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- 2026-04-12 22:51:50
- Policy
- Phase 3 of SK Biopharm's Cenobamate is approved
- by Lee, Hye-Kyung Feb 24, 2022 05:58am
- Clinical trials have been approved at six hospitals, including Seoul National University, for children with partial epilepsy attacks. SK Biopharm will enter phase 3 of clinical trials for pediatric test takers of Xcopri (Cenobamate), a treatment for epilepsy. On the 23rd, the MFDS approved a phase 3 clinical trial plan for Cenobamate (YKP3089) for pediatric testing patients with partial expression attacks submitted by SK Biopharm. This clinical trial will be conducted at six locations, including Yonsei Severance Hospital, Chungbuk National University Hospital, Korea University Guro Hospital, SNU Boramae medical center, Ajou University Hospital, and Seoul National University Hospital. Cenobamate is SK Biopharmate's new drug released in the U.S. in May 2020 after being approved by the U.S. Food and Drug Administration (FDA) in November 2019 for epilepsy partial seizures. Phase 3 clinical trials in the U.S. for adults aged 18 or older with systemic seizure symptoms began in September 2018, and clinical trials in China, Japan, and Korea for adults aged 18 or older were preparing to launch in the U.S., Europe and other Asian regions as patient registration began in March last year. It is known that the registration of phase 3 clinical trials in the United States has recently begun for children and adolescents aged 2 to 17 with partial epilepsy attacks, and Korea will enter phase 3 clinical trials at the same time. SK Biopharm announced on February 8 that its operating profit last year turned into a surplus year-on-year at 95.3 billion won. It recorded a surplus for the first time in five years due to the influx of new drug technology fees, and Cenobamate played a significant role. When Cenobamate transferred its technology to Angelini Pharma (formerly Arvelle Therapeutics), it received $123.22 million worth of technology fees last year. In addition, Cenobamate, which has been released in the U.S. since last year, has generated 78.2 billion won in sales, reflecting its operating profit as it is.
- Company
- Yuhan’s ‘Leclaza’ makes ₩4.1 billion in 6 months
- by Chon, Seung-Hyun Feb 24, 2022 05:58am
- Yuhan Corporation's new drug ‘Leclaza’ has made ₩4.1 billion in its first year of release. In only 6 months since its sales began in earnest with reimbursement listing in July, Leclaza rose to the top among homegrown anticancer drugs, raising expectations on its potential for commercial success. According to the pharmaceutical research institution IQVIA on the 22nd, Leclaza recorded ₩4.1 billion in sales last year. After raising ₩1.5 billion in Q3, sales rose to ₩2.6 billion in Q4. Leclaza is the 31st homegrown new drug that was approved for the treatment of non-small cell lung cancer in January last year. It is indicated for patients with locally advanced or metastatic non-small cell cancer who have developed resistance to the T790 mutation after using 1st or 2nd generation EGFR TKIs. Before ‘Leclaza,’ the treatment options available for prescription in Korea were first-generation EGFR-TKIs ‘Iressa (gefitinib)’ and ‘Tarceva(erlotinib),’ and second-generation EGFR-TKIs ‘Giotrif (afatinib) and ‘Vizimpro (dacomitinib),’ and third-generation EGFR-TKI ‘Tagrisso (Osimertinib).’ Yuhan Corp made its debut in the market in July last year after being listed for reimbursement. The drug received the reimbursement approval only 165 days since its authorization using the ‘approval-benefit appraisal linkage system.’ The drug was approved its reasonableness of receiving medical care benefits was recognized in the cost-effectiveness aspect, as the drug ‘is therapeutically equivalent to Tagrisso (osimertinib) while being cheaper. Leclaza’s sales exceeded expectations, making ₩4.1 billion in the first 6 months. In general, anticancer drugs used in large hospitals may only be prescribed after passing reviews of drug committees in each hospital, therefore it takes a considerable amount of time for such drugs to generate sales after their release. Leclaza rose to the ranks and took the lead among domestically developed anticancer drugs as the most sold product during the past 6 months. Other homegrown anticancer drugs approved before Leclaza in Korea include Supect, Dongwha Pharm’s Milican, Chong Kun Dang’s Camtobell, Sam Sung Pharmaceutical’s Riavax, Hanmi Pharmaceutical’s Olita. Among the drugs, Supect’s sales recorded ₩7.4 billion last year, but its sales in the second half of the year were ₩4.1 billion, similar to Leclaza. Supect is the 18th homegrown novel drug that was approved in January 2012 for the treatment of chronic myeloid leukemia. Camtobell’s only made ₩3.8 billion last year, and other products have been revoked their licenses or withdrawn from the market. Therefore, Leclaza is the first to demonstrate the possibility of commercialization among homegrown anticancer drugs. Leclaza had started being prescribed at a rapid pace after landing in large hospitals with reimbursement. Leclaza can be prescribed in the ‘Big 4’ tertiary hospitals in Korea - the Seoul National University Hospital, Sinchon Severance Hospital, Samsung Seoul Medical Center, and the Seoul Asan Medical Center - and 30 other medical institutions including the National Cancer Center, Seoul National University Bundang Hospital, Seoul St. Mary's Hospital, Chonnam National University Hwasun Hospital, Kyungpook National University Chilgok Hospital, and the Pusan National University Hospital. In Yuhan Corp’s IR data that was recently released, the company presented its mid-to-long-term goal of “rising to the ranks in the global market by becoming the first homegrown new drug to earn over $1 billion (₩1.2 trillion) in annual sales with Leclaza.”
- Policy
- Generic for Revlimid was listed as the lowest price
- by Lee, Tak-Sun Feb 24, 2022 05:58am
- Boryung Pharmaceutical is launching a generic drug called Revlimid (Renalidomide) for multiple myeloma treatment after four years of approval. With three general companies targeting the market since 2018, Boryung has thrown a winning move at the lowest price. According to the contents of the "Partial revision of the drug benefit list and upper limit table" released by the MOHW on the 21st, four capacities of Boryung Pharmaceutical's generic for Revlimid will be listed from March 1. It has been about four years since it was first approved in June 2018 with 25 mg. Generic for Revlimid has been on the market since January 2018. Currently, Chong Kun Dang's Lenaloma, Kwang Dong Pharmaceutical's Lenaldo, and Samyang Holdings' Lenalid are competing with the original drug Revlimid of Celgene. Generic drugs have yet to exert much power in the market. Quarterly sales of original products are around 8 billion won, but generic drugs alone maintain around 1 billion won. According to IQVIA in the second quarter of last year, Celgene's Revlimid recorded 8.8 billion won, Chong Kun Dang's Lenaloma recorded 1 billion won, Kwang Dong's Lenaldo 75.42 million won, and Samyang's Lenalid recorded 143.41 million won. Generic drugs are showing price competitiveness as a weapon against their original status, but it is not easy. Comparing the upper limit based on the 10mg formulation, Samyang's Lenalid costs 51,472 won, Chong Kun Dang's Lenaloma costs 71,874 won, Celgene's Revlimid costs 84,975 won, and Kwang Dong's Lenaldo costs 86,000 won. Compared to the original, Samyang's Lenalid is 20,000 won cheaper, and Chong Kun Dang's Lenaloma is 10,000 won cheaper. Boryung also chose the lowest price. Leblikin10mg is 51,471 won, 1 won cheaper than the current lowest price, Lenalid in Samyang. In particular, it is expected that it will be able to show competitiveness because it is 20,000 won to 30,000 won cheaper than existing products among capsule formulations. Boryung is preparing a variety of new products with generic for Revlimid to target the market for treating multiple myeloma. It is on the verge of developing the first generic of the latest version of Celgene's Pomalyst following Revlimid, and plans to introduce a new drug called Aplidin (Plitidepsin), Aplidin signed a contract with Spanish pharmaceutical company PharmaMar in 2016 to secure domestic copyright. Only Janssen's generic for Velcade(Bortezomib) Velkin was sold. Attention is focusing on whether Boryung will show the power of domestic pharmaceutical companies in the anticancer drug market with the lowest price strategy put forward along with various product lines.
- Policy
- Combination indication for Entresto has changed
- by Lee, Hye-Kyung Feb 24, 2022 05:58am
- The range of patients who can use Entresto (Sacubitril/Valsartan), a treatment for chronic heart failure of Novartis Korea, has become a little clearer. Until now, there has been a debate over the normal range of left ventricular ejection rates, with "chronic heart failure patients with decreased left ventricular contraction function." On February 14, the MFDS changed the effectiveness of Enresto, a heart failure treatment of Sacubitril/Valsartan drugs, and Xnepri by Sandoz. The efficacy at the time of Enresto approval in 2016 were ▲ chronic heart failure: decreased risk of death due to cardiovascular disease and hospitalization due to heart failure in patients with left ventricular contractile function (NYHA class II-IV), and ▲ angiotensin receptor antagonists (ARB) or angiotensin conversion enzymes (ACE) instead of other treatments. In combination therapy, patients with chronic heart failure were specifically specified, and patients with chronic heart failure with reduced left ventricular contraction function were specified as patients with chronic heart failure with a left ventricular ejection rate of 40% or less. The reason for this change was confirmed through the minutes of the central summary released by the MFDS. At the meeting, opinions on 40% and 60% were divided over the range of left ventricular ejection rates. As the left ventricular ejection rate showed consistent effects in the lower 60% group, there were opinions that the left ventricular ejection rate should be clearly described as 60%, and that the existing ejection rate could limit use in clinical sites or make it difficult to determine treatment targets. Some suggested that efforts and procedures to expand the standards for medical care benefits should be carried out together after changing efficacy and effectiveness. In response, the MFDS said, "Among the unauthorized matters, the phrase that this drug is administered in combination with other heart failure treatments instead of ARB or ACE inhibitors was established based on clinical trials and was suitable for existing treatment guidelines." The MFDS suggested, "The domestic guidelines for heart failure have not been changed at the moment, but considering that there is no standard therapy for patients with a 40% or more ejection rate, the phrase should be described only for patients with reduced ejection rate." The committee members generally agreed to the MFDS' change (proposal) saying that the definition of the left ventricular ejection rate is not accurately divided into figures, and finally decided to change the efficacy and effect. Meanwhile, according to UBIST, Enresto's outpatient prescription amount last year was 32.3 billion won, up 37.3% from 23.5 billion won last year.
- Company
- It was improved by changing the targeted therapy formulation
- by Eo, Yun-Ho Feb 23, 2022 05:50am
- According to related industries, Pfizer Korea's breast cancer treatment Ibrance(Palbociclib) has obtained an item license in a type of tablet not a capsule, six years after its launch in Korea. Also, Takeda is also preparing to introduce a tablet formulation of "Zejula (Niraparib toosylate monohydrate)," a treatment for ovarian cancer. It's easy to use both "Ibrance tablet" and PPI Ibrance is the first targeted anticancer drug developed among CDK4/6 inhibitors to be used as a standard treatment along with endocrine therapy in the treatment of patients with progressive or metastatic hormone receptor-positive breast cancer. In postmenopausal women, it is used in combination with "Aromatase inhibitors" for primary treatment and with Fulvestrant for secondary treatment, lowering the risk of disease progression and death in stage 4 breast cancer patients and prolonging survival. Pfizer changed the existing Ibrance capsule formulation to tablets and improved the patient's administration convenience. Ibrance tablet contains biologically the same active ingredient as conventional capsules, but can be taken regardless of food. By coating the tablet with a film, it can also be administered with a Proton Pump Inhibitor or antacids used to control gastrointestinal disorders and diarrhea, which are treatment side effects that usually appear in cancer patients. Zejula, minimize the number of pills pt takes Zejula is a PARP inhibitor and targets the BRCA gene. Lynparza of AstraZeneca Korea, a drug of the same family, has already been released in Korea. The conversion of PARP inhibitors to tablet formulations has the advantage of minimizing the number of pills. This drug has a variety of indications, including monotherapy in adult patients (including ovarian cancer or primary peritoneal cancer) who responded to ▲1st and 2nd platinum-based chemotherapy, and ▲3rd or higher chemotherapy, that is, quaternary monotherapy. Among them, benefits for primary and secondary maintenance therapy are recognized, and benefits are not applied to BRCA-negative patients. The new formulation requires a separate benefit registration procedure. Even if the indications may be different and the same indication is the same, the validity of the changed formulation should be confirmed. It remains to be seen whether anticancer drugs with new formulations will be able to quickly convert prescriptions.
- Policy
- Competition in full swing for the ₩100 bil Humira mkt
- by Lee, Tak-Sun Feb 23, 2022 05:50am
- Competition in the domestic Humira biosimilar market is expected to unfold with Celltrion's entry into the market. On how the market that was once dominated by its only biosimilar option, Samsung Bioepis’ Adalloce, will change with the entry of Celltrion in the market, remains the focus of attention. Humira, which is mainly used to treat rheumatoid arthritis, has formed a market worth ₩100 billion in Korea. Celltrion’s Humira (Abbvie, adalimumab) biosimilar ‘Yuflyma pen injection 40mg/0.4mL)’ will be reimbursed from March 1st. Its insurance price cap was set at ₩244,877, identical to Samsung Bioepis’s ‘Adalloce.’ As the price ceiling for the original drug, Abbvie’s ‘Humira,’ was set at ₩288,091, the price difference between the three products is not large. Humira recorded $20.69 billion (₩24 .8 trillion) in global sales in 2021 and has maintained the lead in pharmaceutical sales for 10 consecutive years since 2012. According to IQVIA, the drug also boasted much use in Korea, recording ₩91.2 billion in sales in 2021. This is a drop from the ₩104 billion sold in 2020, but the decrease was inevitable as Humira’s price cap was reduced by 30% with the approval of Adalloce. Humira is a monoclonal antibody drug that is used to treat various conditions. In addition to rheumatoid arthritis, Humira is indicated for the treatment of psoriasis arthritis, axial spondyloarthritis, adult and pediatric Crohn's disease, psoriasis, ulcerative colitis, Behcet’s disease, hidradenitis suppurativa, uveitis, pediatric idiopathic arthritis, and pediatric plaque psoriasis. With the rapid entry of Humira biosimilars, the industry expects Humira to encounter a crisis within the next two years. In particular, K-biosimilars are emerging as a vanguard that may break down the stronghold held by Humira. Samsung Bioepis launched a Humira biosimilar in the European market in 2018 and has been competing for the first and second place in the biosimilar market ever since. Celltrion is also busy tackling the European market based on the approval it received last year. In 2023, K-biosimilars’ entry into the Humira market is expected to increase further with Humira’s patent expiry in 2023. Pic of Humira and Adalloce In Korea, Samsung Bioepis received reimbursement approval for its ‘Adalloce’ in April last year and released the product. Yuhan Corp, which has a large distribution network, is in charge of its marketing and sales of Adalloce. With the introduction of Adalloce, Humira’s drug price had also been discounted 30%, and therefore may not be able to guarantee its annual sales of ₩100 billion this year. In the meantime, competition between AbbVie, which wishes to maintain its market share, and the biosimilar companies Samsung Bioepis and Celltrion is expected to further accelerate with the reimbursement approval granted for Celltrion. Due to the conservative characteristic of the Korean market, generics or biosimilars generally have difficulty penetrating the Korean market. In particular, latecomers of injections that are administered in general hospitals like Humira have more difficulty entering the market. However, as Celltrion’s Remicade biosimilar ‘Remsima’ successfully penetrated the market and earned ₩20 billion in Korea, attention is focused on whether Humira’s biosimilar may also perform this ‘K-magic.’
- Company
- Lilly-RosVivo signed a contract to transfer diabetes txs
- by Eo, Yun-Ho Feb 23, 2022 05:49am
- Nexturn Bio announced on the 22nd that its U.S. subsidiary RosVivo Therapheutics has signed a "MTA (Material Transfer Agreement)" with Eli Lilly for commercial development of a new drug candidate for diabetes treatment, "RSVI-301. MTA is a contract concluded by the counterparty to verify the efficacy and research results of the drug through experiments. Lilly will review and acknowledge animal experiment data and reaffirm the excellence of RSVI-301 through this MTA. RosVivo's RSVI-301 is a new drug candidate that can fundamentally treat diabetes by restoring the function of beta cells that secrete insulin, the cause of diabetes, and lowering insulin resistance. In the last RSVI-301 diabetes-causing animal test, it was found to be effective in treating obesity, fatty liver, and gastrointestinal disorders. An official from RosVivo said, "The signing of an MTA with Eli Lilly, a global diabetes treatment company, proves the possibility of new drug candidates," adding, "Love calls from various global pharmaceutical companies continue."
- Policy
- Jae-Myung Lee pledges to enact Special Bio Act
- by Lee, Jeong-Hwan Feb 23, 2022 05:49am
- Presidential candidate Jae-Myung Lee of the Democratic Party of Korea announced that he will prepare an appropriate compensation system for domestically developed drugs and new drugs that conduct clinical trials in Korea and enact a ‘Special Act on the Development of the Biohealth Industry’ to foster and develop the Korean bio-health industry into a global leader. Lee also expressed his ambition to establish a public-private matching-fund type megafund to drive the transformation of Korea's bio-health industry. In addition, Lee pledged more specific healthcare policies such as the legislation of public late-night pharmacies, the establishment of a state-led public e-prescription system, voluntary reporting, empowering judicial police power to the NHIS to eradicate illegal establishment of hospitals and pharmacies owned by non-medical personnel, reevaluation of insurance reimbursement for off-patent drugs, and the preapproval of ultra-high priced drugs. These pledges are contained in Lee's policy manifesto that was disclosed by the Democratic Party of Korea for the 20th presidential election on the 22nd. ◆Pharmacuetical and bio-industry pledges = Candidate Jae-Myung Lee had accepted many of the policies proposed by Korea's pharmaceutical and bio-industry, as represented by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association. Although the new establishment of a control tower for new drugs under the immediate control of the president that was proposed by KPBMA and KRPIA was not included in the pledge, Lee promised to enact a ‘Special Act on the Development of the Biohealth Industry’ to foster the Korean bio-health industry into a global leader and to introduce a Deputy Prime Minister System for science and technology innovation. Lee’s vision is focused on reinforcing national competitivity for responding to infectious diseases and on driving Korea’s growth to become a leader in the bio-health industry. Therefore, Lee will promote bio-health policies under a pan-ministry unified system and enact a special law for the bio-health industry, and form a private-led bio-health industry supercluster. The system will help Korea secure the basis for developing the original technology necessary for domestic vaccines and treatments used for new infectious diseases and reinforce the country’s manufacturing capabilities to become a global vaccine hub. Also, Lee plans to prepare measures to expand self-sufficiency in the manufacture of materials, parts, and equipment required for vaccine manufacturing as well as APIs and key parts of medical devices. In addition, Lee will establish a public-private joint mega-fund and expand it to support the development of Phase III trials for blockbuster drugs, expand R&D tax support, develop innovative new drugs, and provide incentives to GMP-certified pharmaceutical companies of advanced countries. For the transformation of the pharmaceutical industry, the subject and criteria for government support will be clarified, and its practicality will be improved through all-cycle integrated support. Also, the pledge includes an appropriate reform of the compensation system for domestically developed and trial conducted new drugs. Also, the pledge includes measures to improve patient access to new drugs such as orphan drugs and high-priced anticancer drugs and raise a patient support fund whose cost will be shared with pharmaceutical companies to fulfill social responsibility. Also, measures to provide stable support of essential medicines that are difficult to supply through a public production system by utilizing government investment facilities and idle private facilities. Also, the candidate plans to secure fiscal sustainability of NHI finances by conducting reevaluations on insurance reimbursements of off-patent drugs, introduce a preapproval system for ultra-high priced drugs through the prescription preapproval system, and prepare a safe and rational medicine use management system. ◆Healthcare pledges= Lee also pledged to establish a policy that grants judicial police power to the NHIS and eradicate the illegal establishment of hospitals and pharmacies owned by non-medical personnel. Also, by reinforcing incentives for voluntary reporting and immunity for whistleblowers, Lee plans to support internal self-purification efforts within the medical community by strengthening criminal penalties for those establishing illegal establishment, realigning basic regulations for the restitution of unfair profit, promoting succession of dispositions such as closure orders and confiscation of non-reimbursed medical expenses. Also, policies to secure vaccine sovereignty and healthcare security through domestic vaccine development and public manufacture of essential medicines will be implemented. For self-sufficiency in the supply of vaccines used in the National Immunization Program, Lee will focus investment on R&D and actively foster expert personnel. Lastly, policies to expand public healthcare such as the assignment of primary care physicians extended NHI reimbursement to dental implants, hair loss treatment, and severe atopic dermatitis in children and adolescents, the establishment of public hospitals and university hospitals, as well as the introduction of local doctors and nurse system that Lee had continuously emphasized, were also included in the pledge.
- Opinion
- [Reporter's view]Will it be different this time?
- by Kim, Jin-Gu Feb 23, 2022 05:49am
- Earlier this month, the government announced "Comprehensive Measures for Stable Supply of National Essential Drugs." In the wake of the COVID-19 crisis, the importance of stockpiling and supplying essential medicines has increased, and the government has stepped up. National essential drugs refer to drugs that are essential for health care, but are difficult to supply stably only with market functions. It will be designated by the MOHW and the MFDS through consultation. Currently, 511 items are designated as national essential medicines. The government announced a comprehensive measure of the same name in 2016. At that time, instead of COVID-19, MERS served as a catalyst for establishing countermeasures. Even then, the government said that a stable supply of national essential medicines is important to cope with the public health crisis. After the announcement of comprehensive measures in 2016, did the stockpiling and supply of national essential drugs improve? The prevailing assessment is that this is not the case. Rather, the suspension of supply of essential national drugs is expanding every year. After the establishment of comprehensive measures, the "Lipiodol incident" occurred in 2018. The reason for repeated supply interruptions is simple. This is because pharmaceutical companies no longer supply them. Currently, the government is compensating pharmaceutical companies that produce and import national essential drugs at the "cost" level. However, the pharmaceutical industry argues that this alone is not enough. Who will step up for the public interest in a structure in which the more they produce, the more damage they incur. The government seems to be fully aware of this reality. In fact, the measures announced in 2016 included contents such as "support for the supply of essential medicines for stockpiling" and "establishment of support measures when the supply is suspended." However, adequate support has not been provided, and the national essential medicine system has been lax and has reached this day. Similar information is included in the measures announced this time. The government said it will support production costs for drugs that have been suspended due to poor profitability. In addition, the government said it would purchase all of its production in the case of rare disease treatments that have less domestic demand than the minimum production. The pharmaceutical industry's response is not positive. It has not yet been decided how much production costs will be supported, but the pharmaceutical industry believes that the scope of support is limited to "production costs," which will be far from appealing to companies. Appropriate compensation is an essential solution for a stable supply of national essential drugs. If a company is judged to make any physiological profits, it will jump into the production of national essential medicines even if the government stops them. You cannot forever appeal to the pharmaceutical industry only for the "public interest." We hope that the details of this measure will include reasonable and appropriate compensation.
- Policy
- Galvus generics to be reimbursed despite exclusivity period
- by Lee, Tak-Sun Feb 22, 2022 05:55am
- Ahn-gook Pharmaceutical’s that was released 55 days before other generics with generic exclusivity approved by partially invalidating Galvus’s substance patent. Generic versions of the anti-diabetic DPP-4 inhibitor ‘Galvus (vildagliptin)’ will be released on the 5th of next month in the marketing exclusivity period that is approved for first generics. This is due to the substance patent period of Galvus that will expire the day before. Therefore, Ahn-gook Pharmaceuticals’ marketing exclusivity will also expire in 2 months. According to industry sources on the 21st, 7 products from 7 companies including Genuone Sciences 'Vildaport tablet 50mg (vildagliptin)’ are preparing to release their products on the 5th of next month. These are all single-agent drugs containing the main active ingredient vildagliptin. Currently, the single-agent drugs listed for reimbursement with the main API as vildagliptin are Novartis Korea’s ‘Galvus tab. 50mg,' and Ahn-gook Pharmaceutical and Ahn-gook New Pahrm’s ‘Avus tab. 50mg,’ and ‘Vildatin tab. 50mg.’ Although other follow-ons containing vildagliptin as an active ingredient were introduced on January 9th, only 2 products, from Ahn-gook Pharmaceutical and its subsidiary Ahn-gook New Pharm, contain vildagliptin as the main active ingredient. All the others contain salt-modified products. Hanmi Pharmaceutical's ‘Vildagle 50mg’ contains ‘vildagliptin hydrochloride,’ and ‘Vilda tab.’ contains ‘vildagliptin nitrate.’ Ahn-gook Pharmaceutical and Hanmi Pharmaceutical invalidated 55 days of the extended patent term of Galvus’s substance patent and was allowed to release their drugs with reimbursement on the 9th of this month. However, other products with the same main active ingredient (vildagliptin) as the original Galvus and Ahn-gook Pharmaceutical’s ‘Avus tab’ were unable to be released despite the 55-day shortened term of Galvus's extended patent. The reason was due to Ahn-gook Pharmaceutical’s ‘first generic exclusivity.’ Ahn-gook, which had succeeded in invalidating part of the patent term, was the first to apply for the marketing approval of its drug among latecomers and to receive approval, therefore becoming the only company to receive generic exclusivity. Ahn-gook Pharmaceutical’s subsidiary Ahn-gook New Pharm’s ‘Vildatin tab’ also received generic exclusivity after satisfying the same conditions. The marketing exclusivity period was set from January 9th, the day when Ahn-gook Pharmaceutical launched its product, to May 29th. In the same period, drugs with the identical ingredient and formulation as Ahn-gook Pharmaceutical’s ‘Avus tab’ were banned from sale. Therefore, although the Supreme Court ruled in favor of Ahn-gook Pharmaceutical and the company succeeded in invalidating part of the extended patent term, no other single-agent drug containing the same main active ingredient (vildagliptin) was allowed for sale. However, with the patent period for Galvus expiring on March 4th, the effect of the sales ban provided by generic exclusivity will also expire accordingly. Under Article 50-10 (1)-2 of the Pharmaceutical Affairs Act, the effect of the exclusive marketing approval expires ‘the day a registered patent is rendered ineffective due to finalizations of a trial ruling or ruling that the registered patent is invalid.’ However, this excludes the petition for a trial or litigation filed by the person who has obtained exclusive marketing approval. This ‘but clause’ is what generic companies are basing their release with reimbursement on, on March 5th. An official from the company said, “Our drug will be listed for reimbursement on March 1st, and will be sold from the 5th upon patent expiry. Our CMO Genuone Sciences received confirmation from the Ministry of Food and Safety that we can release our drugs. First generic exclusivity usually stays effective for 6 months. However, this time, as the patent term expired only 55 days after the launch of its generics, only around 2 months were left for the company to exercise such rights. This is why the industry analyzed that the benefits reaped with Ahn-gook Pharmaceutical's victory in invalidating 55 days of Galvus’s patent was small.
