Between 2002 and 2005, the 39% of new product launches consisted of new formulations of molecules already on the market, and this was limited to the top 50 pharmaceutical companies. It's hard to argue that this isn't a strong trend, and the reasons are also easily traceable: increasingly shrinking pipelines and the need to extend patent coverage, so as to maximize the return on the initial investment, before the generic arrives to move the price competition.
The therapeutic areas most affected by the phenomenon are the central nervous system and metabolic disorders. A recent Datamonitor report goes into detail antipsychotics, antidepressants and analgesics have undergone a restyling, to steal a term from the auto industry, and even methylphenidate has undergone an extended release version. In the gastrentheology and metabolic area are antacids and insulin the most frequently reviewed. But there are also examples of anti-infectives, sex hormones, drugs for the genitourinary system. In these cases the new pharmaceutical forms used ranged from including soluble or chewable, oral suspensions, pre-filled syringes, transdermal delivery systems, gels and creams. More substantial, however, are the many attempts made to switch from the injectable formulation of a drug to the oral one or, in any case, to a less invasive method of administration.
According to Datamonitor, these choices were made simply by looking at the number of potential users, but this is only part of the issue.
The other, and predominant one, is really being able to develop a better product than the "normal" version. So, in the case of switching to extended release for example, demonstrate that this really brings a clinical benefit to the patient. Health authorities, or at any rate the third party payer, are becoming increasingly savvy about granting reimbursements and setting prices, and even radical innovations, such as in the case of inhaled insulin, encounter unforeseen obstacles. In this case it was Pfizer, which was the first to commercialize the product, which collided with the lack of enthusiasm of the National Institute for Clinical Excellence, which has greatly limited the cases in which the new drug can be prescribed at the expense of the health service.
There has also been a case, in recent times, in which the reformulation was even imposed by crime-fighting reasons. This is the case in the United States with over-the-counter decongestants containing pseudoephedrine. The chemists of street gangs, and not only them, had in fact found in these medicines a convenient source of raw material for the synthesis of methamphetamine, known in jargon as "crystal meth". The result was a law, the Combat Methamphetamine Epidemic Act, which in fact greatly limited the sale of these products, making it mandatory to keep them behind the counter and not available to the customer. The first reaction of some manufacturers, such as Pfizer and Johnson & Johnson was the replacement of pseudoephedrine with phenylephrine at least in some brands. A solution which, moreover, has raised a hornet's nest, given that the new active ingredient does not have the same effectiveness, complete with speeches by congressmen and controversies with the FDA.
The therapeutic areas most affected by the phenomenon are the central nervous system and metabolic disorders. A recent Datamonitor report goes into detail antipsychotics, antidepressants and analgesics have undergone a restyling, to steal a term from the auto industry, and even methylphenidate has undergone an extended release version. In the gastrentheology and metabolic area are antacids and insulin the most frequently reviewed. But there are also examples of anti-infectives, sex hormones, drugs for the genitourinary system. In these cases the new pharmaceutical forms used ranged from including soluble or chewable, oral suspensions, pre-filled syringes, transdermal delivery systems, gels and creams. More substantial, however, are the many attempts made to switch from the injectable formulation of a drug to the oral one or, in any case, to a less invasive method of administration.
According to Datamonitor, these choices were made simply by looking at the number of potential users, but this is only part of the issue.
The other, and predominant one, is really being able to develop a better product than the "normal" version. So, in the case of switching to extended release for example, demonstrate that this really brings a clinical benefit to the patient. Health authorities, or at any rate the third party payer, are becoming increasingly savvy about granting reimbursements and setting prices, and even radical innovations, such as in the case of inhaled insulin, encounter unforeseen obstacles. In this case it was Pfizer, which was the first to commercialize the product, which collided with the lack of enthusiasm of the National Institute for Clinical Excellence, which has greatly limited the cases in which the new drug can be prescribed at the expense of the health service.
There has also been a case, in recent times, in which the reformulation was even imposed by crime-fighting reasons. This is the case in the United States with over-the-counter decongestants containing pseudoephedrine. The chemists of street gangs, and not only them, had in fact found in these medicines a convenient source of raw material for the synthesis of methamphetamine, known in jargon as "crystal meth". The result was a law, the Combat Methamphetamine Epidemic Act, which in fact greatly limited the sale of these products, making it mandatory to keep them behind the counter and not available to the customer. The first reaction of some manufacturers, such as Pfizer and Johnson & Johnson was the replacement of pseudoephedrine with phenylephrine at least in some brands. A solution which, moreover, has raised a hornet's nest, given that the new active ingredient does not have the same effectiveness, complete with speeches by congressmen and controversies with the FDA.
Be that as it may, there is a trend towards drug restyling, and this has also resulted in an increase in the turnover (38%) of the companies specializing in this segment. A boom that should continue, given that outsourcing tends to be favored for this type of activity. There could even be a shortage of supply, since they are related
