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- 2026-03-19 01:38:07
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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.
- Company
- 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.
- Company
- 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.
- Company
- 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.
- Company
- 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.
- Company
- 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.”
- Company
- Amgen won the second trial of 'Enbrel' patent
- by Kim, Jin-Gu Jul 09, 2020 06:26am
- Samsung Bioepis, Benepali in Europe, and Eticovo in US Samsung Bioepis' Enbrel biosimilar 'Eticovo' (Etanercept) is expected to postpone the US debut. A patent lawsuit was conducted that could affect the Eticovo's early launch strategy, but the US court sided with the original company. According to the pharmaceutical industry on the 6th, the U.S. Federal Court of Appeals earlier this month has sided with the original company in a patent lawsuit between Enbrel's patentee, Immunex and biosimilar maker Sandoz. Immunex is a subsidiary of Amgen. This is the same result as the first trial made by the New Jersey District Court. The court respected the original trial that Sandoz company's failure to provide sufficient grounds to prove Amgen's patent invalidity. As a result, Amgen succeeded in maintaining and defending Enbrel's patent until 2029. However, the possibility of reversal remains. Immediately after the second trial was announced, Sandoz announced its intention to appeal the third trial. The reason that Sandoz and Amgen's litigation has attracted attention is that this ruling also affects Samsung Bioepis' Eticovo. Sandoz and Samsung Bioepis are actually in a patent dispute with Amgen. Enbrel biosimilar ‘Erelzi’ by Sandoz was approved by the U.S. Food and Drug Administration (FDA) in 2016. Eticovo by Samsung Bioepis was approved in April 2019. However, the two companies are unable to release products to the US market. They have the challenge of overcoming Amgen's patent. It is analyzed that Eticovo’s case is likely to follow the results of Erelzi’s case. It means that it is also determined whether Eticovo will be launched early according to the results of the patent lawsuit between Sandoz and Amgen, which will be judged by the US Supreme Court. Samsung Bioepis is actually watching the lawsuits between Sandoz and Amgen. It is said that there is no full-scale pleading after the lawsuit under the licensed patent linkage system began in April of last year. An official from Samsung Bioepis said, "We are watching the results of the lawsuit between Sandoz and Amgen." Samsung Bioepis currently has four biosimilars in the United States. Eticovo, Remicade biosimilar 'Renflexis', Humira biosimilar 'Hadlima', and Herceptin biosimilar 'Ontruzant', etc. Of these, Renflexis and Ontruzant are currently on sale. Eticovo & Hadlima have been postponed due to patent. However, Hadlima can be released after 2023 according to an agreement with the original company, AbbVie.
- Company
- Phase III clinical trial plan for Rimatil has been submitted
- by Nho, Byung Chul Jul 08, 2020 09:14am
- Chong Kun Dang added a clinical pipeline for COVID-19 treatment following Nafabeltan. On the 18th of last month, Chong Kun Dang began the development of a COVID-19 treatment (clinical phase II) for its anticoagulant and acute pancreatitis treatment drug Nafabeltan (Nafamostat) on the 18th of last month. It is estimated that the mechanism of Nafamostat inhibits protease TMPRSS2, which is known to play a major role in the cell invasion process of COVID-19, and shows several hundred times more antiviral efficacy in human lung cell experiments compared to Remdesivir. On the 30th, IND application for Rimatil (Bucillamine) which is marketed as a rheumatoid arthritis treatment was submitted to the FDA. The Phase III clinical trial for Bucillamine is not directly controlled by Chong Kun Dang, but is hosted by the Canadian pharmaceutical bio company Revive Therapeutics. Rimatil is a safe drug that has been sold in East Asian countries for over 30 years, and is a licensed-introduced drug from Santen company, Japan. If the clinical trial phase III of Bucillamine is successful, Chong Kun Dang, which has exclusive domestic sales rights, will obtain COVID-19 treatment indication. Bucillamine reported that N-Acetyl-L-cysteine significantly alleviates the symptoms of respiratory viral infections and produces significantly positive results in small-scale clinical trials in preclinical and COVID-19 mild patients. According to Revive Therapeutics, the FDA has recommended the clinical phase III of COVID-19 treatment, Bucillamine, and will begin a full-scale clinical trial in the third quarter of this year. The clinical trial is conducted in a double-blind manner in 800 patients with mild COVID-19. Clinical participants receive Bucillamine 100 mg and 200 mg three times a day. The median result is 28 days after the first dose, which is the time when the dose for 210 patients is completed.
- Company
- “Liver cancer option expands, but needs further evidence”
- by Eo, Yun-Ho Jul 08, 2020 05:38am
- Professor Kim Doyoung When a new drug development in a specific area is sluggish, there are two prominent reasons why; either the disease area has low marketability or the drug development itself for the disease is very difficult. In the latter case, a new drug gets an obvious spotlight when it is released to the market. Liver cancer (hepatocellular carcinoma) would be a good example. For over a decade, Nexavar (sorafenib) was technically the only option to be used on liver cancer patients. But now, the disease specialists have heightened anticipation on other options to come. Stivarga (regorafenib) entered the market as a second-line treatment, and Lenvima (lenvatinib) was added as another first-line treatment option at the same level as Nexavar. In the U.S., Tecentriq (atezolizumab) and Avastin (bevacizumab) were approved as a combination therapy recently, which newly added an immunotherapy as an option. The situation in Korea is also taking a step at a time. Early this year, the healthcare reimbursement standard on Nexavar has been adjusted to grant the benefit on patients in Child-Pugh scoring of class B7, a severe case of the disease. The change raised the usability of the pharmaceutical treatment in liver cancer. Daily Pharm interviewed Professor Kim Doyoung of Gastroenterology Department at Severance Hospital and spoke of the hepatocellular carcinoma treatment strategy with more options available now. -First of all, what does expanded coverage on Nexavar mean for a healthcare provider? The patients in Child-Pugh class B7 were considered somewhat of ‘grey area.’ The patient’s liver function level is comparatively close to normal state, but they have risk of developing ascites or jaundice. The patients stuck in the middle did not have a clear answer to choose as a treatment option. These patients need treatment without building liver toxicity. And Nexavar, as proved in various evidences, demonstrates less liver toxicity. Basically, the liver cancer patients hopeless without a proper treatment option can now be treated with Nexavar. -What are some points to consider—like dosage control or administration suspension—when prescribing Nexavar on patients in Child-Pugh class B7? There are no specific precautions to consider. In the GIDEON study that produced global real-world data (RWD) from over 3,000 intent-to-treat participants, Nexavar barely showed much difference between patient groups in Child-Pugh class B7 and Child-Pugh class A. Regardless of class A6 or class B7, normal dosage is recommended but reduced dosage is recommended for patients showing adverse reaction. The dosage does not have to be adjusted from the beginning. -Would the transarterial chemoembolization (TACE) have some changes as Nexavar is now reimbursed and the systemic anticancer therapy option has expanded? Would it be safe to assume this is the period when healthcare providers are trying to reach a consensus on the recommended frequency of TACE and treatment ceasing point? Due to the coverage expansion, some may think of using Nexavar when the patient’s Child-Pugh scoring gets worse after repeated TACE. But the patient’s survival rate would worsen if the Nexavar administration timing is delayed and liver function starts failing according to Child-Pugh scoring. In fact, the talk of when to use systemic anticancer therapy on patients with failed attempt of TACE or refractory condition has continued for over a decade. Although some of the consensus among the healthcare providers has been documented, but it would take a while for the medical practice environment to accept the change and apply it. After practicing TACE for many times, I can see whether or not the patients either should continue on with TACE. Many healthcare providers would agree with me. The decision to continue with TACE should be made promptly but carefully, and switch to another option, if need be. At some point, there was a talk on how beneficial it is to quickly switch to systemic anticancer therapy after TACE. But the argument lacks sufficient evidence in improving the survival rate. -Does that mean, in some cases, there is a concerning factor when following up promptly with a systemic anticancer therapy after TACE? In the past, when Nexavar was the only option of systemic therapy for treating liver cancer, the healthcare providers regarded switching to a systemic anticancer therapy after TACE as a ‘last resort.’ So the treatment switch was not fast enough and it was worrying. But now the healthcare providers seem to agree more that a systemic anticancer therapy is not a ‘last resort,’ as Nexavar is prescribed to patients with comparatively good functioning liver, and also because a follow-on drug Stivarga is commercialized. -As Nexavar is the only systemic anticancer therapy with coverage for patients in Child-Pugh class B7. These patients do not have a choice in later-line treatment with coverage Stivarga’s global REFINE study conducted in a real-world practice conditions in 1,000 patients, diagnosed with unresectable hepatocellular carcinoma, included many of patients in Child-Pugh class B and other more severe cases. Regardless, the study confirmed improved efficacy against Stivarga in global Phase III RESOURCE trial. Based on these findings, Stivarga’s coverage should be expanded to patients in Child-Pugh class B7 for them to resume treatment after Nexavar. -Recently, a combination of immunotherapies was passed by the U.S. health authority. What is your expectation on it? I expect that the prospective competitor of Nexavar to be the combination of immunotherapies. To be honest, I had a great expectation on Opdivo (nivolumab) for treating patients with hepatocellular carcinoma, because its clinical trial had two patients who demonstrated complete response (CR). But using it in the actual practice, the response rate was not as good as I expected. And apparently, Tecentriq combination has exhibited improved result than Nexavar, and it looks ‘good’ at face value. But we need to watch if the combination therapy can show better efficacy in uncontrolled real-world practice conditions. There is also the catch—the patients have to frequently visit the hospital to receive the injection. And of course, the biggest problem of expensive price is still unresolved.
- Company
- Pfizer seeks for coverage on EGFR TKI to launch this year
- by Eo, Yun-Ho Jul 07, 2020 06:13am
- Pfizer Pharmaceutical Korea is quickly taking steps to join the competition in epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) market. According to the pharmaceutical industry sources, Pfizer is in process of listing EGFR TKI Vizimpro (dacomitinib) for healthcare reimbursement. Vizimpro took the pricing negotiation exemption track by accepting the weighted average pricing as an alternative option, taking into account that first generation Iressa (gefitinib), Tarceva (Erlotinib) and directly competing second generation Giotrif (afatinib) have already settled in the market. The drug would be able to launch with reimbursement in the second half of the year. The dacomitinib drug seeking for the reimbursement is a targeted therapy treating patients with non-small cell lung cancer (NSCLC), who have confirmed EGFR gene deletion in exon 19 or 21 L858R substitution mutations. The efficacy of Vizimpro was confirmed in Phase III trial ‘ARCHER 1050.’ The clinical trial compared dacomitinib’s efficacy head-to-head against AstraZeneca’s first generation EGFR TKI Iressa. Total 452 NSCLC patients have registered for the trial. The study reported Vizimpro lowered the risk of progression or death by 41 percent against Iressa, and the median progression-free survival (PFS) was 14.7 months in the Vizimpro group and 9.2 months in the Iressa group. However, Vizimpro demonstrated more adverse reactions. Frequently reported grade 3 events in Vizimpro group were dermatitis acneiform (14 percent) and diarrhea (8 percent), whereas over 8 percent of the Iressa group was reported with abnormal level of liver enzyme. As a result, 60 percent of the dacomitinib group had to adjust the dosage due to the adverse events. Meanwhile, Vizimpro has received marketing approval on three doses (15 mg, 30 mg and 45 mg) from Ministry of Food and Drug Safety (MFDS) in last February.
