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- 2026-04-17 19:19:01
- Policy
- Kolon wins approval on inhaled schizophrenia treatment
- by Lee, Tak-Sun Dec 11, 2019 06:38am
- An orally inhaled medicine for treating agitation associated with schizophrenia is to be released in Korean market for the first time. The public’s interest is heightened by the news as inhalation powder has higher speed of body absorption and delivers effect in the shortest time. , Korean Ministry of Food and Drug Safety (MFDS) on Dec. 5 granted an approval on Kolon Pharma’s license to market Adasuve (loxapine) inhalation powder (10 mg). Adasuve is used as an acute treatment of mild and severe agitation associated with schizophrenia or bipolar disorder in adults. When inhaled with hand held drug delivery technology system ‘Staccato’, powdered loxapine is rapidly absorbed by the lung and achieve maximum plasma concentration in approximately two minutes. The drug’s administration is limited to single 10 mg dose within 24 hours. The approved label of the drug requires it to be administered only by a healthcare professional with immediate on-site access to equipment and personnel trained to manage acute bronchospasm. Developed by a U.S.-based company Alexza Pharmaceuticals, Adasuve was approved by the U.S. Food and Drug Administration (FDA) as the first orally inhaled treatment for schizophrenia in December 2012. Currently, Teva has the license to market the treatment in the U.S. Loxapine has been used for schizophrenia before Adasuve, as products like Loxapac used to be available in Korea. But now there is no other approved product with the same substance. In clinical trials with over 650 patients with acute agitation, Adasuve confirmed reduction of the condition more statistically significant than placebo. Multiple patients treated with the treatment experienced serious reaction of bronchospasm. Patients with asthma, COPD and other lung disease who inhaled the treatment were often reported with bronhospasm, and they were then treated a short-acting beta-agonist bronchodilator. The most commonly reported adverse reactions were dysgeusia, sedation and throat irritation. MFDS designated the treatment as a subject for Risk Management Plan (RMP) to continue monitor its adverse events after the commercialization.
- Company
- Korean biosimilars carving out Herceptin market share
- by Chon, Seung-Hyun Dec 10, 2019 06:31am
- Korean-made biosimilars are gaining more market share in the anticancer treatment Herceptin (trastuzumab) market. The biosimilars have now taken over more than 25 percent of the market share. The total market size has recovered the previous level, before the original’s price fell with new launches of inexpensive biosimilars. Alhtough Celltrion’s Herzuma showed a steep uptrend, Samsung Bioepis’ Safenet was sluggish with the growth. According to pharmaceutical market research firm IQVIA on Dec. 9, the third quarter the total trastuzumab market reached 26.8 billion won. It soared 24.7 percent from the same period last year. Trastuzumab is a substance used for treating breast cancer and metastatic stomach cancer, and Roche’s Herceptin is the well-known brand name of the substance. In Korea, Herzuma and Samfenet are two available trastuzumab biosimilars. Quarterly market share trend of trastuzumab items (Unit: percentage) Source: IQVIA In the third quarter of 2017, the trastuzumab market plummeted by 30.5 percent to 19.1 billion won, compared to 27.5 billion won made a year before. But the figure climbed back up to the point of two years ago. The biosimilars entering the market triggered Herceptin’s price to drop and shrunk the whole market. When Celltrion’s Herzuma was listed for insurance reimbursement in April 2017, Herceptin’s maximum reimbursed price fell two months later from 517,628 won per 150 mg to 414,103 won by 20 percent in. By the principles of the Korean drug pricing system, a biosimilar itemcan be priced at maximum 70 percent of the original’s initial reimbursed price. From October 2016, a biosimilar item developed by a designated Innovative Pharmaceutical Company, a company passing the designation standard, or Korean and multinational companies in partnership can be priced at maximum 80 percent of the original’s price. The same condition applies to items either first approved in Korea or manufactured locally. The off-patent original item’s price is automatically dropped to around 70 to 80 percent of the initial price when biosimilars item is launched. The recent expansion of the trastuzumab market was leveraged by biosimilars. Herzuma generated 6.3 billion won in the third quarter, increasing the sales by 156.7 percent than same time last year. Herzuma started making sales profit from the third quarter 2017, and it grew consistently and surpassed five billion won mark in last second quarter. The accumulated sales in the third quarter reached 16.2 billion won. Samfenet, on the other hand, was not performing as well as Herzuma. In the third quarter, Samfenet generated about 500 million won. Its sales reached 700 million won in last second quarter, but the figure is coming down again. Daewoong Pharmaceutical is in charge of commercializing Samfenet at the moment. Although Samfenet did not show as satisfying growth, Herzuma’s steep growth took a big bite out of the overall trastuzumab market, expanding the general biosimilars’ pie. The biosimilars took over 25.7 percent of market share in the third quarter with Herzumab taking up 23.6 percent and Samfenet taking up 2.1 percent. In general, a highlight of the trastuzumab market was Celltrion and Samsung Bioepis leading the general growth of the market. 150 mg of Herzuma was listed for reimbursement in April 2017 at the maximum reimbursed price of 372,692 won, about 72 percent of Herceptin’s price before its patent expired. Samsung Bioepis’ Samfenet in 150 mg dose was granted with insurance reimbursement since February last year at the maximum reimbursed price of 291,942 won. It was about 56.4 percent of Herceptin’s initial price. Since then, Celltrion brought down its Herzuma’s reimbursed price by 21.7 percent to 291,942 won to match Samfenet’s price. Trastuzumab’s market volume is now about the same as three years ago. It could be analyzed that patients’ access has been improved and accordingly the medicine use has been increased significantly with reasonably priced biosimilars and the original’s lowered price.
- Product
- Metformin impurity amount, theoretically 1/90 of Ranitidine
- by Kim, Jin-Gu Dec 10, 2019 06:31am
- Molecular structure of MetforminWith Metformin, issues of impurity detection have been raised, and it is possible that N-nitrosodimethylamine (NDMA) will be detected much less than earlier Ranitidine or Nizatidine. According to officials at the MFDS on Dec 9, a qualitative structure activity relationship (QSAR) is used as a simple test to determine the toxicity of a substance. It is a test method that compares and predicts physical and chemical properties by similarity of intrinsic chemical structure. Since the properties of a substance are closely related to its molecular structure, it is a principle that similar physical structures have similar physical properties and toxicity. In fact, the results of predicting the toxicity of Ranitidine-Nizatidine in this way are nearly identical to the actual detection of NDMA in both formulations, according to the MFDS official. According to the official, the results of Ranitidine and Nizatidine QSAR were 90 and 5, respectively. The actual detection amounts were 53.50 ppm and 1.43 ppm based on the maximum values. A MFDS official said, "On this extension, Metformin's QSAR test results are only around 1." It is expected that the possibility of actual detection is much lower than that of Ranitidine or Nizatidine. ◆'Ranithidine 90%, Nizatidine 5%, Metformin 1% or less' This is in line with the findings of Agilent, a US material analysis company. Agilent conducted an experiment in May 2017 to investigate the effects of discarded drugs and chemicals on water pollution. Agilent66 substances were selected for the survey. It includes Ranitidine and Nizatidine, and Metformin. Among the various substances, it is explained that a substance that is likely to be transformed into DMA (dimethylamine) is selected. DMA, together with nitrite, is one of the two materials of NDMA Experimental results showed that the rate of NDMA formation was 60-90% for Ranitidine. Of the 100 ranitidine molecules, 60 to 90 change to NDMA. 5% to Nizatidine. Metformin was found to be less than 1%. This is consistent with the description of the MFDS official. However, as in the case of Valsartan, it is not possible to exclude the possibility that NDMA is generated due to reaction of a specific solvent in the manufacturing process. In the case of Valsartan, dimethylamine was formed as a decomposition product during the high temperature process of dimethylformamide (DMF), which was used as a solvent, and the dimethylamine reacted with nitrite under acidic conditions, leading to NDMA formation. An official from the MFDS explained, “It is difficult to identify the cause of NDMA in Metformin right away, and we have to chop up the molecules of Metformin into small pieces to closely examine the similarity with Ranitidine and the toxicity of the substance itself”. "As a result of the QSAR test, Ranitidine was 90 and Metformin was 1, and A detailed survey of Metformin will be performed and it will be compared with the QSAR test results" said the official.
- Company
- Metformin Self Test, undetected cases also listed
- by Lee, Tak-Sun Dec 10, 2019 06:31am
- The domestic pharmaceutical industry is responding quickly to the issue of Metformin impurities. In some cases, the MFDS has already completed testing, instructing its own testing of raw materials and finished products that may generate impurities. The rest of the companies are considering pushing the test through their own research institute or entrusting the test to outside the university research institute. According to the pharmaceutical industry on the 9th, the Korean pharmaceutical industry conducted its own investigation last Friday (December 6) as the US FDA tests whether it detects carcinogen NDMA (N-Itrosodimethylamine) in the diabetes drug Metformin. The issue began with the detection of more than daily NDMA on three Metformin products in Singapore. The MFDS is investigating the influx of finished Singapore products and raw materials into the country. In addition, it is reported that self-investigation is in the future. Prior to this, domestic pharmaceutical companies began their own tests. The MFDS immediately followed its own investigation of raw materials and finished products that are highly likely to detect impurities, and immediately reports any abnormalities detected. An official from a mid-sized pharmaceutical company said, "We have already tested NDMA for pharmaceutical raw materials through a university lab, and there were no detection results as a result of testing on 3 lots of raw materials using a similar method to the Nizatidine method". Large pharmaceutical companies with high sales of Metformin are also in a hurry to promote their own tests. An official from the company said, "We are planning a test through our own laboratory". Other companies are also making rapid progress, including hearing about the detection of metformin's impurities and promoting their own tests. However, the MFDS does not have any further instructions so it is reported that they are struggling over the countermeasure and test result report. A mid-sized company official said, "We do not know how to report the undetected test results to MFDS and there are no directions from MFDS yet".
- Company
- MedPacto: “license out co-developed vactosertib in 2021”
- by Lee, Seok-Jun Dec 10, 2019 06:30am
- CEO Kim Seong-jin of MedPactoMedPacto predicts to sign license out deals on its star pipeline vactosertib in around 2021. Particularly, the company anticipates the license out deal would highly likely to be for the indications on colorectal, stomach and non-small cell lung cancers that are currently in co-development with MSD and AstraZeneca. Vactosertib (TEW-7197) selectively inhibits Transforming Growth Factor (TGF) beta’s signaling pathway as it disrupts immunotherapy’s treatment effect. The substance improves surroundings of tumor for immunocytes to effectively eliminate cancer cells. At a press conference held on Dec. 6, MedPacto CEO Kim Seong-jin stated “Results of two clinical trials, Phase 1b and 2a, collaborating with MSD and AstraZeneca, would be out next year. The trials with about 40 participating patients each is at a globally recognized level of sampling. When the results are out, we expect a couple of global pharmaceutical companies to offer us the license out deals”. “Considering the overall timeline, the vactosertib license out deals would be signed around 2021. When the deal closes, we are not only expecting sales profit, but also a turnaround”, the CEO added. Reportedly, MedPacto is currently conducting Phase 1b and 2a clinical trials on combination therapy indications for colorectal/stomach cancers and non-small cell lung cancer with MSD’s Keytruda and AstraZeneca’s Imfinzi, respectively. While collaborating with MSD and AstraZeneca, MedPacto is provided with their immunotherapy medicines, Keytruda and Imfinzi. So far, the company has been provided with 15 billion won worth of the medicines. In addition, MedPacto is collaborating with the global pharmaceutical companies on clinical strategies and designs. The Korean company is planning to transfer all rights of development for the pipeline license out deal. CEO Kim explained, “While we see the license out deals to be signed in 2021, we are considering on transferring all development rights of the substance. From 2021, when the license out deals are supposed to happen, we would not put down any more clinical trial cost. It is informed that the December public offering fund would cover only up to next year’s vactosertib clinical trial”. “Although the license out deals would transfer all development rights, commercialization in Asian region could be maintained. In such case, clinical trial in Korea could be possible. Profits from vactosertib would used for clinical trial on MA-B2”, the CEO further elaborated. CEO Kim stressed the talks on vactobsertib license out deals would be led independently, regardless of the current pipeline partnership with MSD and AstraZeneca. “Because the pipeline is co-developed with MSD and AstraZeneca, it is highly likely to be licensed out to them. But other pharmaceutical companies are interested in those indications for colorectal, stomach and non-small cell lung cancers. When we are to negotiate license out deals with other companies, MSD and AstraZeneca would not have the rights to refuse”, CEO Kim pin pointed. MedPacto projects it would generate profit of 165.5 billion won until 2022 with pipeline license out deals on vactosertib and MA-B2. The company is predicted to generate profit from 2021. Previously a subsidiary of Theragen Etex, MedPacto split from the company and was established as an independent company in July 2013. As of the first half of the year, Theragen Etex owns 18.1 percent of the company share. The sum of share including specially related person share is 40.34 percent. A former vice president and the largest shareholder of Theragen Etex, Kim Seong-jin is the current CEO of MedPacto.
- Company
- Samil to release FDA-approved conjunctivitis treatment
- by Lee, Seok-Jun Dec 10, 2019 06:30am
- On Dec. 6, Samil Pharm announced it signed a manufacturing and commercialization license with a France-based ophthalmic R&D company, Nicox S.A. for the exclusiv rights of allergic conjunctivitis treatment Zerviate (cetirizine) in Korea. By closing the deal, Samil Pharm would receive the exclusive rights to manufacture and commercialize the ophthalmic solution and start preparing for the release in 2022. The U.S. health regulator granted an approval on Zerviate for preventing ocular itching associated with allergic conjunctivitis in 2017. The treatment is preparing for a launch in early next year. It is the first and only ophthalmic solution to be made with cetirizine. A Phase 3 clinical study in the U.S. demonstrated significantly less ocular itching within a short period of time. The trial also confirmed safety of the solution so that it could be prescribed to a child aged at two and up. Allergic conjunctivitis is an allergic reaction causing conjunctivitis, an inflammation of the thin layer on the surface of the eye. The signs and symptoms may include eye redness, excessive watering, itchy burning eyes, discharge and blurred vision. With its headquarters in France, Nicox S.A. is an international ophthalmology company focused on development and commercialization of ophthalmic pipeline. Other than Zerviate, Nicox S.A.’s ophthalmic pipeline cover glaucoma and other ocular diseases, developed with the company’s novel nitric oxide-donating R&D platform. Based on the technology, a glaucoma treatment Vyzulta (latanoprostene bunod ophthalmic solution) has been commercialized in the U.S. since December 2017.
- Policy
- What should Metformin do?
- by Lee, Tak-Sun Dec 09, 2019 06:27am
- The MFDS, which has undergone a series of Ranitidine and Nizatidine events, has ordered companies to assess the likelihood of impurity on all synthetic drug substances. Of these, raw materials and finished products with high potential for impurity detection should be tested immediately and reported to the MFDS if abnormal quantities are detected. The MFDS announced the impurity safety management plan last month. 14 days later, foreign news was reported that more than quantitative NDMA was detected in metformin. Unfortunately, this was the day of the briefing session on impurity safety management measures. So does the metformin's own research principles apply? The MFDS said it is investigating whether Singapore's raw materials that were in trouble were brought in Korea or not. The MFDS official, who met at the briefing session, also seemed to be worried enough to ask the reporter, "What should I do?“ Metformin is a pharmaceutical ingredient used as a primary treatment in patients with type 2 diabetes. It is a completely different kind of anti-hypertensive Sartan-based and anti-ulcer Tidine-based drugs that have been forbidden by NDMA. Therefore, the test method has not been correctly established in MFDS or foreign institutions. As the MFDA requires companies to conduct their own tests on substances that are likely to be impurity, the test method is ordered to use the MFDA and open test procedures for foreign regulators. However, Metformin is difficult to conduct a reliable test on its own as there is no open test method. Therefore, even if there is no domestic inflow of Metformin raw material, the MFDS seems to have to perform some tests. However, companies do not seem to be looking at the results of the MFDS' own test orders. There is no publicly available test method, but Singapore's regulators have tested it and based on the experiences established in the -Sartan and -Tidine series investigations, it is an observation that it should try its own test. Up to now, the situation is complicated. Although the FDA and the EU have investigated, until now, only the Singaporean authorities have detected NDMA in Metformin, so if there is no problem in the extended investigation, the impact on the country will be minimal. However, if NDMA is found to be more than quantitative in the expanded investigation, it is highly likely to be caught in a vortex from the domestic investigation stage. That's because Metformin's share of diabetes treatment is absolute.
- Policy
- Investigation of raw materials for Metformin in Singapore
- by Kim, Jin-Gu Dec 09, 2019 06:27am
- The three Metformin products recovered from Singapore have yet to be imported in Korea. The Singapore Ministry of Health (HSA) recently surveyed 46 locally Metformin products and recovered three of them. N-nitrosodimethylamine (NDMA) was detected above the daily allowance (96 nanograms), explains the HSA. Two controversial companies are Glorious Dexa and harmazen Medical Pte Ltd. Recovery targets are Glorious’ Glucient XR Tablet 500mg and Pharmazen's Meijumet Prolonged Release Tablet 750mg and 1000mg. In the case of Pharmazen Medical Pte Ltd, the products produced in all batches are subject to recovery. However, the Singapore Ministry of Health does not specifically explain the level or cause of detection. NDMA detection Metformin products released by the Ministry of Health of Singapore. It is confirmed that there are no imports of this drug in Korea NDMA detection Metformin products released by the Ministry of Health of Singapore. It is confirmed that there are no imports of this drug in Korea At present, there is no record of domestic imports of such drugs as confirmed by the Ministry of Food and Drug Safety. However, the drug substance of the finished drug is not confirmed. In other words, the possibility of domestic products using the same drug substance is not completely excluded. An official from the Food and Drug Administration said, “If the drug has imported in Korea, it is required to register the drug, but all three items have not been imported and ewe should contact Singapore directly, the drug substance company should be identified as early as Monday”. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) today announced that they will begin an NDMA test for Metformin preparations on Monday (local time). The direct reason is Singapore’s issue. The Singapore Health Department announced the recovery of three Metformin items four days earlier.
- Company
- Reimbursement expansion of osteoporosis drug 'Prolia'
- by Chon, Seung-Hyun Dec 09, 2019 06:27am
- In the domestic osteoporosis treatment market, the prosperity of 'Prolia' continues. In the six months since the increase in health insurance benefits in April, the company has built a solitary system in the market with sales of about ₩25 billion. Amgen's Prolia, on the 6th, reported sales of ₩13.5 billion in the third quarter, more than three times the previous year's ₩3.7 billion. It is slightly lower than the previous quarter's ₩12.3 billion, but it is showing a rapid growth of Prolia. AmgenProlia's recent upsurge is driven by increased reimbursement expansion. Prolia, released in Korea in November 2016, was the first product to receive attention as a biologic for treating osteoporosis. Prolia is the only biopharmaceutical osteoporosis treatment that targets the receptor activator of nuclear factor Kappa-B Ligand (RANKL), which is essential for the formation, activation, and survival of bone-breaking osteoclasts. Prolia has not received much response from the market, with sales of less than ₩1 billion in the early quarter. However, after reaching ₩2.4 billion in the fourth quarter 2017 when health insurance benefits began to be recognized, sales increased to ₩4.9 billion in this first quarter . Prolia was approved as a first-line therapy for the treatment of postmenopausal women with osteoporosis and for increasing bone density in men with osteoporosis. Since 2017, reimbursement has been applied to secondary therapy only. Quarterly Sales Revenue Trend (Unit: ₩ million, Source: IQVIA) Since April, insurance coverage has been approved for primary care. Prolia is entitled to pay ▲ twice a year if the T-score is -2.5 or less in bone mineral density measurements, and ▲ six times for three years if osteoporotic fractures are found on radiographs.▲After the administration period, benefits will be provided if follow-up continues to require medication with a T-score of -2.5 or less. After Prolia's approval of the first treatment benefit, sales reached nearly ₩25 billion in six months, causing a blast in the market. Prolia surpassed Lilly's “Forsteo”, which had previously ranked first in sales of osteoporosis treatments, from the second quarter. In the third quarter, Forsteo's sales were ₩5.5 billion, less than half of Prolia's. Sales force growth is also a factor for growth in Prolia. Amgen has been selling Prolia in partnership with Chong Kun Dang since September 2017. Amgen Korea is in charge of sales and marketing of Prolia at general hospitals and Chong Kun Dang at semi general hospitals and Clinics. Chong Kun Dang has developed synergies with its sales know-how combined with prolia sales in the musculoskeletal drug market with products such as Osteoarthritis treatment, ‘Imotun’ and anti-inflammatory analgesics, ‘Coxbito’.
- Company
- AbbVie Skyrizi approved, a new option for psoriasis
- by Eo, Yun-Ho Dec 09, 2019 06:26am
- Patients with plaque psoriasis now has another interleukin inhibitor option. On Dec. 3, AbbVie Korea announced Korean Ministry of Food and Drug Safety (MFDS) approved its interleukin-23 (IL-23) inhibitor Skyrizi Prefilled Syringe (risankizumab) for the treatment of moderate to severe psoriasis in adult patients who are candidates for systemic therapy (whole-body therapy including biologic treatment) or phototherapy. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, which AbbVie is managing development and global sales. The ministry’s approval was based on ultIMMa-1 and ultIMMa-2 clinical trials, where patients were treated with Skyrizi showed high level of condition improvement at 16 weeks. And during ultIMMa-1 and ultIMMa-2 trials, 82 and 82 percent of the patients achieved Psoriasis Area and Severity Index (PASI) 90 at one year (52 weeks), and 56 and 60 percent of the patients achieved PASI 100, respectively. PASI 100 indicates the patient’s condition has achieved a complete resolution. Skyrizi administration starts with 150 mg initiation dose injected subcutaneously at week 0 and 4, followed by injection at every 12 weeks. Among the biologic IL-23 inhibitor class medicines approved in Korea, the treatment is has the minimum administration frequency of four times a year, which can be injected at a hospital or self-injected after training. Professor Youn Sang Woon at Dermatology Department of Seoul National University Bundang Hospital explained “Severe psoriasis can gravely affect patient’s quality of life physically, mentally and socially. Respective case has widely different treatment reaction, and patients usually experience various adverse reactions during a long period of treatment”. “In a Phase 3 clinical trial, patients treated with Skyrizi showed over 90 percent of improvement at 16 weeks, and 80 percent of the patients maintained the state even after a year. Such positive findings confirm Skyrizi to be a new competitive treatment option for treating severe psoriasis condition and maintaining recovered state”, the professor elaborated. Skyrizi also reaffirmed its treatment effect and safety in four clinical studies conducted with 2,109 patients (ultIMMa-1, ultIMMa-2, IMMhance and IMMvent). During the ultIMMa-1 and ultIMMa-2 trials, 74 percent of Skyrizi-treated patients demonstrated 90 percent of recovery rate (PASI 90) at week 16, and 36 and 51 percent of patients achieved 100 percent recovery (PASI 100) in the trials, respectively. In fact, an integrated analysis of ultIMMa-1 and ultIMMa-2 showed most patients treated with Skyrizi who recovered 90 and 100 percent (PASI 90 and 100) at week 16 maintained the state at one year point.
