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- 2026-04-17 15:11:30
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- BTX market new comers not bothered by legal dispute
- by Kim, Jin-Gu Jan 17, 2020 06:22am
- The Korean botulinum toxin market competition is reaching the peak. While the toxin strain related legal dispute has not yet been fully resolved, more and more companies are latching on to the market. Bio ventures, on top of the large and small-and-medium companies, have announced their plan to join the over-heated competition. On Jan. 13, Ministry of Food and Drug Safety (MFDS) cleared two botulinum toxin items, ‘Bienox’ and ‘Hitox,’ respectively from BNC Korea and BMI Korea. Founded in 2007, BNC Korea specializes in aesthetic plastic surgery medical devices like dermal filler and hyaluronic acid filler. Established in 2005, BMI Korea is the only pharmaceutical company to base in Jeju Island. It has been mainly manufacturing injections for anesthesia and pain. It seems their strategy is to first receive approval as an export product, and to win sales approval in Korea after conducting clinical trial in the future. With the export approval, the companies may export the products overseas without marketing approval in Korea. The strategy has worked for Huons, when its botulinum toxin product first got cleared for export under the name of ‘Hutox’, and received approval for Korean market later under the name of ‘Liztox.’ Including BNS Korea and BMI Korea, now 12 pharmaceutical companies have Korean government-approved botulinum toxin products. The number goes down to eight, excluding importers like Allergan, Merz and Ipsen. The rest of the list consists of Medytox, Hugel, Daewoong Pharmaceutical, Huons, Pharma Research Bio, Chong Kun Dang Pharmaceutical, BNC Korea and BMI Korea, in the order of approval date. Botulinum toxin products approved by MFDS The list expands to 18 companies if companies with botulinum toxin in development are added. All the latecomers are new bio companies, such as Jetema, Protox, Kanzen, Eubiologics, and Inibio. According to sources, Jetema has recently applied for MFDS’ export approval. The company has been approved as a pharmaceutical manufacturing company in January 2019. The purpose of the company seems to be clear and focused on manufacturing botulinum toxin products. On the other hand, Protox completed the construction of its botulinum toxin production facility in Hyangnam Pharmaceutical Industry Cluster in Hwaseong, Gyeonggi Province. The facility has a capacity to manufacture approximately 2.7 million vials a year. The company plans to conduct Phase 1 trial this year on its independently developed product, ‘Protoxin.’ Eubiologics and Inibio had their clinical trial protocols passed in March and December last year, respectively. Kanzen has registered botulinum toxin strain discovered on a snow mountain. Botulinum toxin products in development As a result, an unprecedentedly intense competition is expected to unfold in Korea. Currently, there are about three to seven global pharmaceutical companies supplying botulinum toxin products. Starting from Allergan, Ipsen and Merz, other global companies like Galderma, US WorldMeds, Revance Therapeutics and Lanzhou Bioengineering are in the game. In around 2022 and 2023, at least 14 companies would be competing against each other with 16 items according to the companies’ development plans. As blunt as it is, the competition would inevitably do more damage. The market, once led by Medytox and Hugel, has gotten saturated with Daewoong Pharmaceutical and Huons joining the market. Sources confirmed Medytox and Hugel have stopped growing already. Also the unresolved legal dispute over the source of botulinum toxin strain could be a burden for the new challengers. At the moment, Medytox and Daewoong Pharmaceutical are preceding astronomically expensive litigation on the source of botulinum toxin strain. The litigation would get close the final decision in around June. An insider of the industry commented, “Depending on the final decision, the two companies may proceed with next litigation.”
- Company
- Mabthera anticipating indication on pediatric polyangiitis
- by Eo, Yun-Ho Jan 16, 2020 03:07pm
- MabtheraPharmaceutical industry is expecting anticancer treatment Mabthera to get indicated for treating pediatric patients in Korea. The industry source reported Roche Korea has submitted an indication expansion application to Ministry of Food and Drug Safety (MFDS) for Mabthera (rituximab) to treat 2-year-old and older pediatric patient with granulomatosis with polyangiitis (GPA) and microscopic plyangiitis (MPA). The application was for intravenous administration of Mabthera, and it is expected to get cleared within this year considering general processing period. The two diseases are rare angiitis that flares up inflammation in small vessels and significantly decreases blood volume, resulting in damaging major organs like lung and kidney and affecting skin. In September last year, the U.S. Food and Drug Administration (FDA) has approved the pediatric indication for Mabthera under a priority review with orphan drug designation. The approval was based on Phase 3 study that consisted of 25 patients aged from six to 17 years with the diseases. The clinical trial observed 14 patients achieving remission after six months of Mabthera treatment, and every patient achieving remission after 18 months. During the study, infections, infusion-related reactions and nausea were the most common side effects reported. And also, patients participating in the study with pediatric GPA and MPA have been observed with hypogammaglobulinemia. Indicated not only for treating hematologic cancer, but also for autoimmune conditions like rheumarthritis, Mabthera has formed an approximately five-trillion-won market (according to IQVIA data from 2018) in the U.S. alone. Currently, the treatment has an emerging competition in the U.S. as Pfizer and Korean company Celltrion’s co-marketed biosimilar with expanding indications.
- InterView
- “Why it took 20 years for new flu drug Xofluza to be out”
- by Eo, Yun-Ho Jan 16, 2020 03:07pm
- Since the 2009 flu pandemic, Tamiflu became a prescription drug with household name like Viagra. Tamiflu (oseltamivir) is a good drug. It shifted the world’s paradigm on influenza management and became the symbol of neuraminidase inhibitor drug. However, the unmet medical needs still exist in the market. Antiviral agent can always develop resistance, but for influenza treatment, no other agent than neuraminidase inhibitor is recommended. In Korea, the influenza vaccination rate boasts a top world class level, but 2.26 million patients have been infected with influenza in 2018. After two decades since Tamiflu was commercialized, Roche has showcased Xofluza (baloxavir). The new drug has a novel mechanism of action that inhibits polymerase acidic endonuclease and treats influenza with only a single dose (Tamiflu requires a five-day treatment). Daily Pharm met with Roche’s Principal Global Medical Director, Aeron Hurt, and spoke with him about the meaning and possibility created by developing Xofluza. He used to serve as a senior research scientist at the World Health Organization (WHO) Collaborating Centre for Reference and Research on Influenza. -What was your role at WHO? And what motivated you to be interested in influenza out of all infectious disease to study? At WHO, I led a team of researchers to analyze and monitor antiviral agents and vaccine for patients with influenza. Analyzing antiviral agents and vaccines’ effect at a research center in Melbourne, Australia, I came to realize the necessity and urgency to mange influenza better and more effectively. And naturally, I got interested in and passionate about advocating the importance of antiviral agent and vaccine to effectively manage influenza. -When it comes down to ‘influenza management,’ it is divided into ‘prevention’ and ‘treatment’ blocking the viral transmission. What is your idealistic management plan incorporating the two factors? First, the National Immunization Program (NIP) has to generate the maximum effect with limited resource. Accordingly, the government could consider conducting or expanding NIP focusing on patient group with high risk of inducing complications or with possibility of optimal vaccination effect. As WHO recommends, patient groups of the highest priority for vaccination—the elderly, children, individuals at high risk of medical complications and pregnant women—should be provided with quadriavalent vaccine than trivalent vaccine for better coverage of influenza vaccination. As far as treatment goes, it is crucial to use an exceptional antiviral treatment as promptly and widely as possible when it is released. Same goes for Xofluza and other antiviral treatment to be released in the future. Instead of saving the new and effective antiviral treatment as a last resort for a pandemic, patients’ symptoms should be alleviated by treating the patient with effective antiviral from the beginning, while social and financial burden of influenza should be lowered. -It sounds like you have Xofluza in mind. Could you elaborate on the major clinical outcomes of the treatment for the readers to fathom its efficacy? Xofluza demonstrated its positive efficacy in CAPSTONE-1 study treating a healthy patient group aged 12 to 64 diagnosed with acute influenza symptoms and CAPSTONE-2 study treating patient group aged over 12 at high risk of serious flu complications. Top-line findings of CAPTSONE-1 study evaluating the flu treatment on healthy adult and adolescent, Xofluza reduced the median time to alleviation of symptoms by approximately 26.5 hours compared to the placebo group. And it also demonstrated comparatively faster cessation of infectious viral shedding than the placebo. Xofluza’s median time of viral shedding marking 24.0 hours (about a day) was meaningful, as the placebo group took 96.0 hours (about four days) and oseltamivir group took 72.0 hours (about three days). Meanwhile, the CAPSTONE-2 study evaluated the treatment’s effect on elderly patient and who are at a high risk for influenza-related complications. The study also found exceptional effect of Xofluza as its median time to alleviation of symptoms in high-risk patient group took 73.2 hours (about three days), cutting down around 29 hours from the placebo group (102.3 hours). Moreover, Xofluza reduced the time to cessation of viral shedding in 48.0 hours, which was about more than 50 percent improvement than the placebo (96.0 hours) and oseltamivir groups (96.0 hours). -In the CAPSTONE-1 study, pediatric patients aged 12 to 19 years did not receive Tamiflu. What was the reason? The study was conducted in the U.S. and Japan from December 2016 to March 2017. The reason why adolescent patients from 12 to 19 were not in the Tamiflu group was because Tamiflu was not recommended to adolescent patients in Japan when the study initiated. Currently, the limitation has been lifted. For your reference, CAPSTONE-1 study had to apply equivalent condition to all participants in the U.S. and Japan, so the U.S. participants from age 12 to 19 only received Xofluza and placebo. -The outcomes of CAPSTONE-1 does not seem to show significant difference between Xofluza and placebo arms’ time to alleviation of symptoms The time to alleviation of symptoms between two groups may not have shown exceptional difference as the evaluation of ‘symptom’ could be subjective. The severity of symptoms could differ from each individual. And a patient infected with influenza virus show cytokine response, which is induced regardless of decreased virus titer. Therefore, it would be quite difficult to reduce the time to alleviation of symptoms by 24 hours more than the available antiviral agents, despite the new antiviral agent considerably shortens time of viral shedding. The most important differences between Xofluza and existing antiviral treatment are reduced time of viral shedding and lessened risk of complications. -With Tamiflu, there was an issue with neuropsychiatric events. Was there any similar event reported from Xofluxa study? The company is closely monitoring patients who have taken Xofluza, and there has not been any report of adverse neuropsychiatric event so far. Influenza itself could affect patients in neuropsychiatric event. And also, the correlation between oseltamivir and neuropsychiatric event in treated patient has not been proven. So medical professionals should carefully consider treatment benefit and adverse reaction from antiviral treatment and prescribe Xofluza according to the patients’ individual conditions. The same applies to Tamiflu. Although there were reports of adverse reaction in Japan about a decade ago, but the Tamiflu prescription limitation has been lifted and the public’s perception has been changing as well. -The present indication for Xofluza is quite narrower than other available flu treatments. Are there any other ongoing clinical studies? A few studies have been completed, but the outcomes have not been officially announced, yet. They specifically were on post-exposure prophylaxis and pediatric patients. The prophylaxis study evaluated probability of a patient diagnosed with influenza transmitting the virus to their household members, who have been administered with Xofluza. The study result found the risk of influenza virus infection has gone down by 86 percent when administered with Xofluza. Another clinical study, MINISTONE evaluated virus titer and time to alleviation of symptoms in children aged one to less than 12. Also, there are three more clinical studies currently calling for participants. The first one is for infants younger than 12 months, whereas the second one named FLAGSTONE is evaluating the efficacy and safety of Xofluza in combination with the current standard of care, compared to the standard of care alone from hospitalised patients. The study would administer Xofluza not by single dose, but by total three times respectively on the first, fourth and seventh day of treatment. Lastly, the CENTERSTONE study is reviewing Xofluza’s effect on patient’s viral infectiousness. Unlike the previously mentioned post-exposure prophylaxis study, the treatment is administered not on the household members, but only on the patient. The study aims to not only confirm time to alleviation of symptoms, but also the infectiousness to household members. -Is there any other investigational drug in development at the moment? Xofluza blocks polymerase acidic endonuclease, an enzyme crucial for viral replication. Other candidate medicines inhibiting different enzymes are in R&D phase by other respective companies. If these investigational medicines have successful clinical trials, they would be commercialized as well. However, pharmaceutical companies, including Roche, have tried researching other mechanism of antivirus treatment like monoclonal antibody, but most of them have failed in clinical trial phase. Considering the challenges, release of Xofluza is particularly meaningful. The fact that Xofluza works in a novel mechanism of action, developed after twenty years, illustrates how the journey of developing an antiviral treatment is challenging and rough.
- Policy
- Chong Kun Dang's development of IMD is accelerating
- by Lee, Tak-Sun Jan 16, 2020 06:07am
- Chong Kun Dang is targeting the market for SGLT-2 inhibitors, a well-known drug for losing weight. Currently, MSD's original drug `` Steglatro '' is being jointly sold, and it is speeding up the development of other drugs such as Forxiga and Jardiance. In particular, post-development of Jardiance is avoiding the crystalline patent of the original drug alone, Chong Kun Dang is expected. The Ministry of Food and Drug Safety approved the Phase I study plan for Chong Kun Dang’s CKD-375 on the 24th of last month. This trial is a randomized, open-label, single-dose, cross-design trial to compare the pharmacokinetics and safety/tolerability of oral administration of high doses of CKD-375 and D390 in healthy adults. In a recent published study, the clinical reference is Jardiance Duo (Empagliflozin-Metformin). Accordingly, CKD-375 can be inferred as Empagliflozin, the main ingredient of Jardiance, and D390 can be inferred as Metformin. CKD-375 received approval for the Phase I clinical trial in last February. The trial at that time was also a randomized, open, single-dose, crossover study to compare pharmacokinetics and safety/tolerability with single doses of CKD-375 and D387, respectively, in healthy adult volunteers. Chong Kun Dang is accelerating a late-release drug of Jardiance because it seems to be due to the fact that PMS is scheduled to expire on August 11 this year. If applying for a permit at the end of the PMS, it will be the first applicant. Chong Kun Dang avoided the Jardiance crystalline patent (which is due to expire on December 14 2026) in last May as a domestic pharmaceutical company, so if it meets the conditions for the first applicant, it can obtain a generic exclusivity. A Generic exclusivity is expected to have a generic monopoly for nine months after March 11 2025, when Jardiance material patents expire. Chong Kun Dang is also in the process of authorizing the commercialization of CKD-387, another SGLT-2 inhibitor for Forxiga. Forxiga is reported to have already filed a permit application by many pharmaceutical companies after the PMS expired on last November 25. SGLT-2 inhibitors, which have a mechanism of selectively inhibiting SGLT-2, which is involved in glucose resorption in the renal glomerular filtration process, have a blood sugar strengthening and weight loss effect, and the size of the market is growing rapidly. On the basis of UBIST, cumulative prescription amount in the first half of 2019 exceeded ₩10 billion, which is a blockbuster, in the first half of the year, including ₩14.7 billion for Forxiga and ₩12.8 billion for Jardiance. Currently, only the original SGLT-2 products such as Forxiga, Jardiance, Suglat, Steglatro and Invokana are sold in Korea. Accordingly, domestic pharmaceutical companies are actively conducting patent challenge and product development in order to release generic drugs early.
- Company
- Pfizer's Novasc 10mg packaging will change to 28 tablets
- by Jung, Hye-Jin Jan 16, 2020 06:07am
- Pfizer's Novasc 10mg packaging unit will change from 30 tablets to 28 tablets. In addition, many drugs, including Bayer's antibiotic Avelox and Samjin Pharm's Gelma suspension, were sold out. According to the wholesale industry on the 14th, 30 tablets of Novask tablet 10mg tablet of Korean Pfizer will be discontinued and 28 tablets packaging will be supplied. The only discontinued item is 30 tablets of 10mg, and 30 tablets of 2.5mg, 5mg tablets and 500 tablets of 5mg tablets are supplied unchanged. Due to the delay in global production and supply, 30 tablets packaging of Bayer's Avelox Tablet 400mg is in short supply. Chong Kun Dang, which distributes Avelox, said it will be available by April 20. Samjin Pharmaceutical announced on the 14th that 125 pouch packaging products (25 pouches*5EA) of Gelma Suspension 10g were sold out. The reason for the absence of stock and the timing of resupply were not disclosed. Pfizer's psychoactive drug, Halcion 0.125mg, is also sold out due to a shortage of supplies. The cause is a delay in the supply schedule, which Pfizer expects to be available from March. Allergy medications Montelukast 10mg and Montelukast Chew 5mg and 4mg from Dongkwang Pharm are also in imbalance between supply & demand, and will be supplied again at the end of next month. It will be resupply in mid-March due to the delay. Jeil's 30-pack package of Bondube 60mg for osteoporosis treatment will be resupplyed in mid-March due to delays in product improvement. The packaging of 30 tubes of Ganfort UD 0.4ml, an eye drop solution by Allergan, is also temporarily sold out due to delays in import schedules. It will be resupplyed on February 14.
- Policy
- IMD-generic drug price differential regulation is revised
- by Lee, Jeong-Hwan Jan 16, 2020 06:07am
- Expectations are growing in the news that the Ministry of Health and Welfare is announcing the reform of the generic drug price regulation, which recognizes the value of IMD and maintains the premium pricing clause. In particular, the revised plan will postpone the regulation of IMD next year instead of this year, and if there are not many new drugs of the same class released, it is likely to include a plan to maintain the current drug price. There is an evaluation that the Ministry of Health and Welfare has signaled that it will implement a policy based on advanced IMD. According to the industry on the 13th, the reform of the drug price regulation of the Ministry of Welfare will not stop at simply easing the price regulation of IMD. Some experts believe that it can also be seen as a ‘game changer’ that will stop the current bitter generic competition and serve as a cash generator to lead the pharmaceutical industry ahead of new drug development. The Ministry of Health and Welfare is expected to proceed with some revised administrative notices of the Amendment and Adjustment Criteria. It contains the Ministry of Welfare's policy to adjust the price of IMD, unlike simple generics, to exempt regulations. The Welfare Ministry will release it as early as this week. In this case, the basic framework of some amendments announced by the government last year is likely to be implemented in July of this year, and the revised parts will be implemented afterwards through administrative procedures. The industry's proposed amendment is to revise the revised synthetic and biopharmaceutical adder system to guarantee the addition maintenance period of IMD. This means that they will be differentiated from generics in recognition of their efforts to develop IMD. This is due to the consensus that the government, the pharmaceutical industry, and the National Assembly's Health and Welfare Committee created a consensus on maintaining IMD’s premium pricing policy. There are two additional scenarios that the industry anticipates: delaying the implementation of IMD price regulations and premium pricing policy demonstrating progress. As a kind of methodology, the postponement of implementation is intended to give a period of preparation for IMD development capabilities for generic pharmaceutical companies. Demonstrating progression In the case of advanced IMD, if a number of IMD of the same type are not developed and released, there is a possibility that a policy will be prepared to maintain the current price advantage. If a IMD can't be released by anyone, it is determined that it is a medicine that has proven to be somewhat progressive. Source: Korea Pharmaceutical Bio Association Specifically, experts in the pharmaceutical industry classify the criteria for the IMD into ▲the improvement of patient medication convenience through the change of administration route, ▲the improvement of patient medication compliance through the change of dosage forms such as sustained-release tablets, and ▲the improvement of dosage and usage through the change of salt. For example, the famous antivirals, Tenofovir by Gillead Science replaces the existing TDF (Tenofovir disoproxyl fumarate, Viread) with TAF (Tenofovir alafenamide fumarate, Vemlidy). This proved progressive. TAF with altered TDF salt improves renal and bone cell side effects and is equally effective with a 10% dose of TDF. It is estimated that 90% of the drug used to obtain the drug is reduced, and the size of the pill is smaller, improving patient safety and medication convenience. The industry understands that the policy of the Ministry of Health and Welfare is to ease the drug price restrictions on the IMD. The pharmaceutical industry is in full agreement with this view. A pharmaceutical company official in Korea said, “IMD proves to be progressive will in some way inspire the development of pharmaceutical companies and encourage the advancement of the entire industry, in particular, the Ministry of Health and Welfare was convinced of the exception of the regulation on the price of IMD, and it seemed to signal the generic developer to turn to overseas market by turning to IMD”. A official said, “But at present, no specific proposals are disclosed, so we cannot expect too much IMD price regulation positively, and The Ministry of Health and Welfare will need to be unveiled on which price exceptions will apply”. Another B Pharmaceutical official said, “We believe that the Ministry of Health and Welfare has largely embraced the claims of the pharmaceutical industry. Both probation and preferential treatment are more than expected, and we wonder how the IMD standards will be proven and many pharmaceuticals will go ahead and improve the constitution”. The official said, “When the government's drug price regulation was first released, it was burdened with the licensing and restriction of the addition system, and the biggest meaning is that the Ministry of Health and Welfare agrees that the IMD is more valuable than generics”.
- Policy
- Atozet generic’s gold rush unaffected by new regulation
- by Lee, Tak-Sun Jan 16, 2020 06:07am
- The Korean pharmaceutical industry is keeping a close eye on a series of generics following MSD Korea’s blockbuster combination drug for hyperlipidemia, Atozet (ezetimibe/atorvastatin calcium hydrate), in development with individual bioequivalence test, as the government has enforced new regulation on joint bioequivalence test. Despite the already-saturated statin-ezetimibe combination drug market and increased cost of developing generic with individual bioequivalence test, the industry experts analyze the industry’s needs for the hyperlipidemia treatment generic is still high. According to Ministry of Food and Drug Safety (MFDS) on Jan 13, total 21 cases of bioequivalence test protocols have been cleared for Atozet generics. 18 cases were approved last year alone, and additional two cases were approved this year. Expecting Atozet’s post-marketing surveillance (PMS) period to expire on Jan. 22 next year, Korean pharmaceutical companies are in a hurry to develop follow-on drugs. The industry has expected many generics would be developed after the blockbuster Atozet generating accumulated prescription sales of 44.8 billion won (according to UBIST) as of third quarter in 2019. 21 bioequivalence test protocols have been approved so far proves the drug’s height of popularity. However, some industry insiders once predicted the popularity of Atozet generic development would subside soon as Ministry of Health and Welfare (MOHW) has announced March last year of a plan to lower pricing of generics developed with joint bioequivalence test from July at earliest. The insiders also hinted the ezetimibe-statin combination drug market being excessively saturated with 202 items approved including Atozet, would affect companies developing follow-on drugs. But it turns out those predictions have completely missed the mark. The number of joint bioequivalence tests has dropped due to the revised pricing regulation, but individual companies seem to be conducting their own tests to develop their generics. After nine companies—Medica Korea, Daewoong Bio, Samik Pharm, Ahn-gook Pharmaceutical, Union Korea Pharm, Intro Bio Pharma, Korea Prime Pharm, Hawon Pharm, Youngil Pharm and Wooridul Pharmaceutical—have been approved for joint bioequivalence test on passed Jan. 30, no other joint test protocol has been approved. The sudden fall in joint bioequivalence test approval is because Atozet generic can apply for approval listing from Jan. 22, 2021 when the original’s PMS expires. But generic based on the joint test would probably take the reduced pricing. Although Wooridul Pharmaceutical and Korea Prime Pharm initially planned to conduct a joint test, they respectively received approval for individual tests on Sept. 20 and Jan. 10 last year. Individually conducted bioequivalence test is more financially burdening for each company, compare to co-conducted test with two or more companies. Nevertheless, the companies are jumping on to take individual tests with no hesitance as they are running out of the list of potential generic development. A pharmaceutical industry personnel noted, “The number of new generics would descend with the healthcare authority regulating joint bioequivalence test, but markets with popular original would be affected far less. A ten-billion-won worth original with soon expiring exclusivity is getting even rarer these days. So it is not surprising Atozet is attracting many companies to develop follow-on drugs.” Meanwhile, some criticizes Korean pharmaceutical companies blindly developing profitable original’s generic, despite the super-saturated market.
- Company
- Zejula indicated for late-line therapy on ovarian cancer
- by Eo, Yun-Ho Jan 16, 2020 06:06am
- Anticancer treatment Zejula is now available for a monotherapy prescription on patient with ovarian cancer, who has been treated with fourth-line or later treatment. Takeda Pharmaceuticals Korea (CEO Moon Hee-seok) official stated Ministry of Food and Drug Safety (MFDS) has additionally indicated Zejula’s (niraparib) on Dec. 24 for treating patient with relapsed ovarian cancer, who has been treated for more than third-line treatment. From March last year Zejula, the first poly ADP ribose polymerase (PARP) inhibitor used regardless of BRCA mutation, has been approved in Korea for maintenance treatment of adult patients with recurrent epithelial ovarian cancer (including fallopian tube or primary peritoneal cancer), who are in a complete or partial response to platinum-based chemotherapy. And in December last year, the government granted healthcare reimbursement on the indication. However, the first reimbursed indication was limited to patients with BRCA mutation. By expanding the indication, Zejula is now the only PARP inhibitor in Korea indicated for BRCA mutation-positive patient regardless of platinum sensitivity, or hormone recombination deficiency (HRD)-positive adult patients, who have been treated with third-line plus chemotherapy. The indication expansion was based on an open-label multi-center QUADRA study evaluating the safety and efficacy of Zejula treating adult ovarian cancer patients with a record of third-line plus treatment. Treating HRD-positive platinum-sensitive patient group demonstrated objective response rate (ORR), a primary endpoint of the study, of 24 percent, whereas BRCA mutation-positive platinum-sensitive patient group, BRCA mutation-positive platinum-resistant patient group and BRCA mutation-positive platinum-refractory patient group demonstrated 39 percent, 29 percent and 19 percent, respectively, which confirmed the clinically meaningful benefit of the treatment. The secondary endpoint of the study, median duration of response (mDOR) of 8.3 months was observed in HRD-positive platinum-sensitive patient group. The finding confirmed the treatment’s safety profile can be managed by controlling the treatment dose.
- Policy
- Daewoong-Merck faces new contender with metformin ER
- by Lee, Tak-Sun Jan 16, 2020 06:06am
- Once almost dominated by Daewoong Pharmaceutical and Merck, the high-dose (1000 mg) metformin extended-release (ER) tablet market has a new competitor. Dalim Biotech has joined the race with newly approved ER tablet. With extensive individual drug portfolio, Dalim Biotech has well-prepared for the competition, sources say. On Jan. 9, Korea’s Ministry of Food and Drug Safety (MFDS) has granted sales approval on Dalim Biotech’s Glupa XR 1000 mg tablet. This is not the first time a high-dose metformin tablet has been approved. The original’s manufacturer Merck and its co-marketing partner in Korea Daewoong Pharmaceutical had Glucophage XR 1000 mg tablet and Diabex XR 1000 mg tablet cleared, respectively, on Mar. 18, 2010. Since then Daewoong Pharmaceutical’s subsidiary Daewoong Bio and Hanall Biopharma also nabbed the approval. Currently, Daewoong Pharmaceutical and Hanall Biopharma are leading the individual metformin ER tablet market, followed by the original’s Merck. Basically, Merck and Daewoong Pharmaceutical are hogging the market. Other pharmaceutical companies have not dared to approach the high-dose metformin ER tablet market, as it requires tablet-size reduction technology. The patent for the technology was still protected until Mar. 10 last year. In July 2018, Dailm Biotech had its bioequivalence test approved and won the approval on high-dose metformin ER tablet after acquiring the drug equivalence. It was first time for a follow-on drug company to achieve the outcome, besides the Daewoong Group. Dalim Biotech actually has a fairly large share in the individual metformin drug market with Glupa tablet. According to UBIST’s data, the drug generated 4.2 billion won until the third quarter last year. Besides the immediate release tablet, Dalim Biotech now has a firm foundation to challenge the once-daily administered ER market with item approval received on ER 500 mg and 1000 mg tablets. The pharmaceutical industry is eyeing on the individual metformin drug market as GC Pharma has recently started supplying its original Glucophamage in Korea. With imminent changes approaching fast, Dalim Biotech’s high-dose ER tablet is expected to shake up the market landscape as well.
- Policy
- IMD, virtually confirmed without drug price restrictions
- by Lee, Jeong-Hwan Jan 15, 2020 06:44am
- The drug price reform plan, which excludes 'proven advancement IMD' from the scope of generic drug price regulation, has been virtually confirmed. The decision was made to maintain some of the existing provisions for drug price benefits, with the difference between IMD and general generics. According to the pharmaceutical industry and the National Assembly's Health and Welfare Committee on the 13th, Myung-seop Kwak, the head of the Insurance and Pharmaceutical Affairs Division of the Ministry of Health and Welfare, met with Hee-mok Won, the Chairman of the Korea Pharmaceutical Biotechnology Association this morning and explained the improvement of the generic drug price regulation, which is expecting in July. The Ministry of Health and Welfare is expected to re-administer the proposed drug price regulation, which contains the provisions for maintaining the premium pricing policy for incrementally modified drugs. The Ministry of Health and Welfare previously announced a partial revision of the ‘Determination and Adjustment Criteria for Pharmaceuticals’, which contains generic drug price regulations on July 2 last year. Since then, the pharmaceutical industry has repeatedly made claims that drug prices should not be regulated by treating generic drugs with equivalent IMD, which have demonstrated excellent advances in patient compliance and side effects. In particular, the National Assembly Health and Welfare Committee sympathized with the claims of the pharmaceutical industry, emphasizing the need to recognize the value of IMD in the domestic pharmaceutical industry that is targeting new drug powers. As a result, the Ministry of Health and Welfare is expected to reintroduce the revised plan of drug price regulation, which was announced last July through administrative procedures. In the re-notification notice, which conditions should be met by the IMD that will maintain the premium pricing policy and what level of premium pricing policy will be provided for the IMD that meets the criteria. An official of a large pharmaceutical company in Korea said, “I understand that the head of a pharmaceutical company met with the head of the Korea Pharmaceutical Association this morning to explain the exception of the regulation of IMD price and to obtain opinions and consent, and the government has partially acknowledged the necessity of the IMD in the pharmaceutical industry”. "In fact, unlike generics, we need a lot of resources to make advanced drugs that are proven to be progressive. We need to demonstrate proper efficacy and function through preclinical animal experiments and phase III clinical trials. “Fortunately, the government seems to have chosen a policy to encourage pharmaceutical companies' will of the IMD”.
