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- 2026-03-19 08:09:25
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- Pelubi’s indication expansion, seeking for breakthrough
- by Kim, Jin-Gu Feb 06, 2020 06:30am
- Pelubi & Pelubi CR Daewon Pharm challenges the expansion of Pelubi's patented indication. Pelubi's indication for osteoarthritis is extended to dysmenorrhea. Recently, Pelubi CR’s phase III trial plan by Daewon was approved from the Ministry of Food and Drug Safety. This is a phase III clinical trial in Korea to evaluate the efficacy and safety of DW9801 in primary dysmenorrhea patients. Currently, Pelubi has indications for osteoarthritis, rheumatoid arthritis and low back pain. There are two related patents. There are formulation patents for Pelubi and formulation patents for Pelubi CR, respectively. The attempt to expand the indication is related to the recent patent challenge. Pelubi has been patented by six pharmaceutical companies since late last year. Yungjin Pharm filed a judgement on passive confirmation of the scope on the Dec 27 last year, followed by Futecs, Huons, Chong Kun Dang, Nexpharm, and Mother’s Pharmaceutical. This is why Daewon Pharm is attempting to expand the indications to Pelubi CR rather than Pelubi. The six companies' patent challenges are headed for Pelubi. Successful overcoming this patent, which expires in November 2028, will be available after September 2021, when the PMS expires. However, even if the patent is overcome, it can be prescribed only for the treatment of osteoarthritis, rheumatoid arthritis, and low back pain, which is an indication limited to Pelubi. Under the assumption that Pelubi CR is extends the indications, it cannot be used for the treatment of dysmenorrhea. So far, no patent challenge has been confirmed for the Pelubi CR. Last year, the combined Rx amount of Pelubi & Pelubi CR amounted to ₩ 28.9 billion. Prescriptions, which amounted to ₩4.6 billion and ₩5.7 billion respectively in 2014-2015, surged to ₩8.5 billion in 2016, ₩13.5 billion in 2017, ₩23.9 billion in 2018, and ₩28.9 billion in 2019. The rapid growth of Pelubi's prescription is analyzed that to there was not a little impact on the release of Pelubi CR. Pelubi was released in 2007 as the new domestic drug No.12. Since its launch. By the first half of 2015, the half-yearly prescription performance was just around ₩2.3 billion. However, since the launch of the Pelubi CR in June 2015, the semi-annual earnings have been on the rise, and since the second half of 2017, it has grown into a blockbuster drug with full-fledged operations by Daewon Pharm. Pelubi RX results (Unit: ₩100 million, Data:UBIST) for the past six years. Since the release of Pelubi CR tablet in June 2015, it has been on the rise.
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- Pharmaceuticals are focusing on domestic actions for NDMA
- by Chon, Seung-Hyun Feb 06, 2020 06:30am
- Investigations have shown that Metformin's impurity content is safe in the US and EU. In Korea, the Ministry of Food and Drug Safety has also begun inspections after deriving the test method. The US Food and Drug Administration (FDA) announced on the website that some of the Metformin products sold under the FDA approval and carcinogenic substance 'N-nitrosodimethylamine (NDMA)' was detected, but the daily intake (96 ng) was not exceeded. Of the 10 products examined, NDMA was detected only in six lots of two Metformin 1000mg ER & Metformin 500mg ER products by Actavis. Detection amount was 0.01 ~ 0.02 microgram (mcg) per tablet. NDMA test results of 10 Metformin products conducted by FDA (Source: FDA) The FDA said that the test did not confirm a sample of Metformin with NDMA detected above the maximum daily intake and currently does not recommend the recovery of Metformin in the United States. In the near future, it will be posted on the website the method for detecting NDMA of Metformin used in the laboratory. On December 6, last year, the European Medicines Agency (EMA) said on its homepage, “There are very few NDMA detected in some Metformin products sold outside of the EU. Metformin products in the European Union have not yet been detected for NDMA detection". In the near future, it is expected that the results of the investigation of Metformin NDMA detection will be released in Korea. The risk of NDMA in metformin was triggered in Singapore. On December 4, last year, the Singapore Health and Science Agency (HSA) surveyed 46 metformin products sold locally, recovering three products and detecting NDMA above the daily allowance. The whole view of the MFDS The MFDS received data on the use of Metformin from pharmaceutical companies. The MFDS has received data on the production of pharmaceuticals containing Metformin hydrochloride and the systematic investigation of raw materials used until December 17 last year. Pharmaceutical companies submitted the total number of drugs containing Metformin, items and number of production records, items and quantity without production record to the MFDS. The Metformin lineage survey at the MFDS is a preliminary activity to prepare for the detection of impurities. If a problem occurs in a particular drug substance or drug product, the intention is to follow up quickly and accurately based on the results of the systematic investigation submitted by the pharmaceutical company. The MFDS unveiled Metformin's NDMA test on January 15, a month and a half after the Metformin NDMA risks were raised in Singapore. It was suggested to test by Gas Chromatography (GC) method. The industry is alert on the results of Metformin's NDMA inspection in Korea. It is not easy for pharmaceutical companies to test whether they detect Metformin's NDMA. That's because there aren't enough institutions with analyzers to make self-checks. Some pharmaceutical companies are reportedly considering buying their own analyzers. However, it costs ₩300 to 500 million for each analyzer and every year, ₩ tens of millions in management costs are inevitable. Pharmaceutical companies fear that if Metformin is the case, with massive losses in Valsartan and Ranitidine, irreversible losses can occur. Metformin is overwhelmingly larger than Valsartan and Ranitidine. According to UBIST data of drug research institutes, the outpatient prescription market of Metformin-containing drugs in 2018 was estimated at ₩420 billion. Ranitidine, which had been suspended from selling all its products, has formed a prescription scale of about ₩200 billion, which is more than double the market. The unit price of Metformin is less than ₩100. That's an overwhelming amount of ranitidine. Outpatient Rx performance of Metformin-containing medicines by year (Unit:₩100 million, Source: UBIST) Tensions are heightened by pharmaceuticals, as the MFDS has taken tough measures on impurities-detecting drugs. In the case of Valsartan, the MFDS discontinued the sale of drug products that used the ingredients in question at least once in January 2015. Many products are likely to be discontinued even though they did not use the raw materials in question. In the United States, only the products using the Zhejiang Huahai Pharmaceutical raw materials were recovered by manufacturing unit. No action was taken to sell the entire item. In Europe, the measure of action was similar. All ranitidine products have been discontinued in Korea. while in the US and Europe, pharmaceuticals were collected by their own lot numbers. In the case of 13 items of Nizatidine have been discontinued, but some of the products have been recalled in Japan, and no products have been ordered in the United States and Europe. An official from the MFDS said, "We are in the process of inspecting the Metformin NDMA test after deriving it".
- Company
- HIV drug as alternative treatment for new coronavirus?
- by Nho, Byung Chul Feb 06, 2020 06:30am
- In the midst of the novel coronavirus outbreak, a few countries are using HIV medication as an alternative treatment. 48 hours after receiving HIV drug, a confirmed patient with initial symptoms in China and a 40-year-old female patient in Thailand have been tested negative for the novel coronavirus. In Korea, the 14th patient has been reportedly treated with HIV drug and Tamiful together. Then why is HIV drug used on a patient against the novel coronavirus? The notion started with the unique inserts in the novel 2019 coronavirus that could be blocked from viral replication with similar mechanism used in HIV drug. HIV medication does not eliminate the virus itself, but inhibits replication of body cell infected with the human immunodeficiency virus. The mechanism repurposes the quality of virus naturally dying when the viral replication has been shut off. In other words, it is unrelated to human immune system. Such mechanism is named ‘repurposing combination therapy,’ because it repurposes combination of existing HIV drug and new flu treatment Tamiflu as an alternative treatment option for the novel coronavirus without a corresponding treatment at the moment. Professor Kim Young-bong of molecular virology at Konkuk University explained, “HIV treatment has protease inhibitor designed to obstruct the action of protease enzyme. While virus repeats producing and fusing polypeptide to replicate (polyprotein), HIV treatment hinders protein from cleaving to become a new virus.” For example, if virus “A” are to produce protein to replicate as virus “B,” “C,” and “D,” the protease inhibitor prevents further replication by blocking out protease connected to B, C, and D. Virus stops replicating when protein-breaking-down enzyme, protease, secretion is inhibited. In short, if coronavirus were to have infiltrated and infected 100 human cells, HIV drug could prevent those infected cells from cleaving into thousands and billions of viruses and let them die naturally. The novel influenza virus treatment, Tamiflu also does not kill the virus itself, but uses neuraminidase mechanism of inhibiting infected cell from proliferating in non-infected cells. The HIV drug currently prescribed to novel coronavirus-infected patients is confirmed to be protease inhibitor Kaletra (ritonavir plus lopinavir). Presumably, the HIV medication is prescribed as first-line treatment to focus on preventing replication of the novel coronavirus and relieving symptoms. Meanwhile, there are approximately 21 HIV treatments available in the market, including nucleoside reverse transcriptase inhibitor (NTRI) Kivexa, non-NTRI Edurant, fusion inhibitor Fuzeon, and CCR5 inhibitor Senzentry.
- Company
- Global companies work from home due to outbreak
- by Kim, Jin-Gu Feb 06, 2020 06:29am
- Impact of the novel coronavirus is spreading through the Korean pharmaceutical industry. Currently, at least nine pharmaceutical companies have been confirmed to work from home and the number is increasing. The industry reported on Feb. 3, Pfizer Korea, Novartis Korea, MSD Korea, AstraZeneca Korea, Bristol-Myers Squibb Korea, Sanofi-Aventis Korea, AbbVie Korea, Amgen Korea and UCB Korea have decided to have their employees work from home. Apparently, all nine of them are multinational companies. On last weekend, MSD Korea has notified all employees that “Employees assigned at a contact point with all clients should work from home from Feb. 3, and employees at office are strongly recommended to work from home.” As for AbbVie, all expecting employees have been recommended to work from home from Jan. 28. The rest of the employees are also working remotely from home from Feb. 3 to coming Friday. Other global pharmaceutical companies have been notified similarly. Pifzer and Novartis have been advised to work from home from Feb. 3. Most of the companies plan to do so until coming Friday. Bristol-Myers Squibb, on the other hand, only advised salespeople to work from home. Employees at Sanofi may work from home upon request. However, employees who are expecting or have young child at home are strongly advised to work from home, unless there is an urgent circumstance. Amgen Korea has been quick to call the decision and had every employee work from home from Jan. 30. Other multinational companies, yet to have recommended working from home, are watching the general industry taking steps. A multinational company insider commented, “The company has not finalized the decision, but it’s contemplating on various measures including working remotely from home watching the spread of novel coronavirus infection.” Meanwhile, none of Korean pharmaceutical company has been confirmed to be working from home. Still, they have required all employees to wear mask when in contact with others, to self-quarantine when having suspicious symptoms, and to tend personal hygiene. A Korean pharmaceutical company insider explained, “The company officially advised employees to refrain from visiting hospitals, where confirmed patient either visited or is admitted, and to must wear mask when enter those hospital.” The insider added, “Although employees with suspicious symptoms like high fever are required to stay at home, no specific guidance on working from home was disseminated.” Another Korean company’s insider explained, “Unlike multinational companies, it would be highly unlikely that a Korean company would ask all of their employees work from home. Majority of global company employees usually visit general hospitals, but Korean company employees usually visit local clinics. So it would be impractical.” But the industry’s concern is deepening as more hospitals and clinics are banning salespeople from visiting. Major general hospitals like Konkuk University Hospital, Inje University Seoul Paik Hospital, and Konyang University Hospital have requested salespeople to not visit the hospitals. Sources report clinic-level healthcare institutes are also asking pharmaceutical company salespeople to refrain from visiting. The Korean company’s salesperson noted, “Some of the hospitals have contacted and requested us to avoid visiting them until the spread subsides. Hearing from many other colleagues, increasing number of clinics is also asking the same.” “On the contrary, the salespeople, whose assigned hospitals have confirmed cases, are afraid of contracting the disease as the latest news have confirmed feasibility of secondary and tertiary infection,” the salesperson added.
- Company
- Boryeong Holdings establishes a US subsidiary
- by An, Kyung-Jin Feb 06, 2020 06:29am
- Boryeong Holdings announced on January 22 that it established a local corporation in San Francisco, USA and officially started business. The local corporation name is ‘HAYAN HEALTH NETWORKS’, and Sung-won Choi, currently the executive director of the global business headquarters of Boryung Pharmaceutical, will be the first director. Boryeong Holdings explained that it had established a base in San Francisco called Hub of Bio and Life Sciences Venture Investment in the Western United States to network and accumulate information with global pharmaceutical companies, investors and early stage R & D companies in the US and Europe. The company is also planning to strengthen strategic alliances and cooperation with business companies such as Boryeong Pharmaceutical, Boryeong Bio Pharma, and Boryeong Consumer. Boryeong pharmaceutical, a subsidiary of Boryeong Holdings, is expected to accelerate the development of the next-generation target cancer drug 'BR2002'. BR2002 is a new drug candidate material that Boryung Pharmaceutical received from Korea Chemical Research Institute in 2016. It represents a mechanism that simultaneously inhibits PI3Kδ (phosphoinositide-3 kinase delta) and DNA-PK (oxyribonucleotide protein kinase), which are the major growth and regulatory factors of cancer cells. Boryung Pharm has proposed the goal of promoting global technology exports while simultaneously conducting clinical trials of 'BR101801' in Korea and the United States. Sung-Won Choi, the first director of the company, said, “The competitiveness of the biohealth care industry, where the borders of AI and digital disappear and speed becomes important, is information and networks. We will increase investment efficiency and strengthen R & D cooperation by opening a local subsidiary in the United States, which is the world's largest pharmaceutical market and has infrastructure including universities, research institutes, experts and capital”.
- Company
- 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.
- 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.
- 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.
