Thomson Reuters: Five of the most promising drug varieties entering Phase III clinical trials
September 29, 2014 Source: Thomson Reuters
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];
Thomson Reuters' five most promising drug varieties entering phase III clinical trials
The first drug to enter Phase III clinical trials this quarter was BMN-701, developed by BioMarin Pharmaceuticals to treat Pompedisease. Pompe disease is a lysosomal dysfunction caused by a defect in the lysosomal enzyme acid alpha glucosidase (GAA), which causes a large amount of glycogen to accumulate in the myocyte lysosomes and the cells to die abnormally. It is a cumulative degenerative disease that affects cardiomyocytes, diaphragms, and skeletal muscles, causing muscle weakness, difficulty breathing, and swelling of the liver and heart. Two kinds of Pompe disease are known, with an adult incidence rate of 1/57,000 and an infant incidence rate of 1/138,000. BMN-701 is a fusion protein of recombinant human insulin-like growth factor 2 (IGF2) that can be fused into GAA, mainly for late-onset Pompe disease. The drug was initially developed by ZyStor Therapeutics using its proprietary Glycosylation Independent Lysosomal Targeting technology, which was acquired by BioMarin in August 2010 with a $22 million advance payment and a subsequent $93 million milestone. ZyStor, although the acquisition does not include a share, has also brought BMN-701 into a milestone in regulatory and commercialization.
The drug uses an enzyme-replacement treatment that binds to the mannose-6-phosphate receptor to enter the lysosomal-degrading glycogen. The drug is certified by the FDA and EMA orphan drugs.
In phase II clinical trials, the subject received a dose of 20 mg/kg body weight every two weeks. The function of the breathing muscles was greatly improved. The inspiratory and expiratory pressures increased by 5.1% and 11%, respectively, while the 6-minute walk test increased by 22m.
In March 2014, the company launched a phase III clinical trial in the United States for patients with delayed-onset who previously used the drug Lumizyme. The clinical trial of the drug in Europe is also planned.
Genzyme's Lumizyme. is the main competitor of BMN-701. It was launched in 2006 and has been in a monopoly since it has no substitutes. BMN-701 pre-clinical studies have shown that its affinity to the mannose-6-phosphate receptor is 10 times greater than that of Lumizyme. To achieve the same effect, Lumizyme requires a 5-fold dose.
According to "Cortellis Competitive Intelligence" statistics, the drug's annual sales in 2019 will reach 229 million US dollars.
In November 2007, Regeneron Pharmaceuticals and Sanofi used Regeneron's VelociSuite technology to develop human therapeutic antibodies. Dupilumab is one of them. The human monoclonal antibody Dupilumab neutralizes the interleukin 4 receptor and prevents it from neutralizing IL-4 and IL-13. This antibody can be used to treat atopic dermatitis, asthma and nasal polyps.
In February 2014, Phase III clinical trials for patients with nasal polyps were initiated in the United States, Canada, Australia, New Zealand, and Europe.
Atopic dermatitis is caused by an immune response induced by type 2 helper T cells (Th2). IL-4 and IL-13 signal through type I and II IL-4 receptors, which are key to the initiation and maintenance of Th2 immune responses. Cytokines, and these IL-4 receptors have an alpha subunit, and Dupilumab regulates the immune response of Th2 by blocking this subunit to regulate IL-4 and IL-13 signaling pathways.
The underlying causes of atopic dermatitis are not known, but some are thought to be caused by genetic or environmental factors, and can occur at any age, especially in infants and children. This inflammatory skin disease causes the patient's skin to turn red, itchy and red, and the skin appears dry and rough plaques, swelling, blistering and cracking of the skin. The global incidence of atopic dermatitis is estimated to be 1 to 20%.
It is estimated that Dupilumab's sales volume will reach 174 million US dollars in 2018, with a market share of 61%, and sales volume will reach 408 million US dollars by 2019.
Andexanetalfa, developed by Portola Pharmaceuticals, is a recombinant Xa derivative that acts as a universal antidote to factor Xa inhibitors, treating bleeding from anticoagulants after major bleeding, or for surgical emergency surgery. In March 2014, the company launched the phase III clinical trial of the drug, and preliminary results are expected in the fourth quarter of 2014.
In clinical trials, by detecting the anti-coagulation factor Xa biomarker, it was found that Andexanetalfa is the only reversal agent for anticoagulants such as factor Xa inhibitors. In November 2013, the drug was recognized by the FDA as a breakthrough treatment and entered the rapid approval channel.
This drug is a bait of coagulation factor Xa, which can bind to the blood in a targeted manner, and isolate those direct or indirect coagulation factor Xa inhibitors. After binding, those inhibitors can not block the true coagulation factor Xa, and the body returns to normal. Coagulation process.
Portola works with a number of companies to evaluate the detoxification of this agent to other specialty drugs. In November 2012, an agreement was reached with Pfizer (Pfizer) and Bristol-Myers Squibb to evaluate the detoxification effect of the drug on Eliquis. (betrixaban), which will also be included in the Phase III clinical trial in January 2014. Similarly, Portola also worked with Jenssen Pharmaceuticals and Bayer in February 2013 to evaluate the detoxification effect of the drug on Xarelto. (rivaroxaban). Again, this trial will be included in Phase III clinical trials. in. Under the two agreements, Portola will receive advance payments and additional legal mileage. At the same time, the company also agreed to evaluate the detoxification effect of Andexanetalfa on Daiichi Sankyo's SavaysaTM (edoxaban) in Phase II clinical trials. Protola has the global commercial right to the drug.
Portola estimates that 1% to 4% of patients will have bleeding after using the factor Xa inhibitor, and 1% require emergency surgery. Andexanetalfa is very important for this type of patient. CortellisTM Competitive Intelligence estimates that the global annual sales of this drug will reach $286 million in 2018.
Lung cancer is the most common cancer in men and the leading cause of cancer death in men. In the female population, lung cancer is the fourth most common cancer, and the number of deaths caused by it accounts for the second highest number of cancer deaths. Non-small cell lung cancer (NSCLC) is the most important form of lung cancer, accounting for 84%. More than half of non-small cell lung cancers express apoptotic ligand 1 (PD-L1). PD-L1 plays an important role in the process of cancer cells escaping from the immune system.
RG-7446 is a genetically engineered monoclonal antibody that targets PD-L1 and prevents cancer cells from evading immune system monitoring. DevelopersGenentech and Chugai launched a phase III clinical trial (NCT02008227) for second-line, metastatic non-small cell lung cancer patients in the United States in February 2014. The trial will compare RG-7446 and Taxotere. (decetaxel) with overall survival as the primary indicator. The efficacy of this antibody in the treatment of renal cell carcinoma and melanoma is being developed.
RG-7446 can replace PD-1 binding to tumor-expressing ligands, allowing interference between ligand and receptor interactions. Genentech's parent company, Roche, is looking for diagnostics to screen out the most suitable patients for this drug.
Data from phase I clinical trials showed that RG-7446 had an objective response rate of 23% in patients with treated, severe non-small cell lung cancer, and a total effective rate of 83.3% in patients with PD-L1 expression of IHC3, PD- The disease control rate of the patient group with higher L1 expression (IHC2/3) was 69%.
Although RG-7446 faces competition from Ono Pharmaceuticals and Bristol-Myers Squibb drug nivolumab and Merck's drug pembrolizumab, the drug still has a fairly good personalized medical market. According to CortellisTM competitive intelligence statistics, this drug was used in 2019. Global annual sales will reach $1.298 billion.
Sanofi is developing LixiLan, a drug for the treatment of type 2 diabetes. Upon obtaining the authorization of the Zealand Pharma company, the drug incorporates the Exendin-4 analog of the Zealand Pharma company and the GLP-1 agonist Lyxumia. (lixisenatide), and the human recombinant insulin analog Lantus. The formulation is administered using a FixFlex injection device that allows multiple doses of insulin glargine to be injected in combination with a fixed dose of Lyxumia.
In February 2014, Phase III clinical trials of the drug were initiated, including two studies. The first was evaluated in the United States, Australia, and Europe for patients whose oral hypoglycemic agents were unable to control their condition, using Lyxumia. or Lantus. alone, and the combination of the two; the second study was compared in the United States, Canada, and Europe. Patients who did not use basal insulin used the effects of LixiLan and Lantus.
The draft of the Phase III clinical trial enabled Sanofi to pay $150,000 in miles to Zealand, and in the future, Zealand will have the right to receive further $160 million in miles from Sanofi, as well as sales from Lyxumia and LixiLan. The division of the two-digit percentage.
Lantus. is the most common basal insulin prescription drug. Given the complementary effects of Lyxumia., in combination with basal insulin and GLP-1 agonists, LixiLan is highly likely to achieve once-daily dosing. Cortellis Competitive Intelligence estimates that LixiLan's global annual sales in 2018 will reach $716 million, accounting for 100% of the diabetes joint treatment market, and sales will grow to $1.3 billion in 2019.
Lower Blood Pressure Plant Extract
Lower Blood Pressure Plant Extract,Nattokinase Powder,Nattokinase Extract,Nattokinase Extract For Cardiovascular
Fufeng Sinuote Biotechnology Co.,Ltd. , https://www.sinuotebio.com