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- 2026-05-11 15:16:33
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- "Ezetimibe combination drug, now key option in dyslipidemia"
- by Eo, Yun-Ho Jul 15, 2020 06:33am
- Professor Heo Jung Ho Statin has been demonstrating outstanding efficacy in low-density lipoprotein cholesterol (LDL-C) level control, while showing an assuring benefit in risk of cardiovascular death. The medicine has surely shifted the paradigm of dyslipidemia management. Nevertheless, there is no perfect drug in this world. Statin also has concerning reports of risk of diabetes and musculoskeletal adverse reactions when using high-dose (high-intensity). Still, the ‘statin plus ezetimibe’ combination is well sought after in the market. Following the current trend in cardiovascular disease treatment—the lower the LDL-C, the better for the benefit in cardiovascular system—the combination drug has taken up a significant share of the pie in dyslipidemia treatment prescription. Even in Korea, many pharmaceutical companies have combined ezetimibe with atorvastatin or rosuvastatin to launch combination drugs. The released drugs have now settled in the market. Daily Pharm interviewed Professor Heo Jung Ho of cardiology division at Kosin University Gospel Hospital to hear about his opinion on the ezetimibe and its efficacy. -Generally, when is ezetimibe combination therapy used? Personally, I still follow the pattern of initiating the prescription from moderate to high-dose statin through high-dose statin. But in some cases, patients cannot reach the recommended LDL-C target level at 70 mg/ dL (Korean guideline), or 55 mg/ dL (U.S. guideline), even with high-dose statin. And this is when I use the ezetimibe combination drug. And for patients seeing musculoskeletal adverse reaction or having high risk in diabetes, the ezetimibe combination therapy could be a good option. -What is your opinion on using the ezetimibe combination therapy as a first-line treatment for dyslipidemia patients? A clinical study in Korea is in process to confirm clear evidences. Currently, Professor Jang Yangsoo at Yonsei University Severance Hospital is leading the head-to-head comparative trial of high-intensity statin and ezetimibe combination therapy in over 3,000 patients with cardiovascular disease in Korea. 200 of the participating patients are registered from Kosin University Hospital. The outcome of the study to be disclosed in three years would give us some clearer answers. Personally, I expect both of the groups would demonstrate clinically meaningful result and efficacy. -Between rosuvastatin and atorvasutatin, what are some circumstances to be considered when prescribing a combination therapy? There is no big difference between the two. But some patients prefer either ‘atorvastatin plus ezetimibe’ or ‘rosuvastatin plus ezetimibe.’ In such case, I base my decision on clinical evidences. The effects of 20 mg of rosuvastatin and 40 mg of atrovasutatin are on par, but the combination that noticeably lowers LDL-C level would be used. -Do you prefer to use a combination drug for ezetimibe combination therapy? First of all, the combination drug is obviously more convenient. The medication convenience along with adherence is high. Patients these days ask many questions and research more information online when the number of drugs goes up. A combination drug is easy to explain how the effect is better with the same amount of drugs, and the patients also comply with the medication well. Moreover, the price of combination drug in Korea is comparatively lower against in other countries. As chronic disease patients are sensitive to the cost, the healthcare system in Korea has also boosted the preference in combination drug. - The Korean dyslipidemia treatment guideline recommends ezetimibe therapy as a second-line therapy. Although the U.S. and Europe recommends LDL-C level in the said ultra high risk group to be lowered to 55 mg/ dL and 40 mg/ dL, respectively, Korea recommends the level to be lowered to 70 mg/ dL. The bottom line is that I agree with the slogan of ‘the lower LDL-C is the better.’ However, it is not the absolute rule to be followed. I personally treat patients targeting LDL-C level at 70 mg/ dL at the moment. But when the patients show risk factors like acute coronary syndrome (ACS), myocardial infarction (MI) or peripheral artery disease (PAD), the target level is lowered to 55 mg/ dL. These patients should be more aggressive in lowering the LDL-C level. And if their level does not respond with ezetimibe, Proprotein convertase subtilisin/ kexin type 9 (PCSK-9) inhibitor is prescribed to breakthrough. According to the healthcare reimbursement standard, ezetimibe has to be prescribed as prerequisite. And this is one of the factors raising the prescription rate of combination drug.
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- Zepzelca by Boryung designated as an orphan Drug
- by An, Kyung-Jin Jul 15, 2020 06:33am
- ZepzelcaBoryung announced on the 13th that it is in the process of receiving a new drug called small-cell lung cancer (SCLC) 'Zepzelca' (Lurbinectedin) as an orphan drug. Zepzelca is an anticancer drug that Boryung has exclusive rights to domestic development and sales. In 2017, Boryung signed a technology introduction contract with PharmaMar in Spain. Since Lurbinectedin obtained a sales license from the FDA last month, it is adjusting the timing of its introduction in Korea. It is confirmed that the application of an orphan drug has been recently submitted to the MFDS and the supplementary documents have been submitted. The indication that Zepzelca has been approved for this time is for adult patients with metastatic small cell lung cancer whose disease has progressed since platinum chemotherapy. The FDA made a rapid approval decision based on data from phase II clinical trials that proved superiority in terms of safety and effectiveness through indirect comparison with the existing treatment, Topotecan. The condition is that additional phase III clinical trial data must be submitted to remain approved. Small cell lung cancer is one of the most aggressive types of lung cancer. It has been known to cause metastasis from the early stages and a high recurrence rate after treatment. Anti-cancer drugs currently approved in Korea for secondary treatment for small cell lung cancer include Novartis Korea's 'Hycamtin' (Topotecan) and Chong Kun Dang's 'Camtobell' (Belotecan). Boryung plans to apply for phase III conditional domestic permit application in the same way as the United States when the designation of an orphan drug of Zepzelca is completed. It is expected that the acquisition of a domestic license will be a new treatment option in the field of recurrent small cell lung cancer. Kim Yeong-seok, chief of anticancer drugs at Boryung said, "Small cell lung cancer is a disease with poor prognosis and limited treatment options, but if Lurbinectedin is quickly approved through the designation of an orphan drug, it is expected to provide new treatment options to domestic patients and medical staff."
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- Xofluza efficacy confirmed in household transmission
- by Eo, Yun-Ho Jul 14, 2020 06:12am
- A next-generation flu drug Xofluxa’s effect of preventing flu virus transmission among the patient’s household member has been confirmed. The latest edition of New England Journal of Medicine (NEJM) published on July 8 reported the clinical findings of Xofluza (baloxavir marboxil) and its flu preventive effect. The study evaluated the flu drug’s positive post-exposure prophylaxis efficacy on household contacts by administrating Xofluza. The outcomes of post-exposure prophylactic efficacy of the drug were confirmed based on household contacts of confirmed flu patients during the 2018–2019 flu season. After identifying the index patients confirmed with influenza of their households from November 2018 through March 2019, the researchers conducted a positive rapid flu diagnostic test on the patients and administered either Xofluza or neuraminidase inhibitor as an antiviral treatment. Based on the clinical trial participants consisting of 545 influenza patients and 752 household contacts, the study screened them twice-daily for axillary temperature until day 10 since the initial influenza diagnostic test and had at least 12-year-old participants self-monitor their influenza symptoms. 95.6 percent of the participants were tested positive for influenza A, 73.6 percent were younger than 12, and 52.7 percent were administered Xofluza. Major adverse reactions in patients over age 12, such as cough and sore throat, headache, nasal discharge or congestion, feverishness or chills, muscle or joint pain, and fatigue were noted. In the age group under 12, different levels of severity was scored by identifying symptoms like cough and nasal discharge or congestion. Participants developing moderate to severe level of flu-like symptoms like fever were instructed to visit respective clinical institutes and provide their samples with nasopharyngeal swabs. The obtained sample was processed with reverse-transcriptase-polymerase-chain-reaction (RT-PCR) analysis to confirm influenza virus, virus type and subtype. The study’s primary efficacy endpoint was the laboratory-confirmed clinical flu, and the secondary endpoint were a ratio of RT-PCR-confirmed viral infection regardless of fever of flu-like symptoms against RT-PCR-confirmed patients with body temperature of at least 37 degrees Celsius or demonstrating at least one moderate or severe symptom. Analyzing Xofluza group of 374 participants and placebo group of 375 participants, the ratio of patients developing clinically-confirmed influenza was lower in Xofluza group against the placebo group. The outcome was noticeably contrasting between 1.9 percent in the Xofluza group and 13.6 percent in the placebo group. The efficacy was also apparent in subgroup analysis in unvaccinated, high-risk and pediatric groups. In the Xofluza group, regardless of symptoms, the influenza risk was measured 57 percent lower. Moreover, the risk of adverse reaction in both groups of Xofluza and placebo did not show significant difference at 22.2 percent and 20.5 percent, respectively. Xofluza is a next-generation influenza drug Roche released after commercializing Tamiflu two decades ago. The new endonuclease-inhibiting flu drug is highly anticipated by the market as it can treat influenza by one-dose oral administration (Tamiflu administered for five days).
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- 14 new drugs approved from Jan to June with no Korean drug
- by Jul 14, 2020 06:12am
- Korea’s Ministry of Food and Drug Safety (MFDS) reported total 14 new drugs have been approved from Jan 1 to June 30 this year. While none of them were a Korean-made, the absence of Korean-made new drug has continued for two years now. Pfizer Pharmaceutical Korea, Astellas Pharma Korea and Bayer Korea received the highest number of new drug approvals with two products each, and Eisai Korea, Novartis Korea, AbbVie Korea, Bayer Korea, Roche Korea, Menarini Korea, MSD Korea, Daiichi Sankyo Korea and Handok respectively received one new drug approval as well. Source: Ministry of Food and Drug Safety Categorized by each month, January had the highest number of new drug approvals at four. From February to June, one, two, one, three and three new drugs were approved, respectively. By disease type, anticancer treatments (five products) had the highest number of approvals, and Janus kinase (JAK) inhibitors treating rheumatoid arthritis with two approvals came second. Early this year, Daiichi Sankyo’s peripheral neuropathic pain treatment Tarlige and Astellas Pharma’s rheumatoid arthritis treatment Smyraf were the first ones to receive approval. Pfizer Pharmaceutical’s antifungal Cresemba and MSD’s human immunodeficiency virus (HIV) treating combination drug Delstrigo followed the next. On Feb. 14, Pfizer Pharmaceutical won the health authority’s approval on second generation non-small cell lung cancer targeted therapy Vizimpro. In March, Xospata, a FMS-like tyrosine kinase 3 (FLT3) inhibitor indicated to treat acute myeloid leukemia by Astellas Pharma, and Ranexa, a novel angina treatment by Menarini were approved. In April, the Korean government green lit Roche’s anticancer treatment Rozlytrek that targets all solid tumors with neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Three new drugs were cleared in May—Handok’s paroxysmal nocturnal hemoglobinuria (PNH) treatment Ultomiris and Bayer’s two anticancer treatments (Nubeqa and Vitrakvi). Nubeqa is an oral androgen receptor inhibitor (ARi) indicated to treat non metastatic castration resistant prostate cancer (nmCRPC), and Vitrakvi is orally taken selective tropomyosin receptor kinase (TRK) inhibitor for targeted therapy. In June, AbbVie’s rheumatoid arthritis treatment Rinvoq, Novartis’ macular degeneration treatment Beovu and Eisai’s Parkinson’s disease treatment Equifina were approved in the order. Including Novartis’ Lutathera approved on July 9, the Korean health authority has cleared 15 new drugs so far this year. No Korean-made drug approved for two years, but expecting one within this year Continuing on from last year, none of the approved drugs were made in Korea this year. Although Handok owns the license over Ultomiris, the drug was originally developed by the U.S.-based company, Alexion. Similarly, all drugs sought after approval last year by Korean companies were licensed from other global companies. HK inno.N’s (formerly CJ Healthcare) potassium competitive acid blocker (P-CAB) K-CAB approved on July 5, 2018, was the last Korean-made drug. As an osteoarthritis gene therapy Invossa’s license was revoked in 2019 and Dong-A ST withdrew licenses on two types of Sivextro, three out of total 31 Korean-made drugs were removed from the market. Finally, however, a long-awaited new Korean-made drug is expected to get approved. Daewoong Pharmaceutical is seeking for an approval on its P-CAB Fexuprazan and the application has been submitted last November. Considering the review process takes approximately ten to 12 months until the final decision, the drug is expected to get passed within this year. But the novel coronavirus (COVID-19) delaying the approval review process could bring unexpected change to the estimated approval date.
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- LG Chem launches filler's clinical trial in China
- by An, Kyung-Jin Jul 14, 2020 02:34am
- china's filler market share (Source: 2019 Samsung securities reasearch) LG Chem is launching a large-scale clinical trial in China with the new product of Yvoire, a hyaluronic acid filler brand. It is an ambition to secure the differentiation and expand the market share by preparing clinical data of Y-Solution, which was introduced as a premium line. LG Chem recently unveiled a new clinical trial plan for Yvoire Y-Solution on clinicaltrials.gov, a clinical trial registration site operated by the National Institutes of Health (NIH). This study is to check the effect and safety of the volume improvement of Y-Solution 720 for 238 subjects. The researchers decided to evaluate the effectiveness by confirming the MFVDS (Mid-Face Volume Deficit Scale) response rate, which is used as a measure of the volume recovery of the central part of the face, at week 26 after the injection of Y-Solution 720. The study begins in earnest from this month and is scheduled to proceed until July 2022. Professor Xiaojun Wang of Peking Union Medical College Hospital was appointed as the Principal Researcher (PI). Yvoire Y-Solution is a premium product among LG Chem's hyaluronic acid filler brand 'Yvoire'. LG Chem introduced Y-Solution series in 2018 to target the premium wrinkle improver market. According to the volume improvement effect, it is composed of three types: 'Y-Solution 360', 'Y-Solution 540', and 'Y-Solution 720'. According to the company, it is expected that the volume improvement effect will be further improved by supplementing the existing product 'Yvoire' with additional viscosity. It is interpreted as the will of LG Chem to actively target the overseas market with filler products. LG Chem started exporting to Russia in 2012 and has exported Yvoire to more than 30 countries including China, France, the UK, Italy and Mexico. China's filler market share (Source: 2019 Samsung securities report) In the case of the Chinese market, it has secured the initiative by introducing the existing Yvoire products early. According to the '2019 Healthcare Report' published by Samsung Securities, among the 7 companies that occupy the hyaluronic acid filler market in China, LG Chem and Humedix are included in Korean companies. LG Chem's 'Yvoire' market share is about 26%, and Elravie by Humedix is about 13%. It is judged that it is necessary to rapidly increase the penetration rate of the market through the launch of new products as China has rapidly emerged as a base for filler industries worldwide. LG Chem is conducting a clinical trial comparing 'Y-Solution 360' with Allergen’s Juvederm in Germany. An official from LG Chem said, "Yvoire has maintained the best selling fillers in the Chinese market by surpassing Chinese local brands and global brands for 4 consecutive years since 2016." "In the future, we plan to expand the sales of Yvre in the center of Europe and South America as a global brand" added him.
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- DongKook & YuYu have challenged Dutasteride &Tadalafil
- by Kim, Jin-Gu Jul 13, 2020 06:13am
- The prostate hyperplasia & erectile dysfunction complex market competition is expected to become even hotter. Gugu tams sales by year (Unit: ₩100 million, Data: IQVIA)With only Hanmi's Gugu tams (Tamsulosin + Tadalafil ) released on the market, DongKook and YuYu Pharma have challenged. According to the pharmaceutical industry on the 13th, DongKook recently approved a clinical trial phase III IND for the development of a combination drug of prostate hyperplasia and erectile dysfunction. DongKook is developing a combination of Dutasteride-based prostate hyperplasia treatment and Tadalafil-based erectile dysfunction treatment. YuYu Pharma is slightly ahead of Dongkuk in the development situation. YuYu Pharma has started clinical trial phase III of the same combination of YY-201 in 2018. A clinical trial is underway in 942 patients with prostate hyperplasia at the Catholic University of Korea Seoul St. Mary's Hospital. If YuYu Pharma and Dongkuk succeed in developing the combination drug, three companies including Hanmi will compete. Gugu tams (Tamsulosin + Tadalafil)Hanmi is currently the only drug in the domestic market that has released 'Gugu tams' as the combined prostate hyperplasia and erectile dysfunction treatment. However, the ingredients are slightly different from the combination drugs that YuYu Pharma and Dongkuk are developing. The active ingredient for erectile dysfunction is same as Tadalafil, but the active ingredient for prostatic hyperplasia contains Tamsulosin, not Dutasteride. In the industry, synergy of prostate hyperplasia and erectile dysfunction is expected to be popular. This is because many patients suffer from both diseases at the same time. According to the Korean Prostate Society, 30-40% of erectile dysfunction patients in their 50s or older in Korea are accompanied by prostatic hyperplasia. According to the drug market research agency IQVIA, the annual sales of Gugu tams are ₩100 million in 2016, ₩1.1 billion in 2017, ₩1.5 billion in 2018, and ₩1.9 billion in 2019. Sales of ₩500 million were raised by the first quarter of this year. Gugu tams sales by year (Unit: ₩100 million, Data: IQVIA) Given that there are many generics in the erectile dysfunction market, this is not a bad outcome. In fact, Gugu tams ranked 11th in the treatment of erectile dysfunction in the first quarter of this year. In particular, in the first quarter of this year, the erectile dysfunction drug market decreased 4.8% year-on-year, and sales increased 5.4% YoY. For this reason, many pharmaceutical companies have developed prostate hyperplasia and erectile dysfunction in the past. Around 2015, along with Hanmi, Chong Kun Dang, Ildong, and Yungjin challenged the development of a Tamsulosin + Tadalafil combination. Yungjin started with YBH-1603 from April 2015, Chong Kun Dang with CKD-397 from June 2015, and Ildong with Double T from December 2015. They initiated Phase III clinical trials to develop a combination of Tamsulosin + Tadalafil combination. However, Hanmi is the only company that has successfully developed. The rest of the pharmaceutical companies have ended the clinical trial, but have not released it. It was reported that a drug company that entered the development at the time proved the effectiveness of Tadalafil, but did not demonstrate the efficacy of Tamsulosin.
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- Eligibility for HPV vaccine Gardasil9 extends up to age 45 i
- by Eo, Yun-Ho Jul 13, 2020 06:12am
- A promotional image for prospective Gardasil9 recipients with expanded vaccination eligible age group Vaccination eligible age for the human papillomavirus (HPV) vaccine Gardasil9 has been extended up to age 45 in Korea. Pharmaceutical industry sources reported Ministry of Food and Drug Safety (MFDS) has approved MSD expanding the indication to vaccinate in female aged 27 to 45. Unlike the U.S., however, the Korean health authority excluded male from the eligible subject scope. The number of young patients with cervical cancer is surging in Korea. Health Insurance Review and Assessment Service (HIRA) reported the number of patients with cervical cancer in 2015 was at 54,603. But the figure soared by 15% in 2019 with 63,051 patients. In the same span of time, the number of patients in 20s and 30s skyrocketed by 47 percent, whereas the number in 40s and 50s was increased by 7 percent. Gardasil9 covers the most number of HPV types, in which it added five more types of HPV (Type 31, 33, 45, 52, 58) from the original Gardasil (Type 6, 11, 16, 18). In Korea, the vaccine is used in female and male aged from nine to 26 to prevent HPV-related cervical cancer, vulva cancer, vaginal cancer and anal cancer. Also the effectiveness of preventing precancerous cervical changes, dysplasia and genital warts has been recognized as well. The indication to vaccinate people aged from 27 to 45 was approved in the U.S. two years ago. In a clinical study on 3,200 women aged from 27 to 45, Gardasil9 demonstrated 88 percent prevention effect in HPV-induced cervical cancer. The study also confirmed the vaccine’s effect on male vaccine recipients. The Korean market supplier of Gardasil9, MSD Korea, is currently in a joint sales and marketing partnership with GC Pharma over the vaccine. The two companies have been in a close partnership since 2013 when they inked the shingles vaccine Zostavax co-sales deal.
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- General hospitals to prescribe Jeil Pharmaceutical Lonsurf
- by Eo, Yun-Ho Jul 10, 2020 06:13am
- Major general hospitals in Korea are readying prescription of Jeil Pharmaceutical’s Lonsurf indicated to treat patients with colorectal cancer. According to pharmaceutical industry sources, Lonsurf (tipiracil/ trifluridine) has been passed by drug committees (DCs) at the Big Five—Seoul National University Hospital, Samsung Medical Center, Seoul Asan Medical Center and Severance Hospital. Jeil Pharmaceutical won the sales license in Korean market over Lonsurf from Japan-based Taiho Pharmaceutical. The drug is indicated to treat patients with metastatic colorectal cancer previously treated with fluoropyrimidine‑, oxaliplatin‑ and irinotecan‑based chemotherapy, an anti‑vascular endothelial growth factor (VEGF) biological therapy, and an anti‑epidermal growth factor receptor EGFR therapy (if confirmed as RAS wild type). It was approved for Korean market in October last year. The drug uses tipiracil to inhibit thymidine kinase that breaks down trifluridine to maintain the blood concentration. A clinical study confirmed Lonsurf’s statistically meaningful improvement in overall survival (OS) against the best supportive care and the treatment meeting the primary clinical endpoints. The drug’s safety was also confirmed in another clinical study conducted previously. As of 2016, according to Korea Central Cancer Registry (KCCR) report, the number of patients diagnosed with colorectal cancer in Korea reached 28,127, coming second after stomach cancer. And the demand for drugs to be used in patients, who do not respond to standard of care, is rising. Specifically, Lonsurf is taking the limelight as a new treatment option that meets the demand. Lonsurf is approved in 75 countries and regions around the world including Korea as a treatment for metastatic colorectal cancer. In last year, the drug was also indicated to treat metastatic stomach cancer in the U.S., Japan and Europe. The drug globally generates approximately USD 30 million. The U.S. National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO) guidelines respectively recommend Lonsurf as ‘Category 2A’ and ‘Level 1/ Grade B’ to patients with metastatic colorectal cancer who have failed to respond to standard of care.
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- 66 companies complain choline alfoscerate coverage reduction
- by Jul 10, 2020 06:13am
- A group of pharmaceutical companies filed a complaint against the government’s decision to reduce coverage on choline alfoscerate drugs. Choline alfoscerate drugs in Korea On July 8, 66 pharmaceutical companies with choline alfoscerate issued a joint statement about their complaint filed for Korea’s Health Insurance Review and Assessment Service (HIRA) to reassess the reimbursement adequacy. The companies reprimanded the decision contrasts against the government’s objective of adopting selective reimbursement system as the pharmaceutical expenditure among senior citizens would rise significantly, it does not properly reflect social demand on the drug, and they claimed the unreasonable decision goes against the order of executing clinical reevaluation first followed by reimbursement reevaluation. The 66 companies argued, “Steeply raising the patient copayment rate from 30 percent to 80 percent on some of choline alfoscerate’s indications (mild cognitive impairment and depression) completely contradicts the foundational goal of National Health Insurance coverage enhancement initiative that provides coverage on non-reimbursements (selective reimbursement system) to lower patient’s burden on medical expense and to improve medical accessibility.” The companies added, “While the global medical scene is still seeking for a proper dementia treatment, lowering the coverage rate on choline alfoscerate that delays the progression of dementia in order to save finance also contradicts the National Dementia Management Program.” The government's decision would leave no choice for the economically vulnerable senior citizens but to give up on using the drug. The companies also rebuked the decision does not properly reflect the social demands based on financial impact, medical importance, affected age group, and patient’s financial burden. To accommodate the social demand, the current special case in patient copayment imposes differentiated rate by categorizing depression as a mild case (copayment rate at 40 percent to 50 percent when prescribed in general hospital), and stroke as a severe disease (copayment rate at 5 percent). However the pharmaceutical companies states the new reevaluation on choline alfoscerate has fixed the copayment rate at 80 percent for all three indications—emotional and behavioral change, senile pseudo-depression, and secondary symptoms induced by mild cognitive impairment and stroke with risk of progressing into dementia. They also complained the order of reimbursement reevaluation was shuffled. The companies criticized, “Generally, drugs undergo reimbursement listing procedure after receiving an item approval, but choline alfoscerate had its reimbursement feasibility evaluation before re-verifying the safety and efficacy of the drug,” and “as a result, the affected pharmaceutical companies’ motivation to conduct the clinical reevaluation on choline alfoscerate has greatly diminished.” The 66 companies urged, “Choline alfoscerate has been prescribed for over two decades in Korea, and even the clinicians stress the reimbursement should be reevaluated based on the Ministry of Food and Drug Safety’s (MFDS) approval details.” On June 11, HIRA has decided to grant selective reimbursement on choline alfoscerate after reevaluating the drug’s reimbursement feasibility. A patient diagnosed with dementia taking choline alfoscerate drug to improve symptoms like cognitive impairment would maintain the copayment rate of 30 percent. But patient prescribed with the drug without the diagnosis would pay 80 percent of the pharmaceutical expense as copayment.
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- No obligation to notify the originals of the split strategy
- by Kim, Jin-Gu Jul 09, 2020 06:27am
- In the patent dispute of Galvus (Vildagliptin),” a diabetes treatment for DPP-4 inhibitors that was recently completed, a blind spot in the licensed patent linkage system occurred. Generic company did not “notify” the original company of the fact that they applied for an item license in the process of challenging patents with a so-called “split indication” strategy. The original company claimed that it was in violation of the Pharmaceutical Affairs Law and the item license was invalid. In response, the MFDS, "It is not considered a violation of the Pharmaceutical Affairs Law." If there is another attempt to overcome the patent with the indication splitting strategy, it is still necessary to decide whether to notify according to the current regulations. ◆Controversy over the violation of the Pharmaceutical Affairs Law in the process of Hanmi's Galvus' patent dispute GalvusHanmi voluntarily withdrew its approval for Vildagle 50mg, generic for Galvus on the 6th. As a result, the patent dispute over Galvus was ended. 'Split indication', which received attention as a new patent overcoming strategy, lost its power. The controversy over the “violation of the Pharmaceutical Affairs Law” was raised in this dispute. The original company, Novartis, filed a claim that Hanmi was violating the Pharmaceutical Affairs Law because it did not notify them of the application for an item license in the process of challenging the patent. According to the licensed patent linkage system stipulated in he Pharmaceutical Affairs Law and the Patent Law, the generic company must notify the patent holder of the application for permission within 20 days from the filing date when applying for a license for a drug listed on the patent list. Hanmi Pharm said there was nothing wrong with it. It was argued that there was no obligation to notify, as the application for an item license was made to the extent that the patent rights were ineffective. Hanmi applied without excluding one of the five Galvus indications. It is a narrow interpretation of the effect of patent rights applied to Galvus. The reason was that Galvus patent is limited to 3 out of 1 to 5 indications. The MFDS has accepted the application. In January of this year, Vildagle was licensed. In April, insurance benefits were also registered. However, Hanmi did not release the product due to ongoing patent disputes. ◆How is the notification obligation required for registration? Novartis filed a lawsuit against the MFDS to revoke the license. It was alleged that the permission of the MFDS was also invalid, because the notice obligations prescribed by the licensed patent linkage system were not observed. As a result, the dispute ended with happening because Hanmi lost the patent trial and voluntarily withdrew the item license from Vildagle. If another generic company challenges the patent with a splitting strategy, it is unclear whether or not the original company should be notified of the application for an item license.. ◆The MFDS, "It is difficult to understand it as a violation of the Pharmaceutical Affairs Law" The MFDS said that there would be no problem without notifying the original company. An official from the MFDS said, “There is no change. It is not a violation of the Pharmaceutical Affairs Law if the scope of the application for item licensing is not related to the extended patent content." "It is legally dependent on what the permission is," he said. "It can be interpreted based on the contents of the extension of the patent office.” However, he said, “The patent judge interpreted the scope of the patent right as specified in Article 95 of the Patent Act as a trial decision. As Hanmi failed to avoid Galvus patents (with a splitting strategy), it is highly unlikely that other pharmaceutical companies will pursue the same strategy.”
