Heavy! This pharmaceutical technology can make old medicine "rebirth"
[China Pharmaceutical Network Technology News] Adding heavy-duty gaseous elements to certain drugs can reduce the decomposition rate of drugs in the human body and prolong the residence time of drugs in the blood. This pharmaceutical technology has been approved by the US FDA for more than 40 years.
Pharmaceutical companies are injecting new vitality into old medicines – hydrogen.
Adding heavy gaseous elements to certain drugs can reduce the rate of decomposition of the drug in the body, thereby prolonging the residence time of the drug in the blood. This means that the patient can reduce the number of medications, so in theory it can reduce the severity of side effects.
Although the pharmaceutical technology has existed for more than 40 years, researchers have spent a long time fully understanding the technology and trying to eventually get the FDA to approve the technology.
The tens of billions of markets to be divested The FDA is reviewing the first sputum (heterohydrogenated) drug to be marketed from Teva Pharmaceutical, which is used to treat hyperkinetic symptoms in patients with Huntington's disease. Teva plans to submit more data to the FDA, which it believes will be available to patients next year.
“This is a new concept, and the FDA's approval decision will make the development path in this area clearer,†said Associate Professor Graham Timmins of the University of New Mexico at the University of New Mexico.
"If Teva's drugs are approved by the FDA, it will open up a new market that could generate tens of billions of dollars in sales." RogerTung pointed out that its founding of Pharmaceutical Pharmaceutical Co., Ltd. is also developing drug.
"The principle of sputum technology is to deal with the enzymatic reaction of hydrogen ions involved in drug metabolism in vivo," Timmins said. Helium, which is heavy hydrogen, has a stronger hydrogen bond than ordinary hydrogen and is more difficult to be decomposed by enzymes, so it can stay in the body for a longer period of time. In addition, the mechanism of action of the drug is consistent with the original.
Some companies have built their own businesses by developing deuterated products for their marketed drugs, and then conducting clinical trials to ensure the safety and efficacy of deuterated drugs, such as Concert Pharmaceuticals and Auspex Pharmaceuticals (which was acquired by Teva last year for $3.5 billion). ).
“In all drugs that have been approved for marketing by the FDA, less than 10% of the drugs can be modified with deuteration techniques due to differences in chemical structure or the decomposition of some drugs in the body.†Timmins said, but this is still a huge market.
Teva has become a pioneer. “The vast majority of large pharmaceutical companies have applied for patent protection for their sputum variants,†Timmins said. “But due to concerns about the high cost of production of bismuth drugs, these pharmaceutical companies have not produced 氘Chemical drugs."
The FDA recently announced that Copaxone (a sales of up to $4 billion) patent is invalid, which paved the way for other generic companies, but added pressure to the Teva. The company urgently needs to develop other best-selling drugs, and for this reason, they are betting on deuterated drugs.
Teva SD-809 is a deuterated tetrabenazine that alleviates the symptoms of involuntary movement associated with Huntington's disease. Huntington's disease is a genetic deficiency disease that causes progressive death of brain cells. Teva estimates that about 90% of the 40,000 patients with Huntington's disease in the United States have symptoms of convulsions, but only 10% of them use tetrabenazine (listed in the US in 2008) because This medicine has many side effects, including lethargy and depression.
"For many Huntington's disease patients, SD-809 may be a viable treatment option," said Mike Derkacz, head of the global nervous system drug division at Teva. Analysts expect SD-809 to have annual sales of $1 billion by 2022, about four times the highest annual sales of Lundbeck's tetrabenazine.
However, SD-809 must first pass the FDA. The FDA required Teva to detect the blood levels of certain metabolites produced by SD-809 after decomposition in vivo, but did not require data on the efficacy of SD-809 versus tetrabenazine. Teva does not intend to conduct a head-to-head clinical trial, which inevitably leads to doubts whether the efficacy of SD-809 is really better than tetrabenazine.
Despite this, this modified drug still provides another treatment option for families with many Huntington's disease patients. "The convulsions associated with Huntington's disease have always been a huge challenge for the patient's family," said Louise Vetter, CEO of the Heinzington Dance Association. "We don't endorse or do any targeted promotion for any therapy. , but we will promote new breakthroughs in listed drugs."
"If SD-809 is approved, it may encourage more pharmaceutical companies to develop anti-chemical drugs," said Nick Paras, a pharmaceutical chemist at the University of California, San Francisco Institute of Neurodegenerative Diseases. He pointed out that for certain diseases, anti-chemical drugs will produce unexpected effects, which is also one of the most important drug development technologies.
Pharmaceutical companies are injecting new vitality into old medicines – hydrogen.
Adding heavy gaseous elements to certain drugs can reduce the rate of decomposition of the drug in the body, thereby prolonging the residence time of the drug in the blood. This means that the patient can reduce the number of medications, so in theory it can reduce the severity of side effects.
Although the pharmaceutical technology has existed for more than 40 years, researchers have spent a long time fully understanding the technology and trying to eventually get the FDA to approve the technology.
The tens of billions of markets to be divested The FDA is reviewing the first sputum (heterohydrogenated) drug to be marketed from Teva Pharmaceutical, which is used to treat hyperkinetic symptoms in patients with Huntington's disease. Teva plans to submit more data to the FDA, which it believes will be available to patients next year.
“This is a new concept, and the FDA's approval decision will make the development path in this area clearer,†said Associate Professor Graham Timmins of the University of New Mexico at the University of New Mexico.
"If Teva's drugs are approved by the FDA, it will open up a new market that could generate tens of billions of dollars in sales." RogerTung pointed out that its founding of Pharmaceutical Pharmaceutical Co., Ltd. is also developing drug.
"The principle of sputum technology is to deal with the enzymatic reaction of hydrogen ions involved in drug metabolism in vivo," Timmins said. Helium, which is heavy hydrogen, has a stronger hydrogen bond than ordinary hydrogen and is more difficult to be decomposed by enzymes, so it can stay in the body for a longer period of time. In addition, the mechanism of action of the drug is consistent with the original.
Some companies have built their own businesses by developing deuterated products for their marketed drugs, and then conducting clinical trials to ensure the safety and efficacy of deuterated drugs, such as Concert Pharmaceuticals and Auspex Pharmaceuticals (which was acquired by Teva last year for $3.5 billion). ).
“In all drugs that have been approved for marketing by the FDA, less than 10% of the drugs can be modified with deuteration techniques due to differences in chemical structure or the decomposition of some drugs in the body.†Timmins said, but this is still a huge market.
Teva has become a pioneer. “The vast majority of large pharmaceutical companies have applied for patent protection for their sputum variants,†Timmins said. “But due to concerns about the high cost of production of bismuth drugs, these pharmaceutical companies have not produced 氘Chemical drugs."
The FDA recently announced that Copaxone (a sales of up to $4 billion) patent is invalid, which paved the way for other generic companies, but added pressure to the Teva. The company urgently needs to develop other best-selling drugs, and for this reason, they are betting on deuterated drugs.
Teva SD-809 is a deuterated tetrabenazine that alleviates the symptoms of involuntary movement associated with Huntington's disease. Huntington's disease is a genetic deficiency disease that causes progressive death of brain cells. Teva estimates that about 90% of the 40,000 patients with Huntington's disease in the United States have symptoms of convulsions, but only 10% of them use tetrabenazine (listed in the US in 2008) because This medicine has many side effects, including lethargy and depression.
"For many Huntington's disease patients, SD-809 may be a viable treatment option," said Mike Derkacz, head of the global nervous system drug division at Teva. Analysts expect SD-809 to have annual sales of $1 billion by 2022, about four times the highest annual sales of Lundbeck's tetrabenazine.
However, SD-809 must first pass the FDA. The FDA required Teva to detect the blood levels of certain metabolites produced by SD-809 after decomposition in vivo, but did not require data on the efficacy of SD-809 versus tetrabenazine. Teva does not intend to conduct a head-to-head clinical trial, which inevitably leads to doubts whether the efficacy of SD-809 is really better than tetrabenazine.
Despite this, this modified drug still provides another treatment option for families with many Huntington's disease patients. "The convulsions associated with Huntington's disease have always been a huge challenge for the patient's family," said Louise Vetter, CEO of the Heinzington Dance Association. "We don't endorse or do any targeted promotion for any therapy. , but we will promote new breakthroughs in listed drugs."
"If SD-809 is approved, it may encourage more pharmaceutical companies to develop anti-chemical drugs," said Nick Paras, a pharmaceutical chemist at the University of California, San Francisco Institute of Neurodegenerative Diseases. He pointed out that for certain diseases, anti-chemical drugs will produce unexpected effects, which is also one of the most important drug development technologies.
Medical Bandage,Medical Wound Sport Protect Bandage ,Surgical Auxiliary Multiple Types Bandage ,Surgical Breathable Elastic Bandage,Non-Woven/Cotton Cohesive Bandage,Elastic Cohesive Bandage
Surgimed Medical Supplies Co.,Ltd , https://www.surgimedcn.com