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    Home > Chemial News > Pharma News > The most noteworthy new "blockbuster" drugs in 2020

    The most noteworthy new "blockbuster" drugs in 2020

    Echemi 2021-01-05

    The so-called blockbuster is a product with annual sales exceeding 1 billion U.S. dollars within 5 years after being put on the market. Among the new drugs approved for the first time in 2020, 10-13 products are expected to reach this level.

     

    1. Veklury (Remdesivir)

     

    On October 22, the FDA approved Gilead's Remdesivir for the treatment of patients 12 years of age and older who need to be hospitalized with 2019 new coronavirus (COVID-19) infection. Because the new crown epidemic is extremely serious, Remdesivir was born at the right time. Although WHO believes that the product has little or no help to hospitalized patients through big data analysis, Gilead’s third-quarter financial report shows that the product will be in the first three quarters of 2020. Sales have reached 873 million U.S. dollars, and annual sales are very likely to exceed 1 billion U.S. dollars, reaching blockbuster level in the year of listing. However, the new crown vaccine has been approved one after another, and it is not known how long the sales of the product will last.

     

    2. Tepezza (teprotumumab)

     

    On January 21, the FDA approved Horizon Therapeutics' teprotumumab for the treatment of thyroid eye disease. Thyroid ophthalmopathy, also known as Graves ophthalmopathy, is an autoimmune-related disease with an annual incidence rate of 19/100,000. The patient base is very large. It is estimated that 15,000-20,000 patients will be treated with Teprotumumab. This product has been granted Orphan Drug and Breakthrough Therapy designation in the United States. It is also the first "special effect" drug approved for the disease. The price is also very high. The treatment fee for each course (6 months) is 34.3 Ten thousand U.S. dollars. According to the third-quarter financial report of Horizon Therapeutics, sales of the product in the past two quarters have reached 476 million U.S. dollars, and it is predicted that the annual sales in 2020 will exceed 800 million U.S. dollars, and the peak sales in the United States will exceed 3 billion U.S. dollars.

     

    3. Nexletol(bempedoic acid)

     

    On February 21, the FDA approved Esperion Therapeutics’ bempedoic acid for use in dietary control and maximum tolerated statin treatments, heterozygous hypercholesterolemia or arteries that still need to further reduce lipoprotein (LDL-C) Treatment of patients with atherosclerotic cardiovascular disease. Bempedoic acid is a new mechanism of oral lipid-lowering drugs, which can reduce the synthesis of LDL-C by the liver by inhibiting the activity of adenosine triphosphate-citrate lyase (ACL). Clinical trials have shown that under the maximum tolerated dose of existing oral lipid-lowering drugs (statins/ezetimibe), the addition of this product can further reduce blood lipids by 17%. Although this product is mainly used for second-line or third-line drugs, more than 50% of patients in the United States are intolerant to statins or cannot effectively control blood lipids with statins alone. Therefore, ESPERION has high hopes for bempedoic acid and believes that Nexletol and Nexlizet (bempedoic acid + ezetmai) Cloth) can win annual sales of 2 billion US dollars.

     

    4. Zeposia (ozanimod)

     

    On March 25, the FDA approved Celgene's ozanimod for the treatment of adult relapsing multiple sclerosis (RMS), including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease. Ozanimod is a sphingosine 1-phosphate (s1p) receptor modulator, and has a very high affinity for s1p 1 and 5. However, the mechanism of action of this product in multiple sclerosis is not yet fully understood. Clinical trials have shown that patients treated with ozanimod have a 48% reduction in the risk of recurrence compared with patients treated with interferon beta. This product was the product with the highest valuation among the products under research in 2018, but the first listing application was rejected by the FDA, and the clinical development of Crohn's disease was frustrated, and the value of this product declined. Despite this, the product is still a leader in the field of MS treatment, and Celgene still predicts that the peak sales of the product will be between 4-6 billion US dollars.

     

    5. Trodelvy (sacituzumab govitecan)

     

    On April 22, the FDA accelerated the approval of Immunomedics’ antibody-drug conjugate (ADC) sacituzumab govitecan for the treatment of adult patients with metastatic triple-negative breast cancer who had previously received at least two therapies. Metastatic triple-negative breast cancer is a kind of aggressive breast cancer, accounting for about 15% of invasive breast cancer. The current treatment is still chemotherapy. However, standard chemotherapy has poor effect on advanced breast cancer, and the response rate is generally only 10%-15%, PFS is only 2-3 months, the approval of this product undoubtedly adds an effective targeted therapy for patients. Breast cancer is the cancer with the highest prevalence in women. Although triple-negative breast cancer accounts for only 15% of breast cancers, the patient base is still very large. This product has a high remission rate, long remission time, and huge market potential. In addition to triple-negative breast cancer, the indications developed for this product also include rectal cancer, prostate cancer, gastric cancer and other solid tumors. It is the most highly valued drug among the products under research in 2019. Although the first NDA was rejected by the FDA, Immunomedics The product’s peak sales forecast is still US$3.1 billion, and the peak time is 2033.

     

    6. Leqvio (inclisiran)

     

    Novartis announced on December 11, 2020 (the official EMA has no exact approval information so far) that the company's siRNA drug Leqvio (inclisiran) has been approved by the EMA for the treatment of adult hypercholesterolemia or mixed dyslipidemia.

     

    Inclisiran is a small interfering RNA drug that can inhibit the synthesis of PCSK9 in liver cells. EMA’s approval of this product is based on a series of clinical research projects called "ORION". In this clinical research project, this product is based on the maximum tolerated dose of statins, and low-density lipoprotein (LDL-C) is further reduced by 52 %. Although there are statins, about 50% of the population is still unable to control blood lipids to safe levels because of statin intolerance or the maximum dose of statins. Even if there are second-line drugs such as ezetimibe and colesevelam, they still There are 5%-10% of patients with stubborn hyperlipidemia. Under the treatment of combination therapy, their blood lipids still cannot reach the standard. The appearance of PCSK9 inhibitors has brought solutions for this type of patients. Although Alirocumab and Evolocumab have been approved for marketing before this, they need to be injected every 2 weeks, which is not as advantageous as Inclisran, which takes 3 injections a year. The capital market's peak sales of this product are forecasted to be 4 billion U.S. dollars, and Evaluatepharma predicts that the product's sales in 2026 can reach 2.008 billion U.S. dollars.

     

    7. Palforzia (peanut allergen powder)

     

    On January 31, the FDA approved Aimmune Therap's Palforzia for the treatment of peanut allergy. Peanut allergen powder is different from other medicines. It is a key allergen extracted from peanuts. Therefore, it is classified as a biological product and approved for marketing by CBER. Peanut allergy is extremely common. In the United States alone, more than 1.6 million children and adolescents are allergic to peanuts. Palforzia is the world’s first oral immunotherapy approved for the treatment of peanut allergies. It has previously been approved by the FDA as a breakthrough therapy. The US investment agency’s sales forecast for the product in 2020 is 1.1 billion U.S. dollars and the sales forecast in 2021. For 1.9 billion U.S. dollars, but due to market size restrictions, the product’s peak sales forecast is 2 billion U.S. dollars. Nevertheless, in terms of Aimmune's second-quarter earnings report, it is less likely to meet this expectation.

     

    8. Evrysdi (Risdiplam)

     

    On August 7, the FDA approved Genentech’s risdiplam for the treatment of spinal muscular atrophy (SMA) in people aged 2 months and older. Risdiplam is a splicing modifier of Survival Motor Neuron Gene 2 (SMN2), which can continuously increase and maintain the level of SMN protein. SMA is one of the most common autosomal recessive diseases in childhood. Data show that type I, type II and type III account for 60%, 27% and 12%, respectively, and the incidence rates are 5.5/100,000 and 1.9/100,000 respectively Compared with 1.7 per 100,000, SMA is also one of the rare diseases with few patients and large market. The annual treatment cost of this product will exceed 340,000 U.S. dollars, and it is also cheaper than other existing therapies. Sales forecast is between 2.6-32 billion US dollars.

     

    9. Blenrep (Belantamab Mafodotin)

     

    On August 5, the FDA accelerated the approval of GSK's ADC drug belantamab mafodotin for the treatment of adult patients with relapsed/refractory multiple myeloma (MM) who have received at least 4 therapies in the past. Belantamab is a monoclonal antibody oriented to B cell maturation antigen (BCMA). The small molecule part is a tubulin inhibitor. Although there are only about 10,000 MM receiving fourth-line treatment in the world, GSK price it as high as 24,000 US dollars per month. In addition, the company is still carrying out earlier drug trials and predicts that the peak sales of the product will be 16 One hundred million U.S. dollars. Due to the scarcity of fourth-line therapy options, this peak may be reached soon, and Evaluatepharma predicts that the product will reach sales of US$1.262 billion in 2026.

     

    10. Retevmo (Selpercatinib)

     

    On May 8, the FDA accelerated the approval of Loxo oncology's selpercatinib for the treatment of RET (transfection rearrangement gene) fusion-positive metastatic non-small cell lung cancer and thyroid cancer, and adult patients with medullary thyroid cancer with mutations in the RET gene . Selpercatinib is the first drug approved by the FDA for RET gene mutations, usually 1%-2% of non-small cell lung cancer, 10%-20% of thyroid papillary carcinoma (80% of thyroid cancer) and 70% of medullary carcinoma Thyroid cancer (accounting for 4% of thyroid cancers) carries this genotype, and the potential user base in the United States reaches tens of thousands. The product is priced at US$20,600 per month. Only 5,000 people use the product each year. Annual sales can exceed US$1 billion. It is one of the 10 most interesting pipelines in 2020. Evaluatepharma predicts that the product will be Sales in 2026 can reach 1.172 billion US dollars.

     

    11. Qinlock (Ripretinib)

     

    On May 15, the FDA approved Deciphera's ripretinib for the fourth-line treatment of metastatic gastrointestinal stromal tumors.

     

    Ripretinib is a broad-spectrum KIT proto-oncogene receptor tyrosine kinase inhibitor and PDGFR (platelet-derived growth factor receptor) alpha kinase inhibitor, which accounts for more than 85% of gastrointestinal stromal tumors and systemic mastocytosis cases KIT or PDGFRA kinase is detected. In addition, acute myeloid leukemia (AML), melanoma, germ cell tumor, lung cancer and glioblastoma also have a certain proportion of KIT or PDGFRA kinase, so the application prospect of this product is relatively broad. The product is currently priced at US$32,000 per month. Deciphera predicts that sales of the product in the US and European markets will peak in 2025, reaching a peak of US$1.36 billion. In addition, Zai Lab acquired the Chinese rights and interests of the product at a price of US$205 million.

     

    12. Tukysa (Tucatinib)

     

    On April 17, the FDA approved Seattle Genetics’ Tucatinib, which is indicated for use in combination with trastuzumab and capecitabine to treat advanced inoperable or metastatic HER2 (human epidermal growth factor receptor-2) Adult patients with positive breast cancer, including patients with brain metastases who have previously received more than one HER2 treatment regimen. The efficacy of this product is very good. Clinical trial data show that 612 patients (2:1) received the treatment of this product + trastuzumab + capecitabine or placebo + trastuzumab + capecitabine. The median PFS and median OS of the product treatment group were 7.8 months and 21.9 months, respectively, while the placebo group was only 5.6 months and 17.4 months, respectively. HER2-positive patients account for about one-fifth of the total breast cancer cases. The price of this product is US$18,500 per month, and the treatment fee for a single course of treatment is US$110,000. The company predicts that the peak sales of this product in the field of breast cancer will reach US$1.6 billion. In addition to breast cancer, this product is also developing rectal Multiple indications such as cancer.

     

    13. Jyseleca (filgotinib)

     

    On July 31st, EMA approved Gilead’s filgotinib, which is indicated for single use or in combination with methotrexate to treat one or more disease-modifying antirheumatic drugs (DMARDs) with insufficient response or intolerance. Patients with severely active rheumatoid arthritis (RA). The JAK inhibitors approved for the market before are almost all blockbuster products, and Filgotinib is a selective JAK1 inhibitor. Compared with non-selective JAK inhibitors, this product has better safety, so Market expectations are even higher. As early as 2018, the capital market predicted that the peak annual sales of the product could reach US$4-6 billion. Unfortunately, the first NDA was rejected by the FDA, which caused the market expectations of the product to decline. In this way, Evaluatepharma predicts that the product's sales in 2026 will reach 1.404 billion US dollars.

     

    In addition to the above products, among the products approved for the first time in 2020, products with a certain potential to become blockbuster products include Rimegepant and Daprodustat, but compared to the previous products, these two products have less potential. The author hereby declares that there are many factors affecting sales, and the sales forecast is for reference only.

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