- LOGIN
- MemberShip
- 2025-12-22 09:17:48
- Company
- Therapeutic device 'improves OS for lung cancer patients'
- by Son, Hyung Min Oct 21, 2024 05:48am
- The first therapeutic device has been approved for use in non-small cell lung cancer (NSCLC). Novocure's therapeutic device, in combination with an NSCLC medication, demonstrated to improve patients' overall survival and won the approval of the U.S. regulatory authority. In South Korea, Nu Eyne is researching the potential of oncology therapeutic devices through clinical studies. According to industry sources on October 19th, the U.S. Food and Drug Administration (FDA) granted approval for Novocure's Optune Lua for the treatment of metastatic non-small cell lung cancer (NSCLC). Optune Lua is approved for use in combination with PD-1/PD-L1 immunotherapy for cancer or docetaxel. Optune Lua is a device that delivers 'Tumor Treating Fields (TTFields),' which exert physical forces on the electrically charged components of dividing cancer cells, resulting in cell death. Novocure says that TTFields do not affect healthy cells because they have different properties (including division characteristics, morphology, and electrical properties). The basis of approval was the Phase 3 LUNAR study. The clinical trial involved 301 patients with NSCLC who had failed during or after platinum-based chemotherapy. The patients were randomly assigned in a 1:1 ratio to the group receiving Optune Lua plus a PD-1/PD-L1 inhibitor or docetaxel or to the single-treatment group receiving a PD-1/PD-L1 inhibitor or docetaxel. Clinical results showed Optune Lua combination therapy recorded a median overall survival (OS) of 13.2 months, set as the primary endpoint. This was 3 months longer than 9.9 months in the control group. Patients randomly administered Optune Lua plus immunotherapy had a median OS of 19.0 months, and patients administered a PD-1/PD-L1 inhibitor alone had a median OS of 10.8 months. The Optune Lua combination therapy group had an OS extension of over 8 months compared to patients treated with immunotherapy alone. Patients randomly administered Optune Lua plus docetaxel had a median OS of 11.1 months, whereas patients treated with docetaxel had a median OS of 8.9 months. However, this figure did not show a statistically significant difference. Device-related adverse events (AE) occurred in 63.1% of patients treated with Optune Lua combination therapy. Most cases were Grade 1-2 and only 4% (6 patients) experienced Grade 3 skin toxicity and discontinued treatment. Optune Lua did not show Grade 4-5 toxicity, and no deaths occurred. Therapeutic device is being developed in South Korea…Nu Eyne challenges the field A Korean company, Nu Eyne, has confirmed the effects of immunotherapy and is conducting therapeutic device development. To confirm treatment effects on cancer, Nu Eyne conducted a cell-based clinical study to compare the stimulated group to the non-stimulated group of cultured cells after 48 hours of electrical stimulation. The results showed that the electrically stimulated group had an up to 80% reduction in tumor size. Nu Eyne's technology for its oncology therapeutic device has been developed to deliver a high-intensity electrical field that responds particularly to cancer cells, thereby inducing cell death. The technology is known to have a low risk of causing side effects on surrounding organs. Nu Eyne is developing advanced systems and materials to maximize oncology therapeutic effects. Using its technology, Nu Eyne aims to develop therapeutic devices to secure indications for treating lung cancer and bone metastatic cancer. Nu Eyne aims to complete the development of a clinical therapeutic device prototype in the second half of 2026. After that, the company plans to conduct clinical trials to secure the FDA regulatory approval.
- Company
- Oxlumo receives orphan drug designation in Korea
- by Eo, Yun-Ho Oct 21, 2024 05:48am
- The primary hyperoxaluria treatment Oxlumo received orphan drug designation in Korea. The Ministry of Food and Drug Safety (MFDS) recently announced the designation through an orphan drug designation notice. Oxlumo (lumasiran) was also recently designated a Global Innovative products on Fast Track (GIFT) by the MFDS. The drug is an RNAi therapeutic for primary hyperoxaluria (PH1), a rare kidney disease that was approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2020. RNAi is recognized as a next-generation gene therapy that has the advantage of providing specific access to disease-causing human genes. PH1 is a rare disease caused by excessive production of oxalate in the liver. Symptoms include the deposition of oxalate crystals or potassium oxalate crystals in the kidneys and urinary tract. As the disease progresses, kidney damage occurs and dialysis is required. Eventually, a liver or kidney transplant is required to cure the disease. The option to treat PH1 with a therapeutic agent became available with the approval of Oxlumo in 2020. Oxlumo is an RNAi therapy that targets hydroxy acid oxidase 1 (HAO1), which encodes glycolate oxidase (GO), the enzyme that produces oxalate. The mechanism of action reduces oxalate by inhibiting HAO1, which reduces GO production. Oxlumo’s efficacy was confirmed through a Phase III clinical trial in 39 PH1 patients aged 6 years and older. Oxlumo reduced oxalate levels in the urine by 65.4% compared to the placebo group. In addition, 84% of patients treated with Oxlumo had urinary oxalate levels near normal. 52% achieved urinary oxalate levels within the normal range.
- Company
- RNAi therapeutic 'Givlaari' receives the ODD in KOR
- by Eo, Yun-Ho Oct 21, 2024 05:48am
- Product photo of Givlaari (givosiran) RNAi therapeutic 'Givlaari' has been designated as an orphan drug following its designation as the GIFT. The Ministry of Food and Drug Safety (MFDS) recently announced this through the posting of the Orphan Drug Designation (ODD). Givlaari (givosiran) had previously been designated as the 'Global Innovative products on Fast Track (GIFT)' by the MFDS. This drug won U.S. FDA approval in 2019 and also received the accelerated approval from Europe's EMA. Givlaari is a subcutaneous injection that targets the enzyme aminolevulinic acid synthase 1 (ALAS1) for the treatment of acute hepatic porphyria (AHP) in adults and adolescents aged 12 years and older. AHP is caused by a genetic deficiency due to the depletion of the enzyme needed for heme biosynthesis in the liver. It is a rare genetic disorder with abnormal accumulation of porphyrins in the body. Patients with AHP experience debilitating symptoms, such as severe abdominal pain, vomiting, and seizures, and chronic pain. The efficacy of Givlaari has been demonstrated through the Phase 3 ENVISION clinical trial. Givosiran was shown to reduce the occurrence of annual porphyria-associated seizures by 74% compared to the placebo. The research outcome was published in The New England Journal of Medicine (NEJM) on June 11th, 2020. During the six months of treatment, the percentage of patients who had not experienced porphyria-associated seizures was 50% for the givosiran-treatment group and 16.3% for the placebo group.
- Company
- Bladder cancer drug Balversa offers new treatment option
- by Whang, byung-woo Oct 18, 2024 05:49am
- The introduction of the targeted therapy Balversa (erdafitinib) in urothelial carcinoma has attracted attention for its potential to address unmet needs. In particular, the emergence of FGFR inhibitors has highlighted the importance of genetic mutation diagnostics to quickly detect the presence of such mutations. (from the left) Professor Tae-Jung Kim, Professor Inho Kim, BU director Yeon-Hee Kim Inho Kim, professor of Oncology at Seoul St. Mary's Hospital, and Tae-Jung Kim, professor of pathology at Yeouido St. Mary's Hospital, emphasized the importance of diagnosing FGFR mutations at a press conference held by Janssen Korea on the 16th, which was held to celebrate the launch of Balversa. Balversa was approved by the Ministry of Food and Drug Safety in January 2022. However, it is still not reimbursed in Korea. Specifically, the drug is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with FGFR2 or FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy, which includes platinum-based chemotherapy, or whose disease has progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy. However, the approval of PD-1 and PD-L1-directed immuno-oncology agents in the first- and second-line settings that followed Balversa’s approval led to the need for Balversa to demonstrate efficacy in patients who previously received these agents. The situation was addressed with the publication of Balversa’s Phase III THOR trial study, which demonstrated a prolonged overall survival (OS) benefit with Balversa over chemotherapy in patients with metastatic urothelial carcinoma with FGFR3/2 gene alterations whose disease progressed after first-line treatment with immuno-oncology agents. In the study, Balversa prolonged overall survival (OS) compared with chemotherapy in patients with metastatic urothelial carcinoma. Results showed that over a median follow-up of 15.9 months, the mOS was 12.1 months in the Balversa arm, reducing the risk of death by 36% compared with the 7.8 months in the chemotherapy arm. Based on these findings, the U.S. Food and Drug Administration granted Balversa formal approval in January, but with a more restricted indication than originally approved. “Bladder cancer is most commonly diagnosed in those in their 60s and older, with frequent recurrences and metastases, so it is important to prevent metastases or treat recurrences and metastases early,” said Professor In-ho Kim. “There is a significant unmet therapeutic need, especially for patients with distant metastases, where the 5-year relative survival rate is only 11.7%.” ‘Balversa is the first targeted therapy for bladder cancer, which is significant because it improves survival in patients who have exhausted both chemotherapy and immuno-oncology options and provides an opportunity for further treatment,’ added Professor Kim. The second speaker, Professor Tae-Jung Kim, emphasized the importance of early diagnosis of FGFR mutations in bladder cancer patients. ‘FGFRs play a significant role in signaling pathways that regulate cell growth, differentiation, survival and migration,’ said Professor Kim. ’FGFR mutations are found in a variety of cancers, but they are particularly common in bladder cancer, where they are observed in approximately 20% of patients.’ ‘The use of mutation-specific targeted therapies may help stop cancer proliferation and progression or improve the effectiveness of other treatments,’ he added. ’The NCCN guidelines also consider or recommend molecular/genomic testing for genetic mutations in some patients, such as those with bladder cancer tumor invasion grade IIIB or higher.’ In other words, for patients with bladder cancer who are in the chemotherapy phase, the guidelines recommend testing for genetic mutations in the early stages of treatment strategy planning. “We are pleased to be able to offer a new treatment option in FGFR-mutated urothelial cancer with Balversa. We plan to communicate the clinical benefits and emphasize the importance of mutation diagnosis so that more patients can benefit from Balversa treatment.”
- Company
- 'Vorasidenib' receives Orphan Drug Designation in KOR
- by Eo, Yun-Ho Oct 18, 2024 05:49am
- 'Vorasidenib,' an anticancer drug targeting brain cancer, has been designated an orphan drug in South Korea. The Ministry of Food and Drug Safety (MFDS) announced this on October 8th through the Orphan Drug Designation (ODD) notice. Vorasidenib is an orally administered dual inhibitor of isocitrate dehydrogenase (IDH) 1/2 that selectively penetrates the blood-brain barrier. The drug's efficacy for selective malignant brain tumors (neuroglioma) was demonstrated through a double-blind Phase 3 clinical trial led by a research team at the University of California, Los Angeles (UCLA). The research team administered the targeted anticancer drug vorasidenib (40 mg single dose per day) or placebo to 331 patients with specified brain tumors (residual or recurrent Grade 2 glioma with IDH mutation) who have undergone brain tumor surgery as their only treatment. Grade 2 gliomas with isocitrate dehydrogenase (IDH) mutation are malignant brain tumors that cause considerable disability in patients, leading to early death. Gliomas tend to advance slowly but are fatal and affect people in their 30s. Study participants were randomly assigned to vorasidenib-treated patients (study group) and placebo-treated patients (control group). 168 of these patients took vorasidenib, and 163 took the placebo. Study results showed that the progression-free survival (PFS) for the vorasidenib-treated patient group was 27.7 months and that for the placebo-treated patient group was 11.1 months. Vorasidenib delayed the progression of malignant tumors by 16.6 months and lowered the death risk to 39%. Additionally, it improved the time until the next anticancer therapy (chemotherapy, radiotherapy), reducing the patient death risk to 26%. The side effects experienced by the vorasidenib-treated patient group were 22.8%, whereas 13.5% in the placebo-treated patient group. However, no significant side effects have been found. The primary endpoint was imaging based PFS and the secondary endpoint was the time to the next anticancer intervention. Of those study participants, 226 (about 68%) patients had a follow-up of 14.2 months (median value) and continued to take vorasidenib or placebo. At 30 months (Sept. 2022), 72% of the vorasidenib-treated patient group was still taking the drug and had not experienced disease progression. Meanwhile, France-based Servier Pharmaceuticals developed vorasidenib and is proceeding with the approval process in the U.S. and Europe.
- Company
- Will blockbuster contraception Mercilon find a new provider?
- by Nho, Byung Chul Oct 18, 2024 05:49am
- Product photo of Mercilon As Alvogen Korea and Chong Kun Dang's co-promotion contracts for oral birth control pills are set to expire, many pharmaceutical·distributors are sending love calls. Sources said that distributors, including pharmaceutical companies with strength in over-the-counter drug sales, have visited Alvogen Korea and Chong Kun Dang to weigh considerations. Alvogen and Chong Kun Dang signed a domestic distribution agreement for Mercilon in 2019. Alvogen has been responsible for the approval·imports·marketing of the drug, and Chong Kun Dang has been responsible for pharmacy sales. At the time, Alvogen chose Chong Kun Dang as the Korean partnership company for Mercilon because it had a variety of line-ups for female diseases and a nationwide pharmacy sales network. Chong Kung Dang has a variety of OTC products for women, including the painkiller PENZAL, Prefemin for premenstrual symptoms, the anemia treatment Bolgre, and the prenatal nutritional supplement Gowoonzymemom. As it is relates to the sales agreement, Alvogen and Chong Kun Dang are remaining silent about 'The termination due to contract maintenance·expiration.' There are opinions that, considering continued generation of sales, Chong Kun Dang may retain the sales rights. Based on pharmaceutical sales performance, Mercilon generated KRW 2.97 billion until the first half of the year, ranking no.1 in the product line containing desogestrel·ethinyl estradiol. Mercilon's exterior growth for 2020·2021·2022·2023 were KRW 7.6 billion·KRW6.9 billion·KRW6.9 billion·KRW7.2 billion. However, if a company proposes conditions like dramatic sales growth, considerable commission reduction, or even taking over all the remaining stock (estimated at KRW 6 billion), another company may acquire the sales rights because Alvogen has nothing to lose. Meanwhile, companies that are likely to get sales growth upon acquiring Mercilon sales right include Dongkook Pharmaceutical, Kwangdong Pharmaceutical, and ZP Therapeutics. Dongkook Pharmaceutical launched the third-generation birth control pill in 2020, but it has not caused a significant shift in the market. Kwangdong Pharmaceutical has Sunhana·Senselibe. However, they have generated KRW 28 million and KRW 1.1 billion, respectively. ZP Therapeutics acquired approval rights for Actinum in 2022, and the company has been actively pursuing sales and marketing. Considering this situation, these pharmaceutical companies are guaranteed annual sales of about KRW 10 billion when they acquire the sales rights of Mercilon, which is close to blockbuster. However, considering the co-promotion fee is 8-15%, the net gain may be lower than their in-house OTC sales. Meanwhile, Mercilon has ranked No.1 in OTC oral birth control pills. It shows contraceptive effects by combining the actions of ethinyl estradiol, estrogen, and desogestrel, progesterone. The clinical trials for Mercilon have been completed in 12 European countries. Mercilon is a global brand sold in 42 companies worldwide.
- Company
- oHCM drug Camzyos's last hurdle to reimb remains high
- by Eo, Yun-Ho Oct 15, 2024 05:50am
- The reimbursement journey for ‘Camzyos’, which is seeking insurance reimbursement in Korea, is going to be a rocky road until the end. According to industry sources, the drug pricing negotiations between BMS Pharmaceuticals Korea and the National Health Insurance Service (NHIS) for the obstructive hypertrophic cardiomyopathy (oHCM) drug Camzyos (mavacamten) have been extended after failing to finalize the deal within the deadline. The deadline extension was primarily due to a disagreement over the number of patients eligible for Camzyos. Camzyos’ reimbursement journey faced difficulties, receiving a redeliberation decision from the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee. The drug passed the committee and entered pricing negotiations in August, but the negotiations were not concluded within the 60-day deadline. Camzyos is the first and only cardiac myosin inhibitor that specifically targets excess cross-bridge formation of myosin and actin proteins, the main cause of oHCM. It improves left ventricular hypertrophy and left ventricular outflow tract obstruction by separating myosin from actin, relaxing the overcontracted heart muscle. Due to the lack of a cure, oHC has long been managed with off-label drug use. In fact, the European Society of Cardiology (ESC) revised its HCM guidelines for the first time in 9 years with the introduction of Camzyos. Before then, HCM guidelines have been based on small observational data reported from individual institutions, retrospective analyses, or expert consensus opinions. Therefore, Camzyos was a game-changer in the field. After demonstrating its significant effect in two large-scale Phase III randomized controlled trials (RCTs), Camzyos was recommended at the highest evidence level, A, for the first time among treatment options in the ESC guidelines. The American College of Cardiology (ACC) and American Heart Association (AHA) are also currently preparing to update their guidelines. Based on the Phase III trial data, Camzyos received a breakthrough therapy designation (BTD) and was approved by the US FDA. In the Phase III EXPLORER-HCM trial, which served as the basis for Camzyos’s approval, Camzyos achieved and improved the primary composite endpoint of the proportion of patients with decreased symptom burden (by NYHA class) and functional capacity (peak oxygen consumption, pVO2) by more than 2 times compared with placebo. In particular, 20% of the patients who received treatment with Camzyos achieved both primary endpoints, pVO2 improvement, and the NYHA class requirement. Also, the dynamic left ventricular outflow tract obstruction was reduced by over 4 times with the use of Camzyos. 7 out of 10 patients treated with Camzyos improved to the extent that they would not consider surgery, and showed consistent benefits over 30 weeks. “Many patients with oHCM have been anxiously awaiting a new drug due to the lack of a suitable treatment,” said Hyung-Kwan Kim, Professor of Cardiology at Seoul National University Hospital. “In particular, expectations for the drug's reimbursement have increased since it was approved by DREC in July, and we hope that the remaining procedures will be completed as soon as possible so that patients and their caregivers in Korea can benefit from the use of the new drug.”
- Company
- “Market for veterinary drugs expected to grow rapidly”
- by Son, Hyung Min Oct 15, 2024 05:50am
- Seung-Hwan (SH) Jung, General Manager at MSD Animal Health Korea “MSD Animal Health Korea’s clients are animals. We believe that the drug distribution channels for animals should be carefully designed to contribute to the health of animals in Korea. Supplying our products to animals that need them quickly, sufficiently, and safely is the biggest principle in designing our domestic distribution network. Seung-Hwan (SH) Jung, General Manager at MSD Animal Health Korea, emphasized so to reporters about the company’s plans for supplying veterinary drugs in Korea. Over the years, MSD Animal Health Korea has launched various new products and provided technical support to meet the needs on-site. In doing so, the company has prevented and treated diseases in economic and farm animals and contributed to improving the productivity of farmers and the health and welfare of companion animals in Korea. MSD Animal Health Korea's flagship products include the ‘Porcilis PVC M Vaccine,’ which prevents the Porcine Circo Virus (PCV) and M.hyo, and the ‘Prime Pac PRRS Vaccine,’ which prevents Porcine Reproductive and Respiratory Syndrome in the swine industry; ‘Exzolt,’ a parasiticide for chickens that eliminates mites; ‘Nobilis SG9R Vaccine,’ which prevents chicken typhoid. The company also has ‘Bravecto,’ which prevents ectoparasites in pets, and ‘Caninsulin,’ the only insulin for pets in Korea. “The global veterinary drug market is estimated to be around USD 45.8 billion in 2023, of which our sales recorded USD 5.6 billion,’ said Jung. “The animal health sector is generally divided into ruminants, poultry, swine, aquaculture, and companion animals, and MSD Animal Health is the global sales leader in four of these five categories, except for companion animals.” In Korea, the veterinary drug market is estimated to be worth around KRW 1.4 trillion, with two-thirds of the market being domestically produced and one-third being imported. MSD Animal Health Korea generated sales of KRW 45 billion last year. ‘Our main business areas in Korea are swine, poultry, and companion animals,’ says Jung. In terms of total sales, the swine and poultry division accounts for the largest share, but we are also expecting rapid growth in the companion animal and livestock sectors.” “Due to issues such as superbugs, most developed countries, including Korea, have banned the addition of growth-promoting antibiotics to feed, and it is becoming increasingly difficult to use therapeutic antibiotics in livestock,’ he explained. ’Personally, I see this as a positive change that is in line with the concept of One Health, which has a common goal of seeking animal and human health. As a result, I believe the veterinary drug industry is also shifting towards prevention rather than treatment, promoting the use of vaccines rather than antibiotics.’ Jung also sees much growth potential in the domestic animal health market. With the rise in the number of people living with companion animals, the demand for animal healthcare has been growing along with the market. “The sector has been growing at an average annual growth rate of 10% with the rising demand for pet healthcare,” said Jung. “The scale of the swine and poultry industry is also large compared to Korea’s population. In particular, consumer demand is shifting to seeking safe animal products from the abundance of animal products in the past. We believe that the use of veterinary drugs to prevent diseases and promote animal welfare in farm animals, including food poisoning and zoonotic diseases, will continue to increase.” Various channels such as veterinary hospitals and pharmacies...”We plan to distribute ETCs and OTCs separately” MSD Animal Health Korea plans to utilize various distribution channels such as veterinary clinics and pharmacies. The veterinary drug market is being developed similarly to that of human drugs such as digestive and diabetes diseases, using various channels. And many pharmaceutical companies, including MSD Animal Health Korea, are looking to enter the field. “The specialization of veterinary drugs is predictable in the same way as the changes we have seen in human medicines,” said Jung, “and we interpret this as a favorable change for our business because we own many products that are unique to MSD Animal Health that other companies do not have.” ‘MSD Animal Health employees around the world are sensitive to changes in the market and disease outbreaks, and these changes are immediately reported to R&D at headquarters, resulting in new products being developed to respond quickly to changes in the market as well as diseases. We expect this strength to persist.’ MSD Animal Health's mission is ‘The science of healthier animals’. At the end of the day, Jung says, MSD's customers are animals, and providing products for healthy animals is the company's number one goal. “We are considering carefully designing the distribution channels of our medicines to contribute to animal health,” said Jung. “The overarching principle of our distribution network design is to get our products to the animals that need them quickly, sufficiently, and safely.” ‘We plan to establish different distribution networks for specialized and over-the-counter products. We will design a new distribution network in the future based on domestic laws.’
- Company
- Dong-A ST’s biosimilar first enters the U.S. market
- by Chon, Seung-Hyun Oct 14, 2024 05:49am
- Dong-A S.T. has succeeded in entering the US market 13 years after declaring its entry into the biosimilar business. It has received approval in the US for a biosimilar version of Stelara, which owns a global market worth KRW 14 trillion. It was the company’s second overseas market with a self-developed biosimilar. The biosimilar's entry into the U.S. market secured additional technology fee revenues and added a new item for the company. Pic of Dong-A ST headquarters According to industry sources, Dong-A ST's Stelara biosimilar ‘Imuldosa’ was approved by the US Food and Drug Administration (FDA) on the 12th. Stelara is a treatment for inflammatory diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. It is a high-grossing product that generated more than KRW 14 trillion in global sales last year. Dong-A ST is the second Korean company to receive approval for a Stelara biosimilar in the US following Samsung Bioepis. Dong-A ST passed the US market gateway 11 years after it started developing its Stelara biosimilar in 2013. Dong-A Socio Holdings began codeveloping Imuldosa with Japan's Meiji Seika Pharma in 2013. In July 2020, the development and commercialization rights were transferred to Dong-A ST for efficient execution of the global project. From 2021 to the end of 2022, Dong-A ST conducted a global Phase III clinical trial of Imuldosa in 9 countries including the United States, Poland, and Estonia, on a total of 605 patients. Trial results confirmed that Imuldosa’s efficacy and safety was equivalent to is equivalent to Stelara for marketing authorization by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) Imuldosa's FDA approval is expected to generate additional technology fees. In July 2021, Dong-A ST signed a technology export agreement with the multinational pharmaceutical company Intas Pharmaceutical to license out Imuldosa. Intas paid a non-refundable upfront payment of USD 10 million. The payments based on clinical, licensing, and sales milestones were set at up to USD 95 million. Royalties on product sales are guaranteed to be at least 10%. In addition, payments from Intas will be shared by Dong-A ST, Dong-A Socio Holdings, and Meiji Seika Pharma. Intas has secured exclusive rights to license and market the product globally, excluding South Korea, Japan, and select Asian countries. Intas is an Indian multinational pharmaceutical company with a global sales network in more than 85 countries. Global commercialization will be handled by Accord Healthcare, a subsidiary of Intas Pharmaceuticals. Accord Healthcare submitted a marketing authorization application for Imuldosa to the European Medicines Agency (EMA) in June last year and submitted an application to the FDA in October last year. By the end of the first half of last year, Dong-A ST had recognized KRW 41 billion as development costs for Imuldosa as an intangible asset. The Financial Supervisory Service has identified Phase III clinical trials as the stage at which new drug R&D costs can be capitalized. This means that KRW 41 billion was spent on global Phase III clinical trials of Imuldosa. Dong-A ST announced its entry into the biosimilar business in 2011. In 2011, Dong-A Socio Holdings established DM Bio with an investment of KRW 57 billion from Meiji Seika Pharma to build a biopharmaceutical plant. In March 2015, Dong-A Socio Holdings spun off DM Bio into a 100% subsidiary and transferred 49% of its shares to Meiji Seika Pharma. In 2021, Dong-A Socio Holdings acquired 1,117,200 shares of DM Bio from Meiji Seika Pharma for KRW 42.1 billion. The company's stake in DM Bio increased to 80.4% as it took over 60% of the 1.86 million DM Bio’s shares held by Meiji Seika Pharma. In 2022, DM Bio changed its name to STgen Bio. STgen Bio will be responsible for the production of Imuldosa. Imuldosa is the second biosimilar product that Dong-A ST has successfully commercialized in overseas markets. Dong-A ST sells Nesp's biosimilar version, ‘darbepoetin alfa’ in Japan. Dong-A ST conducted Phase I clinical trials of darbepoetin alfa and transferred the development and sales rights in Japan to Sanwa Kagaku Kenkyusho (SKK) in January 2014. Based on the results of a local Phase III clinical trial comparing the original Nesp with darbepoetin alfa, SKK received marketing authorization from the Japanese Ministry of Health, Labour and Welfare in September 2019, and launched the drug in late November of the same year. Dong-A ST will export the finished product manufactured on consignment by STgen Bio to SKK, and SKK is in charge of local sales. Last year, Dong-A ST recorded 20.6 billion won in exports with its dabepoetin alfa.
- Company
- ERT demonstrates effectiveness in treating Fabry disease
- by Whang, byung-woo Oct 11, 2024 06:25am
- "'It has been 20 years since ERT treatments became available for patients with Fabry disease. More treatment options are available to treat Fabry disease, but selecting treatment options and strategy requires precise attention based on research data." Analysis suggests that the treatment environment for rare diseases has improved due to the emergence of Enzyme Replacement Therapy (ERT) to treat lysosomal storage disease (LSD), such as Fabry disease. New treatment strategies and research for treatments are being conducted to complement the limitations of ERTs. For example, studies on treatments like Substrate Reduction Therapy (SRT) are being conducted. Antonio Pisani, a professor in the Department of Nephrology at the University of Naples Federico II. However, considering the nature of rare diseases, using available treatment resources to the fullest remains equally important. Antonio Pisani, a professor in the Department of Nephrology at the University of Naples Federico II, has emphasized the importance of monitoring when switching between medicines for treating Fabry disease during a meeting with Daily Pharm. A study comparing ERT→oral drug switching…disease management through monitoring is essential During the WORLD Symposium 2024, held in San Diego, USA, in February, a study result was presented that close monitoring for medication switching is essential. It is because after a patient switch from Fabrazyme to oral drugs, a long-term change in treatment outcomes has been reported. The study is expected to aid in selecting treatments as it compares the efficacy and safety of the ERT treatment, Fabrazyme, to an oral drug, migalastat, using registry data on patients with Fabry disease. "Migalastat has been approved in Europe in 2016. However, the use of the drug has been limited because there is no real-world evidence (RWE) besides pre-clinical or clinical results," Professor Pisani, who conducted the research, said, "The study analyzed data of patients who had been treated with Fabrazyme over a year and then switched to migalasta and continued treatment over six months. It confirmed various biomarkers for Fabry disease, changes to patient symptoms, whether a patient reached first-line treatment goal and clinical symptoms." Based on research results, migalastat treatment, compared to Fabrazyme, worsened an estimated glomerular filtration rate (GFR), a biomarker for Fabry disease, and GL-3 level, a glycolipid in cells. Additionally, a classical-type patient with Fabry disease who switched to migalastat had worsened UPCR and heart index, demonstrating that Fabrazyme is much more effective in treating patients with Fabry disease. "The study confirmed that migalastat has variability in efficacy in a clinical setting," Professor Pisani said, "We concluded that a close monitoring and patient follow-up is important when a patient has been switched to migalastat following Fabrazyme treatment." "A close monitoring of enzyme activation and changes to clinical symptoms is necessary. A change in enzyme activation is expected once a patient starts taking migalastat. Therefore, medication switching requires patient follow-up," Professor Pisani emphasized. Migalastat is approved in South Korea as a long-term treatment for patients over 12 years old diagnosed with Fabry disease with a gene variant. An oral drug can be reimbursed for second-line treatment when a patient has used ERT for over 12 months in a first-line treatment or cannot use ERT. If the study results were to apply to Korea, what could be the possible analysis? Professor Pisani advises that physicians must carefully consider medication switching based on treatment guidelines for Fabry disease. "There are studies implicating positive efficacy of migalastat. However, there are opposite results," Professor Pisani said, "When treating with migalastat, physicians must monitor patients by checking biomarkers, such as eGRF and proteinuria, to confirm the efficacy of the use." Treatment outcomes of migalastat may vary depending on the patient's condition. For example, a classical-type patient with Fabry disease may have a stable or worsened heart-related index upon switching medication to migalastat, but worsening renal functions may accelerate significantly. "In the end, a follow-up of patients is essential, and it is important to closely monitor symptoms and disease progression of patients with poor baseline indexes," Professor Pisani said. Still there are limitations to Fabry disease treatment…what are unmet needs? New Fabry disease treatments are available, and real-world data have been presented. Although these improvements have been made for patients with Fabry disease, there are still unmet needs. Professor Pisani highly values the benefits brought by ERT treatments to patients with Fabry disease. Yet, he emphasizes the need for new drug development. Studies being conducted related to new treatment strategies and drugs to complement ERT treatment limitations. For example, studies on substrate reduction therapy and gene therapy are being conducted. "We can consider possibilities, such as treatment development, including new ERT and chaperone, a combination therapy containing chaperone, or Fabrazyme in combination with gene therapy," Professor Pisani said. "We can approach Fabry disease with new treatments, such as SRT, as it is a lysosomal storage disorder." Yet, new treatment development takes time. Therefore, a strategic approach is necessary using known research results. "There are several possibilities for Fabry disease treatment. Physicians should now plan treatment option selection and strategy using research data," Professor Pisani said. "The dosage of treatment is an important factor for Fabry disease. A sufficient dosage administration can delay the disease progression." "I would like to emphasize the importance of early treatment through early diagnosis. Early treatment can delay the disease progression and worsening," Professor Pisani emphasizes.
