In many people, the process of pharmaceutical companies to develop new drugs seem to be easy, sitting in the laboratory and scientists dealing with bottles and jars, can often develop another one with annual sales of billions of dollars in "heavy bomb". But in fact, this sort of a dream come true event is not the case. Each "blockbuster" basically are hidden behind a number of painful failures, in some cases, these failures even make pharmaceutical companies invest hundreds of millions or even billions of dollars all boondoggle.
Inhaled insulin: Sign in to Pfizer on the beach
Last July, the US Food and Drug Administration (FDA) approved a new drug for treating diabetes - insulin powders for inhalation (Afrezza), after this drug is approved by the industry as a major innovation "in the field of diabetes treatment "Prior to the article" inhaled insulin, sugar faithful gospel? "The has introduced it. But Afrezza not the world's first inhaled insulin, as early as 2006, the world's largest pharmaceutical company Pfizer will launch an inhalation of inhalation of insulin (Exubera), unfortunately, it is just more than a year after the listing then because of the huge losses announced by Pfizer stock. Until now, this case is also a pharmaceutical research and development typical failure, widely circulated in the industry.
As we all know, belongs to the insulin protein hormones, and it includes the vast majority of proteins, including after oral will be hydrolyzed into amino acids and failure. Therefore, so far mainly insulin administered by intravenous or subcutaneous injection. But all day long to hang a bottle of non-diabetic patients hospitalized for is not realistic, subcutaneous blood concentration may be individual differences, thus affecting the efficacy, but also the fact that many patients fear of needles. Driven by these factors, Exubera emerged: it means the insulin by inhalation of atomized powder into the lungs, and then through the alveolar blood circulation effect service of the body into the sky, so that one can make efficacy tends stability, but also to avoid the needle to bring a sense of fear, can be said to serve multiple purposes.
Pfizer is expected to follow, even though such a breakthrough product research and development costs are particularly high, but will also bring in huge revenue for the company, and even become a new "blockbuster." But reality shattered the idea, Exubera sales performance can be described as extremely bleak listed first year sales to mention the hundreds of millions, and even ten million US dollars are not, only $ 500 million. Obviously, this performance let alone make money, want to go back this is a very difficult thing.
Original, Exubera inhalation device is too great, especially the small and bigger wearable insulin pens and insulin pumps more than like a "giant." This need for insulin to carry the drug, it is a bit difficult to take out, and even a patient Exubera from the "rolling pin" nickname, and produced the blockbuster spoof video. Although Pfizer aware of this after the hype, trying to make the patient to accept this arrangement, but still could not pull out a victory. Exubera in October 2007, officially announced the shutdown, and before that in the third quarter of 2007, Pfizer because it pre-tax loss of $ 2.7 billion.
Lipid-lowering drugs: winner takes Shura field
In modern society, hyperlipidemia is undoubtedly a very common chronic disease. And because of its long-term effects (increased heart disease, the risk of stroke onset, and even lead to death) is too significant, the medical community and patients demand for lipid-lowering drugs has been very urgent, which to some extent also the achievements of the current lipid-lowering drugs market. However, lipid-lowering drug market can be described as a tragic Shura field, such as Lipitor (atorvastatin, Pfizer) like a star can achieve annual sales of $ 12.9 billion up to terrible, but those products failed, but pharmaceutical companies often make hundreds of millions of dollars of investment to naught.
In humans, the same time there are two types of cholesterol, including low-density lipoprotein (LDL), triglyceride (TG), etc. Because of the cardiovascular system, there is a huge hazard, known as "bad" and high-density lipoprotein protein (HDL) is beneficial to human health, but also to curb the "bad" cholesterol hazard, it is called "good" cholesterol. And in order to prevent health hazards caused by hyperlipidemia, there are two ideas: One is by blocking the synthesis of cholesterol in the liver or intestinal absorption of cholesterol in the human body to reduce "bad" the other is by acting on various parts of the body, to increase the "good" cholesterol. Lowering drugs ace - statins (statin) drugs Lipitor belongs to, is a typical representative of the former kind of thinking, it can block the synthesis of cholesterol in the liver, a key step, and the liver is the body's main cholesterol synthesis site, so this effect will be able to significantly reduce the "bad" cholesterol levels. In addition, another lipid-lowering drug ezetimibe can be attached to the small intestine villi (the main part of the small intestine to absorb nutrients), the villi by blocking the absorption of cholesterol from food, to reduce "bad" cholesterol levels. In addition to these two drugs significantly improve hyperlipidemia, but also significantly lower in patients with heart attacks, and even the risk of death in the future, so popular doctors of all ages. The vast majority of sales of statins have billions of dollars, ezetimibe and its compound preparation of sales as well.
Lipid-lowering drugs for another idea was once a favorite, because in the large study, HDL levels often and future risk of cardiovascular disease in patients with a negative correlation. However, the so-called "ideal is full, the reality is very skinny", this class of drugs in clinical trials, but it is suffered a setback, so far there is not a success story. Vitamin niacin in large doses can increase HDL, but several large clinical trials, niacin increased HDL levels make nearly 20%, the risk of heart disease but did not moved, the patient one hand, niacin is annoying side effects (such as facial flushing) torture not. Pfizer allows HDL increased nearly 70% of the experimental drug torcetrapib not reduce the risk of heart disease does not say, but also to increased mortality by 60%, was forced to suspend drug development, $ 800 million research and development costs hit hydroplaning. Based on current data, many pharmaceutical companies have research and development of such drugs in misfortune, but also the total loss of billions of dollars.
Prostate cancer vaccine: the gimmicks playing too
Since humans successfully developed a vaccine that can prevent a considerable part of something infectious diseases, scientists have always thought, since the vaccine can prevent diseases, is there a vaccine that can prevent and even treat cancer do this demon it ? Vaccine to prevent cancer'd already realized, everyone played the hepatitis B virus vaccine, is precisely the history of mankind's first cancer vaccine. The vaccine to treat cancer in the United States in 2010 was the launch of a biopharmaceutical company.
However, after today, nearly five years later, the company has announced the complete bankruptcy, this can be a therapeutic vaccine Provenge prostate cancer were large pharmaceutical companies Valeant a "cabbage price" bought. The reason, the company's founder, Stanford University immunologist Edgar Engeerman (Edgar Engleman) is not painless heart said that this vaccine at the time actually creating a gimmick to make of attention, but because of mediocre efficacy , expensive and did not covered by medical insurance and other reasons, and ultimately had to face such a dilemma.
Provenge is called "vaccine", largely because of its ability to give the body the same as the vaccine potential attack cancer cells in a patient who will attack the tumor as a manifestation of the immune system, leading to tumor shrinkage, symptom relief. Its production process is extremely complicated: First, the patient's immune system responsible for "led" by immune cells attack the machine acquisition, to the manufacturing the plant, they will receive special "training" in a petri dish, in order to "exercise" the ability to identify prostate cell after "training" will be completed reinfusion into the patient, they enter the human body, can quickly lead the immune system to fight the tumor.
It is because of this tedious steps, Provenge after the listing sold unimaginable price: a vaccine would cost 16,000 euros (about 110,000 yuan), and the completion of a course is to spend 47,000 euros ( about 320,000 yuan). Such high prices, coupled with its efficacy is mediocre (only able to prolong survival of four months), major US commercial health insurance companies and the UK National Health Service System (NHS) have refused to reimburse the drug. In the latter part of the company's business, even the most basic maintenance costs are difficult to come up until the bankruptcy.
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