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- 2026-05-21 00:37:22
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- 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.
- Company
- 'Jardiance' reaffirms CV benefits over DPP-4 inhibitors
- by Eo, Yun-Ho Dec 09, 2019 06:26am
- Research shows that SGLT-2 inhibitor ‘Jardiance’ has more cardiovascular benefits than DPP-4 inhibitors. Boehringer Ingelheim and Lilly are the first to analyze Jardiance’s effectiveness of the EMPRISE (Empagliflozin Comparative Effectiveness and Safety) Asia study at the International Diabetes Federation, IDF presented at the General Assembly site. The EMPRISE Asia study included approximately 57,000 adults with type 2 diabetes in Japan, Korea, and Taiwan, with or without cardiovascular disease. The first validity analysis of the study showed that Jardiance has benefits in hospitals due to lower heart failure, end-stage renal failure, and all-cause mortality risks compared to DPP-4 inhibitors in real clinical settings. According to the analysis, Jardiance reduced the risk of death from heart failure by 18%, the risk of developing end-stage renal failure by 63% and the risk of death by all causes by 36% in adults with type 2 diabetes. According to the analysis, Jardiance reduced the risk of death from heart failure by 18%, the risk of developing end-stage renal failure by 63% and the risk of death by all causes by 36% in adults with type 2 diabetes. Daejoong Kim, a professor of endocrine medicine at Ajou University Hospital, a researcher at EMPRISE Asia said “"Jardiane has been shown to reduce the incidence of deaths in people with type 2 diabetes compared to DPP-4 inhibitors, and it is a convincing result that the reduction in death of Jardiance, identified through the EMPR-REG OUTCOME study, can be consistently provided to Korean patients in a real clinical setting”. The results of the EMPRISE Asia study complement the findings of the EMPA-REG OUTCOME study, which shows that Jardiance provides cardiovascular and renal benefits in addition to metabolic effects in patients with type 2 diabetes with cardiovascular disease. In the EMPA-REG OUTCOME study and sub-analysis, Jatdiance reduced the relative risk of hospitalization due to heart failure by 35%, the relative risk of death from all causes by 32%, and the relative risk of developing or worsening kidney disease by 39%.
- Company
- Celltrion, achieved first $1 billion exports in Korea
- by Chon, Seung-Hyun Dec 09, 2019 06:26am
- Celltrion Healthcare announced on the 5th that it won '$1 Billion Export Tower award ' at the 56th Trade Day Ceremony hosted by the Korea International Trade Association. Whole view of Celltrion Healthcare HeadquartersCelltrion Healthcare is the first Korean pharmaceutical bio company to surpass $1 billion in annual exports. Only five companies have received more than $1 billion towers. SK Trading International won $10 billion tower, and Hyundai Construction Equipment, Kumho P&B Chemicals, Nexen Tire received the $1 billion tower with Celltrion Healthcare. Celltrion Healthcare is an affiliate of Celltrion and Chairman Seo, Jung-jin, Celltrion, is the largest shareholder (35.69% stake). Celltrion Healthcare receives antibody biosimilar products from Celltrion and sells them to global distributors. Celltrion Healthcare's sales represent the export of biosimilars developed by Celltrion. Celltrion sells a total of three biosimilars in Europe and the United States, including ‘Remsima’, ‘Truxima’ and ‘Herzuma’. Remsima's original drug is Janssen's Remicade. 'Truxima' and 'Herzuma' are Mabthera’s and Herceptin’s biosimilar products, respectively. Celltrion Healthcare received a $1 billion export tower four years after winning the $300 million export tower in 2015 as biosimilar sales increased. According to Celltrion Healthcare's quarterly report, the cumulative exports of the three biosimilars in the third quarter totaled ₩7,828 billion. It was 57.9% higher than ₩4,956 billion in the same period last year. Remsima's exports increased 60.1% yoy to ₩399 billion, and Truxima's exports soared 148.3% to ₩34.6 billon. Although Herzuma's exports fell by 42.2%, Remsima's and Truxima's propaganda boosted exports. According to the Ministry of Food and Drug Safety, ‘2018 Domestic Drug Production Imports and Exports’, total drug exports last year totaled $4.67 billion. Celltrion Healthcare accounts for about 20% of annual drug exports. On this day, Hyeong-ki Kim, the CEO of Celltrion Healthcare, received the prize of the Minister of Trade, Industry and Energy's commendation for leading Korea's pharmaceutical exports. The CEO said, “Three biosimilar products have achieved great results in the global market, opening the era of ₩1 trillion in exports of pharmaceuticals to biopharmaceutical companies, and we will focus on expanding exports with the goal of winning the $ 2 billion Export Tower within the next 1-2 years”.
- Company
- Terramycin out again, Pfizer says February next year
- by Jung, Hye-Jin Dec 09, 2019 06:26am
- Pfizer Korea’s Terramycin ophthalmic ointment (3.5 g) is out of stock yet again. Pharmacies are expecting to fall into confusion as the versatile ointment is used vastly with affordable reimbursed price for various conditions. Pfizer Korea notified distributors and pharmacies recently that the production schedule of Terramycin ophthalmic ointment has been delayed and accordingly the supply would be suspended temporarily. The company expects drug supply would resume in around February next year. The ointment was experiencing a long-term shortage for 18 months from 2016 to 2017, and gained the title of ‘problematic out-of-stock drug.’ At the time, Korean Pharmaceutical Association (KPA) demanded Ministry of Food and Drug Safety (MFDS) for a countermeasure as hospitals and clinics continued to prescribe Terramycin ointment despite the shortage. Terramycin ophthalmic ointment is popular among patients as it is used to treat a wide variety of superficial ocular infections, such as corneal ulcer and conjectivitis, and also because of its affordable price. The usage volume has surged lately as increasing number of pet owners started applying the ointment on their pets Besides, the reimbursed price of 385 won is another attractive factor of the product. The prescribed ointment sold about 180 million won, or about 470,000 units in the first half of the year alone. Even before Pfizer Korea disseminated an official notice, online shops and major distributor have gone out of stock. A number of major online shops have out-of-stock notice on their websites, and distributors are doing their best to find leftover stock. A drug distributor source explained, “When the rumor about the shortage spread, the stock level had already plummeted since the beginning of November. The shortage seems to have begun earlier as some concerned pharmacies have ordered excessive amount than usual”.
- Hesitation of Biosimilar in the immune disease market
- by Kim, Jin-Gu Dec 06, 2019 10:40am
- In the market of TNF alpha inhibitors used to treat autoimmune diseases, domestic biosimilars are showing opposite results. While Celltrion's 'Remsima' has achieved its performance, Samsung Bioepis' Remaroche, SB4, and LG Chem's ‘Eucept' have a weak presence. According to drug research agency IQVIA on the 5th, the market size of TNF alpha inhibitors in the third quarter of this year is ₩56.9 billion. The company has been changing record highs every quarter for the past three years. Compared to ₩37.1 billion in the third quarter of 2016, it increased by 53.0%. Market growth is being driven by Abbie's Humira and Janssen's Simponi. Humira posted sales of ₩ 24.4 billion in the third quarter of this year. It grew 63.8% from ₩39.4 billion in the third quarters 2016, exceeding overall market growth. The market share is still overwhelming at 42.9%. Simponi is the fastest growing. In the third quarter, the company's sales reached ₩8 billion, nearly double that of three years ago (₩4.3 billion). The market share of the entire TNF alpha inhibitor market is 14.1%, which is second only to Remicade (20.5%). Domestic Biosimilar Polarization… Less than ₩1 billion excluding Remsima. Four domestic biosimilars have challenged the TNF alpha inhibitor market. Remsima and Remaroche are remicade's biosimilars, while Etoloche and Eucepl are Enbrel's biosimilars. However, their performance is staggered by item First of all, if you look at the infliximab (remicade and biosimilar) market, all three products are steadily increasing. Among them, Remicade's sales increased 27.2% from ₩9.3 billion in the third quarters 2016 to ₩11.7 billion in the third quarter. It is analyzed that it is leading the challenge of biosimilar. In the same period, Remsima increased 60% from ₩4 billion to ₩6.4 billion. Among biosimilars, he received the most successful report cards. However, it is pointed out that the explosive power does not show as much as in Europe. According to Celltrion, Remsima's European share was 52% at the end of last year, surpassing the original Remicade. Launched in July 2016, Remaroche had virtually no results, but sales began in the second quarter of last year. In the first quarter, sales increased from ₩150 million to ₩800 million in the third quarter. Compared to other products, the sales volume is minimal. In the etanercept market, both original and biosimilars are sluggish. Enbrel is the only decline in sales among all TNFalpha inhibitors. the third quarter sales amounted to ₩4.4 billion, down 9.1% from the third quarter 2016's ₩4.8 billion. Three years ago, it was overtaken by Simponi and Remsima in third place, and now ranks fifth. Etoloche increased more than 13 times from ₩600 million in the third quarter of 2016 to ₩900 million in the third quarter of this year. Eucept, which reported its first sales in the fourth quarter of last year, has grown almost four times in a year, from ₩86 million to ₩383 million. However, the sales volume and proportion of both products are insignificant. Currently, Enbrel and Etoloche + Eucept only account for 77.8% versus 22.2%. Although the share of 1% has risen to 22% over the past three years, the impact from the decline in Enbrel's sales is small. An industry official said, "Because the market is expanding rapidly, biosimilars are not easy to settle except for Remsima." “Unlike generics, the price competitiveness is not high, and we are struggling with the influence of other original products, such as Humira or Simponi".
