- LOGIN
- MemberShip
- 2026-05-14 01:01:07
- Policy
- Hutecs targets pitavastatin market with its lowest-price
- by Lee, Tak-Sun Sep 27, 2022 05:51am
- Hutecs Head Office in Hwaseong City Hutecs Korea Pharmaceutical throws a winning bid in the hyperlipidemia treatment pitavastatin market represented by the original drug Livalo. As the 21st latecomer introduced to the market, Hutecs’ generic is putting pressure on other competitor companies, being listed at a price lower than 85% of the current lowest price. According to industry sources on the 26th, Hutecs succeeded in listing both Lovalow 1mg and Lovalow 4mg with reimbursement. The ceiling price was set at KRW 295 for the Lovalow 1mg, and KRW 527 for Lovalow 4mg. The two products are both listed at the lowest price among the listed products. In particular, the price of Lovalow 4mg was set 28% lower than the current lowest price (KRW 715). Lovalow 4mg is the 21st product to be listed. Under the drug pricing regulations, from the 21st generic listed in the system, the price is set at 85% of the lowest price. However, the price of Lovalow 4mg was set even lower. With the listing, the ceiling price of the already listed Lovalow 2mg will also inevitably be discounted. This is because when a product from the same company with an identical route of administration, ingredient, and formulation, but with a different strength is already listed, the ceiling price of the lower strength is adjusted to be lower than that of the higher strength under regulations. Therefore, the price of Lovalow 2mg was lowered to KRW516 from KRW561. This is KRW 1 lower than that of Lovalow 4mg. As a result, Lovalow 2mg, which was the lowest priced product among the same ingredient drugs, is expected to become the second lowest priced product. Competition in the pitavastatin market is fiercer for the 2mg products. A total of 48 same ingredient products are competing in the market. With its 1mg and 4mg formulations being listed later in the market, Hutex seems to be throwing in the winning bid and extending its price competitiveness to the 2mg formulation market as well. Pitavastatin is a steady seller that has been long beloved in the hyperlipidemia treatment market. Its original, Livalo, had recorded KRW 79.7 billion (Data: UBIST) in outpatient prescriptions last year.
- Company
- Daewoong Nabota is expected to take a global leap
- by Nho, Byung Chul Sep 27, 2022 05:51am
- As Daewoong Pharmaceutical's botulinum toxin product Nabota (Jubo·Jeubeau) is likely to surpass 100 billion won in sales this year, it is drawing attention as it is expanding its global scope as a representative K-toxin product. Nabota, which was launched in Korea in 2014, recorded 15.1 billion won in 2019 It achieved sales of 79.6 billion won last year after Quantum Jump, 233% sales of 50.4 billion won the following year. After the FDA approved the final item license in February 2019, it began to target the North American market in May of the same year. The U.S. occupies 50% of the global toxin market worth 6 trillion won, and Allergan Botox products are leading the treatment, beauty, and plastic surgery market. Europe is the second-largest market for toxin drugs, and Nabota is expected to be launched in the second half of this year. Item licenses in China, which are highly regarded for its rapid growth and potential market value, are also expected to be approved as early as this year, and full-fledged releases and profits are expected from next year. Evolus is in charge of the beauty business partners in the U.S., Europe, Australia, and Canada, while Ion Biopharma is in charge of the treatment business partners in the U.S. Currently, Nabota is in charge of production at the first plant of Hyangnam Pharmaceutical Complex, and when the second plant is completed in 2025, it is expected to become a global leading company as it can produce a total of 5 million vials per year. As of September 2022, Nabota's indications include eyelid wrinkles, eye wrinkles (abnormal beauty), improvement of upper extremity muscle stiffness after stroke, and eyelid cramps (abnormal treatment). As for the progress of additional indications, it is waiting for approval after submitting approval to the MFDS in April 2022 for the world's first item permission to add positive adiabatic hypertrophy (square jaw improvement). In addition, phase 2 clinical trials for chronic and inflammatory migraine and cervical muscle tension are underway in the United States, Canada, and Australia. A panoramic view of Nabota Chronic migraine headaches account for 40% of the total treatment market, and there is no competition other than Botox yet. If Nabota enters this field, it is expected to penetrate the market quickly based on price competitiveness.I t is also preparing clinical trials for gastric paralysis indications, which do not yet have a clear treatment. It is predicted that a new treatment paradigm can be provided in a unique way by injecting toxin directly into the upper and lower parts of the stomach through endoscopy. In addition to the three global toxin markets, plans to release them in niche markets such as Turkey, Chile, Peru, Saudi Arabia, Egypt, and Indonesia are also drawing attention. Nabota is a premium toxin brand based on high-pure technology patent technology. An official from Daewoong Pharmaceutical said, "Nabota is the only product in Asia that has been approved for sales in the United States, Europe, and Canada." "We plan to expand our markets in the U.S., Europe, and China through aggressive investment in the future," he said. Meanwhile, Nabota's ITC lawsuit disappeared in February last year when Daewoong Pharmaceutical's U.S. partner Evolus signed a three-way agreement with AbbVie and Medy Tox, and has since grown rapidly based on U.S. exports. Of Nabota's overseas sales in the second quarter, exports to the U.S. through Evolus amounted to 21.1 billion won, which doubled from the same period last year.
- Company
- 4 pharmaceutical companies challenge to add Vemlidy patents
- by Kim, Jin-Gu Sep 27, 2022 05:51am
- VemlidyGilead Sciences' patent for hepatitis B treatment Vemlidy (Tenofovir) is increasing. While Dong-A ST, Daewoong Pharmaceutical, Chong Kun Dang, and Jeil succeeded in avoiding patents for the first time in March this year, Samjin, Hutechs, DongKook, and Samil have challenged the same patent for the past two months in a row. According to the pharmaceutical industry on the 23rd, Samil recently requested a passive judgment on the scope of rights for the Gilead Vemlidy salt patent. Since Samjin challenged the same patent in July, a total of four companies, including Hutechs and DongKook, have joined patent disputes in the past two months. This patent has already been successfully avoided by Dong-AST, Daewoong, Chong Kun Dang, and Jeil in March this year. Samjin, Hutechs, DongKook, and Samil challenged the same patent as generics. The background of a series of generic challenges is that there is no impact on generic exclusivity. The drug is an upgraded version of Gilead's existing hepatitis B treatment Viread. However, since the main ingredient is Tenofovir, generic for Vemlidy is not given a separate opportunity to acquire generic exclusivity. Gilead developed a new Vemlidy in the form of pro-drug. Through this, drug resistance and renal toxicity side effects have been improved. Vemlidy is rapidly replacing the existing Viread in the hepatitis B treatment market. According to IQVIA, a pharmaceutical market research firm, sales of Vemlidy surged in four years from 500 million won in 2017, the first year of its launch, to 28 billion won last year. During the same period, Vemlidy's sales nearly halved from 129.3 billion won to 63.1 billion won.
- Policy
- MFDS in discord regarding promotion of oral COVID-19 Txs
- by Sep 26, 2022 06:08am
- The government is encouraging the use of oral COVID-19 treatments in high-risk groups, however, accessibility to such has been limited for healthcare professionals due to limitations in emergency use approvals. The Ministry of Food and Drug Safety is being criticized for being passive in making legal interpretations for emergency use authorized drugs, which is in discord with the government’s disease control and prevention measures. According to industry sources on the 26th, pharmaceutical companies are disallowed from conducting academic marketing for their oral COVID-19 treatments as the subject drugs were approved under Emergency Use Authorizations. Usually, when new drugs are released, companies conduct various activities to raise awareness of the drugs, making visits to hospitals to explain their drugs and holding webinars or symposiums to provide educational material. The new drugs in the market can only be actively used after the healthcare professionals gain a better understanding of the drugs and accumulate prescription experience. However, as COVID-19 treatments were granted emergency use according to the Special Act on the Promotion of Development and Urgent Supply of Medical Products in Response to Public Health Crisis, the authorities deemed that the drug are not allowed the advertising privileges granted under the Pharmaceutical Affairs Act. According to Article 68-5 of the Pharmaceutical Affairs Act, the imported pharmaceutical product’s name, manufacture method, and efficacy cannot be advertised unless the drug product has been approved or reported according to Article 42-1 of the Pharmaceutical Affairs Act. As drugs granted Emergency Use Authorization was not approved under Article 42-1 of the Pharmaceutical Affairs Act, the MFDS’s interpretation was that such drugs are not allowed to conduct advertisements. Due to this, the government is solely in charge of providing the necessary information on oral COVID-19 treatments in Korea. The Korea Disease Control and Prevention Agency is in charge of training healthcare professionals to provide medication guidance to patients, etc. However, it has been pointed out that the government’s education sessions are not enough to cover the expanded scope of institutions and pharmacies approved to prescribe and dispense oral COVID-19 treatments. Also, the participation rate, frequency, and effect of KDCA’s education sessions are relatively lower than that of pharmaceutical companies due to lack of promotions among other reasons. There are also opinions that more explanation is needed because the sessions are not carried out by medical professionals. Many healthcare professionals and pharmacists who still have not received a prescription or medication guidance yet have reported experiencing confusion. However still, officials of pharmaceutical companies that can communicate most closely with healthcare professionals have been passive in dealing with the issue due to concerns about violating the Pharmaceutical Affairs Act. As an active explanation of the drugs was prohibited, the officials can only respond when receiving inquiries from healthcare professionals. This is why the prescription rate has not risen much even though the government has greatly expanded the number of institutions that can prescribe oral COVID-19 treatments. According to the Central Disaster and Safety Countermeasure Headquarters (CDSCH), the prescription rate of oral COVID-19 treatments in those over the age of 60 as of the 2nd week of September, remained at 27%. The prescription rate has more than doubled in 4 months with the encouragement of the disease control and prevention authorities, but the government believes it is necessary to further increase the prescription rate. The importance of prescribing oral treatments has risen after the prescriptions had significantly reduced the progression to severe disease in patients in the high-risk group over the age of 60 during the COVID-19 outbreak last summer. The CDSCH’s analysis of its disease control progress and response to the resurge of COVID-19 in the summer showed that the progression to severe disease decreased as the prescription rate for oral COVID-19 treatments increased for those aged 60 years or older. The rate of progression to severe disease, which had been 1.28% in February when the administrate rate was 6.4%, dropped to 0.42% with the rise of the administration rate to 21.7% in August. The disease control and prevention authorities are also busy preparing measures to address the issue of prescriptions being limited due to a lack of clinical information in the field. According to the 'Measures to Raise Prescriptions of Oral COVID-19 Treatments’ that had been reported by CDSCH last month, healthcare professionals were reluctant to prescribe oral COVID-19 treatments due to a large number of contraindicated drugs and lack of clinical information. Accordingly, the authorities are contemplating ways to increase accessibility to information by preparing educational materials and prescription guidelines. To address the continued criticism over the limitations in information, the authorities recently partially granted pharmaceutical companies to produce and distribute materials containing drug information. As such partial activities have clear limitations, voices for proactive allowance of pharmaceutical companies to conduct academic marketing on EUA drugs have also been rising. Contrary to the government's stance, the MFDS had been passive in making legal judgments regarding EUA drugs. At the time of introductions, pharmaceutical companies had made several inquires to the MFDS on what scope of information provision activities is allowed for their drugs. At the time, the MFDS only responded that “It is difficult for the ministry to provide a definite answer due to lack of information in determining the necessity and validity of providing information." The pharmaceutical companies received the response as a “don’t.” Regarding this, the MFDS said, “The COVID-19 treatments that were granted EUA are directly managed by the KDCA, and the KDCA has been providing various information for healthcare professionals and patients. We will consult with the department in charge to see if academic marketing is allowed." The Advisory Committee on Infectious Diseases also agrees on the need for the government to make proactive decisions and improve and expand healthcare professionals’ accessibility to information. During a phone interview with Dailypharm, Gi-Seok Jeong, Director-General of Special Response of the Central Disaster and Safety Countermeasure Headquarters, said, “Despite the state’s efforts in encouraging the prescription of oral COVID-19 there are still many cases in which prescriptions are not available to patients who need them in the medical field. Adding pharmaceutical companies' information provision activities to the effort will help increase the prescription rate. It seems necessary that the government should take active action to overcome obstacles that may hinder engagement in such activities that would lead to an increase in the prescription rate, by requesting authoritative interpretation from the Ministry of Government Legislation.”
- Company
- Praluent can be prescribed at general hospitals
- by Eo, Yun-Ho Sep 26, 2022 06:08am
- PCSK9 inhibitor Praluent has settled on general hospitals. After registering insurance benefits in June 2021, the landing process is steadily underway. According to related industries, Sanofi-Aventis Korea's Praluent passed the Pharmaceutical Affairs Committee (DC), including Samsung Medical Center, Asan Medical Center, Sinchon Severance Hospital, Bundang Seoul National University Hospital, Chonnam National University Hospital, and Pusan National University Hospital. The drug was approved in Korea in January 2017, but was listed last year. Amgen Korea's Repatha, which was approved around the same time, was first registered as a Homozygous Family Hypercholesterolemia (HOFH) indication in August 2018. In other words, there were two PCSK9 inhibitors, but in fact, Repatha was the only option. Since last year's salary registration, Sanofi has carried out the landing process at general hospitals, and as it has shown results this year, the competition between the two drugs is expected to begin in earnest. In January 2020, Repatha succeeded in expanding the criteria for high-risk patients with atherosclerotic cardiovascular disease (ASCVD), heterozygous family hypercholesterolemia (HeFH), and non-heterozygous patients. It is believed that the actual battlefield between the two drugs will also be the ASCVD and HeFH regions. Praluent added a HoFH indication in the United States in April last year. Praluent has a tendency to reduce the risk of all-cause death, and it has the advantage of being able to select patient-specific doses by referring to patient status and LDL-C levels as two approved drugs, Praluent 75 mg and Praluent 150 mg. Meanwhile, MSD is currently developing oral PCSK9 inhibitor. MSD announced phase 1 clinical results of the candidate substance MK-0616 at the American Heart Association (AHA) conference last year. Studies have shown that up to MK-0616 300 mg was administered to healthy men, or LDL cholesterol was reduced without serious side effects or death when administered with Statins in men and women with high cholesterol.
- Company
- The anesthetic drug Byfavo is available in general hospitals
- by Eo, Yun-Ho Sep 26, 2022 06:08am
- Byfavo, the first anesthetic drug in 30 years, has settled on a general hospital prescription. According to related industries, Hana Pharmaceutical's Byfavo passed the Drug Commission (DC) of Big 5 General Hospitals, including Seoul National University Hospital, Asan Medical Center, and Sinchon Severance Hospital. Byfavo is a new anesthetic drug released more than 30 years after the approval of the frequency prescription general anesthetic Propofol. Byfavo, which was launched in March, secured manufacturing rights and exclusive sales rights from Germany's Paion in 2013. Since 2018, phase 3 clinical trials have been completed for 198 subjects who perform general anesthesia in Korea. The main indication is inducing and maintaining general anesthesia in adults. Byfavo is a pure anesthetic new drug that has no analgesic effect, and has pharmacological and pharmacological advantages of existing general anesthetics such as Propofol and Midazolam. Hana is under construction with German freeze-drying facilities through its new Hagi plant, which is expected to operate in 2023, and designed to supply Byfavo to advanced markets. In addition, it acquired additional copyrights to Byfavo in six Southeast Asian countries from the original developer Paion in Germany, and completed all internal work to receive permission documents in these countries
- Policy
- Lipiodol’s price reduced from 25th... 2-year suit dismissed
- by Kim, Jung-Ju Sep 26, 2022 06:07am
- The price of Guerbet Korea’s liver cancer contrast medium, Lipiodol Ultra-Fluid (iodized oil, 12.8g/10mL), which had been under legal dispute for the past 2 years after the government decided to remove the drug from the reimbursement list, will be reduced from the 25th this month. This is because the pricing discount that had been originally made by the government was reapplied upon the court’s dismissal of the lawsuit and the automatic termination of suspension of execution that followed. On the 19th, the Seoul High Court’s Administrative Court Department 6-1 decided to dismiss the administrative lawsuit filed by Guerbet Korea and notified the company and the MOHW of the termination of the suspension of execution. Accordingly, the MOHW announced that it would reduce the drug price as of the 25th as it had decided in 2020. Earlier in July 2020, the MOHW decided to lower the price of Lipiodol through ex officio adjustment upon the listing of its generic, Dongkook Pharmaceutical’s Fattiodol. Under the government’s pricing formula, the upper limit of the first product can be lowered by the government through ex officio adjustments when a generic with the same route of administration, ingredient, and formulation as the original listed. Guerbet Korea immediately filed a suit against the government, and the dispute continued until recently. The Seoul High Court’s Administrative Court Department 7 had previously decided to extend the suspension of execution that had been ordered by Administrative Court Department 12 so that the company could keep its original price. The suit was then passed on to Department 6-1, where it was dismissed. The scope of its reimbursement had also expanded in the long course of the continued litigations. As of July 6th, Lipiodol is reimbursed for lymphography, hysterosalpingography, and transarterial chemoembolization (TACE) in liver cancer. However, the price cut that will be made this time is irrelevant to the reimbursement extension, and the final price of KRW 133,000 will be applied per ample as it was originally reduced in July 2020.
- Company
- Half of pts with macular degeneration have ↓ effect
- by Sep 26, 2022 06:07am
- Researchers expect the new VEGF inhibitor Beovu to address unmet demand. Patients with neovascular age-related macular degeneration in Korea had more than half of retinal exudates at the time of one year of treatment, indicating that the vision improvement effect was not significant. It was found in PROOF, which evaluated the retinal exudate regulation effect of the first year of existing VEGF inhibitor treatment in age-related macular degeneration patients. The results of the PROOF study, in which 12 domestic ophthalmic medical staff, including Kim Jae-hwi, a specialist at Kim's eye clinc, participated as the author, were published in the Scientific Reports on August 19. According to the study, more than half of the age-related macular degeneration patients in Korea treated with existing VEGF inhibitors such as Lucentis and Eylea remained retinal exudates until the first year of treatment, and their vision improvement effects were relatively poor. The PROOF study is a retrospective study based on the medical records of 600 age-related macular degeneration patients who visited ophthalmology hospitals in Korea from January 2017 to March 2019. The primary evaluation index is the proportion of patients with retinal exudations such as intra-retinal fluid/retinal subcutaneous fluid in the first year of treatment. In the early stages of treatment, 97.2% of patients had retinal exudate, and the rate after one year was 58.1%. The intra-retinal fluid, sub-retinal fluid, and retinal pigment epithelial fluid remained in 24.7%, 37.6%, and 21.2%, respectively. The proportion of patients with retinal exudate in the second year (24 months) of treatment reached 66.0%. In the first year of treatment, patients who did not have retinal effusions adjusted showed better eyesight improvement compared to those who did not. Patients with continuous retinal exudation control for a long period of time until the first year of treatment also showed better vision improvement effects. Whether retinal exudates remain is a major factor affecting vision improvement. Retinal exudates are frequently observed through optical tomography in age-related macular degeneration patients. Some studies have shown that if a new retinal exudate occurs during treatment, vision is likely to decrease by more than five characters. Retinal exudation is considered a sign of disease activity and requires additional VEGF inhibitor treatment. The researchers explained, "In actual clinical sites, there is a burden of treatment of existing VEGF inhibitors due to problems such as frequent administration and frequent hospital visits, and patients are not seeing the optimal treatment effect from a long-term perspective." Accordingly, it is expected that new anti-VEGF treatment therapy will be expected to help solve the unmet demand by reducing the burden of treatment with a prolonged mechanism of action. The researchers mentioned Beovu as a new anti-VEGF treatment. Brolusizumab is an antibody fragment drug that inhibits all VEGF-A isomorphic proteins. In phase 3 clinical trials, the Blucizumab 6mg dose group showed better disease control effects, including superior retinal exudation control effects compared to the Aflibercept 2mg group. After administration of loading dose, the Aflibercept group was administered every 8 weeks, while more than 50% of the Brolucizumab group was administered every 12 weeks. Kang Se-woong, an ophthalmologist at Samsung Medical Center at Sungkyunkwan University, said, "The emergence of anti-VEGF treatments has lowered the rate of blind or vision-damaged patients, but there is still an unmet demand for retinal exudation." He said, "We welcome the introduction of new and diverse treatment options to clinical sites and hope that this will help address unmet demand and ultimately prevent patients from impaired vision."
- Policy
- HCV treatment Epclusa·Vosevi start pricing negotiations
- by Lee, Tak-Sun Sep 23, 2022 05:52am
- The National Health Insurance Service is known to be conducting pricing negotiations with Gilead Science Korea for the company’s new Hepatitis C treatments, ‘Vosevi (sofosbuvir/velpatasvir/voxilaprevir)’ and ‘Epclusa (sofosbuvir/velpatasvir).’ The two drugs received conditional approval from the Drug Reimbursement Evaluation Committee in July this year. According to industry sources on the 22nd, the NHIS disclosed the negotiation status above while updating the list of new drugs subject to drug pricing negotiations on the NHIS webpage. Epclusa is a new drug that was approved in February, and Vosevi in March by the Ministry of Food and Safety. Gilead, which used to dominate the Hepatitis C treatment market with ‘Sovaldi,’ had been pushed down to second place due to Abbive’s ‘Mavyret.’ In an attempt to take back its throne, Gilead has released two new drugs – Epclusa and Vosevi. Like Mavyret, Epclusa can be used in all HCV genotypes 1 to 6, this is why Gilead believes that it has a winning shot against Abbvie. Gilead is planning to fuel its drive by adding another product, Vosevi, which contains an additional ingredient. Based on IQVIA, Mavyret recorded KRW 46.6 billion in sales last year. On the other hand, Gilead’s Sovaldi made KRW 0.2 billion, and Harvoni KRW 11.7 billion. Ironically, as HCV treatments have a high cure rate if the treatments are taken within the recommended treatment period, the sales performance of these drugs tends to decline over time. Therefore, pharmaceutical companies need to attract new patients to raise sales. Currently, the new influx of patients is concentrated around Mavyret due to its low price and its broad use in all genotypes. Mavyret’s insurance ceiling price is KRW 65,014 per tablet. Compared with the KRW 126,186 of Sovalidi and KRW 130,011 of Harvoni, this is around twice the difference. Therefore, if Gilead attempts to turn around the market, the industry sees that the company would need to set the price of Epclusa and Vosevi at the same level as Mavyret. When DREC announced the results of its deliberation in June, it said it would recognize the appropriateness of the drugs’ reimbursement if the two drugs will accept a lower price than the evaluated price. As the drugs have passed the reimbursement adequacy review by the Health Insurance Review and Assessment Service and are in pricing negotiations with the NHIS, Gilead would have had to accept a price lower than DREC’s evaluated price. Although DREC’s evaluated price was not disclosed, if Mavyret was used as the alternative drug in evaluations, Epclusa and Vosevi may likely be listed at a lower price than expected.
- Company
- Nubeqa can be prescribed at general hospitals
- by Eo, Yun-Ho Sep 23, 2022 05:52am
- Nubeqa, a prostate cancer treatment, can be prescribed at general hospitals. According to related industries, Bayer Korea's oral androgen receptor inhibitor (ARi) Nubeqa for nmCRPC treatment passed the DC of medical institutions such as Samsung Medical Center, Seoul National University Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital. Nubeqa has not yet been covered by insurance benefits, so it is expected to take time to lead to actual prescription activation. The drug has not been registered since the HIRA Cancer Disease Review Committee ruled it failed in February 2021. Nubeqa is an androgen receptor inhibitor with a unique chemical structure that binds to androgen receptors to inhibit the growth of prostate pressure cells through strong antagonism. It was approved based on ARAMIS, a phase 3 clinical study that compared and evaluated the efficacy and safety of Nubeqa and placebo controls in combination with ADT. The main evaluation item of the study, MFS, was 40.4 months in the Nubeqa and ADT combinations, demonstrating significant improvement over 18.4 months in the placebo and ADT combinations. It was confirmed that the risk of death decreased by 31%. In addition, the Overall Survival data derived from the final analysis results pre-specified in a recent ARAMIS study was published in the New England of Medicine (NEJM) on the 9th. As a result of the study, the combined survival period of the Nubeqa and ADT groups was statistically significantly improved compared to the combined placebo and ADT groups, and the risk of death decreased by 31%. This result is significant in that as of November 15, 2019, when data for final analysis was confirmed, 55% of patients in combination placebo and ADT received treatment for Nubeqa or other life extension as follow-up treatment.
