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- 2026-03-18 17:36:35
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- Stepped pricing to put pressure for patent challenge
- by Kim, Jin-Gu Jan 14, 2021 06:16am
- The stepped drug pricing system, revived since last July, seems to have affected the pharmaceutical industry’s patent strategy. The pricing system would create a structure to naturally diminish the drug pricing competitiveness in other companies, when 20 or more companies simultaneously and successfully challenge the patent. Pharmaceutical companies’ patent strategy originally focused on winning the preferential sales right, but the revised pricing system would unfold even more competitive patent challenge scene as the success would not only bring the preferential sales right but also more favorable generic pricing. Some complain now the companies are inevitably pressured to challenge the patent to defend the generic competitiveness. ◆Patent challenge inevitable to claim better generic pricing According to the pharmaceutical industry source on Jan. 14, the pharmaceutical companies are to face heated competition to nab the generic approval first as the stepped pricing system has been enforced from last July. The core objective of the system is to differentiate the pricing after listing a 20th product with a same substance. 53.55 percent of the original’s pricing would be applied on up to first 20 drugs to be listed. And other drugs listed afterwards would be applied with pricing lower by 15 percent each. In other words, up to 19th generics, except for the one original drug, would be able to receive the pricing level of the upper limit. Considering the reimbursement listing is decided once every month, the stepped pricing system has been technically extended to a first-come-first-served approval competition. Stepped pricing system effective from July 2020 With the shift in regulation, generic makers would be pushed to challenge patent to obtain the maximum pricing. The approval competition would be passed straight on to patent challenge competition. As for pharmaceutical companies, the regulatory change has increased the benefit in patent challenge. Previously, the benefit was limited to earning a preferential sales right, but now it can also grant the top pricing. But in the same sense, a company that did not challenge the patent would have to market their generic later and cheaper than others. ◆49 generic makers challenged Jardiance patent when new pricing system emerged Some say the patent challenge scene has gotten saturated already due to the revised pricing system. Product image of Forxiga For instance, over 60 companies, started from Chong Kun Dang, have challenged the crystalline form patent on Boehringer Ingelheim’s sodium-glucose cotransporter-2 (SGLT2) inhibiting antidiabetic treatment Jardiance (empagliflozin). Eventually, the ruling was in favor of 50 generic companies. The interesting part of the proceeding was the timing of these patent challenge cases. Most of the companies filed the patent litigations after April 2019, when the framework of the stepped pricing system surfaced. Starting from Chong Kun Dang in March 2015, 12 companies requested for the patent nullification, in which all of them lost. Three years later, Chong Kun Dang retried and requested for the negative confirmation of the scope in January 2018. The Korean company was alone during the legal case, but it won in May 2019. From June 2019, other generic makers tried their luck. 49 companies challenged the exact same patent as of August last year. The industry notes the swarm of patent challenge rushed in after the stepped pricing regulation came in sight. The majority of them were shooting for the ‘good pricing.’ A pharmaceutical industry insider explained, “Usually the patent challenge is filed within 14 days from the day of first case registration to win the preferential sales rights. But for Jardiance patent, the tens of companies jumped into the patent challenge a year and a half after Chong Kun Dang began the patent challenge.” He added, “It could be that some tried after Chong Kun Dang’s success, and some joined the legal suit to not fall behind in the pricing competition.” ◆Patent challenge could mean nothing if generic not developed before patent expiration Regardless of increased benefit in challenging a patent, some raise the voice of concern. Small and medium enterprises without the capacity to challenge the original patent argue the regulation is cutting them out of pricing competition. 25 companies have challenged AstraZeneca’s antiplatelets Brilinta (ticagrelor) and received the preferential sales rights before the patent expires late this year. The preferential sales would be protected from November this year to August next year. Assuming the 25 companies would all launch their products, other generics to be released to the market after August next year would receive already reduced pricing. And there is no guarantee of the maximum pricing to all who successfully challenged the original patent overcoming all difficulties. Product image of JardianceCurrently, 19 companies have evaded product patent on AstraZeneca’s SGLT2 inhibitor Forxiga (dapagliflozin) to be expired January 2024. These companies can launch their generics after April 2023. But if one of them fails to finish developing their generic by April 2023, any of other 25 companies that evaded the product patent can launch their generic from January 2024. Regardless of all resources put into the legal case, the company would lose the upper limit pricing when their generic is not ready to be launched when the patent is expires. A pharmaceutical industry insider said, “The patent challenging competition was initially intense to begin with for the sake of preferential sales right. But exclusivity in the market for nine months and receiving lower pricing are quite different story. The generic makers would now have to engage in even more fierce competition centering patent challenge.”
- Company
- JW Pharma is speeding up the development of Dumirox·Actemra
- by Jan 13, 2021 06:12am
- Dumirox and Actemra, which are monopolized by JW Pharma's domestic development and copyright, are emerging as a possible treatment for COVID-19 On the 8th, the MFDS approved sponsor-investigator trials for patients with COVID-19 of Dumirox 100mg (Fluvoxamine maleate), an antidepressant drug. With the approval of this clinical plan, AMC will conduct a randomized, placebo-controlled method to investigate the treatment effect of Fluvoxamine maleate for 406 mild COVID-19 patients admitted to the Community Treatment Centers. Dumirox is a selective serotonin reuptake inhibitor as an antidepressant primarily prescribed for patients with depression and obsessive-compulsive disorder. It was developed by Abbott in the United States, and JW Pharma secures the exclusive copyright in Korea. It is widely known as Luvox abroad. Dumirox has already proven the effectiveness of COVID-19 treatment in overseas clinical trials. According to the online edition of the Journal of American Medical Association on November 12 last year, research has shown that Dumirox can help prevent the condition from becoming severe by significantly reducing the likelihood of hospitalization for patients with COVID-19. Eric Lenze, Wallace and Lucille K. Renard Professor of Psychiatry at the University of Washington School of Medicine, USA, conducted a clinical trial in Illinois and Missouri in 152 patients with COVID-19, mild to moderate, aged 18 years or older, in self-isolation at home. "Six out of 72 people who took placebo were classified as severely ill, whereas all 80 people taking Dumirox did not get worse," the research team said. "We found that Dumirox may reduce the risk of hospitalization and death in patients with COVID-19." Rheumatoid arthritis treatment Actemra (Tocilizumab) has been shown to lower the mortality rate of critically ill patients with COVID-19 abroad, and the UK government recommended that the treatment be prescribed for the treatment of COVID-19 starting on the 8th (local time). According to the Guardian on the 7th, a study by the Remap-Cap research team showed that the mortality rate of the group receiving general treatment was 35.8%, while the mortality rate of those receiving Actemra treatment was 28%. In addition, patients injected with Actemra left the intensive care unit 7 to 10 days earlier than the control group. In September of last year, global pharmaceutical company Roche unveiled the results of EMPACTA, the second global phase III clinical trial of Actemra, a rheumatoid arthritis treatment to be developed as a treatment for COVID-19. A total of 389 patients were studied, and the risk of dying or wearing a ventilator was 44% lower than that of placebo. The third global phase III clinical trial REMDACTA, which Roche is in cooperation with Gilead Sciences, is also raising expectations. REMDACTA is a trial that evaluates efficacy and safety as a combination therapy of Remdesivir and Actemra, and has been in progress on a total of 450 COVID-19 patients since June of last year. JW Pharma is developing a treatment for COVID-19 through its own new drug strategy. JW Pharma recently secured the right to own and use the results of a study on COVID-19 infection animal model of CWP291 from the Korea Research Institute of Bioscience and Biotechnology (KRIBB), and entered the subsequent development stage. As a result of the efficacy evaluation for the golden hamster of CWP291, a high rate of improvement in lung lesions was shown, and an excellent reduction effect was also confirmed in the amount of virus remaining in the lung tissue (PCR). This can be judged as the result obtained by the GRP78 binding mechanism that CWP291 was identified in the clinical phase I study of the existing target anticancer drug. GRP78 is reported as a host factor for several single-stranded RNA viruses, including COVID-19, MERS, Dengue, Zika, and Japanese encephalitis in many academic data.
- Company
- Sanofi financially supports adolescent Dupixent users
- by Jan 13, 2021 06:11am
- On Jan. 11, Sanofi Aventis Korea (President Kay Bae) presented a patient drug expense support program to partially cover the cost of Dupixent Prefilled injection 200 mg (dupilumab) prescribed to adolescent patient with atopic dermatitis. The program aims to contribute in improving the patients’ quality of life by financially supporting the patients with the drug expense, and to allow them to receive the treatment at the right timing. A topical treatment Dupixent is a first ever biologic drug to be indicated to treat adolescent and adult patients aged 12 years or older with moderate to severe atopic dermatitis. After the 300 mg dose, 200 mg dose was also released to the South Korean market in last October. 200 mg of Dupixent is injected to an adolescent patient aged 12 years or older with atopic dermatitis but weighing less than 60 kg. Other adolescent patients weighing over 60 kg and adult patients are administered with 300 mg. At the moment, the drug’s National Health Insurance reimbursement covers only the adult patient. As a result, Sanofi has decided to operate a program to cover a part of the adolescent patients’ pharmaceutical expense. Patients prescribed with 200 mg of Dupixent, whose median household income level is under 180 percent. Adolescent patient with severe case of atopic dermatitis has high probability of experiencing negative social interactions, such as bullying and isolation struggling with mental issues like anxiety, inferiority and depression. The company anticipates the financial support program to not only grant access to the treatment, but also give benefit of improving the quality of life. Sanofi Aventis Korea’s Specialty Care business unit CEO Park Hee-kyung commented, “To provide treatment access to adolescent patients with moderate to severe atopic dermatitis, who are neglected from the National Health Insurance benefit, the company has decided to contribute a part of Dupixent 200 mg expense.” The company’s call center and website can be reached for any inquiry on the partial refund and expense support on Dupixent.
- Company
- Ferring & Chong Kun Dang signed a contract for Nocdurna
- by Jan 13, 2021 06:11am
- Ferring Korea and Chong Kun Dang announced on the 11th that they have signed a joint sales contract for 'Nocdurna Sublingual Tab (Desmopressin acetate)', a treatment for nocturia. Following the signing of this contract, Ferring Korea will be in charge of marketing for general hospitals from the 18th, and Chong Kun-dang will be in charge of sales and marketing on clinics. Ferring Korea and Chong Kun Dang have been jointly selling Minirin, a treatment for nocturia since 2019. Nocdurna with an additional contract is Minirin's low-dose product. Nocdurna improves the symptoms of nocturia caused by polyuria at night, which accounts for up to 88% of the causes of nocturia. It is a new treatment that improves the safety of patients to reduce the number of nocturia in adults and improve the quality of sleep. Nocdurna 50 μg is administered once a day for men, and Nocdurna 25 μg is administered once a day for women. According to the results of the Nocdurna Phase III study, Nocdurna 25 μg and 50 μg were effective in controlling nocturia-related symptoms in women and men, respectively. Compared to placebo, Nocdurna reduced the average number of nocturia and increased the time to first nighttime urination, prolonging the initial sleep period. Compared to placebo, the quality of life and sleep quality associated with nocturia increased significantly. Yong-beom Choi, CEO of Ferring Korea, said, "We are pleased to sign a joint sales contract for Minirin and Nocdurna with Chong Kun Dang. We hope that Nocdurna will make it easier for elderly patients over 65 who are suffering from sleep disturbances due to nocturia." Chong Kun Dang CEO Kim Young-joo said, "Based on Chong Kun Dang's excellent sales force, we will do our best so that more domestic nocturia patients can Nocdurna’s benefit at clinics visited by many patients."
- Company
- Celltrion's CT-T43 was approved for Phase III clinical trial
- by Kim, Jin-Gu Jan 13, 2021 06:10am
- Celltrion announced on the 8th that it has received approval for the Phase III clinical trial plan of Stelara (Ustekinumab)'s biosimilar. Janssen's autoimmune disease treatment Stelara is a mechanism that inhibits interleukin (IL)-12·23, and has indications for psoriasis, Crohn's disease, and ulcerative colitis. It is known that global sales amount to ₩7 trillion. Celltrion plans to compare the efficacy, pharmacokinetics, and safety of CT-T43 and Stelara at 7 domestic institutions. Clinical trials are conducted simultaneously with global trials. Global clinical trials are conducted in Europe and Korea with 446 patients. Global clinical trials have already begun with European approval on December 21st last year. This phase III clinical trial aims to end in the second half of 2022. Celltrion plans to commercialize the CT-P43 in September 2023 and July 2024, when Stelara's material patents expire in the United States and Europe. Celltrion will secure a diverse portfolio in the autoimmune disease treatment market when CT-P43 is commercialized. Celltrion has two types of Remicade biosimilar Remsima (IV and SC), Herceptin biosimilar Herzuma, and Rituxan biosimilar Truxima. In addition, it is developing Humira biosimilar CT-P17 and Xolair biosimilar CT-P39. CT-P17 is expected to be approved in Europe in the first half of this year, and CT-P39 is aiming to end clinical trials in the first half of 2023.
- Company
- What domestic pharmaceuticals JP Morgan paid attention to?
- by Moon, sung-ho Jan 12, 2021 06:22am
- More than 20 domestic pharmaceutical and bio companies are invited to the world's largest pharmaceutical and bio industry event, annual J.P. Morgan Healthcare Conference. According to the pharmaceutical industry on the 8th, more than 20 domestic pharmaceutical and bio companies, including Samsung Biologics and Hanmi, will participate in the J.P. Morgan Healthcare Conference. which will be held from the 11th to the 14th local time in San Francisco, USA. It is 39th event where about 500 large global pharmaceutical companies as well as domestic companies participate in the event to share new R&D achievements and status, and discuss the future direction of the pharmaceutical and bio industry. It can be an opportunity for domestic pharmaceutical and bio companies to achieve the greatest goals of technology export and partnership signing. A representative example of domestic companies that will attend the conference is Samsung Biologics. It is the only domestic company in charge of the announcement of the Main Track scheduled for the 13th, and the new CEO John Rim will introduce the company's main business details and vision. Celltrion, known as a regular customer of the conference among domestic companies, is expected to be absent from this event. It is the intention to focus on the development of the COVID-19 antibody treatment that is currently being promoted, and the results of the global phase II clinical trial will be announced on the 13th. Companies presenting at the subsidiary session Emerging Market are Hanmi, LG Chem, Hugel, HK inno.N, and Genexine. Hugel, which participated in the conference for the second consecutive year, presented ‘2020 achievements and vision for 2025' based on the success secret of 'Letybo', a botulinum toxin that was recently approved in China, while major overseas institutional investors during the conference. It will also hold 1:1 meetings with institutional investors. Genexine is planning to introduce the business strategy of 'Continuous Interleukin 7 (GX-I7)', which is also being developed as an anticancer drug and COVID-19 treatment at this event. HK inno.N, participating for the first time, plans to introduce autoimmune disease treatment and non-alcoholic steatohepatitis, including K-CAB Tab. LG Chem also decided to disclose its business strategy, including the new drug pipeline. LG Chem is currently conducting phase II gout treatment, phase II treatment for autoimmune diseases, phase I treatment for rare obesity, and phase I treatment for non-alcoholic steatohepatitis. There are various pharmaceutical and bio companies that do not make presentations, but participate in conference meetings. JW-Pharma, Crystal Genomics, Genome & Company, Shaperon, SCM Life Science, AptaBio, MedPacto, ABL bio, Syntekabio, Pharmabcine, Cellivery, KoBioLabs, Oscotec. JW-Pharma decided to introduce research projects through video meetings and conduct one-on-one partnership consultations and consultation meetings for joint research with global investment companies including multinational companies. In particular, JW-Pharma plans to take this opportunity to discuss additional global technology alliance projects for URC102, a gout treatment that has been successfully exported last year and has been recognized in the global market. Pharmabcine will introduce major pipelines, including Olinvacimab, and plan to jointly research materials and transfer technologies. An official from a pharmaceutical company participating in the conference said, “It is difficult to be sure that the progression online will lead to the creation of results such as the export of Lazertinib technology. Nevertheless, global pharmaceutical companies and investors will be informed of differentiated competitiveness to develop even in COVID-19 situation.”
- Company
- MSD received administrative disposition for packaging
- by Whang, hyung-woo Jan 12, 2021 06:19am
- MSD Korea has been subject to administrative disposition for violating the provisions of supplying small packages. However, it was confirmed that they were looking for a way through the exception. Considering the characteristics of taking 2 tablets a day, it applied for relief saying that it had to admit an exception to the packaging of 60 tablets. However, there are many opinions that time is imminent as the import suspension measures for the item will proceed from next week immediately. #The MFDS imposed administrative measures to suspend manufacturing and import operations for pharmaceutical companies that violate the regulations on supplying small quantities of medicines in small quantities. MSD Korea was found to violate Article 42 of the Pharmaceutical Affairs Law due to the lack of standards for supplying small quantities of medicines in 2019, two items, Isentress (Raltegravir) and Isentress HD (Raltegravir, potassium micronized). According to the supply regulations related to package packaging for pharmaceuticals, manufacturers must supply 10% of the annual manufacturing/import volume for each item. However, if there is little data or product demand on inventory and disposal, the ratio can be set lower than 10%. In the case of MSD, it violated the regulation of 30 tablets packaging. Accordingly, the drug cannot be imported into Korea from January 15 to February 14. In the case of a violation of the current regulations on supplying small-sized packaging units, an administrative disposition for one month of suspension of the manufacturing business is applied, and in the case of the second violation, a three-month suspension of manufacturing business is imposed. However, MSD is planning to receive an exception to the regulation of the small package as both Isentress (Raltegravir) and Isentress HD (Raltegravir, potassium micronized) have characteristics of dosage. The dosage of Isentress published on the MSD official website is 400mg twice a day in combination with other antiretroviral drugs for the treatment of adult patients infected with HIV-1 on an adult basis. According to the current regulations, the two products must be packaged in a small package of 30 tablets or less, but the related product is characterized by taking 2 tablets a day, so it will be recognized that there is only one packaging unit of 60 tablets. MSD noted that it is in the process of being reviewed with relevant data submitted to the MFDS in order to obtain an exception. An MSD official said, "We have submitted data to receive exceptions considering the dosage of the product. The package of 60 tablets should be accepted as an exception considering the dosage characteristics of the drug." However, the time is imminent in that the administrative disposition procedure will start from the 15th, apart from the review of the MFDS. An MSD official said, "As a result of the current analysis, the problem in supply and demand of medicines due to import suspension is expected to be negligible."
- Company
- HK inno.N wins big in huge shift of global vaccine licenses
- by Kim, Jin-Gu Jan 11, 2021 06:11am
- Started from late last year, the massive shift in South Korean market sales rights over global vaccines has come to an end. Global companies like MSD, GSK and Sanofi Pasteur, and South Korean companies like GC Pharma, SK Bioscience, HK inno.N, Yuhan Corporation and Handok were involved in the mass migration of the businesses. The industry sees that HK inno.N took the biggest piece of the pie during the process. SK Bioscience letting go of one deal and taking another was also evaluated to have defended its position successfully. Also Handok was able to maintain its deals. However, GC Pharma and Yuhan are to minimize their loss of losing existing deals by concentrating on other items. ◆HK inno.N embraces deals worth 140 billion won as MSD entrusts all seven vaccines On Jan. 6, SK Bioscience announced it inked the co-marketing contract over five types of GSK vaccines. The announcement marked the end of global vaccine sales license migration in the South Korean market started since late last year. HK inno.N is supposedly the biggest winner of the shift that lasted three months. The Korean company signed the co-marketing and distribution contracts for seven of MSD vaccines in last November. Initially, GC Pharma had three of the deals and SK Bioscience had four of them, but all of them were transferred to HK inno.N. The pharmaceutical market research firm IQVIA says the seven MSD vaccine generated 141.5 billion won in last one year (Q4 2019 through Q3 2020). As a result, HK inno.N is to make 140 billion won more from this year on. ◆SK to fill up the 30 billion won loss from MSD vaccine deals with GSK vaccines The industry views SK Bioscience has done a good job compensating the damage of losing four MSD vaccines with five new GSK vaccine deals. Although HK inno.N took over four MSD vaccine contracts from SK Bioscience in last November, the company actually nabbed five of GSK vaccine deals early this year. When the previous four vaccines used to make 31.4 billion won annually, the new five vaccines would make 26.2 billion won. The simple math may indicate an immediate loss, but the increase in vaccine types could mean potential growth through strengthened sales strategy. Also the five adult vaccines by GSK could create synergy effect with the Korean company’s vaccines, Sky Zoster (varicella virus vaccine) and Sky Cellflu (influenza vaccine). ◆Handok and Sanofi extend co-promotion contract valued at 20 billion won annually Handok was able to successfully defend all existing deals with Sanofi Pasteur. In May 2019, Handok sealed the deals with Sanofi Pasteur on co-promoting six vaccines. The deals expired late last year, but the two companies have agreed to extend the terms before the expiration. The details of the extension have not been disclosed. The six vaccines have generated 21.6 billion won in last 12 months. Handok is to keep the annual income for this year. ◆Yuhan and GC lose sales licenses in South Korea, “Concentrating more on our own" Meanwhile, Yuhan Corporation and GC Pharm ended their vaccine deals with GSK and MSD during their contract extension negotiation. The damage of losing Zostavax and Gardasil would cost GC Pharma 110 billion won a year. Yuhan would also miss out on 20 billion won a year due to the terminated contract. The two companies plan to focus on their own products to minimize the loss. Specifically, Yuhan’s focal point would be on a lung cancer treatment lazertinib expected to receive conditional approval in the first quarter. The company has already hired anticancer sales people for the new business. GC Pharma is to also keep itself busy with its own influenza and varicella virus vaccine sales. Apparently, GC Flu’s last year sales have improved significantly in the third quarter due to COVID-19. Also the company’s varicella virus vaccine line-up has been updated to a new generation. Instead of the existing Suduvax, the new Barycela would be sold from this year. A pharmaceutical industry insider noted, “The companies would probably integrate the previously dispersed sales forces for their own products. The sales gap would not be that drastic.”
- Company
- Allergan Korea names Kim Sook-hyun as new CEO
- by Jan 11, 2021 06:10am
- New CEO, Kim Sook-hyun Allergan Korea Aesthetic-AbbVie Company said it has selected Kim Sook-hyun as the new CEO as of Jan. 1 She is a global healthcare professional with 22 years of experience in Korea, Asia, and headquarters receiving an MBA at Kelley School of Business after graduating from industrial pharmacy at Seoul National University. She joined Abbott Korea in 2006, as the Humira Business Unit Manager and served as the director of Commercial Business Divisions in Japan and Asia Pacific in Singapore in 2011. In 2015, she took over the head of the Immunization Division at AbbVie, Korea. Since 2018, she has been contributing to the establishment of immune drug brand strategy and organizational change by serving as the global marketing and commercial division of the AbbVie headquarters, as well as the global marketing director for new business markets in Japan and Australia. She said, "I am pleased to be with Allergan Aesthetics for the growth and development of Korean business, which has led the global innovation in the medical aesthetics field, and I feel a heavy responsibility at the same time. Based on the experience accumulated in the pharmaceutical market, we will do our best to provide cutting-edge medical esthetic solutions to meet the expectations and demands of the rapidly evolving Korean medical beauty market."
- Company
- 51 Jardiance patent-challenging generics released in 4 years
- by Kim, Jin-Gu Jan 08, 2021 06:20am
- Product image of Jardiance Six more pharmaceutical companies are to evade the patents on Boehringer Ingelheim Korea’s antidiabetic sodium-glucose co-transporter-2 (SGLT2) inhibitor Jardiance (empagliflozin). As a result, total 51 companies would be able to avoid charges on infringing the product’s patent. The pharmaceutical industry source reported on Jan. 7 that the Intellectual Property Trial and Appeal Board approved of Kolmar Korea and Kolmar Pharma’s request to negatively confirm the scope of Boehringer Ingelheim Jardiance’ crystalline form patent on Jan. 5. And on Jan. 6, the Board also accepted the request filed by Kuhnil Pharm, Penmix, GL Pharma and Kyongbo Pharmaceutical. Now there are two outstanding cases left without a ruling, yet. The industry anticipates the generic makers—Korea United Pharm and Korea Biochem Pharm—would win the case challenging the Jardiance’ crystalline form patent. If they were to win, total 53 companies would be able to overcome Jardiance patent barrier. Since Chong Kun Dang first evaded the patent in May 2019, other generic companies have followed the footstep and challenged the patent. The generic companies mostly won the cases. The challenged patent is to expire in December 2026. The generic companies that successfully challenged the original’s patent may launch their follow-on drugs after March 2025, when the product patent expires. In four years time, 50 companies could release generics to the market all at once.
