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- 2025-12-23 04:23:08
- Company
- Orion bids KRW 548.5 bil to enter the pharma industry
- by Kim, Jin-Gu Jan 17, 2024 05:29am
- The Orion Group has become the largest shareholder of LegoChem Biosciences, a prime new drug developer. With the acquisition of LegoChem, Orion is expected to jump into the pharmaceutical bio-industry in earnest, breaking away from its previous passive activities such as signing a memorandum of understandings, making indirect investments, and establishing joint ventures. According to industry sources on the 16th, Orion announced on the 15th that it will acquire 9.36 million and 3,283 shares of LegoChem Biosciences for KRW 54.85 billion. After the acquisition, Orion will possess a 25.73% stake in the company, making it the largest shareholder of LegoChem Biosciences. Orion will acquire 7,963,282 million new shares via a third-party allocated capital increase at an additional KRW 469.8 billion. It will also purchase 1.4 million existing stocks from Orion’s largest stakeholders, CEO Yong-Zu Kim (1.2 million shares) and President Se-jin Park (0.2 million shares). Orion’s subsidiary, Pan Orion Corp., which is located in Hong Kong, will take charge of the acquisition procedure. After Pan Orion, which is a holding company for 7 corporations finalizes the acquisition, a holding company for seven entities in China, completes the acquisition process, Orion will incorporate LegoChem Biosciences as its affiliate. Orion is expected to enter the pharma-bio industry in earnest with the acquisition of the new drug developer LegoChem Biosciences. Orion announced its entry into three new businesses in 2020 and pointed to the pharmaceutical bio industry as one of them. However, before the acquisition of LegoChem Biosciences. However, as the company had only shown activity in the diagnostics business and mainly focused on laying the foundation for overseas businesses before the acquisition, the industry’s evaluation was that the company had sought to indirectly enter the market through joint ventures, etc., taking a step back from making direct investments. In 2020, Orion signed an MOU with diagnostic kit maker Sugentech, and in 2021, it signed a license-out agreement with Genomictree for its early diagnosis technology for colorectal cancer. The same year, it formed a joint venture in China with Shandong Lukang Pharmaceutical. In 2022, the company signed a joint development agreement with Quratis to jointly develop a vaccine for tuberculosis. In December 2022, the company established Orion Biologics. Orion Biologics is a 6:4 joint venture between Orion Holdings, the group's holding company, and Hysense Bio, a dental disease treatment venture company. However still, Orion Biologics is considered to be focusing on supporting the company’s diagnostic and vaccine business in China rather than Korea’s pharma-bio industry. But with the acquisition of LegoChem Biosciences, Orion is seemingly making entry into the pharma-bio industry in earnest. The company seems to be focusing the group's pharmaceutical bio business capabilities on LegoChem Biosciences while maintaining the existing management and operating system for the rest of its businesses. The pharmaceutical industry is paying attention to the potential of LegoChem Biosciences that Orion seeks to acquire. LegoChem Biosciences specializes in the development of antibody-drug conjugates (ADCs), which have recently attracted great interest from global big pharmas. LegoChem Biosciences has signed more than 10 technology transfer agreements in the ADC field since 2015. Starting with the technology transfer to China's Fosun Pharma in 2015, the company has made 13 known technology transfers. Of these, 4 candidates have entered the clinical stage. In addition to the upfront payment, the company is expected to receive additional milestone payments upon achievement of commercial milestones. The most recent deal was signed in December last year. The company signed a technology export agreement with the multinational pharmaceutical company Janssen for its ADC drug candidate 'LCB84'. LCB84 is an ADC candidate drug that can target various solid tumors, including triple-negative breast cancer and non-small cell lung cancer. LegoChem Biosciences has a proprietary ConjuAll linker. An ADC consists of a linker, a payload (drug), and an antibody. The ConjuAll linker is believed to be able to overcome the release of cytotoxic drugs in the blood and attack normal cells. Based on this potential, the company has a market capitalization of more than KRW 1.5 trillion on the KOSDAQ market as of the closing price on the 15th. It ranks 28th in market capitalization on the KOSDAQ market. It ranks 7th among pharma-bio companies listed on KOSDAQ.
- Company
- KRPIA's new BOD is full of Korean members
- by Eo, Yun-Ho Jan 17, 2024 05:29am
- KRPIA has launched its new board of directors for the 2024 New Year. The Korean Research-based Pharmaceutical Industry Association (KRPIA) has recently announced its new board of directors (BOD). The new BOD stands out as it is primarily made up of Korean members. Among the 13 BOD members, which includes KRPIA chairman Dong-Wook Oh (CEO of Pfizer Korea), only two are foreign nationals, making up 85% of the board as Korean members. Because multinational pharmaceutical companies appointing Koreans as CEOs of their Korean branch instead of foreign nationals, it has likely led to the BOD members consisting primarily of Korean members. CEO of Astellas Pharma Korea, Junil Kim, CEO of Bayer Korea, JinA Lee, and CEO of MSD Korea, Albert Kim, are Koreans who were newly appointed last year. Of note, Albert Kim holds Canadian nationality. New foreign members of the BOD include Maurizio Borgatta, CEO of GSK Korea, and Christoph Hanman, CEO of Merck Korea. Meanwhile, KRPIA is facing substantial changes in the coming years. The association has recently appointed Choi In-Hwa, an executive at Roche Korea, to oversee the association's policy business following the retirement of Kim Min-Young (currently the Director of Market Access at Gilead Sciences Korea), who left the position in February of last year. This appointment fills the vacancy after a year. Additionally, the current chairman of the association is also nearing the end of the term. Chairman Oh Dong-Wook's term is set to expire this month (January), and it is expected that a new chairman will be appointed in February. Chairman Oh has been leading the association since his appointment as chairman in 2021.
- Company
- Whan In has exclusive distribution rights for Sanofi's Arava
- by Kim, Jin-Gu Jan 16, 2024 06:09am
- On the 10th, Whan In Pharm had signed an exclusive promotion & distribution agreement with Sanofi-Aventis Korea for Arava tablet in Korea. On the 10th, Whan In Pharm announced that the company signed an exclusive promotion and distribution agreement with Sanofi-Aventis for Arava Tablet, a rheumatoid arthritis treatment containing the active ingredient leflunomide, in Korea. Whan In Pharm is recognized for its business specialization in the central nervous system (CNS) field. Through this agreement, Whan In Pharm plans to expand its business focus into areas beyond the CNS. Arava Tablet is a drug for alleviating rheumatoid arthritis symptoms, active psoriatic arthritis symptoms, and others. The drug is steadily generating sales of around 6 billion won every year. “We are pleased to announce our first partnership in the non-CNS field with Sanofi,” Lee Wonbum, CEO of Whan In Pharm, stated. “We anticipate that our collaboration with Sanofi will drive mutual growth and enhance our market competitiveness in the rheumatology field. “We are thrilled to establish a strategic alliance with Whan In Pharm, a company with a proven track of success in the CNS field. Through this partnership, we anticipate that we will be able to steadily supply Arava, an important treatment for Rheumatoid Arthritis, to patients in need,” Suk Sang Kyu, Foundation Business Unit Head at Sanofi-Aventis Korea stated.
- Company
- Gov't will reduce fines for companies that adopt CPs
- by Kang, Shin-Kook Jan 16, 2024 06:08am
- A revised Fair Trade Act that grants benefits, such as reduced penalty surcharges to companies that have adopted and excellently operated a Fair Trade Compliance Program (CP), will be enforced on June 21st this year. On the 15th, the Fair Trade Commission announced that it would prepare sub-statutes, including the Enforcement Decree and Notification of the revised Fair Trade Act , to stipulate standards and procedures for the implementation of the system in February for the timely enforcement of the revised Fair Trade Act CP is an internal compliance system that companies establish and operate independently to comply with fair trade-related laws and regulations. The system, which includes training and supervision, was introduced proactively by the private sector in 2001. The FTC has been providing various benefits to companies that introduced and operated CPs to activate the CP system since its introduction, and has been operating a CP rating system since 2006 to grant differentiated benefits based on operational performance to induce the sound operation of the system. However, as the CP system is based on established rules rather than the law, the government had difficulty preparing incentives to actively induce and operate the CP. To address these issues, the FTC amended the Fair Trade Act in June last year to legislate the CP system, and CP operation rating system, and prepare a legal basis to provide support such as fine reductions or rewards to companies that have excellently operated their CP. Also, to promote the implementation of CP in companies, the FTC plans to minimize the burden on companies by reducing the cost of introducing and operating CP and making it easier and simpler to apply for rating evaluations, and providing more substantial benefits to excellent CP companies, such as reducing penalty surcharges, lowering the Korea Credit Guarantee Fund fee rate, and award premiums when assessing implementation of the fair trade agreement with franchisees and agents. An FTC official said, "We expect the number of companies introducing and operating CP to increase with the establishment of a legal basis for the CP system and support, such as penalty fine reductions. The number of companies that applied for CP rating evaluations had increased to 28 companies in 2023 when the legal basis for the CP system had been prepared. This is a 1.75-time increase from the 16 companies that applied in 2022.”
- Company
- Reimbursed drugs hit four-year low amid regulatory changes
- by Chon, Seung-Hyun Jan 16, 2024 06:08am
- The number of drugs on the health insurance reimbursement list has reached its lowest point in four and a half years. Due to pricing revisions for generic drugs and regulations related to joint development, the introduction of new drugs is significantly reduced. The number of approvals has decreased by more than 70% compared to the figures from four years ago. According to the Health Insurance Review and Assessment Service (HIRA) report on the 16th, the total number of drugs listed on the reimbursement listing as of January 1st was 22,889. This represents a decrease of 754 drugs compared to 23,643 drugs listed in January of the previous year. Furthermore, the number of reimbursed drugs has reached its smallest in four years and four months, compared to 22,912 drugs reimbursed in September 2019. The number of drugs listed for reimbursement peaked at 26,527 in October 2020 and has been steadily decreasing. Over the course of three years and three months, there has been a decrease of 3,638 drugs. In other words, 3,638 more drugs have been either withdrawn from or forced to exit the market compared to new drug entries into health insurance reimbursements in the past three years. The number of listed drugs for reimbursement was 20,689 in November 2018, and it increased to 26,527 in October 2020, increasing by 5838 in just a year and eleven months. Over this period, the volume of listed drugs for reimbursement expanded by 28.2%, demonstrating that new drug entries exceeded market exits. Out of the 22 months from November 2018 to October 2020, December 2019 witnessed a decrease in the number of listed drugs compared to the previous year. In other words, for the remaining 21 months, the scale of listed drugs was larger compared to previous months. In contrast, the number of listed drugs for reimbursement has consistently declined. While there was an increase of 497 more drugs listed over the two months from October to November 2023, this increase is a temporary phenomenon attributable to the opening of the generics market for diabetes drugs. During this period, as the patent for the diabetes treatment ‘sitagliptin’ expired, a significant number of generic products entered the reimbursement listing. Sitagliptin is an active ingredient in the DPP-4 inhibitor-class diabetes treatment ‘Januvia.’ The number of currently listed drugs reached its lowest point in 33 months, following a total of 25,694 in February 2020. The number of listed drugs for reimbursement has significantly decreased as a result of the revision to the drug pricing system. The decrease in the number of reimbursed drugs since 2020 was primarily initiated by the revised drug pricing system. The revised drug pricing system, implemented in July 2020, requires generic products to meet both bioequivalence testing and the use of registered raw materials to maintain a maximum reimbursement price of 53.55% compared to the current patent-expired original drugs. The revised drug pricing system includes a stepped pricing system, which involves a lower maximum reimbursement price for drugs that are newly listed for reimbursement. If there are twenty or more generic versions available for a specific active ingredient in the market, the maximum reimbursement price for newly listed items can be set at up to 85% of the previous lowest price. Because the drug pricing significantly decreases when a pharmaceutical company does not develop the drug itself or undergo bioequivalence testing, generics produced by Contract Manufacturing Organizations (CMOs) have seen a more substantial decline in approval. Recently, the number of approvals for prescription drugs has significantly declined. Last year, the number of approvals for prescription drugs was 1,046, showing a decrease of 6.4% compared to the previous year. Compared to 2021, which had 1,600 approvals, there was a 34.6% decrease in approvals over two years. Since 2019, when there were 4,195 approvals, the scale of approvals for prescription drugs has shrunk by 75.1% over four years. Compared to four years ago, the number of approvals for prescription drugs decreased by 3,149. The number of approvals for prescription drugs was 1,562 in 2018, averaging 130 approvals per month. In 2019, this figure increased to 4,195, more than doubling to an average of 350 approvals per month. By May 2019, the monthly approvals reached 584. However, starting in 2020, it gradually declined and returned to the previous year’s level. From October 2018 to July 2020, over 100 prescription drugs were approved each month. However, in August 2020, after 23 months, the number of approvals for prescription drugs dropped to less than 100 per month. Last year, there were only two months with over 100 approvals for prescription drugs. The regulatory barriers for approvals have also been raised. Starting in July 2021, with the implementation of the revised Pharmaceutical Affairs Act, the number of incrementally modified drugs (IMD) and generics that can be approved through a single clinical trial has been limited. This new regulation, known as the '1+3' rule, restricts the number of IMD and generics approved through a single clinical trial. When a pharmaceutical company conducts bioequivalence tests directly and manufactures the drug in the same facility using the same prescription and manufacturing method for all production processes, the utilization of bioequivalence data is restricted to three times. In other words, only four generics can be approved based on one set of bioequivalence tests. Clinical trial data is also limited to products from the pharmaceutical company that conducted the tests directly, in addition to three other products for which a clinical trial data agreement is possible. In the past, when a particular pharmaceutical company obtained approval for generics through bioequivalence testing, other pharmaceutical companies frequently used the same documentation for obtaining approvals for CMO generics. However, due to the regulation of joint development, the "unlimited copying phenomenon of generics" has become practically impossible. There are criticisms suggesting that the government may have played a role in the increase in generic drug approvals in 2019 and 2020. The government's measures at strengthening regulating generics may have resulted in this surge in generic approvals. In 2018, there was a ban on the sale of 175 pharmaceutical products containing the active ingredient valsartan, used to treat high blood pressure, due to excessive impurities. In response, the Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS) established the "Committee for Improving Generic Drugs Policies" to formulate measures to control the excessive production of generics. However, as pharmaceutical companies attempted to secure generic products in advance, there was a temporary surge in generic approvals. Following the government’s regulatory revision, the number of generic approvals returned to previous levels.
- Company
- 'Discussing Rinvoq based on Korean RWD'
- by Eo, Yun-Ho Jan 15, 2024 05:47am
- Professor Ahn Ji Young, affiliated with the Department of Dermatology at the National Medical Center The value of Real World Data (RWD) increases in areas where the development of new treatment options has been slow, primarily due to insufficient medical field experience and limited information beyond randomized controlled trials (RCT). Atopic dermatitis is one of the fields that has seen a shortage of new drugs in the past. However, in recent years, there have been notable shifts in prescription patterns, with the inclusion of JAK inhibitors and interleukin inhibitors. Amidst ongoing developments, Korean researchers have unveiled RWD research findings related to the JAK inhibitor 'Rinvoq (upadacitinib)' in Korean patients. The study, led by Professor Ahn Ji Young from the Department of Dermatology at the National Medical Center, involved a retrospective analysis of the medical records of 85 atopic dermatitis patients who were treated with Rinvoq for a minimum of 16 weeks between Oct. 2021 and Dec. 2022 at the National Medical Center. As as result, Rinvoq demonstrated clinically significant improvements in patients with moderate to severe symptoms, as indicated by evaluation parameters including the Eczema Area and Severity Index (EASI), Pruritus numerical rating scale (pNRS), Life Quality Index (LQI), Patient-Oriented Eczema Measure (POEM). DailyPharm sat with Professor Ahn for an interview. -What was the background for conducting the RWD research in Korea? RCTs were available, but there could be disparities between RCT data and data collected from patients in real-world clinical settings. Furthermore, overseas data frequently originate from research that primarily involves Caucasian populations. While the drug dosage may be the same, variations can arise in the medical environment and conditions between Asian or Korean patients and those in other countries. There are also situations that cannot be satisfied solely through overseas clinical studies. Considering these factors, the objective was to acquire data customized for Korean patients. With this data, it will be possible to share information with medical professionals in Korea, potentially leading to more effective patient treatments in the future. -What was the research design? This research was not originally planned as part of the study but was conducted retrospectively after the data had already been collected. Once a substantial volume of patient data had been gathered, we analyzed the data from these patients, covering periods from the start of treatment up to 2, 4, and 16 weeks, in order to monitor changes in the patients' conditions. In addition, we assessed various parameters including pNRS, DLQI, POEM, ADCT, and others. Furthermore, we examined the types of side effects experienced by patients during treatment and identified which drugs had proven effective for those who showed improvement. We evaluated various conditions to determine which aspects indicated a positive response in patients. The research findings showed that Rinvoq demonstrated a rapid onset of action during the early stages of treatment, particularly in patients with elevated eosinophil counts. This research has allowed us to identify points that could be beneficial for patients. -Can eosinophil count possibily be a biomarker? Yes. Patients with high eosinophil counts may experience positive effects from Rinvoq treatment, and we concluded that this outcome can be explained through a specific mechanism. -What were the conditions of patients? Based on the data from patients with atopic dermatitis lasting for 16 weeks or more between 2021 and 2022 at the National Medical Center, it was found that there was a slightly higher proportion of males among these patients. Typically, these patients had developed atopic dermatitis during childhood. Approximately 19% of patients developed the condition after reaching adulthood. Many patients often mention that they developed atopic dermatitis after reaching adulthood. However, upon further inquiry, it is common to find that these patients actually experienced atopic dermatitis during childhood, but it improved during that time and then worsened again after they became adults. -Any other prominent results, in addition to eosinophil counts? Based on the research results, we examined which parts of the body showed the most improvement. In terms of the body, there was overall improvement. There were concerns about the effect of interleukin inhibitors like "Dupixent (dupilumab)" on the condition of the head and neck, but Rinvoq showed improvement across various body parts. In terms of symptoms, lichenification and excoriation were more common in the acute phase, especially lichenification tended to become hardened in the chronic phase. These symptoms improved rapidly, and patients expressed high satisfaction with these improvements. -Can it be seen as the characteristics of JAK inhibitor? Rather than categorizing it as a JAK inhibitor, it is seen more as a distinctive feature of Rinvoq. Among Korean and Asian atopic dermatitis patients, lichenification is often observed, so the improvement of lichenification is a highly significant aspect. Although not yet conclusive, with more data in the future, it may be possible to say that this drug is particularly effective for Asians. However, the issue is that there was a significant occurrence of acne. While it typically appears in clinical trials at around 10%, in this research, it was observed in nearly 40% of cases. Additionally, It was observed that the incidence of acne decreased with an increase in age. -What are the benefits of Rinvoq found from the research? The key benefits include rapid onset of action and its effectiveness in improving itching. In real-world clinical practice, Rinvoq is the preferred treatment option when patients suffer from itching, -Are all JAK inhibitor and interleukin products covered by insurance? Are there any frustrations regarding the current reimbursement criteria? One of my frustrations would be the switching. Doctors affiliated with the Korean Atopic Dermatitis Association might agree to this. It's indeed a challenging situation when a patient is unable to switch to another medication, even when the initially prescribed drug proves to be ineffective. Since accurate biomarkers are not available, medical professionals often face difficulty in determining the most suitable medication for a patient right from the start. Therefore, switching should be reimbursed.
- Company
- Tarlatamab designated as an orphan drug for SCLC
- by Eo, Yun-Ho Jan 15, 2024 05:36am
- Amgen’s drug candidate ‘Tarlatamab,’ intended for treating small cell lung cancer (SCLC), has received orphan drug designation in Korea. The Ministry of Food and Drug Safety (MFDS) announced this decision through its first orphan drug designation posting of the New Year. The approved indication is for treating adult patients with progressive SCLC whose cancer had progressed after previous second-line treatments. The research team led by Professor Ahn Myung Ju, from the Division of Hematology-oncology in the Department of Medicine at Samsung Medical Center, has confirmed Tarlatamab as a potential treatment for second-line treatment in SCLC. Their research article was published in the New England Journal of Medicine (NEJM). The research team demonstrated the treatment potential of bispecific T-cell engagers like Tarlatamab. Tarlatamab is a novel bispecific T-cell engager drug that recognizes antigens present on both cancer cells and immune cells. Even when cancer cells manage to evade immune cells, Tarlatamab can engage immune T-cells, directing them to closely target cancer cells and initiate an attack. Professor Ahn’s research team conducted this research with the goal of identifying a novel therapeutic strategy that could maximize the effects of Tarlatamab while ensuring the safety of patients. They conducted a study enrolling 220 patients who had not responded to the first-line treatment for SCLC, from 56 institutions across 17 countries and randomly assigned to clinical groups for evaluation. According to the U.S. Food and Drug Administration (FDA), the research team administered two different doses of Tarlatamab, 10mg and 100mg, to patients and assessed various prognosis such as treatment reactions and drug-related side effects. As a result, the optimal dosage for the drug was determined to be 10mg of Tarlatamab administered every 2 weeks, which led to clinical improvements in prognosis and a reduction in side effects. According to the research group, patients who received 10 mg showed an objective response rate of 40%, which was higher than the 32% response rate observed in those who received a 100 mg dose. The median progression-free survival in the 10-mg group was 4.9 months, higher than the 3.9 months in the 100-mg group. The overall survival, measured at nine months following the treatments, was 68% for the 10-mg group and 66% for the 100-mg group. The 10-mg dose demonstrated a higher treatment effect with fewer side effects. Since Tarlatamab is a T-cell activating therapy, the most common side effect is ‘cytokine release syndrome.’ In the 10-mg group, 51% of the patients experienced cytokine release syndrome, whereas, in the 100-mg group, 61% did. “SCLC, classified into limited and extended stages, is characterized by its rapid progression without clear incremental stages. For most patients, metastasis to other lungs or organs presents treatment challenges. Currently, treatment options remain limited. Consequently, I hope that ongoing research will contribute to alleviating the suffering of patients,” Professor Ahn said.
- Company
- Boryung partners with Baxter for 2 anesthesia drugs in Korea
- by Kim, Jin-Gu Jan 12, 2024 07:06am
- Boryung announced on the 10th that it signed a sales agreement with Baxter Korea to sell inhalation anesthesia ‘Suprane Solution (desflurane)’ and blood substitute ‘Plasma Lyte 148 Inj’ in the domestic market. Suprane, developed by Baxter, is a premier inhalation anesthesia for inducing or maintaining anesthesia during surgery. It offers rapid and accurate control of the depth of anesthesia and has the lowest solubility among inhaled anesthetic, enabling fast and predictable patient recovery after anesthesia. Plasma Lyte 148 Inj is an original fluid solution developed by Baxter. It is a physiologically balanced blood substitute with sodium, magnesium, and potassium levels similar to human plasma. Plasma Lyte 148 Inj is used to replenish and adjust extracellular fluid in cases of decreased circulating blood volume and interstitial fluid and to adjust metabolic acidosis. Plasma Lyte 148 Inj, a fluid therapy that can improve therapeutic outcomes for critically ill patients, has demonstrated its effectiveness in decreasing the mortality rate in patients with SIRS when compared to the Normal Saline group. It has also been shown to reduce risk factors associated with post-operative complications in open surgeries. An additional advantage is that Plasma Lyte 148 Inj is calcium-free, allowing its administration before and after a blood transfusion, as well as during a transfusion. Inhalation anesthesia Suprane (left) and blood substitute Plasma Lyte 148 Inj 1000 mL(right). The recent contract will broaden Boryung’s portfolio of anesthesia-related drugs and enhance its business capabilities. Boryung has been actively involved in sales marketing efforts for its anti-vomiting drug ‘Naseron (ramosetron)’ and drug designed to reverse neuromuscular blockade, ‘Breathon (sugammadex).’ Naseron ranks the first in the market among ramosetron-based products, while Breathon is the second-leading product in the sugammadex-based market. With its anesthesia task force and academic sales marketing expertise, Boryung will concentrate its efforts on expanding the market share of these two products. "Suprane and Plasma Lyte 148 Inj are important drugs for ensuring the safety and quality management of surgical patients undergoing anesthesia," Jung Woong-je, RX Division Leader at Boryung, commented. "Based on these two products, our focus will center around strengthening our market presence within the field of anesthesiology."
- Company
- Generic companies partially win Trajenta patent challenges
- by Kim, Jin-Gu Jan 12, 2024 07:06am
- Generic companies have won the dispute over unregistered use patents of Trajenta (linagliptin). Although the unregistered formulation patent remains, this patent is reportedly relatively easy to avoid or invalidate. As such, the industry expects there is a higher possibility that generic versions of Trajenta will be released earlier after the drug’s substance patent expires in June. According to the pharmaceutical industry on the 11th, the Intellectual Property Trial and Appeal Board ruled that the validity of claims in the invalidation trials against the three Trajenta use patents by Genuone Science and others against Boehringer Ingelheim were established. Genuone Sciences had filed trials against Boehringer Ingelheim to invalidate 3 Trajenta’s use patents (10-1558938, 10-1655754, 10-1806786) in October 2020. Kukje Pharm, GC Biopharma, Mother’s Pharmaceutical, and Boryung had also joined in the trial with Genuone Sciences at the time. After about a year and three months, the first instance court, the Intellectual Property Trial and Appeal Board ruled in favor of the generic companies. All three patents expire in May 2027. If the patent challengers had lost in the first instance court, the release of a generic version of Trajenta would have been pushed back to after 2027. However, with the win, Trajenta generics will likely be available sooner, after the expiry of Trajenta’s substance patent in June this year. The first substance patent for Trajenta expired in August last year, and the second substance patent will expire in June this year. In July last year, Genuone Science and the other companies also succeeded in avoiding the unlisted formulation patent through a trial to confirm the passive scope of patent rights. It is estimated that 7 unlisted formulation patents and 1 unlisted use patent remain for Trajenta. However, industry insiders believe that the remaining patents are generally easy to avoid or invalidate or were registered later and do not have a significant impact on the early launch of Trajenta generics. Moreover, in the case of the 3 use patents, which are key to the launch of generic versions of Trajenta, the IPTAB clearly stated the grounds for their invalidation, such as lack of description and inventiveness, the generic company has a high chance of winning later trials even if the original company appeals. On the reason for invalidating Trajenta’s use patents, IPTAB pointed to “The experimental data related to linagliptin dosage is not disclosed in the patent specification, and linagliptin dosage or combination therapy with other diabetes drugs can be easily be invented from prior art." In other words, the trial court invalidated Trajenta’s patents on two grounds: lack of description and inventiveness. In effect, all 3 use patents directly related to Trajenta’s indication were invalidated, increasing the likelihood of early generic launch after the expiration of Trajenta's substance patent. Jong Hyuk Park, a patent attorney who participated in the patent trial, said, "This decision is significant in that it the court judge on the patentability of additional unlisted use patents that were later registered through divisional patent applications when the indications are already preannounced. Since it was determined that the patents were invalid in terms of both lack of description and inventiveness, it is unlikely that the decision will be reversed on appeal."
- Company
- New colorectal cancer drug Braftovi will receive reimb
- by Jan 12, 2024 07:05am
- Ono Pharmaceutical Korea held a press conference celebrating reimbursement listing of Braftovi (ingredient: encorafenib), a targeted drug for the treatment of metastatic colorectal cancer (mCRC) harboring a BRAF V600E mutation. All eyes are on Braftovi, a new targeted drug for metastatic colorectal cancer emerging after a 15-year gap, for its potential to address unmet demands for treatment options. Experts have assessed that, based on proven efficacy, Braftovi is likely to be highly utilized. On the 11th, Ono Pharmaceutical Korea held a press conference celebrating the reimbursement listing of Braftovi (ingredient: encorafenib), a targeted drug for the treatment of metastatic colorectal cancer (mCRC) harboring a BRAF V600E mutation. Braftovi is a targeted drug, emerged 15 years after Merck’s Erbitux (cetuximab), for the treatment of colorectal cancer. In Phase 3 BEACON CRC studies, Braftovi has demonstrated efficacy and a safety profile in patients with BRAF V600E mutation who have developed tolerance to previous therapies. Based on clinical results, patients who received the combination therapy of Braftovi and cetuximab demonstrated a median overall survival (OS) of 9.3 months, a significant extension compared to the 5.9 months observed in those treated with the combination therapy of irinotecan and cetuximab. The mortality risk decreased by 39%. The therapy’s benefits were consistently observed, regardless of the patient’s systemic therapy outcomes, the number of previous therapies, tumor metastasis range and location. The group that received the combination therapy of Braftovi and cetuximab has shown 10 times higher overall response rate (ORR) compared to the comparative thearpy group (19.5% in Braftovi combination therapy group vs. 1.8% in comparative therapy group). With a three-fold increase in Progression free survival (PFS), the risk of disease progression and death was reduced by 56%. Moreover, the group that received the combination therapy of Braftovi and cetuximab has shown an overall satisfactory safety profile, with a lower rate of severe adverse drug reactions compared to the comparative therapy group. "In the treatment of metastatic colorectal cancer, conventional therapies such as FOLFIRI and FOLFOX, in addition to Erbitux, have been used. However, there were concerns about drug toxicity and side effects. The combination therapy of Braftovi and Erbitux has shown longer treatment duration and a lower treatment discontinuation rate," Cha Yongjun, Professor in the Hematology-Oncology Department at the National Cancer Center, stated. Braftovi may have a role in treating BRAF V600E, which is associated with poor prognosis The BRAF V600E mutation occurs in approximately 4.7% of patients with metastatic colorectal cancer in Korea. Patients carrying this mutation tend to have worse prognosis, such as larger tumor size and peritoneal metastasis, compared to those who do not have the BRAF V600E mutation. In metastatic colorectal cancer patients with BRAF V600E mutation, the OS was 11.4 months, which was less than half of the 43 months for BRAF V600E-negative. The guidelines of the European Society for Medical Oncology (ESMO) and the National Comprehensive Cancer Network (NCCN) have identified the BRAF V600E mutation as a factor associated with poor prognosis in metastatic colorectal cancer, and they recommend BRAF mutation testing for all diagnosed patients. In clinical practices, it is recommended for all metastatic colorectal cancer patients to undergo RAS mutation testing and BRAF mutation testing. As a result, the analysis suggests that Braftovi may have broad clinical utility. “Currently, the available treatment options for colorectal cancer are limited. The therapeutic outcomes for second-line treatments following unsuccessful first-line treatment have been minimal. Nine out of ten patients have failed to proceed to third-line treatments. There is a critical need for new therapeutic options,” Kim Seung Tae, Professor of the Division of Hematology-Oncology at the Samsung Medical Center, commented. Professor Kim analyzed that “BRAF V600E mutated metastatic colorectal cancer is associated with poor prognosis and a significantly high rate of peritoneal metastasis. While the first-line standard treatment typically includes anti-EGFR therapy such as Erbitux, it has been reported that BRAF V600E mutation is less responsive to chemotherapy. Therefore, Braftovi could potentially become a first-line treatment option.”
