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- 2025-12-23 07:52:31
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- Marketability of homegrown drugs being tested in the US
- by Chon, Seung-Hyun Dec 20, 2023 05:41am
- Domestic pharmaceutical and bio companies are entering the US one after another. GC Biopharma succeeded in entering the US market with its blood product on its third try. Since last year, 3 domestically developed drugs have passed the US market gateway, starting with Hanmi Pharmaceutical and Celltrion. Until now, homegrown drugs that have entered the U.S. were deemed to be far from market success. In this sense, the success potential of homegrown drugs is now being tested in earnest in the US market. GC Biopharma announced on the 18th that it received marketing authorization for its Alyglo from the US Food and Drug Administration on the 15th. ALYGLO is a liquid solution containing immunoglobulin G for intravenous infusion, manufactured from pooled human plasma from US donors. It is used to treat primary humoral immunodeficiencies such as congenital immune deficiency and Immune thrombocytopenia. In Korea, the drug is being sold under the brand name, ‘IV-Globulin SN Inj.’ GC Biopharma was able to pass the barrier to US market entry and receive FDA approval on its third try. GC Biopharma first applied for the approval of its IVIG-SN 5% product at the end of 2015. In November 2016, the company was asked to supplement the manufacturing process data. In September 2017, the authorities again requested GC Biopharma to submit supplementary material, delaying approval. As a result, the company revised its strategy to introduce the more marketable 10% dosage to the U.S. market first. In 2020, it completed the North American Phase 3 clinical trial of IVIG-SN 10% Alyglo and submitted a biologics license application to the FDA in February 2021. However, in February of last year, the company received a notice of delay from the FDA. Due to the COVID-19 pandemic at the time, the review was conducted non-face-to-face in Q4 2021, but the FDA decided to postpone the drug’s approval due to the need for on-site inspection of the manufacturing facility. In April, the FDA team conducted an inspection of the manufacturing facility and quality system, including the fractionation and finishing of IVIG-SN at GC Biopharma’s Ochang plant. After completing the GMP inspection of the Ochang plant, GC Biopharma resubmitted the license application in consultation with the FDA and received final approval this time. Among those made by Korean pharma and bio companies, three homegrown drugs from Hanmi Pharmaceutical, Celltrion, and GC Biopharma have entered the U.S. market since last year. In September last year, the FDA gave the final approval to Spectrum Pharmaceuticals' application for Rolontis (U.S. brand name Rolvedon) Rolvedon Rolvedon is a biological drug Hanmi Pharmacuetical had licensed out to Spectrum in 2012. is administered to prevent or treat neutropenia in cancer patients who receive myelosuppressive chemotherapy in Korea. In Korea, the drug received approval as the 33rd homegrown novel drug in March 2021. Rolontis is manufactured at Hanmi’s Pyeongtaek plant. It is the first Korean biological drug to enter the US market after being produced in a domestic plant that passed the FDA’s on-site inspections. Rolvedon became the 6th new drug developed by a domestic company to clear the FDA approval process. In October, Celltrion received approval from the US FDA to market Zymfentra, a subcutaneous (SC) formulation of its antibody biosimilar Remsima as a new drug. Remsima is a biosimilar product of Remicade. Zymfentra is licensed and marketed in Europe under the name Remsima SC. Zymfentra is Celltrion's first product licensed as a new drug in the United States. ZymfentraThe FDA recognized the product's differentiated value from the approval discussion stage and recommended the company take the new drug approval process. To obtain approval as a new drug, Celltrion conducted two new global Phase III clinical trials. Based on the safe safety and efficacy results demonstrated through the clinical trial Celltrion submitted an application for approval in December of last year in accordance with the FDA's new drug approval process and obtained approval in 10 months. LG Chem’s antibiotic Factive was the first among homegrown new drugs to pass the US gates in 2003. Then, Sivextro that Dong-A ST licensed-out was approved by the FDA in 2014. Then, in 2016, SK Chemical’s hemophilia drug Afstyla received FDA approval. Afstyla is a new genetic recombinant drug that was developed by SK Chemical with its proprietary technology. SK Chemical licensed the drug candidate to Australia’s CSL Behring in the preclinical stage in 2009, and CSL Behring conducted the clinical trials and received approval for the drug in the US and Europe. In 2019, two of SK Biopharmaceuticals’ drugs - the narcolepsy drug Sunosi and the new epilepsy drug Xcopri - received FDA approval. In 2019, Sunosi, SK Biopharmaceuticals’ sleep disorder drug that the company licensed out, received final approval from the FDA. SK Biopharmaceuticals completed Phase I trials for the candidate drug after discovery and licensed-out the candidate Jazz Pharmaceuticals in 2011. Jazz acquired the global commercialization rights for Sunosi, including those for the US and Europe, completed Phase III trials, and reached the commercialization stage. In November 2019, the company also received FDA approval for its epilepsy treatment Xcopri. Xcopri is the first new drug to be solely developed and applied and granted FDA approval by a domestic company. Xcopri is a positive allosteric modulator of the y-aminobutyric acid (GABAA) ion channel, which blocks the voltage-gated sodium currents, causing the reduction in repetitive neuronal firing, and reducing seizures. As such, the industry believes this is the time to test the potential for commercial success of homegrown drugs in the United States. So far, domestic drugs that have received US approval have been far from conquering the global stage. Factive’s overseas expansion was hindered when its partner GlaxoSmithKline withdrew from the deal over clinical data. More than KRW 300 billion was invested in its development, but its sales in the U.S. have been negligible. Sivextro, which was approved by the FDA in 2014, and Afstyla, which debuted in the U.S. market in 2016, have not performed as well commercially as expected. The company voluntarily withdrew the license for Sivextro, citing low drug prices in Korea. Quarterly Sales of Xcopri in the US (Unit: KRW 10 million, Data SK Biopharm). On the other hand, SK Biopharm's Xcopri is gradually expanding its share in the US market. Since its launch in the US, Xcopri has continued to renew its sales record every quarter. After posting initial sales of KRW 2.1 billion in the US in 2020, the drug generated sales of KRW 75.7 billion in Q3 this year. Xcopri’s cumulative sales in the US last year were KRW 169.2 billion, and in Q3 of this year alone, Xcopri surpassed last year's sales with KRW 193 billion. Xcopri’s cumulative sales in the U.S. over the past 3 years totaled at KRW 452.1 billion. Rolvedon, a drug licensed out by Hanmi Pharmaceutical, has also continued to grow in the US market, with sales of $15.6 million (KRW 20 billion) and $21 million (KRW 28 billion) in Q1 and Q2 respectively. Rolvedon was developed by Assertio Holdings, a pharmaceutical company specializing in central nervous system, pain, and inflammation, which acquired Spectrum Pharmaceuticals in April.
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- LG Chem joins in the 3-way race in Humira biosimilar mkt
- by Chon, Seung-Hyun Dec 19, 2023 05:54am
- LG Chem has joined in to compete for a share of the Humira biosimilar market. Humira is an original autoimmune disease treatment. With the introduction, a three-way competition will start between Samsung Bioepis, Celltrion, and LG Chem in the KRW 100 billion annual market. It has been 2 years since biosimilars entered the Humira market, but the original product still has a stronghold and remains unrivaled in the market. LG Chem announced on the 15th that it has received marketing authorization from the Ministry of Food and Drug Safety for its adalimumab Humira biosimilar Xelenka. Two types of Xelenka - Xelenka Prefilled Syringe Inj and Xelenka Autoinjector Inj – were approved at the time. Xelenka is approved for the following adult indications: rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, adult Crohn's disease, psoriasis, ulcerative colitis, Behcet's enteritis, hidradenitis suppurativa, and uveitis. It is also approved for 3 pediatric indications: pediatric Crohn's disease (6 to 17 years of age), pediatric idiopathic arthritis, and pediatric plaque psoriasis. As a result, three domestic companies, with LG Chem following Samsung Bioepis and Celltrion, have released Humira biosimilars in the market. In July 2020, Samsung Bioepis received approval for Adalloce, the first Humira biosimilar, followed by the approval of Celltrion’s Yuflyma in June 2021. Humira posted sales of KRW 104 billion in 2019 and KRW 91.2 billion and 85.8 billion in 2021 and last year, respectively. Quarterly saels of Humira (Unit: 100 million, Data: IQIVA). Competition in the Humira biosimilar market started in earnest when Samsung Bioepis’s Adalloce was approved with reimbursement in May 2021. Although 2 years have passed since domestic companies started selling Humira biosimilars, the pace of expansions made by the biosimilars has been deemed to be slow.. According to the market research institution IQVIA, the market for adalimumab reached KRW 25.3 billion in Q3. This is a 3.7% YoY increase and a 17.6% rise 2 years from the KRW 21.5 billion in Q3 2021. The original Humira has maintained a solid stronghold over the market despite the entry of its biosimilar. Humira's Q3 sales decreased 2.3% YoY to KRW 21.5 billion. This is still a 1.8% rise from the KRW 21.1 billion it had raised in Q3 2021. Adalloce’s Q3 sales were KRW 3.4 billion. This was a 54.5% increase from Q3 last year and a 13.3% share of the adalimumab market. Yuflyma’s Q3 sales reached KRW 400 million. The market share of the two domestic biosimilars combined was 14.9% in Q3. The share of biosimilars in the Humira market has been gradually expanding after exceeding 10% in Q4 last year, but the sales gap with the original product remains large. Experts have attributed the slow market penetration rate to the small gap in the prices of original products and biosimilars. The insurance ceiling price of Adalloce Prefilled Syringe 40mg/0.4ml and Yuflyma Pen 40mg/0.4ml are KRW 248,877 each, which is only a 15.0% difference from the price of Humira Prefilled Syringe 40mg/0.4ml and Humira Pen 40mg/0.4ml, which are set at KRW 288,091. In principle, under the Korean drug pricing system, biosimilars can receive insurance prices up to 70% of the original drug price that was set before patent expiry. Since October 2016, the price of ‘items developed by innovative pharmaceutical companies, or are equivalent, or those developed by domestic pharmaceutical companies in partnership with foreign companies, or items for which Korea grants first approval, or items produced domestically’ are set up to 80% of the original drug’s price. The price of original drugs whose patents have expired is automatically reduced to 70-80% of its previous level upon the introduction of its biosimilars. Even if a biosimilar is listed at a price 30% or more lower than the original drug's pre-patent expiry price, as the original drug's price is reduced at the same time, it is difficult for the generic company to secure price competitiveness. Some analysts believe that in the field of autoimmune diseases, as drugs are used to treat severe illnesses, doctors and patients may prefer new drugs from multinational pharmaceutical companies that have accumulated trust over time if there is not much difference in drug prices. However, biosimilars are known to contribute to financial savings for national health insurance by lowering the price of original drugs. As of June 7, 2021, the insurance ceiling price of Humira has been reduced by 30% from the previous price. The price of 3 drugs, Humira Pen Inj 40mg/0.4mL, Humira Prefilled Syringe Inj 40mg/0.4mL, and Humira Inj 40mg Vial, were cut 30% from KRW 415,058 to KRW 280,891, and the price of Humira Prefilled Syringe Inj 20mg/0.2mL was cut from KRW 224,002 to KRW 156,801. Humira recorded sales of 27.5 billion won in Q1 2021, but sales had fallen 24.9% the next quarter to 20.7 billion won due to price cuts.
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- 2 new JAK inhibitors secure expanded reimb
- by Son, Hyung-Min Dec 19, 2023 05:54am
- The treatment market for active ankylosing spondylitis, which had been previously dominated by Tumor Necrosis Factor-alpha (TNF-α) inhibitors such as Humira and Remicade, is transforming. As of the 1st of this month, reimbursement has been applied and expanded to include major Janus Kinase (JAK) inhibitors and biologic agents for treating active ankylosing spondylitis; thereby, forecasting a likely surge in market competition. According to the industry on the 16th, the two JAK inhibitors, Pfizer’s Xeljanz (tofacitinib) and AbbVie’s Rinvoq (upadacitinib), newly passed the reimbursement criteria for treating active ankylosing spondylitis. Eli Lilly’s Taltz (ixekizumab) and Novartis’ Cosentyx (secukinumab) now receive expanded reimbursement criteria for primary treatment options active ankylosing spondylitis. Active ankylosing spondylitis is an autoimmune disease that involves inflammation in the spine and, over time, can cause progressive spinal rigidity. The inflammation in spine joints results in pain and loss of flexibility. If left untreated, active ankylosing spondylitis can restrict movements because the bones in the spine fuse in a fixed position. Until now, TNF-α inhibitors were used as the first-line treatment for active ankylosing spondylitis. Due to the lack of treatment options for patients who developed resistance, anticipation is rising on the effect the newly reimbursement treatments will provide to the field. Xeljanz and Rinvoq, first JAK inhibitors to add reimbursement standards for active ankylosing spondylitis. Patients with severe active ankylosing spondylitis who have stopped receiving treatment due to poor response to one or more types of TNF-α inhibitor or IL-17A inhibitor will be able to receive reimbursement for the JAK inhibitors Rinvoq and Xeljanz. JAK inhibitors suppress JAK enzymes., which play a critical role in facilitating processes in the immune system; however, their overactivation can lead to several autoimmune diseases. JAK inhibor Pfizer Rinvoq and Xeljanz proved effective in patients who failed prior treatments in clinical trials as well. In the Phase 3 SELECT-AXIS 2 clinical studies, which enrolled patients with ankylosing spondylitis who failed previous treatments with TNF-α inhibitor or IL-17A inhibitor, the ASAS40 (Assessment of Spondyloarthritis International Society response standard improvement of 40% or more) response rate for patients treated with Rinvoq was 45.0% at week 14. This was significantly higher than that of the placebo group (18.0%). In the Phase 3 S-I clinical trial, which enrolled patients with active ankylosing spondylitis who had an inadequate response to prior TNF-α inhibitor treatments, the ASAS40 response rate for patients treated with Xeljanz was 41%, as opposed to 13% in the placebo group. Due to the current expansion of reimbursement, the patients with active ankylosing spondylitis will be able to receive reimbursement for Xeljanz and Rinvoq, the drugs previously used for eczema, rheumatoid arthritis, and ulcerative colitis. Notably, two drugs offer an advantage over other treatment options due to their convenience in administration, as they are oral treatments. Cosentyx and Taltz, which are biologic drugs, succeeded in expanding the reimbursement criteria as first-line treatments for active ankylosing spondylitis The reimbursement criteria are expanded for Novartis's Cosentyx and Eli Lilly's Taltz, biologics that inhibit IL-17A, to include first-line treatments for ankylosing spondylitis. Previously, reimbursement criteria were limited to cases where there was an inadequate response to one or more TNF-α inhibitors, or when treatment was discontinued due to side effects or incompatibility. Cosentyx and Taltz both function by selectively binding to the cytokine IL-17A, an inflammatory mediator, and inhibiting its interaction with respective receptor. IL-17 inhibitor Novartis Through expanded reimbursement, Cosentyx and Taltz can now be used under the same criteria as TNF-α inhibitors. The reimbursement criteria for these treatments have been expanded for patients with severe active ankylosing spondylitis who had shown insufficient response or drug side-effects despite treatment with two or more types of non-steroidal anti-inflammatory drugs (NSAIDs) or biological Disease-Modifying Anti-Rheumatic Drugs (bDMARDs) for over three months. In the four-year long-term MEASURE 1 study, Cosentyx has shown that in approximately 80% of active ankylosing spondylitis patients, there was no progression of spinal deformity (modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) changes less than 2) over four years. Moreover, the MEASURE 2 study demonstrated the long-term effect of Cosentyx in improving key symptoms of active ankylosing spondylitis, including morning stiffness, spinal pain, fatigue, and nocturnal back pain up to 5 years. The effectiveness of Taltz was demonstrated in COAST-V clinical studies in patients who are biologic disease-modifying antirheumatic drug (bDMARD)-naïve, and COAST-W Phase 3 studies in patients who previously had an inadequate response or were intolerant to tumor necrosis factor (TNF) inhibitors. The COAST-V clinical trial result demonstrated that the ASAS40 response rate for patients treated with Taltz was 48% at week 16, a significantly higher response rate compared to the 18% in the placebo group. In addition, the COAST-W clinical trial also demonstrated a higher ASAS40 response rate for Taltz compared to the place group (Taltz: 25.4%, Placebo: 12.5%). Cosentyx and Taltz have shown consistent results not only in clinical trials but also in real-world data, confirming their effectiveness and safety in real medical settings.
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- Baxter-JW-HK Inno.N-Kabi introduce 4th gen 3 chamber TPNs
- by Nho, Byung Chul Dec 19, 2023 05:53am
- The race to expand the market share of ‘new lipid formulation total parenteral nutrition’ has been ignited by pharmaceutical companies specializing in parenteral nutrition. The new intravenous lipid total parenteral nutritions that have been introduced to the market are regarded as 4th generation total parenteral nutritions and are an amino acid admixture to the existing three-chamber bags for parenteral nutrition. It consists of refined fish oil (Omega-3) or refined olive oil, amino acids, and glucose. Baxter was the first company to enter the market with a 4th generation product, which received authorization in August last year. Baxter’s Olimer N12E Inj is an olive oil containing amino acid-reinforced lipid emulsions that comes in650·1000·1500·2000ml sizes and are priced at KRW 29,746, KRW 37,777, KRW 43,835, and KRW 55,202, each. The company launched the product in Korea after signing a domestic distribution agreement with Boryung Phramacetucial, a sales and marketing powerhouse in general hospitals in Korea. Among domestic pharmaceutical companies, JW Pharmaceuticals, the domestic leader in the third-generation three-chamber bag for parenteral nutrition, was the first to receive approval and reimbursement for its new product and was expected to rival Baxter's Olimer N12E Inj. In the case of the Winuf A Plus Inj has increased the ratio of amino acids by including refined fish oil, refined olive oil, and refined soybean oil, the fluid is being considered as an upgrade of the company's preexisting three-chamber bag Winurf Inj, which has a market size of KRW 70 billion. Winuf A Plus Inj comes in 1089·1090·1438·1452ml sizes and are priced at KRW 41,609, KRW 41,197, KRW 46,049, and KRW 46,679, respectively. HK Inno. N’s Omapone Plus Inj, which uses refined fish oil, has also recently obtained approval from the Ministry of Food and Drug Safety and is receiving drug price calculations. Although HK Inno.N failed to become the first domestic company to launch a 4th generation product, as its product comes after JW Pharmaceutical, HK Inno.N has newly registered a patent for a 'pharmaceutical composition comprising of omega fatty acids and fluid preparation that contains the same' to differentiate its product theoretically from others. JW Pharmaceutical Fresenius Kabi also received approval to import its Ntense Inj. in September last year, which contains a higher proportion of amino acids such as refined fish oil. The company plans to promote it as a next-generation product to replace its own Smofkabiven Inj. In terms of the drug distribution performance, Smofkabiven Peripheral Inj posted KRW 27.1 billion in sales last year and ranked second in the third-generation three-chamber bag for parenteral nutrition following Winuf. The price of Smofkabiven had suffered cuts due to the combination of products that contain the same components, but the company is looking to turn things around by introducing Ntense Inj. According to reports, Ntense Inj and Omapone Plus are expected to receive prices that are similar to those set for Winuf A Plus. Therefore, the industry prospect is that the fourth-generation lipid emulsions based on refined fish oil and olive oil will form a new market and ignite fierce competition in 2024.
- Company
- Who will take over the Forxiga market worth 50 bil?
- by Chon, Seung-Hyun Dec 18, 2023 05:31am
- The pharmaceutical industry is closely monitoring the potential withdrawal of the diabetes drug Forxiga from the market in Korea. This withdrawal is expected to intensify competition among companies aiming to fill the market gap left by Forxiga. Companies that have recently introduced generics of Forxiga are predicted to enter intense market competition. Furthermore, there is speculation that Daewoong Pharmaceutical, having launched a new medication from the same class this year, could benefit from these developments. According to the industry, AstraZeneca Korea has officially declared on the 14th its exit from the Korean market with its diabetes treatment Forxiga. This decision by AstraZeneca to withdraw from the market is attributed to increased competition arising from the introduction of generics, drug price cuts, and restructuring of their portfolio. Forxiga is a SGLT-2 inhibitor class treatment for diabetes and contains dapagliflozin as its active ingredient. SGLT-2 inhibitors function by preventing the reabsorption of glucose in the kidneys, which leads to the excretion of glucose via urine and consequently lowers blood sugar levels. According to the data from UBIST, a market research firm, Forxiga’s prescription totaled to 51 billion won in the previous year. Therefore, pharmaceutical companies already in the SGLT-2 inhibitor market may likely benefit from the Forxiga's withdrawal. SGLT-2 inhibitors, which are used as diabetes treatments, has recently shown rapid growth in sales. In Q3 of this year, SGLT-2 inhibitors monotherapy achieved outpatient prescription sales of 37.7 billion won. This reflects a 41.0% increase compared to the previous year. From Q3 of 2020, where it reached 20.1 billion won in sales, there has been a remarkable 87.2% growth over three years. SGLT-2 inhibitors, unlike DPP-4 inhibitors which are another class of diabetes treatments, offer an insulin-independent mechanism of action; therefore, they are not affected by insulin resistance. Additionally, clinical studies that demonstrate benefits in weight loss are seen as a positive factor contributing to the market expansion of SGLT-2 inhibitors. The recent sales for dapagliflozin monotherapy, including Forxiga, have shown a steep increase in growth. Q3’s prescription sales of dapagliflozin monotherapy reached 20.5 billion won, up 56.0% YoY compared to the last year. The market size has approximately doubled from the 10.9 billion won in Q3 of 2021, demonstrating substantial expansion over just two years. The market has significantly expanded recently with the introduction of Forxiga generics. Following the expiration of Forxiga's substance patent in April, numerous pharmaceutical companies in Korea rushed to release generics containing the dapagliflozin. Currently, there are approximately 60 companies that have introduced generics of Forxiga monotherapy. Dapagliflozin’s prescription sales was recorded at 14.5 billion won in Q1, and it increased to 17.9 billion won in Q2, up 23.4%. Compared to Q1, the prescription sales in Q3 increased by 40.8%. For pharmaceutical companies, Forxiga's market exit is seen as an opportunity to grow through the substitution of generics that contain the same active ingredient. In the early stage of the Forxiga generic market, Boryung Pharmaceutical and Hanmi Pharmaceutical are emerging as key players. Boryung's Trudapa has achieved prescription sales of 1.2 billion won since its introduction, while Hanmi's Daparon has recorded a prescription amount of 1.1 billion won in the past six months. Additionally, other companies like Chong Kun Dang, Aju Pharm, KyugDong Pharmaceutical, and Daewon Pharmaceutical have also seen prescription figures exceeding 500 million won. Following Forxiga's withdrawal, prescriptions of other for-2 inhibitors like empagliflozin, ipragliflozin, ertugliflozin, and enavogliflozin may also rise. Empagliflozin, already a significant player in the SGLT-2 inhibitor market alongside dapagliflozin, is expected to potentially benefit from this market shift. Empagliflozin monotherapy’s sales from prescription reached 14.6 billion won in the Q3, a YoY 53.0% increase from 9.5 billion won in the Q3 of 2020, demonstrating a strong growth. As for Empagliflozin-class monotherapy, Boehringer Ingelheim's Jardiance is currently the only product. Daewoong Pharmaceutical's new drug Envlo may rise to become a viable competitor in the SGLT-2 inhibitor market. Envlo, which contains the active ingredient Enavogliflozin, is Daewoong Pharmaceutical’s SGLT-2 class inhibitor, which was developed for the first time among domestic pharmaceutical companies. It received domestic approval last year and was launched in May. Envlo demonstrated superior efficacy with just 0.3 mg, which is less than one-thirtieth of the dose required by existing SGLT-2 inhibitors. In phase 3 clinical trials involving patients with type 2 diabetes, it proved superior in lowering glycated hemoglobin (HbA1c) and fasting blood sugar levels, as well as in safety, compared to existing drugs. Since its introduction, Envlo has achieved a prescription sales of 1.6 billion won. In Q2, it reached 400 million won in prescriptions, which then increased to 1.1 billion won in Q3. Despite being relatively new to the market and thus having a smaller prescription volume, Envlo has already outperformed the sales performance of ipragliflozin and etugliflozin, making it the third most prescribed drug in its class. In this sense, Envlo is beginning to establish a significant presence in the market, outshining Forxiga's generics. Daewoong Pharmaceutical’s past experience in marketing is postulated for the background of Envlo's market expansion. Since 2018, Daewoong Pharmaceutical has been a co-distributer of Forxiga, and had led its market expansion. Daewoong Pharmaceutical has proven its sales power in the anti-ulcer drug market. The company distributed AstraZeneca's PPI class anti-ulcer drug Nexium for 13 years, from 2008 to last year. This year, they have focused on selling self-developed gastroesophageal reflux disease drug, Fexuclue. Fexuclue has successfully penetrated the market, recording a prescription amount of 37.4 billion won in its second year until the Q3 of this year. Last year, Daewoong Pharmaceutical launched Nexierd, containing the active ingredient Esomeprazole, and its cumulative prescription sales in Q3 of this year reached 4.8 billion won, ranking it among the top in its class. AstraZeneca has secured the domestic supply of Forxiga until the first half of next year and is discussing patient protection measures with the Ministry of Food and Drug Safety (MFDS).
- Company
- Dupixent seeks to expand its indication to COPD
- by Eo, Yun-Ho Dec 18, 2023 05:31am
- Indications for the interleukin inhibitor ‘Dupixent’ is being expanded actively in the field. According to industry sources, after being approved for rashes, Sanofi’s Dupixent (dupilumab) has further demonstrated efficacy in chronic obstructive pulmonary disease (COPD) and is seeking to expand its indication to the area. Its indication for itchy rashes has been approved recently in Korea. Specifically, it has been approved for the treatment of adult patients aged 18 years or older with moderate-to-severe prurigo nodularis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Prurigo nodularis is a chronic, debilitating inflammatory disease that is correlated with the skin, immune system, and nervous system in association with type 2 inflammation. The intense itching arising from the condition can be worsen continuously due to neuro-immune interactions. It can occur at any age but has a particularly high incidence in people in their 50s and 60s. More than 80% of patients experience itching lasting more than 6 months and more than 50% experience itching lasting more than 2 years. Over 60% experience sleep disturbances and affected patients were found to be more likely to suffer from depression and anxiety than healthy individuals. Dupixent is a fully human monoclonal antibody that inhibits the signaling pathways of interleukin-4 (IL-4) and interleukin-13 (IL-13), which are the main causes of Type 2 inflammation. IL-3 and IL-13 are known to be key and central drivers of the type 2 inflammation that plays a major role in multiple diseases including prurigo nodularis, atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), etc. The indication expansion to prurigo nodularis was made based on the data from two placebo-controlled Phase III trials, PRIME and PRIME2. Pruritus improvement in the two trials, as measured by the proportion of patients with a ≥4-point reduction in Worst Itch Numeric Rating Scale (WI-NRS), showed that 60% and 57.7% of patients in the Dupixent arm of the PRIME and PRIME2 study achieved significant WI-NRS reduction, compared with the 18.4% and 19.5% in the placebo arm, respectively. In terms of treatment effect on skin lesions, 48% and 45% of patients in the Dupixent arm of the PRIME and PRIME2 trial continued to show improvement at Week 24, achieving more than double reduction of ‘clear’ or ‘almost clear’ skin. Expectations for the drug’s potential in COPD had risen with the company’s announcement of positive results from its second Phase III trial, NOTUS. The NOTUS is a placebo-controlled Phase III trial that evaluated the efficacy and safety of Dupixent in adults whose conditions are not controlled using triple therapy of inhaled corticosteroids (ICS), long-acting beta-agonists (LABA), and long-acting muscarinic antagonists (LAMA). The study found that Dupixent rapidly and significantly improved lung function by week 12 and that these benefits were sustained through week 52. Based on the positive results of the landmark BOREAS study the FDA granted Breakthrough Therapy designation for Dupixent as an add-on maintenance treatment in adult patients with uncontrolled COPD associated with a history of exacerbations and an eosinophilic phenotype
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- SK pneumococcal conjugate vaccine nears global entry
- by Chon, Seung-Hyun Dec 15, 2023 05:51am
- SK Bioscience is fast-tracking its global market strategy for its next-generation pneumococcal vaccine. Nine years following the start of their joint development with Sanofi, the company has now progressed to the last phase of clinical trials for commercialization. SK Bioscience has also been improving its vaccine production facilities to prepare for the commercial manufacturing of pneumococcal vaccines. SK Boscience announced on 11th that SK Bioscience and Sanofi have submitted a Phase 3 Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for its jointly developed 21-valent pneumococcal conjugate vaccine candidate, GBP410 (Sanofi’s project name: SP0202). SK Bioscience and Sanofi aim to enroll infants from various nations including the US, Europe, and Korea and complete Phase III clinical trials by 2027. In March 2014, SK Bioscience signed an agreement with Sanofi to jointly develop and commercialize an next-generation pneumococcal vaccine. The companies have rogressed to the last phase of clinical studies for the vaccine’s commercialization, nine years after signing the joint development agreement. GBP410 is a protein conjugate vaccine that combines specific proteins with the polysaccharide capsule of Streptococcus pneumoniae, which causes pneumonia and invasive pneumococcal disease. The conjugate vaccines are well known to provide superior protection among pneumococcal vaccines developed to date. GBP410s anticipated to offer broader protection over existing pneumococcal vaccines, given that it includes 21 serotypes. Serotypes are one of the key pathogenic factors in pneumococcal bacteria, and different serotypes are associated with varying pathogenicity. The newly introduced pneumococcal vaccine in Korea helps protect against 15 serotypes. SK Bioscience and Sanofi are preparing to commence the Phase 3 clinical study based on the successful completion of their Phase 2 clinical study of GBP410, The Phase 2 study by SK Bioscience and Sanofi was commenced in May 2020, enrolling 140 toddlers aged 12 to 15 months and 712 infants aged 42 to 89days from the US, Canada, and Honduras. GBP410 and a comparator vaccine were given to the cohorts as primary vaccination (2·4·6 months of age) and then as a booster vaccination (12-15 months of age). The results demonstrated comparable immunogenicity of GBP410 compared to the comparator vaccine. In terms of safety, no serious vaccine-related adverse reactions were reported in the GBP410-vaccinated group. GBP410 demonstrated equivalent immunogenicity and safety compared to the comparator vaccine when co-administered with recommended vaccines for infants and children, such as those for tetanus, diphtheria, pertussis, polio, and Haemophilus influenzae type B. SK Bioscience SK Bioscience has also started securing production facilities for GBP410. Last month, the company's board of directors agreed to invest approximately 81.5 billion won to expand their Andong L House vaccine production facility. This expansion, supported by a joint-investment with Sanofi, will lead to the construction of a roughly 45,208 square feet production facility. Once the FDA approves GBP410, SK Bioscience aims to manufacture the vaccine at Andong L House and distribute it to the global market . Once the commercialization of GBP410 is finalized, SK Bioscience plans to also launch the vaccine in Korea. Previously, SK Bioscience suffered defeat in the pneumococcal vaccine market in Korea. In 2016, SK Bioscience gained approval from the Ministry of Food and Drug Safety (MFDS) to market its pneumococcal vaccine, SKYPneumo Prefilled Syringe. SKYPneumo Prefilled Syringe is SK Bioscience's first premium vaccine. The company is positioning premium, next-generation vaccines as a pivotal element in its growth strategy. To achieve this, SK Bioscience has invested approximately 400 billion won in enhancing vaccine business infrastructure and R&D efforts. A significant step in this direction was the completion of the L House in Gyeongbuk Andong, in 2012. This facility stands as the largest vaccine factory in Korea, with an investment of about 200 billion won solely for its construction. After losing a patent lawsuit against Pfizer, SK Bioscience failed to launch SKYPneumo Prefilled Syringe. SK Bioscience had contested the validity of Pfizer's patent for PREVENAR 13 Inj by filing a lawsuit. In December 2018, the Supreme Court rejected the suit. Consequently, SKYPneumo Prefilled Syringe cannot be marketed until the Prevnar 13's patent expires in 2026. In response, SK Bioscience voluntarily withdrew the license for SKYPneumo Prefilled Syringe in 2020 but reacquired it the following year. “We are getting closer to successfully developing the pneumococcal conjugate vaccine that only few of the world’s top vaccine companies have succeeded in,” said Ahn Jaeyong, CEO of SK Bioscience. With 740,000 infants, children, and adolescents dying from pneumonia every year, we seek to contribute to global public health and rise to become a market-leading company by successfully developing GVP410."
- Company
- Reimb for Cold Agglutinin Disease drug Enjaymo starts in KOR
- by Eo, Yun-Ho Dec 15, 2023 05:51am
- The cold agglutinin disease treatment ‘Enjaymo’ is seeking reimbursement listing in Korea. According to industry sources, Sanofi Korea has filed a reimbursement application for its Enjaymo (sutimlimab) as a treatment for hemolysis in adult patients with Cold Agglutinin Disease (CAD) Enjaymo’ is a first-in-class humanized monoclonal antibody that is designed to selectively target and inhibit the classical complement pathway-specific serine protease, C1s. The drug was found to increase the CAD patients’ hemoglobin level and reduce profound fatigue. CAD is a very rare type of autoimmune blood disorder where part of the body’s immune system mistakenly continues to attack and destroy the body’s healthy red blood cells. When patients with CAD are exposed to a temperature below body temperature, they can experience▲ anemia due to chronic hemolysis, ▲ extreme fatigue, ▲ dyspnea, ▲ hemoglobinuria, ▲ acrocyanosis, and ▲ thromboembolism, with a median survival of 8.5 years after diagnosis. CAD is a very rare disease that develops in 1 in 1 million individuals. The number of CAD patients in Korea cannot be accounted for as the disease does not even have a disease code in Korea yet. Enjaymo has been approved in Korea based on the results of 2 clinical trials that demonstrated the drug’s efficacy and safety profile in adult patients with CAD. In the 26-week open-label, single-arm pivotal Phase III CARDINAL study that was conducted on 24 patients over 18 years of age, 54% of the patients (13/24) met the composite primary endpoint criteria - achieved normalization of hemoglobin (Hgb) level ≥12 g/dL or demonstrated an increase from baseline in Hgb level ≥2 g/dL at the treatment assessment time point and no blood transfusion from weeks 5 through 26 or medications prohibited per the protocol from weeks 5 through 26. Also in the 26-week randomized, placebo-controlled Phase III CADENZA study that was conducted on 42 adult CAD patients with one or less transfusion history within 12 months or no transfusion history within 6 months before enrollment, 42 patients were randomized to the Enjaymo arm (22) and placebo arm (20.) Study results showed that 73% of the Enjaymo arm (16/22) had showed an hemoglobin increase ≥1.5 g/dL at treatment assessment timepoint, avoidance of transfusion, and study-prohibited CAD therapy, whereas only 15% (3/20) achieved the same in the placebo arm. Based on the drug’s proven efficacy and safety profile, Enjaymo received the Orphan Drug designation, Priority Review, Breakthrough Therapy designation, and then officially approved the drug in February 2022. The drug was approved by the Japanese Ministry of Health, Labor and Welfare in June 2022, and by the European Medicines Agency (EMA) in November 2022.
- Company
- US-expanded Cresemba faces reimb challenges in KOR
- by Son, Hyung-Min Dec 15, 2023 05:51am
- The antibiotic Cresemba has received expanded indications in the US to include pediatric patients. However, in Korea, the reimbursement for Cresemba is being delayed because of challenges in economic evaluations, limiting patient access to this medication. According to the industry on the 15th, the U.S. Food and Drug Administration (FDA) approved an expanded indication for Cresemba (isavuconazonium sulfate) for use in pediatric patients 1 to 17 years of age. Cresemba’s prescribed injection is indicated for 1 year and older, whereas the prescribed capsule is indicated for children 6 years of age and older (weight of 16kg or more). PfizerDue to the approval, Cresemba is now the only azole antifungal treatment approved by the FDA for use in pediatric patients with invasive aspergillosis and invasive mucormycotic. Cresemba is an antibiotic (antifungal agent) jointly developed by Switzerland's Basilea Pharmaceutica and Japan's Astellas Pharma. Pfizer holds the rights for commercial release in the European region and the distribution rights in Asia-Pacific regions, including Korea. Astellas has received approval for Cresemba in the US and Japan. The expanded indication approval for Cresemba was based on findings from the two Phase II clinical studies. The researchers assessed the safety and efficacy of Cresemba for the treatment of invasive aspergillosis (IA) or invasive mucormycosis (IM) in 31 patients aged 1 to 17. The clinical result has shown that 54.8% of patients were able to achieve a successful response rate. In terms of safety, the most common adverse effects observed in Cresemba-treated pediatric patients were abdominal pain, rash, and injection site reaction. All-cause mortality rates through days 42 and 84 were 6.5% and 9.7%, respectively. There have been no reports of death related to the treatments. In addition, the FDA granted pediatric exclusivity for CRESEMBA, extending its period of market exclusivity in the US by an additional six months. Despite expanded use of Cresemba, the reimbursement of antifungal drugs is pending. While the indication for Cresemba is expanding overseas, its reimbursement is challenging in Korea. Cresemba has been approved in Korea in 2020 for the treatment of IA and IM in adults aged 18 and older. MSDYet, the discussion for reimbursement approval is still pending. Antibiotics include antibacterial drugs effective against bacteria, antifungal drugs effective against fungal infections, and antiviral drugs effective against viruses. Currently, antifungal and antiviral drugs are not included in the range of drugs exempted from the economic evaluation (cost-effectiveness assessment exemption). The government has granted cost-effectiveness assessment exemption to antibacterial products, but it views the inclusion of antifungal products as not aligning with the criteria of severity and urgency. However, there is an increasing demand for the inclusion of new antifungal drugs in reimbursement. This is in response to the escalating global prevalence of fungal infections. Despite this need, there have been no recent cases of new antifungal drugs being reimbursed. Since 2014, MSD's Zerbaxa (ceftolozane·tazobactam), Dong-A ST's Sivextro (tedizolid), Cresemba, and Pfizer's Zavicefta (ceftazidime·avibactam) have been approved in Korea. Among these, only Zerbaxa has been included in the reimbursement. Zavicefta, an antibacterial drug, is currently in pricing negotiations with the National Health Insurance Service. Sivextro, also an antibacterial drug, was withdrawn from the market in 2020, primarily due to challenges such as low pricing and the absence of insurance coverage.
- Company
- Domestic market withdrawal of Forxiga remains a mystery
- by Kim, Jin-Gu Dec 14, 2023 05:47am
- Pic of ForxigaAstraZeneca’s decision to withdraw its SGLT-2 inhibitor diabetes drug Forxiga (dapagliflozin) from the Korean market is being considered an unusual move by the industry. This is because the decision to pull out of the Korean market would essentially mean giving up KRW 50 billion in annual sales for AstraZeneca. While AstraZeneca's official position is that the decision is part of the company’s "portfolio overhaul," the mysteries surrounding the decision are not expected to be resolved anytime soon. Therefore, the industry's eyes are on AstraZeneca's next move, especially as it has been in stark contrast with MSD’s treatment of Januvia (sitagliptin). MSD Korea, which had faced a similar situation with Januvia, had sold its domestic sales rights for a large sum to a Korean company. #SB Company suddenly decides to withdraw ‘Forxiga,’ whose prescription sales exceed KRW 50 billion from the Korean market#EB According to industry sources on the 12th, AstraZeneca Korea decided to withdraw Forxiga from the Korean market. The withdrawal is limited to the single-agent drug Forxiga. Its metformin combination Xigduo, sitagliptin combination Sidapvia, and saxagliptin combination Qtern will continue to be supplied through local pharmaceutical companies. Forxiga is an SGLT-2 inhibitor class diabetes drug. It was approved in Korea in 2013. Since then, it has rapidly increased its prescription sales. The annual prescription amount for the drug exceeded 30 billion won in 2019 and reached the 50 billion won mark last year. Yearly prescriptions of Forxiga (Unit: KRW 100 million, Data: UBIST). In Korea, it had dominated the SGLT-2 inhibitor market with Boehringer Ingelheim Korea’s 'Jardiance empagliflozin).’ Among single-agent drugs, prescriptions had been KRW 51 billion for Forxiga and KRW 48.3 billion for Jardiance last year. Sales of Astellas' Suglet (ipragliflozin) and MSD's Steglatro (ertugliflozin) accounted for less than KRW 5 billion during the same period. The joint sales agreement AstraZeneca had made with Daewoong Pharmaceutical is said to have contributed to the increase in prescription performance in Korea. Daewoong has been jointly selling Forxiga since 2018. The agreement between the two companies will end at the end of this year. Forxiga's rise to prominence hit a major inflection point earlier this year. Forxiga’s substance patent expired in April. More than 60 pharmaceutical companies launched generic versions of Forxiga upon patent expiry. This coincided with reimbursement for the use of SGLT-2 and DPP-4 inhibitor combinations, heralding a very fierce competition between the original and generic companies. AstraZeneca Korea deployed an aggressive defense strategy to maintain Forxiga’s position in the market. It filed an administrative appeal against the price reduction made upon entry of the generic version. At the same time, it applied for an injunction for the stay of execution of the government's price reduction. The court granted the request. As a result, the price of Forxiga is set to remain at the same level until February next year. AZ "Drug price reduction disposition unreasonable”…U-turns its stance after half a year The enforcement order was cited on June 1. However, just over 6 months later, AstraZeneca Korea decided to withdraw Forxiga from the Korean market. This is a 180-degree turnaround for the company, as this means the company decided to abandon Forxiga just half a year after it challenged the Ministry of Health and Welfare's decision to lower the drug's price with an administrative lawsuit. AstraZeneca's official position is that it is "discontinuing the domestic supply of Forxiga to realign the company's portfolio." On the surface, this seems to indicate that the company intends to reorganize its portfolio around anti-cancer drugs such as Tagrisso, Imfinzi, and Lynparza and focus on related businesses. In the industry, there are also assumptions that the market withdrawal decision was driven by the rush of generics that entered upon patent expiry and the pressure of excessive competition. Others argue that AstraZeneca Korea has exhausted resources and accumulated fatigue negotiating with the government to expand reimbursement for its Forxiga and other key products such as Tagrisso. However, those who believe otherwise point to how Forxiga's influence in the market remains strong even though more than 60 companies have launched generic versions of the drug. In fact, Forxiga's outpatient prescription performance has increased slightly YoY after the release of its generics. In Q2, Forxiga's prescriptions totaled to KRW 14.1 billion, up 15% YoY. In Q3, prescriptions increased 4% YoY to reach KRW 13.7 billion. While generic products generated KRW 3.9 billion in prescriptions in Q2 and KRW 6.8 billion in Q3, they did so by opening up new markets rather than by taking over Forxiga's share. Moreover, Forxiga’s indication was being expanded to not only diabetes but also heart failure and kidney disease. Forxiga has recently added a series of indications. They were for ▲ the treatment of heart failure with reduced ejection fraction (HFrEF), ▲ left ventricular ejection fraction/ heart failure with preserved ejection fraction (HFpEF)/heart failure with mildly reduced ejection fraction (HFmrEF), and ▲ chronic kidney disease (CKD). Of these, the company had applied for the drug’s reimbursement in HFrEF and CKD. The company was also reportedly conducting negotiations with the government for reimbursement extensions until recently. From AstraZeneca's point of view, extending Forxiga's reimbursement to heart failure could have further increased the prescription amount. In contrast with MSD's sale of Januvia rights … Competition will intensify to close the KRW 50 billion void The pharma industry focused on how MSD decided to sell Januvia’s domestic sales rights before patent expiry. Pic of JanuviaJanuvia is a DPP-4 inhibitor class diabetes drug. Januvia has various similarities to Forxiga, such as the fact that it is a flagship item with a prescription value of KRW 42.6 billion last year and a large number of generics were launched after its patent expiry in July this year. In May, Chong Kun Dang signed a licensing agreement with MSD to acquire domestic rights for 3 products - Januvia, Janumet, and Janumet XR. Chong Kun Dang will acquire all domestic sales, distribution, licensing, trademark, and manufacturing rights for the 3 Januvia series drugs. The contract amount was 45.5 billion won. Chong Kun Dang paid MSD an upfront payment of KRW 23 billion and additional milestone payments of KRW 22.5 billion based on sales performance. MSD made a considerable profit by handing over all domestic rights for the antidiabetic drugs to Chong Kun Dang ahead of Januvia's patent expiration, at a time when generics were expected to be launched. The deal was seen as a win-win, as MSD could focus on sales and marketing of its other products instead of competing with domestic drugmakers, and Chong Kun Dang could secure a stable cash cow that brings in over KRW 100 billion a year. On the other hand, AstraZeneca made a contrasting move, deciding to withdraw from the Korean market instead of selling the rights for Forxiga to a Korean company. The company had made no moves to sell Forxiga's domestic rights to any company. AstraZeneca also drew the line regarding its plans to resupply Forxiga in Korea. An AstraZeneca Korea official said, "We have secured enough domestic supply to last until the first half of next year. We are discussing patient protection measures with the Ministry of Food and Drug Safety. However, at this time, we are not considering resupplying the drug after the first half of next year."
