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- 2026-04-16 08:12:13
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- Korean drug industry prepares for Peramiflu generic
- by Kim, Jin-Gu Sep 11, 2020 06:29am
- Peramiflu supplied by GC Pharma South Korean pharmaceutical companies are speeding up the launch preparation for a flu drug Peramiflu (peramivir) generic. After filing trials for invalidation of original patent late last year, ten pharmaceutical companies recently applied for the generic approval. If Ministry of Food and Drug Safety (MFDS) approves the generic and the companies win the ongoing patent dispute, the Peramiflu generics would be accessible in the market from coming winter at earliest. The pharmaceutical industry sources reported on Sept. 11 that three Korean pharmaceutical companies have applied for approval on their Peramiflu generics in the last two months. Peramiflu is an influenza drug sold by GC Pharma in South Korea. GC Pharma licensed the drug from the U.S.-based BioCryst and received the Korean health authority approval in 2010. The drug has a valid substance patent that expires on Feb. 12, 2027. Apparently, 10 Korean companies have challenged Peramiflu’s patent by filing a patent nullification case in December last year. Ilyang Pharmaceutical, Penmix, JW Pharmaceutical, Kolon Pharma, Kolmar Korea, Kolmar Pharma, HK Inno N, Chong Kun Dang, and Hanmi Pharmaceutical are part of the case. Sources confirm three companies among the patent challengers have applied for the item approval so far. Apparently, all three companies have their own manufacturing facilities. The applications were submitted to MFDS on July 22, 30, and Aug. 14, respectively. As a result, the three companies have met two out of three prerequisite conditions (first to file patent trial and first to apply for approval) to win the preferential sales rights. Only one condition is left for them to achieve—they would need to win the patent trial. The patent trial proceeding has reportedly picked up its speed again after being delayed by COVID-19 for a while in the first half of the year. The industry expects the trial decision to be made by the end of the year at earliest. The industry insiders also predict the generic could be released in winter, if the companies win the patent trial. An official from a pharmaceutical company challenging the Peramiflu patent noted, "Currently, the patent dispute is actively progressing on paper. We are expecting the Intellectual Property Trial and Appeal Board to conclude the trial within this year," and “meanwhile, the company is proceeding with patent dispute and item approval to launch the generic in coming winter.” Peramiflu is an improved formulation of oseltamivir, a substance of the top selling influenza treatment Tamiflu. When Tamiflu has to be administered orally for five days, Peramiflu can be effective with only a single intravenous injection for 15 to 30 minutes. Boosted by its convenience, Peramiflu is rapidly growing in the flu treatment market. According to pharmaceutical market research firm IQVIA, Peramiflu has made 7.1 billion won last year. Compared to 2 billion won generated in 2017, the sales almost tripled in three years. In last two years, sometimes the supply was unable to keep up with demand and some regions experienced shortage.
- Company
- Qurient, expects a big deal for Q203, Q301, Q702, & Q901
- by An, Kyung-Jin Sep 11, 2020 06:28am
- There are high expectations for Qurient to sign a large technology transfer contract in the second half of the year. All four key tasks, including immune anticancer drugs, atopic dermatitis and multi-drug-resistant tuberculosis treatment, are all in the process of discussing technology export, and there is a possibility that at least one contract will be signed within this year. Qurient held IR(Investor Relations) on the 9th to 10th to introduce the status of the project. Qurient is a new drug development company established in July 2008. In February 2016, it was listed on the KOSDAQ market through a special listing of technology growth companies. Make full use of the project management-based network research and development (R&D) business model. It is a type of NRDO (No Research Development Only) that introduces promising initial tasks from outside and then entrusts them to external research institutes to conduct research and development. Qurient shared the development status of four key new drug tasks at IR on this day. ▲Immune anticancer drugs 'Q702' and 'Q901' ▲Multi-drug resistant tuberculosis treatment 'Q203' ▲Atopic dermatitis treatment 'Q301'. All four projects are in the process of negotiating technology exports with global pharmaceutical companies, and some have opened up the possibility of signing contracts within this year. Introduction of new drug projects held by Qurient (Source: Qurient IR) In terms of the speed of development, Qurient believes that two types of multi-drug-resistant tuberculosis treatment 'Q203' and atopic dermatitis treatment 'Q301' are the right time to transfer technology. Both types have secured successful initial clinical data. Multi-drug-resistant tuberculosis treatment 'Q203' (Telacebec) ended phase IIa clinical trial last December. As a result of drug treatment for 14 days, 'Q203' showed clear anti-tuberculosis efficacy compared to two commercially available resistant tuberculosis treatments. It is explained that the interest of Big Pharma increased as it was published in the New England Journal of Medicine, an internationally recognized academic journal earlier this year. Since it was previously designated as an orphan drug and a drug subject to rapid review, it predicted that it is possible to quickly enter the market through the conditional approval procedure after completing phase IIb clinical trial. Cream-typed atopic dermatitis treatment, 'Q301', also secured successful data in phase IIb, and ended last May. Although in the early stages, the immune anticancer drugs 'Q702' and 'Q901' are at the stage of successful technology export with a differentiated mechanism. Qurient said, "We are reviewing various business alliance plans such as technology export for all pipelines the company has. We can not comment on specific timing, but we expect rapid results." "In the long term, it was established in Dortmund, Germany earlier this year. "We plan to focus on the development of proteasome inhibitors through a joint venture, QLi5 Therapeutics."
- Policy
- GSK withdraws adult TD vaccine from Korea
- by Lee, Tak-Sun Sep 11, 2020 06:28am
- Green Cross TD vaccine successfully localized in 2016GSK will stop supplying the adult TD vaccine 'Td-pur', which was imported and sold in Korea. The company said there was no additional import after November 30. Until now, adult TD vaccines have been dependent on imports, but GC Pharma succeeded in localizing them in 2016. With GSK's supply discontinuation of Td-pur, the localization of GC Pharma is in the limelight. According to the MFDS, GSK announced the shutdown of the supply of TD-pur in July. TD-pur is an adult TD vaccine. It is a vaccine that prevents diphtheria and tetanus. Four adult TD vaccines are licensed in Korea. SK Td Vaccine Inj by SK Bioscience, Access Pharma's TD Booster SSI', 'Green Cross TD Vaccine PFS' by GC Pharma, and TD-pur by GSK have been competing. Among them, the only domestic product is Green Cross TD Vaccine PFS. It was approved for an adult TD vaccine made with its own technology in November 2016. This product is regarded as a case of successful localization by receiving consulting support from the MFDS since 2010. The MFDS at the time explained that the localization of the TD vaccine is expected to replace imports for 450,000 people every year. SK TD vaccine is a product that is imported from GSK Germany and sold as a finished product in Korea. In addition, DT Booster SSI is imported from Denmark SSI in finished form. With the withdrawal of GSK TD-Pur in Korea, the market will now compete for these three items. GSK said that it was unavoidable in the process of consolidating and overhauling the production line for business efficiency after the acquisition of Novartis Vaccine Division in 2015 due to the reason for the interruption of the supply of TD-Pur. In Korea, competitiveness has also been lost since the launch of Green Cross TDI vaccine. Last year, the sales of TD-Pur based on IQVIA amounted to about ￦300 million. On the other hand, SK TD vaccine and Green Cross TD vaccine ranked first and second with ￦1.9 billion and ￦1.3 billion. This year, the Green Cross TDI vaccine was ranked first for the first time. The cumulative sales in the first half of the year were ￦600 million for Green Cross TD vaccine and ￦460 million for SK TD vaccine. The domestic product has risen to the No. 1 market after 3 years of launch. The localization of Green Cross TD vaccine is shining even more with the withdrawal of TD-Pur from GSK. An industry insider said, "Since we can not guarantee a stable supply of imported vaccines as in this case of TD-Pur, there is no need to say the need for a domestic vaccine for the management of infectious diseases."
- Policy
- First drug for ultra rare Batten disease Brineura approved
- by Lee, Tak-Sun Sep 11, 2020 06:28am
- The first treatment for a pediatric rare disease, Batten disease, has received the South Korean health authority’s approval. As Batten disease is an inherited metabolic disorder that can cause loss of sight, the new treatment could give hopes to the patients and their families. Ministry of Food and Drug Safety (MFDS) has approved Brineura 150 mg injection, supplied by MediTip, on Sept. 8. The product is indicated to treat ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency. Recently, TPP1 or CLN2 is widely known as Batten disease. The disease is an inherited metabolic disorder, discovered by a Pediatric Doctor Batten in 1903. It is considered as an ultra rare disease with prevalence rate of one out of 100,000 in the U.S. Symptoms of Batten disease Symptoms, such as slow deterioration of eyesight, cognitive decline and behavioral change, would be expressed from age of four to 10. When the symptoms worsen, the patient could lose vision. The medication is injected with a catheter to cerebrospinal fluid once in two week. Developed by the U.S.-based BioMarin Pharmaceutical, Brineura won the U.S. Food and Drug Administration’s (FDA) approval as a first Batten disease treatment in April 2017. BioMarin Pharmaceutical is an emerging global pharmaceutical company specializing in rare disease treatment. For the Korean market, a healthcare consulting company MediTip applied and received the marketing approval on Brineura.
- Company
- Hunterase by GC Pharma is entering the Chinese market
- by Chon, Seung-Hyun Sep 11, 2020 06:28am
- Hunterase by Green Cross is entering the Chinese market GC Pharma announced on the 9th that Hunterase, a treatment for Hunter syndrome, has obtained a license from the NMPA of China. This is the first time that a drug for Hunter syndrome has been approved in China. Hunterase by Green Cross GC Pharma applied for Hunterase's item license, July of last year in China, and was designated as a priority subject of review by the NMPA in September. The commercialization of Hunterase in China and other China region is undertaken by “CANBridge Pharmaceuticals,” which has signed an export contract. Hunter syndrome, referred to as 'type II mucopolysaccharide', is a rare congenital disease that shows various unpredictable symptoms such as skeletal abnormalities and decreased intelligence, and dies early around 15 years of age. In general, it occurs at the rate of 1 in 150,000 males, and one of the Greater China countries, about 1 in 50,000 to 90,000 cases occurs in Taiwan, and it is known that the incidence rate in East Asian countries is higher. Currently, more than 3,000 patients with Hunter syndrome in China are estimated. GC Pharma developed Hunterase as the world's second hunter syndrome treatment in 2012 and is now supplying it to 11 countries around the world. It is also planning for Hunterase to enter Japanese market. GC Pharma' partner, Clinigen K.K., applied for an item license of 'Hunterase ICV (intracerebroventricular)', a ventricular administration method, to the Japan Pharmaceutical and Medical Device Administration (PMDA) in March. Hunterase ICV is a novel formulation in which drugs are administered directly to the ventricle by inserting a device into the head. ICV has the advantage of overcoming the limitations of existing intravenous formulations that do not improve the symptoms of decreased intelligence because drugs can not penetrate the blood brain barrier (BBB). Eun Chul Huh, President at GC Pharma said, “It is of great significance in that we are able to provide new treatment environments and opportunities for patients with Hunter syndrome in China. I will do my best.” James Xue, CEO of CANbridge, said, "The approval of this product will be an important step forward in our efforts to commercialize the desperately needed treatment for rare diseases in China and around the world."
- Company
- Hanmi to turn efpeglenatide crisis around with new partner
- by An, Kyung-Jin Sep 10, 2020 06:24am
- Hanmi Pharmaceutical’s glucagon-like peptide-1 (GLP-1) agonist ‘efpeglenatide,’ initially licensed out to a global pharmaceutical company Sanofi in 2015, was ultimately returned to the South Korean company. Four months after when the global company indicated its intention to return the rights on the drug May, Sanofi has decided to suspend clinical studies on the antidiabetic treatment and officially informed each clinical institutes. Hanmi Pharmaceutical plans to take over all five Phase III clinical trials Sanofi was conducting, and look for new opportunities to commercialize efpeglenatide. Over the past three years, three global Phase III clinical trials on efpeglenatide have recruited 5,391 participants, and collected a vast amount of data. Various options are in discussion, such as finding a new commercialization partner in the antidiabetic treatment field, exploring new indications treating other metabolic diseases, and developing a combination therapy with the Korean company’s new drug pipeline. ◆Sanofi says “R&D strategy has changed,” and returns the rights over efpeglenatide after five years Apparently, the sign of the contract termination was looming from last year. CEO Paul Hudson at Sanofi, held an investors event to talk about R&D strategies in late last year. He declared the company "would halt researches in the diabetes and cardiovascular programs." His plan is to focus R&D investment in four areas, including oncology, blood disorders, rare disease, and neurology diseases. Even at the time, Sanofi had unchanged commitment to continue developing the long-lasting GLP-1 agonist efpeglenatide. The company was determined to complete the five Phase III clinical trials on efpeglenatide, but wanted find another commercialization partner to take charge of global sales and marketing activities after receiving the approval. CEO Paul Hudson affirmed, “It was the best decision for the successfully launch of efpeglenatide while maximizing the productivity of our research engine. It was irrelevant to efficacy and safety of the substance, and it would make no changes on license-in agreement with Hanmi Pharmaceutical." However, Sanofi overturned its initial position in just five months, and informed Hanmi Pharmaceutical of its intention to return the rights over efpeglenatide. The two companies concluded the efpeglenatide returning procedure on Sept. 8 (local time) after a 120-day negotiation period as stated on the contract terms. Hanmi Pharmaceutical would not take any legal actions like litigation for damage compensation the company has previously claimed. Sanofi is expected to hand over all data collected from the on-going Phase III clinical trials to Hanmi Pharmaceutical, and step away from the entire development process. Hanmi Pharmaceutical has also agreed to take over the one Phase III clinical trial to be completed in October. Including the compensation and research cost coverage, the conditions for breaching the contract were undisclosed. ◆Market competition intensified with oral GLP-1 agonist Rybelsus The pharmaceutical industry pin points the cause of Sanofi giving up on developing efpeglenatide lies on the pipeline growing unattractive for the market. The global GLP-1 agonist market is expanding rapidly. Nevertheless, the industry sees that the latecomers would struggle to enter the market as multinational pharmaceutical companies like Novo Nordisk and Eli Lilly are firmly dominating the market. (From left) Product image of Victoza, Ozempic, Rybelsus and Trulicity Eli Lilly's once-weekly subcutaneous injection Trulicity (dulaglutide) owns majority of the share in the single therapy market. In addition, Novo Nordisk is expanding its market presence as it added newly launched the world's first oral GLP-1 agonist Rybelsus (semaglutide) to its existing line up of once-daily subcutaneous injection 'Victoza (liraglutide)' and once-weekly injection 'Ozempic (semaglutide).'. Lily's Trulicity generated global sales of USD 4.23 billion (approximately 4.91 trillion won), surging by 29 percent compared to the previous year. The drug is expected to reach its new record in yearly sales as it made 2.50 billion dollars in the first half of this year. Novo Nordisk's three GLP-1 agonists have earned overall DKK 33.22 billion (approximately 6.26 trillion won). The Danish company’s first GLP-1 Victoza had a sales dip of 21.93 billion kroner, but the company had even more significant growth with the recently launched Ozempic sales increasing up to 11.24 billion kroner, and newly released Rybelsus making 50 million kroner. In the first six months of the year, the Ozempic sales grew up to 9.60 billion kroner, and surpassed Victoza sales reaching 9.23 billion kroner. Rybelsus marked six-month sales of 584 million kroner immediately after its release. The three drugs’ sales in total reached 19.4 billion kroner (approximately 3.65 trillion won) in the first half of the year. A GLP-1 agonist efpeglenatide has extended the administration term to once-weekly by incorporating Hanmi Pharmaceutical’s key platform technology, ‘Lapscovery’. However, the industry experts analyze the investigational drug’s competitiveness as a follow-on drug is faltering when Trulicity and Ozempic dominate the once-weekly injection market and even an oral option Rybelsus emerges. ◆Hanmi with 6,000 participants’ data, committed to rekindle efpeglenatide’s potential The industry experts address Sanofi’s three-year worth of abundant clinical data as an engine to bring efpeglenatide back to life. Sanofi has been operating five Phase III clinical trials since it signed the deal over efpeglenatide from Hanmi Pharmaceutical in 2015. Two years into the deal, a Phase III AMPLITUDE-M study that compared efpeglenatide against placebo on the blood glucose level reduction effect was initiated from late 2017, and four Phase III clinical studies have started as of last year. Following are the four Phase III trials; AMPLITUDE-D study compares efpeglenatide against Trulicity plus metformin combination therapy; AMPLITUDE-O study evaluates efpeglenatide’s effects on the cardiovascular system in type 2 diabetes patients; AMPLITUDE-L study administers efpeglenatide and other existing insuling treatment to type 2 diabetes patients; and AMPLITUDE-S additionally administers efpeglenatide to type 2 diabetes patients, who cannot control blood sugar level even after using metformin alone or metformin and sulfonylurea combination. AMPLITUDE-M, AMPLITUDE-D and AMPLITUDE-O studies have completed subject registration. Total 5,391 participants registered for the three studies. Considering the number of participants registered for the remaining two studies, the number would sum up to around 6,000. Hanmi Pharmaceutical plans to conduct and complete the AMPLITUDE-M study scheduled to end in October. AMPLITUDE-M study is the first Phase III clinical study initiated by Sanofi after it licensed in efpeglenatide. Companied called for participants from 56 research institutes in four countries including the U.S., Germany, Poland, and the U.K. from December 2017, and compiled the roster with 406 participants by early September last year. The endpoint of the study is to evaluate the change of goal is to evaluate the rate of change in hemoglobin A1c at week 30 of the treatment. The entire study is scheduled to conclude by next month after the participants’ visits and data collection. Based on the efpeglenatide data collected so far, Hanmi Pharmaceutical is determined to turn the crisis around with a plan to seek a new commercialization partner and also by opening options to explore new indications and research about combined treatment effect with other Lapscovery-based pipelines.
- Product
- 10,000 pros & cons for generic substitution
- by Kim, Min-Gun Sep 10, 2020 06:23am
- There are a lot of unusual comments in the National Assembly legislation, where not even a single comment is usually posted. These are the 'Simplification Act for Generic Substitution Post Notification' and 'The Act on Restriction of 1+3 Joint Biological Equivalence'. All of them are laws related to the issue of generc prescription. Among the 304 bills posted on the National Assembly Legislative Advancement System on the 9th, a total of 13,000 comments were posted on two partial amendments to the Pharmaceutical Affairs Act, initiated by Seo Young-seok (Bucheon), Rep. of Democratic Party of Korea. List of legislative notices posted on the National Assembly Legislative Notice System on the 8th By around 11:30 a.m. on that day, 7681 comments were posted on the legislative notice of the Simplification Act for Generic Substitution Post Notification bill, and the number of views exceeded 69,934. Likewise, 5857 comments were posted on the legislative proposal for the The Act on Restriction of 1+3 Joint Biological Equivalence proposed by Seo, and the number of views was 48,395. This is three to four times more than the Wildlife Protection Act (2,454 comments) with the most opinions among the comments posted on 302 other legislative proposals. In particular, except for the top five legislative notices, most bills do not have less than 100 comments. There are only hundreds of views. As the two bills passing generic prescription spread to confrontation between doctors and pharmacists, it can be assumed that a systematic commenting campaign is underway. Lee * Eun, who appears to be a doctor, objected to the bill when he claimed that "even if the ingredient is the same and passed the bioequivalence test, the effects and side effects of the drug are not the same." Hwang * Deok also pointed out, "It is not the same drug because the ingredients are the same. The drugs used for each patient are different, which is contrary to the current trend of advocating precision medicine." However, Chansung, who appears to be a pharmacist, also confronted this. Kim *Ah argued, "We need to change the perception of the same ingredient preparation. Even now, it is awkward to say that doctors who prescribe the same drug to another drug company every few months to designate a company according to the patient." Mr. Kim *Han also said, "I agree with the legislation that changes the name of the generic substitution with the same ingredient name to reduce public confusion. It is very ridiculous for doctors to prescribe a company's medicine that is not clear to the manufacturer and rather changing it to an original. In many cases, not a single comment is posted on the legislative proposal of the National Assembly Legislative System The same comment was also occupied by the MFDS’ proposed The Act on Restriction of 1+3 Joint Biological Equivalence, which were unsuccessful contrary to the Regulatory Reform Committee. The main idea of this bill is to limit the number of generics per original drug to three. Rep. Seo cited the reason, "The outbreak of consignment generics due to unlimited sharing of biometric data weakens illegal distribution such as rebates and R&D of pharmaceutical companies." There is a reason for the pros and cons of the legislation to limit the number of generics produced by bioequivalence testing. This is because it also contains the content that 'because the type, content, and route of administration of the active ingredients are the same as for new drugs, bioequivalence test data must be submitted for drugs that are requested based on safety and efficacy data such as new drugs.' Oh *-hyun, who argued against this, commented, "It is said that it is the same, but if you take medicine, will you take the original, or will you take flour medicine from a third-rated pharmaceutical company that you have never heard of?" Regardless of the bill, Kim *young wrote, "If the pharmacy changes to a different drug with the same ingredient, patients can not take the medicine which doctor prescribe under specific manufacturer" He wrote a comment on a similar bill that would run on the bill. Mr. Kwon *-jin, who agreed to the bill, refuted, "People who disagree haven't read the text properly. The prescription for the brand name in force now leads to rebates between doctors and pharmaceutical companies, causing reckless competition for generic drugs." Kwon said, "The prescription of ingredient names will limit the number of generics. The case of using expensive original drugs without taking into account the patient's economic situation through rebates will disappear." He argued, "It can prevent the reckless competition for mass production of generics by pharmaceutical companies."
- Policy
- The MOHW’s new budget focuses on new drugs·COVID-19 trial
- by Lee, Jeong-Hwan Sep 10, 2020 06:23am
- While the budget plan of the MOHW for 2021 was released, it was found that the new budget focused on the treatment field, such as the national new drug development project and non-clinical support for COVID-19 treatment and vaccine. The new budget for the national new drug development project was ￦150.5 billion, and the new budget for non-clinical support for COVID-19 treatment and vaccine was ￦7.4 billion. In particular, compared to the previous year, the budget for clinical support for COVID-19 treatments and vaccines increased by ￦17.7 billion to ￦62.7 billion, and vaccines increased by ￦19.7 billion to ￦68.7 billion. Looking at the 2021 budget for the Ministry of Health and Welfare, Health Industry Policy Bureau of the Ministry of Health and Welfare on the 8th, 27.0% of the total ￦934.3 billion requested by the MOHW is adjusted to ￦79.37 million. Among them, the new net increase budget next year was ▲general government regenerative medical technology development project (R&D) ▲national drug development project ▲disease-centered mediation research project (R&D) ▲public interest medical technology research (R&D) ▲digital pathology-based Cancer-specialized AI analysis solution development project (R&D) ▲ Big data construction specialized for critically ill patients and AI-based CDSS development (R&D) ▲ Multilateral life research resource advancement project ▲ COVID-19 treatment/vaccine non-clinical support. What stands out are the national new drug development project and non-clinical support for COVID-19 treatments and vaccines. The national new drug development project, with a net increase of ￦15.1 billion, aims to become a competitive blockbuster new drug in the global market, and supports the entire cycle of new drug development from discovery of candidate substances to phase II clinical trials. It is conducted by the Ministry of Welfare, the Ministry of Science and ICT, and the Ministry of Industry, and the next year's budget is only reflected for six months, considering the preparation period for the first year. The main contents are the 'new drug base expansion research' budget of ￦3.93 billion, which aims to continue supplying excellent initial pipelines, and the'new drug clinical development' budget of ￦3.7 billion, to vitalize the entry of basic research results into the clinical stage. Non-clinical support for COVID-19 treatment and vaccine was allocated ￦7.4 billion. ￦6.4 billion is for non-clinical support, and ￦1 billion is for medical product evaluation support using advanced animals. ￦7.17 billion was allocated for the development of a digital pathology-based AI analysis solution specializing in cancer. It costs ￦2.62 billion for the expansion of the pathology data digital curation base, ￦1.68 billion for the development of a digital pathology data platform for AI development, and ￦2.62 billion for the development of intelligent pathology AI SW specializing in cancer. In addition, ￦6.41 billion was allocated for the regenerative medical technology development project of all ministries. It consisted of ￦1.98 billion for regenerative medicine source technology development, ￦2.64 billion for regenerative medicine-linked technology development, ￦702 million for regenerative medical treatment technology development, and ￦1,158 million for operating expenses. The government’s regenerative medicine technology development project secures core and source technologies in the field of regenerative medicine, and supports the development of linked technologies, treatments, and treatment technologies and early clinical application. The disease-centered mediation research project was allocated ￦3.63 billion, the public medical technology research project was ￦4,17 million, and the critically ill-specialized big data construction project was allocated ￦7.06 billion. The public medical technology research project aims to verify the concept and secure clinical basis by supporting the development of practical technology for solving public medical demand such as low birthrate, rare diseases, and patient safety. On the other hand, the MOHW has organized the budget for clinical support for COVID-19 treatment and vaccines, which is also higher than the previous year. In the case of clinical support for treatment, ￦62.7 billion was allocated, an increase of ￦17.7 billion (39.3%) from ￦45 billion, and vaccine clinical support was allocated ￦68.7 billion, an increase of ￦19.7 billion (40.2%) from ￦49 billion.
- Policy
- MFDS to shorten fast-track review by a month
- by Lee, Tak-Sun Sep 10, 2020 06:23am
- With the latest reorganization effective from Aug. 31, South Korea’s Ministry of Food and Drug Safety (MFDS) has formed ‘Fast-track Review Division’ and ‘Preliminary Consulting Division’ under National Institute of Food and Drug Safety Evaluation (NIFDS) to expedite the review process on innovative new drugs. The pharmaceutical industry is expecting the fast-track review on Korean-made new drug and incrementally modified drug (IMD) would expand as MFDS has added ‘new drug developed by Innovative Pharmaceutical Company’ to the expedited review subject scope. However, MFDS clarified only the drugs defined under the Article 58 of Pharmaceutical Approval Review Regulation are eligible for the fast-track review, which means even a new drug developed by an innovative pharmaceutical company may not be eligible for the fast-track review unless the regulation defines so. Recently, the pharmaceutical industry’s anticipation was heightened as MFDS newly established an operational plan to provide fast-track review on healthcare products meeting any one of following conditions—pharmaceuticals aiming to treat life-threatening diseases or severe diseases (including orphan drug or orphan drug in development), and have no alternative option or demonstrate efficacy significantly better than the existing option; pharmaceuticals aiming to prevent or to treat infectious disease with risk of threatening public health, such as bioterrorism or infectious disease pandemic (including outbreak of infectious disease with potential to develop as a pandemic), and have no alternative option or demonstrate efficacy significantly better than the existing option; new drugs developed by an innovative pharmaceutical company; rare medical devices; innovative medical devices; and innovative healthcare products with convergence technology. The MFDS operation plan would have the ministry to designate subjects for fast-track review among products the companies applied for. A MFDS official said, "The operation plan would cut the current fast-track review period by 30 days from 120 days and complete it in 90 days.” And the applicant may accelerate the commercialization by having a pre-review consulting and fully preparing for the review without submitting supplementary materials. The Korean pharmaceutical industry seems to be anticipating on adding ‘new drugs developed by innovative pharmaceutical company’ as subject for the fast-track review. So far, 31 companies—mostly Korean companies like Hanmi Pharmaceutical and Yuhan—are designated as ‘innovative pharmaceutical company.’ Moreover, MFDS elaborated IMDs could also be designated to take the fast-track review. Such MFDS regulation on fast-track review is nothing new. But such specific application procedure for pharmaceutical company did not exist. The fast-track review regulation is described in Article 58 of the Pharmaceutical Approval Review Regulation According to the regulations, companies with following pharmaceuticals may apply for the fast-track review—pharmaceuticals with treatment efficacy expected on life-threatening or severe diseases such as AIDS or cancer; urgently needed pharmaceuticals due to existing treatment options unable to treat or tend to develop resistance; and pharmaceuticals the Minister of Food and Drug Safety deems necessary for patient treatment or industrial development, such as anticancer treatment, orphan drug and DNA chip. Some of evidential materials can be submitted after the market release, and the review process can be prioritized to accelerate the procedure. Moreover, the regulation clarifies, the fast-track review would be accessible to pharmaceuticals meeting the following conditions—new drug or IMD; pharmaceuticals submitted evidence on clinical trial outcome conducted in South Korea; pharmaceuticals underwent preliminary review on evidential material submission standards regarding toxicity, pharmacology test, and clinical outcomes according to the Article 35-2; pharmaceuticals, applicable by Item 3 of Paragraph 2 of Article 25, that submitted common technical document (CTD) according to Paragraph 1 of Article 6. But as the fast-track review is not stipulated in the Pharmaceutical Affairs Act, the ministry would have limitations in expanding the system. Regarding the limitation, the ministry is in process of supporting a lawmaker’s bill. On the contrary, fast-track reviews on cell and gene therapies are stipulated under the recently legislated Advanced Regenerative Medicine and Biopharmaceutical Act. The newly established Fast-track Review Division would not handle pharmaceuticals managed under the Advanced Bio Act, but the Cell and Gene Therapy TF Team would process their fast-track review under the new law. For the time being, the Fast-track Review Division plans to prioritize and review COVID-19 treatments and vaccines over other subjects. A MFDS official noted, "The COVID-19 treatment and vaccine would be processed first,” and “the fast-track review subjects stated by the operational regulation would be processed under the Article 51 of Pharmaceutical Review and Approval Regulation." Meanwhile, MFDS plans to hold an online seminar on the issue from Sept. 9 to 10 to inform about the preliminary consulting and fast-track review system and related procedure in detail.
- Company
- Pfizer pays ￦12 million to Upjohn‘s employees
- by Sep 10, 2020 06:23am
- Pfizer Pharmaceuticals Korea decided to pay ￦12 million in consolation to the employees of Upjohn who were transferred to Viatris, which was created as a merger with Mylan. According to the pharmaceutical industry on the 8th, Pfizer Pharmaceutical Korea has concluded negotiations with the union on consolation payments following the division and merger of Pfizer Upjohn. Previously, Pfizer Pharmaceuticals Korea separated its patent-expired drug business division to establish Pfizer Upjohn and merged with Mylan. Since then, the management and the union have conducted intense negotiations under the condition of a 'A special contract not to file a lawsuit' that the employees of Upjohn will not file a lawsuit based on their move. After several negotiations, the labor and management agreed on August 31 to pay ￦12 million in condolences to all employees. According to the Supreme Court precedent in 2013, ‘the right to refuse to move,' which allows workers to refuse to move in the event of a division of a company, is not recognized, but the current situation after 7 years may be changed in a new way. It is known that the labor and management agreed to pay the consolation money on the premise of a sub-complaint agreement, as the possibility that the case law could be overturned if the Pfizer Industry employees, whose tranfer was determined, file a lawsuit. Meanwhile, MSD Korea, which is in the process of dividing the corporation following Pfizer Pharmaceuticals, is expected to have related negotiations after the list of executives and employees is announced.
