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- 2026-03-18 22:46:44
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- ↓generic's approval as the drug price system is implemented
- by Chon, Seung-Hyun Aug 26, 2020 06:22am
- The number of approval for generic drugs has declined for the second consecutive month. If the bioequivalence test is not performed, the new drug price system, which gives low drug prices, was implemented, and greatly reduced the number of new licenses for authorized generics. Some point out that the government's move to strengthen generic regulations has caused an unprecedented confusion as pharmaceutical companies have already installed as many generics as possible. According to the MFDS on the 13th, a total of 70 generic prescription drugs were approved last month. Following 73 in June, it fell short of 100 for the second consecutive month. The number of generic licenses recorded more than 100 for 17 consecutive months from January last year to May this year. During this period, an average of 323 new generics per month were granted. In May of last year, 560 generics were licensed in a month, and more than 200 new generics were launched every month this year. In May, 412 generics were licensed, but from June the number of licenses dropped significantly. Number of generic licenses per month (Unit: number, Source: The MFDS) Since last year, intensive licensing of generics is due to the government's move to strengthen regulations. This is because it tried to get as many generics as possible before the regulation was strengthened. .The new drug price system, which was implemented from this month, is pointed out as a factor in the surge in generic licenses .Generic products must meet both the direct bioequivalence test and the use of the registered drug substance to maintain the 53.55% upper limit price compared to the original drug before the current patent expiration .Whenever one requirement is not met, the upper limit goes down by 15% .If one of the two requirements is satisfied, the upper limit is lowered to 45.53%, and if there is no satisfaction requirement, the upper limit is lowered to 38.69% .The reorganized drug price system includes a stepped drug price system in which the upper limit is lowered as the time for registration of benefits is delayed .If more than 20 generics are listed in the specific ingredient market, the upper limit of the newly listed item will be up to 85% of the existing lowest price .It is pointed out that the Ministry of Food and Drug Safety's move to tighten regulations on permits has also encouraged the approval of a bunch of generics .In April of last year, the MFDS announced a reinforcement of regulations on joint bioequivalence test through a partial amendment to the “Regulation on Pharmaceuticals Approval, Notification and Review” .This is the content of limiting the number of consigned manufacturers to one original manufacturer .Although the reinforcement of joint bioequivalence test regulations was not initiated due to the recent recommendation of the Regulatory Reform Committee of the The Office for Government Policy Coordination, the number of applications for generic licenses increased significantly shortly after the plans to strengthen bioequivalence test regulations were revealed earlier last year .According to the MOHW, the previous drug price system is applied to products applied for benefit registration in May .Generics, which have been approved since June and applied for reimbursed registration, are said to receive low drug prices by applying the new drug price system .Even if both the bioequivalence test and the requirements for the registered drug substance are satisfied, the price of the drug is further reduced as the stepped drug price system is applied .This is the background of the sharp decline in the number of new generic licenses from June .# of authorized generics licenses to all processes per month Since June, the number of generics licensed through the entire process consignment method has decreased significantly .The number of commissioned generics licensed in June and July was 39 and 42, respectively, which was less than 20% of the average of 273 from January to May this year .Last year, a total of 3173 new generics were entered .This means that an average of 264 commissioned generics per month poured out .The proportion of authorized generics to the total number of generic licenses is also on a decline .Among the new licensed generics in June and July, the proportion of authorized generics was 53% and 60%, respectively .From January to May, authorized generics accounted for 84% of licensed generics .Last year, the proportion of authorized generics reached 82% .It is interpreted that the number of attempts to enter new markets decreased as authorized generics could no longer receive high drug prices due to the implementation of the new drug price system .As pharmaceutical companies have been intensively licensed for generics within a short period of time, the number of areas for further entry has greatly decreased .Most of the generics that pharmaceutical companies could sell before the tightening of regulations were granted .The number of generics licensed for last year is more than five times that of 741 in 2018 .Recently, pharmaceutical companies have tried to apply the previous drug price system for the last time .From January to May this year, around 300 drugs were newly listed on the reimbursed list each month .Following 558 drugs in June and 653 in July, 836 products were newly added to the list in August .That's about 2,000 in three months .It is an unprecedented generic listing in the government's regulatory reinforcement movement in the market.
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- There is still misinformation and choice regarding MPHL
- by Eo, Yun-Ho Aug 25, 2020 06:14am
- Professor Shim Woo-young The male-type hair loss treatment'Propecia (finasteride 1mg)' was introduced in Korea, and hair loss was treated in earnest in 2000. Propecia identified the correlation between type II 5-alpha reductase and male pattern hair loss, suggested the therapeutic potential of male pattern hair loss, which was considered an incurable hereditary disease, and brought a major change in the treatment environment. Now, 20 years later, interest in hair loss treatment is growing even more. It is estimated that 14.1% of patients suffer from male pattern hair loss in Korea. In particular, unlike in the past, which was considered exclusively for middle-aged men, the number of young patients who visit hospitals for hair loss treatment is steadily increasing in recent years. In fact, about half (44%) of patients who received hair loss treatment in Korea in 2019 were in their 20s to 30s. The hair loss treatment market has also achieved explosive growth in line with this. After the launch of Propecia, the market competition was fierce as the Avodart(Dutasteride), and domestic generic drugs such as Finasteride and Dutasteride were also launched. As a result, sales of the entire domestic hair loss treatment market exceeded ₩100 billion last year. There were also unpleasant issues with a lot of interest. In recent years, as the hair loss community and online platforms such as YouTube have become active, there have been cases of patients who suffer damage with false information related to unconfirmed diseases and treatments, and there have also been cases of illegally purchasing hair loss pills through overseas direct purchases and experiencing side effects. False hype advertisements such as cosmetics and foods for which hair loss symptoms improvement or hair growth effect has not been verified are also a chronic problem that hinders the correct diagnosis and treatment of hair loss patients. Dailypharm met Shim Woo-young, professor of dermatology at Gangdong Kyunghee University Hospital, to hear about changes in hair loss treatment trends and future tasks. --As of 2020, what is the standard treatment method for male pattern hair loss and what are the latest treatment guidelines? Drug therapy is the most commonly used medical treatment method. As drugs to be taken, there are Finasteride and Dutasteride, which are mechanisms that inhibit the occurrence of DHT (dihydro-testosterone), and Minoxidil formulations are drugs that are applied directly to the scalp. Hair transplantation, in which the hair is transplanted into the hair loss site, can also be considered. In the case of transplantation, it is effective to continue drug treatment even after surgery. -You have been examining patients for 20 years, are there any differences from the past? First, compared to the past, the number of patients who visited the hospital for hair loss has increased. In particular, there are more young patients, with patients in their 20s and 30s accounting for about half of the total. As the number of young people who are relatively interested in appearance has increased, patients' willingness and aggressiveness to treat them have also increased overall. Also, as there is a lot of information online, such as portal sites and YouTube, the level of knowledge of patients about diseases and treatments is much higher than in the past. -What does the emergence of 5-alpha-reductase inhibitors such as Propecia and Avodart mean for hair loss management? In the case of male pattern hair loss, it can be said that the era of full-fledged medical treatment began with the advent of oral drug treatments. In the past, there was little recognition that hair loss was a disease, and treatment was mainly based on folk remedies. However, after the launch of Propecia in 2000, hair loss has been recognized as a disease that can be overcome with good management, and interest in treatment has also increased. -As mentioned earlier, two drugs are competing for 5-alpha-reductase inhibitors, Propecia and Avodart. You always hear the superiority and opinions are divided. -As mentioned previously, there are Propecia and Avodat for 5-alpha-reductase inhibitors, and these drugs are competing. Opinions are divided. Also, it can be said that my own know-how has been prescribed according to the situation and symptoms through sufficient consultation with the patient. However, it is important to take hair loss pills consistently. Recently, as many patients start treatment at a young age, I am paying more attention to the long-term efficacy and safety of patients. -Many men worry that 'hair loss drug = decreased sexual function' Side effects can occur. However, if they are contemplating hair loss treatment itself due to side effects, I would like to say that it is not necessary. Erectile dysfunction and decreased libido are frequently mentioned as sexual side effects of oral treatments, It is only about 1-2 out of 100. In fact, there are far fewer patients experienced at the clinic. It is also explained as a nocebo effect is said to occur when negative expectations of the patient regarding a treatment cause the treatment to have a more negative effect than it otherwise would have. It is believed that the patient received incorrect information through the Internet and such side effects appeared. In many cases, side effects disappear after sufficient explanation to the patient. Non-medical management methods such as hair loss shampoo and scalp nutrition are still prevalent. It is very unfortunate that many patients rely on non-medical management methods and get hurt if they do not work. There are cases of giving up hair loss treatment as it is. There is also a big problem for companies such as hair loss shampoo in creating this situation. Although there is no medical evidence that hair loss shampoo or scalp nutrients are effective for hair growth, they advertise as hype. This will require the regulation by government. And even hair loss patients need to be wary of accepting unconfirmed advertisements or information easily. Overseas illegal purchase of hair loss drugs is also a big issue. The Korea Consumer Agency made a presentation pointing out the dangers of this in last year. First of all, it is illegal to purchase oral hair loss treatment drugs without a prescription from a medical staff because they belong to Rx drugs. But more importantly, the patient's safety can be threatened. Taking fake medicines or unconfirmed products may cause severe hair loss or experience fatal side effects. Therefore, in order to treat alopecia, it is correct to visit a hospital and consult a specialist to find an effective treatment method. -What do you think will be the trends or key keywords of hair loss treatment in the future? 'Safety' is the top priority. The number of young patients is increasing as mentioned earlier. This means that the treatment period is prolonged. Long-term safety and effectiveness will be considered first when choosing a hair loss agent.
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- Celltrion begins to develop oral Remsima following SC type
- by Kim, Jin-Gu Aug 24, 2020 06:19am
- Celltrion starts developing oral 'Remsima'. Celltrion announced on the 20th that it has signed a joint research agreement with British biotechnology company Intract Pharma. Remicade, Remsima's original drug, is a drug administered by intravenous injection.. Celltrion has already developed and commercialized Remsima SC, the first in the world, with an improved administration method in the form of SC. It is expected to become the world's first oral infliximab drug if Celltrion succeeds in development. According to Celltrion, Intract Pharma was separated from University College London in 2015. It has its own oral formulation technology that efficiently delivers protein drugs to the intestine. It has conducted joint research with various global pharmaceutical companies such as Abbvie, Janssen, and Merck. Intract Pharma is exempted from non-clinical and phase I clinical trial for oral Infliximab from the UK Medicines and Healthcare products Regulatory Agency(MHRA), and is clinically targeting inflammatory bowel disease (IBD) patients in earnest from the second half of next year, and will launch in phase IIa clinical trial. Under this contract, Celltrion will supply clinical raw materials to Intract Pharma, and Intract Pharma will develop and verify the oral Infliximab product. Celltrion has secured the right to generic exclusivity upon completion of phase II clinical trials. In addition, it has agreed to allow part of the sales to be returned as royalties even when the license is out. In addition, Celltrion will exclusively supply Infliximab for the production of commercial substances even when Intract Pharma or another pharmaceutical company that has transferred the technology successfully commercializes the product. A Celltrion official emphasized, "We started developing oral Infliximab products with high efficacy, safety and ease of use, and we will proceed with preparations for development from the clinical design stage without any problems through close cooperation."
- Company
- United promotes phase III tx for COVID-19 in the Philippines
- by Aug 24, 2020 06:18am
- Korea United Pharmaceutical (CEO Kang Deok-young) is starting to develop a cure for COVID-19. It is Drug Repositioning of the company's Incrementally Modified Drug 'UI030'. United said on the 19th, "UI030 has confirmed the antiviral effect of up to 30 times compared to Ciclesonide in cell experiments." According to the company, UI030 is a combination of Desonide & Formoterol, an Incrementally Modified Drug developed by United for six years as an asthma treatment. AstraZeneca's treatment for asthma and chronic obstructive pulmonary disease 'Symbicort' is a salt-modifying product. It is characterized by a low risk of systemic side effects as it is an inhaled formulation that allows patients to easily administer drugs directly. Recently, in a cell experiment on human lung cells (Calu-3 cells) at the Biosafety Center, Korea University, the possibility of treating COVID-19 was discovered. UI030 confirmed the antiviral activity of 5 to 30 times that of Ciclesonide. Ciclesonide was previously found to be twice as effective as Remdesivir in an antiviral test conducted by Institut Pasteur Korea. United expects that UI030 can simultaneously exhibit antiviral and immunomodulatory effects, which are the mechanisms of treatment for COVID-19. The company is preparing application documents for approval of the phase III clinical trial protocol for the development of UI030's COVID-19 treatment. In Korea, phase I clinical trial is conducted with Asthma as an indication. When the clinical trial in the Philippines is successfully completed, it is seeking to obtain a domestic new drug license based on this. The target time for permitting is in the first half of next year.
- Company
- Patent dispute for Promac, eventually to Supreme Court
- by Kim, Jin-Gu Aug 24, 2020 06:18am
- PromacThe patent dispute over the anti-ulcer drug, Promac (Polaprezinc) was finally concluded in the Supreme Court. According to the pharmaceutical industry on the 19th, SK Chemical, which holds a formulation patent for Promac, recently filed an appeal to the Supreme Court against Hana Pharm and Korea Prime. Earlier, on the 17th of last month, SK Chemical received a ruling against the plaintiff in a patent invalidation trial cancellation lawsuit by the Patent Court (second trial). Promac is a gastric mucosa protective agent used to improve gastric ulcers, acute gastritis, and chronic gastritis, and Polaprezinc, the active ingredient, was developed by Zeria in Japan. SK chemicals improved its marketability by developing the existing product in the form of granules into tablets in 2013. The patent held by SK Chemicals is also about converting granules into tablets. Several domestic companies have challenged this formulation patent. Hana Pharm in April 2018 and Korea Prime in November of the same year filed a request for a trial to confirm the passive scope of rights. Generic companies won in the first trial. In March 2019, a trial decision was made for Korea Prime and Hana Pharm in July of the same year. The Intellectual Property Trial and Appeal Board judged that similar formulations developed by generic companies do not infringe the patent. SK Chemical appealed to the Patent Court. However, the second trial was ended as the Patent Court sided with the generics company following the first trial. SK Chemicals is aiming for a dramatic reversal in the Supreme Court with this appeal decision. Promac is one of SK Chemical's flagship products, and according to UBIST, a drug market research institute, Promac's outpatient prescription last year amounted to ₩11.1 billion. The prescription performance was ₩6.3 billion in the first half of this year. Promac is facing tough challenges from generics regardless of SK Chemical's appeal. Korea Prime's first-trial victory received a exclusivity for generic product and launched the first generic, Prezinc at the end of last year. Prezinc produced ₩51 million in prescription results in the first half of this year. The exclusivity period ends on the 30th of this month. In addition to Prime Korea, Hana Pharm, Pharvis, Pharmedix, Hutecs, Kukje, Medix Pharm, REYON, Samsung Pharm, Wooridul, Daewoo, Medica Korea, Dong-gu Bio, Daewoong Bio, Jin Yang, Binex, Ilhwa, Dongkook Pharm, Guju Pharm, Ahngook, Daehan New Pharm, Intro Bio Pharma, Hanpoong Pharm, Mothers Pharm, Kolmar Korea, Korea Global Pharm, Jungwoo, Eden Pharma, Nexpharm, Firrson, etc. are trying to launch a generic for Promac.
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- Drug industry back on full alert as COVID-19 cases resurge
- by Aug 21, 2020 06:26am
- The pharmaceutical industry is on full alert again as the confirmed cases of novel coronavirus infection (COVID-19) is resurging rapidly around Seoul metropolitan area. Some companies have already reinitiated emergency working system with employees working in shifts or from home. The South Korean government has recently decided to toughen the social distancing measures in Seoul and Gyeonggi Province to level two. The threat of massive surge in confirmed COVID-19 cases is imminent after more than 200 cases have been confirmed in a single day. Daily confirmed case of COVID-19 reported in last seven days (Source: KCDC) The pharmaceutical industry is now in a heightened alert mode. But because many companies have implemented flexible working conditions during the first surge of COVID-19, the companies were able to take the necessary actions quickly. Centering heavily affected regions, the pharmaceutical companies are ordering the employees to work from home. Most of multinational companies order employees to work in shifts Multinational pharmaceutical companies are taking actions fast. Even before the government raised the social distancing level, most of the multinational companies have been rotating working hour shifts. The employees have been coming to the office every other day or working from home two to three days a week. But with the resurging of confirmed cases, the companies are reiterating the need of the strict measures. Due to the government’s tightened infection control measures in Seoul metropolitan area and a confirmed case reported from Seoul LS Yongsan Tower, Janssen has closed down the office until the end of the week and disinfected the area for the safety of employees. In particular, the employees working at the LS Yongsan Tower are all working from home until the end of the week. GSK Korea, also headquartering in the same building, is recommending the employees to work from home. And a biweekly schedule was given to those who have to come into the office. Lilly had their in-office employees to work from home from Aug. 18 to 19, and they are rotating their office hours from Aug. 20. Their sales people are only allowed to visit designated hospitals. Following the government’s order, Bayer has decided to work from home twice a week until the end of August, while Sanofi, Novartis, MSD and Takeda Pharmaceuticals are working from home every other day from Aug. 18. Companies like Roche, Bristol-Myers Squibb (BMS), Astellas and Pfizer have already been rotating office hour shifts or voluntarily working from home, and they plan to maintain the existing system. An associate from a multinational company commented, “The company would closely follow the reports of confirmed cases and update the working guideline accordingly to put the employees’ safety first.” Large Korean companies to work from home again Korean pharmaceutical companies have ended the order of working from home and returned to their regular working system as the social distancing has ended in last May. But with the resurge, the companies are bringing back the social distancing working system. First, Yuhan has ordered all employees to work from home, and the same order was give to in-office employees at the GC Pharma headquarters. JW Pharmaceutical is rotating two-shift to work from home. The company seems to have different shift systems in each department. Daewoong Pharmaceutical has asked employees to voluntarily work from home but to refrain from convening an in-person meeting or gathering. Dong-A ST has banned employees to come to office in regions with level-two social distancing order and refrained them from visiting hospitals. Boryung Pharmaceutical and Chong Kun Dang are still reviewing the working system as they closely watch the emergency status. An associate commented, “From various perspectives, the company is reviewing the period, type and subject of the shift in working system,” and “A guideline would be set as the situation is worsening.’ Moreover, off-line symposium and workshops, initially planned as the spread of COVID-19 seemed contained, are to be canceled. Korea United Pharm had scheduled an employee workshop from Aug. 21 to 22, but now the company is considering on cancelling it. Even if the event carries on, it would only convene less than 50 people. The workshop venue is located in Gwangju, Gyeonggi Province, where an event with over 50 people is banned. Korea United Pharm official said, “There is a possibility of canceling the event. But if not, the company would strictly follow the infection control regulations.”
- Company
- Companies are worried about a sharp decline in Rx drug sales
- by Chon, Seung-Hyun Aug 20, 2020 06:24am
- Pharmaceutical companies are again tense with COVID-19. The prescription drug market suffered a temporary sluggishness due to the aftermath of COVID-19, and while it is recovering, the market has contracted again and is worried. Business activities can be greatly affected by the spread of telecommuting. According to UBIST on the 19th, the total amount of outpatient prescriptions last month was ₩1.292 trillion, an increase of 1.8% from the same period last year. Compared to the 8.2% increase in the prescription price in July last year from 2018, the growth rate has slowed somewhat, but it has continued to rise for two consecutive months following June. Monthly outpatient Rx amount trend (Unit: ₩100 million, Source: UBIST) In June, the prescription amount was ₩1.286 billion, an increase of 11.7% from the same period last year, recording a sharp growth trend. Starting this year, the prescription drug market has been showing great ups and downs, continuing its jagged pace. In January, prescription amount decreased by 4.4% from the previous year, but in February they increased by 13.0%. As the Lunar New Year holidays this year was pulled to January, which is earlier than the previous year, it is analyzed that the rate of increase or decrease in the prescription amount in January and February showed a deviation according to the increase or decrease in the number of business days. Prescription performance in April and May fell 8.7% and 9.4%, respectively, compared to the previous year, showing extreme sluggishness. However, in June, it recorded a large growth trend, and it was observed that COVID-19 generally did not show a significant effect in the prescription drug market. The industry believes that the slowdown in the prescription drug market in April and May was the impact of COVID-19. It is analyzed that a considerable prescription gap occurred in the second quarter as patients with chronic illnesses, who are reluctant to visit medical institutions, were prescribed a large amount of necessary medicines in advance. In fact, when the number of COVID-19 patients surged, it is known that the number of cases receiving prescriptions for 3 to 6 months in advance increased significantly. Monthly outpatient Rx amount increase/decrease from the same period last year (Unit: %, Source: UBIST) In fact, there was a common trend in which the prescriptions for chronic diseases decreased significantly in April and May and then increased rapidly in June. The prescription amount of statin drugs used in the treatment of dyslipidemia decreased 2.8% and 5.1% in April and May, respectively, compared to the same period last year. But in June, it jumped 14.9% from last year. The prescription performance of the “ARB+CCB” combination drug, which is most commonly used among hypertension treatments, increased 3.2% and 1.4%, respectively, from the same period last year in April and May, but rose a whopping 22.6% in June. It is also observed that the number of visits to hospitals itself may have decreased as the incidence of disease among infants and children has decreased due to factors such as delaying school opening, social distancing, and strengthening personal quarantine. Prescription performance of oral Cephalosporins in the first half was ₩110.4 billion, down 16.6% from the previous year. In the first half of last year, it decreased by 1.5% from the previous year, but the decline was even more pronounced after a year. Prescriptions of oral PCNs in January and February increased by 7.0% and 2.9%, respectively, compared to the previous year, but decreased by 42.9% from last year in March, and in April (-60.8%), May (-52.8%), 6 All months (-24.5%) showed a sharp decline. As the number of COVID-19 confirmed cases rapidly increases, pharmaceutical companies are again tense. COVID-19 confirmed patients by city (Unit: persons, Source: the KCDC) According to the KCDC, 297 new cases of COVID-19 occurred compared to the previous day as of 0:00 on the 19th. Since 103 confirmed cases on the 14th, more than 100 new cases have occurred for 6 consecutive days. On this day, 283 out of 297 new confirmed cases are infected locally, and the number of confirmed cases is increasing rapidly in Seoul and other metropolitan areas. Since most pharmaceutical companies are headquartered in Seoul, there is no choice but to be more tense than when the number of COVID-19 confirmed cases surged in Daegu and Gyeongbuk. Many companies have started working from home. Core personnel are also banned from entering factories or research centers, which could be severely affected when COVID-19 confirmed case occurs. This is because major damage is inevitable if the laboratories and factory workers are confirmed for COVID-19 and are closed for a certain period of time. Pharmaceutical companies are also concerned about a decline in sales activity. It is a difficult condition for active sales in a situation where they are reluctant to visit a salesperson centering on clinics. If there is a confirmed case among the sales staff of a pharmaceutical company, the affiliated company cannot avoid accusations of promoting the spread of the virus. This is because even though there is a possibility of being a super propagator, if the spread of new coronas is socially promoted by visiting dozens of medical institutions, it cannot be good for the company. An official from a pharmaceutical company said, "Recently, there are many confirmed patients with COVID-19 and the market is intensively occurring in the metropolitan area, so we have a lot of worries about our sales strategy." "It's time to find a variety of strategies so that there are no disruptions in our activities."
- Company
- Big 5 except Severance clear Novartis’ Kisqali prescription
- by Eo, Yun-Ho Aug 19, 2020 06:28am
- South Korean general hospitals are ready to prescribe a third cyclin-dependent kinase (CDK) 4/6 inhibitor Kisqali approved after Ibrance and Verzenio. According to the related industry sources, Novartis’ Kisqali (ribocilib) has passed drug committees (DC) at all Big Five general hospitals—Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary’s Hospital and Seoul Asan Medical Center—except Severance Hospital. And other major institutes like National Cancer Center, Korea University Anam Hospital and Konkuk University Hospital have completed the processing for the drug. Late last year, Kisqali submitted applications for both item approval and healthcare reimbursement listing and the Drug Reimbursement Evaluation Committee (DREC) recently labeled it as a non-reimbursed drug after the Cancer Deliberation Committee passing it in last January. If Novartis accepts the drug pricing offered by the health authority, National Health Insurance Service (NHIS) would initiate a pricing negation with the company. The CDK4/6 inhibitor market competition would be heightened when Kisqali is listed, as the first-in-class Ibrance (palbociclib) and the second Verzenio (abemaciclib) have been covered already. Unlike Ibrance and Verzenio, Kisqali can be prescribed to perimenopausal patients who have not had an oophorectomy. The Phase 3 MONALEESA-7 clinical trial evaluated Kisqali combined with endocrine therapy (either an aromatase inhibitor or ovarian function suppression) as a first-line treatment in pre and perimenopausal women with HR+/HER2- advanced or metastatic breast cancer, and confirmed the drug’s effect of significantly extending patient’s overall survival (OS). Specifically, the Kisqali combination group demonstrated median progression-free survival (mPFS) of 23.8 months, whereas endocrine therapy only group had 13 months. In a subset analysis on Asian patients only, the Kisqali combination group’s mPFS was at 24.7 months, which was about 14 months longer than the endocrine therapy only group’s. Also in Phase 3 MONALEESA-3 study, Kisqali confirmed its effect of extending the OS in pre and postmenopausal women. At the point of 42 months, the OS in Kisqali combination group was at 58 percent, and fulvestrant only group was at 46 percent. Professor Im Seock-Ah of Hemato Oncology Department at Seoul National University Hospital explained, “The MONALEESA-7 study was mainly proposed and led by an Asian researcher, and had 30 percent of Asian patients as registered sample. These findings reflect how Asian region still has a great need for a new treatment option in premenopausal women with breast cancer”.
- Company
- Daewoong signs an export contract for Fexuprazan
- by Kim, Jin-Gu Aug 19, 2020 06:28am
- Daewoong announced on the 14th that it has signed an export contract with EMS in Brazil for the P-CAB-affiliated gastric secretion inhibitor Fexuprazan. The contract amount is $72.58 million. EMS will be responsible for the local approval of Fexuprazan in Brazil. The export is expected to proceed in earnest after obtaining permission to Brazil. The contract period is 10 years after approval from Brazil. In the future, Fexuprazan will be supplied according to the sales forecast agreed upon by the two companies, and the minimum purchase quantity is 70% of the contract amount excluding technology fees. Fexuprazan is a P-CAB family of drugs called the next-generation gastric secretion inhibitor. HK inno.N's Kcab (Tegoprazan) and Takeda's Vocinti (Vonoprazan) were approved in Korea. Daewoong also applied for Fexuprazan's approval earlier this year.
- Company
- “Safe, effective and convenient Zejula for ‘all-comers'"
- by Eo, Yun-Ho Aug 18, 2020 06:03am
- Professor Park Jeong-yeol Different drugs in a same class can have different indications. It could be a development strategy by pharmaceutical companies or a Columbus’ egg. But clearly, the respective companies would try to appeal for different indications in different prescription area and relevant benefit proven from safety and efficacy data. Two poly ADP-ribose polymerase (PARP)-inhibiting targeted therapies, introduced recently with the heightened anticipation from the ovarian cancer treatment scene, are the examples of the said strategy. Takeda Pharmaceuticals’ Zejula (niraparib), in fact, has been indicated for treating ‘all-comers’ in all approved lines of treatment, regardless of mutation in the targeted BRCA genes. AstraZeneca’s Lynparza (olaparib), approved before Zejula, has a limited indication to only treat ovarian cancer patients with BRCA mutation, except for the second-line treatment. It is not the matter of choosing a superior treatment, but about an option. But having an all-comer targeted therapy is an interesting factor to consider. Daily Pharm interviewed Professor Park Jeong-yeol of gynecology department at Asan Medical Center on the use of PARP inhibitor and Zejula in ovarian cancer treatment. -What are the realistic expectations of medical professionals on Zejula indicated for all-comers in all lines of treatment? Considering the largely unmet medical needs, their expectations are obviously high. Besides as a standard therapy, Zejula could be used as a treatment on all patients diagnosed with ovarian cancer regardless of the line of treatment. In the NOVA study, PARP-inhibiting Zeula confirmed its efficacy in all patient groups regardless of biomarkers statuses like germline BRCA (gBRCA) mutation or homologous recombination deficiency (HRd). The study confirmed the Zejula-treated patient group carrying germline BRCA mutation achieved the median progression-free survival (mPFS) four times longer than that of the control group, and also their risk of disease progression or death was reduced by 74 percent. And Zejula doubled the mPFS in a gBRCA mutation-negative group, and also significantly improved mPFS in a HRd-negative, gBRCA mutation-negative patient group. -Zejula is not the sole option for PARP inhibitor. What would be the reason for treatments with specific targeted gene showing such efficacy? The academia is still discussing which class shows treatment efficacy in all patients. Nevertheless, Zejula is the only proven treatment for all-comers so far, so it would be versatile. -Compared to its competitor Lynparza, Zejula user has to take frequent blood test to confirm hematological adverse reaction. Isn’t it inconvenient for the patients? The complete blood counts (CBC) monitoring is conducted once-weekly for the first month, once-monthly for the next 11 months, and once every two to three months after a year. The ovarian cancer patients generally visit hospital to get a blood test a week after their chemotherapy. Additional treatments would be provided, in case of discovering an adverse reaction in blood test, and the patient has to come in the next week to confirm the status again. So, none of the patients complained of inconvenience in visiting hospitals weekly after administering Zejula. On the contrary, there are more patients satisfied with orally administering Zejula, two to three pills a day. Also from a doctor’s perspective, conducting a weekly CBC monitoring for the first month of administering Zejula does not seem like a problem. -Going back to the NOVA study, the dose of Zejula was controlled depending on the individual tolerance. How do you adjust the dose? For a patient weighing less than 77 kg or showing platelet counts less than 150,000/ μL would start with 200 mg dose, but it would be lowered to 100 mg, if need be, and the administration would be halted for the second reduction of dose. Most of the patients in Korea start the treatment with 200 mg dose. Other patients weighing more than 77 kg and showing platelet counts over 150,000/ μL initiate the therapy with 300 mg, and the dose can go down to 200 mg and 100 mg for first and second reduction, respectively. After reducing the dose down to 100 mg, the administration has to be haltered if the dose needs further reduction. But most of the patients only reduce the dose once. Not many of them actual halt the therapy. In the NOVA study, only 4 percent of the patients exited the therapy due to hematological adverse reaction. Generally, patients lowering the dose down from 200 mg to 100 mg stabilize their adverse reaction and maintain the recovered status. Most of the patients subjectively do not feel the adverse reaction when taking 200 mg. An exploratory data analysis on the NOVA study actually found the efficacy of the treatment was maintained at the optimum dose for individual patients. -The Korean government is conservative about Zejula being effective in patients ‘regardless of BRCA mutation,’ although it has been indicated for all-comers. The clinical evidence demonstrated its efficacy, but the efficacy level differed in HRd-negative patients with BRCA mutation. Would you say the insurance coverage is needed for the all-comer indication? Indeed, it is. Generally, only 15 percent of epithelial ovarian cancer patients have been known to have mutated BRCA 1/2 gene. And it means, 85 percent or the majority of the patients do not express BRCA-mutated gene. So at the moment, the majority of the ovarian cancer patients do not receive coverage on using an effective PARP inhibitor. The academia is still urging for the coverage. As you may know, Lynparza initially had reimbursement limitation of covering only up to 15 months. The academia raised the voice on it to remove the limitation and they a good end result. Recently, the academia is pressing on the government to grant the insurance benefit regardless of biomarker status. Apparently they have requested the government to expand the current insurance standard. -Have you contemplated on the order of therapies, now that the variety of ovarian cancer treatment including PARP inhibitors and Avastin combination therapy is available? Many of the researchers are also interested in the topic. Currently, there has not been a clinical study head-to-head comparing the efficacy of PARP inhibitor and Avastin (bavacizumab). A real-world research would be possible, when both are approved for the first-line maintenance therapy in ovarian cancer treatment and the related cases are collected. When choosing a medication, adverse reaction from the treatment addressed in a study is considered as crucial as the confirmed efficacy. Moreover, patients’ opinions are definitely a factor to consider. But when it comes down to the order of treatment, using more effective drug seems to be better. All drugs demonstrate better efficacy when used in the first-line treatment.
