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- 2026-04-18 02:23:25
- FDA and EMA warn patients taking high dose of Xeljanz
- by Nho, Byung Chul Nov 19, 2019 06:34am
- The European Medicines Agency (EMA) has decided to limit high dose prescription of a Janus kinase (JAK) inhibitor medicine, Xeljanz (tofacitinib citrate), following a similar move by the U.S. Food and Drug Administration (FDA), and now Korean Ministry of Food and Drug Safety (MFDS) is also expected to make a similar decision in response. On Nov. 15 (local time), EMA officially confirmed that the maintenance therapy taking 10mg twice daily should not be used in patients with ulcerative colitis who are at high risk of blood clots unless there is no suitable alternative treatment. Previously, EMA’s safety committee, also known as Pharmacovigilance Risk Assessment Committee (PRAC), issued a statement in last May and warned healthcare providers “must not prescribe” 10mg twice daily dose of Xeljanz to patients with high risk of pulmonary embolism (PE), who take combined hormonal contraceptives, are receiving hormone replacement therapy or undergoing major surgery. While 10mg is higher dose only recommended to patients with ulcerative colitis, PRAC has recommended patients with the condition and are at high risk of blood clots “must not” start with Xeljanz, but to choose another option. EMA then stated it would announce a revised guidance as soon as a review result is out. And on Nov. 15, the agency officially confirmed its restriction on the JAK inhibitor. On Nov. 15, EMA posted an official statement about Xeljanz on its website In last July, the U.S. FDA also amended one of Xeljanz’s indications as first-line treatment for patients with ulcerative colitis to second-line treatment of the condition. Negotiating with FDA, Pfizer cited the Xeljanz’s risks on its ‘black-box warning’ and revised indication for ulcerative colitis around the same time. With the FDA’s most stringent warning labeled, Xeljanz can now be prescribed to ulcerative colitis patients who took conventional therapy, but did not have a response with tumor necrosis factor (TNF) inhibitor. In a nutshell, Xeljanz in the U.S. has been removed from first-line treatment for ulcerative colitis and was pushed down to second-line, and also the drug has a formal restriction on prescription for patients at high risk of blood clot in Europe. Initially, Xeljanz was approved as a treatment for rheumatoid arthritis, psoriatic arthritis and ulcerative colitis. The approved dose for rheumatoid arthritis is 5mg twice daily, whereas for ulcerative colitis is 10mg twice daily for the first eight weeks and either maintain 10mg or decrease to 5mg twice daily depending on the treatment reaction. Xeljanz treatment for ulcerative colitis previously required starting dose of 10mg for the first eight weeks. But the interim analysis on post-marketing clinical trial studying Xeljanze in comparison to a TNF blocker, a same class as Humira and Remicade, significantly influenced the U.S. and the European health authorities’ decisions to amend approval and restrict prescription. The analysis apparently found concerning reporting of 19 cases of blood clots in the lung and 45 cases of death from all causes out of 3,884 patient-years of follow-up in patients who received Xeljanz, compared to three cases of blood clots in the lung and 25 cases of death out of 3,982 patient-years in patients who received TNF blockers. On the foreign health authorities’ decisions, MFDS and Pfizer Korea officials noted, “We are paying a close attention on the FDA and EMA’s decision and actions. The ministry and the company are in mutually cooperative talks to take an appropriate action considering the safety of Korean patients.” When EMA issued a temporary restriction on the drug in last May, Pfizer Korea disseminated a letter of safety warning and held seminars for healthcare providers in Korea. But the company has not yet made a decision on the news of the drug being pushed down to second-line treatment or prescription restriction on patients at high risk of blood clots. Meanwhile, Japanese Ministry of Health, Labor and Welfare in last August added venous thromboembolism (VTE) as a ‘serious adverse reaction’ on Xeljanz’s label, and recommended doctors to consider other options when prescribing a treatment to a patient at high risk of cardiovascular events.
- Company
- Power of Innovative Drugs, Keytruda & Spinraza Shake Market
- by Chon, Seung-Hyun Nov 19, 2019 06:34am
- New products, which are regarded as innovative new drugs in the domestic pharmaceutical market, are shaking the upper hand. Keytruda, an immunocancer drug, spearheaded Lipitor to the chin with a steep rise. Rare disorder treatment “Spinraza” presented a remarkable quarterly sales of ₩20 billion immediately after applying for health insurance reimbursement. According to IQVIA,the health information technology and clinical research on the 18th, Pfizer's Lipitor, medicine that lowers cholesterol in the blood, posted the highest sales of ₩36.3 billion in the third quarter. It rose 5.5% over the same period in the previous year. Lipitor, which was released in Korea in 1999, is still well despite the entry of more than 100 generic products after the patent expiration in 2009. Top 10 sales medications in third quaeters 2019 (Unit: KRW million, %, Source: IQVIA) Keytruda's propaganda was noticeable. Keytruda's the third-quarter sales grew 78.9% over the same period in the previous year to ₩33 billion ranking second after Lipitor. The company's quarterly sales gap with Lipitor is narrowed to ₩3.3 billion threatening its lead. Keytruda binds to the PD-1 receptor, blocking both immune-suppressing ligands, PD‑L1 and PD‑L2, from interacting with PD-1 to help restore T-cell response and immune response. When functioning properly, T cells are activated and can attack tumor cells. Since August 2017, insurance reimbursement has been applied as a secondary treatment for non-small cell lung cancer. Quarterly sales of Keytruda jumped from ₩4.9 billion in the fourth quarter of 2017 to ₩13.6 billion in the first quarter of 2018. Keytruda exceeded sales of ₩ 20billion in the fourth quarter of last year and has recorded sales of ₩30 billion since the second quarter of this year. Keytruda has booked a record-breaking ₩100 billion in sales in the third quarter of this year. It also attempt to get top position of Lipitor. The sales gap between Lipitor and Kitruda is ₩19 billion based on cumulative sales in third quarter Quarterly Sales Revenue by Quarter (Unit: KRW million, Source: IQVIA) Biogen's Spinraza made a surprise blast with sales of ₩20.4 billion in the third quarter. The company did not generate sales until the second quarter, but sold more than ₩20 billion at a stretch. Spinraza is a rare disease treatment that treats hereditary diseases of the neuromuscular system, in which the muscles are contracted by damage to the spinal cord and brain stem motor neurons, called spinal muscular atrophy (SMA). Cognitive function is normal, but muscle tension is poor, tongue muscle contractions, such as normal life is difficult. Spinraza, which was approved in Korea in December 2017, was listed on the health insurance list at the maximum price of ₩92.3 million in one bottle (5ml) in April after drug pricing negotiating with National Health Insurance Service. Spinraza does not have a large number of patients and must undergo a rigorous procedure that requires prior review before administration. However, due to the high price, it made ₩20 billion in sales. Roche's anti-cancer drug 'Avastin' was ranked 3rd overall with sales of ₩30.7 billion, up 18.1% from the previous year. Avastin, which is used for metastatic colorectal cancer, metastatic breast cancer, and non-small cell lung cancer, surpassed the annual sales of ₩100 billion for the first time since its domestic approval last year. Cumulative sales for the third quarter of this year stood at ₩89.2 billion, which is likely to exceed ₩100 billion for two consecutive years. Abbvie's autoimmune disease treatment product, Humira, recorded ₩24.4 billion in sales in the third quarter up 12.4% from the previous year. Humira is a TNF-alpha inhibitor that inhibits the expression of tumor necrosis factor (TNF-α). and continues to rise due to the merits which has the most indications among the TNF-alpha inhibitors. Humira's 3rd quarter cumulative sales increased 15.1% year-on-year to ₩71.3billion. AstraZeneca's anti-cancer drug Tagrisso jumped to fifth place in the third quarter with sales of ₩21.1 billion. The growth rate was 42.0% year-on-year. Tagrisso is a second-line treatment prescribed for patients with non-small cell lung cancer (NSCLC) who developed resistance after conventional EGFR tyrosine kinase (TKI), such as Iressa, Tarceva, and Gilotrif. It is called a third generation drug because it overcomes the resistance of the existing EGFR-TKI. Tagrisso, which was launched in December 2017, received nearly ₩60 billion in sales last year, making it the leading EGFR anticancer drug. Revenue continued to rise after exceeding ₩20 billion in the previous second quarter. Gilead's hepatitis B treatment, Viread, which was once the leader in overall sales, recorded only ₩20.7 billion in the third quarters sales, down 29.3% from the previous year. After patent expiration, market share dropped sharply due to drug price cuts and generic emergence.
- Product
- The Minister Lee, Enhanced post-de-factor management
- by Jung, Heung-Jun Nov 18, 2019 10:21pm
- Lee Eui-kyung, the Minister of MFDS has released a long-term follow-up plan to strengthen the post-de-factor safety management system. On the 15th, the Minister Lee attended Korean Academy of Social & Managed Care Pharmacy and presented the four directions of drug safety management in four categories: patient safety, accessibility, safety ecosystem, and globalization. In particular, the Minster Lee emphasized that she will lead to a paradigm shift centered on patients by strengthening post-de-factor management. She said, "In the meantime, in the event of Invossa’s case , it was most of the time that the license was revoked or changed. In the future, we will thoroughly control the side effects, operate the long-term follow-up management system, and carefully regulate the damage. I will lead the paradigm. " For 3,000 patients for injecting Invossa, she will select 20 medical institutions and conduct a long-term follow-up survey for 15 years. "We have registered for 80 to 90 percent of our patients." she said, "Patients have used 400 medical institutions, but the concern is about cancer. So long-term follow-up should be in a hospital with oncology." "We plan to track them all at large hospitals, and we will also carry out causality research of cancer." On this day, the “Long-term patient tracking survey system (Draft)”, which will be applied to future risk medicines, was announced. According to the plan, when the MFDA issues a follow-up order, companies make a plan and MFDA goes through approval process. Companies conduct follow-up investigations. Causality evaluations and follow-up actions are conducted with the MFDS. The Minister Lee said, "We still have to be specified liability compensation. The government thinks that product defects should be shouldered by pharmaceutical companies. But, pharmaceutical companies have different positions that they are not responsible for what they didn't know at the time. We are discussing the responsibility with the relevant committees” ◆Strengthen practical use of RWD (Real World Data), R &D investment extension. In addition, MFDS will strengthen the use of RWD (Real World Data) and RWE(Real World Evidence) next year to strengthen patient safety management It plans to establish big data utilization system such as clinical site RWD and RWE in clinical trial RCT. To this end, it will actively invest in R & D costs. She said, “We will make an official announcement in January about the plans for using big data. MFDS R & D expenses rose from ₩85 billion to ₩100 billion this year. But most of them are the cost of experimentation. I'm going to turn this into RWD study”. She also announced that she will soon disclose ways to improve safety for conditional phase3 permits. "There is a lot of controversy about whether a conditional phase3 permit will guarantee the patient first, or if he will give the opportunity after ensuring full safety, if there is no alternative." We will soon release to the media on how to make it work more securely. ” ◆As new drug development countries become more important, permit strengthening of MFDS expertise She said that as Korea is actively developing new drugs, licensing is becoming more important, so the MFDA will also strengthen its expertise. She said, “If the drugs were reviewed at least once because foreign new drugs were introduced into the country in the past, currently there is a need to be more burdensome in terms of initial authorization and to reinforce professionalism since new drugs are being developed in Korea. Only about 350 people are screened by the MFDS, but there are 6,000 Ph.D in US. The MFDS will focus on strengthening its expertise in the future.” She also said “MFDS or pharmaceutical companies can’t do it alone, Infrastructure maturity must increase” "The long-term policy is needed to fundamentally improve the problem," She said. It is true that there is a lack of policy research think tank, ” She also recognized the necessity of analyzing and evaluating the future system.
- Policy
- Champix patent expires soon, follow-ons eager to launch
- by Lee, Tak-Sun Nov 18, 2019 10:21pm
- Despite a joint sales deal with Pfizer Korea on a quit-smoking medication Champix (varenicline tartrate), Yuhan Corporation is currently developing a follow-on medicine of the original. Seemingly, Yuhan is preparing for the Pfizer’s Champix’s patent to expire in next July. On Nov. 11, Ministry of Food and Drug Safety (MFDS) approved an investigational new drug application for Phase 1 clinical trial on Yuhan’s candidate medicine, ‘YHP190’. The study protocol states it aims to compare and evaluate pharmacokinetics of healthy adult subject arms taking 1mg of YHP1903 and 1mg of Champix tablet, respectively. The commercial clinical trial is to be initiated for the regulators to approve Champix’s follow-on medicine. Yuhan’s development of Champix’s follow-on drug and its clinical trial has gotten the industry’s attention as the company is currently co-promoting the original Champix with Pfizer Korea. In September last year, Yuhan signed a joint sales deal with Pfizer Korea. It was a co-promotion strategy to defend Champix’s market share from incrementally modified drug (IMD) launching in November same year. The IMD with a change in saline substance of Champix was able to enter the Korean market as it evaded extended term of the original’s substance patent. The Intellectual Property Trial and Appeal Board ruled the IMD does not infringe the original’s patent with extended term. However, the table turned in last January, as the Supreme Court on other case ruled that an IMD with changed saline substance does not evade extended patent. The Champix’s IMD released in November last year stopped most of its manufacturing after January. Korean court is expected to hand down the ruling on Champix’s IMD on coming Dec. 20. On the other hand, MFDS has already approved of 72 IMDs related to Champix. But initially Yuhan did not submit a follow-on drug approval application, due to its joint sales deal. Although the sales of IMDs are blocked at the moment, it would resume from July next year when the extended patent term expires on July 19, 2020. There are saline substance and composition variant patents expiring on Jan. 31, 2023, but most of Korean companies are evading the patent as they are using different substances. At last, July next year would be the long-awaited start of the heated smoking-cessation medication market competition. While many companies are eager to launch items in same class, the pharmaceutical industry is keeping a close eye on Yuhan with co-promotion deal over the original, to see if it would also join the follow-on drug market competition. Meanwhile, IQVIA reported Champix sales in the first half of the year plummeted by 51.1 percent, compared to same time last year, and that the drug only generated 11.5 billion won. The sudden drop of sales was affected by the original’s price reduction due to release of IMDs and decreased number of participants applying for government-supported quit-smoking program.
- Company
- Kolon Life Science faces 88.5-billion-won damage lawsuits
- by Kim, Jin-Gu Nov 18, 2019 10:21pm
- Kolon Life Science is facing a series of damage lawsuits asking for 88.5 billion won as compensation for the Invossa incident. Kolon Life Science stated in the third quarter report that the company’s properties have been seized by Mitsubishi Tanabe and outstanding contract payment from Mundipharma has been suspended. It is facing number of damage lawsuits filed by individuals and insurance companies since last May. 1,572 individuals and companies from home and abroad demanding 88.5 billion won As of last Oct. 31, 1,572 individuals have filed litigation cases against Kolon Life Science. Most of them are shareholders of Kolon Life Science and Kolon TissueGene. Some of patients who had been taking Invossa are claiming the damage as well. Other 19 corporations, including Kyobo Life Insurance Company, KB Insurance, and Meritz Fire & Marine Insurance, have also decided to sue Kolon Life Science. Their total litigation value adds up to 58.4 billion won. Meanwhile, Japan-based Mitsubishi Tanabe has submitted a request for arbitration to International Chamber of Commerce (ICC). The Japanese company demands the Korean company to return the upfront payment of JPY 2.5 billion (about 26.9 billion won) and to pay about 300 million yen (3.2 billion won) for damage. Regarding the issue, Kolon Life Science explained “The company received 2.5 billion yen as an upfront payment, without a return condition, when Mitsubishi Tanabe and Kolon Life Science signed the technology transfer deal in 2016. But in December 2017, Mitsubishi Tanabe requested for contract cancellation and return of contract payment, and in last May, the company submitted a request for arbitration to ICC against Kolon Life Science as it added another grounds for the contract revocation”. As a result, Kolon Life Science faces litigation value of about 88.5 billion won from companies in and out of Korea. List of damage lawsuits filed against Kolon Life Science 14.4 billion won-worth property frozen, 15 billion won contract payment suspended The third quarter report also disclosed the fact Kolon Life Science’ property worth 14.4 billion has been put under provisional attachment by Mitsubishi Tanabe. Kolon Life Science headquarter building seized by Mitsubishi Tanabe Mitsubishi Tanabe requested Korean courts to attach three of Kolon Life Science’ real estate properties under provisional attachment, and Daegu, Cheongju, and Seoul Southern District Courts ruled seizure of Kolon Life Science’ assets. Accordingly, land and building of Second Gimcheon Plant (valued at around 3.3 billion won), land and building of Chungju Plant (valued at around 7.8 billion won), and Magok headquarters building (valued at around 3.3 billion won) have been seized. Also the outstanding contract payment from Mundipharma has been put on hold. Kolon Life Science may have to return the already received 15 billion won. Previously, Kolon Life Science and Mundipharma signed a license deal worth of 30 billion won in November, 2018. Mundipharma agreed to pay the Korean company 15 billion won each in the third and fourth quarter of this year. The company has received 15 billion won from the global company in the past third quarter as stated on the agreement. But in last May, Kolon Life Science agreed on signing Mundipharma as pledge of movables for collateral security, which in result suspended the outstanding fourth-quarter payment of 15 billion won. And when the pledgee’s condition is activated, Kolon Life Science may have to return the received 15 billion won.
- Policy
- 5 or more medications were taken by 68% for older people
- by Kim, Jung-Ju Nov 18, 2019 05:34pm
- Korean proportion of 75 years and over who are taking more than 5 medications concurrently exceeded 68%. It is far exceeding the average of 48% of OECD –member countries. Diabetic prescription rate of first choice antihypertensive medication patientsis 78%, which is lower than the average of 83% in OECD-member countries, but is steadily increasing. In particular, more than eight out of 10 patients said they had enough consulation hours. MOHW(Ministry of Health and Welfare) announced on Nov 17th analyzing the level and status of Korea and each country based on the 2017 results of health care presented by the OECD. In Korea, ▲ the quality of acute care and outpatient care is continuously improving. ▲ In particular, the level of colorectal cancer and gastric cancer is the highest level among OECD countries. ▲ The level of outpatient prescription is gradually improved, but management by the multi combination prescriptions is required. The multi combination prescriptions means administration of five or more drugs with different ingredients for more than 90 days. Acute myocardial infarction and stroke 30 days mortality after admission to hospital ◆Acute care= Acute myocardial infarction and stroke 30 days mortality rate are representative indicators of the quality of the acute care area. within 30 days of acute stage patients over 45 years of age. The 30-day mortality rate for patients hospitalized for ischemic stroke (over 45 years) in 2017 was 3.2%, the superior level among OECD countries. The OECD average is 7.7%. The 30-day mortality rate for acute myocardial infarction has declined since 2008, but has increased since 2016, with 9.6% in 2017, higher than the OECD average. The OECD average is 6.9%. Cancer five year net survival ◆Chronic disease = Among the chronic diseases that are managed well in primary care areas, hospitalization rates for asthma and diabetes were 81 patients per 100,000 people and 245.2 patients per 100,000 people, respectively, higher than the OECD average. The OECD average is 41.9 patients per 100,000 people for asthma and 129 patients for diabetes. Chronic disease admission rates have only declined since 2008, and COPD disease admission rates are approaching the OECD average ◆Cancer care = The five-year net survival rate in Korea is the highest level of cancer care, with colorectal cancer of 71.8%, rectal cancer of 71.1% and gastric cancer of 68.9% Five-year net survival means the cumulative probability that a cancer patient will survive five years after diagnosis if cancer is the only cause of death. The 5-year net survival rate of lung cancer patients (25.1%) was higher than that of OECD countries (17.2%), and acute lymphocytic leukemia was 84.4%, slightly higher than the OECD average (83.7%). ◆ Outpatient prescription = Outpatient prescription level is determined by ▲ multidrug prescription ▲ opioid prescription ▲ antipsychotic prescription ▲ antibiotic prescription rate ▲ diabetes patient prescription ▲ benzodiazepines prescription. Data on multidrug, opioid and antipsychotic prescriptions were first collected this year. First, a multi-drug Prescription is defined as the proportion of patients 75 years of age or older who are chronically taking five or more drugs. In 2017, Korea accounted for 68.1%, the highest among the seven countries that submitted statistics (average: 48.3%). The total prescription for opioids, a narcotic analgesic, was 0.9DDD / 1000 people per day, the lowest next to Turkey. In Korea, narcotics prescriptions are low due to strict narcotics regulation and control , and repulsion from the term of “narcotics”. Defined Daily Dose (DDD) is the average dose that must be taken throughout the day for the main ingredients of the drug to take effect. The prescription rate for antipsychotics for patients 65 years of age and older is 36.2 per 1000 prescription populations, which is among the lowest in the 16 countries where statistics were submitted. Hospital admission rate In 2017, the amount of antibiotics for outpatient’s prescriptions in Korea was 26.5DDD / 1000 persons / day Medication prescription adequacy in diabetics is measured by first-choice antihypertensive * and hypolipidemic ** prescription rates. Primary antihypertensive agents are drugs used in the initial treatment of hypertension and include diuretics, beta blockers and alpha beta blockers, calcium antagonists, angiotensin converting enzyme inhibitors (ACE inhibitors), and angiotensin receptor blockers (ARBs). Lipid lowering agents are drugs that control blood lipids, such as cholesterol. For diabetics, higher prescription rates produce better results. Prescription rate to reduce the risk of diabetic nephropathy and to slow the progression of hyperalbuminemia in patients with diabetes with high blood pressure is 78%, which is lower than the OECD average (82.9%), but is increasing. In order to prevent cardiovascular disease in diabetic patients, the medical guidelines * recommend prescribing lipid-lowering drugs.In Korea, the level of drug prescription ** in diabetics increased by 23.3% p from 44.1% in 2011 to 67.4% in 2017. Hypnotic benzodiazepines are drugs that require caution due to the increased risk of side effects such as cognitive impairment and falls when taken over 65 years. The long-term prescribing of benzodiazepines was 10.1 patients per 1000 population over the age of 65, lower than the OECD average (33.9). Among the benzodiazepines, long-acting drugs were prescribed for 146.3 patients per 1000 people over the age of 65, more than the OECD average of 52 (52), but significantly lower than in 2011 (241.5). Long-term action of benzodiazepine drugs is expected to have a longer half-life when taken by the elderly, resulting in negative effects due to excessive sedation. Prescribing in primary care related patient safety Prescription and mental health related to patient safety = 80.8% of patients reported that their doctors had enough time to check out their consultation based on the 2018 medical service experience survey. In addition, 82.9% and 82.4% of the respondents explained that the doctor explained it in an easy-to-understand manner and participated in the decision-making process. The excess mortality rate for schizophrenia was 4.42 and 4.21 for bipolar affective disorder, higher than the OECD average (4, 2.9, respectively).
- Company
- AI-driven Drug Discovery is already signigicantly high level
- by Kim, Jin-Gu Nov 18, 2019 04:47pm
- Global pharmaceutical companies are showing great interest in the development of new drugs using artificial intelligence (AI). It is expected that AI will drastically reduce the time and costs associated with finding a candidate substance through clinical trials and approvals before entering the market. What about the perspective of the computer science industry, not the pharmaceutical industry? Prof. Kang, Jaewoo, Dept. of Computer Science and Engineering, Korea University, explained that AI-driven Drug Discovery is already coming to reality at 'BIOplus 2019' held at COEX in Seoul on Nov 12. Prof. Kang presented as a speaker at a session called ''AI Medicine: Data-driven Drug Discovery. He expects AI to be particularly strong in clinical trials including Drugs Pipeline discovery & verification. In addition, he introduced cases of this and added his experience of winning the global competition continuesly, According to him, the most prominent step in AI development is Drugs Pipeline discovery. At present, the discovery of candidate materials is mainly done by manual method through document retrieval like Pub Med, the world's largest medical thesis site, reads related articles and formulates hypotheses. However, the number of new articles published in Pub Med is 5000 conservatives a day. It is impossible for a person to check one by one. AI can contribute to this, Professor Kang explained. He focused on AI's "human language learning ability." He succeeded in creating a program called 'BioBERT' last January based on Google's 'deep learning' technology. AI will answer it. if you enter the medical question you want in the program. It is an expansion of the pharmaceutical bio sector of 'BERT' which Google disclosed earlier. Google learned Wikipedia's language with deep learning and created a program called BERT. Data was entered as Wikipedia's language. Instead of Wikipedia, BioBERT learned the language of Pub Med and PMC (another medical article search site). 16 billion words were entered as data. BioBERT's capabilities have been recognized globally. He won first place in BioASQ, one of the AI bio competitions in the pharmaceutical bio sector. Google was in second place. It came with Google's model and reborn as a better program than Google. He said,“It was a test to see how accurate the program would answer, and we can significantly reduce time and effort to find candidates (via BioBERT)." Next step is to verify it once you formulate a hypothesis. Prof. Kang also explained that AI contributes a lot. He added real experience. It was a competition called 'IDG-DREEM' this year. When professors at Mount Sinai Medical School in New York presented their hypothesis as a problem, AI experts around the world searched for answers. Professor Kang won the championship for two consecutive years. He became a co-winner this year. It is in the same position as Illinois State University, China National University of China, and North Carolina State University. The problem was that 'find ZINC15 (Pharmaceutical Bio-Sector Compound DB)' to determine what is most effective when combined with certain drugs in thyroid cancer. In the case of drugs with different structures and similar mechanisms, Prof. Kang's group trained machine learning models to recognize as similar drugs. As a result, It was successful to find 10 substances. Seven of these substances were also confirmed to have related papers. AI could also help with clinical trials, Pro. Kang predicted. "We can predict which patients will be particularly effective for which patients or for which biomarkers," he said. In 2016, AstraZeneca held a contest with Sanger. After revealing the patient's genetic information and the effects of the drug, the problem was predicting which cancer would be most effective. Prof. Kang said that more data is required than the previous stage of finding and verifying candidates. Even though it was the latest professional computer at that time, it took over 20 hours to solve a problem on its own. Eventually, 20 more computers were purchased and the processing speed was increased by 20 times and then reduced to 1 hour. Prof. Kang's group, who first entered the competition, placed second . The following year, he was ranked No. 1 in a competition hosted by the National Cancer Institute (NCI) in 2017. "In 2016 and 2017, we were able to succeed because we used the good quality of patient information that was organized in advance by the organizer." "It is very important to reine data for AI and Even in the field, quality & quantity of information is very important.“ "AI also learns from data… the more the better" In the subsequent presentation, the importance of the data was emphasized. Ph.D Shin, Hyun-jin, who is in charge of AI drug development at Takeda Pharmaceuticals, said, "I feel like I'm floating in the ocean. It's water everywhere but there's no water to drink." There is a lot of data, but no useful data available. "In order for machine learning to evolve, standardized data must be available. However, different data formats are difficult to use these days.“ “Dissemination is the most important to win the war in the long run”he said. "It is same as AI drug development. Both the quantity and quality of the data is important. lower quality may result in lower accuracy, while lower quantities may result in biased results“ He emphasized.
- Policy
- VMS treating fezolinetant Phase 3 approved in Korea
- by Lee, Tak-Sun Nov 18, 2019 06:23am
- An investigational medicine treating vasomotor symptoms (VMS) associated with menopause is to conduct a Phase 3 clinical trial in Korea. On Nov. 15, Ministry of Food and Drug Safe approved of Investigational New Drug (IND) application of fezolinetant for transnational Phase 3 clinical trial taking place in Korea. Acquired by a Japanese pharmaceutical company Astellas in 2017, a Belgium-based pharmaceutical company Ogeda SA has been developing the fezolinetant pipeline. The approved trial is to investigate efficacy and safety of fezolinetant on Asian women struggling with moderate-to-severe menopause-related VMS like hot flashes. Fezolinetant, an oral selective neurokinin-3 (NK3) receptor antagonist, is an emerging non-hormonal option for managing VMS. Reportedly, more than a half of women around the world in menopause experience VMS. The most prevalent symptoms are hot flush, heart palpitation, night sweating, anxiety and depression. To this day, estrogen-like hormone therapy was recommended the most. But hormone therapy should be taken with a caution as it could cause risk of breast cancer and other adverse reaction. The Phase 2 trial of fezolinetant reported significant reduction of the VMS frequency, specifically for hot flush, compared to a placebo group. The trial did not have any apparent adverse reaction reported. Having a high expectation on the innovativeness of fezolinetant, Astellas acquired Ogeda SA with a paycheck of EUR 800 million (about 1.29 trillion won). As soon as the non-hormonal VMS compound completes its late stage clinical trial in Korea successfully, it would initiate regulator’s approval procedure.
- Company
- Pfizer’s Upjohn changed in business name to Viatris
- by Eo, Yun-Ho Nov 18, 2019 06:23am
- Pfizer's Upjohn is expected to be reborn as a complete independent corporation, or one pharmaceutical company, next year. According to the relevant industry, Pfizer and Mylan decided to change the name of the company to Viatris in 2020 after the merger of the patent expiry division. This means complete company separation. Currently, Pfizer’s Upjohn is still operating under Pfizer's name under Pfizer Pharmaceutical. In fact, Pfizer Korea general manager, Oh Dong-wook is also in charge of the two subsidiaries. As Mylan has not entered the Korean market yet, the Pfizer’s Upjohn’s business division will be operated under Pfizer's control for the time being, but in the end, independence will be achieved if all the matters are prepared with the name’s change in the next year. In particular, due to the nature of the domestic market, the sales volume of expired patented drugs is not small, and Pfizer's Upjone has big items such as Lipitor (Atorvastatin calcium), Norvasc (Amlodipine besylate), and Celebrex (Cerecoxib). So, Pharmaceutical company of a certain scale is expected to be established. Compared to global corporations, the number of employees in Korean subsidiaries is also overwhelming. CEO Dong-wook Oh reorganized the company's internal corporate structure into Pfizer Korea Pharmaceutical which specializes in innovative drugs based on the development of new drugs, and Pfizer Korea Upjohn with concentrating on off-patent brands and generic drugs. He said, "We look forward to growth potential to be better realized in each area“ He said, "We will focus on improving the quality of life by providing timely treatments to more patients based on the various drug pipelines and medicines in each business division. It is the stage to discuss which direction to take, and also, Employees' roles and responsibilities remain unchanged in this process. ”
- Company
- Combination therapy dominates in DPP-4 inhibitor market
- by Chon, Seung-Hyun Nov 17, 2019 05:35pm
- While dipeptidyl peptidase-4 (DPP-4) inhibitor products are currently leading the Korean oral diabetic treatment market, combination drugs reaffirmed its dominance over the DPP-4 market taking up two-thirds of the pie. Even compared with monotherapy prescription volume, MSD’s combination drug with DDP-4 inhibitor and metformin, Janumet outdid other products. On the other hand, Boehringer Ingelheim’s Trajenta topped the monotherapy market. According to the pharmaceutical research frim, UBIST on Nov. 13, outpatient prescription sales of DPP inhibitor class diabetes treatment grew by 7.2 percent than the same time year before, reaching the total of 398.6 billion won. The figure includes both monotherapy and combination therapy. DPP-4 inhibitor medicine outpatient prescription sales trend (unit: KRW 1 million) Source: UBISTSince the launch of MSD’s Januvia in 2008, total of nine DPP-4 inhibiting products have been released. The products aim to treat diabetes by blocking the action of DPP-4 enzyme breaking down secreted insulin. The type of medicine has the biggest pie in the oral diabetes treatment market in Korea. Apparently, the medicine adequately controls the blood glucose level, while it lowers the risk of adverse events like hypoglycemia and increased body weight than any other medicine. Also, there are other DDP-4 inhibitor-based combination therapies available with metformin and pioglitazone. The Korean market has been heated up as six out of nine DPP-4 inhibitor products launched in the market are co-promoted by two companies. ◆Januvia and Janumet top market share, Tenelia and Suganon leap forward Individual sales-wise, Januvia and Janumet kept their top prescription sales in the third quarter with accumulated sales of 117.4 billion won. The figure was increased by 3.0 percent than the previous year. MSD and Chong Kun Dang are co-promoting Januvia products in the Korean market. Trajenta and Trajenta Duo, co-promoted by Boehringer Ingelheim and Yuhan Corporation, had a 5.1 percent growth than the previous year reaching accumulated prescription sales of 87.4 billion won in the third quarter. The total sales figure may be lower than Januvia, but it had a greater growth. LG Chem’s Zemiglo and Zemimet accumulated prescription sales of 71.3 billion won until the third quarter, soaring 13.0 percent than last year. After launching Zemiglo in 2012, LG Chem partnered with Sanofi to co-promote the product but it resigned the partnership deal with Daewoon Pharmaceutical instead in 2016. Daewoong Pharmaceutical has been cumulating expertise in diabetes treatment sales for eight years since 2008 with the first DPP-4 inhibitor drug, Januvia. Combined sales experience and knowledge, Daewoong Pharmaceutical has been evaluated to have led the prominent sales power of Zemiglo in recent days. Tenelia and Suganon jumped into the game late but their performances so far have been notable. Along with Tenelia M, Handok’s Tenelia generated accumulated outpatient prescription sales of 25.9 billion won by the end of September. The figure has surged by 18.9 percent than the same time last year. Dong-A ST’s Suganon and Sugamet generated 62.0 percent growth from the year before, recording 10.9 billion won this September. However, Galvus and Galvus Met were a few that showed a decrease in prescription than last year among DPP-4 inhibitor medicines. ◆Janumet undoubtedly tops combination therapy market, Trajenta leads monotherapy Comparing DPP-4 inhibitor monotherapy and combination therapy, the combination therapy products had a steeper growth. Accumulated prescription sales of DPP-4 inhibitor monotherapy were 144 billion won in the third quarter, recording 5.1 percent growth from the year before. But, DPP-4 inhibitor in combination with metformin and pioglitazone generated prescription sales of 254.6 billion won, surging about 8.4 percent from last year. Making a steeper growth than monotherapy, combination therapy took over 63.9 percent of the whole market share. Within the DPP-4 inhibitor combination therapy market, Janumet, a combination of sitagliptin (Januvia) and metformin, dominated the market share. Janumet and Janumet XR swallowed up 33.0 percent of the whole combination therapy market with accumulated prescription sales of 84.9 billion won in the third quarter. Another combination therapy, Zemimet followed right behind with 46.4 billion won prescription sales, beating Trajenta Duo. Meanwhile, monotherapy market showed a contrasting trend. Accumulated prescription sales of Trajenta reached 43.9 billion won and topped the market share, when Januvia’s figure only reached 32.6 billion won. Trajenta was ranked on the third place in the combination therapy market, but the medicine still remains strong in the monotherapy market. Galvus was the fourth most selling medicine in the combination therapy market, but its rank in monotherapy market dropped to sixth after Tenelia and Nesina.
