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- 2026-03-18 17:36:35
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- 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.
- Company
- Talzenna didn’t pass the Cancer Assessment Committee
- by Eo, Yun-Ho Dec 01, 2020 06:15am
- The government is conservative about breast cancer-related insurance benefits for PARP inhibitors. According to related industries, Pfizer's Talzenna (Talazoparib) was submitted to the HIRA's Cancer Assessment Committee held on the 25th, but failed. As the range of indications for breast cancer of PARP (poly ADP ribose polymerase) inhibitors such as Talzenna is wide, insurance authorities are concerned. Prior to the Cancer Assessment Committee was skeptical about the indications for breast cancer even at the time of AstraZeneca's Lynparza (Olaparib). As a result, discussions about the benefit of PARP inhibitors for breast cancer have to look forward to next year. There are some differences in the indications for breast cancer between the two drugs. Lynparza includes ▲adult patients with breast cancer susceptibility gene (gBRCA) mutation and human epithelial growth factor receptor 2 (HER2) negative metastatic breast cancer who have previously experienced chemotherapy treatment, and in the case of Talzenna, locally advanced patients are added. Indications for these drugs include the area of triple-negative breast cancer (TNBC), which lacks treatment options, and is attracting attention from academia. Another PARP inhibitor, Takeda's Zejula, has not yet secured an indication for breast cancer. However, in the case of Zejula, ▲ there is a single maintenance therapy for platinum-sensitive recurrent highly serous ovarian cancer that fully or partially responds to platinum-based chemotherapy that is negative for gBRCA, that is, All-comer. The discussion is also skeptical. Talzenna's efficacy was evaluated by comparing the Talzenna alone group and the group selected by the research team in the 431 HER2-negative local advanced or metastatic breast cancer patients with gBRCA mutations who had previously experienced up to 3 chemotherapy treatments. It was verified through an open label, randomized, multinational, large-scale phase III clinical study, EMBRACA. The median progression-free survival (mPFS), the primary endpoint of EMBRACA, was 8.6 months in the Talzenna group alone, and significantly improved compared to 5.6 months in the chemotherapy group. The risk was found to be 46% lower.
- Company
- Lynparza, a big change in the tx of BRCA-mutated cancer
- by Dec 01, 2020 06:15am
- "Most ovarian cancers are found in the 3rd to 4th stage because there is no subjective symptoms. After the first treatment, 70% recur within 3 years, and the 5-year survival rate is only 38%. Maintained by the release of Lynparza. The prognosis of patients is greatly improved through therapy. In particular, the first published 5-year follow-up result among PARP inhibitors suggests the possibility of long-term survival of ovarian cancer." Professor Byungki KimByung-ki Kim, Professor of obstetrics and gynecology, University College of Medicine, told a press conference on the 27th that the appearance of the first PARP inhibitor Lynparza (Olaparib) had on the treatment of ovarian cancer. On this day, AstraZeneca Korea held an online press conference on the topic of Lynparza's clinical value and significance in the field of ovarian cancer treatment, in celebration of the 5th anniversary of Lynparza's launch in Korea. Lynparza, launched in Korea in August 2015, is a targeted anticancer drug targeting BRCA. Not only can it be used for secondary or higher therapy, but recently it is expanding its scope to maintenance therapy. The SOLO-1 study is a phase III demonstrating the efficacy of Lynparza as a primary maintenance therapy for advanced ovarian cancer with BRCA mutations. At the third year of study, Lynparza reduced the risk of disease progression and death by 70% compared to placebo. Subsequent SOLO-2 studies demonstrated the effectiveness of Lynparza as a second-line maintenance therapy. A real-world study in Korea was conducted on Lynparza maintenance therapy. This study shows actual clinical results in the field of BRCA mutant highly serous recurrent ovarian cancer. As a result of the analysis, the median progression-free survival (mPFS) of patients taking Lynparza was 14.6 months, and the progression-free survival rate (PFS) was 42.4% at 24 months of treatment. This data is similar to the results of the Lynparza STUDY-19 study, which did not include Koreans, and Professor Kim interpreted it to mean that the effect of Lynparza appeared at least the same or better than the clinical trial of Korean patients. In particular, Professor Kim viewed Lynparza as the best option for patients with BRCA mutations. Currently, Zejula, the competitive drug, can be used as a first-line maintenance therapy for ovarian cancer patients regardless of the BRCA mutations. Zejula is widely used, while Lynparza provides specialized treatment options for patients with BRCA mutation and HRd positive. Of course, Zejula also obtained data on BRCA mutations and HRd positive patients through subgroup analysis. However, the Lynparza data dominate when it comes to drug selection. Professor Kim said, "All-comer (Zejula) drugs also have subgroup analysis data, but there is definitely a difference in mortality risk (HR)." "When it comes to patients with BRCA mutant ovarian cancer, Lynparza is a breakthrough without a choice. The benefits they receive are completely different," he said. What are Lynparza's future prospects? Professor Kim expected that in the future, Lynparza could be used as a drug used at all stages, such as platinum-based chemotherapy at all stages. He said, "According to the current data, Lynparza is a one-time use only for the 1st or 2nd phase. Whether it can be used in both 1st and 3rd phases, it is necessary to secure evidence through additional research." He said, "If the recurrence occurs after a certain period of time after taking Lynparza in the future, it is expected that Lynparza can be used again."
- Company
- Whanin ends sales of Sandoz antidepressants
- by Dec 01, 2020 06:15am
- Sandoz's supply of four antidepressants, which Whanin supplied, will end this year. According to the drug distribution industry on the 27th, Whanin announced that the supply of four Sandoz antidepressants will be suspended as the contract with Sandoz ends on the 30th. The items are ▲Sandoz Escitalopram 5·10·15mg ▲Paroxetine 20mg ▲Sultran 50·100mg ▲Mirtax 15·30mg/Mirtax ODT 15·30mg. The actual contract termination is on December 24th. Whanin has been selling Sandoz antidepressants since 2011. In February 2011, it signed an exclusive domestic sales contract for Sultran and Paroxetine, and in 2012, Sandoz Escitalopram was added. In 2015, it continued co-promotion for 4 antidepressants, including Mirtax. As of last year, Whanin's psychiatric treatment sales amounted to ₩130 billion, accounting for 81.7% of total sales (₩159.1 billion). Whanin is focusing on strengthening its own lineup of products for CNS, such as treatments for epilepsy and Parkinson's disease. In addition, in preparation for the recent increase in production, it has decided to acquire a pharmaceutical plant in Hyangnam of Janssen Korea for ₩46 billion. Whanin is also planning to end supply of Novartis Korea's Atorvin Tablet 10·20mg on the 24th of next month.
- Company
- TNBC treatment adds newly approved immunotherapy option
- by Eo, Yun-Ho Nov 30, 2020 06:21am
- Anticipation is heightening for the use of an immunotherapy Tecentriq (atezolizumab) in the triple-negative breast cancer (TNBC) treatment scene. Pharmaceutical industry sources reported Roche Korea’s PD-L1 inhibiting immunotherapy Tecentriq has recently successfully expanded the indication as a first-line treatment for TNBC, combined with nanoparticle albumin-bound (nab) paclitaxel, in the U.S. and now in South Korea. Moreover, the U.S. health authority also additionally indicated the drug to treat the disease in combination with Merk’s PD-1 inhibiting chemotherapy Keytruda (pembrolizumab) as a first-line treatment. The medical scene is closely following the news with an anticipation of opening more practical options of immunotherapy in TNBC treatment area currently lacking a variety of options. Since Roche Korea submitted the National Health Insurance (NHI) reimbursement application last month, the South Korean health authority is currently in process of reviewing the coverage on Tecentriq. However, it is still unknown how long the listing procedure would take. Tecentriq’s first reimbursed indication, treating patients with non-small cell lung cancer (NSCLC) as a second-line treatment, was approved by the South Korean government after the company accepted the condition to cover the initial administration cost. However, Roche has not commented if it would take the same condition for the expanded coverage. In the Phase III IMpassion130 trial, the combination of Tecentriq and nab-paclitaxel demonstrated median progression-free survival (mPFS) of 7.5 months in first-line treatment of patients with PD-L1 positive metastatic TNBC, and lowered the risk of progression or death by 40 percent compared with nab-paclitaxel alone. Keytruda has even longer way to go. Although there is no apparent barrier yet, the drug’s reimbursement expansion for the first-line lung cancer treatment has been sluggish so far. In the KEYNOTE-355 study, evaluating PFS in patients with locally recurrent unresectable or metastatic TNBC, the Keytruda combination therapy resulted in statically meaningful improvement in reducing the risk of disease progression or death by 35 percent through a first-line treatment in patients, who had not been previously treated with chemotherapy and the expression of tumor PD-L1 was over CPS 10. The mPFS in the Keytruda combination therapy group marked 9.7 months, when the chemotherapy-only group reached 5.6 months. To this date, the needs for the treatment in patients specifically with TNBC—reacting negatively on all receptors (estrogen, progesterone and HER2)—have been unmet. For a long time, chemotherapy was the only option for patients with TNBC. Roche’s targeted therapy Avastin (bevacizumab) still remains as a non-reimbursed option, although it was the first one to win the indication in South Korea. But the selection of TNBC treatment options has been widened recently with a poly ADP ribose polymerase (PARP) inhibiting targeted therapy Lynparza (olaparib) and other immunotherapy added to the market.
- Company
- Can HPV vaccine for men be included in the NIP?
- by Eo, Yun-Ho Nov 30, 2020 06:21am
- It is worth paying attention to whether vaccinating men with HPV vaccine can be included in the National Immunization Program (NIP). Earlier this month, Hye-young Choi, a member of Democratic Party of Korea said that the human papillomavirus (HPV) vaccine NIP, which is currently being conducted only for 12-year-old girls, includes both men and women under 18 years of age. Representatively initiated the 'Amendment of the Act on the Act'. HPV is a virus that is transmitted through sexual contact and can be infected by both sexes, regardless of gender. Most of them disappear naturally when infected with HPV, but if they are continuously infected, women can develop cervical cancer, vulvar cancer, and vaginal cancer, and anal cancer and genital warts can appear in both men and women. The HPV vaccine, which is well known as a cervical cancer vaccine, is a necessity that if inoculated to men, it can prevent the occurrence of penile cancer, oral cancer, oropharyngeal cancer, anal cancer, and genital warts related to HPV 16 and 18 as well as preventing female cervical cancer. .In fact, Korean academia also recommends HPV vaccination for both men and women .In 2019, the Korean Society of Infectious Diseases revised the guidelines for adult vaccination after 7 years, adding males to the HPV vaccination recommendations .Cancer centers designated by the World Health Organization (WHO), American Cancer Society (ACS), and National Cancer Institute (NCI) prevent HPV in male and female adolescents aged 13 to 15 by 2020 with the goal of eradicating cancer caused by HPV, regardless of gender .It announced a plan to increase the inoculation rate to 80% .In addition, 20 out of 37 OECD countries include boys for HPV vaccination .However, the current domestic NIP includes only 12-year-old female adolescents who are eligible for free HPV vaccination .Woong Ju, professor of obstetrics and gynecology at Ewha University Seoul Hospital, said, "As a result of an active policy that includes boys in the HPV vaccine NIP in 2013 in Australia, the annual cervical cancer mortality rate is expected to drop to 1 per 100,000 population in 2034 ."It is necessary to expand the target of domestic NIP policy to both men and women, and to carry out active HPV prevention projects." Last August, at the Korean Gynecological Oncology Spring Association, Sohn Gyeong-bok at Ewha Womans University College of Pharmacy, presented the theme of 'A Study on Economic Evaluation of HPV Vaccine 12-year-old Male and Female Vaccination.' He confirmed that HPV vaccine vaccination for men and women at the age of 12 is more cost-effective than the current NIP and non-vaccinated groups .When both men and women were vaccinated with the HPV vaccine, the number of HPV-related cancer patients decreased by 30% in both men and women .Currently, Korea's NIP is asking one of the two-valent vaccines 'Cervarix' and the tetravalent vaccine 'Gardasil' to be inoculated as a cervical cancer vaccine.
