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- 2026-05-20 18:53:31
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- Targeted therapy and immunotherapy as new TNBC options
- by Eo, Yun-Ho Feb 05, 2020 05:59am
- 린파자와 티쎈트릭 Sources say one of highly unmet medical need, triple negative breast cancer, now has two more treatment options. The pharmaceutical industry reported on Feb. 5 that AstraZeneca’s targeted therapy Lynparza (olaparib) and Roche’s immunotherapy Tecentriq (atezolizumab) respectively received new indication in last October and January, to treat patients with triple negative breast cancer (TNBC) in Korea. The Korean health regulator has indicated poly ADP ribose polymerase (PARP) inhibitor Lynparza for patients with TNBC and gBRCA mutation, who has been treated with chemotherapy before. Lynparza’s new indication was approved based on the key endpoints demonstrated in Phase III OlympiAD study. The trial confirmed patient group treated with Lynparza showing 42 percent lower risk of disease progression and death than a group treated with standard of care. The Lynparza arm’s median progression-free survival (mPFS) was 7.0 months, whereas the standard of care arm’s was 4.2 months. Respective groups had general response rate of 59.9 percent and 28.8 percent. And a sub-analysis found olaparib-treated patient group with TNBC demonstrated benefit of reducing risk of disease progression and death by 57 percent than in chemotherapy-treated group. PD-L1 inhibitor Tecentriq was approved as a first-line treatment in combination with paclitaxel to treat patients with PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer. The Tecentriq combination therapy indication was approved based on Phase III Impassion130 trial outcome. During the trial, PD-L1 positive patient group treated with Tecentriq plus albumin-bound paclitaxel combination therapy achieved mPFS of 7.5 months, about 40 percent lower risk of disease progression and death than the placebo group. And Tecentriq combination therapy reached median overall survival (OS) of over two years in PD-L1 positive patient group, while the group’s objective response rate (ORR) was 58.9 percent when the placebo group was at 42.6 percent. 15 percent of overall breast cancer patients are diagnosed with TNBC, which is a kind of breast cancer with all negative receptors (estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2)). Showing a mix of various properties of cancer, TNBC is the most complicated and more aggressive type of breast cancer usually found in young patients. However, for a long while, chemotherapy has been the only treatment option for TNBC. Although Roche’s targeted therapy Avastin (bevacizumab) received the indication first in Korea, it has remained as non-reimbursed option to this day.
- Company
- Lazertinib by Yuhan launches global phase III clinical trial
- by An, Kyung-Jin Feb 05, 2020 05:59am
- (From left) Professor Kyung-Hee Lee, Youngnam University Hospital, Jin-Hyung Kang, Seoul St. Mary Global Phase III clinical trial of anticancer drug candidate 'Lazertinib' by Yuhan is in full swing. On the 3rd, Yuhan Corporation announced that it will hold an initiation meeting for each institution after receiving the Lazertinib phase III clinical trial approval (IND) from the MFDS in December last year, and will soon begin recruiting patients. So far, Serbia and Malaysia have completed application for the approval of Lazertinib for Phase III clinical trials and plan to gradually expand the clinical process to 17 countries worldwide. The research name was set to 'LASER301'. The Phase III trial aims to evaluate the potential of Lazertinib as a primary treatment in 380 patients with epidermal growth factor receptor (EGFR) mutant-positive non-small cell lung cancer (NSCLC). After randomization, the subjects were divided into four groups, and then the Lasertinib and AstraZeneca's target anticancer drugs 'Iressa (brand name for Gefitinib)' or placebo were used to compare efficacy and safety. In Korea, which has the fastest pace, 27 hospitals, including Severance Hospital, Samsung Seoul Hospital, Seoul National University Hospital, Seoul St. Mary's Hospital, and Seoul Asan Hospital, confirmed the participation. More than 100 researchers and officials attended the research conference held by Yuhan Corporation for domestic participating organizations. Lazertinib is a targeted anticancer agent being developed for primary treatment of EGFR mutant positive non-small cell lung cancer patients or secondary treatment of EGFR T790M mutant non-small cell lung cancer patients. Yuhan Corporation received $ 50 million in November 2018 from Janssen Biotech, with no obligation to return Lasertinib to technology transfer. Successful commercialization requires up to $1.25 billion, including a tiered technology fee (milestone). In phase I/II clinical trial in patients with EGFR T790M mutant-positive non-small cell lung cancer, a dose of 120 mg or more resulted in 12.3 months of progression free survival (PFS) and safety. Byung-cheol Cho, a professor at Severance Hospital, who is leading the global phase III of Lasertinib, said, “The Lazertinib study paper, which proved safety and anti-tumor effect in the Phase I/II trial of non-small cell lung cancer patients, was recognized for its value in October last year at the Lancet Oncology, and we will do our best to be a good treatment alternative for patients with high prevalence of EGFR mutation-positive non-small cell lung cancer in our country”. An official of Yuhan Corporation said, "Korea is the first country in this multinational clinical trial phase III. We will make every effort to ensure that many countries enter the clinical trial phase III successfully in the future".
- Company
- Last to join HCV treatment game Mavyret tops in 1 year
- by Kim, Jin-Gu Feb 05, 2020 05:59am
- 마비렛 제품사진. Taking up 81 percent of the market share, Mavyret has been prominently leading the hepatitis C treatment market making 40.3 billion won last year. However, the prescription volume fell for two consecutive quarters due to reduced number of patients. Pharmaceutical market research firm UBIST on Feb. 3 said eight of direct-acting antiviral (DAA) treatments for hepatitis C generated 49.9 billion won for outpatient prescription last year, which was increased by ten percent than at 45.2 billion won in 2018. ◆ Mavyret dominates the market at 81 percent market share Mavyret has been predominant in the market. Owning 81 percent of the overall hepatitis C-treating DAA market pie, the treatment generated 40.3 billion won last year alone. Considering its prescription volume and market share in 2018 were respectively at 4.5 billion won and ten percent, Mavyret’s growth has basically skyrocketed exponentially. The treatment’s quarterly prescription volume started from 300 million won in third quarter 2018, which steeply soared to 4.2 billion won in following fourth quarter, 8.2 billion won in first quarter 2019, and 12 billion won in second quarter, but climbed down to 10.9 billion won in the next third quarter and 9.2 billion won in the fourth quarter. In the same period, it took up the market share of three percent, 44 percent, 71 percent, 84 percent, 83 percent and 85 percent, respectively. Mavyret is the first pan-genotypic treatment for chronic hepatitis C to be available in Korea. As other existing treatments targeted limited genotypes (type 1 to 6), it was easy for Mavyret to take over the others’ pie. Besides, the treatment’s strength of reducing about a month of treatment period than other DAA has been evaluated as its key to rapid growth. Quarterly prescription volume of 8 hepatitis C treatments (Unit: KRW 100 million) Source: UBIST ◆ Prescription volume dips for two consecutive quarters Although Mavyret seems to be at its height, no one can clearly predict how long it would last. The biggest reason is the unique quality of hepatitis C. The prevalence rate of the blood-borne virus in Korea is relatively lower than in other countries. The exceptionally outstanding effect of the drug is also affecting the descending prescription volume. DAA for hepatitis C has significantly high response rate and has short treatment period. The number of patients fell more and more, as most of the patients administered with the treatment have recovered. Quarterly prescription volume of Mavyret (Unit: KRW 100 million) Source: UBIST In fact, the overall prescription volume of all eight drug products has decreased since the third quarter of 2016. The overall volume went up for a short while from the fourth quarter in 2018, but it bounced back down since last second quarter. The trend was not so different for Mavyret, either. In last second quarter, the drug volume peaked at 12 billion won, but it kept on dropping down to 10.9 billion won in the following quarter and 9.2 billion won in the next. The fall got steeper as well. The volume fell from the second to third quarter last year by nine percent, but it took a 16-percent fall from the third to fourth quarter. ◆ Prescription volume of Harvoni, Sunvepra and Zepatier plunges As Mavyret’s market share soared, the former market leaders from Gilead Sciences, Harvoni and Sovaldi’s prescription volume took a rapid fall. Harvoni generated 4.2 billion won last year, whereas Sovaldi only generated 2.2 billion won. Compared to their golden age in 2017 respectively making 61.8 billion won and 10.7 billion won, Harvoni and Sovaldi’s pie in the market have vastly shriveled. Yearly prescription volume of 8 hepatitis C treatments (Unit: KRW 100 million) Source: UBIST Other treatments in the same market are not too far off. Bristol-Myers Squibb’s Daklinza and Sunvepra each generated 300 million won and 100 million won last year. First ones to be released as DAA for hepatitis C, the two treatments used to top the market making 36.8 billion won and 9.3 billion won, respectively. But soon after, the market was engulfed by follow-on drugs with evolved effects. Reportedly, their monthly prescription volumes (Sunvepra: 7.65 million won; Daklinza: 1.94 million won) did not even reach ten million won in last December. They would soon become the drugs of the olden days. Zepatier by MSD has made 2.6 billion won last year. Blocked by Harvoni around the launch and then by Mavyret, the MSD’s treatment has never shined through the market and is now sliding down the slope. Other hepatitis C treatment by AbbVie, Exviera and Viekira, have not been prescribed for even once from July last year. Mavyret presumably absorbed the entire pie of those two treatments. ◆ Accumulated prescription volume, Harvoni tops followed by Daklinza and Mavyret Then which company profited the most from the DAA for hepatitis C? Gilead Sciences accumulated total of 162.2 billion won up to year 2019—Harvoni generated 133.9 billion won and Sovaldi generated 28.3 billion won. Accumulated prescription volume of 8 hepatitis C treatments (Unit: KRW 100 million) Source: UBIST Bristol-Myers Squibb then followed with 74.3 billion won. The company’s Daklinza made 62.0 billion won and Sunvepra made 12.3 billion won. All three DAA by AbbVie, Mavyret, Viekira and Exviera made 49.2 billion won together. Mavyret made 44.8 billion won, and Viekira and Exviera made 4.1 billion won and 400 million won, respectively. At the bottom of the rank, MSD made 14.5 billion won for four years with Zepatier.
- Policy
- Illegal botulinum toxin dealing salesmen sent to prosecutor
- by Lee, Tak-Sun Feb 05, 2020 05:58am
- A couple of salespeople from a pharmaceutical company were caught red-handed illegally supplying botulinum toxin injections, used to reduced wrinkles, to unlicensed vendors. Korea’s Ministry of Food and Drug Safety (MFDS, Minister Lee Eui-kyung) announced on Jan. 3, it sent two salesmen, aged 44 and 40, and four unlicensed brokers to prosecutor’s office after concluding their violation of Pharmaceutical Affairs Act and illegal distribution of prescription drug, botulinum toxin injection. According to the Pharmaceutical Affairs Act, an individual, neither a pharmacy owner nor working pharmacist at the pharmacy, cannot sell or purchase pharmaceutical products for sales purpose. An investigation uncovered salesmen “A” and “B” from a pharmaceutical company have schemed to illegally supply botulinum toxin injection (total 17,470 units worth 440 million won) to unlicensed broker “C” from December 2017 to August 2019. The injection was illegally distributed either by putting an order of the injection more than the actual order from plastic surgery or dermatology hospital or clinic and pocketing the remainder, or by putting a fake order in as a hospital or clinic and selling the supply to unlicensed brokers. Apparently the motive behind the illegal dealing with broker was to raise sales performance to gain incentives and earn advantage for promotion. Moreover, the four brokers sold off the botulinum injections acquired from the salespeople to foreign buyers, so-called “peddlers,” with cash transaction. Regarding illegal pharmaceutical dealing like the botulinum injection case, MFDS vowed to strictly investigate and manage such cases to prevent Koreans from abusing or overdosing food or drug.
- Policy
- The KOEDC, real-time check on 2019-nCoV treatment
- by Lee, Jeong-Hwan Feb 05, 2020 05:58am
- The KOEDC (President Young-mi Yoon) said it is checking the overseas status of alternative treatment candidates such as antiviral agents in real time in order to cope with a 2019-nCoV infection known to have no treatment. As the agency is in charge of domestic supply and demand of rare medicines worldwide, it is intended to support the rapid introduction of candidates in Korea when a situation worsens or a drug that can suppress infection is identified. An official of the KOEDC on the 2nd said, "We immediately reported our willingness to request and support the relevant medicine checklists from the KCDC and the MFDS immediately after the Lunar New Year holidays, when the 2019-nCoV crisis began to spread". Currently, the KCDC and the MFDS have delivered lists of antibiotics and antivirals to the KOEDC that may be effective in preventing 2019-nCoV proliferation. With about 10 items, the drug name was decided to be closed because the drug's efficacy was not clearly proven. The world is focusing on the prevention of the spread of 2019-nCoV, and at the same time working on the discovery of therapeutics. Hubei Province, Hubei Province, China, which is known as the source of new virus because there is no suitable treatment, is confirming the treatment effect of the confirmed patients by replacing antiviral drugs such as human immunodeficiency virus (HIV) treatment. In fact, US pharmaceutical companies have begun sending antivirals to China at the request of Chinese health authorities. AbbVie, Johnson & Johnson and Gilead are the most representative. AbbVie decided to donate about $2 million worth of Kaletra, the first approved HIV treatment 20 years ago, to China. Johnson & Johnson has also decided to ship China's HIV drug, Prezcobix, which combines two antiviral agents. Gilead is discussing with U.S. and Chinese researchers a trial of using Remdesivir, a drug for the treatment of Ebola, in 2019-nCoV confirmors. This drug is not yet available in the United States. First, the center is keeping an eye on the global 2019-nCoV trend, including the medicines, and is checking volume and distribution of related drugs overseas continuously. In addition, a visitor list was prepared for the safety of patients and guardians who visited the center directly to receive orphan drugs, and the center has also strengthened measures to identify visitor prior symptoms such as fever and cough. In particular, the center is expected to have a significant increase in the number of visitors to receive medicines as ‘delivery of orphan drugs consignment delivery service with keeping a fixed temperature during the shipping', which has been promoted over the past year, ends this month. Therefore, the center plans to strengthen further inspection. The center expects that the average daily number of orphan drug recipients will increase to 40 to 60 people daily, which has increased by 4 to 6 times for the time being due to the completion of the pilot project. An official of the center said, "The reason for the existence of the center is the domestic supply of rare drugs overseas. We informed the KCDC and the MFDS about necessary data support plans, including candidate materials, and have a consultation system among the working groups, when they candidate data that can be used as a 2019-nCoV treatment material, we grasp the volume and distribution of overseas pharmaceuticals”. The official said, “The level of protection was also increased for the safety management of patients and guardians who visited the center directly. Since relatively severe patients are visiting, it is necessary to reinforce the countermeasures of patients with low immunity, even if they are not 2019-nCoV infected, and we are strengthening the preventive measures of visitors such as coughing and adding & considering adding a waiting room for suspect visitors”.
- Company
- Heated argument over Botulinum lawsuit in USA is expected
- by Kim, Jin-Gu Feb 05, 2020 05:58am
- A trial of the controversial botulinum toxin strain between Medytox and Daewoong Pharmaceutical began in the United States. According to the pharmaceutical industry, the US International Trade Commission (ITC) entered a trial on the 4th of the case against Daewoong Pharmaceutical and Medytox. The trial lasts four days until the 7th. The final decision was announced in October. However, on June 5, it is expected that it will be possible to determine which prevails in the form of 'preliminary judgment'. The issue is whether Daewoong Pharmaceutical's Nabota infringed the patent between Meditoxin·Allergan. The controversial use of Daewoong Pharmaceutical's strain is also likely to be revealed in this process. Daewoong Pharm and Medytox both saved their breath. Officials from both companies said in a call to the Dailypharm, "We will carefully watch the progress". Whatever the conclusion, Party defeated is predicted that a lot of damage is inevitable. The two companies have already invested nearly ₩10 billion in litigation costs. According to the financial statements of the two companies, Medytox used ₩7.8 billion and Daewoong Pharm used ₩10.4 billion as litigation costs. Further civil proceedings will be burdened by the trial results. Both Daewoong Pharmaceutical and Medytox are reportedly planning to file a civil lawsuit in Korea based on the results of the trial. Daewoong Pharmaceutical also raises concerns that Nabota's export path to the US will be blocked. According to Evolus, which is responsible for Nabota's U.S. sales, last year's cumulative sales of Jeuveau (US brand name for Nabota) was up to ₩ 39.9 billion. If Daewoong Pharm loses, the immediate sales loss of ₩40 billion is inevitable. In addition, there is no guarantee of civil action in the United States from Evolus. If a preliminary decision is made in June, the results will be served to both parties. The final decision is in October. In most cases, the results are the same as the preliminary judgment, but the opposite may be the case. The preliminary decision is made by the administrative judge and the final decision is made by the committee. There is, of course, an appeal after the final decision. They may appeal to the Federal Circuit Court of Appeals within 60 days. However, the CAFC decides whether to accept the appeal.
- Opinion
- [Reporter’s View]Trust is essential to prevent a MERS II
- by Lee, Hye-Kyung Feb 05, 2020 02:22am
- As the fourth confirmed person in China's Wuhan Pneumonia (2019-nCoV Infection) emerges, there is growing concern over whether outbreak of the Middle East Respiratory Syndrome (MERS) that occurred in 2015 could be reproduced. Beyond the concerns, people who have experienced the MERS crisis, as well as nursing institutions such as hospitals, clinics and pharmacies are terrified. On December 31, Wuhan in China, announced that 27 patients with unknown pneumonia (Wuhan pneumonia) were in quarantine treatment, the first death of Wuhan pneumonia occurred in China on January 10 this year. The incident occurred in China close to Korea, but until this time, people did not imagine that Wuhan pneumonia would become a concern of the whole nation as it was called 'SARS II' or 'MERS II'. The Korean people began to pay attention after January 20, when a Chinese woman (35) who entered Korea was confirmed as the first confirmation of Wuhan pneumonia. Until this time, Wuhan pneumonia was the 'item' covered in major daily newspapers, and there were very few articles on Wuhan pneumonia or new coronavirus in the professional journals. However, when the second confirmed person (male, 55) on the 24th, the third confirmed person (male, 54) on the 26th, and the fourth confirmed person (male, 55) on the 27th, all the media has been talking about Wuhan pneumonia or new coronavirus. It is a feeling that the 'MERS II' situation has been reproduced from the media. Five years ago, as a result of the MERS outbreak, as a journalist, I vowed to deliver prompt, accurate information to the public. In addition, I thought that the press should act as a 'bridgehead' to ensure that our government publishes the right information in the flood of false information, and that the people can trust the official announcement without disturbing the false information. This belief has not changed at all. The government is actively coping with Wuhan pneumonia faster than the MERS outbreak. The KCDC raised the warning level of infectious disease crisis from 'interest' to 'caution' after the first confirmation of Wuhan Pneumonia. The National Medical Center was designated as the 'new coronavirus infectious institution'. The Central Accident Prevention Division was set up by the Minister of Health and Welfare. Everything was done seven days after the first confirmation. People should work together to prevent the spread of Wuhan pneumonia by checking information on the outbreak trends and press releases through the website of the KCDC (http://www.cdc.go.kr/). Not only the trust of the people, the government, and the media, but also the efforts of medical professionals who are committed in the medical field are needed. On the 21st, the day after the announcement of the first confirmed patient in Korea, the Health Insurance Review and Assessment Service distributed information to medical institutions and asked for checking entrant information of the area where Wuhan pneumonia occurred through the Drug Safety Use Service (DUR). However, because the law does not enforce the use of DUR, some hospitals, clinics, and pharmacies have turned off the DUR program or have turned off the ITS(International Traveler Information System) program in the DUR. According to the HIRA, 30% of medical institutions do not use ITS. At this time, medical institutions should turn the ITS in the DUR system to 'ON' to receive information on the immigrants from Wuhan-pneumonia-infected areas and make efforts to prevent contact with them sooner. Five years ago, we overcame the MERS crisis while listening to the news of patients dying from MERS daily. According to experts, Wuhan pneumonia is likely to cause severe pneumonia, but there is no vaccine to treat. However, no deaths have occurred in Korea yet. This is because secondary infections are prevented by administering antiviral agents or antibiotics depending on the patient's condition. In the flood of information that is poured out every day, I hope that people will only select the right information and don’t forget 'hand washing' and 'masking', which are guidelines for preventing infectious diseases.
- Policy
- Insurance not covered if Revlimid prescribed multiple up
- by Lee, Hye-Kyung Feb 04, 2020 08:16pm
- Insurance will not be covered if Revlimid’s lower dose such as 5mg in multiples by Celgene is prescribed instead of Revlimid 10mg, 15mg, 20mg, or 25mg. Reimbursed price of Revlimid 25mg is ₩101,768, whereas Revlimid 2.5mg, 1/10 dose of Revlimid 25mg, is ₩53,904. If 10 tablets of Revlimid 2.5mg is prescribed instead of 1 tablet of Revlimid 25mg, it will cost more than ₩500,000. The Health Insurance Review and Assessment Service recently released the list of reimbursed pharmaceuticals with cost-effective dose in January 2020. The list was made in accordance with the revision of the pharmaceutical list and reimbursed limit table on December 31 of last year. Effective date is from March 1st. The full reimbursed list is subject to automatic computerized checks for DUR information and review of reimbursed payments. Last year, the HIRA was in the process of reconfirming unmanaged items in batches, allowing DUR additions and deletions to be adjusted. In the newly added list of oral prescription with benefit cut in case of prescribing multiple up of lower dose, a total of 200 item combinations were added due to the confirmation of production items, and 92 item combinations were designated as shortage prevention drugs and were removed from the list. In addition, the following combinations of items that were subject to DUR adjustment due to the establishment of low-high doses; Allenaon 10·20mg, Mini Ressin 0.1·0.2mg, Glimedi 2·4mg, DaeWoongBio Atorvastatin 20·40mg, Intrack 6.25·12.5mg, Pitastin 2·4mg, Matiran 20·40mg, Crowon 5·10mg, Litor 10·20mg, Esomedin 20·40mg, Leviepil 0.25·0.5g, 0.25-1g, Eso-mp 20·40mg, Since January 1 of this year, due to the elimination of the low-high doses, Elosuva 10·20mg, Dulota 30·60mg, Lowgan 10·20mg, Omertec 20·40mg, Norvasc ODT 5·10mg , and Cavedia 12.5·25mg have been dropped from the DUR screening. Injectables include Genpenem 0.5·1g, Cralevo 50·150ml, Astriaxone 1-2g, Samsung Merophenem 0.5·1g, Copenem, 0.5·1g as a result of the product confirmation, Mecapem 0.5·1g and Cifloxin 0.2·0.4g will be automatically cut from DUR when prescribed multiple up of lower dose medication from next month.
- Company
- DC passes second PARP option Zejula fast with reimbursement
- by Eo, Yun-Ho Feb 04, 2020 06:32am
- After winning National Health Insurance reimbursement, anticancer treatment Zejula has been quick to get listed on general hospital prescription list. According to the pharmaceutical industry on Jan. 4, Takeda Pharmaceuticals Korea’s Zejula (niraparib) has been passed by drug committees of 16 major hospitals nationwide, including Seoul National University Hospital, Korea University Anam Hospital, Pusan National University Hospital, Hanyang University Guri Hospital, and CHA Bundang Medical Center. The Big Fives with Samsung Medical Center, Seoul St. Mary’s Hospital and Seoul Asan Medical Center are currently in process of landing the code. A DNA repairing poly ADP ribose polymerase (PARP) inhibitor, Zejula, was indicated as maintenance treatment of adult patients with recurrent epithelial ovarian cancer (including fallopian tube or primary peritoneal cancer), who are in a complete or partial response to platinum-based chemotherapy from last July and earned reimbursement in last December. During a key clinical trial, the drug has improved median progression-free survival (mPFS) exceptionally, regardless of BRCA mutation, compared to the placebo arm. The patient group with ovarian cancer and BRCA mutation, who were treated with Zejula, has demonstrated mPFS of 21.0 months, about four times longer than the placebo group with 5.5 months. Even in the group without BRCA mutation, Zejula-treated group had mPFS of 9.3 months, showing clinically meaningful improvement than the placebo group with 3.9 months. In a recent PRIMA study, Zejula also confirmed efficacy as a first-line therapy for ovarian cancer, regardless of BRCA mutation. However, its reimbursed indication is limited to patients with BRCA mutation. President Kim Seung Cheol of Korean Gynecologic Oncology Group (Professor at Gynecologic Cancer Center of Ewha Womans University Hospital) stated, “Zejula is the first PARP inhibitor used regardless of BRCA mutation. Two to three tablets conveniently taken once daily, the drug also showed satisfying safety profile in adverse reaction as it could be managed by adjusting dose taken.” The first PARP inhibitor to be approved in Korea was AstraZeneca’s Lynparza (olaparib), and it received reimbursement in October 2017 with expenditure cap type risk sharing agreement (RSA) negotiated under pharmacoeconomic analysis exemption route. Apparently, Pfizer’s Talzenna (talazoparib) is preparing for Ministry of Food and Drug Safety’s approval as a third PARP inhibitor in Korea.
- Policy
- Patent litigation to decide prospects of Olostar generic
- by Lee, Tak-Sun Feb 04, 2020 06:32am
- For the first time, a generic drug with same active ingredient (olmesartan medoxomil, rosuvastatin calcium) contained in Daewoong Pharmaceutical’s blockbuster co-morbid hypertension and dyslipidemia treatment, Olostar, has applied for approval. Presumably, the generic manufacturer would be either Kolmar Korea or a CMO as Kolmar Korea’s bioequivalence test protocol for the generic has been approved in last March. However, the company cannot immediately release the generic product despite acquiring the item approval, because Olostar’s pharmaceutical patent is valid until Mar. 22 of 2033. The pharmaceutical industry reported on Jan. 2 that olmesartan medoxomil-rosuvastatin generic has submitted an approval application to Ministry of Food and Drug Safety (MFDS). As Olostar’s post-marketing surveillance period has expired on Jan. 28, a follow-on drug has no problem applying for approval. But the generic would face restriction according to patent-approval linkage system, because the original’s drug patent is listed on MFDS’ patent list. The original manufacturer may request for sales ban on generics via patent litigation. And if generic manufacturer wins the patent litigation, the restriction protecting the original would be lifted. Kolmar Korea has already filed negative confirmation of scope on the original to evade patent infringement on June 3 last year. And Hutecs Pharmaceutical Korea, Mother’s Pharm, Daehan New Pharm, Sinil Pharmaceutical, Hana Pharm, White Life Science, Korea Prime Pharm, Hanpoong Pharm, and Crystal Life Sciences have also filed the same case. Kolmar Korea has been developing the generic until now. The company’s bioequivalence test protocol has been approved last March to prove equivalence between tentatively named Olmetin tablet 20/20 mg and Olostar tablet 20/20 mg in healthy adult subject. Kolmar Korea has highly likely to have developed the generic drug and other patent challengers would be supplied with the contract manufactured generic. Sources report review on the negative confirmation of scope filed on Olostar has almost been completed and is waiting for the last decision. If Intellectual Property Trial and Appeal Board are to cite the generic manufacturer, the generics could be released after clearing the approval. However, the pressure of patent infringement has not been resolved fully, yet, as the patent owner, Daewoong Pharmaceutical, has a possibility of filing an appeal at a higher instance. Since the approval in July 2013, Olostar has been enjoying its success in the hypertension and dyslipidemia treatment market. According to UBIST, the drug generated total 12.1 billion won of outpatient prescription volume last year, easily surpassing the standard of Korean blockbuster drug at ten billion won. Definitely, the original has the marketability attracting the generics to hurry the early launch. But, the success of generics in the market is not guaranteed. Although a generic with the exact same substance as the original is not available at the moment, a few combination drugs with telmisartan and rosuvastatin calcium in the same class as Olostar have been released already. And 11 companies are supplying the telmisartan-rosuvastatin drugs. Moreover, the competition would intensify by coming October, as the original’s post-marketing surveillance period is to be expired then. Other combination drug for co-morbid hypertension and dyslipidemia with amlodipine besylate and atorvastatin calcium (brand name: Caduet by Pfizer) had its post-marketing surveillance period expired in 2010 and now it has total 78 follow-on drugs. Basically, the market cannot get anymore saturated. Nevertheless, small and medium companies are still betting on the generic as the number of originals with soon-to-be-expired market exclusivity is limited, and an item earning over ten million won from outpatient prescription is even rarer. Meanwhile, the original manufacturer is expected to take aggressive legal action against the generic manufacturers, because the generic entering the market would impact the company with drug pricing reduction. Accordingly, Daewoong Pharmaceutical would likely to concentrate on patent litigation.
