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- 2025-12-23 06:57:22
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- Interleukin inhibitors approved for palmoplantar pustulosis
- by Eo, Yun-Ho Apr 15, 2024 06:06am
- (From upper side) Tremfya, Skyrizi Interleukin (IL)-23 inhibitors, which are mainly used for psoriasis, are making their way into the field of palmoplantar pustulosis in Korea. Following the approval of Janssen Korea’s ‘Tremfya (guselkumab), AbbVie Korea’s Skyrizi (risankizumab) has also added an indication for palmoplantar pustulosis and has signaled competition in the area. In the case of Tremfya, its reimbursement standard was extended to cover palmoplantar pustulosis as well. Currently, Tremfya is reimbursed for: ▲patients with a PPPASI score of 12 or higher, who have been treated with acitretin or methotrexate or cyclosporine at therapeutic doses for at least 3 months but are unable to continue treatment due to no response or side effects, or ▲ patients who were treated with phototherapy for at least 3 months but is unable to continue treatment due to no response or side effects. The drug was approved as a treatment for adult patients with plague psoriasis in April 2018 and as a treatment for adult patients with active psoriatic arthritis in March 2021, and the indications were applied insurance benefits in September 2018 and May 2022, respectively. Skyrizi was recently approved by the Ministry of Food and Drug Safety for the treatment of moderate to severe palmoplantar pustulosis in adults who have had an inadequate response to, or are intolerant of, standard therapy. Skyrizi was initially approved in Korea in June 2019 for the treatment of moderate-to-severe plaque psoriasis and its indication was later expanded as a treatment for active psoriatic arthritis in adults in January 2022. The approval for palmoplantar pustulosis was based on the results of the JumPPP study, a Phase 3 clinical trial conducted in Japan to evaluate the efficacy and safety of Skyrizi. The study analyzed 119 patients and showed that from baseline to week 16, the PPPASI (Palmoplantar Pustulosis Area and Severity Index) index decreased by an average of 11.96 in the Skyrizi treatment group, which was significantly greater than the 8.48 point decrease in the placebo group. Yong-Beom Choe, President of the Korean Society of Psoriasis (Konkuk University), said “Palmoplantar pustulosis is a cutaneous immune disease characterized by an eruption of sterile pustules on the palms and soles. As it is often accompanied by itching and pain, it severely affects the quality of life of patients. And due to frequent relapses, it needs to be constantly managed with correct diagnosis and effective treatment.”
- Company
- MSD Korea’s sales 7%↓ due to the transfer of Januvia sales
- by Son, Hyung-Min Apr 15, 2024 06:05am
- The sales of MSD Korea last year declined by 7.3% year-over-year (YoY). The sales of cancer immunotherapy 'Keytruda' have increased significantly, while the sales of COVID-19 treatment 'Lagevrio' have decreased. The company’s external growth appears to have stalled. Moreover, the transfer of local sales rights of a diabetes drug 'Januvia' series to Chon Kung Dang Pharmaceutical might have also contributed to the decline in sales. According to the Financial Supervisory Service on April 13th, MSD Korea recorded KRW 760.9 billion last year, down 7.3% from KRW 820.4 in 2022. Its revenue amounted to KRW 27.4 billion, down 4.2% YoY. The trend in MSD Korea’s sales performance (unit: KRW 100 million ). MSD Korea’s sales were KRW 471.6 billion in 2019 and KRW 484.7 billion in 2020, exceeding KRW 500 billion in 2021. In 2022, the company experienced significant growth, reaching KRW 800 billion, but the sales declined slightly the following year. Keytruda, MSD Korea’s main product, saw sales rise 66.4% from KRW 239.6 billion in 2022 to KRW 398.7 billion last year. However, the industry analysis suggests that the absence of the diabetes drug Januvia lineup and the sales decline of COVID-19 treatment Lagevrio may have led to an overall performance decline. In May of last year, MSD Korea transferred the sales rights of its diabetes drug, including the Januvia series, Steglatro and Stegluzan, to Chon Kung Dang Pharmaceutical. At the same time, the company closed the general medicine (GM) business division. According to UBIST, a market research agency, the outpatient prescriptions for Januvia (sitagliptin), Janumet (sitagliptin·metformin), and Janumet XR (sitagliptin·metformin) amounted to KRW 136.8 billion. The sales of Stegluzan (ertugliflozin·sitagliptin) and Steglatro (ertugliflozin) amounted to KRW 11.2 billion. The analysis suggests that the sales decline was caused by the absence of the cash cow, which generated around KRW 150 billion. The decline in sales of the COVID-19 treatment 'Lagevrio' has been pointed out as contributing to the overall decrease in sales. Global sales of Lagevrio amounted to US$1.4 billion, down 75% from US$5.7 billion in 2022. This sharp decline in sales was due to a decrease in COVID-19 patients as the world transitioned to an endemic. Pharmaceutical industry experts postulate that the South Korean market might have experienced a similar situation. In fact, the Korean government cut down on related funds after announcing an endemic. According to the Korea Disease Control and Prevention Agency (KDCA), the budget allocated to purchase COVID-19 drugs decreased by almost half, from KRW 384.3 billion in 2022 to KRW 179.8 billion last year. Additionally, the sales of the HPV vaccine Gardasil 9 experienced a slight decrease. While Gardasil 9 sales significantly increased from KRW 72.6 billion in 2021 to KRW 117 billion in 2022, it decreased by over KRW 10 billion YoY to KRW 106.4 billion last year. With Keytruda receiving reimbursement expansion and the launch of Vaxneuvance, will MSD Korea bounce back? MSD Korea hopes to bounce back with the reimbursement expansion of its cancer immunotherapy Keytruda and newly launched Vaxneuvance, immunization for the prevention of pneumococcal disease caused by Streptococcus pneumoniae. Last year, Keytruda experienced rapid growth in sales, increasing by more than 60% YoY. As of the end of last year, Keytruda's market share was 54.6% in the anticancer immunotherapy market. Keytruda's revenue expanded from KRW 11 billion in 2016 to over KRW 100 billion in 2020, surpassing KRW 200 billion the following year. Last year, the sales topped KRW 400 billion, recording rapid growth. The main driver for Keytruda's growth lies in its expanded indications. Keytruda has the most indications among anticancer drugs, with 26 approved indications in South Korea. However, the health insurance reimbursement applies to only four cancer types: lung cancer, Hodgkin's lymphoma, urothelial carcinoma, and melanoma. MSD is planning to expand reimbursement to various solid cancer types, including triple-negative breast cancer and head and neck cancer. If reimbursement is expanded, Keytruda's sales growth potential is expected to increase. Cancer immunotherapy Keytruda·pneumococcal vaccine Vaxneuvance. MSD Korea also expects sales growth for its new vaccine, Vaxneuvance, which was released this year. Vaxneuvance is indicated for preventing invasive diseases and pneumonia caused by pneumococcal serotypes (1, 3, 5, 6A, 9V, 14, 18C, 19F, 22F, 23F, 33F). In particular, Vaxneuvance has been included in the National Immunization Program (NIP) starting this month. The NIP vaccination is inteded for infants aged two months to under five years who have not yet received or completed the schedule for the pneumococcal conjugate vaccine. Vaxneuvance is expected to compete with Pfizer's 13-valent pneumococcal vaccine Prevenar13. According to market research firm IQVIA, Prevenar13 recorded sales of KRW 45.8 billion last year.
- Company
- Boryung actively pursues co-promotion deals…
- by Kim, Jin-Gu Apr 12, 2024 05:41am
- Boryung proactively seeks opportunities to partner with pharmaceutical and biotechnology companies in South Korea and overseas. Boryung appears to be in full swing after signing a co-distribution agreement with HK inno.N for 'K-CAB' and the four items of 'Kanarb' series at the end of last year. Pharmaceutical industry experts anticipate that Boryung could achieve synergy, including external growth, portfolio expansion, and strengthening its capacity in a vulnerable market, through a co-promotion expansion strategy. Joint distribution of breast cancer treatment 'Nerlynx'…Boryung strengthens its anticancer therapy portfolio Boryung reported on April 9 that it signed a mutual co-promotion agreement with Bixink Therapeutics for two types of breast cancer treatment. According to the agreements, they will begin jointly selling and marketing Bixink Therapeutics’ 'Nerlynx (neratinib)' and Boryung’s 'Fulvet (fulvestrant).' Nerlynx is an oral HER2-positive breast cancer treatment. It was approved by the U.S. Food and Drug Administration (FDA) in 2017, and Bixink Therapeutics introduced the drug in South Korea in 2021. Nerlynx is the only extended adjuvant therapy available in South Korea, designed to lower the risk of HER2-positive early-stage breast cancer recurrence and prevent brain metastasis. Fulvet is a generic version of Faslodex that was launched by Boryung last year. It is used either alone or as a combination therapy to treat patients with hormone receptor-positive or HER2-negative, post-menopause progressive·metastatic breast cancer. Boryung expands its portfolio. The current agreement is expected to provide a synergy to both companies. Bixink Therapeutics can expect to strengthen its sales and marketing capacity, while Boryung can expect to expand its product portfolio. Boryung has added new anticancer drugs, 'Xeloda'·'Taxol'·'Samfenet,' to its portfolio. According to IQVIA, a pharmaceutical market research agency, Nerlynx generated KRW 8.2 billion in sales last year, an increase of sevenfold compared to KRW 1.2 billion in 2022, when it first launched. With Boryung’s sales capacity, the drug’s annual sales can be expected to surpass KRW 10 billion. This year, the company has signed several co-promotion deals for 'Sonon 500L'·'Suprane Solution'·'Plasma Lyte' On March 21, Boryung has signed a co-promotion agreement with Healcerion for the portable ultrasound device 'Sonon 500L.' Since the beginning of this month, Boryung has been distributing Sonon 500L to nephrology clinics nationwide. The Sonon 500L is a wireless ultrasound device developed by Healcerion for clinical diagnosis. It is convenient and economically affordable compared to bulky conventional wired ultrasound machines. This product assists in locating blood vessel positions during blood dialysis. Dialysis patients need to insert a needle into their blood vessels three times a week for dialysis. However, the lack of nephrology dialysis rooms equipped with ultrasound machines has caused inconvenience in this process. Through the Sonon 500L co-promotion, Boryung expects to strengthen its position in nephrology. Boryung is the only domestic pharmaceutical company operating a specialized dialysis agency that supplies products related to kidney disease treatment. By adding an ultrasound device targeting dialysis rooms, synergy with existing nephrology-related products is anticipated. Boryung’s CEO Duhyeon Chang (left) and Healcerion’s CEO Jeong-won Ryu (right). In January of this year, Boryung signed a domestic sales agreement with Baxter for the inhaled anesthetic 'Suprane Solution' and the IV infusion 'Plasma Lyte.' Suprane Solution is a conventional inhaled anesthetic used for inducing and maintaining anesthesia during surgeries. Plasma Lyte is an IV infusion developed by Baxter. It is used to supply and correct extracellular fluid when the circulating blood volume or interstitial fluid is reduced. Through this agreement, Boryung expanded its portfolio of drugs used for anesthesia. Boryung previously sold the antiemetic 'Naseron (ramosetron)' and the reversal agent of muscle relaxant 'Breathon (sugammadex).' On April 3, Boryung signed a memorandum of understanding (MOU) with Vivozon Pharmaceutical to commercialize the non-narcotic analgesic Unafra (opiranserin) in South Korea. Opiranserin is a non-narcotic analgesic used for postoperative pain, and domestic product approval is expected by the end of the year. Upon receiving product approval, Vivozon Pharmaceutical will supply finished products to Boryung, and both companies will be responsible for distribution and sales, respectively. Boryung started to strengthen its partnership after signing a co-distribution agreement for its 'K-CAB'-'Kanarb' series last year Boryung appears to be in full swing for expanding partnership after signing a co-distribution agreement with HK inno.N for 'K-CAB'-'Kanarb' series at the end of last year. In December of last year, Boryung partnered with HK inno.N to jointly sell 'K-CAB' and four items of the 'Kanarb' series (Kanarb·Dukaro·Dukarb·Dukarb Plus). These two items are both blockbuster drugs with annual sales of over KRW 100 billion. HK inno.N’s CEO Dalwon Kwak (left), Boryung’s CEO Duhyeon Chang (right). Pharmaceutical industry experts anticipate that Boryung’s proactive expansion through partnerships will bring positive effects, including increased external growth, portfolio diversification, and entry into new markets. Boryung has set a sales target of 1 trillion won for this year. Last year, Boryung recorded sales of KRW 859.6 billion. Mathematically, sales need to increase by more than KRW 140 billion compared to the previous year, and it is expected that the contribution of K-CAB will likely play a significant role in this. In addition, it is also likely that the products covered by the co-promotion agreement signed this year will contribute to achieving this goal. By adding Nerlynx to their anticancer portfolio, Boryung can anticipate portfolio expansion, building on past strengths. Additionally, the company can now aim to strengthen its position in areas such as gastroenterology, nephrology, and anesthesiology, where its marketing and sales capabilities have been analyzed as lacking. The K-CAB co-promotion is expected to significantly boost Boryung's marketing and sales capabilities in the gastroenterology field. “We will create momentum for sustained growth through mutual co-promotion with diverse companies. We will also seek opportunities for mutual growth by establishing a 'collaborative business model,' which has been difficult to find in the industry,” the official from Boryung stated.
- Company
- ‘Mounjaro may shift the Type 2 diabetes treatment paradigm'
- by Son, Hyung-Min Apr 12, 2024 05:41am
- Dr. Thomas Forst, professor of Internal Medicine and Endocrinology at the Johannes Gutenberg University in Main, Germany (Chief Medical Officer, CRS Clinical Research Services, Germany) Mounjaro has shown the most potent effect among incretin-based therapeutic agents. Based on the dramatic effect it showed in reducing blood sugar levels and weight loss in clinical trials, we expect the drug will bring about many changes field of diabetes treatment.” Thomas Forst, Professor of Internal Medicine and Endocrinology at the Johannes Gutenberg University in Main, Germany (Chief Medical Officer, CRS Clinical Research Services, Germany), met with Dailypharm and said Mounjaro has the potential to become a game-changer in the field of diabetes. Developed by the global pharmaceutical giant Eli Lilly, MUNJARO is a treatment for type 2 diabetes that acts on both the glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). People with type 2 diabetes have reduced incretin effect. This decrease in incretin effect is primarily due to decreased secretion of GLP-1 and impaired insulin-stimulating effects of GIP. GLP-1 and GIP are responsible for two-thirds of the postprandial insulin response. By acting on GIP in addition to GLP-1, Mounjaro can further improve glycemic control. Another of its strengths is its weight loss benefit. In 3 clinical studies of patients with type 2 diabetes, more than half of patients lost 5% or more of their body weight. As most patients with diabetes are pre-obese or obese, weight management is a critical issue. This is why the analysis is that Mounjaro’s use could increase on-site. The number of diabetes patients on the rise globally...emphasizing the importance of blood sugar management The number of diabetics is on the rise globally. According to a study published in the medical journal Lancet, approximately 529 million people were living with diabetes worldwide in 2021. By 2050, the number is expected to reach approximately 1.31 billion worldwide. "With the increase in people with type 2 diabetes, complications such as hypertension and dyslipidemia are also on the rise," said Professor Forst. "The increase in the incidence of diabetic complications means that the number of myocardial infarctions, strokes, and deaths from cardiovascular disease is also on the rise. Therefore, there is a great need for the discovery of new therapeutic agents and their effective use.” The number of diabetes patients is also on the rise in Korea. According to the 2021 fact sheet released by the Korean Diabetes Association (KDA), the prevalence of diabetes in adults aged over 30 years was 16.7%. The number has been on the rise for the past 9 years. The problem is in the treatment outcomes. Despite being treated with oral hypoglycemic medications or insulin, 75% of diabetes patients in South Korea do not achieve a glycated hemoglobin (HbA1c) level below 6.5%, which is the treatment goal and pre-diabetes stage. About 20% of people with diabetes have HbA1c levels above 8.0% and are in need of more aggressive treatment. “HbA1c is a measure that gives you a big picture of how well a patient had controlled his or her blood sugar levels over a three-month period,” explained Professor Forst. “Looking at fasting blood glucose level alone can lead to a false sense that your blood sugar is being well controlled.” Due to this importance in achieving an HbA1c level, there has been a need for a treatment that effectively lowers the blood glucose level. Mounjaro demonstrated its blood glucose reduction effect in clinical trials. In the SURPASS 1-5 trials, the drug showed greater HbA1c reduction than semaglutide, insulin, and other existing diabetes treatments. More specifically, in the SURPASS 4-5 and SURPASS J-mono trials that were conducted on patients with type 2 diabetes, Mounjaro reduced HbA1c by a mean of -2.11% to -2.8%. "In clinical trials, many patients achieved their target HbA1c level,” said Professor Forst. “Even patients who did not achieve the HbA1c level goal of 6.5%, which is the diagnostic threshold for diabetes, benefited from the use of Mounjaro." 'Weight loss effect’ is another benefit of the diabetes drug Mounjaro One of the other strengths of Mounjaro is its weight-loss benefit. In clinical trials, most patients who were administered the drug lost weight. Currently, Mounjaro is approved as a treatment for type 2 diabetes and is not indicated for weight loss. However, it is clear that weight loss can be of great benefit to diabetes patients. In Korea, 78% of people with type 2 diabetes are pre-obese or obese. The more obese the people with type 2 diabetes are, the more likely they are to have poor blood sugar control and develop diabetes-related complications Therefore, domestic and international clinical practice guidelines recommend that overweight or obese diabetics lose 5-15% of their body weight. Major international academic societies also concur. The American Diabetes Association (ADA) emphasized the importance and urgency of weight management in the overall care of people with diabetes in its 2024 diabetes treatment guidelines that it released recently. According to the ADA, adult patients with type 2 diabetes can achieve better glycemic blood levels, blood pressure, and lipid control when they lose 3-7% of their body weight, and weight loss of 10% or more can have a positive long-term impact on reducing cardiovascular mortality. In the SURPASS 4-5 and J-mono studies, 48-89% of patients who were administered Mounjaro achieved a weight loss of 5% or more. In the SURPASS-2 study, Mounjaro also demonstrated faster weight loss results compared to the GLP-1 agent semaglutide. "Weight gain and obesity are important risk factors for diabetes, and diabetes is also linked to several inflammatory and cardiovascular diseases, including hypertension and dyslipidemia. Maintaining a healthy weight is as important as controlling the blood glucose level for people with diabetes.” He added, "I would say Mounjaro is a good option for people with diabetes who are struggling with weight control, as the drug has been clinically proven to help them lose weight." ” Mounjaro will rise as a game changer if it also demonstrates cardiovascular benefits" Currently, some diabetes drugs are expanding their area after demonstrating cardiovascular benefits. SGLT-2 inhibitors, for example, are approved for heart failure and chronic kidney disease. The SURPASS-CVOT clinical trial is also underway for Mounjaro to evaluate the drug’s cardiovascular benefits. It has enrolled more than 13,000 adult diabetes patients with comorbid cardiovascular disease. Dr. Forst expects Mounjaro to become a game-changer if it proves to be effective in cardiovascular disease. "We will have to wait for the results of the ongoing studies that have cardiovascular events as an endpoint, but if Mounjaro proves to be more effective than GLP-1 receptor agonists in reducing cardiovascular events, I am confident that Mounjaro will be a game-changer,” said Dr. Forst.
- Company
- K-Pharma wins another patent dispute against ‘Entresto’
- by Kim, Jin-Gu Apr 11, 2024 05:45am
- Generic companies win the third trial surrounding the method-of-use patent of Novartis’ ‘Entresto,’ a heart failure treatment. As generic companies win the third trial surrounding the method-of-use patent of Novartis’ ‘Entresto,’ a heart failure treatment, they are one step closer to an early entry of their generic products. Now, the patent hurdle is down to two for early entry of generic versions of Entresto. If generic companies succeed in overcoming the remaining two patents, an annual market size of KRW 60 billion is anticipated to open. On April 8, the pharmaceutical industry reported that the Supreme Court ruled of ‘discontinuance of a trial’ on Novartis’ appeal against Hanmi Pharmaceutical and others in Entresto’s method-of-use patent nullification trial. The ‘discontinuance of a trial’ ruling refers to the system under which the Supreme Court ceases to hear appeals, dismisses such appeals, and confirms that a lower court ruling is intact. In other words, Novartis appealed to the court, arguing that the patent court ruling was unjust, but the Supreme Court ruled that there was no basis for the appeal. Generic companies won the first and second trials of the method-of-use patent dispute trials. In April 2021, Hanmi and other pharmaceutical companies claimed nullification of Entresto’s method-of-use patent and requested a ruling. Last November, Generics also won a case in the second trial following Novartis’ appeal. Subsequently, Novartis appealed against the decision yet again, but the Supreme Court ultimately dismissed Novartis’ final appeal. As a result, only two patents remain for the early entry of generic versions of Entresto: the salt· hydrates patent, which expires in November 2026, and the crystalline form patent, which expires in September 2027. Regarding these patents, the generic companies won their cases during the first trial of patent dispute. After losing the first trial, Novartis appealed to the patent court, asking to cancel the first trial decision. If the generic companies win the second trial, generics can be released earlier in the market. There is a possibility that Novartis may appeal to the Supreme Court. Since the generic companies have already won both the first and second trials, they will face less burden due to patent infringement. According to UBIST, a market research agency, Entresto recorded outpatient prescription sales of KRW 57.5 billion last year, up 35% compared to 2022. Entresto was launched in October 2017 with reimbursement. It consistently expanded its indication, generating outpatient prescription sales of KRW 5.5 billion in 2018, KRW 14.3 billion in 2019, KRW 22.4 billion in 2020, KRW 32.4 billion in 2021, and KRW 42.5 billion in 2022.
- Company
- SK’s CMO business posted KRW 812 billion last year…
- by Chon, Seung-Hyun Apr 11, 2024 05:44am
- SK Group's contract manufacturing organization (CMO) business posted a deficit last year. Sales reached nearly KRW 1 trillion, but its growth was sluggish. Investments increased due to the expansion of production facilities at acquired companies, and demand for contract manufacture of COVID-19 drugs from overseas pharmaceutical companies decreased. According to SK on April 9, SK Pharmteco’s sales revenue last year was KRW 812 billion, down 10.5% from the previous year. SK Pharmteco posted an operating profit of KRW 49 billion in 2022 but turned to an operating loss of KRW 89 billion. Quarterly sales of SK Pharmteco (Unit: 100 mil, Source: SK). Established in January 2020 in California, U.S., SK Pharmteco is SK Group's contract manufacturing organization (CMO) in charge of the company’s manufacturing of consigned pharmaceutical products. SK Pharmteco is comprised of five entities: SK Biotech, SK Biotech Ireland, AMPAC, Yposkesi, and CBM. The company has a localization strategy that allows the company to carry out CMO businesses in the U.S. and Europe by establishing local manufacturing facilities. Quarterly sales of SK Pharmteco (Unit: 100 mil, Source: SK). SK Pharmteco’s sales increased from KRW 651 billion in 2020 to KRW 776 billion in 2021, and KRW 907 billion in 2022, but the growth slowed down last year. In terms of quarterly sales, SK Pharmteco recorded KRW 249 billion in sales in Q4 2022, followed by KRW 197 billion in Q1 2023, a 20.9% decrease from the previous quarter. The company posted a loss of KRW 15 billion in Q1 last year. Sales rebounded to KRW 214 billion in Q2 last year but fell 15.7% YoY to KRW 183 billion in Q3. The decline in orders for COVID-19 drugs from large pharmaceutical companies created a revenue gap for CDMOs. SK Pharmteco posted a loss of KRW 15 billion each in Q1 and Q2 last year. The losses reflected costs related to the expansion of its production facility in Virginia, U.S. In the Q4 last year, sales reached KRW 218 billion, up 19.1% from the previous quarter. The company explained, “Sales increased due to the expansion of our pipeline that includes our core products, and the effect of the acquisition of CBM.” The company posted a loss of KRW 59 billion in Q4 last year, which reflects the initial operating loss of the gene cell therapy business following the acquisition of CBM. SK Pharmteco acquired the management rights for The Center for Breakthrough Medicines (CBM), a U.S. cell and gene therapy CDMO, in September last year. In January 2022, SK Pharmteco invested USD 350 million (approximately KRW 420 billion) to fortify its bio business in the U.S. and became the second-largest shareholder. It ascended to become CBM's largest shareholder afterward by exercising the call option rights it secured during that time. CBM is building a 65,000㎡ facility, the world's largest single manufacturing facility for cell and gene therapies, of which approximately 28,000㎡ have been completed to house its Viral Vector GMP facility and development and analytical laboratories. When the GMP production facility for plasmids, the raw material used for cell and gene therapy drugs, is completed this year, the entire process, including development, production, and analysis, from plasmids to finished products such as viral vectors and cell therapy products, will be provided in one place. Viral vectors are virus-based gene transfer vectors that insert therapeutic DNA into viruses for safe and efficient administration to the human body. Compared to using different suppliers for each development and production process, the production period and cost can be reduced. SK is implementing a strategy at the group level to develop SK Pharmteco into a global CDMO company. Unlike how Samsung Biologics, whose CMO business has been growing rapidly in recent years, produces and supplies biopharmaceuticals ordered by overseas customers at its Songdo plant in Incheon, SK Pharmteco implemented a localization strategy and built production bases in the U.S., Europe, and other countries to develop its CMO business. SK Biotech, which is in charge of the domestic production base, was established in April 2015 by spinning off SK Biopharm's raw pharmaceutical material business. In 2016, SK incorporated SK Biotech as a 100% subsidiary. SK invested KRW 40 billion in March 2016 and KRW 172.5 billion in November 2017 through a paid-in capital increase. SK Biotech engages in the business of developing new raw materials using its proprietary technology. SK SK Pharmteco has secured a total of 5 overseas bases since 2017. SK Biotech Ireland is the successor of BMS’s Ireland plant, which was acquired by SK Biotech in June 2017 for KRW 170 billion. In 2019, SK acquired a 100% stake in U.S. biopharmaceutical CDMO AMPAC to secure a U.S. manufacturing base. AMPAC has production facilities in California, Texas, and Virginia. SK Group invested about KRW 1 trillion to acquire SK Biotech Ireland and AMPAC. The three entities, SK Biotech, SK Biotech Ireland, and AMPAC, produce synthetic drugs. In March 2021, SK Pharmteco expanded into the biopharmaceuticals sector with the acquisition of French gene and cell therapy drug contract manufacturer Yposkesi. Last year, it became the largest shareholder of CMB and secured an additional production base for cell and gene therapy. SK Pharmteco plans to strengthen its global market penetration through integrated operations of CBM and Yposkesi. Yposkesi’s second plant was completed in June last year, and totaled at 10,000㎡, the largest in Europe.
- Company
- NIP vaccine Vaxneuvance lands in ‘Big 5’ hospitals in KOR
- by Eo, Yun-Ho Apr 11, 2024 05:44am
- The pneumococcal vaccine Vaxneuvance, which can now be received free of charge in Korea, is quickly landing in general hospitals in Korea. According to industry sources, MSD’s vaccine has passed the drug committees (DCs) of the ‘Big 5’ tertiary hospitals in Korea, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital. It is also being rapidly supplied to local clinic-level institutions as well. Vaxneuvance, which has been included in the National Immunization Program (NIP) since January 1, is used to prevent invasive diseases and pneumonia caused by a total of 15 pneumoniae serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) in all ages from 6 weeks of age and above. All children 2 months to 5 years of age who have not yet received the pneumococcal conjugate vaccine or who have started but have not completed their schedule are eligible to receive Vaxneuvance through NIP. Vaxneuvance confirmed its cross-immunization ability with the existing PCV13 through pediatric clinical studies, so children who have received at least one dose of existing PCV13 may cross-vaccinate the remaining recommended doses with Vaxneuvance. In addition to protection against the 13 serotypes it shares with PCV13, Vaxneuvance offers protection against two new serotypes, 22F, and 33F, which are the leading causes of invasive pneumococcal disease. With an increase in serotype replacement, which refers to the expansion of non-vaccine serotypes caused by serotypes not included in existing vaccines, being reported globally, Vaxneuvance is rising as a preventive option that meets the current pneumococcal disease situation. The immunogenicity of individual serotypes in a vaccine is as important as the range of prevention in vaccine selection criteria, as it can predict the efficacy of a vaccine. The World Health Organization (WHO) has recommendations for standardized immunogenicity testing of pneumococcal vaccines. In a total of 12 clinical studies on adults or infants, children, and adolescents, Vaxneuvance confirmed its immunogenicity was non-inferior to conventional PCV13 in the 13 shared serotypes, and superior against unique serotypes 22F and 33F, confirming equivalent levels of immunogenicity across all 15 serotypes included in the vaccine. In addition, there remained an unmet need for protection against serotype 3, which causes fatal invasive disease in children, as it continues to be reported following conventional pneumococcal vaccination, and Vaxneuvance confirmed superior immunogenicity over PCV13 against the serotype.
- Company
- Mundipharma Korea closes its opioid analgesics business
- by Son, Hyung-Min Apr 09, 2024 05:50am
- Mundipharma Korea is drastically reorganizing its opioid analgesics specialty drug business unit. This is the second time the Korean branch made such large-scale reshuffles since the bankruptcy of its US headquarters, Purdue Pharma in August 2022. The company is known to be searching for a domestic pharmaceutical company to take over the sales of its opioid analgesics and manage its sales with a minimum number of employees. According to industry sources on the 5th, the company is conducting an Early Retirement Program (ERP). This time the target is 25 sales and marketing employees in the specialty drug business unit for the opioid analgesics. The ERP compensation terms are monthly base salary*(years of service*2+9) + severance pay, calculated as of 2024. The retirement bonus is KRW 20 million for less than 5 years of service, KRW 30 million for less than 10 years of service, KRW 40 million for less than 15 years of service, and KRW 50 million for 15 years or more years of service. If an employee with 20 years of service whose monthly salary is KRW 5 million leaves the company, he or she will receive 49 months of salary plus KRW 50 million, or KRW 295 million. Mundipharma Korea is experiencing the aftermath of its U.S.-based Purdue Pharma's downsizing of its opioid analgesics division. Opioid analgesics have become a social problem in the U.S., with overdose deaths and addiction leading to trillions of dollars in fines for drugmakers. In 2019, Purdue Pharma agreed to pay a KRW 5 trillion settlement to 15 U.S. states after admitting that it aggressively marketed its opioid analgesic OxyContin and concealed its addictive properties. The company has filed for bankruptcy since then. Currently, the opioid analgesics sold by Mundipharma Korea in Korea are Norspan, OxyContin, IR cordon, Targin, OxyNorm, etc. The combined annual sales of these products grossed around KRW 30 in 2023. However, sales of all of these products have been declining since 2019. Currently, Mundipharma Korea is looking for a domestic pharmaceutical company that can handle the sales of its opioid analgesics. It plans to retain 4 internal employees (two wholesale call sales personnel, one collaboration personnel, and one strategy personnel) to manage the distribution network. Psychotropic drugs such as Norspan will be sold and distributed by the partner company, and the other products will be distributed by Mundipharma Korea. This is why the company seeks to only retain the staff necessary for distribution and collaboration. The company said, "This personnel reduction decision was made on a global level, and the local management has no authority to make decisions on the matter.” The company's labor union is also expressing dissatisfaction. A union official said, "The company had carried out a personnel restructuring a year and a half ago, and we have been showing high productivity with the remaining few. So we feel a greater sense of loss with this year’s reduction. The negotiations regarding our job security are at a standstill. We are also in the process of wage negotiations, but feel like the company is drawing a line." "Sales of major opioid analgesics are down, but I think the 25 people have done a good job of covering the work that had been done by over 100 people. It is disappointing that this effort has not been recognized and that the company has shown no willingness to avoid layoffs."
- Company
- Korean and global pharmas in race for lung cancer drugs
- by Son, Hyung-Min Apr 09, 2024 05:50am
- Pharmaceutical and biotechnology companies in South Korea are conducting clinical trials to overcome drug resistance in conventional non-small cell lung cancer (NSCLC) therapy. These companies are developing 4th-generation lung cancer treatments that have proven effective in patients with drug resistance after the use of 1st-to-3rd-generation targeted therapies. Conventional EGFR-positive NSCLC therapies are categorized into 1st-generation AstraZeneca’s Iressa (gefitinib) and Roche’s Tarceva (erlotinib), 2nd-generation Boehringer Ingelheim’s Giotrif and Pfizer’s Vizimpro (dacomitinib), and 3rd-generation Yuhan Pharmaceutical’s Leclaza (lazertinib) and AstraZeneca’s Tagrisso (osimertinib). However, drug resistance can still occur when using targeted therapies with proven effectiveness. The C797S mutation is the most common mutation in EGFR-positive targeted therapies. Treatment options following the targeted therapies are limited. Patients with resistance to targeted therapies have the option of using anticancer chemotherapy, docetaxel, or cancer immunotherapy. However, these drugs do not significantly improve response rates. Latecomer companies target a C797S mutation that causes resistance after the conventional 1st-to-3rd-generation targeted therapies, aiming to seek commercialization opportunities. The analysis is that these drugs compete against antibody-drug conjugates (ADC), which have proven effective in patients resistant to targeted therapies, for commercialization. The K-Bio industry is conducting clinical trials targeting C797S mutation According to industry sources on April 6, domestic biotech venture J INTS BIO presented clinical phase 1/2 results on its 4th-generation EGFR-positive candidate JIN-A02. Byoung Chul Cho (Director of the Lung Cancer Center at Yonsei Cancer Hospital), who is also in charge of Leclaza and Rybrevant, leads the clinical stage of JIN-A02. JIN-A02, a 4th-generation EGFR tyrosine kinase inhibitor (TKI), has an underlying mechanism of action that selectively binds to C797S, which causes resistance to 3rd-generation NSCLC treatment. In the clinical study, JIN-A02 confirmed a partial response (PR) in one patient and stable disease (SD). J INTS BIO explained that among 4th-generation EGFR-TKI treatments, it is the first instance of PR in patients with the C797S mutation. Bridge Biotherapeutics is developing BBT-207, a 4th-generation EGFR-positive lung cancer treatment. A phase 1/2 trial of BBT-207 is currently being conducted, enrolling 90 patients with EFGR-positive NSCLC in South Korea and the United States. Bridge Biotherapeutics plans to understand data on different mutations in patients acquired through liquid biopsy. In a preclinical trial, BBT-207 demonstrated anti-tumor effectiveness in various EGFR mutations, including the C797S mutation. Therapex has received approval from the Ministry of Food and Drug Safety (MFDS) for a phase 1/2 TRX-221 trial last month. Therapex plans to determine the recommended dose in Phase 1 and assess effectiveness in Phase 2a. The company aims to obtain approval for the indication in advanced NSCLC with EGFR C797S mutation. Previously, Therapex demonstrated the drug’s dose-dependent anticancer efficacy and blood-brain barrier (BBB) permeability in a Tagrisso-resistant brain tumor mouse model. Voronoi has obtained approval for a phase 1 trial in South Korea and is conducting the clinical trial. Voronoi also targets EGFR C797S. Through this phase 1 trial, the company plans to evaluate the drug’s effectiveness against the C797S-resistant mechanism of action. HK inno.N is conducting research on IN-119873, a 4th-generation targeted anticancer treatment, for patients who have shown resistance in the first-line treatment of NSCLC or have an L858R mutation. Unlike conventional treatments that target the binding site of adenosine triphosphate (ATP), an energy source of cancer cells, IN-119873 targets the allosteric binding site (one of the protein binding sites) of the EGFR, providing a significant advantage. Korean and overseas companies are developing fourth-generation EGFR-positive targeted lung cancer treatments. For overseas pharmaceutical companies, Black Diamond Therapeutics leads the clinical race…Will it surpass ADC Overseas pharmaceutical companies, as well as Korean biotechnology companies, are actively conducting clinical trials on 4th-generation lung cancer treatments. Black Diamond Therapeutics confirmed the highest number of partial responses (PR) in their phase 1/2 clinical trial. They are repurposing their existing brain tumor treatment, BDTX-1535, as a 4th-generation lung cancer targeted therapy. In a clinical trial targeting NSCLC patients with acquired resistance to targeted therapy, Black Diamond Therapeutics's 4th-generation EGFR-TKI treatment, BDTX-1535, yielded results of five patients with partial response (PR) and six patients with stable disease (SD) out of a total of twelve. In contrast, the U.S.-based Blueprint Medicines faces difficulties in drug development as it failed to confirm efficacy in Phase 1 clinical trials. The company faced setbacks with its 4th-generation targeted therapy candidate, BLU-945 monotherapy. However, the company is currently exploring the possibility of commercializing it as a combination therapy with Tagrisso. Blueprint Medicines plans to target exon 21 L858R mutations rather than the C797S mutation in Tagrisso-resistant patients. However, the commercialization of these targeted therapies faces a challenge in surpassing ADC clinical results. Currently, Daiichi Sankyo and MSD are jointly developing an ADC that has shown effectiveness in Tagrisso-resistant patients, and their data are being disclosed. Daiichi Sankyo and MSD’s Patritumab deruxtecan, which targets human epidermal growth factor receptor 3 (HER3), has shown effectiveness in EGFR-TKI patients compared to platinum-based chemotherapy in the phase 2 HERTHENA-Lung01 study. In the clinical trial, patritumab demonstrated complete responses (CR) and confirmed 66 partial responses (PR). The objective response rate (ORR) was observed at 29.8%. Currently, this treatment is designated as a priority review drug by the U.S. Food and Drug Administration (FDA), with approval expected to be finalized in June of this year.
- Company
- Ilaris reimb passes DREC review, but again with a condition
- by Eo, Yun-Ho Apr 09, 2024 05:50am
- The orphan drug 'Ilaris' has again received a conditional reimbursement decision in Korea. Ilaris (canakinumab), Novartis Korea’s treatment for hereditary periodic fever syndrome, was quickly resubmitted to the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee on the 4th after receiving a conditional reimbursement decision at the same level in February but faced the same results. However, whether the scope of additional data requested by the government was reduced compared to before remains key to the drug’s road to reimbursement. Novartis was unable to accept the conditions set by the DREC in February. However, it is unlikely that DREC would have set the same level of additional documentation requirements in its second conditional reimbursement decision. In other words, what the government took into consideration this time and whether the drugmaker accepts the new terms will determine the future fate of Ilaris. Since being approved in 2015, Ilaris has already failed two reimbursement attempts. With patients waiting more than 8 years, it will be interesting to see if the government and the pharmaceutical company can reach an agreement and move toward expanding coverage. Ilaris is indicated in Korea to treat ▲Cryopyrin-Associated Periodic Syndromes (CAPS), ▲Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), ▲hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), ▲ Familial Mediterranean Fever (FMF), and ▲ Systemic juvenile idiopathic arthritis (JIA). Among the indications, CAPS is further categorized into ▲Familial Cold Autoinflammatory Syndrome (FCAS)/Familial Cold Urticaria (FCU), ▲Merkle-Wells Syndrome (MWS), and ▲Neonatal Onset Multisystem Inflammatory Disease (NOMID)/Chronic Infantile Neurological Cutaneous Articular Syndrome (CINCA). With such a small patient population and complex indications, reimbursement discussions for the drug have not been easy. The number of patients for the many indications of Ilaris’ is extremely small. Some indications for Ilaris don't even have disease codes or have only recently been registered. Dr. Dae-Cheol Jeong, President of the Korean College of Pediatric Clinical Immunology (Department of Pediatrics, St. Mary's Hospital, Seoul, Korea), said, "There are many challenges to reimbursing Ilaris because due to its very specific indications and the very small number of patients each. The current situation is regrettable as some patients are even considering emigrating to countries where Ilaris can be prescribed with reimbursement."
