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- 2025-12-25 15:34:14
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- Latecomer JAKi ‘Rinvoq’ now has the most indications
- by Oct 08, 2021 05:56am
- The latecomer JAK inhibitor, Abbvie’s ‘Rinvoq,’ is seeking to overturn the market landscape by greatly expanding its indications. Whether the drug can break the two-way lead battle between Xeljanz and Olumiant, is gaining attention. According to the Ministry of Food and Drug Safety, Abbvie’s ‘Rinvoq (upadacitinib)’ received additional approval for psoriatic arthritis, ankylosing spondylitis, and atopic dermatitis indications. With the original rheumatoid arthritis indication, Abbvie’s drug is now approved for 4 indications in total. More specifically, Rinvoq is indicated for the treatment of adults and patients over the age of 12 with moderate to severe atopic dermatitis. In ankylosing spondylitis, Rinvoq can be used to treat adult patients who show inadequate responses to existing treatments. Also, in psoriatic arthritis, the drug can be used as monotherapy or combination therapy in patients who are intolerant or do not respond appropriately to disease-modifying anti-rheumatic drugs (DMARDs). In particular, the drug became the second JAK inhibitor after Olumiant to be approved for atopic dermatitis, a condition that has limited treatment options. Unlike Olumiant, which can only be used in adults, Rinvoq can also be used in adolescents aged 12 or older. With the addition of Rinvoq, biologic treatment options for atopic dermatitis have now increased to three in the market that used to be dominated by Sanofi Aventis’s ‘Dupixent.’ Abbvie has been actively targeting the atopic dermatitis treatment market, conducting a head-to-head trial between Rinvoq and Dupixent. In the Phase 3b Heads Up study, 71.0% of patients treated with Rinvoq achieved EASI 75 at week 16, which was higher than the 61.0% in the Dupixent-treated group. More recently, the patients’ eczema area was divided into 4 (head and neck, body, arm, leg) to assess the rate of EASI 75 response at week 16 in the areas. At EASI 76 at week 1 in all 4 areas was higher for Rinvoq, and lasted so until week 16. In other words, the study indicated that Rinvoq can relieve symptoms faster than Dupixent, regardless of the affected area. Rinvoq is a latecomer JAK inhibitor that was introduced in Korea in June last year. This is 2.6 years later than Olumiant and 6 years later than Xeljanz. During this period, Xeljanz had overtaken the market by expanding the area to rheumatoid arthritis, ulcerative colitis, psoriatic arthritis, and releasing an extended-release formulation. Then, Olumiant started to show strength in rheumatoid arthritis and divided the JAK inhibitor market into a two-way race. Also, Olumiant became the first to receive approval for atopic dermatitis, pioneering a new market. According to the market research institution IQVIA, Xeljanz enjoyed the sole lead old 14.7 billion won in sales in 2019. Its sales in 2020 were 16.2 billion won. Olumiant only sold 2.2 billion in 2019, but its sales rose greatly to 9 billion last year. In the first half of this year, Xeljanz (including the XR formulation) sold 7.8 billion, and Olumiant sold 5.6 billion, greatly narrowing the gap. Rinvoq, which started to record sales at the end of last year, sold 600 million won in the first half of this year. Its sales have been rising with the rapid reimbursement, however, the degree of growth is yet too small to catch up with Xeljanz nor Olumiant. However, Rinvoq suddenly increased its indications to 4 and change the future landscape. With the added indications, Rinvoq now owns the most amount of indications among JAK inhibitors. Pfizer plans to approach the atopic dermatitis market with a different JAK inhibitor other than Xeljanz. Unlike Xeljanz, which mainly inhibits JAK3, ‘Cibinqo (abrocitinib)’ mainly targets JAK1. Pfizer is known to have applied for Cibinqo’s approval and is being reviewed. However, the safety concern that remains in all JAK inhibitors is the issue. Based on the post-marketing safety study of Xeljanz, the US FDA concluded that it may increase the risk of severe heart disease such as heart attacks, etc. The FDA did not limit the boxed warning requirement to just Xeljanz, but expanded the alert to all JAK inhibitors and requested all three products to contain black box warnings. If this safety concern is not resolved, and the scope of treatment becomes restricted, this may affect and shrink the entire JAK inhibitor market.
- Company
- Roche and Lilly to launch RET targeted cancer drugs in Korea
- by Eo, Yun-Ho Oct 06, 2021 06:06am
- Two types of RET targeted anticancer therapies are concurrently seeking domestic entry. According to industry sources, Roche Korea's Gavreto (pralsetinib)’ and Lilly Korea ‘Retevmo (selpercatinib)’ are under review for domestic approval. Both are anticancer drugs that target RET (Rearranged during transfection) gene fusions. The drugs not only inhibit primary RET fusions and mutations but also secondary RET mutations that cause resistance to treatment, and are receiving much attention on whether they will be able to address unmet needs in various types of cancer. Retevmo became the first to receive global approval by a few months. Retevmo received marketing authorization from the US FDA in May last year, and Gavreto in September. Retevmo was approved for the Non-small Cell Lung Cancer (NSCLC) and thyroid cancer indications, whereas Gavreto was first approved as a lung cancer treatment, then approved for the thyroid cancer indication in December of the same year. Although the drugs were initially approved for lung cancer and thyroid cancer indications, the companies are expected to actively pursue more indications for RET inhibitors in the future. RET gene fusions are present at a low frequency in colorectal cancer, breast cancer, pancreatic cancer, and EGFR-positive NSCLC. Like NTRK (Neurotrophic tyrosine receptor kinase) targeted therapies like ‘Rozlytrek (entrectinib)’ etc., RET inhibitors have the potential to be used as tumor-agnostic, personalized treatment. Meanwhile, Retevmo’s efficacy was verified through the Phase I/II LIBRETTO-001 study. Retevmo’s overall response rate (ORR) was 64% in 105 RET-gene positive patients with small cell lung cancer who have previously received platinum-based chemotherapy. Also, 81% of the patients who showed treatment response showed a response for at least 6 months. Also, Retevmo recorded a high ORR of 84% in 39 RET-gene positive, treatment-naive patients. In 143 medullary thyroid cancer patients that have previous treatment experience with ‘cabozantinib’ or ‘vandetanib,’ etc., the ORR was 69%. And 76% of the patients maintained treatment response for at least 6 months. In other RET-gene positive thyroid cancer, the ORR of patients with radioactive iodine-refractory (RAI) was 79%, 87% of which showed continued treatment response for over 6 months. Gaverto was initially approved as a lung cancer treatment based on the ARROW study. In the study, Gavreto showed an ORR of 57 % and a complete response (CR) rate of 5.7 % in NSCLC patients that were previously treated with platinum-based chemotherapy (87 patients). Also, ORR was 70% and CR 11% in newly treated patients (27 patients).
- Company
- Evrysdi (PO) is differentiated due to its low price
- by Oct 06, 2021 06:06am
- Roche's "Evrysdi (Risdiplam)," the second treatment for spinal muscular atrophy (SMA) in Korea, signaled its launch after about a year of approval. With the differentiation of the only PO drug and low prices, fierce competition in the SMA market was predicted. "Evrysdi is the first oral drug among SMA treatments and is applicable to patients with difficulty in treating SMA, and has confirmed its effectiveness and safety in patients of a wide range of ages and types," Roche Korea stressed at an Evrysdi meeting on the 5th. Evrysdi (Risdiplam) is a prescription medicine used to treat spinal muscular atrophy (SMA) in adults and children 2 months of age and older. Spinal muscular atrophy (SMA) is a rare genetic disease in which the SMN1 gene is inherently deficient or mutated, resulting in gradually shrinking muscles. It is known that about one per 10,000 newborns worldwide, and about 30 patients (based on 300,000 newborns) occur every year in Korea. Three new drugs were released in Korea in three years, starting with Biogen's Spinraza in SMA diseases, which had no cure so far. Evrysdi is the second new drug approved in November last year and is the only PO drug. It has been almost a year since the license was granted, but it has not yet been released on the market. As a result, it was delayed than Novartis' Zolgensma, which was belatedly approved. Novartis applied for Zolgensma's benefit in June. Evrysdi began the registration process only in July, eight months after the permit. Roche is expected to officially release Evriesdi after completing the registration process. It is expected to be reimbursed well as Spinraza, which is already more expensive, has been reimbursed. Evriesdi is also known to be likely to follow RSA ( the Expenditure Cap) applied to Spinraza. Lee Seung-hoon, director of Roche Korea, said, "We are currently trying to get reimbursed within the same range as Spinraza." He explained, "I think access to insurance is more important than anything else because receiving rapid treatment for patients has a great impact on the prognosis." Roche explained that it is the only PO drug and that the relatively low cost is Evrydi's strength. Spinraza prices exceed 90 million won, and Zolgensma, which is negotiating benefits, is a "one-shot" treatment that costs more than 2 billion won per time. Evrysdi's final drug price has not been determined, but it is much lower than the prices of Zolgensma and Spinraza. In particular, it is expected to be cheaper for infants and toddlers. Jung-hyun Chang of Roche Korea said, "Unlike other products, Evrysdi's dosage is determined by age and weight, so we expect infants and toddlers under the age of 2 to be treated at a much lower price than adults, greatly reducing the burden of drug costs." Evriesdi can be self-administered at home, which can reduce the socioeconomic burden, he added. Attention is also being paid to which drugs medical staff and patients will choose. Lee Yoon-jung, a professor of pediatrics at Kyungpook National University, emphasized "patient accessibility." Fast diagnosis and treatment are of paramount importance because SMA's symptoms deteriorate rapidly within a short period of time and the slower the treatment, the less effective it is. Professor Lee said, "No matter how active treatment is, the disability often remains no matter how active the treatment is," adding, "As diagnosis and initial administration are very important, we need to consider what drugs can speed up the initial administration as much as possible."
- Company
- Yoo Byung-Jae took office as the new president of Novartis
- by Oct 06, 2021 06:05am
- Yoo Byung-Jae, the new CEO of Novartis Korea Yoo Byung-Jae took office on the 1st as the new president of Novartis Korea. New President Yoo is an expert who has accumulated organizational management and management skills in the global healthcare industry for 15 years. Until recently, he served as president of North Asia, including South Korea, Taiwan, and Hong Kong, at Johnson & Johnson Medical, exceeding his target performance every year. It is evaluated that it has created business excellence and led organizational development by growing in all business fields. New President Yoo said, "I am happy to join Novartis, which leads the global pharmaceutical industry, based on our innovative portfolio." "We will do our best to provide patients with various innovative treatments, including the cellular therapy portfolio that Novartis is currently focusing on, contribute to the innovative ecosystem of the domestic healthcare industry, and become a socially trusted company," he said. The new president Yoo, a graduate of Korea University's business administration department and Harvard Business School, joined the marketing team of Johnson & Johnson Medical's blood vessel division in 2006. Since then, he has been in charge of marketing leaders in orthopedic departments in the United States, the United Kingdom, and Australia, and has successfully led various business fields since returning to Korea in 2010. In addition, he gained brand management experience in famous consumer goods companies such as Coca-Cola and Unilever, and worked as a management consultant for Boston Consulting Group.
- Company
- “Dupixent, a trusted AD treatment without safety concerns"
- by Oct 05, 2021 05:58am
- The biologic agent ‘Dupixent (dupilumab)’ holds an 'unrivaled' position in the treatment of severe atopic dermatitis. In the AD treatment environment that had used immunotherapies that bring a high burden of side effects, the introduction of a safe and effective option has greatly improved the symptoms and quality of life in AD patients. Due to its strong effect, requests for reimbursement to be extended to cover the pediatric and adolescent indications have been flooding. Unlike systemic immunosuppressants, Dupxient selectively inhibits IL-4, IL-13 signals, the key drivers of type 2 inflammation, and therefore is known as a drug that can be safely used without concern over side effects. Dailypharm met with Dong Hun Lee, Professor of Dermatology at the Seoul National University Hospital to hear about the effect and safety of Dupixent. The following is a full QA with Professor Lee. Professor Dong Hun Lee-How has the introduction of Dupixent changed the atopic dermatitis treatment environment? =Before Dupixent, we mainly prescribed immunosuppressants such as cyclosporine and methotrexate, etc. to treat severe atopic dermatitis. Atopic dermatitis is a chronic condition that requires continued treatment and management, however, immunosuppressants have limitations in their treatment efficacy or have side effects that occur with long-term use that prohibit continuous use. This is why major practice guidelines do not recommend continued use of cyclosporin for over 1-2 years. In addition to clinical trials that demonstrated Dupixent’s superior efficacy, the company also recently disclosed the drug’s long-term safety data in adult patients with moderate-to-severe atopic dermatitis. Also, in clinical practice, Dupixent generally showed a good effect in patients whose symptoms were not controlled by immunosuppressants such as cyclosporine. Unlike other immunosuppressants that require regular monitoring every 1-3 months after administration, no separate blood tests are required for the use of Dupixent. In this aspect, patients may see this convenience in administration as a benefit. -Dupixent is being reimbursed applied the special calculation system in adults, but it has been pointed out that the set standards are too strict. What is your opinion on this? =First, I would like to say that I am glad and thankful that many patients with severe AD are now benefiting through the reimbursement and special calculation system. The EASI score that is used to assess the severity of AD only considers a patient’s symptoms and the extent (area) of eczema. However, adult AD patients with atopic dermatitis mainly show symptoms on exposed areas such as the face, neck, and hands, and even though the area is small, the quality of life is greatly reduced and itching is severe and requires aggressive treatment. To address this, the Korean Atopic Dermatitis Association presented an atopic dermatitis severity guideline that comprehensively reviews the Dermatology Life Quality Index (DLQI) and Numerical Rating Scale (NRS) score, in addition to the EASI score to assess the severity. -Recently, Dupixent was approved for the treatment of moderate-to-severe atopic dermatitis in pediatric patients aged 6 to 11 in addition to adults and adolescents. What were the limitations of previous treatment options for pediatric patients with moderate-to-severe atopic dermatitis? What should be considered when expanding Dupixent reimbursement to pediatric patients in the future? = Prevalence of AD is around 10% in children and 3% in adults. Like adult patients with AD, pediatric patients also often have severe symptoms and are prescribed systemic immunosuppressants or Dupixent. However, long-term use of systemic immunosuppressants is not recommended in major guidelines because of the risk of side effects with long-term administration. The burden of disease, school, peer relationships, and the increased burden of care borne by the family is larger for pediatric and adolescent patients. Considering the specificities, such as the importance of initial treatment and a relatively small number of patients who will be needing reimbursement, I do hope that the reimbursement standards are relieved to cover these patients. -Recently, a JAK inhibitor, ‘Olumiant,’ was approved in Korea for AD, with more JAKis to come. Some companies developing JAK inhibitors have been taking active steps to such as conducting head-to-head clinical trials with Dupixent in AD. How do you see the use of JAK inhibitors will go in the treatment of AD? =JAK(Janus kinase) inhibitors block a range of cytokines related to inflammatory responses by acting on the JAK signal pathway. Its MOA works broader than Dupixent but narrower than other immunosuppressants such as cyclosporine in blocking inflammatory responses. Although clinical trial results for the use of JAK inhibitors in AD are available, no real-world data is yet available. We would need to wait and observe these results from the field. Therefore it is yet difficult to make short- and long-term comparisons of JAK inhibitors and Dupxient. -I would like to know your opinion on the safety issue that recently arose for JAK inhibitors. The FDA’s black box warning does not include Dupixentl. Is Dupixent safe in this respect? =The US FDA’s recent Dear healthcare Professional letter indicated that the use of the JAK inhibitor ‘tofacitinib’ in rheumatoid arthritis patients raises the risk of cardiovascular disease compared to the use of TNF inhibitors. However, the JAK inhibitor in question is not approved for atopic dermatitis, and JAK inhibitors do not need to be avoided as a whole as drugs in the same class can also have different efficacy and safety. However, in consideration of the commonality in MOA of JAK inhibitors, continued monitoring as well as caution when prescribing the class in high-risk patients may be needed until further data is available. In the case of Dupixent, the 3-year long-term safety data of the drug in adult patients have been recently added to the product label. Also, patients in Korea who have been using the drug for over 3 years with the ‘Early Access Program (EAP)' before it was approved in Korea, are continuing their treatment in satisfaction until now. No notable adverse reactions have been observed in patients who received Dupxient long-term, therefore no separate monitoring is required for its prescription, such as blood tests. Also, patients do not prefer such additional tests. -What common characteristics do patients who do not respond to Dupixent have? =It is effective in most patients, however, there were occasional cases where the effect was relatively small in patients who have high lgE or LDH levels that reflect the severity of disease or in overweight patients. However, the level of non-response was not particularly noteworthy. Also, almost no notable side effects were observed in patients that were prescribed Dupixent. Symptoms such as conjunctivitis or facial redness did appear, but at a controllable level.
- Company
- All 15 pharmaceutical unions gathered together
- by An, Kyung-Jin Oct 05, 2021 05:56am
- The chairmen of the union of 15 pharmaceutical companies constituting the consultative body (data: NPU) A labor union composed of workers from 15 domestic pharmaceutical and bio companies has begun in earnest to integrate. According to the industry on the 29th, representatives of labor unions from 15 pharmaceutical and bio companies currently active in Korea gathered to form the National Pharmaceutical & Bio Labor Union (NPU) and began official activities. NPU is a consultative body to launch labor unions by pharmaceutical and bio industries under the Federation of Korea Trade Union and The Federation of Korean Chemical Workers' Union. Currently, Novo Nordisk, Bayer Korea, Sanofi Aventis Korea, Alvogen Korea, Amgen Korea, Ipsen Korea, Novartis Korea, Merck Korea, Beringer Ingelheim Korea, Viatris Korea, AstraZeneca Korea, Janssen Korea, and Hyundai will participate. The total number of union members is about 2,500. The reason for the launch of NPU is because of the problem of recognizing the difficulties faced by pharmaceutical industry workers as common problems in Korea's pharmaceutical industry and finding solutions together. Although public interest in the pharmaceutical and bio industries is increasing in COVID-19 pandemic, industry workers point out that they are in danger of slowing industrial growth, job insecurity and income reduction due to changes in the business environment. However, it is known that the launch of the industrial union has been delayed in consideration of the COVID-19 pandemic situation. As strengthened "social distancing" measures continued and smooth communication between large-scale gatherings and members was restricted, the government decided to temporarily operate a consultative body, which is an intermediate level. According to Article 16 of the Trade Union and Labor Relations Adjustment Act and the conventions of trade unions by each company, more than two-thirds of the registered union members must agree with the resolution. As an alliance, NPU plans to strengthen solidarity and improve the working environment of workers in the pharmaceutical industry. It is predicted that the official industrial union will be launched as early as June next year, shifting the organization form sequentially from the organization where the union member vote was completed. The ambition is to work hard to raise the working level of 2,500 union members to the next level, led by Ahn Deok-hwan, chairman of the NPU. NPU Chairman Ahn Deok-hwan said, "Although it is launched as an intermediate consultative body, we will respect and solidarity with each other like the official industrial union," adding, "We will upgrade the wages and welfare of workers in the pharmaceutical industry through strategic and efficient bargaining support. We will also respond to problems such as employment insecurity caused by low growth and digital marketing by directly communicating with the National Assembly, the government, and civic groups."
- Company
- Liver cancer pioneer ‘Nexavar,' the star in its guidelines
- by Eo, Yun-Ho Oct 01, 2021 06:09am
- There are two reasons why new drug development is slow for a certain disease: its marketability is low or the development of the drug is difficult. When developed, new drugs developed in the latter situation attract more widespread attention. Liver cancer (hepatocellular carcinoma) is a typical example of this. And the only targeted anticancer therapy that was available in this difficult-to-develop field of liver cancer for over 10 years was ‘Nexavar (sorafenib).’ Of course, new drugs are now available, such as ‘Stivargar (regorafenib)’ as second-line treatment, and ‘Lenvima (Lenvatinib),’ which is used as first-line treatment like Nexavar. Also, an immunotherapy option was added in the field with the approval of the ‘Tecentriq (atezolizumab)+Avastin (bevacizumab)’ combination therapy. Still, Nexavar’s legacy remains strong ◆The liver treatment that was introduced for the first time in 30 years Nexavar, which was the first in the world to receive FDA approval for hepatocellular carcinoma, opened the door to targeted anticancer therapy in the field. At the time, Nexavar was a significant achievement that was made after a series of attempts and failures by pharmaceutical companies for around 30 years. In Korea, after receiving the first-ever approval for hepatocellular carcinoma from the Ministry of Food and Drug Safety in March 2008, the drug has accumulated the most amount of treatment experience as the only first-line targeted therapy for over a decade since then. And the drug kept on evolving. Data from the GIDEON study that was conducted on 3,371 liver cancer patients in 39 countries around the globe, the drug showed a consistent safety profile in Child-Pugh class B7 patients with liver damage (11%, n=359) and 에서 Child-Pugh class A patients (61%, n=1968). Based on this, Nexavar is currently the only drug recommended as a first-line systemic anticancer therapy in patients with Child-Pugh class B7 in the 2020 NCCN guidelines (Version 5). ◆The significance of reimbursement approval in Child-Pugh class B7 and the rising position of Nexavar By succeeding to expand its insurance benefit, Nexavar once again strengthened its position in the field. With Nexavar’s insurance benefit approved to Child-Pugh class B7 patients, or severe disease patients, the drug’s utility in liver disease has even more increased. Before then, Child-Pugh class B7 was a sort of ‘grey area’ in the field of liver cancer. With the approval, Nexavar can now be used with reimbursement in patients with advanced hepatocellular carcinoma (HCC, including pediatric patients) who cannot receive local treatment such as surgery or transarterial chemoembolization (TACE) that are: ▲Child-Pugh class A or B7; ▲at Stage Ⅲ or higher; or ▲ whose ECOG performance status (PS) is 0-2. Also, the biggest advantage of the first-line treatment Nexavar is that it has a second-line treatment Stivarga available for use in sequence with reimbursement. A clinical trial showed that the use of Nexavar in sequence with the second-line treatment Stivarga prolonged overall survival (OS). However, limitations still exist as Nexavar is the only systemic anticancer treatment reimbursed for Child-Pugh class B7 patients, and no sequential treatment is available for use with reimbursement after Nexavar. Also, there are unfavorable views on the limited reimbursement status of its competitor drug Lenvima. ◆Patent expiry, drug price cuts, and the entrance of competitor drugs However, in terms of sales, Nexavar is now on its descent. It's not about the prescription amount, but about the patent expiry and the resulting drug price cut. According to IQVIA, Bayer’s hepatocellular carcinoma treatment sold 5.6 billion won in the first half of the year. This is a 45% decrease from the 10.3 billion won that was sold in 1H last year. In the same period, sales of Eisai’s Lenvima increased 27% from 5.7 billion won to 7.2 billion won. With the steep fall in sales of Nexavar and a significant increase in sales of Lenvima, the position of the two drugs has changed. This is a first in 13 years since the drug started being used as a liver treatment and 3 years after the release of Lenvima. Nexavar took a hard blow in February this year with its insurance ceiling being reduced by 30%. The government cut Nexavar’s drug price 30% ex officio from 18,560 won to 12,992 won. This was because Hanmi Pharm’s released Nexavar’s generic after overcoming Nexavar’s patent.
- Company
- Only Taejoon’s succeeds in avoiding Simbrinza’s patent
- by Kim, Jin-Gu Oct 01, 2021 06:09am
- Taejoon Pharmaceutical succeeds in avoiding the patent for Novartis’s glaucoma treatment ‘Simbrinza eyedrops (brimonidine+ brinzolamide).’ Being the only company to successfully avoid Novartis’s patent, Taejoon Pharmaceutical will now be able to develop a generic version of Simbrinza Eye Drops in a relatively relaxed manner. According to industry sources on the 30th, Taejoon Pharmaceutical recently won the Passive Trial to Confirm the Scope of Patent Rights it filed against the composition patent of Novartis’ Simbrinza Eye Drops. Taejoon Pharmaceutical had filed the suit in July last year, and this is the only patent registered in Korea for Simbrinza Eye Drops. The patent will expire by June 2030, and its PMS has expired in June this year. With the victory, Taejoon Pharmaceutical prepared a foothold for the early release of its Simbrinza generic. If Taejoon Pharmaceutical succeeds in developing its generic and receives marketing approval, the company may immediately release its product. Currently Taejoon Pharmaceutical is the only company to succeed in avoiding its patent. Originally, Chong Kun Dang had challenged the patent with Taejoon Pharmaceutical, however, CKD had dropped its suit, and Taejoon continued on its challenge by itself. With no generic competitor, the company will be able to continue developing its generic in a relatively easier manner. Taejoon Pharmaceutical is currently selling other glaucoma treatments in the market. Its Xalost Eye Drops (latanoprost)’ is a generic of Pfizer’s ‘Xalatan Eye Drop,’ and its ‘Combisopt Eye Drops (timolol+dorzolamide’ is a generic of Santen Pham Korea’s ‘Cosopt Eye Drops.’ Taejoon Pharmaceutical plans to bring synergy into the glaucoma treatment market by adding a Simbrinza generic to its portfolio. According to the pharmaceutical market research institution IQVIA, its Xalost sold 6.5 billion won and Combisopt sold 0.2 bill won last year. Simbrinza Eye Drops have steadily sold around 2 billion won annually. The product has recorded 1.1 billion won in sales in the first half of this year.
- Company
- Pfizer’s 2nd JAK inhibitor ‘Cibinqo’ to soon enter Korea
- by Eo, Yun-Ho Sep 30, 2021 05:57am
- Pfizer is planning to introduce a new JAK inhibitor after ‘Xeljanz’ to Korea. However, the new drug will target the ‘atopic dermatitis’ treatment market. According to industry sources, Pfizer Korea has recently submitted an application requesting marketing authorization for its Cibinqo (abrocitinib). The approval is expected to be made in the first half of next year. The drug, which is taken once daily, has been approved for the treatment of moderate-to-severe atopic dermatitis (AD) in adults and adolescents aged 12 years and over that are candidates for systemic therapy. The drug has not received marketing authorization in the U.S yet. Cibinqo is a selective Janus kinase (JAK)1 inhibitor that modulates multiple cytokines involved in AD including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSL). Xeljanz inhibits JAK3 rather than JAK1 or JAK2. With only Lilly’s ‘Olumiant (baricitinib)’ currently approved for the atopic dermatitis indication, more JAK inhibitors are expected to soon enter the market. Lilly is working to extend Olumiant’s insurance benefit to its atopic dermatitis indication Meanwhile, Cibinqo’s efficacy in atopic dermatitis was identified through the Phase III JADE Mono-1 trial. Study results showed that at Week 12, 62.7% of patients who received 200mg of Cibinqo showed improvement in their EASI (Eczema Area and Severity Index 75 response rate) score of 75% or higher, a significant improvement compared to the 11.8% in the placebo group. Also, the proportions of patients who achieved EASI-90 were 38.6% and 5.3% for Cibinqo 200mg and placebo, respectively Also, the proportion of patients achieving an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) skin was 43.8% and 7.9% for Cibinqo 200mg and placebo, respectively, indicating that around half of the Cibinqo-treated group showed response within 12 weeks of treatment. Recently, the FDA had issued a Dear Healthcare Professional Letter regarding the safety of JAK inhibitors such as Pfizer’s ‘Xeljanz (tofacitinib),’ Lilly's ‘Olumiant (baricitinib),’ Abbvie’s ‘Rinvoq (Upadacitinib),’ etc. Whether the drugs may resolve the issue and settle as a viable treatment option for atopic dermatitis remains to be seen.
- Company
- It does not affect sales of Rivaroxaban 2.5mg
- by Kim, Jin-Gu Sep 30, 2021 05:57am
- Xarelto 2.5mg Hanmi dismissed the possibility of legal disputes over the patent registration of the original company ahead of the launch of Xarelto's generic. The company said that the scope of validity of patents registered late does not affect Hanmi's new drug to be released. In addition, Hanmi emphasizes that it did not take issue when it sent certification of contents to Bayer, the original company. According to the pharmaceutical industry on the 29th, Hanmi is planning to release Riroxban, Xarelto's generic, on the 4th of next month. 133 items from up to 66 companies, including Hanmi, will be released simultaneously after the expiration of Xarelto's patents. Expected items to be released are Rivaroxaban 10mg and Rivaroxaban 15mg. On top of that, Hanmi's Riroxban 2.5mg is the only one to release. This is because Hanmi succeeded in overcoming the composition patent registered exclusively in Rivaroxaban 2.5mg, and first of all, it received generic for exclusivity. In the case of Rivaroxaban 2.5 mg, there may be legal disputes with the original company. This is because Bayer registered a patent for use of Xarelto 2.5mg in September 2019, more than two years after obtaining generic for exclusivity. The patent expires in June next year. Regarding Bayer's registration, the pharmaceutical industry said it was aimed at hindering the early launch of generic. In addition, the pharmaceutical industry predicted that if Hanmi pushes ahead with the sale of Riroxban 2.5mg, it will lead to a legal dispute between the two companies in the future. Hanmi said, "There will be no impact on the launch of the Riroxban 2.5mg product." This is because the scope of validity of the registered patent is different from that of Hanmi's Riroxban 2.5mg. According to the Korean Intellectual Property Office, the patent registered by Bayer is about "Oxazolidinone for combination therapy." Specifically, it explains, "It relates to a composite agent of Oxazolidinone and other active ingredients, the preparation method and use of the composite agent as a drug, and in particular, its use as a drug for the prevention and treatment of thromboembolic disorders." In other words, if it is a "combination drug" with Xarelto 2.5mg added with other ingredients, Aspirin is likely to be added as another active ingredient if it is recognized as a patent for use. Bayer is said to have tried to register a combination therapy with other ingredients as a patent as a single drug. Bayer did not release domestic combination drug and only patents are listed. Hanmi said that Riroxban 2.5mg is not a combination type, so it is not a problem. An official from Hanmi said, "Actually, the use of Rivaroxaban 2.5mg is limited to combination drugs, so it does not affect the single drug Riroxban 2.5mg. There will be no problem with the launch of Riroxban 2.5mg."
