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- 2025-12-26 19:25:59
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- Roche Xofluza to be prescribed for flu prevention in Korea
- by Eo, Yun-Ho Dec 08, 2020 06:11am
- The prescription of a next-generation influenza new drug Xofluza is to get accessible in South Korea for prevention purpose. According to the pharmaceutical industry sources, Roche Korea applied for approval on Xofluza to the Ministry of Food and Drug Safety (MFDS) after the drug’s new indication to prevent influenza was cleared by the U.S. Food and Drug Administration (FDA) in November. The ministry is currently reviewing the application and the final decision would be made from the beginning of 2021. Endo-nuclease inhibiting Xofluza is a new influenza treatment, approved two decades after the launch of ‘Tamiflu (oseltamivir),’ and it treats flu patients with a single dose (Tamiflu requires five-day administration). The flu prevention efficacy was confirmed in Phase III BLOCKSTONE study, where Xofluza lowered the risk of influenza infection by 86 percent compared to a placebo. The primary endpoint of the study was to evaluate the proportion of participants who tested positive for the influenza virus, and the secondary endpoints was the proportion of patients, who tested positive through a reverse transcription polymerase chain reaction (RT-PCR) test with no apparent symptom like fever, and patients, who tested positive through RT-PCR test with severe influenza symptoms or fever higher than 37 degrees Celsius. The primary endpoint found 1.9 percent of Xofluza-treated subject group was tested positive, compared to 13.6 percent of the control group. And the protective effect was even more highlighted during the subgroup analysis targeting non-vaccinated, high-risk and children and adolescent groups. Moreover, the Xofluza group and placebo group did not show significant difference in adverse reaction with 22.2 percent and 20.5 percent, respectively. Xofluza is currently in process of receiving the National Health Insurance (NHI) reimbursement in South Korea. When listed, the industry expects the drug would be quickly prescribed widely. Targeting to expand the influenza drug market share, Roche has inked the co-promotion deal for Xofluza with Chong Kun Dang in last March.
- Company
- Daewoong succeeded in evading patent for Belkyra
- by Kim, Jin-Gu Dec 07, 2020 06:06am
- Daewoong has passed the final gateway for the early release of a generic for Belkyra (Deoxycholic acid), an injection for improving submandibular fat. The original company Allergan succeeded in avoiding the remaining one of the two divisional patents. According to the pharmaceutical industry on the 3rd, the Intellectual Property Trial and Appeal Board recently decided on 'Establishing a Claim' in a trial to confirm the passive scope of rights that Daewoong recently filed for formulation patent for Belkyra. Daewoong succeeded in evading Belkyra’s patent. Daewoong successfully avoided Belkyra's formulation patent on June 19 and November 20. It was Belkyra's last patent. Daewoong's patent challenge for Belkyra began in January 2018. Daewoong filed a judgment on formulation patent for Belkyra to confirm the scope of the passive rights. Daewoong won the patent trial. In June, the Intellectual Property Trial and Appeal Board filed a trial decision for the settlement of the claim, and it was confirmed on July 23, when Allergan abandoned the appeal. However, there were two more obstacles that Daewoong had to overcome. In January and April this year, when Daewoong and Allergan were in the midst of a fight, Allergan registered two more new Belkyra patents. Allergan removed and registered only some of the existing patents. It was part of the 'evergreening strategy' that continues its duration through divisional applications. In the end, Daewoong had to challenge the two split patents. In March of this year, Daewoong filed a trial for a passive confirmation of the scope of rights to the newly registered formulation patent for Belkyra. With this trial decision, Daewoong succeeded in targeting all three patents. In the case of a trial decision made earlier in June, Allergan accepted the result without appealing to the Patent Court of Korea and was confirmed. The two trial decisions are also likely to be confirmed. Daewoong is developing its own injection for improving submandibular fat under the name DWJ211. Since March of last year, it has entered phase III clinical trial for 150 patients at Konkuk University Hospital and Chung-Ang University Hospital. The indication for DWJ211 is improvement of moderate and severe submandibular fat, which is the same as that of Belkyra. When the development is complete, Daewoong may be sued for patent infringement from Allergan. The trial decision is expected to be appropriately used for defense purposes.
- Company
- Ninlaro starts pricing negotiation after three long years
- by Eo, Yun-Ho Dec 04, 2020 05:55am
- An oral multiple myeloma treatment, Ninlaro is initiating the drug pricing negotiation to seek for the National Health Insurance (NHI) reimbursement. The pharmaceutical industry sources reported the drug has started the pricing negotiation with the National Health Insurance Service (NHIS) on the only oral option in multiple myeloma treatment, Ninlaro (ixazomib), according to the Ministry of Health and Welfare’s (MOHW) order to negotiate given on Nov. 30, as the drug passed the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC). The treatment was designated as an orphan drug in May 2017, and was approved for the South Korean market in July same year. But its reimbursement application has been pending for over three years. The supplier, Takeda Pharmaceutical, has been providing the treatment to the South Korean market for free of charge since October last year. Although the drug could not utilize risk sharing agreement (RSA) with its competitor already in the market first, the multiple myeloma drug was able to sign the refund type RSA and receive clearance from the DREC as a law was passed recently to stipulate RSA on follow-on drugs as well. Ninlaro, combined with lenalidomide and dexamethasone, can be prescribed to treat multiple myeloma patients who have not responded to at least one standard therapy. The proteasome inhibiting drug Ninlaro confirmed its efficacy and safety I Phase III TOURMALINE-MM1 clinical trial conducted with 722 patients with relapsed or refractory multiple myeloma. The study found the triplet regimen of ixazomib, lenalidomide, and dexamethasone had significantly improved the duration of progression-free survival (PFS) to average 20.6 months, 14.7 months longer than a combination of placebo, lenalidomide and dexamethasone. Meanwhile, the triple combination therapy with Revlimid is the most recommended multiple myeloma treatment option according to the U.S. National Comprehensive Cancer Network (NCCN) guideline and the European Society for Medical Oncology (ESMO). And Revlimid (lenalidomide) is the backbone for all triple combination therapies. Following are some of major triple combination therapy options for second line and later treatments; Amgen’s Kyprolis (carfilzomib) KRd combination (Kyprolis, Revlimid, dexamethasone); BMS’ Empliciti (elotuzumab) ERd combination (Empliciti, Revlimid, dexamethasone); Takeda’s Ninlaro (ixazomib) IRd combination (ixazomib, Revlimid, dexamethasone); and Janssen’s Darzalex (daratumumab) DRd combination (Darzalex, Revlimid, dexamethasone).
- Company
- The liver cancer treatment market is fluctuating
- by Kim, Jin-Gu Dec 04, 2020 05:53am
- Nexavar (left) and Lenvima The liver cancer treatment market is fluctuating greatly. Sales of Nexavar (Sorafenib), which occupied an absolute position in the market, declined significantly, while sales of Lenvima (Lenvatinib) increased. Hanmi's Soranib, which succeeded in overcoming Nexavar's patent, is scheduled to be released, and attention is focused on whether the change in this market will be faster in the future. According to the drug market research agency IQVIA on the 3rd, the cumulative sales of Nexavar in the third quarter of this year is ₩15 billion. Compared to the cumulative ₩20 billion in the third quarter of last year, it decreased by 25%. Lenvima, another liver cancer treatment, surged from ₩4.6 billion to ₩8.8 billion over the same period. The gap in sales between the two treatments sharply decreased from ₩15.3 billion to ₩6.3 billion in a year. In this situation, Nexavar's generic 'Soranib' will be released soon. The MFDS approved Hanmi’s Soranib on October 30th. Hanmi can sell generic for Nexavar exclusively until July 29, next year. Nexavar's sales may further decline further. Changes in cumulative sales in the third quarter of Nexavar and Lenvima, the primary tx for liver cancer (left) and quarterly sales (unit: ₩billion, data IQVIA) Currently, the only first-line treatments for liver cancer that have been released in Korea are Nexavar and Lenvima. The advantages and disadvantages of both drugs are clear. When analyzing clinical data, Lenvima precedes Nexavar. As a result of conducting a one-to-one comparative clinical trial with Nexavar, it was found that the objective response rate (ORR) and progression-free survival (PFS) were improved. The advantage of Nexavar is that it has a follow-up drug. Stivarga (Regorafenib) and Cabometyx (Cabozantinib) can be used as follow-up drugs. Lenvima cannot use Stivarga or Cabometyx as a follow-up drug if the first-line treatment fails. In the case of both treatments, indications and benefit standards are also limited to patients who have failed Nexavar treatment. Even though Lenvima was released with better data after 10 years of Nexavar's release, the reason why Lenvima still struggles is that there is no follow-up drug. Accordingly, opinions on allowing Stivarga to be used even for patients who have failed Lenvima treatment have been steadily raised by the medical community and patients, but the discussion is still in the beginning. If Lenvima solves the problem of follow-up drugs, future sales are expected to increase even more rapidly.
- Company
- Sanofi's multiple myeloma tx Sarclisa was approved in Korea
- by Dec 04, 2020 05:53am
- Sanofi-Aventis Korea (CEO Kyung-Eun Bae) announced on the 2nd that its relapsed and refractory multiple myeloma treatment Sarclisa (Isatuximab-irfc) was approval from the MFDS on the 1st. Sarclisa was previously approved as a combination therapy with Pomalidomide and Dexamethasone in patients with multiple myeloma who received more than one treatment, including Lenalidomide and proteasome inhibitors. Sarclisa is a monoclonal antibody treatment that induces tumor cell death by binding to a specific epitope of the CD38 receptor present in multiple myeloma cells. Despite receiving more than two treatments, it is expected to provide better treatment benefits to patients with advanced myeloma in Korea. The Phase III clinical ICARIA-MM study, which was the basis for approval, was conducted in 307 adult patients with relapsed and refractory multiple myeloma who previously received two or more treatments including Lenalidomide and proteasome inhibitors. Clinical results showed that the Sarclisa + Pomalidomide + Dexamethasone combined treatment group (hereinafter referred to as Isa-Pd therapy) reduced the risk of disease progression or death by 40% compared to the standard therapy, Pomalidomide + Dexamethasone combination administration group (hereinafter referred to as Pd therapy). Progression-free survival (PFS), was extended by 5 months. President of Sanofi Genzyme, Park Hee-kyung said that the approval of Sarclisa will provide another treatment option to patients with multiple myeloma in Korea who are suffering from recurrence despite two or more treatments. Sarclisa is a combination therapy with Pomalidomide and Dexamethasone in adult patients with relapsed and refractory multiple myeloma who previously received two or more treatments including Lenalidomide and proteasome inhibitors from the US Food and Drug Administration (FDA) in March 2020. Licensed. In May 2020, the European Medicines Agency (EMA) had experience of two or more treatments, including Lenalidomide and proteasome inhibitors. In addition, it was approved as a combination therapy with Pomalidomide and Dexamethasone in adult patients with advanced relapsed and refractory multiple myeloma.
- Company
- Joint venture Akijen withdrew in 6 years
- by An, Kyung-Jin Dec 04, 2020 05:53am
- Samsung Biologics Akijen, a joint venture established by Samsung Biologics and multinational pharmaceutical company AstraZeneca, is going through the process of rearranging the business in six years. According to Samsung Biologics' quarterly report submitted to the Financial Supervisory Service on the 2nd, the company decided to stop research and development (R&D) activities of AstraZeneca and Akijen Biotech in September. a SAIT101, biosimilar of Mabthera (Rituximab), which ended earlier this year, has been completed with a phase III clinical trial. An official from Samsung Biologics said, "We decided to suspend the business in September under discussion with our partners. We are in the process of finalizing clinical trials that have been underway." "We will announce again it when a specific schedule comes out," he said. Akijen is a joint venture established by Samsung Biologics in June 2014 by investing 50% of each with AstraZeneca. Samsung Biologics first invested ₩71.3 billion in Akijen Biotech. Since 2016, it is reported that a total of about ₩250 billion has been invested while conducting clinical development related to SAIT101 which is prescribed for rheumatoid arthritis and lymphoma. SAIT101 is a project that Samsung Advanced Institute of Technology stopped after 8 months after entering the global phase III clinical trial in 2012. As Akijen resumed clinical development after 4 years, it attracted industry attention, but after 6 years, the development was discontinued again. The results of the Phase III clinical trial ended earlier this year were valid, but the fact that Rituxan's biosimilars are already on sale is confirmed to have had a decisive effect. This is because it was judged that the competitiveness of the original drug would fall if it missed the position of 'First Mover' that enters the market first after the patent expiration. Currently, in the US and Europe, a number of Rituximab biosimilar products such as Celltrion's Truxima and Pfizer's Rexience have been released and are competing.
- Company
- Rob Kempton inaugurated as the new president of GSK
- by Dec 03, 2020 11:32am
- GSK announced on the 30th that it will appoint Rob Kempton as the president of GSK's Korean subsidiary on Dec 1st. New president Rob Kempton is a healthcare professional with over 20 years of pharmaceutical experience in the US, UK and Asia. After joining GSK in 2013, he was in charge of sales management in the United States of Viiv Healthcare, a company specializing in HIV, and then in charge of marketing of Dolutegravi in the United States. As Vice President of Field Sales, he led the launch of Trelegy Ellipta, a single COPD (chronic obstructive pulmonary disease) treatment in the United States, and recently served as Vice President of Global Sales for GSK's follow-up pipeline. New President Rob Kempton said, "Based on the foundation so far, the goal is to establish GSK's Korean subsidiary as a leading pharmaceutical and vaccine company in Korea, and we will do our best for the continuous growth of our business with them." Meanwhile, President Julien Samson, who has been leading GSK's Korean subsidiary since 2018, was appointed Vice President of Global Vaccine Sales and Head of Sales Strategy Division at GSK headquarters.
- Company
- Celltrion completes acquisition of Takeda APAC products
- by An, Kyung-Jin Dec 03, 2020 06:00am
- On Dec. 1, Celltrion announced it completed the acquisition for the Asia-Pacific market products from a multinational pharmaceutical company Takeda Pharmaceutical Company (“Takeda”). In last June, the South Korean company signed a deal to take over the rights to Takeda’s 18 Primary Care product assets from the Asia-Pacific markets for a total of USD 278 million (approximately 307.4 billion won). The company’s subsidiary in Singapore, ‘Celltrion APAC,’ has been in charge of the acquisition process. With the completed acquisition, Celltrion APAC would be able to directly and indirectly practice rights over the 18 products available in nine markets including South Korea, Thailand, Taiwan, Hong Kong, Macao, the Philippines, Singapore, Malaysia and Australia. The list of the product assets ranges from prescription drugs like antidiabetes drug ‘Nesina’ and ‘Actos,’ antihypertensive drug ‘Edarbi,’ to OTC drugs like cold drug ‘Whituben’ and stomatitis drug ‘Albothyl.’ Considering Nesia and Ebarbi are protected by their substance patents until 2026 and 2027, respectively, Celltrion expects to see stable growth in sales for a while. Celltrion Healthcare is to utilize its own sales network for the global market, while Celltrion Pharm is to lead the local sales in South Korea. For the mean time, Celltrion plans to use the existing manufacturing facilities owned by Takeda under a manufacturing and supply deal with the multinational company to maintain the stable supply. In the future, some of the drugs would be manufactured in Celltrion Pharm’s cGMP level manufacturing facility for local and global markets. Celltrion says the acquisition has created a momentum for the company to leap as an integrated global biopharmaceutical firm by strengthening the chemical drug business on top of the company’s already competitive biopharmaceutical business. Based on the R&D capacity and newly secured substance patent, the South Korean company plans to reinforce the incrementally modified drug (IMD) and insulin biosimilar line-ups in extended release and combination drug form, and also to complete the line-ups in antidiabetic and antihypertensive products. Moreover, the headquarters have set a plan for the new subsidiary Celltrion APAC to gradually expand the businesses by seeking deals for contract development and manufacturing organization (CDMO) and contract research organization (CRO) and establishing biopharmaceutical cold chain in Asia-Pacific region. A Celltrion official stated, “By successfully completing the acquisition process, the company has created a stepping stone to develop IMDs and to expand market share to penetrate the APAC markets. Celltrion would also do its best to grow as an integrated global biopharmaceutical company by expanding the R&D and CDMO businesses in the APAC biopharmaceutical markets.”
- Company
- Hanmi's Xoterna wins first trial in patent dispute
- by Kim, Jin-Gu Dec 02, 2020 06:06am
- Xoterna Hanmi won the patent dispute between Hanmi and Novartis over Xoterna (Indacaterol/Glycopyrronium), a treatment for COPD (chronic obstructive pulmonary disease). The Intellectual Property Trial and Appeal Board recently issued a trial decision for partial approval and dismissal in a trial for invalidation of a patent for the Xoterna partial approval composition that Hanmi recently requested against Novartis. The trial of partial dismissal was based on Novartis' deletion of some of the claims during an invalidation trial. It is the judgment of partial approval that the deleted claim is inappropriate because there is no subject of judgment. In reality, Hanmi won. Respiratory disease inhalation treatments were rare in patent challenges by domestic companies. This is because localization was difficult in that it had to develop not only drugs but also devices for inhalation. The share of imported items is absolutely large. In the case of Xoterna, in 2015, after Novartis launched the product in Korea, Hanmi, Ahn-Gook, and Chong Kun Dang challenged the composition patents in turn, requesting an invalidation trial, but all three companies dropped the judgment shortly after. However, Hanmi once again challenged itself in June of last year. Having succeeded in overcoming the composition patent in about 1 year and 6 months, Hanmi has advanced the release of the first generic by 2 years. The expiration date of composition patent of Xoterna is May 2025, and Hanmi can release the generic for Xoterna from January 2023, when the substance patent expires. If Hanmi releases generic for Xoterna early, it is expected to strengthen its line-up of inhaled treatments. Hanmi was the first domestic company to license Fluterol, generic for Seretide, in 2014, and Tiotropium, generic for Spiriva, in 2015. At the same time, Hanmi device was also independently developed. Both products are used for both asthma and COPD. Xoterna was launched in July of the following year after Novartis obtained domestic approval in 2014. It is jointly sold by Novartis and Yuhan. The prescription amount last year was ₩7.7 billion. In particular, as the Korean Academy of Tuberculosis and Respiratory Diseases revised the COPD guidelines at the end of 2017, Xoterna's performance is also steadily increasing. At that time, the society designated LABA (beta-2 agonist) and LAMA (persistent anticholinergic) combination as the first-line treatment. Xoterna is a representative two-component combination.
- Company
- The sales of Dupixent tripled in a year
- by Kim, Jin-Gu Dec 02, 2020 06:06am
- DupixentSales of Dupixent (Dupilumab), a treatment for severe atopic dermatitis, are increasing. Sales have increased since it was applied to health insurance benefits in January of this year. It posted a cumulative sales of ₩15.6 billion in the third quarter, and is expected to exceed ₩20 billion by the end of the year. According to IQVIA, a drug market research firm on the 30th, Sanofi Aventis' third-quarter sales of Dupixent, a treatment for severe atopic dermatitis, were ₩7.1 billion, an increase of 3.4 times from ₩2.1 billion a year earlier. It is analyzed that what was listed on the health insurance pay list in January of this year was decisive. In fact, if you look at Dupixent's quarterly sales, ▲₩1.5 billion in the first quarter of last year ▲₩1.7 billion in the second quarter ▲₩2.1 billion in the third quarter ▲₩2.7 billion in the fourth quarter, from ₩1 billion to 2 billion in the first quarter of this year with benefits applied. In the second and third quarters, sales jumped even further. It recorded sales of ₩5.2 billion and ₩7.1 billion, respectively. The cumulative sales amount until the third quarter of this year is ₩15.6 billion. Quarterly sales of Dupixent (unit: ₩100 million, data from IQVIA) In March 2018, Dupixent was licensed, and in August of the same year, it was released for non-payment. However, there were many difficulties until it was listed. In February 2019, it was not submitted to the HIRA's Pharmaceutical Evaluation Committee for nearly a year. It was judged by the government that the price of drugs exceeding ₩2 million per month was too expensive. Patients with severe atopic dermatitis appealed for the application of benefits through a national petition at Cheongwadae. Eventually, the government expanded the scope of the risk-sharing contract system (RSA). Subsequently, code for a severe atopic dermatitis disease was newly established. Finally, from January this year, Dupixent's benefit was applied. It was the first drug to be listed after RSA expansion. Dupixent's sales growth is expected to continue for some time. Currently, Dupixent is the only drug released in Korea as a treatment for severe atopic dermatitis. Until now, mainly non-steroidal topical treatments have been used, but there is a disadvantage that the probability of cure is lowered even after long-term treatment only helps relieve symptoms. Accordingly, the expectations of the medical staff and patients for Dupixent are high. In addition, Sanofi plans to expand its scope more actively by releasing new doses and expanding indications. Sanofi released a new dose of 200mg on October 26 this year. The previously approved dose was 300mg. It is in phase III clinical trial to expand indications with nodular prurigo. It is a skin disease similar to hives. It is also a disease that causes secondary infection after scratching due to severe itching. Like atopic dermatitis, currently available drugs only relieve symptoms in the short term, and there is no fundamental treatment. Dupixent is a mechanism that selectively inhibits the signaling of two major cytokines, interleukin-4 and interleukin-13, considered to be atopic dermatitis triggers. It was jointly developed by Sanofi and Regeneron, and is also the first drug designated by the US FDA as a 'breakthrough therapy' for skin diseases other than skin cancer in 2014.
