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â € OEME-ŢÕõÀ € Drugs: Good or Bad?

Introduction

A drug that is structurally very similar to drugs already known, with only minor differences. The term "me-too" has a negative connotation. However, me-too products in May to create competition and prices down1 player.

The majority of new products off the industry are â € € ŢÕõÀ OEME-drugs, which are almost identical to current treatments, but â € ŒNO better than drugs already on the market to treat the same condition.â € About 75 percent of new drugs approved by the FDA are me-too. They may be less effective than current drugs, but as long as thei ™ € re more effective than placebo, they can get the regulatory green light2.

This nâ € ™ t surprising at all, as someone working in the field, but these so-called â € € ŢÕõÀ OEME-narcotics, which are better than their ancestors, is driving costs. Has â € € ŢÕõÀ OEME-drug is a drug that has its origins in another drug. Probably the most famous example of this is Prilosec (â € OETH Purple Pilla €) and Nexium (œTodayâ € â € ™ s Purple Pilla €). Prilosec € ™ s ingredient asset is omeprazole. Nexium € ™ s active ingredient is called esomeprazole. The difference is that Nexium is the lefty version of omeprazole. In chemistry, the S stands for sinister, meaning that the molecular conformation has a left orientation. (D would be entitled to be delivered.) So, this S-omeprazole is half the mixture that consists of its predecessor. In choosing specifically the S conformation, the drug is more powerful. Sounds good, but its efficiency is only marginally better than Prilosec, which has a generic version, and costs about one third less than Nexium. Some other â € OEME-ŢÕõÀ € medicines include: Claritin (loratadine) and CLARINEX (desloratidine), Celexa (citalopram) and Lexapro (escitalopram) 3.

What are "me-too" drugs?

Not since the advent of modern chemotherapy, when drugs were discovered and developed Through the process of screening thousands of molecules for a variety of pathological conditions, using animal models, there was a growing criticism molecules that too many have been developed with a similar chemical structure and the same pharmacological profile, with very little to distinguish each other under their therapeutic usefulness. In other words, once the first breakthrough discovery is made of pharmacological activity again for a new molecule, subsequent years saw the emergence of a host of new molecules or "me-too" drugs the same chemical class and having the same pharmacological profile.

Such monitoring of medications have been known molecular changes, casters or molecular mimics the development of which he is alleged to be motivated by purely commercial considerations. They are also regarded as implying lower levels of innovation compared to the original molecule. It is important to analyze the perspective Historic final results of these efforts in different therapeutic areas to develop new molecular entities, such as generation products later, after an initial breakthrough discovery has been made and well-founded technical, medical and commercial development of such drugs.

Development of "me-too" drugs

The success rate in finding new chemical entities with fundamentally new Chemical and biological profiles of activity are very low. In fact, the same chemical entities in the same class structure of a drug approved are rare today, compared to the period of the sixties to eighties. In 2001, 26 billion dollars were spent development of new drugs and the FDA has approved only 9 new chemical entities. At the same time, two thirds of drugs approved from 1989 to 2000 were modified versions of existing drugs or even identical to those which, under new forms and formulations4.

Of the 1035 drugs approved by the FDA from 1989 to 2000, only 361 or 35% containing new active substances. Among them, only less than half received the priority review status by the FDA. The impression is that these drugs are slightly modified versions of existing drugs, with little to offer in terms of improved activity and tolerance, not to mention new pharmacological profiles. The implication is that such drugs are developed, such as patents on medicines most sold original exhausted and not many truly new drugs are discovered. The indication that many of these drugs do not offer major advantages over existing drug is given by the refusal of the FDA granted priority review for most of them.

Moreover, conventionally, regulatory agencies, including FDA, are not required to consider better efficiency compared to existing drugs as a condition for approval, but rather, they require the establishment efficacy and safety of new drug to placebo.

How good are they?

Notwithstanding these perceptions, historically, many "me too" drugs have proved much better than their original counterparts. Examples are a series of generations beta-blockers, which are released after the original drug Propanalol was discovered by ICI, with most of them have merits in terms better efficiency, cardio-selectivity and safety. Ranitidine, the first monitoring drugs after the introduction of the first H-2 antagonist receptor, cimetidine, was followed by Famotidine and in each case, "me too" "a remarkable merits of the original drug.

Outside of major breakthrough in the development of beta-lactam antibiotics active oral penicillin and cephalosporin class, in same derived orally, there were significant improvements caused by changes in side chains incorporated by condensation agents with specific 6-APA, 7-ADCA and 7-ACA. A brand new range of broad spectrum antibiotics such as structural classes could be developed. In each major class of antibiotics classified by their mechanisms of action, namely inhibition of the synthesis of cell wall (Beta lactams, vancomycin), inhibition of bacterial protein synthesis (erythromycin, tetracycline, streptomycin), inhibitors of DNA or RNA replication (Quinolones, Rifamycins), inhibition of the biosynthesis of folic acid coenzyme (sulfonamides, trimethoprim), it There were several "me-too" drugs marketed.

An important recent example to show that "me-too" drugs must be developed is the case of troglitazone administration of oral hypoglycemic drugs, approved as an anti-diabetic drug in 1997. The drug was withdrawn reports on the markets following hepatotoxicity unacceptable. Monitoring of "me-too drugs, rosiglitazone and pioglitazone are much less toxic and are now widely used. If these drugs have not been developed, the withdrawal of troglitazone has left a therapeutic void Most in the anti-diabetic.

"Me-too" drugs: Strategies for New Drug Research for Indian companies

Breakthrough innovations in the pharmaceutical industry, new drugs such as beta-blocker, first, the first NSAID, the first each class of antibiotics, calcium channel blockers, ACE inhibitors, sulfonyl ureas, biguanides, insulin, glitazones, glinides, tricyclic antidepressants, Traquillisers major and minor receptor selective serotonin inhibitors, H-1 and H-2 receptor antagonists, inhibitors of the pump proton, etc. are relatively rare and although some of the original drugs in these classes are still in use, they were replaced in the most cases, the latest generation products, many "me-too". The new drugs are discovered both through incremental innovations on the original drugs, as well as new research.

In general, the original discovery led to a feverish activity within both the innovator and competitor in laboratories to develop better products in the therapeutic class. The warning key to commercial success, however, is that the newly discovered molecules should meet minimum standards of patentability. By example, in the three years following the discovery of the highly successful Sildinafil citrate (Viagra), three other new releases for the same indications were patented developed5.

Me-too drugs also provide therapeutic advantage6. For medical practitioners, there is the benefit of drug created MoA by a "me-too" drugs, coupled with clinical studies which – hopefully – the patient-centered show benefits such as improved side events profiles, less frequent dosing, the potential to reduce the discomfort of drug / drug interactions, and so on. A "me-too" drug is a helluva lot easier to incorporate into practice as a superb medication7 novel.

"Me-too" the Drugs: The dynamic cache

The most common criticism centers drug development on the so-called "me-too" drugs that use the mechanism biological as well as pioneering brands. This involves much more than such far-reaching objectives such as anti-ulcer Nexium. We should think with antidepressants, reduce cholesterol drugs, diabetes treatments, anti-psychotics, and other therapeutic categories which saw sales success and rapid innovation. There is little evidence that monitoring drug many patients do very well. Statins newer for example, often better than the older in clinical trials where the endpoints are the number of heart attacks and deaths prevented.

Me-too drugs are also a powerful tool to reduce costs of health care. We should be happy that our industry research does not target the only brand new biological mechanisms. It would be a very expensive model indeed. Fortunately, the industry also works on marginal improvements by exploiting opportunities to improve drug therapy and sometimes opening the door to improvements really radical that happen to lie more or less close, scientifically speaking. In the meantime, we get the price competition as a byproduct. Me too-almost still below the prices of drugs pioneers.

Another part of me-too story is almost entirely ignored, even if it is extraordinary important. For me-too manufacturers, to advance science is a way to gain competitive advantage. The classic example is the statin drug cons cholesterol. Search on one of the suites on the drug (Pravachol) has demonstrated for the first time that a statin to reduce cholesterol would actually prevent death from heart attacks, which had been previously assumed, without proof. Other tests for several statins, including Lipitor, the formidable challenger for Zocor and Pravachol, have shown that serum cholesterol is much more important that almost everyone thought (to prevent stroke, for example).

There are many other stories about the research benefits of me-too, but they are part of a larger story: new uses for old drugs. The data indicating a slowdown approval of new drugs to exclude the essential information: the discovery of new uses for old drugs. This type of discovery is become so common that it amounts to a "new revolution-use". One of the ironies scientists of the new era of research pharmaceutical drugs that are becoming more narrowly focused on biological mechanisms, their use actually become more diversified. It is because the body generally uses specific mechanisms, again and again, sometimes in what appear to be ways quite independent.

Consider SSRI antidepressants. A recent scientific article on the various applications and unexpected effects of drugs that play with serotonin reuptake is that SSRIs not concluded that the very term "antidepressant" is misleading because there is no scientific reason to think this drug as just for depression. Fight against depression has happened to the first really good condition that was explored for this class very interesting drugs.

Another example is the Cox-2 inhibitors like Celebrex (and Vioxx, which is important in this story and may return to the market partly for this reason). They were invented to relieve arthritis pain. But COX-2 appears to be important for many things including cancer and Alzheimer's. The clinical use of these tracks have been underway for years. Celebrex has been approved for reducing the risk of colorectal cancer, and Vioxx has also obtained promising results. Of course, the big news recently was that these drugs may cause seizures heart. But even here, me-too economy is of surpassing importance. Traditional NSAIDs (nonsteroidal anti-inflammatory drugs) Allevè as Advil and may have the same risk of heart attack. The potential is there for decades, but only new drugs, COX-2s have – been a large scale long term clinical trials because they are the only ones still under patent. This is an example of how me-too development Drug adds mostly based research. Thank you to the me-too, we are learning on NSAIDs, heart attacks, cancer and possibly many more.

Also dominated by new uses are the new targeted drugs against cancer, that attack specific biological mechanisms that prevent such to kill all fast-growing cells in order (as traditional chemotherapy tends to do).

The implications are clear. The annual count of approvals new drugs do show a tick when a new drug against cancer or another statin obtain approval first time. But a new Using an old drug may be as valuable as a new drug entirely, or even more value when you consider that we know more about the safety profile of older drugs and medication can sometimes do the work of two (to prevent both heart attacks and stroke, for example) 8.

Me-too products can sometimes have significant benefits of tolerance or dose. This could help to create more competition and lower prices. If you have five me-toos, perhaps the sixth is something that is a little better. For plans to decide on behalf of their patients. And even if it has the same mechanism of action, more competition could help lower the price of the class. Thata € ™ s an important influence, with potentially improving the health of greater access.

How are they bad?

Even if the major problem of antibiotic therapy, namely drug resistance can not be addressed by the development of "Me-too" drugs, because of the propensity of the same class to develop cross-resistance in most cases, the new semi-synthetic derivatives have distinct advantages over previous ones. Thus, for example, first generation cephalosporins are useful for Gram-positive infections, while second-generation drugs cover a wider spectrum including Gram-negative organisms. The third generation drugs offer resistance against the enzyme beta-lactamase and that act against some of the infections harder to solve, such as those caused by strains of Pseudomonas and Klebsiella.

Even as the pharmaceutical industry is families of me-too for relatively mild conditions rich people, he pays almost no attention to serious diseases such as malaria, which affect poor people. It also gives little attention to less profitable drugs, so there is currently a shortage of some vaccines and save lives drugs9.

The big problem with me too, it they are chemically very similar to other drugs already available, but they are marketed as if they were important new advanced, with very high prices. Many new, expensive me-too is not necessarily better than older drugs and less expensive. Most of the time they are compared with placebos rather than the comparison drug.

"Me-too" drugs are responsible for 80% increase expenditure in recent years and on average they are four times more expensive than comparable older alternatives10. By the Patented Medicine Prices Board Review (PMPRB) definitions, at the time of their introduction OEME-€ â € ŢÕõÀ drugs have been tried to ensure a modest improvement, if any – in terms of efficiency and security – compared to older solutions. However, on average, â € OEME-ŢÕõÀ € medicinal drug prices to about 2.5 times more per prescription as comparable older. The question is whether the real or perceived differences justify the increased costs. New drugs have a role in some cases and for certain patients. However, it makes sense to use old drugs as effective when possible11.

Changing the rules of the FDA to discourage me too Approval Drug R & D would make it much more expensive would discourage competition and thus increase the costs of health care, and would prevent the wave of new research that has revolutionized scientific understanding of the therapeutic categories where competition was more intense.

Conclusion

New drugs are not required to give old, and there € ™ s usually no way of knowing if they do. Although the FDA should test medicines before they are marketed, they nâ € ™ t need to be compared with similar drugs already on the market. The FDA requires only that they are reasonably safe and better than nothing, low indeed. This fault in the FDA opened the door to an unlimited number of me-too, which are easier to develop innovative medicines.

Any given It is therefore not surprising that these more expensive OEME-€ â € ŢÕõÀ drugs cost money for the medical industry. The prevalence of me-too really speaks volumes about the lack of innovation in the pharmaceutical industry. If you look at the new drugs marketed in over six years, 78 percent were not even new chemical compounds. They were just new combinations or formulations different from older drugs. And 68 percent were classified by the FDA as unlikely as improvements over drugs already on pharmacy shelves.

At the same time, there is a shortage of some important drugs that pharmaceutical companies are hardly interested in making because they are not as profitable as the me-too's. But businesses do not have to put out the necessary medicines, if they are not lucrative. And they do not.

References

1. http://www.medterms.com/script/main/art.asp?articlekey=33748

2. http://www.motherjones.com/news/qa/2004/09/09_401.html

3. http://polyscience.org/2005/09/me-too-drugs

4. http://www.shvoong.com/books/465475-me-too-drugs

5. http://www.pharmabiz.com/article/detnews.asp?SecArch=&articleid=14604&sectionid=46

6. http://direct.bl.uk/bld/PlaceOrder.do?UIN=162532605&ETOC=RN&from=searchengine

7. http://www.archivum.info/sci.med/2005-09/msg00257.html

8. http://www.aei.org/publications/filter.all, pubID.27443/pub_detail.asp

9. http://blogs.wsj.com/health/2007/05/17/in-praise-of-me-too-drugs

10. http://www.chepa.org/KnowledgeExchange/LabelleLectureship/tabid/84/Default.aspx

11. http://www.ti.ubc.ca/pages/letter59.html

About the Author

About Authors:

Bhumika Yogi
M. Pharm (Pharmaceutical Chemistry)
Rajiv Academy for Pharmacy, Mathura

Sujeet Gupta
M. Pharm (Pharmaceutical Chemistry)
Rajiv Academy for Pharmacy, Mathura

Yogesh Murti
Lecturer, Deptt. of Pharmaceutical Chemistry
Rajiv Academy for Pharmacy, Mathura

Devender Pathak
Director
Rajiv Academy for Pharmacy, Mathura

Patrick cheung cut for cancer @ UBC