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- PPC signs co-marketing partnership with Biosuntek
- by Eo, Yun-Ho Jan 10, 2020 06:23am
- From left; CEO Kim Sanghee, CEO Michael Stibilj, President Cho Joon-sang and Senior Director Suh Young-hwan PPC Korea and Biosuntek Laboratory (“Biosuntek”) have agreed to co-market pharmaceutical clinical development. PPC Korea, a contract research organization (CRO) providing service in Asian region, has invested in a bioequivalence test analyst institute, Biosuntek Laboratory and signed a strategic partnership agreement on Jan. 8. The signing event had PPC Group CEO Michael Stibilj, PPC Korea CEO Kim Sanghee, President of Biosuntek Cho Joon-sang and many other related company personnel. With the partnership agreement, Biosuntek and PPC Korea would offer one-stop service covering early clinical development to last phase clinical trial by respectively providing bioequivalence test analysis and early clinical trial services and post-clinical trial service. Together, two companies are now able to provide services ranging from project management, regulatory affairs, clinical monitoring, data management, biostatistics, medical writing, pharmacovigilance, and also bioequivalence study based on pharmacokinetic analysis and protein analysis. Established in 2010, PPC Korea is PPC Group’s offshoot in Korea and it has been a leading CRO conducting clinical trials not only for synthetic drug, but also for innovative investigation medicine like cell therapy, biosimilars and anticancer treatments for global and Korean companies. The parent company, PPC Group has conducted over 600 clinical trials for investigation drugs and over 2,000 bioequivalence studies in Korea, China and Taiwan since 1997. In China and Taiwan, the company owns four clinical pharmacology units to conduct Phase I study, three bioanalytical labs and a central lab. In 2019, the company was listed as APAC Top 10 CROs by Pharma Tech Outlook with its leading position in Asian CRO market. Founded in 2008, Biosuntek has been offering services, such as analytic methodology development, analytic validation and sample analysis, biosimilars and proteins including antibody protein analysis, bioequivalence test, PK, DDI and related clinical trial. And as of 2019, the laboratory has been an industry leader with over 200 ingredient analytic methodologies. PPC Korea CEO Kim Sanghee stated, “We are very pleased to now provide more valuable service to clients by investing on an outstanding analytic laboratory, Biosuntek, and agreeing on strategic partnership and co-marketed clinical study.” President of Biosuntek Cho Joon-sang commented, “As PPC Korea became a shareholder of Biosuntek, we have constructed a strong foundation to offer global-level one-stop new drug development solution based on the optimal synergy created from two companies’ technology and capacity.”
- Company
- Big Pharmas butting heads over Faslodex combination
- by Eo, Yun-Ho Jan 09, 2020 09:06am
- Three investigational drugs are busy preparing for applying reimbursement on a combination therapy with Faslodex. The competing three investigational drugs are cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor treatment—Pfzier’s Ibrance (palbociclib), Lilly’s Verzenio (abemaciclib), and Novartis’ Kisqali (ribociclib). The three global pharmaceutical companies are expected to intensely compete against each other over reimbursement on an indication of second-line combination therapy with AstraZeneca’s Faslodex (fulvestrant) to treat patients with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2) breast cancers. According to industry sources, Ibrance and Verzenio have simultaneously entered a negotiation with Risk Sharing Agreement Subcommittee in the end of last year, and Kisqali, approved for marketing in Korea the last in November, would be deliberated by Cancer Disease Deliberation Committee soon. The close race may continue with only Ibrance and Verzenio starting a Drug Reimbursement Evaluation Committee (DREC) deliberation first, or all three of them undergoing reimbursement feasibility review at the same time. Nevertheless, the three drugs have different circumstances. Ibrance, as first-line therapy (combination with letrozole), has already been listed for reimbursement through refund type risk sharing agreement, but it is now applying for reimbursement on the additional indication. Ibrance had applied for reimbursement on the expanded indication several times before, but the talks fell through as Faslodex as a monotherapy was not listed for reimbursement at the time. Meanwhile, Verzenio was approved for the Korean market in May, when monotherapy Faslodex was listed for reimbursement, and applied for reimbursement immediately. So far, the drug could take the RSA procedure as no other drug has received reimbursement for a combination therapy with Faslodex, yet. As for Kisqali, speed would unlock the door to the final race. Regardless of the Cancer Disease Deliberation Committee passing the drug in January, Kisqali can be deliberated by DREC only after getting passed by Pharmacoeconomic Evaluation Subcommittee and RSA Subcommittee.
- Company
- Near miss, tension in the Middle East
- by Kim, Jin-Gu Jan 08, 2020 06:18am
- Amid rising military tensions between the United States and Iran, there is also concern about bad influence on trade between Korea and Iran. In the case of drugs, exports have already been blocked since last year. There is also concern that the resumption of exports will be postponed indefinitely. According to the Korea Customs Service's import and export statistics on the 7th, pharmaceutical products exported from Korea to Iran for the past five years (January 2015-November 2019) totaled $90 million. The annual average is $18 million. Earnings are $20,000 over five years, virtually zero. Compared to Korea's total exports of pharmaceuticals ($ 36.24 million, provisional in 2019), the proportion is small at 0.5%. Imports and Exports of Pharmaceuticals to Iran by Year, Data: Korea Customs Service Exports to Iran steadily increased to $ 13.78 million in 2015, $ 17.9 million in 2016, $ 22.89 million in 2017, and $ 24.5 million in 2018, but dropped sharply to $ 10.95 million last year. Considering that last year's statistics are up to November, a significant decrease is observed. The sharp drop in exports last year was due to US sanctions against Iran. The United States has sanctioned trade with Iran since 2010. However, medicines were classified as 'humanitarian trade items' and recognized as an exception. In 2018, pharmaceutical exports were at an all-time high as sanctions eased. But in last May, the United States raised sanctions. At the same time, it refused to recognize even humanitarian trade items. In fact, the export of medicines to Iran has been blocked. Last October, the International Court of Justice decided that "sanctions could not be imposed on humanitarian trade," but the US still does not follow. Korea is in the same situation. In this situation, the military tension between the United States and Iran is at its peak, and the resumption of humanitarian trade is indefinitely postponed. If the situation prolongs, the pharmaceutical industry will inevitably lose ₩21 billion annually. .A pharmaceutical industry official said, “In recent years, more and more pharmaceutical companies have entered or are advancing into the Middle East .However, the situation has raised concerns not only in Iran but also in the Middle East”.
- Company
- Tension on impurity diabetic drugs is for a month
- by Chon, Seung-Hyun Jan 08, 2020 06:17am
- The whole view of the MFDS It's been a month since concerns of impurity Metformin were triggered overseas, but there are still no clear conclusions. Expectations are raised in the pharmaceutical industry that there is no recovery country other than Singapore and that it can only be a surprise. However, there is still a lot of tension that if there is a recovery from the excess of impurities from overseas, there will be an instant spark in Korea. According to the industry on the 5th, no further follow-up measures have been taken at home and abroad for a month after some Metformin recovery measures have been taken in Singapore. Molecular structure of MetforminOn December 4, last year, the Singapore Health Sciences (HSA) surveyed 46 Metformin products sold locally and recovered three products. This is because NDMA above the daily allowance was detected. Shortly after Singapore's recovery, Metformin impurities were investigated in the US and Europe. The US Food and Drug Administration (FDA) has begun investigating the detection of NDMA in Metformin products in the United States. The European Medicines Agency (EMA) has also ordered companies to investigate Metformin's NDMA detection. Japan's Ministry of Health, Labor and Welfare also instructed manufacturers and distributors of Metformin-containing preparations to conduct risk analysis on NDMA incorporation of ingredients and drug products and report the results. A month has passed since then, but no conclusions have been made regarding the recovery of Metformin in countries other than Singapore. No follow-up has been made in Korea yet. This is not the same as the case of Valsartan and Ranitidine. The biggest difference is that both Valsartan and Ranitidine have been preempted in Europe and the United States. Valsartan immediately suspended the sale of products using the drug substance when recovery news came from Europe. Ranitidine began collecting inspections in the country after cases of discontinuation in the United States, and secondly suspended all products after announcing "no problem." In Korea, the MFDS has already submitted the usage data of Metformin preparations from pharmaceutical companies. Last month, the MFDS instructed pharmaceutical companies to submit the production history of the drug containing 'Methformin HCl' and the system for investigation of the active drug substance by the 17th. Pharmaceutical companies submitted the total number of drugs containing Metformin-containing products, items and number of production records, and items and number without production record to the MFDS. The Metformin lineage survey at the MFDS is a preliminary motion in preparation for the detection of impurities. If a problem occurs in a particular drug substance or drug product, the intention is to follow up quickly and accurately based on the results of the systematic investigation submitted by the pharmaceutical company. In the pharmaceutical industry, anxiety continues: "Is there a problem with the drug substance used in products recovered from Singapore?" The MFDS formalized its stance on the 16th to conduct an investigation into Metformin impurities. It is known to look into the NDMA detection potential in the Metformin’s chemical structure and manufacturing environment. The industry points out that there is no standardized Metformin NDMA test, which limits the self-inspection. As soon as possible this week, the MFDS will draw up a test method for detecting N-nitrosodimethylamine (NDMA) in Metformin and present it to pharmaceutical companies. Initially, the plan was planned to be completed by the end of last year, but the schedule was delayed. Given the NDMA test method of Metformin preparation, it is expected to be actively checked in Korea. The pharmaceutical industry is expecting a final conclusion on whether or not to detect NDMA after the preparation of the test method. The possibility of preferentially conducting a collection inspection on the drug substance used in products recovered in Singapore is raised. Metformin's drug product recovered from Singapore has never been imported into Korea. In Singapore, however, it was determined that the recovery of the test results for the drug product, not the drug substance. If Metformin preparations are collected in the US or Europe, the same raw materials or finished drugs can be promptly inspected in Korea. In reality, it is impossible to conduct a full survey on Metformin preparations in Korea. Metformin is the most widely prescribed diabetic drug used as a primary treatment for glycemic control in patients with type II diabetes. There are 642 Metformin-containing products in Korea. Virtually all pharmaceutical companies have Metformin. Metformin is overwhelmingly larger than Valsartan and Ranitidine. According to UBIST data of drug research institutes, the outpatient prescription market of Metformin-containing drugs in 2018 was estimated at ₩420 billion. Ranitidine, which had been suspended from selling all its products, formed a prescription scale of about ₩200 billion, which is more than double the market. The unit price of Metformin is less than ₩100. In terms of usage, it is overwhelmingly higher than Ranitidine. Pharmaceutical companies are already paying attention to domestic and international measures. In the face of massive losses in Valsartan and Ranitidine, there is a strong concern that Metformin can cause irreversible loss if fire breaks out. Some pharmaceuticals are struggling to minimize the damage, saying “NDMA has not been detected by our own tests,” even though the FDA's test method was not proposed. An official of the pharmaceutical company said, “There are no test methods yet, and there are not enough organizations to check, so we did not proceed with NDMA inspection of metformin, and plan to check quickly after the preparation of test method”.
- Company
- Pfizer Korea is looking for a new office
- by Kim, Jin-Gu Jan 07, 2020 06:29am
- Pfizer Korea Myeongdong Office Pfizer Korea is pursuing the sale of its Myeong-dong office, which has stayed for the past 13 years. Location of new office is planning Yeouido, Jamsil or Pangyo. According to the pharmaceutical industry on the 6th, Pfizer Korea is considering the sale of its office and relocation of its office. Currently, Pfizer Korea is located at 110 Toegye-ro, Jung-gu, Seoul (1-11 Hoehyeon-dong 3-ga). An industry official said, “We believe that Pfizer has pursued the sale of the Myeong-dong headquarters since last year, and we have selected a real estate asset manager to manage the sale at the end of last year”. Another official said, "We were thinking about the most suitable place such as Jamsil, Pangyo, or Yeouido, and the company made an internal decision to one of the three recently considering the accessibility and the rental price." The specific sale and transfer dates are not confirmed. However, Pfizer Upjohn is expected to coincide with the launch of a joint venture with Mylan, according to the US Pfizer headquarters plan. Earlier, Pfizer signed a merger and acquisition agreement with Mylan, a generic pharmaceutical company in last July. It is the launch of a joint venture between Pfizer's business division in charge of patent expiry medicine and Mylan. The merger will be finalized this year. The new corporation was named Viatris. As it is a separate corporation, Pfizer Upjohn's Korea subsidiary is reportedly seeking a third place separately from Pfizer. Pfizer Pharmaceuticals moved to the current Myeong-dong office from Gwangjang dong, Gwangjin-gu, Seoul in June 2007. Prior to this, Myeong-dong office was purchased in June 2006. At the time, the purchase price was reported to be ₩58 billion. According to officials from the real estate industry, the price of Pfizer Korea’s Myeongdong offices is currently set at around ₩100 billion to ₩120 billion. Profits of more than ₩60 billion were generated In 13 years.
- Company
- SNU professor investigates new anti-cholesterol medicine
- by Eo, Yun-Ho Jan 07, 2020 06:29am
- 김효수 교수 Researchers in Korea are onto developing a next generation anti-cholesterol medicine. Pharmaceutical industry reported on Jan. 7, a team of Seoul National University researchers led by Professor Kim Hyo-soo is preparing a Phase 1 clinical study on candidate medicine inhibiting cyclase-associated protein 1 (CAP1). Previously, Seoul National University Hospital’s Research-driven Hospital Project—Inflammation/ Metabolism Unit Program led by Professor Kim Hyo-soo and Professor Jang Hyun-duk discovered CAP1 protein essential for protein convertase subtilisin/kexin type-9 (PCSK9) to destroy low-density lipoprotein (LDL)-receptor and identified the mechanism. LDL-cholesterol, when combined with LDL-receptor on the surface of hepatocytes, enters into the hepatocyte through a pathway called clathrin. Then the LDL-cholesterol is broken down, while LDL-receptor moves back to the cell surface and is reused. After then, CAP1 carries PCSK9 combined with LDL-receptor to an intracellular pathway, caveolin, where LDL-receptor is broken down by lysosome without getting reused. In short, PCSK9 is essential for CAP1 to break down LDL-receptor. Interestingly, CAP can be found in every organ of a human body, which means CAP1-inhibiting mechanism could be effective not only for lowering cholesterol level but also for other disease. In fact, the CAP1-inhibitor, currently under investigation by Professor Kim’s team, is targeting for indication on treating fatty liver and cancer. Professor Kim Hyo-soo stated, “With the six-year-long research, we have confirmed possibility of the investigational medicine, and we are planning for a Phase 1 trial on the medicine. Although PCKS9-inhibitor has been commercialized and demonstrated effectiveness, CAP-inhibitor could be another treatment option.” The team has already conducted a study with CAP1-inactivated mice. The outcome found the mice lacking CAP1 had hepatocyte surface with increased LDL-receptor and had significantly lower the level of LDL-cholesterol level in its blood. Also when intentionally breaking down LDL-receptor in liver of mice injected with PCSK9 antibody, the symptom of degraded LDL-receptor has been improved noticeably in mice without CAP1. Moreover, the research team analyzed PCSK9 gene mutation in people with considerably low LDL-cholesterol and found mutated PCSK9 could not properly bind with CAP1 to be functional.
- Company
- Ildong starts distribution of GSK generic drugs
- by Jung, Hye-Jin Jan 07, 2020 06:28am
- From the 6th, Ildong will begin supplying nine OTC drugs from GlaxoSmithKline. Orders from wholesalers and direct-selling pharmacies began on the 3rd, and the products are shipped from the 6th, depending on the order amount Under the co-promotion agreement with GSK, Ildong has sold a comprehensive cold medicine 'Theraflu', an ophthalmic drug 'Otrivin', a smoking cessation drug 'Nicotinell', a hyperhidrosis drug 'Driclor', and an external anti-inflammatory drug 'Voltaren', denture attachments 'Polident', toothpaste 'Sensodyne' and 'Parodontax', and co-band medical expander 'BreatheRight'. Last year, domestic sales of nine products stood at about ₩46 billion. These products have been sold by Dong-wha until last year. Traders are interested in supply prices. In particular, it is common practice for OTC drugs to raise their supply prices when their sales corporation changes. First, pharmacies that deal directly with Ildong will receive their products at prices similar to those offered by Dong-wha. An official at Ildong said, “It is an internal decision that there is no price increase on a direct pharmacy basis. OTC drugs are particularly easy to raise when prices change due to higher drugstore and consumer resistance, but considered pharmacy convenience as much as possible”. On the other hand, the purchase price of wholesalers is likely to be slightly adjusted. Some wholesalers are adjusting their orders because nine items will see a 3% price increase overall. A wholesaler said, “It is reported that the price will increase by 3-4%. The exact price will be known next week.” Unlike reimbursed drugs with a fixed insurance premium, non-paid drugs, over-the-counter drugs, are sold by margins by wholesalers at supply prices set by pharmaceutical companies. In general, wholesalers spend about 8% of their supply on distribution, so over-the-counter drug margins are determined within 8-10%. When wholesaler prices rise, pharmacy sales and consumer prices go up. However, Ildong responded that there will be little price increase due to the high proportion of direct pharmacies. It is because Ildong operates Ildong Shop, a pharmaceutical online mall, and since Ildong is a pharmaceutical company with a high proportion of OTC sales among domestic pharmaceutical companies, most of them are directly dealing with pharmacies. An official of Ildong said, “The high proportion of direct pharmacies is also beneficial to correct the distribution order, in the case of GSK products, we would like to maintain stable sales by increasing the proportion of direct drug sales rather than wholesale supply”.
- Company
- 5-year ‘Botox War’ to end this year
- by Kim, Jin-Gu Jan 06, 2020 11:00pm
- The legal dispute between Daewoong Pharmaceutical and Medytox over botulinum toxin strain would come to an end this year. While the industry predicts the final decision would be made in coming June, legal experts see either one of them losing the case would take a heavy blow. According to industry sources on Jan. 3, the U.S. International Trade Commission (ITC) has scheduled to have Daewong Pharmaceutical-Medytox strain trial in February, preliminary decision in June and final decision in October. ITC has announced a specific schedule of the trial on June 5 EST. The question of has Daewoong Pharmaceutical stolen Nabota’s botulinum toxin strain as accused by Medytox or it was discovered by Daewoong Pharmaceutical as it claims would be answered on June 6 in Korea. Unlike other general court litigation, the U.S. ITC patent investigation is dealt in a unique style. What differs the most is the role of Staff Attorney. The staff attorney is a third party, apart from either the complainant or defendant, appointed by the judge. The assigned staff attorney takes a role of investigating honest and fair proceedings of the two disputed parties during “discovery” and representing “public interest” during trials as an independent party. Specifically, the staff attorney conveys their position on the patent infringement accusation to the judge. The judge, on the other hand, is not mandated to accept the staff attorney’s position, but it is perceived as significant influence on the outcome, according to patent dispute experts. It has been reported Korean-American attorney Brian Koo has been appointed as a staff attorney for the case. Basically, other than the judge, the attorney is holding the key to the litigation result. After the preliminary decision has been forwarded to the two parties in June, the proceeding would end with the final decision in October. Generally, the preliminary decision goes unchanged for the final result, but it could be flipped. The judge rules the preliminary decision, while the Commission makes the final decision. After the final decision has been forwarded, each company can file an appeal to the U.S. Court of Appeals for the Federal Circuit (CAFC) within 60 days. However, CAFC would decide whether or not to accept the appeal. Regardless of the result, industry and legal experts say either one of the parties would take a significant impact. Several tens of billions have been spent on the litigation already. The two companies’ financial statement from the third quarter last year found that Medytox and Daewoong Pharmaceutical have spent 7.8 billion won and 10.4 billion won, respectively. Meanwhile, their financial burden would snowball after they initiate civil suit proceedings after the final ITC decision.
- Company
- BMS re-applied for suspension about Eliquis
- by Kim, Jin-Gu Jan 06, 2020 06:21am
- Eliquis' price has dropped by 30% since last 1st. This is in accordance with the Seoul Administrative Court's decision at the end of last year. However, It is also likely that drug prices will rise again in the 2nd course of legal disputes. The Ministry of Health and Welfare recently announced that Eliquis' suspension of price cuts has been lifted as of January 1 through a notice of the ‘Pharmaceutical Benefit List and Reimbursement Limit Table’. Eliquis’ price has been reduced from ₩1,185 to ₩830. The action is in response to a decision made by the Seoul Administrative Court on December 19 last year. The administrative court went for the defendant, welfare department in a minimum lawsuit for the adjustment of the upper limit on the amount of drug adjustments filed by BMS against the minister. It was ruling that Eliquis' disposal of the drug price was justified following the launch of the generic.. Eliquis' price was initially to be reduced to July 1. However, BMS has filed a series of petitions for suspension of drug price reduction and a minimum lawsuit. The court accepted the BMS' claim. The decision was made to suspend the price cut. The Ministry of Health and Welfare delayed the Eliquis’ price cut twice. The suspension lasted until December 31 of last year. The court ruled in favor of the Ministry of Welfare, leaving approximately two weeks before the suspension of the Ministry of Welfare. The suspension was lifted. The price was automatically lowered from January 1 Eliquis' price may rise again. This is because BMS who lost the first trial appealed to the Seoul High Court. Indeed, BMS, the legal representative of BMS, was confirmed that the Ministry of Health and Welfare applied for suspension from the Seoul High Law immediately the day after the Ministry of Health and Welfare announced the suspension of drug price reduction. The application for suspension shall be decided by the court, independent of a trial on an appeal case(Original suit). The decision of the original case and the decision to suspend execution were allotted to the ninth administration of the Seoul High Court. It is unknown whether the court will accept the BMS’ application. The relevant trial date has not been set yet. In general, most courts cite the application for suspension of drug price reduction, but it is difficult to predict easily that there is also the opposite case. In the first trial, part 14 of the Seoul Administrative Court accepted the application for suspension of BMS. On the contrary, in last September, part 6 of Seoul Administrative Court rejected the application for price reduction’s suspension of the disposable eye drops from 21 domestic pharmaceutical companies.
- Company
- SK gets world’s first quadrivalent flu vaccine PQ by WHO
- by Lee, Seok-Jun Jan 06, 2020 06:20am
- For the first time in the world, a quadrivalent influenza vaccine passed prequalification (PQ) by the World Health Organization (WHO). SK Bioscience announced on Jan. 2 WHO has completed the seven-month long PQ evaluation and granted a certification of PQ on its Sky Cellflu Quadrivalent. This marks the first time in the world history for a cell-cultured quadrivalent influenza vaccine to pass WHO’s PQ evaluation procedure. Even including egg-based vaccines, only three quadrivalent influenza vaccines, except Sky Cellflu Quadrivalent, have passed the PQ. WHO’s PQ evaluation follows strict set of criteria to verify safety and efficacy of vaccine by assessing the finished pharmaceutical product’s manufacturing procedure, quality and clinical trial outcomes. The evaluation procedure includes technical document review of clinical trial and quality test data, sample quality test, and due diligence on GMP and quality control system. A company with PQ certification is eligible for international bidding for vaccine procurement called by UN-affiliated UNICEF and Pan American Health Organization (PAHO). As of last year, the PAHO’s market volume for influenza vaccine has reached about USD 700 billion (about 81.4 billion won). Sky Flucell Quadrivalent is a vaccine preventing four types of influenza viruses. Unlike typical egg-based vaccinea, the Korean-made quadrivalent vaccine is produced with top-of-the-line aseptic culture system, which does not require preservative. With the unique qualities, the vaccine has less risk of allergic reaction or adverse reaction from egg or antibiotics when administered. Besides, the vaccine can be manufactured quickly as its production time is close to a half of other vaccine’s. Since its split from SK Chemical in July 2018, SK Bioscience has been specializing in vaccine production. The company’s vaccine portfolio includes Korea’s first trivalent cell-cultured influenza vaccine ‘Sky Cellflu,’ the world’s first quadrivalent cell-cultured influenza vaccine ‘Sky Cellflu Quadrivalent,’ the world’s second shingles vaccine ‘Sky Zoster’ and the second Korean-made varicella vaccine, ‘Sky Varicella.’
