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- 2026-05-09 03:10:15
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- Will the situation in the Atozet market improve?
- by Kim, Jin-Gu Aug 16, 2022 05:46am
- With the revision of guidelines for treating hyperlipidemia in Korea announced, attention is focused on how it will affect the prescription performance of major drugs. The pharmaceutical industry predicts that the Atorvastatin and Ezetimibe market, which has recently been growing rapidly, will benefit the most from the revision of the guidelines. Domestic pharmaceutical companies that have recently entered this market are also in the midst of preparing marketing and sales strategies with guidelines in mind. ◆ Proactive treatment for patients with high-risk hyperlipidemia According to the pharmaceutical industry on the 9th, The Korean Society of Lipid and Atherosclerosis is planning to officially announce the fifth edition of the "2022 dyslipidemia treatment guidelines" in September. The core of the new guidelines is active treatment for high-risk patients. Patients in stages 1 to 3 of CKD are regarded as high-risk groups and their LDL-C is actively lowered. Currently, the LDL-C level of high-risk patients is lowered to 70, but the revised guidelines lower this target to 50. ◆ The pharmaceutical industry expects Atorvastatin and Ezetimibe to benefit In the case of Ezetimibe, it is expected that its use as a combination therapy with statins will expand in the primary treatment of high-risk patients who are not controlled by Statins alone. In this process, it is predicted that the use of Statin + Ezetimibe will increase. Atorvastatin has a lower burden on the mechanical kidney than other statin drugs such as Rosuvastatin. This is because it is an mechanism of action that is excreted by the liver, not the kidney. Given that the new guidelines see patients with chronic kidney diseases in the first to third stages as high-risk groups, Atorvastatin, which can be used regardless of whether they have kidney disease, is expected to benefit. In the case of Rosuvastatin, as a precaution in use, it is stated in the product manual that do not administer it to patients with severe renal failure. Pitavastatin also includes patients with moderate to severe renal impairment among patients. Atorvastatin and Simvastatin do not include this in the administration indication. ◆Announcement of competitive heating of hyperlipidemia compound, preparing the details that match the guidelines If the guidelines are revised, it is predicted that competition in the Statin+Ezetimibe combination's hyperlipidemia complex market will intensify. According to UBIST, a pharmaceutical market research firm, the performance of Rosuvastatin and Ezetimibe in the first half of the year was 232.9 billion won, up 11.4% from the first half of last year. During the same period, prescription performance of Atorvastatin and Ezetimibe increased 80.6% from 50.3 billion won to 90.8 billion won. The market for Atorvastatin and Ezetimibe is growing explosively with the addition of a large number of generics last year. Until 2020, the Atorvastatin·Ezetimibe combination was one item of Atozet by Organon Korea. Since Chong Kun Dang was approved for Lipilouzet, in October 2020, 113 pharmaceutical companies have entered the Atojet market with generic licenses until June last year. The revision of the guidelines is raising expectations for the growth of the Atorvastatin and Ezetimibe markets. At the same time, it is in the midst of preparing marketing and sales strategies tailored to the revision of guidelines. An official from a pharmaceutical company selling the item said, "We are aware of the revision of the guidelines," adding, "If the guidelines are revised as scheduled, we plan to focus on this part in the second half of the year to further increase prescription performance." Another pharmaceutical company official said, "We expect changes due to the revision of the guidelines to appear first in general hospitals." He explained, "In the local area, we are preparing related details to expand prescriptions tailored to the new guidelines."
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- Wakix, a new narcolepsy drug, can be prescribed at Big 5
- by Eo, Yun-Ho Aug 12, 2022 05:58am
- Wakix, a new narcolepsy drug, can be prescribed at the Big 5 General Hospital. According to the industry, it is Mitsubishi Tanabe Pharma's Wakix recently passed the DC of the Big 5, including Samsung Seoul Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital. Wakix has been on the insurance benefit list since February, forming a confrontation with Nuvigil of Handok Teva. The pay standard for this drug is that in adult patients over the age of 19 who have been confirmed to have narcolepsy, CSF hypocretin-1 immunoreactivity level corresponds to one or more of the patients with hypocretin deficiency measured to be less than 1/3 of the normal level or less than 110 pg/mL. Wakix, a counteracting and antagonist that selectively binds to histamine H3 receptors, is a new mechanism drug that increases histamine concentration in the brain. Nuvigil, an active isomer of sleep seizure treatment Provigil, activates dopamine in the brain to promote awakening and improve the duration of existing drugs. Narcolepsy, a rare and intractable disease, has limited treatment options in Korea. In the United States and Europe, Modafinil, Sodium Oxybate, Solriamfetol, and Pitolisant are used as narcolepsy treatments, but only Modafinil and isomer Armodafinil are permitted in Korea. Narcolepsy is a sleep disorder disease characterized by confusion in the sleep awakening cycle and abnormal expression of REM sleep due to the loss of neurons that produce a neurotransmitter called hypocretin in the brain. Chronic Daytime Sleepiness (EDS) and cataplexy, in which REM sleep is expressed in awakening conditions Cataplexy is known to appear in 70% of narcolepsy patients. Wakix is the first treatment in Korea to be approved for demonstrating clinical efficacy and safety of cataplexy.
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- Verquvo for CHF, aims to enter insurance benefits
- by Eo, Yun-Ho Aug 11, 2022 06:03am
- Verquvo, a new drug for heart failure, aims to enter insurance benefits. dksl According to related industries, Bayer Korea has submitted an application for payment of Verquvo, a water-soluble guanylate cyclase (sGC) promoter that promotes the synthesis of intracellular cyclic Guanosine (cGMP). Verquvo was recently approved in December last year as a combination therapy to reduce the risk of death from cardiovascular disease and hospitalization due to heart failure in patients with symptomatic chronic heart failure, whose left ventricular ejection rate, which experienced intravenous diuretic administration, has decreased to less than 45%. Existing heart failure treatments have been a method of blocking harmful effects from the natural neurohormone system activated by myocardial and vascular dysfunction. Verquvo has a new mechanism to improve myocardial and vascular function by promoting the synthesis of intracellular cyclic monophosphate guanosine (cGMP), which regulates heart contraction, vascular tension, and heart remodeling with a water-soluble sGC stimulant. It was approved as the world's first-in-class chronic heart failure treatment as an sGC promoter. Verquvo demonstrated efficacy through phase 3 clinical VICTORIA The VICTORIA study was conducted in 5, 050 patients with high-risk heart failure with NYHA Class (Grades 2-4) and reduced left ventricular ejection rate to less than 45% who were hospitalized due to heart failure or experienced intravenous diuretic administration outpatient. 59.7% of the patients who participated in the study were undergoing three-drug therapy, and 41% of severely ill patients with NYHA grades 3 and 4. Patients were administered placebo or up to a target maintenance dose of Verquvo 10 mg in combination with other heart failure treatments. As a result, Verquvo had about 10% lower risk of first hospitalization due to cardiovascular disease death or heart failure during 10.8 months (median value) of follow-up, with an annual Absolute Risk Reduction of 4.2%, meeting the primary evaluation variable. The annual absolute risk reduction rate of hospitalization due to heart failure was 3.2%, and as a result of comprehensive evaluation of hospitalization due to death from all causes or heart failure, Verquvo group showed a 10% risk reduction compared to the placebo group. Heart failure is a disease that appears as a final complication of various cardiovascular diseases such as coronary artery disease and high blood pressure without delivering as much oxygen as necessary to the peripheral organs due to structural or functional abnormalities of the heart. Heart failure is a major cause of hospitalization for patients aged 65 or older, and the prevalence of heart failure in Korea has been steadily increasing over the past decade as the population ages. Heart failure is at high risk of worsening over time, and about 50% of patients diagnosed with heart failure have a low survival rate, with death within five years.
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- AKLIEF can be prescribed at general hospitals
- by Eo, Yun-Ho Aug 10, 2022 05:53am
- According to related industries, Galderma Korea's AKLIEF passed the Drug Committee (DC) of higher general hospitals such as Samsung Medical Center and Sinchon Severance Hospital. AKLIEF is a retinoid-based treatment that has been recommended as the primary treatment for acne, and is evaluated as an innovative treatment that can simultaneously treat face and torso acne by overcoming the limitations of existing treatments that have been limited to face acne treatment. Acne is known to occur mainly on the face, but body acne is a common phenomenon. 50% of patients with acne on their faces develop body acne together. According to a clinical study of 965 people, chest and torso acne rates were 45% and 61%, and another study found that about 22% of patients with face and torso acne did not voluntarily report body acne, but more than 75% of those who were offered body acne treatment wanted treatment. Since most treatments have focused on treating facial acne, the reality has been that there has been no appropriate treatment to treat the face and body at the same time. AKLIEF is evaluated as an alternative to overcome the limitations of existing acne treatment. AKLIEF targets retinoic acid receptor gamma (RAR-), the most common RAR on the skin, and is the only large-scale clinical three-phase study to demonstrate efficacy, drug resistance, and safety for face and torso acne. According to PErFEcT1 and 2, a 12-week phase 3 of more than 2,400 people, AKLIEF reduced inflammatory and non-inflammatory lesions quickly from week 1 compared to the control group and effectively decreased body acne from week 2.
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- Gov improvement plan may reduce patient drug access
- by Eo, Yun-Ho Aug 10, 2022 05:53am
- The focus is on lowering the price of the drug rather than improving the registration, shortening the time and effectiveness are insignificant." "There was no discussion with the consultative body. It's hard to gather opinions from the industry." The KRPIA expressed strong opposition to the government's plan to strengthen access to new drugs. Rather, it is pointed out that it will reduce patient accessibility. According to KPRIA on the 9th, the "plan to enhance patient access to high-priced severe disease treatments and strengthen salary management" reviewed by the Health Insurance Policy Review Committee of the MOHW on the 20th of last month focuses only on strengthening follow-up management of insurance drugs such as "PVA reduction rate revision" and "foreign drug price adjustment". Among the contents of "Quick registration through benefit evaluation and negotiation" included in the management plan, the part that shortens 60 days during the 210-day deliberation period of the current regulation does not have a practical shortening the period. It is argued that this not only hinders the motivation for innovative growth of the domestic pharmaceutical bio industry, which is currently developing new drugs, but also goes against the new government's stance to become a bio powerhouse as it can shrink the entire industry. According to a 2022 study, the average period for new drugs registered over the past 10 years was more than 690 days for rare drugs and 930 days for anticancer drugs. Through this, the association has already suggested that the effect of improving accessibility felt by patients will be very insignificant by shortening some periods (60 days) in the current salary evaluation system, which requires more than three to four times the actual legal period. The KRPIA said, "It is necessary to review and introduce a more proactive rapid registration system." It evaluated that "expansion of the PVA rate" and "additional restriction of the PE system to minority patients" included in the announcement of the management plan overlooked the fact that it could reduce the motivation to develop innovative new drugs and hinder access to treatments for severe rare diseases. The current system is already listed as the lowest in the world through comparison of foreign drug prices and has a longer evaluation period, making it difficult for domestic pharmaceutical companies as well as global pharmaceutical companies to release new drugs. The KRPIA also expressed concern about the fact that it did not collect opinions with related industries in the process of reviewing management plans. He added, "The MOHW's public-private consultative body for improving the drug price system, which has been operated by the HIRA, the NHIS and pharmaceutical organizations since early last year, also had a chance to review and discuss it in advance with the industry."
- Company
- Baxter International’s GM Dong-Wook Hyun suddenly resigns
- by Eo, Yun-Ho Aug 09, 2022 05:56am
- Former General Manager Dong-Wook Hyun Dong-Wook Hyun, General Manager of Baxter International Korea, resigned. According to industry sources, Hyun submitted his letter of resignation last month and left the company. The exact reason for his resignation remains unknown. With Hyun’s resignation, Baxter is now seeking a new head, during which Kwang-hyuk Im, Vice President of Renal Care at Baxter Korea, will be acting as interim CEO. The former GM Dong-Wook Hyun graduated from the University of California in the U.S. with a degree in Biology and Bioscience. Hyun accumulated extensive experience in the industry, beginning at the medical device company Medtronic from 1999 to 2004. After serving various posts in sales and marketing in the Asia-Pacific region, Hyun was appointed the Country Manager of Medtronic. Since then, Hyun served as the General Manager of Baxter from 2004 to 2008, and then as the Managing Director of MSD Korea for 8 years, after which he was again appointed as the General Manager of Baxter Korea in 2018. Meanwhile, Baxter is a global healthcare company based in the U.S. that entered the Korean market with its hemodialysis business in 1972. The company established its Korean subsidiary in 1991 and has been supplying pharmaceuticals such as anesthetics, intravenous nutrition, etc. as well as medical devices including peritoneal dialysis solutions and automated peritoneal dialysis systems to Korea.
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- Korean companies win first round of Entresto patent suit
- by Kim, Jin-Gu Aug 08, 2022 06:09am
- Pic of Entresto. The first patent dispute over Novartis’s heart failure treatment ‘Entresto (valsartan+ sacubitril) ended with the victory of the Korean generic companies. The exclusive market approval (first generic exclusivity) that received attention is expected to be granted to 10 companies including Hanmi Pharmaceuticals, with the possibility of Daewoong Pharmaceuticals additionally receiving generic exclusivity. However, the industry analysis is that there remain risks for the generic companies' early release of Entresto latecomers as the original company Novartis has announced its plan to appeal, and separate legal disputes such as patent infringement suits and injunction applications are still ongoing. ◆10 companies overcome the fourfold patent hurdle…meets first generic exclusivity requirements According to industry sources on the 28th, the Intellectual Property Trial and Appeal Board ruled in favor of the generic companies in the 2 trials to confirm the passive scope of rights of Entresto’s composition patent that was filed by 9 companies including Chong Kun Dang against Novartis. Nine generic companies including Chong Kun Dang, YooYoung Pharmaceutical, Hanlim Pharm, Hana Pharm, Ahn-Gook Pharmaceutical, Genuone Sciences, GenuPharma, Samjin Pharm, Elyson Pharm received the favorable ruling. With the ruling, on which companies will be receiving generic exclusivity has been somewhat revealed. Hanmi Pharmaceuticals was the first company to overcome all 4 of Entresto’s patents, and with the addition of the 9 companies that received the recent ruling, a total of 10 companies have now paved the way for the early release of their generics. The companies have obtained the ‘first to request for trial’ requirement by filing claims from January 2021. In April, the companies also applied for generic marketing authorization together and fulfilled the ‘application for first latecomer drug approval’ requirement as well. By ‘winning the patent suit,’ the companies met the last requirement to receive first generic exclusivity. The companies would now only need to receive official approval from the Ministry of Food and Drug Safety. Also, Daewoong Pharmaceuticals may also additionally secure first generic exclusivity. Daewoong Pharmaceuticals succeeded in invalidating or avoiding 3 of 4 Entresto’s patents. The company is currently challenging Novartis to invalidate the last remaining patent, and if Daewoong wins the last suit, the company will also be able to satisfy all of the first generic exclusivity requirements like the other 10 companies. The ruling on the trial is expected to be made within this month. ◆"Non-listed and newly-listed patents remain risk factors on the safe release of generics" The industry evaluates that Entresto’s patent dispute has virtually been settled with the generic companies’ win in the first trial. However, there is also an analysis that risks remain for the early release of the generic companies’ generics despite the complete victory they had made in the first round. The biggest risk factor is Novartis’s appeal. Novartis appealed against the first trial ruling and filed a suit for the annulment of the first trial decision, taking the case to the second trial. The company may likely file appeals for the other cases that it had not yet appealed to as well. If the first trial decision is reversed in the second trial, the early release of generics by generic companies will be reinterpreted as patent infringement. In this case, Novartis will file claims for damages on the patent infringement to the companies. In line with this, the generic companies need to overcome the patent infringement suit and the injunction application filed by Novartis to the Seoul Central District Court and others. Novartis filed a suit against the generic companies for infringing Entresto’s patent, and also filed an injunction requesting that the release of generics be banned until the results are made. The results of the injunction application are yet to be released. On the generic companies’ part, Novartis’s remaining non-listed and newly listed patents remain a burden. In the case of Entresto, 2 other patents remain in addition to the 4 patents that generic companies have now overcome. One of the 2 remaining patents is a salt·hydrate patent that was not listed in the patent register. This patent is set to expire in November 2026. Daewoong Pharmaceuticals, Hanmi Pharmaceuticals, and Elyson Pharm have challenged the patent, and a ruling has not been made yet. The other patent is a newly listed use patent that was registered after the generic companies applied for marketing authorization. The new patent will expire in August 2033, and no company has yet challenged the patent. The generic companies can release their generics without avoiding or invalidating the two patents. The two remaining patents will not affect the companies’ acquisition of first generic exclusivity. However, there is the possibility that the court may make a patent infringement judgment apart from the Intellectual Property Trial and Appeal Board’s ruling based on those two patents. From the generic companies’ point of view, the companies cannot rule out the concern over compensation for damages that may arise from this patent infringement. An industry official said, “Entresto is protected with several layers of patents, and generic companies have to bear the burden of overcoming all the patents; On the other hand, Novartis can prevent the early release of its generics even if it wins only one of all of its disputes.” Entresto’s ongoing patent dispute is the largest single product lawsuit in progress in the Korean pharmaceutical industry. 20 Korean companies have filed trials to confirm the passive scope of rights and patent invalidation trials on 4 patents. Novartis countered the suits by filing patent infringement and injunction applications to the Seoul Central District Court. The number of trials and litigations related to Entresto patents that have been filed with the Intellectual Property Trial and Appeal Board, the Patent Court of Korea, and the Seoul Central District Court has reached 130.
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- Revised guidelines for dyslipidemia in Korea
- by Eo, Yun-Ho Aug 08, 2022 06:09am
- In the management of dyslipidemia, it is believed that drug prescriptions will be more aggressive in Korea. In April, The Korean Society of Lipid and Atherosclerosis unveiled some of the contents of the fifth edition of the 2022 dyslipidemia treatment guidelines at the Spring Conference, and will officially announce it in September. What is noteworthy in the new guidelines is that patients with Chronic kidney disease stage 1-3 are considered to be at high risk, and a reduction in low-density lipoprotein cholesterol (LDL-C) is recommended as a basic treatment goal. In 2017, the American Association of Clinical Endocrinologists (AACE) established an extreme risk for cardiovascular disease and recommended that LDL cholesterol be adjusted to less than 55 mg/dL (future unit omitted). The 2019 European Society of Cardiology (ESC) has emerged as an important issue, with LDL-C levels in extreme risk groups considering up to less than 40. On the other hand, in 2018, Korea stuck to the LDL-C treatment target of the ultra-high-risk group at 70. The guideline recognized the need to actively reduce LDL-C for high-risk patients in the trend that "The lower is the better," and the lower the LDL-C level, the higher the cardiovascular disease-related benefits. Drugs that are expected to increase their utilization are Ezetimibe and Atorvastatin. If 70 is viewed as an ideal number, it is correct that Ezetimibe has less needs in primary treatment. However, if LDL-C reduction is targeted in CKD patients, Ezetimibe combination therapy is more likely to be supported as statin alone therapy may not be achieved. The fact that Atorvastatin's mechanism of action is excreted as a liver rather than a kidney is also likely to act as an advantage. Atorvastatin, including Lipitor, is not affected by the plasma concentration or LDL-C reduction effect depending on whether it is a kidney disease, so you can freely select it without having to adjust the dose when administered to the patients.
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- Nabota's sales in US in 1Q of the year were 92 billion won
- by Aug 08, 2022 06:09am
- Daewoong Pharmaceutical's botulinum toxin drug Nabota broke a new quarterly sales record in North America. Sales also improved in the second quarter following the first quarter, surpassing 90 billion won in sales in the first half. Daewoong Pharmaceutical's partner Evolus announced on the 3rd (local time) that its sales of Jubo (Nabota) reached $37.16 million in the second quarter. This is an increase of 46.3% compared to the same period last year. This quarter's sales are the highest since Navota's launch in North America in the second quarter of 2019. It surpassed 34.66 million dollars in the fourth quarter of last year, breaking a new quarterly sales record. Nabota's sales in North America in the first half of the year increased 87% year-on-year to $70.39 million. Since its launch, its cumulative sales have reached $260.2 million. Evolus is a global copyrighted partner of botulinum toxin Nabota developed by Daewoong Pharmaceutical. Since approval by the U.S. Food and Drug Administration (FDA) in February 2019, Nabota has been actively sold in North America. In particular, it resolved the negative factors by ending the International Trade Commission (ITC) dispute with Allergan and Medy Tox early last year. It has become possible to actively market Jubo without legal concerns. Navota's quarterly sales, which stood at $20 million last year, exceeded $30 million for the first time in the fourth quarter of last year. Nabota added 590 new accounts in the second quarter, securing more than 8,100 customers so far. The percentage of re-orders remains above 70%. In the first half of this year, about 180,000 Evolus Reward loyalty programs were used. Evolus is conducting more aggressive marketing. Following the creation of more than 250 million media exposures in the second quarter, it also launched the largest promotional campaign under the name of "Switch Your Tox and Love Evolus Forever" last month.
- Company
- 3rd PD-1i Jemperli to soon receive approval in Korea
- by Eo, Yun-Ho Aug 05, 2022 06:06am
- A third PD-1 inhibitor is knocking to enter the Korean market. According to industry sources, GSK Korea’s PD-1 inhibitor cancer immunotherapy ‘Jemperli (dostarlimab),’ which the company applied for approval earlier this year, may be approved within the year. If approved, Jemperli will become the third PD-1 inhibitor introduced to the Korean market following Ono·BMS’s ‘Opdivo (nivolumab),’ and MSD’s ‘Keytruda (pembrolizumab).’ Unlike the other two drugs that were first indicated as melanoma treatments, Jemperli was first approved in the US in April last year as a treatment for mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.’ In August of the same year, Jemperli was additionally approved for the treatment of adults with dMMR recurrent or advanced solid tumors who have progressed on or following previous treatment and have no satisfactory therapeutic options. GSK plans to add other indications to endometrial cancer in Korea as well. The efficacy of Jemperli was confirmed through the multicohort GARNET trial that included a cohort of patients with dMMR/MSI-H endometrial cancer who progressed on or following prior treatment with a platinum-containing regimen. Trial results showed an objective response rate (ORR) of 43.5% and the disease control rate of 55.6% in the Jemperli-treated group. The median duration of response was not reached yet, and the rate of patients whose duration lasted 6 months and 12 months were 97.9% and 90.9%, respectively. Meanwhile, the other companies are also actively working to expand their indication and reimbursement for Keytruda and Opdivo in Korea as well. MSD succeeded in expanding the reimbursement standards for Keytruda to first-line NSCLC in 1H this year, and Opdivo's indication as a first-line treatment in gastric cancer has passed the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee.
