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- 2025-12-27 08:45:29
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- KDA finally agrees on SGLT2 inhibitor benefits
- by Eo, Yun-Ho Apr 14, 2020 06:15am
- SGLT-2 inhibitors approved in Korea The Korean Diabetes Association (KDA) has finally reached an agreement on expanding reimbursement on sodium-glucose transport protein 2 (SGLT2) inhibitor combination therapy. KDA has submitted a statement to the Korean government regarding the needs of expanded coverage on SGLT2 inhibitor plus off-label diabetes treatments, including dipeptidyl peptidase 4 (DPP-4) inhibitor or thiazolidinedione (TZD). The academy has begun fine-tuning their opinions on the reimbursement expansion for the SGLT2 inhibitor combination therapy after the 11th president, Professor Yoon Geon-ho (department of endocrinology at Seoul St. Mary’s Hospital), was appointed in last January. The talks on reimbursed use of the combination therapy actually was started by the medical professionals. Due to the differences in reimbursed indications among same-class drugs, the prescribers have been confused and experienced reduction in expected reimbursement and other inconveniences. Accordingly, the government has started accepting their opinion officially, but the academy itself had internal dispute. Some argued reimbursement expansion should be handled carefully on drugs without clinical evidences, regardless of other reimbursed drugs in the same class. As the closely related academy seemed to be doubtful, the government has halted reimbursement expansion discussion until now. Regarding the issue, Health Insurance Review and Assessment Service (HIRA) official stated, “Based on the statement by KDA, HIRA would further accept and review more opinions submitted by Korean Endocrine Society, other academic societies and Ministry of Food and Drug Safety that grants the approval.” Currently, there are four SGLT2 inhibitors available in Korean market—Forxiga (dapagliflozin), Jardiance (empagliflozin), Suglat (ipragliflozin) and Steglatro (ertugliflozin). Total of 36 clinical studies would have to be conducted for all combinations of therapies, based on nine DDP-4 inhibitors and the four SGLT2 inhibitors commercialized in Korea, to acquire proper data for approval according to the principle. In the same sense, combination therapies with two TZDs and four SGLT2 inhibitors should undergo total eight clinical trials.
- Company
- KPBMA “Exempt transferred originals from pricing reduction"
- by Eo, Yun-Ho Apr 14, 2020 06:12am
- All of pharmaceutical industry is responding against the risk in pricing reduction on original drugs transferred due to a split-off. Pharmaceutical industry sources reported, Korea Pharmaceutical and Bio-pharma Manufacturers Association (KPBMA) plans to deliver an official statement to the health authority demanding the government to exempt items transferred due to corporate restructuring from the soon-to-be enforced drug pricing reduction system. The stepped drug pricing system to come in effect from July stipulates pricing 21st drug to be listed within the same substance group at 85 percent of either the lower price between the lowest price of the drugs or 38.69 percent of the original’s price, despite qualifying two differentiated pricing standards. However, a conflict fired up among the industry as the government is seemingly endorsing the legal interpretation enabling the pricing system to reduce pricing on an original drug transferred due to corporate division. Korean Research-based Pharmaceutical Industry Association (KRPIA) has already submitted a similar statement on Apr. 2. KPBMA’s statement specifically requests the Section Ma (마) of the drug pricing notice revised last February to add ‘corporate division’ as one of the exemption conditions. The Section Ma of the revised drug pricing notice stipulates an item applying for pricing decision, listed previously but de-listed, would be priced at its latest maximum price, if it is either a drug transferred by inheritance, business transfer or merge as stated by the Pharmaceutical Affairs Act Paragraph 1 of Article 89, or transferred by importer’s inheritance, business transfer or merge as stated by the Pharmaceutical Affairs Act Paragraph 2 of Article 42. Therefore, the pricing reduction would not be applied on an item transferred, along with the business license, to or by a manufacturer (typically a Korean company) or an importer (multinational company). Nevertheless, the Section Ba (바) of the notice stipulates a drug applying for pricing decision, listed previously but de-listed, would be priced at a lower price between its latest maximum price or newly calculated price, if it is transferred by the manufacturer’s business transfer as defined by the Pharmaceutical Affairs Act Paragraph 2 of Article 89. This could mean the drug reapplying for pricing could face pricing reduction depending on the number of listed generics and standard qualification stated by the drug pricing notice. But KPBMA argues the legal interpretation contradicts the true objective of stepping away from the ‘same substance-same pricing’ approach and applying differentiated pricing to value the effort of developing new drug and preventing relisting of a generic evading administrative measure and drug pricing reduction. KPBMA official said, “The number of cases where generic manufacturers resort to an expedient is also very limited. Regardless of a Korean or global company, the status of first-in-class drug (mostly new drug) should be sustained. The government needs to promptly reconsider the interpretation to prevent any confusion in the market and to follow the original objective of the regulation.”
- Company
- Roche’s ADC Kadcyla retries coverage on early breast cancer
- by Eo, Yun-Ho Apr 10, 2020 06:28am
- Roche is reapplying for Kadcyla’s expanded reimbursement on its early-stage breast cancer indication. According to pharmaceutical industry sources, Roche has recently submitted an application for additional reimbursement on antibody-drug conjugate (ADC) Kadcyla (trastuzumab emtansine). The reimbursement expansion is on the indication as an adjuvant treatment on patients with HER2-positive early breast cancer with residual invasive disease after taxane and Herceptin (trastuzumab)-based neoadjuvant treatment. The application would be reviewed by the Cancer Deliberation Committee in May at earliest. As the anticancer treatment’s first attempt to pass the Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee for the additional reimbursed indication failed last year, the multinational company seems to have prepared more evidences and enhanced financial strategy. Kadcyla, listed for reimbursement in August 2017 via refund type risk sharing agreement (RSA), is available for prescription currently to patients with HER2-positive unresectable locally advanced or metastatic breast cancer, who have been treated with Herceptin and taxane-based anticancer treatment. When the treatment’s reimbursement standard is expanded, Kadcyla would be more prevalently used in treating early breast cancer. Kadcyla’s benefit on early breast cancer treatment was confirmed in Phase III KATHERINE study. Participants of KATHERINE study were divided into Kadcyla only or trastuzumab only group in one-to-one ratio and received 14 weeks of post-surgery adjuvant treatment. The primary endpoints of the study included invasive disease-free survival (iDFS). The study result showed that Kadcyla has significantly reduced the risk of iDFS by 50 percent compared to trastuzumab. In the KATHERINE study, Kadcyla’s effect of cutting the risk of disease recurrence was demonstrated consistently regardless of lymph node and hormone receptor-positive, and in sub-analysis based on the type of targeted therapy administered for neoadjuvant treatment. And new safety issue of the treatment, besides the ones addressed during previous Kadcyla studies, was not found.
- Company
- Novartis Korea recorded the largest sales last year
- by An, Kyung-Jin Apr 10, 2020 06:28am
- Novartis Korea recorded the largest sales last year. The first time since the launch of Korea, the sales of representative medicines and new drugs have reached ₩500 billion. According to Novartis Korea's audit report submitted to the Financial Supervisory Service on the 8th, the company's sales last year were ₩493.4 billion, up 4.1% from the previous year. It is the largest since the establishment of the Novartis Korea branch in 1997. In the same period, operating profit decreased by 85.9% from the previous year to ₩6 billion. Novartis Korea is a foreign-invested company founded in September 1984 under a joint venture agreement between Dongwha Pharm. Co., Ltd. (now Dong-wha) And Swiss pharmaceutical company Sandoz (now Novartis AG). In April 1997, the company name was changed from Korea Sandoz Co., Ltd. to Novartis Korea. Novartis AG and Novartis Pharma AG own 98.3% of the shares and Dong-wha Pharm has the remaining 1.7%. Novartis Korea's newly launched products led the sales increase. According to the drug market research institute IQVIA, the sales of the chronic heart failure treatment drug Entresto (Sacubitril/Valsartan) last year increased by 106.1% from the previous year to ₩13.2 billion. Sales of psoriasis treatment Cosentyx (Secukinumab) amounted to ₩12.3 billion, a 283.5% increase from the first year of release. Entresto and Cosentyx alone recorded sales of over ₩25.4 billion. Lucentis (Ranibizumab), a treatment for macular degeneration, is not a new product, but sales have skyrocketed since the release of the pre-field formulation. Lucentis made sales of ₩30 billion last year. 48.2% year-on-year, breaking record sales. Sales of existing products are also on the rise. Last year's sales of ARB-based hypertension complex Exforge (Amlodipine/Valsartan) increased by 2.3% year-on-year to ₩70.6 billion, the highest among Novartis' drugs. Exforge is a representative item that enjoyed reflex profits after generic drugs were discontinued after NDMA, a carcinogenic substance was detected in Chinese Valsartan-based drug (API) in July 2018. Sales continued to rise after sales exploded in the third quarter of 2018. The sales of leukemia treatment ‘Gleevec’ last year were ₩46.7 billion, and 'Tasigna' sales were ₩40 billion, an increase of 8.3% and 8.4%, respectively. Although the profitability slightly deteriorated as the expenditure increased during the new product release process and the base effect resulting from the achievement of the largest operating profit in the past year, both the existing product and the new product showed stable sales. Novartis Korea posted an operating loss of ₩58.5 billion in 2017. After receiving investigations from the prosecution in the first quarter of 2016 on charges of providing inappropriate economic benefits to health professionals through medical magazines, etc., the deficit was recorded in 15 years, reflecting the fines imposed. As a result of the prosecution for violating the pharmaceutical affairs law, an initial trial this year was sentenced to a fine of ₩40 million and the second trial is in progress. Novartis is expected to accelerate its pipeline restructuring this year. The company compiled some items from the central nervous system (CNS) medicines that had relatively low profitability last year. In addition, the two domestic licenses of the antiepileptic drug 'Trileptal' and the Alzheimer's dementia drug 'Exelon' were handed over to Handok, and the rest of the items, such as the antiepileptic drug 'Tegretol', Parkinson's disease drugs 'Stalevo', and 'Comtan' were not assigned a separate sales marketing manpower according to the ploicy of the head office. This year, it plans to focus on introducing 'Kymriah', a CAR-T treatment that has recently applied for permission, and 'Zolgensma', a treatment for spinal muscular atrophy (SMA). An official from Novartis Korea said that sales of new products such as Entresto and Cosentyx are growing steadily. He said this year, that the company will focus on the reimbursement expansion of asthma treatment 'Xolair' and anti-cancer drug 'Kisqali' and introducing entirely new treatment platforms such as Kymriah and Zolgensma.
- Company
- Yuhan receives KRW 43 bln for first lazertinib milestone
- by An, Kyung-Jin Apr 10, 2020 06:28am
- On Apr. 8, Yuhan has announced Janssen Biotech would pay out USD 35 million (approximately 43 billion won) to the Korean pharmaceutical company for the licensed out lazertinib’s first milestone. The lazertinib pipeline has reached the first development milestone as clinical study on a combination therapy with Janssen’s anticancer medicine ‘JNJ-372’ and lazertinib is on its way. On a consolidated basis, the payout would exceed 2.5 percent of Yuhan’s 1.65 trillion-won equity capital. Lazertinib is a targeted therapy in development as a first-line treatment in patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation or as a second-line treatment in patients with NSCLC with EGFR T790M mutation. In November 2018, Yuhan has signed lazertinib license-out deal with Janssen Biotech and received an upfront payment of 50 million dollars (approximately 55 billion won). When lazertinib is successfully commercialized, the Korean company would receive up to 1.25 billion dollars for reaching all milestones.
- Company
- Social distance postponed tax investigations
- by Nho, Byung Chul Apr 09, 2020 06:26am
- In order to prevent the spread of COVID-19, tax investigations by some pharmaceutical companies in progress are reportedly delayed. According to the industry, Daewoong Bio, Bayer Korea, and Hanmi Pharm are currently under investigation by the National Tax Service. This survey is believed to be a regular tax investigation, not a special tax investigation. On the 30th of last month, the National Tax Service announced the policy of minimizing on-site tax investigations of local tax offices and front-line tax offices to actively participate in the government's social distance following COVID-19. As a result, the pharmaceutical industry's tax investigation schedule is also postponed until the COVID-19 situation calms down. When conducting an on-site tax investigation, the National Tax Service is minimizing on-site investigations based on the judgment that face-to-face contact with investigators and the company's working team is inevitable, and it can also put more psychological burden on the company. However, it said that it is performing as scheduled on issues that are bad or urgent such as act of cornering and hoarding of masks or hand sanitizers. Since mid-February, the NTS Jungbu Regional Office has been conducting tax investigations by dispatching employees from the Bureau 1 to the Daewoong Bio Office. A representative of Daewoong Bio explained, "The NTS Jungbu Regional Office Bureau 1, 2, and 3 are usually in charge of general tax investigations. Since 2015, they have been faithfully engaged in regular tax investigations received in five years." In the 2015 tax investigation, the NTS Jungbu Regional Office judged the commission paid by Daewoong Bio to CSO (sales agency) in full, and collected ₩15.3 billion in taxes the following year. In response, Daewoong Bio brought a judgment against the Tax Tribunal and was finally judged by the National Tax Service's misconduct. In 2017, there was a precedent that received a total of ₩15.3 billion back, which is the total collection tax amount related to sales agency fees. Unlike the claims of the Korea Customs Service, through the final ruling, the tax tribunal clearly identified the substance of the CSO, paid a fee according to the contract, and the CSO also filed a tax return as an import amount while also acting as a pharmaceutical sales agent for pharmaceutical companies other than Daewoong Bio. Was judged to be a normal business activity. In addition, on the basis of the fact that it was difficult to judge that the CSO sales agency activity violated related laws and social order, such as the pharmaceutical affairs law the company decided that it was difficult to consider the company to spend entertainment expenses. At the time, about 40% of the fees that Daewoong Bio paid to the CSO were judged as entertainment expenses, and taxes were collected. In a ruling, the tax tribunal said that there was no specificity at the industry's normal level. Currently, the pharmaceutical industry typically pays 40% to 50% of the fees paid to CSOs. The owner-related specialty corporation mentioned in the last tax investigation was also found to be one of the largest number of CSOs operated by Daewoong Bio, which is currently less than 1% of the total CSO operation fee. At that time, Daewoong Bio was using about 200 CSOs.
- Company
- HIRA Cancer Committee canceled and postponed again
- by Eo, Yun-Ho Apr 08, 2020 06:24am
- The talks on anticancer treatment coverage enhancement has been postponed yet again. Pharmaceutical industry sources reported the Korean health authority has canceled the Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee’s meeting, initially scheduled today on Apr. 8. The government agency plans to push the meeting back two weeks later. After postponing the Cancer Deliberation Committee meeting from Feb. 26, the schedule has been called off again. Affected pharmaceutical companies are expressing their concerns, now that Deputy Director Choi Kyung-ho of Pharmaceutical Benefit Division at MOHW has been reportedly dispatched to Central Disaster and Safety Countermeasure Headquarters on COVID-19. The delayed meeting schedule has added more items on the committee’s agenda, and some items were inevitably put off to May agenda depending on their priority level. Originally, major items like AstraZeneca’s targeted therapy Tagrisso (osimertinib) and Ono Pharmaceutical and Bristol-Myers Squibb’s (BMS) immunotherapy Opdivo (nivolumab) were supposed to be deliberated in February. And in April, the Cancer Committee was supposed to review BMS’ multiple myeloma treatment Revlimid (lenalidomide) and MSD’s immunotherapy Keytruda (pembrolizumab). A multinational pharmaceutical company official said, “Despite the national emergency, cancer patients are still waiting for their treatment to get listed. Delaying the meeting twice would cause a significant damage. The government should be more considerate of those patients when handling pharmaceutical reimbursement listing and expansion.” Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso has an ongoing deliberation over expanding its reimbursed indication to cover a first-line treatment for patients with EGFR-mutated non-small cell lung cancer (NSCLC). PD-1 inhibitor Opdivo has a number of indications seeking for reimbursement, such as renal cell carcinoma-treating first-line combination therapy with Yervoy, second-line treatment for renal cell carcinoma, second-line treatment for relapsed or metastatic head neck squamous cell carcinoma, and second-line treatment for classical Hodgkin’s disease. But, the controversial indication as a second-line treatment for NSCLC regardless of expression of PD-L1 was omitted from the application. Moreover, Revlimid was targeting reimbursement expansion on its maintenance treatment indication as a monotherapy, and Keytruda’s reimbursement expansion application included an indication as a first-line treatment for NSCLC, bladder cancer and Hodgkin’s lymphoma, which have been denied previously, but also included two new indications—first-line treatment for metastatic non-squamos NSCLC as a combination therapy with pemetrexed and platinum chemotherapy, and first-line treatment for metastatic squamous NSCLC as combination therapy with carboplatin and paclitaxel.
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- Tylenol shortage boosts Penzal sales by over 40%
- by Jung, Hye-Jin Apr 07, 2020 06:40am
- Due to the COVID-19 outbreak, acetaminophen’s top brand product Tylenol has been experiencing shortage and seemingly other alternatives are seeing a surge in sales. Chong Kun Dang Pharmaceutical official announced on Apr. 2 the sales volume of Penzal-Q in last February and March has soared over 40 percent than same time last year. And Penzal ER tablet’s volume in the same period has also leapt by 56 percent than the previous year. Besides the popular OTC, Penzal brand has a prescription tablet line and the surge in the prescribed ER tablet volume could mean it was an easy option for pharmacies to replace Tylenol. In last March alone when the acetaminophen shortage issue has surfaced, the combined volumes of Penzal-Q and Penzal ER tablet have spiked 48 percent more than the year before. Accordingly, the industry experts view the Korean-made acetaminophen brand sharing a common substance with Tylenol has profited it. Recently, the World Health Organization (WHO) recommended ‘consuming acetaminophen instead of ibuprofen as a nonsteroidal anti-inflammatory drug to relieve symptoms suspected of COVID-19,’ but the organization withdrew the recommendation after two days. However, the two days were enough to hype the demand on acetaminophen in the market. Regardless of prescription or OTC line, Tylenol has become rare to find in the market. The supplier, Janssen Korea claims the product is distributed in Korean market in the same amount as pre-COVID-19 outbreak, which supports the theory that the exponential increase in demand on Tylenol has caused the shortage. Undergoing a product renewal and price raise in April, Samjin Pharm’s Geworin has doubled in sales from February to March. However, considering the pharmacies were stocking up the product before the price jump, it is too early to conclude the COVID-19 outbreak was the direct cause of the surge. The direct correlation would be apparent in the next second half of the year when the re-order has been made. An insider from the distribution industry commented, “On the day Tylenol comes in stock once in a month, all the stock is exhausted within the same day. It seems like the both consumers demand and pharmacies’ preorder volume have skyrocketed.” The distribution industry also agrees the general acetaminophens sales have increased. The sales volume of acetaminophens recorded by the top distributor has shown a significant rise in OTC acetaminophens. Some items’ volumes have even doubled from February to March. A pharmaceutical company associate noted, “The public’s heightened interest in acetaminophens has boosted demands in specific items, and it eventually affected their sales volume. The industry has recognized the COVID-19 outbreak as one of causes of the sales influx.”
- Company
- Big5 general hospitals codes in 2nd PARP inhibitor Zejula
- by Eo, Yun-Ho Apr 06, 2020 06:28am
- The world’s second poly ADP-ribose polymerase (PARP) inhibitor Zejula’s drug code has been implemented by Big 5 general hospitals in Korea. A pharmaceutical industry source reported an ovarian cancer treatment by Takeda Pharmaceuticals Korea, Zejula (niraparib) has been registered by drug committees (DC) around 24 general hospitals so far since its reimbursed release in last December, The prescription code for the treatment was passed by regular DC in Seoul National University Hospital, Seoul Asan Medical Center and Seoul St. Mary’s Hospital, and by emergency DC in Samsung Seoul Medical Center and Severance Hospital. Currently, the code landing procedure is in process at Jeonbuk National University Hospital, Chonnam National University Hwasun Hospital, Kyungpook National University Chilgok Hospital, and Chunguk National University Hospital. A first PARP inhibitor to be used regardless of BRCA mutation, Zejula was approved in Korea as a monotherapy for the maintenance treatment of patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to second or later-line platinum-based chemotherapy. Although it was listed for reimbursement last December, the first reimbursement standard was limited to patients with gBRCA mutation. However, in major clinical studies, Zejula has demonstrated outstanding improvement on median Progression-Free Survival (mPFS) against placebo regardless of gBRCA mutation. Takeda Pharmaceuticals is currently working on expanding Zejula’s reimbursement standard. The anticancer treatment is targeting two additional indications; monotherapy for the maintenance treatment of gBRCA-negative patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy; and monotherapy to treat relapsed ovarian cancer after receiving fourth or later-line chemotherapy. The fourth or later-line indication has been approved based on multicenter, open-label QUADRA study in adult patients with ovarian cancer, who have been treated with third or later-line therapy. During the clinical study, Zejula reached its primary efficacy endpoint and demonstrated clinical efficacy with an object response rate (ORR). The patient group with platinum-sensitive homologous repair deficiency (HRD) demonstrated ORR of 24 percent, where as BRCA-positive platinum-sensitive group, BRCA-positive platinum-resistant group and BRCA-positive platinum-refractory group recorded ORR of 39 percent, 29 percent and 19 percent, respectively.
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- Otsuka is setting new records for sales & operating profit
- by An, Kyung-Jin Apr 06, 2020 06:27am
- Korea Otsuka Pharmaceutical has achieved the best performance since its launch last year. Although the sales of healthcare products were low due to the boycott of Japanese-made products, sales of professional medicines surged, setting new records for both sales and operating profit According to the audit report of Korea Otsuka Pharmaceutical, which was submitted to the Financial Supervisory Service on the 4th, the company's sales were ₩180.2 billion last year, up 11.4% from the previous year's ₩161.7 billion. During the same period, operating profit was ₩38.5 billion, an increase of 23.0% from the previous year. Both sales and operating profit are the largest since the establishment of the Korean subsidiary. Otsuka Korea Otsuka Pharmaceutical is a foreign-invested company founded on July 9, 1982. Otsuka Pharmaceutical Co., Ltd. of Japan owns 70% of the shares as the largest shareholder, and Jeil Pharma Holdings Holds 22.5%. In the industry, there were many observations that the sales of Otsuka Pharmaceutical were inevitable due to the boycott of Japanese products triggered by export restrictions by the Japanese government last year. Men's skin care brand 'Uros', sold by Korea Otsuka Pharmaceutical, was also mentioned as a representative boycott product on the 'Nono Japan' site. In fact, the company explained that the healthcare business including cosmetics sales have suffered. However, even growth in the range of specialized pharmaceutical products offset the decrease in sales in the healthcare sector such as cosmetics. Sales of existing products such as 'Abilify' and 'Mucosta' continued to grow, and new products such as 'Iclusig' and 'Samsca' successfully entered the market, leading to increased sales. Otsuka According to the drug market research institute IQVIA, the two types of drugs, 'Abilify' and 'Abilify Maintena', were combined with sales of ₩42.6 billion. This is an increase of 24.9% from the previous year's ₩37 billion. Abilify Maintena was released in 2016 as a long-acting injection of Aripiprazole. When administered once, the drug lasts for 4 weeks and can be administered once a month. The oral formulation, Abilify, has experienced a synergistic increase in sales since its exposure to generic competition after the expiration of the patent in March 2014, but increased exposure since the release of Abilify Maintena. Since 2015, the annual sales growth rate of double digits has been recorded, and the company's signature products have recovered. Sales of gastritis and gastric ulcer drugs 'Mucota' are also on the rise. Last year, sales were ₩15.3 billion, up 7.0% from the previous year. Since the second half of last year, 'Samsca' has been recognized as a health insurance benefit for autosomal dominant polycystic kidney disease (ADPKD), its sales have doubled compared to the previous year. In 2018, 'Iclusig', a leukemia treatment drug that had been controversial due to unsuccessful supply, began to be prescribed in earnest, and sales volume has tripled. An official at Korea Otsuka Pharmaceutical said that continued growth of flagship products and successful market entry of new products are considered to be the main causes of sales growth last year and as the drug sales grew and management efficiency efforts to improve per capita productivity achieved, the operating profit margin increased.
