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2026-05-16 03:41:29
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Company
Avastin’s Q1 sales drop sharply… future sales prospects?
by
May 25, 2022 05:47am
Roche’s blockbuster anticancer drug ‘Avastin (bevacizumab) has recorded the lowest quarterly sales in 5 years. The drug had been much influenced by the drug price cut that followed the introduction of its biosimilars. However, whether the drop will continue remains to be seen due to the rise of new variables from the additional price cut applied recently, the indication expansion to liver cancer, and the possibility of intensified competition among biosimilars this year. ◆Avastin’s sales drop sharply for 2 consecutive quarters… due to a 30% price cut According to the pharmaceutical market research institution IQVIA, Avastin’s sales in Q1 this year were ₩19.3 billion, a 32.6% YoY decrease from the ₩28.7 billion it made in the same period last year. Avastin is a blockbuster drug that has made ₩100 billion in annual sales over the past 5 years. Avastin inhibits VEGF, the main protein involved in inducing angiogenesis to create an antitumor effect. It is used in various cancer types including breast cancer, non-small cell lung cancer, renal cell carcinoma, and ovarian cancer. Avastin’s sales, which recorded ₩92 billion increased to ₩104.5 billion in 2018, and then ₩119.3 billion the next year. However, sales fell to ₩118.1 billion in 2020 and then dropped 4.9% last year to record ₩112.3 billion. Avastin's sales decline began in earnest in Q4 last year. Avastin's sales, which reached ₩30.9 billion in Q3 last year, fell 27.2% to ₩22.5 billion in Q1 this year. Then, in the first quarter of this year, it fell to ₩19.3 billion. This is the first time Avastin’s quarterly sales recorded less than ₩20 billion in the past five years. The sales drop was greatly influenced by the price cut that was made due to the introduction of its biosimilars. Samsung Bioepis received approval for the first Avastin biosimilar ‘Onbevzi’ in March last year and entered the market in earnest after being listed for insurance reimbursement in September. With Onbevzi’s listing, Avastin’s price ceiling fell 30% in October last year. Price of Avastin 0.1g/4mL fell from ₩330,387 to ₩231,271 and Avastin 0.1g/16mL fell from ₩1,077,531 to ₩752,746, respectively. In other words, the company received a sales hit corresponding to the 30% price cut. Avastin’s sales drop increased greater with Onbevzi generating ₩1.8 billion in sales in Q1 this year, and Samsung Bioepis is attempting to expand its market and signed a co-promotion agreement for the sale of Onbevzi in Korea. Onbevzi’s price was set at 63% of Avastin’s price, at ₩208,144 (0.1g/4mL) and ₩677,471 (0.4g/16mL). ◆Reimbursement expansion, additional price cuts, intensified competition….entangles the bevacizumab market Although Avastin’s sales dipped in the recent 2 quarters, whether the drop will continue remains unknown. For one, Roche received reimbursement approval for the combination of Avastin and its cancer immunotherapy ‘Tecentriq’ in liver cancer. In addition, other variables such as the additional price cuts, difference in price with its biosimilars, entry of additional competitors, etc had risen recently. On April 29th, the Ministry of Health and Welfare assigned reimbursement standards for the Tecentiq+Avastin combination therapy in the first-line treatment of hepatocellular cancer. This is the first time reimbursement was applied to a combination therapy that uses cancer immunotherapy in liver cancer. The Tecentiq+Avastin combination therapy may now be used as a first-line treatment option with other existing first-line treatments – Nexavar and Lenvima. This reimbursement extension has laid the foundation for Avastin to rebound in sales. Also, the reimbursement extension had made Avastin’s drug price similar to its biosimilars. With insurance benefits extended to liver cancer, the price ceiling of Avastin has been reduced by an additional 5% since October last year. From this month, the price ceiling of Avastin will be ₩218,782 (0.1g/4mL) and ₩712,098 (0.4g/16mL). The price difference between the 4mL doses is only ₩1,638 and ₩34,627 for the 16 mL dose. This reduced gap in price is analyzed to have decreased the biggest strength held by its biosimilars – the price competitiveness. On the other hand, Avastin’s biosimilar market has been unfolding in a more complex manner. The industry prospects are that Pfizer's Zirabev which was approved in May last year, and Alvogen’s Alymsis which was approved in January will join in the competition this year. On top of that, Celltrion also applied for permission for its 'CT-P16' in October last year. The Avastin biosimilar market, which had only one product, has quickly formed a multilateral competition structure. In particular, each of the Avastin biosimilars is showing a difference in price and its indications, and some biosimilar developers are in a patent dispute with the original company over some indications, including ovarian cancer. Recently, Alvogen lost to Roche in one patent invalidation trial. Its impact on the original Avastin will vary depending on the outcome of further lawsuits.
Product
The supply of Tylenol suspension has been postponed again
by
Kim JiEun
May 25, 2022 05:47am
The sale of children's Tylenol suspension will be extended further. The supplier originally promised to supply it in June, but it seems that it will not be available until August, two months later. Johnson & Johnson Korea recently sent an official letter to drug distributors on the "Delay Notice on the Supply Schedule of Children's Tylenol Suspension 500ml." As of January 3, children's Tylenol suspension 500ml was distributed from Janssen Korea to Johnson & Johnson Korea, and the vendor was changed. In this official letter, the company said, "The supply schedule of children's Tylenol suspension 500ml products will be delayed from June to August due to internal circumstances," and added, "We will do our best to provide stable products." Earlier this month, the government also decided to urgently introduce Tylenol suspension and tablets distributed in Australia due to the prolonged sale of children's antipyretic analgesics containing acetaminophen. Tylenol suspension 50ml for children was scheduled to be supplied from this month, and Tylenol 500mg tablet from June through wholesalers nationwide. As of last week, Australian children's Tylenol suspension 50ml began to be distributed to pharmacies, but this is also not easy to order. Currently, 100, 500, 200ml of Tylenol suspension is on sale at drug store, It has been confirmed that only Tylenol suspension 200ml can be ordered in small quantities. In most pharmacies, consumers' perception has changed to some extent compared to the early Tylenol crisis, so the number of cases of explaining and selling generics for Tylenol has increased. A pharmacist in Seoul said, "Since there are many products from domestic pharmaceutical companies, I understand and purchase them when I explain them to mothers these days," adding, "As even orders are not easy for years, I have virtually given up ordering them these days." In the case of Australian Tylenol suspension, caution is required when instructing drugs at pharmacies as the dose per dose is unknown due to the difference in the concentration of active ingredients compared to domestic products. For ages 7 to 8, 10ml of existing Tylenol suspension, 7.5ml of Australian Tylenol, 15ml of existing Tylenol and 11ml of Australian Tylenol are recommended. At the age of 12, 20ml of existing Tylenol suspension and 12.5ml of Australian Tylenol suspension are recommended doses.
Policy
Xarelto's generic 15 items have been revoked
by
Lee, Hye-Kyung
May 25, 2022 05:47am
The MFDS canceled the item license of Rivaroxaban-based products, which were sold before the expiration date of the registered patent right as of the 27th. The cancelled product is Rixa 10mg, 15mg, 20mg, Wirelto 10mg, 15mg, 20mg, Jabaroxa 10mg, 15mg, 20mg Xarel-Q 10mg, 15mg, 20mg Xarelivan 10mg, 15mg, 20mg. The composition patent of the original Bayer Xarelto is until November 2024, and the material patent ended in October last year. However, it was confirmed that five pharmaceutical companies distributed generics to wholesalers before Xarelto's patent expired on October 3 last year, and the cancellation of the item license was decided this time. The reason was that generic products were distributed to wholesalers before the expiration of Xarelto's patent (October 3, 2021). According to Article 76(1)5-8 of the Pharmaceutical Affairs Act, "If a person who applied for an item permit or permission to change a registered patent right to sell it after the expiration of the period sells the drug" is subject to cancellation and suspension. The items that were decided to cancel the item license were reportedly distributed to some wholesalers first for distribution purposes after October 13 last year. Xarelto's outpatient prescription (UBIST) performance reached 59.6 billion won last year.
Opinion
[Reporter’s view] What was gained and lost with COVID R&D
by
Kim, Jin-Gu
May 25, 2022 05:47am
Literally, the companies have played it out to the end. By the companies, this reporter is referring to the developers of COVID-19 treatments and vaccines. Just 2 years ago, the developers had received the investors’ utmost interest. Stock prices soared when news broke out that a company is developing COVID-19 treatments or vaccines. The domestic stock market had been in a boom then, and every day, press releases on related news poured in. Some companies had even made malicious attempts to ride the investment boom. Many new treatments and vaccines were released in the past 2 years, but many of the companies that attempted to develop COVID-19 treatments and vaccines have also waved the white flag. In the case of the other companies still continuing on their R&D journey, their motive and drive have weakened significantly. Skepticism prevails over how many of these companies will continue to carry out their COVID-19 R&Ds to the end. The investors’ interest has also dropped sharply. They are no longer interested in whether the companies applied to initiate clinical trials, completed patient enrollment, or saw positive interim results. The stock prices of the companies that dangerously soared 2 years ago are making their way back. The COVID-19 R&D companies have both gained and lost much during the past 2 years. One gain is that the companies were able to imprint their names into the investors’ minds amid fierce competition. Also, the companies accumulated practical experience deriving candidate substances and conducting clinical trials in an emergency situation like the pandemic. Some companies also secured considerable cashable assets by selling their shares when their stock prices rose. On the other hand, many of these companies are losing their investors' interest and trust in return. In particular, the declining investor trust seems to be adding weight to the bubble theory in the pharmaceutical and bio industry. KRXHLTH, which represents the stock price of the pharmaceutical and bio-industry in Korea, has returned exactly to the level it had been before the pandemic. KRXHLTH rose 89.3% from 2915.31 at the start of 2020 to 5517.31 at the end of 2020 but then has been steadily declining to return to the pre-COVID-19 level of 2916.62 (as of May 20th). Among the 17 industry sectors that make up the KRX sector, the decline compared to the end of 2020 has been the largest in Healthcare. Now, there is rising concern that KRXHLTH may become lower than even before the COVID-19 outbreak. It is not about applauding the companies that have succeeded and criticizing those that failed to develop COVID-19 treatments and vaccines. It is more about asking the conscience of the companies that have carried out massive promotions about their development of COVID-19 treatments and vaccines. What did you truly gain, and what have you lost?
Policy
GSK meningococcal vaccine Bexero PFS was approved in Korea
by
Lee, Hye-Kyung
May 25, 2022 05:47am
The MFDS recently approved the item permission of Bexero PFS applied by GlaxoSmithKline (GSK). Bexero PFS is used to prevent invasive meningitis disease by Neisseria meningitidis B group at least 2 months of age. The safety and effectiveness of this vaccine in infants under 8 weeks of age have not been established. This vaccine injects deeply into the muscles. It is recommended to inoculate infants under 12 months of age to the outside of the thigh and to the upper arm deltoid area for those older than that. If inoculated at the same time as other vaccines, the injection site is different. Bexero PFS should not be intravenously, subcutaneous, or intradermally injected, nor should it be mixed in the same syringe as other vaccines. Bexero PFS is the only vaccine approved in Europe in 2016 to prevent type B meningitis and is a drug obtained by GSK through asset exchange with Novartis in 2015. The vaccination purpose of this vaccine is to prevent invasive meningococcal disease (IMD) by promoting antibody production that recognizes the vaccine antigens NHBA, NadA, fHbp, and PorAP1.4 (immune dominant antigen present in OMV components). In approximately 1000 meningococcal B group isolates collected in 5 European countries from 2007 to 2008, between 73 and 87% of meningococcal B group isolates, depending on the country of origin, showed MATS antigen profiles prevented by this vaccine. Phase 3 clinical trials showed that the vaccine was inoculated twice every two months for complement deficiencies (40 patients) aged 2 to 17, asymptomatic or spleen impaired patients (107), and healthy subjects (85) of the same age, with 87% and 97% for fHbp antigens, 95% and 100% for PorA P1.4 antigens, and 73% and 94% for NHBA. In the UK in September 2015, Bexsero PFS was introduced as NIP with a schedule of two additional inoculations (two months of age and four months of age) to infants.
Company
Yuhan Leclaza's first-quarter sales were 3.2 billion won
by
Chon, Seung-Hyun
May 24, 2022 05:55am
Yuhan's new anticancer drug Leclaza posted sales of 3 billion won in the first quarter. It has continued to rise since it entered the domestic market in earnest in the second half of last year. It is expected to surpass 10 billion won in annual sales for the first time among new anti-cancer drugs developed in Korea. According to IQVIA, on the 23rd, Leclaza recorded 3.2 billion won in sales in the first quarter. Leclaza is a non-small cell lung cancer treatment approved as the 31st new drug developed in Korea in January last year. Patients with local progressive or metastatic non-small cell lung cancer who developed T790M resistance after administration of the first and second generation epithelial cell growth factor receptor (EGFR) tyrosin kinase inhibitor (TKI) are eligible for administration. It acts as a mechanism to suppress the proliferation and growth of lung cancer cells by interfering with the signal transmission involved in lung cancer cell growth. Leclaza made its market debut in July last year with the listing of health insurance benefits. Leclaza made 4.1 billion won in sales in the second half of last year alone. The first sales of 1.5 billion won occurred in the third quarter of last year and 2.6 billion won worth of sales were sold in the fourth quarter. Cumulative sales have been estimated at 7.3 billion won since the third quarter of last year. Since anticancer drugs usually used in large medical institutions can be prescribed after the passage of the drug committee, it takes a considerable amount of time for sales to occur at the beginning of the release. Leclaza can be prescribed at more than 30 medical institutions, including Seoul National University Hospital, Sinchon Severance Hospital, Samsung Medical Center, and Asan Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Hwasun Chonnam National University Hospital, Chilgok Kyungpook National University Hospital, and Pusan National University Hospital. At this rate, it seems likely that annual sales will surpass 10 billion won in the second year of its release. None of the new anticancer drugs developed by domestic pharmaceutical companies has yet exceeded 10 billion won in annual sales. Domestic developed anticancer drugs licensed before Leclaza include Supect of Ilyang Pharmaceutical, Chong Kun Dang's Camtobell, Samsung's Riavax, and Hanmi's Oilta. Among them, Supect recorded 7.4 billion won in sales last year. Sales in the first quarter of this year are 1.9 billion won. Supect, which was approved as the 18th new drug developed in Korea in January 2012, is a drug used as a treatment for chronic myeloid leukemia. However, compared to the anticancer drugs of multinational pharmaceutical companies used for similar purposes to Leclaza, there are hurdles to overcome in the future. EGFR targeted anticancer drugs approved for use in Korea before the release of Leclaza include Iressa and Tarceva, the first-generation drugs, Giotrip and Vizimpro, and Tagrisso. Tagrisso posted 26.4 billion won in sales in the first quarter, up 8.0% from a year earlier. Tagrisso is a secondary treatment prescribed for non-small cell lung cancer (NSCLC) patients who developed resistance after administration of existing EGFR tyrosin kinase (TKI), such as Iressa, Tarceva, and Giotrif. It is called the same third-generation drug as Leclaza in that it overcomes the resistance of existing EGFR-TKI. Tagrisso, which received domestic permission in 2016, saw its sales increase significantly after applying health insurance benefits in December 2017. Tagrisso surpassed 10 billion won in sales in the third quarter of 2018 and has been recording 20 billion won in sales since the second quarter of 2019. It recorded sales of about 100 billion won for two consecutive years in 2020 and last year. Beringer Ingelheim's Geotrip, which is classified as a second-generation EGFR target anticancer drug, recorded 5.8 billion won in sales in the first quarter, up 13.2% from the previous year. Iressa and Tarceva, the first-generation drugs, showed sales of 3.4 billion won and 1 billion won in the first quarter, respectively. Yuhan Corporation has secured a total of $150 million in technology fees with Leclaza. Yuhan Corporation exported Leclaza to Janssen Biotech in November 2018. At this time, he received a deposit of $50 million without obligation to return it. Yuhan Corporation received $35 million in milestone from Janssen in April 2020. Janssen paid additional milestones to Yuhan Corporation when he began clinical trials of combination therapy with Amivantamab and Leclaza at the time. In November 2020, Janssen paid an additional $65 million to Yuhan Corporation when it began recruiting subjects for this clinical trial.
Company
Duodart may be prescribed at general hospitals in Korea
by
Eo, Yun-Ho
May 24, 2022 05:55am
The combination drug ‘Duodart’ that contains ‘dutasteride’ and ‘tamsulosin’ may be prescribed in general hospitals in Korea. According to industry sources, Duodart, GSK Korea’s fixed-dose combination drug for benign prostatic hyperplasia (BPH), has recently passed the drug committee (DC) review of Sinchon Severance Hospital and is undergoing landing procedures at major medical institutions across the country. The drug was granted insurance benefits starting in March this year. Duodart is reimbursed for ?? patients with ‘benign prostatic hyperplasia (BPH)’ who satisfy both of the following conditions: International Prostate Symptom Score (IPSS) of 8 or higher and ▲ Ultrasonography shows a prostate size of 30ml or larger, or Digital rectal examination shows moderate or higher BPH or the patient’s prostate-specific antigen (PSA) level is 1.5ng/ml or higher. Duodart is the first fixed-dose combination of dutasteride and tamsulosin introduced for BPH in Korea and can be administered orally once daily in a capsule form to treat moderate-to-severe symptoms of BPH. The drug was approved by the EU and the US FDA in 2010 and approved in May last year in Korea. The combination of the 5α-reductase inhibitor (dutasteride) and antagonist of α1a-adrenoreceptors (tamsulosin hydrochloride) is recommended in global clinical practice guidelines. Rapid symptom improvement and long-term disease progression control were expected through the combination of the two drugs with complementary mechanisms of action. In real-world data, patients using Duodart showed statistically significantly higher compliance compared with those using 5α-reductase inhibitor/ Alpha1-adrenergic antagonist free-combination therapy. The European Association of Urology (EAU) currently recommends introducing the 5α-reductase inhibitor (5-ARI) and Alpha1-adrenergic antagonist combination therapy in the early stages of treatment in patients with BPH with accompanying lower urinary tract symptoms (LUTS). The American Urological Association (AUA) also recommends using combination therapy in the early stages of BPH treatment. According to the CombAT study, the clinical trial that became the basis for Duodart’s approval, patients in the dutasteride-tamsulosin combination therapy group showed rapid symptom improvement at Month 3 like the tamsulosin monotherapy group. Also, the combination demonstrated superior symptom improvement over either monotherapy from Month 9, which lasted until Month 48. In addition, the combination therapy reduced the risk of BPH symptom progression and risk of AUR-related surgery than either monotherapy.
Company
Janssen makes first bid into lung cancer mkt with Rybrevant
by
May 24, 2022 05:55am
“We will work to make Rybrevant, which had been first approved to treat EGFR exon 20 insertion mutations, the No.1 option for lung cancer patients in Korea.” Janssen Korea expressed so at the press conference that was held on the 23rd to celebrate the launch of Rybrevant in Korea. Rybrevant (amivantamab) received marketing authorization from the Ministry of Food and Drug Safety in February and was officially released this month. As the first and only dual inhibitor that targets both the EGFR exon 20 insertion mutation and MET, the drug is approved for use in patients whose disease has progressed during or after platinum-based chemotherapy treatment. According to the CHRYSALIS trial that became the basis of Rybrevant’s approval, the overall response rate (ORR) of the Rybrevant monotherapy-treated group was 40%. 4% of the participants achieved a complete response (CR), and 36% achieved a partial response (PR). The median duration of response (DOR) was 11.1 months. Based on such results, the National Comprehensive Cancer Network guidelines recommend Rybrevant as a treatment option for patients with EGFR exon 20 insertion mutation NSCLC after platinum-based chemotherapy treatment. Professor Byoung-Chul Cho, Chief of Yonsei Cancer Center (Professor, Division of Medical Oncology, Yonsei Severance Hospital) who first identified the potential of Rybrevant in exon 20 insertion mutations, said, “While conducting a Phase I trial on lung cancer patients with Rybrevant, we found that the drug showed a dramatic effect in patients with exon 20 insertion mutations. After identifying its potential through various preclinical trials, we quickly initiated the CHRYSALIS study to come up with results.” Exon 20 insertion mutations are present in around 10% of all patients with EGFR mutations. Due to its various subtypes, patients with the mutation are unable to achieve desired results with existing EGFR-targeted cancer therapies. Compared to the PFS of patients with common EGFR mutations (Exon 19 deletion, L868R) which was 11 months, the PFS of patients with Exon 20 insertion mutations was a mere 3 months. The 5-year survival rate of patients with common EGFR mutations is 19%, but only 8% in patients with Exon 20 insertion mutations. This was why the need for a new targeted therapy had been rising for the specific mutation. Professor Cho believes that Rybrevant has a high potential to expand to other indications as it simultaneously targets both the EGFR and MET mutations and has a unique mechanism of action that activates immunity by engaging NK cells, monocytes, and macrophages. Cho said, "Exon 20 insertion mutation presents in various subtypes. Subgroup analysis results of the CHRYSALIS study showed that Rybrevant showed an even response across various subtypes. Also, Rybrevant is promising as it has an immunological mechanism in addition to the target inhibition effect held by targeted therapies." Janssen Korea is also conducting various clinical trials to test the expandability of Rybrevant. A Phase III trial in combination with chemotherapy and a Phase I study of Rybrevant monotherapy on MET exon 14 skipping mutation is underway. The most anticipated combination is its combination with Leclaza (lazertinib) to target common EGFR mutations. The company is conducting 3 clinical trials using the Rybrevant+Leclaza combination. Two of the trials are Phase III trials, MARIPOSA-2, which identifies the potential of Rybrevant+Leclaza+chemotherapy as a treatment used after Tagrisso, and the MARIPOSA trial which directly compares Rybrevant+Leclaza to Tagrisso, is underway. Also, Janssen Korea is exploring Rybrevant’s potential in various solid cancers including breast cancer and ovarian cancer. Professor Cho said, “EGFR and MET are key targets that are commonly present in various other solid cancers as well. The fact that Rybrevant is a bispecific antibody that inhibits both at the same time holds immense potential, and with the various clinical trials in progress, we may expect the drug to expand to other indications in the future.”
Company
Alvogen, 1 in 3 failed patent attempts for Avastin
by
Kim, Jin-Gu
May 24, 2022 05:55am
Alvogen Korea failed to cross the last hurdle in the Roche anticancer drug Avastin patent challenge. It challenged three patents, but succeeded in overcoming only two and failed one. The Korean Intellectual Property Tribunal recently dismissed the Avastin patent invalidation trial filed by Alvogen Korea against Roche. As a result, the original company Roche succeeded in defending one out of three related patents in the first trial. Roche has registered a total of four patents in Avastin. It is one patent for substance and three patents for use. One patent for substances registered in Korea has already expired in April 2018. In August last year, Alvogen filed a series of invalidation trials for the three patents. The results of the first trial related to this began to come out last month. In the case of two use patents that expire in February 2031, Alvogen succeeded in invalidating them last month and early this month. In the case of a patent for use that expires in February 2033, the Korean Intellectual Property Tribunal sided with the original company. Alvogen's plan to develop Avastin biosimilar while overcoming related patents has also become inevitable. As a result, the pharmaceutical industry predicts that Alvogen will continue the patent dispute through the patent court appeal. Avastin is a blockbuster anticancer drug developed by Roche and is used for treatment of non-small cell lung cancer, metastatic direct bowel cancer, metastatic breast cancer, and glioblastoma. According to IQVIA, a pharmaceutical market research firm, Avastin's domestic sales reached 112.3 billion won last year.
Policy
Atopic Dupixent Pen will be available in Korea
by
Lee, Hye-Kyung
May 24, 2022 05:54am
Dupixent, an atopic treatment that is expected to improve convenience when self-injecting at home with easy operation, will be available in Korea. The MFDS recently approved 200mg and 300mg of Dupixent PF Pen applied by Sanofi Aventis. Dupixent PF Pen formulation, which was approved by the U.S. FDA in June 2020, secured adaptations to atopic dermatitis and asthma among the existing Dupixent PFS-approved indications. Existing Dupixent was approved in Korea as a treatment for atopic dermatitis that was ineffective with existing treatment in January 2018, and additional indications were approved as a severe or intractable bronchial asthma treatment that cannot control asthma symptoms with existing treatment in March 2019. Dupixent PF Pentype has the advantage of being able to inject drugs with simple operation. It consists of a visual and auditory feedback device that shows visual indications and sounds when the administration function is executed, as well as a pre-filled pen with hidden need or syringe with need shield. Existing PF pen is used for self-administration after being administered at hospitals and clinics or trained by medical personnel on how to administer it.
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