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- 2026-05-09 09:56:04
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- Emergency Contraception (EC) monopolized by Hyundai
- by Oct 11, 2022 05:50am
- As generics enter the Emergency Contraception (EC) market, which is dominated by Hyundai Pharmaceutical, a maximum of five-way race is expected. Generics that avoided patents led by GL Pharma predicted full-scale sales this month. According to the pharmaceutical industry on the 8th, Arlico Pharmaceutical, The U, GL Pharma, and Kwangdong Pharmaceutical will release EC containing Ulipristal ingredients this month. They obtained an item license from the Ministry of Food and Drug Safety in June last month. All are generics of Hyundai Pharmaceutical's Ellaone, and GL Pharma is in charge of producing all four products. GL Pharma was the first to obtain generic for Ellaone and then recruited companies to launch the generic together. In the process, the U, Arlico, and Kwangdong joined. GL Pharma filed a passive judgment in December last year on Ellaone's patent for Ulipristal after successfully developing a formulation that avoided the scope of Ellaone's patent. When the Korean Intellectual Property Tribunal cited the plaintiff's claim on September 14, not only GL Pharma but also three pharmaceutical companies that participated in the consignment secured generic for exclusion. Ellaone is an original ingredient of Ulipristal and was developed by French pharmaceutical company Laboratoire HRA Pharma and introduced by Hyundai Pharmaceutical in Korea. It currently generates the largest sales in the oral contraceptive market. Last year's sales amounted to 3.3 billion won. Norebwon (Levonorgestrel), is following with 2.2 billion won. The Emergency Contraception (EC)) market is largely divided into two active ingredients: Levonorgestrel and Ulipristal. Among the Levonorgestrel ingredient emergency contraception (EC) market, Hyundai Pharmaceutical exclusively occupied the Ulipristal ingredient. Hyundai Pharmaceutical's Ellaone patent expires in 2029. However, as GL Pharma succeeded in avoiding the scope of Ellaone patents last month, it advanced the release of generics by about seven years. From the fourth quarter of this year, GL Pharma is expected to be the biggest beneficiary when the Ulipristal market enters the generic competition system. GL Pharma is a pharmaceutical company specializing in sex hormone drugs and has been researching, producing, and supplying various contraceptives and sex hormone drugs over the past four years.
- Company
- The second CGRP migraine drug Ajovy's benefit is listed
- by Eo, Yun-Ho Oct 11, 2022 05:50am
- According to related industries, Handok Teva has begun negotiations with the HIRA on the drug price of Ajovy, a target migraine treatment for Calcitoningenene-related peptide (CGRP). Ajovy passed the HIRA Drug Benefit Evaluation Committee last month. Ajovy's drug price is expected to be negotiated as its competitive drug and first item, Emgality, was applied in September. If Ajovy succeeds in registering, competition for the prescription of the two drugs is expected to begin in earnest. Emgality and Ajovy are the same category of drugs, but there are differences in dosage, so they are being selected according to the characteristics of severe migraine patients. Emgality is administered 240 mg (two consecutive subcutaneous injections each of 120 mg) once at a loading dose, and then subcutaneous injections of 120 mg once a month. Ajovy 225 mg is used once a month or 675 mg (three consecutive times of 225 mg) is injected subcutaneously once every three months. Ajovy proved its validity through a 12-week HALO EM/CM clinical trial in 2,000 EM and CM patients. In a HALOEM study conducted to verify the efficacy and safety of Ajovy compared to the placebo group, Ajovy was evaluated to meet the primary evaluation variable by significantly reducing the number of monthly migraine occurrences in both monthly and quarterly administration groups. The proportion of patients whose average monthly migraine days decreased by more than 50% was also higher in the Ajovy monthly administration group and 44.4% in the quarterly administration group compared to 27.9% in the placebo group. In the HALOCM study, the average number of monthly headache reduction days in the Ajovy administration group was 4.6±0.3 days, and the quarterly administration group was 4.3±03 days, which was significantly reduced compared to 2.5±0.3 days in the placebo group.
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- Only 2 out of 10 are prescribed monotherapy for diabetes
- by Kim, Jin-Gu Oct 07, 2022 06:04am
- The use of combination therapies in diabetes has been increasing further. Already, 8 of 10 patients are prescribed two or more drugs at once. In particular, the triple therapy combination regimen seems to be rapidly establishing its presence in the field. By ingredient, DPP-4 inhibitor class drugs are still showing strength, but their growth is gradually slowing down. On the other hand, SGLT-2 inhibitor class drugs are gaining influence, while sulfonylurea class drugs are on a steady decline. ◆From dual to triple therapies…the diabetes treatment paradigm is shifting The Korean Diabetes Association published a ‘2022 Diabetes Fact Sheet’ that contained the information above. Based on the national health insurance claims data, the Fact Sheet contains the prevalence, treatment rate, and drug prescription rate of diabetes in Korea from the year 2002 to 2019. Present status of Oral Hypoglycemic Agent combination therapies (Data: 2022 KDA Diabetes Fact Sheet) According to the data, the prescription rate of monotherapy in diabetes was 22.2% in 2019. 2 in 10 diabetes patients have been prescribed a single drug for their condition. The other 77.8% are receiving two or more drugs at once. The rate of combination therapy prescriptions had risen 5.4%p in 5 years from the 73.4% in 2014. In particular, the prescription rate of three-or-more drug combinations is on the rise. The three-or-more drug combination therapies that had been prescribed in only 31.9% of all cases until 2014, had risen 6.1%p in 5 years to 38.0%. In the same period, prescription of dual combination therapies had decreased by 1.7%p from 41.5% to 39.8%. Prescription of monotherapies had fallen 4.4%p in 5 years from the 26.6%. The gap between prescription of dual and triple combination therapies had been 9.6%p in 2014, which had been reduced to 1.8% in 5 years. The industry has been interpreting this as a shift in the diabetes treatment paradigm, of how the diabetes treatment paradigm is moving from dual combination therapies to triple combination therapies. This phenomenon is also reflected in the number of drugs that are initially prescribed after being diagnosed with diabetes. First drug prescription for diabetes after diagnosis (Data: 2022 KDA Diabetes Fact Sheet) In 2009, 66.7% of the patients first diagnosed with diabetes were prescribed monotherapy. The prescription rate of dual combination therapies had been 30.6%, and triple combination therapies 2.7%. In 2019, the prescription rate of monotherapies in those first diagnosed with diabetes had become 58.9%, a 7.8%p decrease in 10 years. On the other hand, the prescription rate of dual combination therapies had increased 4.9%p to 35.5%, and triple combination therapies 2.9%p to 5.6%. ◆Sales of metformin and DPP-4i surge... sulfonylurea sales fall, SGLT-2i rise By ingredient, metformin and DPP-4 inhibitor class drugs are still the most popular. As of 2019, 87.5% of all diabetes patients were prescribed metformin, followed by 63.9% receiving DPP-4 inhibitor class drugs, 41.7% sulfonylurea (SU), 11.6% TZD class, 10.8% SGLT-2 inhibitor class, 8.4% insulin (duplicate prescriptions reflected in the statistics). Compared to 5 years ago in 2014, the prescription rate of metformin increased by 2.1%p from 85.4% to 87.5%. In the case of DPP-4 inhibitors, prescriptions increased by 18.5%p from 45.4% to 63.9% in the same period. After it was first introduced in 2008, the prescription of DPP-4 inhibitors increased rapidly to reach 59.1% in 2016. However, since then, its growth slowed to 61.8% in 2017, 63.4% in 2018, and 63.9% in 2019. Analysis of prescription patterns by diabetes drug ingredient (Data: 2022 KDA Diabetes Fact Sheet) In the case of sulfonylurea, sales are on a constant decline. Although it had been the most-prescribed drug until 2009, the prescription rate of sulfonylurea started to slow down with the introduction of DPP-4 inhibitors. Due to this the prescription rate of sulfonylurea class drugs, which had reached 75.8% in 2009, fell to 51.2% in 2015, and then was overtaken by sales of DPP-4 inhibitors. Sales continued to decrease further to 41.7% in 2019. On the other hand, SGLT-2 inhibitor class drugs have been rapidly increasing their influence since their introduction in 2014. Their prescription rate, which had been only 2.4% in 2015, rose to 10.8% in 2019.
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- Lilly prepares to introduce Olumiant for hair loss in Korea
- by Eo, Yun-Ho Oct 07, 2022 06:04am
- JAK inhibitors may soon be prescribed to treat hair loss in Korea as well. According to industry sources, Lilly Korea is preparing to apply and expand the indication for its JAK inhibitor Olumiant (baricitinib) to severe alopecia areata to the Ministry of Food and Drug Safety. After the drug was approved in June for the indication by the US FDA, the company is quickly entering global commercialization. Olumiant selectively and reversibly inhibits JAK1 and JAK2 to reduce the expression of inflammatory cytokines and demonstrates an overall anti-inflammatory effect. It was first approved as a treatment for rheumatoid arthritis, then expanded its indication to atopic dermatitis in Korea and some other countries. In the US, Olumiant is also prescribed to treat hospitalized COVID-19 patients. Alopecia areata is also an autoimmune disorder that causes the body to attack its own hair follicles, resulting in hair falling out. In addition to scalp hair, eyebrows and eyelashes can also fall out. The efficacy of Olumiant in severe alopecia areata patients was demonstrated through the company’s BRAVE-AA1 and BRAVE-AA2 trials. The two trials evaluated the safety and efficacy of Olumiant in 1,300 patients compared with a placebo. In the AA1 trial, 22% of the 184 patients that took Olumiant 2mg, and 35% of the 281 patients that took Olumiant 4mg showed an appropriate level of scalp hair coverage and achieved a Severity of Alopecia Tool (SALT) score of 20 or less. The rate was only 5.3% in the placebo arm. The higher the SALT score, the more severe the degree of hair loss is considered to be. 31% and 35% improvements in eyebrow and eyelash coverage were also observed in the Olumiant 2mg and 4mg arm, respectively. In the AA2 trial, 17% of the Olumiant 2mg arm and 32% of the Olumiant 4mg arm achieved a SALT score of 20 or less, which was significantly higher than the 2.6% in the placebo arm. According to a Sungkyunkwan University report, around 25% of adults in Korea are known to have severe or worse alopecia areata, with less than 10% of these patients progressing to the extent that their hair almost falls out.
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- GC Pharma sells GSK's new shingles vaccine Shingrix together
- by Kim, Jin-Gu Oct 07, 2022 06:03am
- ShingrixGC Pharma and GSK will jointly sell the shingles vaccine Shingrix. The two companies are expected to sell a new shingles vaccine as early as the end of this year. According to the pharmaceutical industry on the 6th, GC Pharma and GSK recently signed a co-promotion contract for Shingrix and started product training for salespeople before its full-scale release. It is expected that the product will be released at the end of this year. GSK obtained Shingrix permission from the Ministry of Food and Drug Safety in September last year. It was originally planned to be released in February this year, but the schedule was delayed. Shingrix is a vaccine used to prevent herpes zoster in adults over the age of 50 and immunocompromised people over the age of 18. When Shingrix is released, it is expected to be the third shingles vaccine in Korea after MSD Zostavax and SK Bioscience's Sky Zoster. It is evaluated that the effect of preventing shingles confirmed in clinical trials is superior to that of the two existing vaccines. In Shingrix clinical trials (ZOE-50) for adults over the age of 50, the effect of preventing shingles was 97% at 3.2 years after vaccination. In clinical trials (ZOE-70) for those aged 70 or older, it was 90% at 3.7 years after vaccination. In the case of Zostavax, a competitive product, it has a preventive effect of 51% for those over 50 and 41% for those over 70. Sky Zoster demonstrated Zostavax and specific heat in clinical practice. It is analyzed that there is no significant difference from Zostavax in terms of prevention rate. GC Pharma has experience in co-selling MSD's shingles vaccine Zostavax in the past. Since 2013, GC Pharma has co-sold Zostavax for eight years until 2020 through a contract extension once after signing a co-promotion contract with MSD. In the process, Zostavax has grown into a large item with annual sales of 80 billion won. However, SK Bioscience launched its competitive product Sky Zoster at the end of 2017, and sales have decreased significantly since 2020 due to the prolonged Corona crisis. According to IQVIA, a pharmaceutical market research firm, Zostavax sales last year amounted to 27 billion won, down 68% in four years from 83.7 billion won in 2017. This year, sales were only 11.6 billion won until the first half of the year. The pharmaceutical industry expects Shingrix to lead the domestic shingles vaccine market to rebound. In the global market, Shingrix's sales, which had already been dampened by the Corona crisis, began to recover in the second half of last year. In the first half of this year, Shingrix's global sales were £1.429 billion, more than doubling compared to the same period last year. An official from GC Pharma and GSK Korea said, "There is nothing to mention regarding Shingrix's domestic sales."
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- Daewoong Pharmaceutical launches botulinum drug in the UK
- by Chon, Seung-Hyun Oct 06, 2022 06:05am
- The botulinum toxin drug developed by Daewoong Pharmaceutical has been released in earnest in the European market. Daewoong Pharmaceutical announced on the 5th that Nabota, a botulinum toxin drug, was officially released in the UK under the product name Nuceiva. It started selling in the UK last month through Daewoong Pharmaceutical's overseas partner Evolus. The UK is the largest single market in Europe, accounting for about 30% of the European botulinum toxin market worth 650 billion won per year. Evolus, a North American and European beauty indication partner of Daewoong Pharmaceutical, is in charge of Nuceiva's distribution and marketing in the UK. Evolus formed a strategic partnership with Wigmore, a local British distributor with a history of more than 35 years, and established a specialized distribution network. Since the beginning of this month, the latest knowledge and Nuceiva product training have been conducted for local medical personnel. Daewoong Pharmaceutical and Evolus will also enter other European countries with high marketability, such as Germany and Austria, to target the European market in earnest. Park Sung-soo, vice president of Daewoong Pharmaceutical, explained, "With the release of Nuceiva in the UK, we have officially entered the U.S. and Europe, the world's No. 1 and No. 2 botulinum pharmaceutical markets." "We will actively promote Nabota's excellent product power in the global market and contribute to enhancing K-Bio's status," he said.
- Company
- ILSUNG signs 3rd generation CCB HTN tx co-promotion
- by Lee, Seok-Jun Oct 06, 2022 06:05am
- ILSUNG, Intro Bio Pharma, and Pharmavision, have signed a partnership for Azelnidipine copromotion. According to ILSUNG on the 4th, Intro Bio Pharma received the first approval in Korea for Azelnidipine-based medicine in September 2021. Azelnidipine is a third-generation CCB hypertension treatment (Calblock) developed by Daiichi Sankyo Korea in Japan. Compared to Amlodipine, it has excellent blood pressure drop effect and fewer side effects, so it is most commonly used in Japan along with ARB hypertension treatment. It is known to have an excellent blood pressure control effect when used in combination with ARB series. Intro Bio Pharma and Pharmavision selected ILSUNG, which has strength in general hospitals, as a partner for Azelnidipine. Amlodipine has recently passed the Pharmaceutical Affairs Evaluation Committee and is expected to be listed. What is unique about this three-way contract is that Pharmavision, a research, and development venture that was established in 2019 and has completed the transfer of about 20 pharmaceutical technologies to many pharmaceutical companies so far. Based on R&D technology, Azelnidipine cooperation between Intro Bio Pharma, a pharmaceutical R&D venture company Pharmavision, and ILSUNG, which is taking a leap forward through innovation, can be a new B2B model. Kim Byung-jo, head of ILSUNG's development division (executive director, Ph.D. ), said, "Azelnidipine can be a new alternative for hypertension patients who have difficulty controlling blood pressure with Amlodipine or Lercanidipine HCl CCB hypertension treatment." Through three-way cooperation, it will become a necessary and differentiated item for patients.
- Company
- Koselugo is keen to discuss the registration of benefits
- by Eo, Yun-Ho Oct 05, 2022 06:11am
- Attention is focusing on whether Koselugo, a drug-free treatment for neurofibroma, will succeed in registering insurance benefits. According to related industries, AstraZeneca's new neurofibromatosis drug Koselugo is under final coordination at the Drug Benefit Standards Subcommittee. AstraZeneca quickly supplemented the data in May and resumed discussions on registration at the HIRA Drug Benefit Evaluation Committee in March. As it is a rare disease area where there were no treatment options, it remains to be seen whether Koselugo will be able to draw a decision this time. Neurofibroma has relied on symptomatic treatment without proper treatment. Neurofibroma is a rare disease in which tumors occur in nerve tissue, bones, and skin, and about 85% are type 1 in which the NF1 gene of the 17th chromosome long arm is mutated. This disease begins with 1~3cm sized cafe au lait macules appearing in children. It experiences symptoms such as brain tumors at the age of 6 and scoliosis at the age of 6 to 10. In adults, Lisch nodule, which occurs in the iris, is mostly found. It is a method of removing possible areas through surgery or chemotherapy and radiation treatment. However, most of the surgeries recur, and most of them are major surgeries, so both medical staff and patients are burdened. In particular, pediatric patients often have to take painkillers even after several surgeries and suffer from speech and motor disorders. Koselugo is a treatment jointly developed by AstraZeneca and MSD. It blocks MEK activity and inhibits cell line growth. In the SPRINT phase 2 clinical trial on which the permit was based, Koselugo reduced tumor size by more than 20% in 68% of administered patients, achieving the primary evaluation index, ORR. In addition, 82% of patients who showed partial reactions continued to respond for more than 12 months. Half of the patients who did not receive treatment suffered from disease progression after 1.5 years, and only 15% of the patients who used Koselugo developed the disease up to three years ago.
- Company
- Moderna's Spikevax bivalent Original/Omicron BA.1
- by Oct 05, 2022 06:11am
- Moderna announced on the 4th that it conducted Spikevax bivalent Original/Omicron BA.1 launch Webinar, a divalent vaccine containing omicron, on September 29. At the event, Jin Beom-sik, head of the Infectious Medicine Center at the National Medical Center, was the chairperson, and Kim Hee-soo, vice president of Moderna Korea's medical department, was the speaker. With a total of 2,124 participants, the next generation of COVID-19 showed keen interest in the vaccine by domestic medical staff. Spikevax bivalent Original/Omicron BA.1 is a next-generation bivalent vaccine that combines 25μg of the existing Moderna COVID-19 vaccine and 25μg of a vaccine candidate substance targeting the omicron mutation (BA1). On the 8th of last month, it was approved for emergency use by the Ministry of Food and Drug Safety as a vaccine to prevent COVID-19 over the age of 18. From the 11th, a divalent vaccine can be vaccinated. The main announcement on this day is phase 2/3 clinical data that evaluated the efficacy of Spikevax bivalent Original/Omicron BA.1. In this clinical trial, Spikevax bivalent Original/Omicron BA.1 met all major evaluation variables, including neutralizing antibody responses, compared to existing COVID-19 vaccines in participants without a history of COVID-19. The divalent vaccine booster shot increased the GMT for Omicron by eight times. Spikevax bivalent Original/Omicron BA.1 induced stronger neutralizing antibody transliteration for omicron sub mutants BA.4 and BA.5. Based on pre-vaccination, the geometric mean multiple increases (GMFR) for BA.4 and BA.5 mutations was 6.3 times that of the divalent vaccine, which was 3.5 times greater than that of the conventional vaccine. These results were consistent regardless of the presence or absence of COVID-19, including those aged 65 or older. Spikevax bivalent Original/Omicron BA.1 showed an effect consistent with the reactivity and safety profile of the currently approved booster. An official from Moderna Korea said, "According to the recently announced government's COVID-19 vaccination plan, timely vaccination with the latest vaccine is an effective way to protect the health of the public from the potential re-proliferation of COVID-19 this winter."
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- Il-Yang “has not exaggerated COVID-19 trial results
- by Kim, Jin-Gu Oct 04, 2022 06:07am
- On the 29th, Il-Yang Pharmaceutical announced that it “has not exaggerated clinical trial results” regarding the ongoing police investigation on the company’s COVID-19 drug candidate ‘Supect.’ This announcement was made in response to one media report that Il-Yang Pharmaceutical is being investigated for exaggerating the clinical trial results for its COVID-19 drug to raise the stock price. According to the report, the police saw that the company had provided misleading information to investors, claiming that ‘Supect reduced COVID-19 infection by 70% within 48 hours of administration compared to the control group’ based on its non-clinical (in-vitro) trial results. With the news, the media added that Il-Yang Pharmaceutical’s stock price soared fivefold in four months, and the company's management sold a large number of company stocks in July 2020 at the peak price. During a phone interview with Daily Pharm, an official from Il-Yang Pharmaceuticals’ explained, “The investigation is currently complete, and the results are expected to come out soon. We have fully explained the company's position to the police." The official emphasized, “We have never exaggerated clinical data nor misled the public. Also, our management has never sold a large amount of stock.” “The manipulation of clinical data or sales of stock by management are all just accusations that were made unilaterally by some investors. The investigation was carried out because these investors repeatedly filed claims to the police.” “All clinical trials have the potential to fail. Failing a trial is not a crime. Also, we are not the only COVID-19 treatment developer that failed its clinical trial.” In March, in the early stages of the COVID-19 pandemic, Il-Yang Pharmaceutical announced in-vitro trial results that showed that the company’s leukemia treatment Supect reduced COVID-19 infection. Then, the company received approval to initiate a Phase III trial in Russia through the local pharmaceutical company, R-Pharm. In March of the following year, Il-Yang Pharmaceutical officially announced that it will abandon development as the company wasn’t able to demonstrate the drug’s efficacy in its Phase III trial in Russia.
