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- 2025-12-25 10:13:29
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- Skyrizi adds psoriatic arthritis indication
- by Feb 10, 2022 05:54am
- Pic of Skyrizi Abbvie’s ‘Skyrizi’ has expanded its indication to psoriatic arthritis. As the fourth interleukin inhibitor to receive approval for the indication, Skyrizi has set out to overtake the market with its convenience in administration. On the 9th, Abbvie Korea has held a ‘Press Conference to celebrate Skyrizi’s indication expansion to psoriatic arthritis’ online. Skyrizi, which was first approved for moderate-to-severe plaque psoriasis in 2019, added the psoriatic arthritis indication on the 5th of last month. Skyrizi may be used to treat adult patients with active psoriatic arthritis who had responded inadequately or were intolerant to disease-modifying anti-rheumatic drugs (DMARDs). Professor Young-Beom Choi of the Department of Dermatology at Konkuk University Hospital said, “Biologic drugs tend to lose their effect with long-term administration due to tolerance issues and need to be replaced with other drugs. Therefore, we doctors are pleased that a new treatment option has been introduced to the area. Skyrizi has provided new treatment opportunities to patients with its improved convenience in administration.” Young-Beom Choi, Professor of Dermatology at Konkuk University Hospital Psoriatic arthritis, which is related to psoriasis, develops in various forms such as peripheral arthritis, dactylitis (inflammation of the fingers and toes), skin psoriasis, and enteritis. It affects all joints but is especially common in smaller joints such as the hands and feet. Around 10% to 15% of patients who develop psoriasis progress to psoriatic arthritis in 4 to 5 years. Skyrizi’s efficacy in psoriatic arthritis was demonstrated in the two Phase III KEEPsAKE-1and KEEPsAKE-2 trials. The drug showed a significant effect compared to placebo in the primary endpoint of ACR20 (20% improvement in joint symptoms) at week 24. In the two studies, 57% and 51% of patients receiving Skyrizi achieved the primary endpoint of ACR20 response at week 24, respectively, compared to the 34% and 27% receiving placebo. Also, the patients’ presence of enthesitis and dactylitis had improved by 24 weeks and the effect was maintained until week 52. Skyrizi was late to receive approval for the psoriatic arthritis indication than Tremfya, another drug that has the same mechanism of action. Tremfya received approval for the psoriatic arthritis indication in April last year and became the 3rd interleukin inhibitor to receive approval for the indication. Other interleukin inhibitors that had been previously used are the IL-17 inhibitor ‘Cosentyx’ and ‘Taltz.’ Late in entering the market, Skyrizi is attempting to expand its market share with its differentiated advantage, its less frequent administration regimen. Professor Choi also pointed to the dosing schedule as Skyrizi’s most prominent feature. Skyrizi is administered the least in a year among all IL-17 and IL-23 inhibitors. Contrary to IL-17 inhibitors that are administered every 4 weeks, 12 times a year, Skyrizi is administered every 12 weeks, 4 times a year. Professor Choi said, “Younger adults who work have difficulty visiting hospitals every month. Patients prefer Skyrizi because they only need to visit once every three months. In addition to comorbidities and symptoms, patient preference is also an important factor considered when selecting drugs.” In addition to psoriasis and psoriatic arthritis, Abbvie plans to expand the reach of Skyrizi further to various autoimmune diseases. Seok-Yui Kim, Director of Medical at AbbVie said, “Global Phase 3 trials for Skyrizi are ongoing in Crohn's disease, ulcerative colitis, and the rare autoimmune disease hidradenitis suppurativa.”
- Company
- SK Bioscience releases second batch of COVID-19 vaccines
- by Kim, Jin-Gu Feb 10, 2022 05:54am
- SK Bioscience announced that it had shipped its second batch of commercial COVID-19 vaccine products. By manufacturing vaccines for AstraZeneca and then Novavax, the industry's evaluation is that the company has well demonstrated its large-scale and stable manufacturing capacity. SK Bioscience announced that it had shipped the first batch of Nuvaxovid from its L House in Andong, North Gyeongsang Province in the morning of the 9th. The released batch is predicted to be 840,000 doses of the vaccine that was approved for lot release by the Ministry of Food and Drug Safety the day before. SK Bioscience plans to ship out 2 million doses by the end of this month. Also, the manufacturing amount is expected to further increase from next month. SK Bioscience had signed an agreement with the government to supply 40 million doses of Nuvaxovid within this year. This is twice the amount of AstraZeneca’s vaccines that were supplied by the company to Korea last year. Last year, AstraZeneca signed a CMO deal with SK Bioscience to supply 20 million doses of its vaccine. SK Bioscience is known to have supplied 9,998,300 doses of AstraZeneca’s vaccine just in August last year, demonstrating its ability to manufacture and supply up to 10 million doses a month. SK Bioscience is considered to have well demonstrated its large-scale vaccine production capacity with its verified commercial batches of AstraZeneca and Novavax vaccines. Biologic agents, including vaccines, require quality verification by the MFDS every time a batch is produced for commercialization. According to SK Bioscience, its L House can manufacture up to 560,000 doses of vaccines per day. Multiplying the capacity by 252 working days, the maximum manufacturing capacity of the plant can be estimated to be around 141.12 million doses. By Q3 of last year, SK Bioscience had manufactured 43.25 million doses of vaccines, including AstraZeneca’s vaccines. In only 3 quarters, the company had manufactured four times the 11.48 million doses it had manufactured during the previous year. By the end of last year, the company had manufactured over 60 million doses. Based on the company’s stable manufacturing capacity, SK Bioscience anticipates it will be able to produce its own COVID-19 vaccine ‘GBP510’ in development without any problem even if it is approved in the first half of this year Currently, 9 lines are in operation in the L House. Excluding the one line used to preserve vaccine solutions (cell bank), a total of 8 lines are being used for the actual manufacturing of vaccines. 3 of the lines produce finished Nuvaxovid vaccine products for domestic supply. 2 of the other 5 lines produce vaccine solutions for separate supply to Novavax. The remaining 3 lines produce chickenpox, shingles, and pneumococcal vaccines. If GBP510 is approved in the first half of the year and starts being supplied in earnest in Korea, the company may switch a few of the chickenpox, shingles, and pneumococcal vaccine manufacturing lines for its manufacture. SK Bioscience plans to further expand its production capacity in the long term. The company plans to expand its manufacturing facility in two phases. First, the company has secured a new site near L House to establish additional manufacturing facilities for finished products such as pre-filled syringes and liquid vials by 2024. Also, the company set a goal of adding 12 animal cell incubators of a 2,000-liter scale and two microbiological incubators of a 1,000-liter scale at the same time. As the second step, the company plans to additionally secure manufacturing facilities for raw and finished products to triple its capacity by 2026.
- Company
- Effect of the release of generics for Tamsulosin
- by Ji Yong Jun Feb 10, 2022 05:54am
- The size of the Tamsulosin market, a treatment for prostatic hypertrophy, has soared. The market is also expanding as the influence of generic products has increased since the patent expired in 2015. According to UBIST, a pharmaceutical market research firm, on the 5th, Tamsulosin's outpatient prescription amount last year was 191.2 billion won, an increase of 5% from the previous year. The Tomsrosine market, which was worth 136.9 billion won in 2017, grew 40% in four years. Tamsulosin is α blocker that selectively act on bladder and prostate receptors to lower side effects. It is an ingredient prescribed for prostate hypertrophy patients. As prostate hypertrophy is an senile disease, the number of patients is also increasing recently. According to The HIRA, the number of patients treated for prostate hypertrophy in 2020 was 1.34,329, an increase of 9.4% from 2017 (1191,1595). Tamsulosin is analyzed to have expanded the market in line with the increase in prostate hypertrophy patients and the generic offensive. After the expiration of the original Harunaldi's patent in 2015, generics began to enter the market one after another. As of last year, 87 companies are competing in the Tomsrosine market, as the number of companies entering the generic market has steadily increased. Generics are increasingly influential in the Tamsulosin market. Last year, the amount of outpatient prescriptions for Tomslosin was 116.7 billion won, up 14% from the previous year. Tomslosin, which was worth 63.7 billion won in 2017, increased 83% in four years to 116.7 billion won in 2021. Generic's market share also jumped 14.5% points from 46.5% to 61% during the same period. Among the generics, Hanmi Tams of Hanmi Pharmaceutical and Hanmi Tams OD stood out. The amount of joint prescriptions for the two items last year was 31.7 billion won, up 16.1% from the previous year. Compared to four years ago, it surged 174%. It increased 27.6% from 11.6 billion won in 2017 to 14.8 billion won in 2018, and continued to grow to 19.8 billion won in 2019 and 27.3 billion won in 2020. Industry people say that the introduction of higher capacity than the original was the main reason why Hanmi Tams and Hanmi Tams OD were able to grow. Among generics, Genuonescience's Taminal amounted to 7 billion won, up 3.9% from the previous year. In addition, Dongkoo's Uropa, Kyung Dong's Uronal, Daewoong Bio's Bearosin, and Celltrion 's Tamsol raised more than 4 billion won in outpatient prescriptions. Sales of the original Harnal-D of Astellas are slowing down a little due to the release of generics. Last year, sales of Harnal-D amounted to 74.5 billion won, down 6% from a year earlier. Compared to the amount of outpatient prescriptions in 2017, it increased by 2%. Harnal-D increased 10.8% over the past two years from 73.2 billion won in 2017 to 81.1 billion won in 2019. However, in 2020, the following year, it fell 1.9% from the previous year to 79.6 billion won, and the decline continued last year.
- Company
- Sales in the PPI market are↑ 60% over the past 3 years
- by Kim, Jin-Gu Feb 10, 2022 05:53am
- The PPI anti- ulcer drug market has changed rapidly since the Ranitidine crisis. The market expanded sharply shortly after Ranitidine crisis, but growth has slowed down in the past year. Esomeprazole, Rabeprazole, and Ilaprazole enjoyed the reflective effect of Ranitidine crisis. On the other hand, in the case of Lansoprazole and Pantoprazole, it was difficult to expand their influence on the Ranitidine situation. ◆PPI market grows 61% compared to just before Ranitidine crisis According to UBIST, a pharmaceutical market research firm on the 4th, the amount of outpatient prescriptions for PPI-based anti- ulcer drugs last year was 732.5 billion won. Compared to 454.9 billion won in 2018, it increased by 61% in three years. PPI-based anti- ulcer drugs are the treatments that treat peptic ulcers and gastroesophageal reflux diseases by blocking proton pumps, the final stage of gastric acid secretion, and maintaining a high hydrogen ion index (pH) in the stomach. The reason for the rapid expansion of the market is the Ranitidine incident that occurred in 2019. In June 2019, impurities were detected in Ranitidine, an H2 receptor antagonist-based anti- ulcer drug. Eventually, the sale of this drug was stopped. When Ranitidine, the most commonly used in the market, was removed from the market, and PPI-based drugs enjoyed reflective effects. The annual prescription performance of PPI drugs by year increased to around 10% every year until 2018. In 2019, when the Ranitidine crisis occurred, the increase increased by 18% year-on-year. Then, in 2020, when Ranitidine was completely removed from the market, it increased 24% year-on-year. However, the growth trend that has continued since Ranitidine crisis last year seems to have slowed somewhat. The prescription amount of PPI-based drugs increased by 10% to 732.5 billion won last year. Some analysts say that the rapid growth of K-cab, a new P-CAB anti- ulcer drug, and the prolonged COVID-19 crisis have played a combined role. HK inno.N's K-Cab has posted 30.9 billion won in prescription performance that year since its release in March 2019. In 2020, it more than doubled to 76.1 billion won. Last year, it recorded 109.6 billion won, exceeding 100 billion won in prescriptions in the third year of its launch. ◆Esomeprazole·Ilaprazole vs Lansoprazole·Pantoprazole Esomeprazole, Ilaprazole, and Rabeprazole greatly expanded their influence after Ranitidine crisis. The drug that enjoyed the greatest reflective effect is Esomeprazole. Esomeprazole posted 319.4 billion won in prescription last year. Compared to 19.8 billion won in 2018, before Ranitidine crisis, it increased 63%. In the case of Rabeprazole, it increased 34% from 125.9 billion won to 169.1 billion won during the same period. Ilaprazole increased 33% from 28.3 billion won to 37.6 billion won. In the case of Lansoprazole and Pantoprazole, it is analyzed that they did not enjoy the reflective effect properly despite the gap of Ranitidine. Lansoprazole's prescription amount increased only 4% from 49.1 billion won in 2018 to 51 billion won last year. Pantoprazole increased 4% from 34.7 billion won to 36.3 billion won during the same period. Last year, both ingredients showed a decrease in prescription performance compared to the previous year.
- Company
- Opdivo to be deliberated by CDDC for stomach cancer indicati
- by Eo, Yun-Ho Feb 09, 2022 06:10am
- Whether a reimbursed treatment option would become available in the field of gastric cancer is receiving attention. According to industry sources, Ono and BMS’s PD-1 inhibitor immuno-oncology drug ‘Opdivo (nivolumab)’ will be deliberated by the National Health Insurance Service’s Cancer Disease Deliberation Committee on the 23rd of this month. In June last year, the Ministry of Food and Drug Safety approved an additional indication for Opdivo as ‘first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy for patients with advanced or metastatic gastric adenocarcinoma, gastroesophageal junction or esophageal adenocarcinoma.’ With the approval, Opdivo became the first and only immunotherapy to be approved in Korea as first-line treatment for gastric cancer. Gastric cancer is considered to be the most important area in need of extended reimbursement for immunotherapy drugs after lung cancer. Gastric cancer is the most prevalent cancer and the fourth most common cause of cancer deaths in Korea. Although gastric cancer has a favorable survival rate when detected in its early stages, its relative survival rate drops to 5.9% with distant metastasis. The current standard of care for HER2-negative gastric cancer has been chemotherapy for the past decade due to the unavailability of new drugs approved for its first-line treatment. Opdivo is expected to become a suitable alternative for these patients. Meanwhile, the efficacy of the combination therapy using Opdivo was demonstrated in the large-scale, Phase III CheckMate-649 trial. The median overall survival (mOS) of patients was 13.8 months for all patients randomly assigned to receive the Opdivo combination compared to the 11.6 months in the control group. Among PD-L1 positive patients (CPS ≥ 5), mOS of the group receiving the Opdivo combination was 14.4 months, a 29% reduction in risk compared to the 11.1 months of the control group. Also, Opdivo improved the overall response rate (ORR) by 12% in the all-randomized population, and by 15% in PD-L1 positive patients (CPS ≥ 5). The complete response (CR) rate was also higher for the Opdivo combination group in both the all-randomized population and PD-L1 positive patients.
- Company
- Famotidine market triples 2 years after ranitidine issue
- by Chon, Seung-Hyun Feb 09, 2022 06:09am
- The H2 receptor antagonist market had fluctuated with the ban of the ranitidine ingredient in antiulcer drugs. The gap made by the exit of ranitidine initially shrunk the market into nearly half its size. Famotidine enjoyed the most reflective benefits with its market size increasing nearly threefold after the ranitidine impurity issue. Also, nizatidine, which also experienced an impurity issue, recently showed strong growth. According to the market research institution UBIST on the 8th, outpatient prescriptions of H2 receptor antagonists last year recorded ₩151.8 billion, an 11.2% increase from the previous year. This is the first time in 3 years the market showed year-on-year (YoY) growth. H2 receptor antagonists such as ranitidine, famotidine, nizatidine, lafutidine, roxatidine, and cimetidine are used for gastric and duodenal ulcers and reflux esophagitis. The H2 receptor antagonist market had significantly shrunk for two consecutive years since recording ₩346.5 billion in prescriptions in 2018. Its prescription market shrunk 60.6% in two years to record ₩136.5 billion in 2020. The market took a hard blow with the ban of its leading ingredient, ranitidine. In September 2019, the Ministry of Food and Safety decided to ban sales of all products containing ranitidine due to an excessive amount of a carcinogenic substance, ‘n-nitrosodimethylamine (NDMA),' being detected in the products. At the time, prescriptions of ranitidine-containing pharmaceuticals had accounted for 77.7% of the H2 receptor antagonist market, bringing in ₩269.2 billion in prescriptions in 2018. Although the H2 receptor antagonist market took a hard blow with the exit of ranitidine, the market has been making a rebound recently with the increase in prescriptions of other ingredients of the same class. Outpatient prescriptions of H2 receptor antagonists other than ranitidine recorded ₩151.7 billion last year, an 11.2% increase from the previous year. This is more than twice an increase from the ₩77.2 billion made by the same ingredients in 2018, before the ranitidine impurity issue. Among the ingredients, the famotidine market has shown the strongest growth. Prescriptions of famotidine recorded ₩60.5 billion last year, an 8.9% growth from the previous year. Compared to the ₩13.7 billion made in 2018, its market expanded by over threefold in three years. In 2018, famotidine’s sales had been on a downward trend, showing a 44.4% decrease YoY. However, its sales took an upward turn with the exit of ranitidine from the market. Famotidine had only accounted for 4.9% of the market in 2018, but its share surged 39.9% last year. Dong-A ST’s Dong-A Gaster drove the growth. Dong-A Gaster sold ₩12.5 billion last year, a fourfold increase from the ₩3.1 billion 3 years ago. Nizatidine, which had once been embroiled in impurity issues, has also shown strong growth. Nizatidine’s prescriptions recorded ₩46.1 billion last year, which is a 32.9% increase from the previous year. Also, its sales expanded 50.0% in two years from the ₩30.8 billion in 2019. The MFDS had suspended sales of 13 nizatidine products in October 2019 due to excessive level of impurities detected in the products. The industry’s analysis was that the permit to sell the nizatidine products that were not found to have impurity issues had allowed the products to enjoy reflective benefits from the ban of the ranitidine ingredient. Nizatidine had ranked third in the H2 receptor antagonist market after famotidine and lafutidine but then jumped to rank second with the surge in its prescriptions. Prescription of lafutidine products recorded ₩36.1 billion last year, a 2.3% increase from the previous year. This is also an 11.5% increase from the ₩16.8 billion 3 years ago. Although its growth had slowed down somewhat recently, its overall market size had grown significantly since ranitidine’s exit. Sales of roxatidine products had also nearly doubled from ₩2.6 billion in 2018 to ₩5.1 billion last year. The only major H2 receptor antagonist ingredient that did not enjoy reflective benefits from the ranitidine ban was cimetidine. Prescription of cimetidine products fell to ₩3.9 billion, a 75.2% drop from 3 years ago. Such reduction in prescriptions is analyzed to have been due to the prolonged unavailability of key products that arose due to disruptions in the supply of its raw materials.
- Company
- Can the Antigen Rapid Test be widely used?
- by Choi-sun Feb 09, 2022 06:09am
- Although they are concerned about the transition to the COVID-19 test system, which adds the Antigen Rapid Test to the current PCR test, opinions are divided as they argue that this is only a concern. Unlike the initial virus that occurred in Wuhan two years ago, mutant viruses such as Omikron have a lot of detection in the body, so the Antigen Rapid Test can play a sufficient role, but they are still concerned. According to the medical community on the 28th, concerns and expectations were simultaneously confirmed by the medical association over the government's transition to the COVID-19 test system. The COVID-19 test method includes PCR tests that amplify and test genes and Antigen Rapid tests that use the principle of antigen detection by immune responses after virus infection. PCR (rRT-PCR, qRT-PCR), which collects secretions by inserting cotton swabs into the nostrils, has more than 98% accuracy and 100% specificity, and PCR through saliva reaches 92% sensitivity and 100% specificity. Although the accuracy is high, the results can be confirmed one to two days after the test, considering the time required for genetic testing and sample transfer. On the other hand, the Antigen Rapid Test has a sensitivity of 90% or more and a specificity of 99%. The Antigen Rapid Test is used at a time when the amount of virus in the body is high to obtain more accurate results, and when used at a time when the amount of virus is low, false negative results are likely to be derived. GCMS's Antigen Rapid Test "GENEDIA W COVID-19 Ag" The sensitivity of 80% means that 80 out of 100 samples confirmed positive by genetic testing are tested positive, but 20 are incorrectly tested negative. However, the Antigen Rapid Test has the advantage of being able to determine whether or not to be infected immediately when rapid results are needed in the field. The KSLM is concerned about the government's transition to the inspection system Sung Heung-seop, director of infection control at The KSLM, said, "We have built up to 850,000 test capabilities a day with PCR, but it is difficult to understand why it was approved as a test method even though experts pointed out the low sensitivity of rapid antigen testing several times." He pointed out, "The fact that the accuracy of the rapid antigen test is more than 90% is the value when the virus emission is at its maximum level from 3 to 5 days after the onset of symptoms." The argument that the test system needs to be changed is also convincing as antiviral drugs that are directly linked to the prognosis were introduced in the early stages of administration. Unlike the early Wuhan virus, the late mutation that led to Delta and Omicron is characterized by strong propagation power due to the large amount of viruses. 99% of new confirmed patients in the U.S. are infected with Omicron, and more than 50% of them are currently infected with Omicron in Korea, and have already become the dominant species. Kang Yoon-hee, a specialist in diagnostic testing, explained, "Before delta mutations, there were certainly not many detection of viruses in the body, but the situation changed rapidly due to mutations." Specialist Kang Yoon-hee explained, "The lower the Ct value, the higher the amount of virus emitted, the more sensitive the sample was 81%, and most of the ohmicron mutations were less than 23%." Studies on the subject of changes in the sensitivity of antigen testing and relative accuracy with PCR are also accumulating.A comparative test of the Antigen Rapid Test and PCR conducted by researchers at Johns Hopkins Bloomberg School of Public Health (JHSPH) such as Andy Pekosz was released in November last year. The study compared the two test methods by collecting upper respiratory samples from 251 people 7 days after the outbreak of COVID-19. As a result, the positive prediction value of the Antigen Rapid Test was 90%, higher than 70% of rt-PCR. Based on this, the researchers judged that "antigen testing can be a better factor for people with a high risk of having a highly contagious virus."
- Company
- EUSA Pharma establishes subsidary in Korea
- by Eo, Yun-Ho Feb 08, 2022 05:55am
- The UK-based pharmaceutical company EUSA Pharma is entering the Korean market. According to industry sources, EUSA Pharma established the Asia Pacific Regional Headquarters in Korea and launched its Korean subsidiary, EUSA Pharma Korea. EUSA Pharma is a global specialty pharmaceutical company that focuses on rare and incurable diseases that were established with funding support from a leading life science investor EW Healthcare Partners. The company is currently a multinational pharmaceutical company that has branches in Europe, the Middle East, Africa, the United States, South America, the and Asia Pacific region, and recorded sales of 130 million euros as of June 2021. Its leading product is ‘Sylvant (siltuximab),’ a Multicentric Castleman‘s Disease treatment that is being distributed by Janssen Korea in Korea. Sylvant is being listed and prescribed with reimbursement from February 2018. Also, Yeon Jae Lee was appointed General Manager of the Asia Pacific region and Korean subsidiary. Lee is a seasoned professional in the pharmaceutical industry, who served in various posts at Novartis Korea, Daewoong Pharmaceuticals, and as the Country Head of UCB Korea and the Head of Rare Blood Disorders at Sanofi-Aventis Korea. Meanwhile, the Italian pharmaceutical company Recordati confirmed the deal to acquire EUSA Pharma at the end of last year. As the acquisition process is expected to be completed within the first half of this year, Whether EUSA Pharma will be maintained in its current form remains to be seen.
- Company
- Entresto's outpatient prescriptions exceed ₩30 billion
- by Feb 08, 2022 05:54am
- Pic. of Entresto Sales of Novartis’ chronic heart failure treatment ‘Entresto’ exceeded ₩30 billion only 5 years into its release. In the midst of drug price cuts and domestic patent challenges, Entresto is seeking greater growth this year by expanding the scope of indications and reimbursement benefits. According to the market research institution UBIST on the 29th, outpatient prescription sales of Entresto recorded ₩32.3 billion, a 37.3% growth from the ₩23.5 billion made in the previous year. The product made such growth in only 4 years since its release in October 2017. Entresto is a first-in-class angiotensin receptor-neprilysin inhibitor (ARNI) that combines the angiotensin receptor blocker (ARB) valsartan and neprilysin inhibitor sacubitril. The drug may be used as an alternative to an angiotensin receptor blocker (ARB) or an angiotensin-converting enzyme (ACE) inhibitor in patients with left ventricular (LV) dysfunction in combination with other heart failure treatments. Entresto received marketing authorization in April 2016 and was officially launched with reimbursement in October 2017. Entresto’s explosive growth was well expected. The drug demonstrated its efficacy and safety in acute heart failure in addition to chronic heart failure, and academic societies in Korea and abroad recommend Entresto as a standard of care. Also, the American Heart Association recommended Entresto as the standard of care for heart failure with reduced ejection fraction (HFrEF). Until now, ACE or ARB inhibitors were mainly used in patients with chronic heart failure. Replacing this demand, Entresto quickly increased its share in the market. Its outpatient prescription sales, which started at ₩300 million in 2017, increased 20 times to ₩6.3 billion the next year. In 2019, its sales doubled once more to ₩15 billion, then rose to exceed ₩30 billion only 2 years since then. To slow down such growth, pharmaceutical companies in Korea have aggressively set out to challenge Entresto’s patent. 13 domestic companies including Hanmi Pharmaceuticals and Chong Kun Dang filed patent challenges last year. The Intellectual Property Trial and Appeal Board ruled in favor of the generic companies in the trial to confirm the passive scope of rights of Entresto’s crystalline patent. By overcoming the key patent among 5 of Entresto’s patents, the domestic generic companies are speeding up their challenges. Also, Entresto’s price will undergo additional price cuts. The Ministry of Health and Welfare is working to cut Entresto’s price by 6.6% as of February 1st under the ‘‘Amendment to the drug reimbursement list and reimbursement ceiling price table.’ Entresto is subject to pricing cuts under the ‘Use amount-price linkage-type B’ where a product whose use increased over 10% in an amount over ₩5 billion undergo price cuts. The price of Entresto, which was listed at ₩2,243 at the time of first listing, will be reduced to ₩1,910 through three pricing adjustments. Novartis plans to continue its strong growth by adding indications and expanding Entresto’s reimbursement standards. Its indication for HFpEF is one of the company’s key areas of interest. Although around half of all patients with heart failure suffer HFpEF, which is defined as a left ventricular ejection fraction of 40% or higher, no appropriate treatment had existed for the condition yet. Novartis demonstrated that Entresto can reduce the risk of hospitalization from heart failure and cardiovascular death through the PARAGON-HF trial. The UF Food and Drug Administration additionally approved the HFpEF indication for Entresto in January last year. In line with the added indication, Novartis is working to expand the scope of Entresto’s reimbursement to first-line therapy in HFrEF.
- Company
- Celltrion begins global P3T for its inhaled COVID-19 therapy
- by Ji Yong Jun Feb 07, 2022 05:57am
- Celltrion HQ Celltrion has begun global Phase III trials on its ‘inhaled antibody cocktail therapy’ that is in development to respond to major variants of the COVID-19 virus, such as the Omicron variant. According to the clinical trial registry ClinicalTrials.gov operated by the US National Institutes of Health (NIH), Celltrion newly registered a clinical trial protocol on initiating a Global Phase III trial for its ‘inhaled antibody cocktail therapy’ on the website on the 4th. The trial will assess the therapeutic efficacy of the combination of ‘CT-P63’ and ‘CT-P66’ in an inhaled form to patients that were infected with mild-to-moderate COVID-19. After enrolling patients who experienced symptom onset within 7 days of COVID-19 diagnosis, participants will be divided into two groups and be administered the ‘CT-P63’ and ‘CT-P66’ combination or placebo for 14 days to assess the combination’s clinical efficacy. The patients who were administered the CT-P63’ and ‘CT-P66’ combination will be monitored for 90 days for adverse reactions. Celltrion plans to start the trial in April and expects to complete the trial by January next year. CT-P63 is an antibody cocktail therapy developed by Celltrion to respond to the emerging COVId-19 variants. CT-P63 demonstrated strong neutralizing activity against various major variants including the alpha, beta, gamma, and delta variant, and also showed strong neutralizing activity against the Omicron variant in a pseudovirus testing that Celltrion conducted with NIH. Also, a Phase I clinical trial that was conducted in Poland in 24 healthy subjects since September last year showed that CT-P63 was safe and well-tolerated, with no significant drug-related adverse events (AEs). CT-P66 is an inhaled formulation of Regkirona that is being analyzed in a Phase I trial after completing administration. The inhaled antibody cocktail therapy is considered to be more convenient in administration compared to the existing Regkirona formulation that is administered through intravenous infusion. IV infusions like the existing formulation had to be administered at the hospital for over an hour, but an inhaled formulation can be administered by the patients at home, therefore being well utilized. Celltrion said, “After developing our COVID-19 antibody treatment Regkirona, we have been developing our ‘inhaled antibody cocktail therapy’ for over a year and a half now. We expect our treatment to become a convenient and economic treatment that can respond to various COVID-19 variants, including the Omicron variant.”
