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- 2026-04-16 01:49:56
- Company
- All bets are off for patent dispute of Galvus
- by Kim, Jin-Gu Nov 18, 2020 06:36am
- 가브스 제품사진. The patent dispute over the DPP-4 inhibitor-based diabetes treatment'Galvus (Vildagliptin)' turns around and ends at the KIPO. The Patent Court of Korea sided with Novartis, and Ahn-gook, who lost, gave up the Supreme Court appeal, and the KIPO finally took over the case again. According to the pharmaceutical industry on the 17th, Ahn-gook abandoned its appeal to the Supreme Court after losing the second trial in patent dispute of Galvus with Novartis. With Ahn-gook giving up his appeal, the stage of the dispute is expected to shift back to the KIPO. ◆Conflicting 1st and 2nd Judgment... Material patent invalidation period 187 days → 55 days Ahn-gook and Novartis have been in dispute for more than three years. The issue is how much of the'extended duration' of Galvus material patent of Galvus is invalid. When Novartis first registered the material patent of Galvus, it requested that the patent duration be extended by the time it took to supplement the data required by the MFDS. The request was accepted by the Patent Court of Korea, and the duration was extended by two years and two months. In short, the material patent expiration has been delayed from January 2020 to March 2022. In July 2017, Ahn-gook argued that some of this extended substance patent duration was invalid. The KIPO sided with Ahn-gook. Out of a total of two years and two months, it was decided that '187 days' was invalid. ◆Novartis objected. The KIPO filed a lawsuit in the Patent Court to cancel the trial decision. After the patent court of Korea ruling, Ahn-gook had two options. Through appeal, the Supreme Court had to more actively insist the period of invalidity, or whether to renounce the appeal and return to the Patent Court of Korea to be tried again. Consequently, Ahn-gook chose to abandon the appeal. To choose to go to the Supreme Court, an appeal must be filed within 14 days of the date the decision was reached (October 30), but Ahn-gook did not file an appeal within the deadline. It is said that Ahn-gook was deeply concerned about the decision to abandon the appeal. The reason Ahn-gook struggled was that the second trial ruling was unclear. Ahn-gook benefited from the court's ruling in some of Novartis' prevailing decisions. Although the period of invalidation of Ahn-gook was reduced from 187 days to 55 days, it is still evaluated that it is not practically bad in that some were recognized as invalid. Moreover, considering that there has been no case of overcoming the duration of an original material patent by invalidity even for a single day, it is worth just 55 days. With Ahn-gook's renunciation of appeal, the dispute is expected to continue at the KIPO again. It has a similar shape to the case that the superior judge canceled and returned the lower court in the general court. ◆Will the KIPO accept the judgment of “55 days” The key is whether The KIPO will accept the opinion of the Patent Court of Korea's '55 days of validity'. In the usual remand after reversal case, the lower judge mostly cites the opinion of the higher one. However, in this case, Novartis is strongly opposed to acknowledging the period of invalidity, and the dispute is expected to develop fiercely again. If the KIPO accepts the opinion of the Patent Court of Korea, the release date of Ahn-gook's Galvus generic is likely to be delayed by 130 days from mid-August 2021 to early January 2022. A pharmaceutical industry patent official said, "Novatis, who won the second trial as Ahn-gook gave up the appeal, has legally lost its appeal status. Patent dispute of Galvus is automatically resumed at the KIPO." "The dispute between Novartis and Ahn-gook will be fierce again over how much invalidity will be," he said.
- Company
- General hospitals pass antifungal Cresemba for prescription
- by Eo, Yun-Ho Nov 18, 2020 06:35am
- South Korean general hospitals have started registering Pfizer’s novel antifungal Cresemba for prescription. According to pharmaceutical industry sources, the Drug Committee (DC) at the Big Five general hospitals and other healthcare institutes in South Korea, including Seoul Asan Medical Center and Severance Hospital, have cleared Cresemba (isavuconazonium). In last January, the Ministry of Food and Drug Safety (MFDS) has approved Cresemba, indicated to treat adult patients in age of 18 and older with invasive aspergillosis, and adult patients in age of 18 and older with mucormycosis for whom amphotericin B is inappropriate. With a wide variety targeted antifungal spectrum, Cresemba can treat both invasive aspergillosis and invasive mucormycosis. The drug is currently the only azole antifungal in South Korea indicated for invasive mucormycosis. However, the drug faces an issue with the healthcare reimbursement. In last month, the Health Insurance Review and Assessment Service (HIRA) internally revised the regulation on the pharmaceutical reimbursement subject evaluation standard and procedure. HIRA narrowed the scope of prospective subject for pharmacoeconomic (PE) analysis exemption, initially suggested as ‘antibiotics,’ to ‘antibacterials.’ Both the industry and academic scholars supported the government’s plan to expand the subject scope of the PE analysis exemption. But their definition of antibiotics was controversial. Medically speaking, an antibiotic means antimicrobial medicines that cover antibacterial, antifungal and antiviral. And the constant increase of antimicrobial resistance (AMR) is considered as the most critical public health risk around the world. Due to the major public health risk, some were disputing over unifying the definition of the new PE exemption subject—antibiotics—as ‘antibacterial’ based on the variant definitions of antibiotics. And the government sealed the deal by ‘limiting the exemption to ‘antibacterial’.’ Cresemba, categorized as an antifungal, is in shock of the government’s decision. President Choi Jung-hyun (Catholic University of Korea Eunpyeong St. Mary's Hospital) of Korean Society for Antimicrobial Therapy (KSAT) said, “The risk of secondary nosocomial infection increases higher, when a patient with COVID-19-like severe disease is hospitalized for a long term or uses respirator for a long term. While the demand for securing sufficient amount of infectious disease drug is becoming ever more important to respond against novel infectious disease and secondary nosocomial infection, it is regretful that the government had to neglect the academic society’s advice and narrow down the definition of antibiotics.” Including South Korea, the number of fungal infection cases around the world has been surging as more than one million people reportedly die annually from fungal infection. However, the number of developed antifungal is limited. Among all fungal infection, the invasive aspergillosis is considered as one of three most dangerous invasive fungus to the human race. Even in Korea, the infection is counted as one of most frequent causes of death in patients with immune deficiency, due to increased number of patients receiving anticancer therapy and fighting against AIDS.
- Opinion
- [Reporter’s View] The sluggish shift in stepped pricing
- by Eo, Yun-Ho Nov 18, 2020 06:34am
- In June, South Korea’s Ministry of Health and Welfare (MOHW) issued an administrative notice to withdraw the plan to apply the stepped drug pricing reduction on drugs transferred by business restructuring. And it has been three months since the ministry completed collecting the public opinion in August. But the finalized notice has not been disclosed. When the decision was made, the pharmaceutical industry seemed relieved and also complimented the government for swiftly changing the policy to reflect the public opinion. Daily Pharm also praised the MOHW’s action as an example of a ‘Smart healthcare administration.” However, the companies, who were relieved about the change and pushing on with their product transfer along with the business restructuring, are now idling. Some even assumed the final notice was issued and proceeded with the healthcare reimbursement listing procedure, which they ended up withdrawing. Initially, the stepped drug pricing, in effective from August, sets the upper limit pricing of a drug, regardless of qualifying two criteria for top-level pricing, at 85 percent of either the lowest pricing or 38.69 percent of the first-in-class drug, if the number of listed same-substance drugs exceeds 20. However, the Pharmaceutical Decision and Adjustment Criteria amended in last February opened up a room for the stepped pricing to be used on a product that succeeds business status due to corporate restructuring—for example in case of M&A, corporate split or license sell-off. Accordingly, companies like Pfizer Pharmaceutical Korea (Upjohn) and MSD Korea (Organon) preparing for multiple transfer of original products to the respective split off companies, fear of the possible pricing reduction. Takeda Pharmaceuticals Korea that recently sold off an antidiabetic treatment pipeline to Celltrion could not be completely free from the same fear. The controversy seemed to have died out as the ministry decided to set the upper limit price as before, according to the Pharmaceutical Affairs Act Article 89 notified to be enforced in June, when a drug is transferred by inheritance, business transfer or merge; a manufacturing license is switched to an import license or vice versa; and license is dropped and receives license as a same-substance drug due to Pharmaceutical Affairs Act, MFDS notice or the corporate status change. When a government body admits finding an error or side effect in a policy and decides to take a change, speed also becomes an integral part. Surely, the government body has to take time to carefully consider consequences. Taking numerous reconsiderations, even after accepting the public opinion, makes sense for such major policy shift like reviving the stepped drug pricing system. Regardless, the pricing reduction on the transferring original product should be a minor amendment. The speed is crucial for the significant shift in policy. Affected companies are already missing the business schedule. The bigger problem is that they still cannot fathom when it would be finalized. When there are companies waiting and the precious time is ticking away, the companies at least deserve an explanation.
- Company
- How can the domestic drug price system be improved?
- by Nov 17, 2020 06:28am
- As drugs that target specific genes or activate the immune system to treat diseases have been released, the use of one drug for various types of cancer has become more frequent. As of 2018, 75% of target anticancer drugs are multiple indications, and in the case of immune anticancer drugs, thousands of single and combined clinical trials for various carcinomas are reached. There are many opinions that the current drug price system needs to be changed. This is because, as indications are added, only the factors that lower the drug price increase, reducing the patient's access to new drugs. How can the domestic drug price system be improved? To find the clues, Dailypharm held the 40th Future Forum on the 11th at the Moonjeong-dong office building under the theme of 'prerequisites for introducing drug prices by indications'. From left, Professor Dongcheol Seo (Chair), Professor Mihye Park, Secretary Kyungho Choi, Manager Younghee Lee, and Chiyoung Ryu The forum was attended by Professor Seo Dong-cheol of the College of Pharmacy at Chung-Ang University. Park Mi-hye, professor of the College of Pharmacy at Sungkyunkwan University, Choi Kyung-ho, secretary of the Department of Health and Welfare Insurance and Pharmaceutical Affairs Department, Lee Young-hee, head of the Drug Price System Improvement Department of the Health Insurance Corporation, and Ryu Chi-young, director of the Korea Global Pharmaceutical Industry Association (KRPIA), attended. Prof. Mi-Hye Park, who came out as a speaker on this day, analyzed the drug price system for each foreign indications under the theme of 'A measure of valuation when expanding indications of new drugs-Focusing on immune anti-cancer drugs and targeted anti-cancer drugs', and suggested the most suitable method for the domestic environment. Currently, Korea is maintaining or lowering drug prices in consideration of the additional usage (additional financial requirements) of already approved drugs. This is a method that recognizes only the first value assigned at the time of listing of the first salary and not the value of other indications. For this reason, as the standard is expanded, the drug price gradually decreases. Based on the standard anticancer drug, as the number of supplementary extensions increased, the tendency of drug price cuts was more pronounced, and as indications increased, the dropping rate was found to be greater. Professor Park Mi-hye Prof. Park pointed out that the current method, which does not recognize the value of additional indications, is also contrary to the 'value-based evaluation system', which determines whether or not to pay benefits based on relative clinical usefulness and cost-effectiveness when listing new drugs. .This is because even if an unlicensed drug proves high value in a new indication, it is excluded .There are also concerns about this .Professor Park Mi-hye explained, "If the value of the additional indication is higher and it is not recognized as a drug price, there is a possibility that pharmaceutical companies will not promote the expansion of the standard." In the light of research by Cole et al., "If the value of each indication is recognized, high-value indications can receive high drug prices .Therefore, pharmaceutical companies will be more active in research and development on new indications, so that patients' treatment options can be wider .Therefore, social welfare can be further increased.” Differential structure of drug prices by actual indication, such as Australia and Italy How to determine reimbursement of multiple indication drugs abroad ?As a result of an analysis of the survey published this year by Professor Park by the OECD, it was found that there are no countries that explicitly operate the drug price system by indication, but some countries are implementing a structure in which the price of drugs by indications is substantially different for certain drugs .As a result of the OECD survey, Australia, France, Greece, and Italy said that when an indication is added, they concluded a new RSA and the drug price was substantially different Norway and the UK charge all indications at that price when cost-effective .Australia and Germany calculate single-weighted pricing for each indication, reflecting the cost-effectiveness of the patient group for each indication when determining drug prices for multiple indications .In addition, Italy, Belgium, France, Switzerland, etc .negotiate a risk-sharing system (RSA) for each indication, so that the drug price is substantially different .Professor Park said, "Typically, Australia is making changes by calculating a single weighted average price by referring to the Medicare data collected during the prescription period." "Also, Italy has established a registry very well for nearly 20 years, so that which drug is suitable for any indication of a patient .It is possible to track how much it has been used .Based on this, different types of risk-sharing drugs are implemented for each indication even for the same drug." In addition, Italy, Belgium, France, Switzerland, etc .negotiate a risk-sharing system (RSA) for each indication, so that the drug price is substantially different With the increasing number of anticancer drugs with multiple indications, what is the most appropriate drug price system considering the domestic environment ?Prof .Park disclosed the results of the survey to practitioners related to drug prices of pharmaceutical companies registered with the Korea Global Pharmaceutical Industry Association (KRPIA), the Korea Biopharmaceutical Association (KoBIA), and the Korea Pharmaceutical Bio Association (KPBMA) .System 3 is the most supported from▲ Calculation of a single weighted average price according to the value of each indication (system 1), ▲ application of a different risk-sharing system for each indication (system 2), and ▲ different drug prices for each indication (system 3) .Professor Park said, "The majority of respondents evaluated the current system as negative in terms of improving access to new drugs and reflecting appropriate values, and more than 90% agreed with System 2, which received an overall positive evaluation in the direction of system improvement." He said that the way to give different drug prices is practically limited .Based on this, Professor Park proposed to introduce a method that practically differentiates drug prices by applying different types of risk-sharing system for each indication, as in Italy .Professor Park said, "In Korea, RSA is already being implemented, and since 2018, selective benefits have been introduced to medicines, and a system that differentiates the level of reimbursement for each patient has been established, so it seems to be a sufficiently accessible policy." Even when considering harmony, it is considered the most feasible solution." He added, "Currently, the RSA application is operated on a relatively strict basis, so it is difficult to apply it to all drugs for which indications are expanded .This part requires coordination." Professor Park said, "In the future, the possibility of expansion of the indications for anticancer drugs is very high, but the potential risk is left alone .If this situation is repeated, the damage will eventually be suffered by the patients .It is time for a future-oriented policy alternative."
- Company
- A heated panel discussion on indication-basis drug pricing
- by Eo, Yun-Ho Nov 17, 2020 06:27am
- In this day and age of a single drug offering a variety of indications, the problem now lies on the drug pricing. The negotiation between the South Korean government and pharmaceutical company is slowing down and the patients have to wait longer as the country’s drug pricing system cuts the pricing when a drug expands its uses. From left: Professor Suh Dong-churl as speaker, Professor Park Mi Hye, Deputy Director Choi Kyung-ho, Director Lee Young-hee and Senior Manager Ryu Chiyoung On Nov. 11, Daily Pharm convened the 40th Future Forum on the topic of priorities in introducing the drug pricing system by indication. The pharmaceutical industry, government and academic society representatives gathered to find the answer of unending question of treatment access and appropriate pricing. Professor Suh Dong-churl of Chung-ang University College of Pharmacy led the forum as a speaker, where Professor Park Mi Hye gave a keynote speech on ‘Introducing Indication-basis Drug Pricing to Improve Patient Access,’ followed by a heated discussion among panelists like Deputy Director Choi Kyung-ho of the Ministry of Health and Welfare (MOHW) Pharmaceutical Benefits Division, Director Lee Young-hee of National Health Insurance Service (NHIS) Drug Pricing System Improvement Division and Senior Manager Ryu Chiyoung of Korean Research-based Pharmaceutical Industry Association (KRPIA). Senior Manager Ryu Chiyoung ◆The need of introducing the indication-basis drug pricing system: The indication-basis drug pricing system decides the price of a drug by each indication and its innovativeness. Last month, the industry finally solved the problem of applying risk sharing agreement on follow-on drugs that have treatment level on par with a first-in-class drug and favorable cost-effectiveness. However, the government has added another condition; while allowing follow-on drugs to sign RSA, any drug seeking to expand reimbursement, regardless of being the RSA subject, would have to prove cost-effectiveness (administration cost comparison or pharmacoeconomic (PE) analysis). In other words, when the Health Insurance Review and Assessment Service (HIRA) requires cost-effectiveness evaluation, a drug would be priced at lowest level compared to either PE or clinical evidence with reference drug, and have the price reduced according to the same standard as the first-in-class drug. Senior Manager Ryu Chiyoung stated, “These days, a single drug now gains 15 to 20 indications through various researches. But if their pricing drops as they expand indications, then which company would voluntarily take an additional action to actually expand the indication? KRPIA proposes the government to apply weighted average pricing by indication or to adjust refund rate, if it looks for cost-effectiveness when approving additional indication.” Deputy Director Choi Kyung-ho He added, “Besides the system revision, many of market access managers in multinational companies are struggling to negotiate with the headquarters on supplying new drugs in South Korea. Increasing number of other countries using the international reference pricing (IRP) is worsening the risk of the ‘Korea Passing’ phenomenon.” ◆The unavoidable issue of ‘financial burden’: When the reimbursement scope of a drug is extended, patients receive the benefit, but at the same time the financial burden also gets bigger. Under the National Health Insurance (NHI) system, the government has to contemplate on cost-effectiveness whenever it lists a new drug. The controversial premise of ‘reducing drug pricing when use is expanded’ is also a result of the contemplation. Deputy Director Choi Kyung-ho said, “Taking a look at immunotherapy, the indication expansion of the drug in South Korea has been sluggish compared to the company’s expectation. Two to three indications are added a year. If the talks on reimbursement are delayed, more and more indications would be left non-reimbursed.” But the deputy director also explained, “The additional expenditure for the expanded reimbursement is through the roof and the indication-basis pricing is unprecedented. The government does see the issue, and it would try to find the point of agreement through thorough discussion.” Regardless, the academic scholars highlighted another means of approaching the issue. Director Lee Young-hee Professor Park Mi Hye advised, “The NHI finance is both about drug pricing and the use. But the country heavily relies on the drug pricing that it is losing flexibility in the financial management, which is also why the industry and the government are in a deadlock for a longer period of time. It may be better to shift the paradigm away from reducing the expenditure simply through drug pricing.” However, the government is also highly concerned of the drug pricing increase due to the indication-basis pricing. Director Lee Young-hee claimed, “The drug pricing could be increased when a number of indications receive weighted average pricing or differentiated refund rate on a single labeled pricing. NHIS can only pay when it has money. The agency has no choice but to be careful about the indication-basis pricing as it is directly related to the sustainability of NHI.” The industry representative gave a clear answer on the government’s concern. Senior Manager Ryu disputed, “No company would demand for pricing increase, when adding an indication with the revised system. But, what we are saying now is that we need to adjust the current pricing reduction measure.” ◆The realistic difficulties and hastiness: The change in administration could only be cumbersome. Giving different pricing for each indication would have to input two to three codes for a single drug. Accordingly, the billing system HIRA and NHIS operate would have to undergo a significant change, and even the healthcare institute could get confused by inputting the major and minor disease codes. Professor Park Mi Hye Director Lee noted, “When applying differentiated refund rate, various side effects, such as erroneous claim, claim omission and the system abuse by the healthcare institute, could break out. Generally considering the detailed execution plan, the indication-basis pricing requires comprehensive revision on the system and other supplementary actions.” Some argue introducing the indication-basis drug pricing to the South Korean market could be a hasty decision at the moment. Director Lee elaborated, “From 2013 through 2017, total 45 novel anticancer treatments were released in the Korean market, and the number indications surged from 265 to 935. So far, only six countries have adopted the indication-basis pricing, although all countries are experiencing the same issue with indications and pricing. It testifies how the system is difficult for everyone accept.” KRPIA official rebutted the claim straight on. Senior Manager Ryu said, “The current billing system in South Korea allows input up to top ten. I beg to differ that the disease code monitoring could get difficult and cause confusion. South Korea is one of the few countries that have successfully unified and systematized the billing system. Only because other countries are not adopting the system, it would not make sense for Korea to be hesitant to take the lead and revise the system.”
- Company
- Korus Pharm is in charge of Russian COVID-19 vaccine
- by Kim, Jin-Gu Nov 17, 2020 06:27am
- COVID-19 vaccine Sputnik V product photo developed by Russia (Photo by BBC) It was confirmed that Korus Pharm, a small and medium-sized pharmaceutical company, is in charge of the Korean production of the Corona 19 vaccine developed by Russia. According to the pharmaceutical industry on the 13th, GL Rapha signed a three-party contract with the Russian Direct Investment Fund (RFID) and Yas Pharmaceuticals of the United Arab Emirates (UAE) for the production and supply of Sputnik V in September. Korus Pharm, a subsidiary of GL Rapha, is responsible for the production and supply of this vaccine. All vaccines produced by Korus Pharm are supplied to the Middle East through Das Holdings, known as a UAE pharmaceutical company. The supply is estimated to be 150 million doses per year. Korus Pharm's main business is the overseas export of antibiotics and generic drugs. The unlisted company's sales last year were about ₩38 billion. Although there is no history of directly developing and producing vaccines, it is reported that the company recently expanded its business to biopharmaceutical research and development and built related facilities. The specific contract amount related to this production and supply contract is not known, but it is estimated to be tens of billions of dollars. Vaccine production is handled by two factories located in Chuncheon and Andong. Although it has not entered full-scale production yet, it is expected that initial shipments will be possible in the first half of next year. However, Korus Pharm explained that there are no plans to sell this vaccine in Korea. An official from Korus Pharm said, "It is a plan to supply all vaccines to the Middle East according to the contract." Earlier, in August, Russia approved the world's first Sputnik V as a vaccine for COVID-19. Since then, Tthe CEO revealed the possibility of Korean production, and attention was focused on where the company was in the domestic pharmaceutical industry. However, domestic vaccine companies and CMO companies denied consignment production of Russian vaccines. GC Pharma, SK Bioscience, Ilyang, Eu Biologics, Celltrion, and Samsung Biologics. Russia chose Korus Pharm, a small and medium-sized pharmaceutical company, over Korean vaccine companies and CMO companies. Russia chose Korus Pharm because the UAE's Yas Pharmaceuticals brokered it. Korus Pharm had exported medicines to the Middle East even before the corona vaccine supply contract.
- Policy
- Multiple myeloma treatment 'Ninlaro' passed by the committee
- by Lee, Hye-Kyung Nov 17, 2020 06:27am
- Takeda Korea's multiple myeloma treatment'Ninlaro (Ixazomib)' passed the committee's deliberation. The HIRA (President Kim Sun-min) released the results of the deliberation on the adequacy of medical care benefits at the '11th Drug Benefit Evaluation Committee in 2020' on the 13th. The new drugs that have been deliberated on the adequacy of reimbursement this time are a total of 5 items including 'Ninlaro' 2.3·3·4mg, Beovu, and Beovu PFS. Ninlaro, which passed the committee, was designated as an orphan drug in May 2017 and was approved in Korea in July. After challenging the reimbursment since 2017, it was lost, and prescriptions were made at the hospital with free supply from last year. This drug has been approved for combination therapy with Lenalidomide and Dexamethasone in patients with multiple myeloma who have received more than one treatment. Novartis Korea's neovascular (wet) age-related macular degeneration treatments, Beovu and Beovu PFS, have Benefit Adequacy, but failed to pass the committee review due to the high price submitted by the pharmaceutical company. However, if Novartis accepts less than the evaluation amount suggested by the HIRA, the deliberation will pass. Beovu and Beovu PFS received domestic approval in June and July respectively.
- InterView
- “30-year-old Novarsc is our pride”
- by Eo, Yun-Ho Nov 17, 2020 06:26am
- Norvasc (amlodipine) is not the world’s first calcium channel blocker (CCB). However, it is undisputedly the most famous CCB. Launched in 1990s, Norvasc was not the first-in-class but it instigated a notable change in the market with the first once-daily administration. Some say the drug marked the early beginning of the present convenient administration marketing. A key hypertension drug market presence Novarsc is now celebrating its 30 year anniversary of marketing approval in South Korea. Surely it is an old drug, but it still has its high reputation firmly built around ceaseless evolution. In 2017, Norvasc T was released to the market for the patients, who need amlodipine and telmisartan simultaneously. The company also introduced an improved bottle packaging to enhance the convenience of patients and healthcare providers storing and managing Norvasc T and to absorb the moisture of telmisartan. And besides the existing line of 5 mg and 10 mg tablets, the brand also launched 2.5 mg tablet for children from age six to 17, which was the first among all CCB original drugs for hypertension. From then on, Novarsc has been offering necessary dosage options to effectively bring down blood pressure in patients ranging from six years of age to elderly. Prior to next week’s launch of Viatris, Daily Pharm interviewed Pfizer Upjohn Regional Sales Manager Lim Hye-sook and a rookie Sales Executive Lee Chang-hwan, who have been in charge of Novarsc sales. Regional Sales Manager Lim Hye-sook-Please, give us a short instruction Lim Hye-sook (Lim): I started from the Clinic Team when I joined Pfizer in 2005, and the first product was Novarsc. Although I’m the youngest out of all regional sales managers, I was still the last one Pfizer Upjohn Korea appointed before we spilt as Viatris. It has been 15 years since I joined the company, and I still manage Novarsc sales. The drug is basically an old pal now, keeping me company for all these years. Lee Chang-hwan (Lee): Ever since I was young, I had an admiration for the company Pfizer. I had to apply for the job for seven times to get it. Because my father was a doctor, I was familiar with the name from early on. After learning that the company is the biggest pharmaceutical company in the world, I dreamed of joining the company since then. -Managing the Novarsc brand for 15 years, you must be particularly attached to the brand? Lim: Of course. I’m not sure about the rookies these days, but when I was managing private clinics, I was frequently recognized as the ‘Novarsc Account Executive.’ I still remember the days when I had to take quizzes every three months on the product. The entire sales department had to retake the quiz on their own products when they failed. Because Novarsc had a vast amount of clinical data, I had to cram in quite a bit of information. -I assume there were also bad days on the job Lim: When managing the hospitals, defending the Novarsc code was very difficult. At a hospital-level healthcare institute, your role as a salesperson is significantly narrowed when you lose the code. It is a challenge for any salesperson. Then again, there is nothing more exhilarating to see your product’s code getting registered. While I became a regional sales manager and celebrating the 30 years of Novarsc, a new 2.5 mg tablet was released. I was grateful to see the 2.5-mg tablet registered at multiple general hospitals. Three decades could be a long time for some, but it could be a new beginning for some. When we introduced the 2.5-mg tablet, the healthcare providers commented that Novarsc is still trying new things. Sales Account Executive Lee Chang-hwan -Let’s hear from the rookie now. When did you actually felt that Novarsc has the worthy fame? Lee: A new account, any hospital or clinic, or even a doctor who has never heard of the drug was still prescribing at least a case of Novarsc. At the moment I’m managing seven products, and the Novarsc brand gives me a leverage to introduce other products’ code to a hospital. That’s the time I can see that everyone knows, uses and prescribes Novarsc. -What are some hardships you face amid COVID-19? Lee: Due to COVID-19, the sales had to work from home for about three months. When we came back to in-person work, I initially though it is not easy coming back. But it seems like everything I have done so far is coming through in this time of darkness. As in-person meeting became risky, the sales who did not get to build rapport with existing clients face limitations. But for those who have been earnestly doing their job, the work seems to be easier amid COVID-19. It almost seems like we have less competitors. As for the regional sales manager, what would like to say as a word of encouragement to your fellow colleagues? Lim: I’ve mention of my 15-year experience here, but there are employees who have been with the company for 30 years. Just like Novarsc has been with us for three decades, I wish we can together see the 40 and 50 year anniversary of the brand. -What would you like to do next as a second-year account executive? Lee: I came to the company, because I desperately wanted to try the pharmaceutical sales. I’m managing clinic accounts at the moment, but I also want to move on and experience other general hospital channels as well. And if I get a chance, I also want to make decisions in marketing strategy at the marketing team. -Soon, Novarsc would start a new beginning under Viatris. How do you feel about the new beginning? Lim: We have prepared for it for a long time. I was a part of taskforce team last year and I’ve been anticipating it. Knowing that it’s just next week, I can’t wait any longer. I have big expectations for the changes I would experience in Viatris. As I handled other changes so far, I’m hoping the upcoming changes would be positive. Lee: As I said before, I came to the company with my admiration for Pfizer. So I didn’t know how to react to the news of splitting off as Viatris. But starting off as a new company and joining the first starting member of a new business model intrigued me. So far, Pfizer has been topping the ETC industry. I do not fear anything about joining Viatris, as I would still be with the colleagues, products and amazing culture that enabled Pfizer to maintain the reputation. Now I’m just looking forward to it. I just want to say, “Thank you, Pfizer. Let’s go, Viatris!”
- Policy
- Cyramza OS Clinical 9.6 months vs. RWE 7.9 months
- by Lee, Hye-Kyung Nov 17, 2020 06:26am
- Apparently a study in South Korea comparing the clinical trial result and real world data has found a targeted therapy for stomach cancer Cyramza (ramucirumab) and a targeted therapy for breast cancer Kadcyla (trastuzumab) have shorter overall survival in the real world. The clinical trial report on Cyramza stated its overall survival (OS) reached 9.6 months (8.5-10.8), but a statistic claim billing analysis by the Health Insurance Review and Assessment Service (HIRA) found the figure to be at 7.9 months (6.3-8.4), and it marked 10.0 months (9.3-10.7) in an analysis on medical record archived by research participating hospitals. As for Kadcyla with insufficient period of monitoring, patients’ progression-free survival (PFS) was compared and found the initial clinical trial result was at 9.6 months, which was 1.6 months longer than the actual medical record analysis at 8.0 months (6.8-9.4). The said gaps between clinical trial result and real-world data (RWD) was verified in the Retrospective Study on Designing the Real-world Evidence (RWE) Platform for Improved Pharmaceutical Reimbursement Management (Principle investigator: Dr. Kim Dong-suk and Dr. Byun Ji-hye) published by HIRA on Nov. 12. HIRA selected Lilly’s Cyramza (ramucirumab) and Roche’s Kadcyla (trastuzumab) as subjects for RWD-basis outcome study to generate RWE. The research was conducted as randomized controlled trial (RCT), the same method the pharmaceutical companies have used, when listed the drugs, by collecting and analyzing medical records from 242 healthcare providers (68 hospitals) associated with Korean Cancer Study Group. ◆Cyramza: The RCT evidence used when listing for the healthcare reimbursement compared the paclitaxel single therapy against Cyramza in combination with paclitaxel, which confirmed the combination therapy’s efficacy, statistically. Based on the billing data collected from May 2018—the point of Cyramza listing—through December 2018, the fatality rate in patients with a record of Cyramza prescription, from the point of first stomach cancer diagnosis to death, was reviewed. As a result, 1,023 out of 1,419 patients have died. The median OS was approximately 240 days (7.9 months), which was shorter than 9.6 months from the original RCT. The majority of the patients, or around 55% of them, were administered with the drug four times or less, followed by the number of patients who used the drug five to six times and over 10 times. The average number of administration marked 5.3 times among all patients. Analyzing the impact of variables affecting the OS with Cox proportional hazards model, the OS was statistically better when the diagnosis was given over a year ago, administration period was over 12 weeks, the number of administration was over seven times, and when it was at tertiary hospitals. The outcome study on electronic medical record (EMR) analyzed patient survival after using Cyramza with Kaplan-Meier estimator. The study concluded the time to progression (TTP) to be at 4.2 months, PFS at 4.03 months and OS at 10.03 months. The RWE based on these RWD confirms Cyramza in combination with paclitaxel showed shorter OS, compared to the original RCT. ◆ Kadcyla: Apparently, 331 out of 1,009 patients have died among the patients who were administered with Kadcyla at least once for year since the point of listing in August 2017 through July 2018. The median OS was approximately 449 days (15 months), which was shorter than both 29.9 months (Dieras et al, 2017) and 22.7 months (Krop et al, 2017) demonstrated in the company’s RCTs. But HIRA said there is a limitation with the insufficient time of monitoring as the drug received the reimbursement only from August 2017. Even with EMR data, the PFS in patients who used Kadcyla was at 6.8 months (6.2-7.4), but again the monitoring period was too short to confirm median OS.
- Opinion
- [Reporter's View] Did they have to sell that day?
- by An, Kyung-Jin Nov 16, 2020 06:03am
- The whole world was excited when the news about COVID-19 vaccine developed by Pfizer last week was delivered. This is because Pfizer announced an interim result that the mRNA vaccine, which is being developed jointly with BioNTech in Germany, showed more than 90% prevention effect. The company recruited about 44,000 participants in clinical trials from five countries, including the United States, and divided them into two groups, receiving COVID-19 vaccine on one side and a placebo on the other. Among them, as a result of analyzing 94 people who were diagnosed with COVID-19, participants who received the vaccine twice had an infection rate of less than 10%, and no serious side effects were observed. Uğur Şahin, CEO of BioNTech, said in an interview with foreign media, "I believe that this vaccine can end COVID-19 outbreak." As the spread of COVID-19 across the United States is accelerating, including the tightening of blockade measures in major cities such as San Francisco and Chicago, starting with New York, it is expected that the current level of data alone will provide dramatic protection effects. Albert Bourla, CEO of Pfizer, said, "We will apply for Emergency Use Authorization (EUA) to the US Food and Drug Administration (FDA) in the third week of November." and he added,"Vaccines can be manufactured in quantities that can inoculate 15 to 20 million people within the year." In the long term, Pfizer is planning to increase the dose of vaccine to 1.3 billion doses per year. Although it has been pointed out that detailed clinical data has not been disclosed and there are many issues to be solved, such as the distribution process, the good news that came after a long time moved the market. As the anticipation for the development of a COVID-19 vaccine and economic recovery was reflected, the New York Stock Market continued to rise overall, and Pfizer's share price rose about 15%. However, Pfizer CEO Albert Bourla sold a large number of stocks on the day of the announcement of the interim results of COVID-19 vaccine clinical trial. On that day, CEO Albert Bourla sold 62% of Pfizer's shares he owned and made a profit of ₩6.19 billion. Pfizer's vice president Sally Susman is also reported to have sold 44,000 treasury shares for $1.8 million (₩2 billion) on the same day. Of course, there is no legal problem with their selling. Pfizer said, "The sale of this stock is part of Bulla's personal financial plan and a pre-determined plan." The stock sale was approved on August 19th (local time), and the sale was made in accordance with the insider trading regulations, but there are no matters that violate the regulations. Nevertheless, public opinion is not good about this. There are also criticisms that it was inappropriate for Pfizer to announce the interim results of the clinical trial on the day the CEO decided to sell the treasury stock. As a result, doubts about the effectiveness and safety of the vaccine, which are still not established, have been raised. Moreover, this is not the first time such a controversy. Controversy arose as US pharmaceutical company Modena executives sold their stocks and earned profits after announcing the results of the interim phase I clinical trial of COVID-19 vaccine in May of this year. Even at this time, the company held a position that there was no legal problem with the executives' stock sales. The development of COVID-19 vaccine and an end to the pandemic are the wishes of not only investors who own Pfizer shares, but also the people around the world. Could they have acted more carefully if they were conscious of their responsibility for such aspirations? We hope that the stock sale will end in controversy as the remaining vaccine development and supply schedules proceed smoothly.
