarding drug pricing, but today it would be about a few updates on meaningful court decisions made on pricing reduction as an illegal rebate penalty. However, it would mainly be summarized points of the issues as the lower court made the decisions and the issues are still open for long-running disputes. As I introduced in a column titled ‘Rebate and Kick-back’ published December last year, the Korean Ministry of Health and Welfare (MOHW) imposed maximum reimbursement price reduction on 340 items from 11 pharmaceutical companies accused of providing rebate. Currently, the most of affected pharmaceutical companies have filed administrative litigation against the matter. The pricing reduction penalty has not been imposed for years and related legal dispute has not been talked, either. So the recent legal disputes were raised since various issues occurred with MOHW imposing penalty of the massive scale. Going through each dispute issue, the first issue is about whether to consider nature or property of drug pricing reduction penalty as a sanction or not, according to the Item 12 of Paragraph 4 of Article 13 of Regulation for Criteria for Providing Reimbursed Services in the National Health Insurance, stating “a drug that has been confirmed as having disturbed trade orders by offering money or good for sales promotion, etc”, or also known as former rebate regulation. The distinction of the sanction is crucial, because the ministry’s jurisdiction could change depending on the recognition of the discretionary sanction. In other words, when the court recognizes the penalty as discretionary sanction, the judiciary would then decide the penalty was legitimate respecting the administrative agency’s judgment, if without a significant flaw, but if not then the court could revisit the issue. On the issue, the lower court decided drug pricing reduction penalty imposed based on the former rebate regulation ‘could not be seen as sanction, but rather the maximum reimbursement price adjustment should be judged as discretion of reasonable penalty.’ Therefore, the court meant that it would be considered as a legitimate penalty within the discretionary jurisdiction only when the jurisdiction is considered reasonable. With the said premise, the court ruling made decision on jurisdiction of discretionary authority for each specific disputed issue. First, the court ruled that the Minister of Health and Welfare was not obligated to lay down detailed basis of maximum reimbursement price calculation to affected companies, when imposing the price reduction penalty. The court did not see the legitimate reason as for the minister to consider the company as direct subject, because the regulation defines subjects for notice on reimbursed drug are mutually applied among healthcare institute, National Health Insurance Service (NHIS), policyholder, and dependent. Among drugs provided from Pharmaceutical Company B to Hospital A, should the price be reduced only for drugs prescribed by the rebate-received medical profession? Or should maximum reimbursement prices of all drugs supplied by Company B and prescribed by Hospital A be reduced? The court stated all drugs from Company B could be subject for the maximum price reduction. Rebate provision itself is highly likely to have been provided to promote sales of a specific company’s product, and there was no objective evidence to prove the rebate was provided for a specific product instead. So the court decided the Ministry of Health and Welfare’s penalty was within its jurisdiction of discretionary authority. Then what about a case of Hospital A providing both reimbursed and non-reimbursed drugs. How should the maximum reimbursement price reduction rate be calculated? Should the rebate on non-reimbursed drug be disregarded from the calculation of price reduction rate? The court decided proportionally dividing rebate amount on reimbursed drug, while completely disregarding non-reimbursed drug, was a faulty calculation of maximum reimbursement price reduction rate. The calculation formula for the price reduction rate was wrongful as rebate could have been provided for the non-reimbursed drug, and removing the amount provided to non-reimbursed drug from the calculation would have resulted in excessive reduction rate. Lastly, if the rebate provided to a pharmacist was for the cost of the provider’s prescription drug, would it be possible to reduce the maximum price including the rebate cost? Besides from violating Pharmaceutical Affairs Act, the court saw that the company’s act of providing rebate is difficult to relate back to prescription and sales of the prescription drug. The principle and the norm of dispensing and sales of prescription drug is decided by doctor’s prescription, so the court judged it is unlikely to see the correlation between rebate provided to pharmacist and ‘promotion of dispensing and sales of prescription drug’, except for a special occasion. Therefore, the court stated reduction rate should be calculated without the rebate cost provided to the pharmacist. As for the last decision, the court reviewed standard and process of imposing maximum reimbursement price adjustment penalty more specifically than other previous rebate decisions, which sets judging standard to see if the maximum reimbursement price reduction penalty was reasonable based on the ministry’s discretionary authority. The decisions were made during respective first trials and they are waiting for the appeal. Attention on the issues is heightened to see if the preceding decisions would be sustained in the appeal. In fact, there is a possibility of the change in decision during the appeal, and whichever decision is made at the Supreme Court later, the cases would definitely be the precedents setting a standard of the rebate-induced drug pricing reduction penalty. The heated legal disputes seem inevitable for the healthcare sector, as it is Korea’s new economic growth engine with visible rapid expansion in quality and quantity. Besides, the highly political and technical drug pricing is right in the center of the dispute. Previously mentioned drug pricing paradigm shift seems like it would bring more interesting topics on the table than just the rebate case. Surely the drug pricing policy would attract even more attention in the coming year 2020.
- Company
- Ildong exclusively sells 9 kinds of GSK generic drugs
- by Chon, Seung-Hyun Dec 04, 2019 06:41am
- Ildong Pharmaceuticals announced on the 2nd that it has signed 9 co-promotional contracts with GlaxoSmithKline Consumer Healthcare Korea, including general medicines. With this agreement, Ildong Pharmaceuticals is a comprehensive cold medicine ‘ theraflu’, an ophthalmic drug ‘Otrivin’, a non-smoking supplement ‘Nicotinell’, a hyperhidrosis cure, ‘Driclor soln’, an external anti-inflammatory analgesic ‘ Voltaren’, a denture attachment ‘Polident’, toothpaste ‘Sensodyne’, ‘Paradontax’, and band medical expander,‘Breathlite’. Last year, domestic sales of nine products stood at about ₩46 billion. It is equivalent to 9% of last year's consolidated revenue. Ildong Pharmaceuticals will be in charge of distribution, sales and marketing of co-promotional products to the pharmacy market from next year. GSK Consumer Healthcare Korea will support brand marketing and customer service related tasks. Dong-wha Pharmaceticals was in charge of distribution and sales of products that Ildong Pharmaceutical decided to sell. Dong-wha Pharmaceutials entered into a copyright agreement with GSK until 2020, but due to the merger of GSK and Pfizer Healthcare, the company was terminated and decided to terminate the contract by the end of this year. Ildong Pharmaceutical anticipated that, starting next year, the company will be able to achieve annual sales of more than ₩200 billion only through the OTC pharmaceutical business. Ildong Pharmaceuticals is known to have differentiated competitiveness in the field of OTC and consumer healthcare by possessing a number of well-known brands such as Aronamin, the No.1 best selling drug in Korea, and specialized sales and marketing organizations and human resources. The company explained that the company's online drug store 'Ildong Shop' was able to increase profitability as well as sales through efficient distribution and inventory management. A representative of Ildong Pharmaceutical said, “We have expanded our cooperation with GSK Consumer Healthcare Korea and OTC / Consumer Healthcare after co-promotion of flu medicine, Relenza with GSK Korea. We will continue to look for partnerships that will allow us to work together and grow together in the medium to long term”.
- Company
- Narcolepsy treatment, Nuvigil settled down in Big 5 hospital
- by Eo, Yun-Ho Dec 04, 2019 06:41am
- Narcolepsy treatment, Nuvigil are facing the entry in Big 5 hospitals. According to the industry, Handokteva's Nuvigil (Amordafinil) has passed the SNUH, Severance Hospital, SMC, and ASAN Medical Center's drug commitee (DC). In addition, prescription code was generated at St. Vincent's Hospital of Catholic University. The system of St. Mary's Hospitals is centralized, and must be approved by the Seoul St. Mary's Hospital before the code is applied to the entire St. Mary's Hospital. It has entered into an unusual case. Nuvigil was released last September in the health insurance reimbursement list in June last year for the treatment of hypersomnia related to adult narcolepsy. Narcolepsy is a symptom controlled through drug treatment. Currently, there are few treatments, so the choice is very limited. Nuvigil is an R-isomer of Amordafinil, which is currently used as a treatment for narcolepsy, and is characterized by an improved drug convenience by improving the duration of drug efficacy. Nuvigil, the active isomer of sleep seizure treatment Provigil (Modafinil), is a blockbuster drug with sales of about $80 million (about ₩94.8 billion). Teva acquired Nuvigil in 2011 by taking over Cephalon inc, the original developer. In Korea, it was approved as an indication for 'excessive drowsiness related to narcolepsy'. Nuvigil is prescribed for sleep attacks, obstructive sleep apnea, and shift work sleep disorder. In particular, a study comparing Nuvigil and placebo in 245 patients with shift work sleep disorder was noted. In this study, the proportion of patients whose sleep latency was more than 5 minutes, measured by multiple sleep latency tests, was 38% in the Nuvigil’s group, 17% above placebo. An official of the Sleep Society said, "Nuvigil is a drug that improves waking conditions without interfering with the sleeping state. Although there is a late entry into Korea, it is expected to be used in various ways".
- Company
- 8 multinational companies name new CEOs in Korea
- by Eo, Yun-Ho Dec 03, 2019 03:21pm
- From top left; Vice-chair Lee Youngshin, CEO Moon Hee-seok, CEO Shin Jung-beom, President Alberto Riva, CEO Kang So Young, CEO Lee Hye-young, CEO Kim Jinyoung, and CEO Kang Sangwook Sources report eight global pharmaceutical companies have appointed new CEOs of Korean affiliates this year only. Daily Pharm surveyed a roster of major 30 multinational companies’ Korean affiliate CEOs as of Dec. 4, and found about 28 percent of the companies have either replaced or newly appointed the top executive personnel. While several companies had a regular personnel reshuffle, others had a new personnel this year for specific reasons like merger, corporate split, and disciplinary dismissal. Roster of Korean affiliate CEOs of multinational pharmaceutical companies (as of Dec. 2019) First, Takeda Pharmaceutical and Bristol-Myers Squibb completed their acquisitions of Shire and Celgene, respectively, and welcomed new CEOs to their merged organizations. As for Takeda Pharmaceutical Korea, when the former CEO Mahender Nayak left the position it was vacant until the former CEO of merged company Shire Korea, Moon Hee-seok took over. With such development, the pharmaceutical industry had their eyes on the recently merged Bristol-Myers Squibb (BMS) and Celgene Korea’s CEO. BMS ultimately chose a promotion from within. BMS also had a vacant CEO position for a while as the former CEO Park Hye-sun left suddenly before her term ended in May. And the former CEO of Celgene, Ham Tae-jin was re-elected for another term. Although the BMS headquarters interviewed number of major candidates from Korean pharmaceutical industry, including CEO Ham Tae-jin, it appointed then acting CEO and former head of Legal and Compliance division of BMS Korea as an official CEO of the merged company. Some top executives, who served their company for a long term, left the position. A former general manager of Abbvie Korea, Yoo Hong-Ki had his retirement ceremony in last March after leading the company for over a decade, even before Abbvie was split from Abbott. As he left the company, he appointed former vice-president Kang So Young as a new general manager of the Korean branch. Menarini Korea also saw the former president Albert Kim leave last year, who served the company since before Invida was acquired by Menarini. The position was replaced by Park Hyeyoung. Pfizer Upjohn Korea, established with the recent Pfizer split, appointed Lee Hye-young as the first head of the company. Before she was appointed as a CEO, Lee used to lead Pfizer Korea’s off-patent product division. In addition, Lilly Korea appointed Alberto Riva, LEO Pharma Korea appointed former Roche personnel Shin Jung-beom, and GSK Consumer Healthcare invited former L'Oréal personnel Kang Sangwook as the new heads of their Korean affiliates. The Korea Research-based Pharmaceutical Industry Association (KRPIA) also welcomed a new CEO, Youngshin Lee. Meanwhile, this year’s ratio of Korean personnel, as a CEO of Korean affiliate of multinational pharmaceutical company, soared to 66 percent from 50 percent last year. And overall female CEO ratio in the multinational companies reached 30 percent.
- Policy
- Opdivo label changes but reimbursed scope unchanged
- by Lee, Hye-Kyung Dec 03, 2019 05:55am
- Ono Pharmaceutical’s immunotherapy Opdivo’s (nivolumab) 240 mg dose secured an approval from the regulator and expanded scope of administration on the label, but apparently the treatment’s reimbursed level of dose would remain unchanged. Health Insurance Review and Assessment Service (HIRA) recently collected public comments on the revised ‘notice on medicine prescribed and used for cancer patients.’ The agency then clarified the insurance reimbursement would only be granted for Opdivo used to treat patients with non-small cell lung cancer or melanoma with dosing schedule of 3 mg/ kg every two weeks. It would be in effect from Dec. 9. After Ministry of Food and Drug Safety (MFDS) approved of Opdivo 240 mg in April, the immunotherapy received expanded approval on dosing schedule of ‘240 mg for every two weeks or 480 mg for every four weeks’ and added it to the label of Opdivo 20 mg, 100 mg and 240 mg, on Nov. 7. However, HIRA decided not to approve of reimbursement on the new dosing schedule as Opdivo’s clinical result did not demonstrate meaningful differences between several different doses. The agency explains because Opdivo 240 mg product is not listed for reimbursement, the cost-effectiveness of additional higher dose and administration is uncertain. “HIRA has decided to grant insurance reimbursement only for using the immunotherapy under the initial dosing schedule of ‘3 mg/ kg every two weeks’, as stated on the MFDS-approved label”, HIRA official said.
- Policy
- Hyperalgesia possibility if Fentanyl mucosa not control pain
- by Lee, Tak-Sun Dec 03, 2019 05:54am
- 대표적 펜타닐 점막투여제 Fentanyl mucosal drug, a typical narcotic analgesic used for the treatment of cancer patients, may not be controlled by hyperalgesia and resistance, will be reflected in the permit. This was done by the Agency by reviewing safety information from the European Medicines Agency (EMA). The permission change adds that fentanyl mucosal medications may cause hyperalgesia if pain is not controlled, and that dose reduction and discontinuation may be considered. In particular, new content is added to the usage and dosage located in the upper line of the permit. The additional phrase is, "If pain is not properly controlled, there is a possibility of hyperalgesia, tolerance and underlying disease progression, which should be taken into account." Hyperalgesia is an abnormally sensitive condition for a painful stimulus. In addition to the general precautions, "Optimal drug-induced hyperalgesia should be considered when there is a lack of pain control compared to increasing fentanyl doses, as with other opioids. Fentanyl dose reduction or discontinuation may be considered." Adverse events such as drug abuse and Synching Withdrawal Syndrome from postmarketing experience are also added. The MFDS asked for a review by December 12. Fentanyl mucosal drugs approved in Korea are 26 items in six companies, and the items are Narco Sublingual Tab. 200μg of BC World Pharmaceuticals, Actiq oral transmucosal tab of Hyundai Pharmaceuticals, Abstral sublingual tab of Menarini Korea, Daewoong Pharmaceutical's 'Instanyl Nasal Spray', Pharmbo’s Fentakhan sublingual tablet, Teve-handok’s Fentora Buccal tab. Of these, Fentora's sales amounted to ₩6.8 billion in 2018 and Abstral recorded ₩5.9 billion based on IQVIA.
