Billions for the development of innovative drugs

Win the lottery, or the Price of innovation in the pharmaceutical industry
Evgenia Lukyanchuk, "Weekly Pharmacy" www.apteka.ua
based on FierceBiotech materials: The world's biggest R&D spenders

Innovative developments are both a way to develop the pharmaceutical business and a source of maximum financial risks. The players of Big Pharma do not adhere to a single strategy in the field of research and development, everyone chooses their own path. And it's all the more interesting to find out where he will lead them. In this publication, we will review the successes and defeats faced by pharmaceutical companies that formed the top 10 R&D budgets in 2010.

In 2010, companies in the top 10 of the R&D budget rating invested a record large amount in the development of innovative medicines, which amounted to 67.4 billion US dollars (table). According to the results of 2010, despite the reduction by some companies of their research and development expenses, the funds invested in R&D by 10 leading companies in this field in 2010 increased by 10% compared to 2009.

Top-10 rating of R&D budgets of pharmaceutical companies for 2010 n/a, 2010

They were invested both directly in the development of innovations and in the purchase of licenses for medicines that have already gone a certain way to regulatory approval and their prospects are more predictable. Also, some pharmaceutical companies, in order to expand their product portfolio, acquired successful R&D companies, including biotechnological ones.

Experts attribute the activation in the field of innovative developments to the fact that the terms of patent protection of many blockbusters of the world's leading companies are running out. Thus, pharmaceutical companies have carried out several major acquisitions, as well as created many of their own programs for the development of innovative medicines. For some of them, such an expansion strategy works quite well, while for others, the billions invested in the development of the product portfolio do not bring the expected results. Thus, the R&D segment has turned into a game of luck and often the chances of winning turn out to be the same as winning the jackpot in the lottery. Many people wonder if there is no other, more reliable way to develop the pharmaceutical business? Not yet.

Joe Hammang, Senior Director of Pfizer Inc., believes that the R&D model is changing dramatically. Cooperation of different pharmaceutical companies in the field of development is increasingly expedient. The process of obtaining regulatory approval for an innovative drug is also becoming more complicated. In addition, J. Hammang noted that as consumers, we all want products that have minimal risk when used. This has led to increased pressure on regulatory authorities, which have significantly raised the bar for drug requirements regarding side effects.

Sanofi-aventis S.A. and some other pharmaceutical companies have become more loyal to outsourcing in the development of innovative drugs. And if the leaders of Pfizer are trying to reduce the costs of the R&D segment, other pharmaceutical companies are not in a hurry to follow its example yet. "Roche Holding AG", "Merck&Co. Inc.", "Novartis AG" and other pharmaceutical companies have published quite ambitious plans for 2011, for the implementation of which they will have to obtain regulatory approval for drugs that are currently in phase III clinical trials, and create new drugs with performance indicators much more higher than their predecessors.

Regardless of the company's development strategy, R&D expenses remain consistently impressive. AstraZeneca, Johnson & Johnsonis, GlaxoSmithKline, Sanofi-aventis, AstraZeneca, and Eli were among the top ten companies with the largest R&D budget in 2010. So, according to the results of 2010, Pfizer, Roche, Merck &Co., Novartis, Johnson & Johnson, GlaxoSmithKline, Sanofi-aventis, Eli Lilly" and "Bristol-Myers Squibb".

Pfizer's purchase of Wyeth last year gave it the opportunity to become the leader of this rating. At the same time, Pfizer does not intend to gain a foothold in the image of the largest investor in the R&D segment in the future and plans to reduce its expenses in this direction.

Pfizer had previously planned to reduce its R&D costs in 2012. up to $8-8.5 billion, but recently a more radical decision was made – the budget was cut to $6.5–7 billion. Thus, it is expected that in 2011 the R&D budget of Pfizer will be less than the budgets of Roche, Merck, Novartis and Johnson & Johnson.

In 2010, the company abandoned developments in such areas as urology, allergy, RNA interference, and also closed research centers in Sandwich (UK) and Groton (Connecticut, USA), cutting 1,000 jobs.

At the same time, Pfizer has carried out work on combining its research centers, concentrating them in three major cities – Boston, Cambridge and San Francisco. To solve the issue of strengthening the product portfolio, the company actively uses outsourcing.

Despite the reduction of staff engaged in developments in the field of oncology and inflammatory processes, Pfizer continues to be one of the leaders in terms of R&D budget in this area. The company has high hopes for drugs for the treatment of oncological diseases, such as krizotinib, intended for the treatment of non-small cell lung cancer, axitinib, used for kidney cancer, and bozutinib for the treatment of chronic myeloid leukemia.

In November 2010, preliminary results of phase III clinical trials were published, according to which tofacitinib (formerly known as tasocitinib) is an anti–inflammatory drug that significantly reduces the severity of symptoms of the disease and improves the physical condition of patients. Later, in March, the company announced the successful completion of phase III clinical trials among patients with rheumatoid arthritis. This drug, according to representatives of Pfizer, has great prospects and may become a blockbuster in the near future, since its indicators represent the optimal risk/benefit ratio.

Apixaban, a drug owned by Pfizer and Bristol-Myers Squibb, has demonstrated good results in stroke prevention. Another drug, bapineuzumab, for the treatment of Alzheimer's disease, owned by Pfizer, Elan Corp. and Johnson & Johnson, is in phase III clinical trials, but their completion is not scheduled this year. Despite the fact that Pfizer has one of the largest R&D budgets, the research results have not led to a significant expansion of the company's product portfolio. Tony Butler, an analyst at Barclays Capital, noted the low productivity of Pfizer's innovative developments against the background of the largest R&D budget.

In 2010, Roche established itself as a trendsetter of global R&D fashion for all representatives of Big Pharma. The company has conducted a launch of new drugs, which are predicted to be the fate of blockbusters, and also absorbed the company "Genentech Inc.", a recognized world leader in innovative technologies and biotechnological developments. The amount of this transaction amounted to $ 47 billion. The antidiabetic drug taspoglutide did not meet the expectations of the company's representatives due to the presence of significant side effects when taking it. The pharmaceutical giant transferred the program for the development of this drug back to Ipsen and wrote off its costs for testing. Roche received another unexpected blow from the US Food and Drug Administration (FDA), which rejected an application for approval of the T–DM1 drug developed by a division of ImmunoGen Inc. Against the background of these problems, the success of Avastin/Avastin (bevacizumab) has faded.

Roche, like some other representatives of Big Pharma, decided to reconsider the direction of development of its activities in the R&D segment. Thus, it was forced to abandon developments in the field of RNA interference, since no significant progress was noted in this direction and it was recognized as unprofitable. Nevertheless, RNA interference remains a very promising area of research. In addition, in 2010, Roche stopped the development of a drug intended for the treatment of hepatitis C, which it conducted jointly with Ligand Pharmaceuticals Inc.

In November 2010, representatives of the company "Roche" announced plans to reduce the staff involved in the R& D sector - 600 jobs. In addition, Severin Schwan, CEO of the company, noted that he will continue to work aimed at increasing the economic impact of the R&D segment in 2011.

Despite the management's desire to minimize R&D costs in 2011, Roche still has ambitious plans for new research and development of innovative drugs. The delay in the approval of the drug T-DM1 could not dissuade the company's representatives that it remains one of the most promising medicines intended for the treatment of late-stage oncological diseases. Roche plans to make every effort to ensure that the drug is approved for use in breast cancer.

Another promising development of the company together with Plexxikon Inc. is the drug PLX4032 (or RG7204), which has demonstrated good results in the treatment of metastatic melanoma. Thus, in 2010, the company had to face a number of difficulties related to the failures that befell their drugs at the late stages of clinical trials. Roche, like Pfizer and Novartis, has big plans for investing in R&D centers in China. The Asian pharmaceutical market is one of the largest and most promising in the world, and China's R&D segment can become a platform for entering it.

At a time when Pfizer plans to reduce its costs for the creation of innovative medicines, Merck &Co. is developing a plan for the development of the R&D division. Thus, even after the sale of Schering, the R&D budget of Merck &Co. in 2010 amounted to $8 billion.

Nevertheless, Merck &Co. will save money, but only on short-term projects, and the company's long-term strategy aimed at business development until 2013 will be investing in the creation of innovative products. This, according to Kenneth Frazier, CEO of the company, will contribute to the success of Merck & Co. in the future. Peter Kim, head of the research division of Merck & Co., noted in an interview with Korea Economic Daily that there is a possibility of increasing R&D spending to $8.5 billion in 2011.

This is a very risky strategy. Recall that in 2009, the total amount of the company's expenditures on innovative developments amounted to $ 5.6 billion. How expensive can failure to develop a new drug cost a pharmaceutical company? Expensive, very expensive. For example, the development costs of the drug vorapaxar amounted to $ 1.7 billion, which had to be written off after receiving unsatisfactory research results.

Then the company's management began to actively work in the R&D direction in order to compensate for the costs spent on the implementation of the project. One of the promising products may be boceprevir, a drug for the treatment of hepatitis C, but it may face competition from Vertex Pharmaceuticals' telaprevir. Another hope of Merck & Co. may be the drug anacetrapib, which reduces cholesterol levels in the blood. Clinical studies of this drug have shown very encouraging results. Thus, anacetrapib in combination with statins increases the level of "good" cholesterol by 138% and reduces the level of "bad" cholesterol by 40%. Another success for Merck & Co. was the drug ridaforolimus for oral use, which can provide targeted drug therapy for oncological diseases of several localizations. In addition, a year ago, Merck & Co. restructured the partnership agreement with Ariad Pharmaceuticals Inc., thus gaining control over all developments intended for the treatment of oncological diseases, as well as their marketing promotion.

As part of its R&D strategy, the company also does not abandon the conclusion of license agreements and the acquisition of small companies. For example, Merck & Co. bought the company SmartCells, which develops therapy for diabetes mellitus. The transaction amount amounted to $ 500 million. The company is making great efforts to become a leader in the field of creating biosimilar drugs.

Merck & Co. is clearly moving towards its goal, and if any of the existing research areas do not fit into the overall picture, the company's management gets rid of them with an unwavering hand. So they did with the company "Schering", whose shares were sold to "Bayer". At the same time, Merck &Co. remains faithful to its long-term strategy to expand innovative programs and in light of this, we should not expect a significant reduction in its R&D budget.

Reduce the R&D budget? No, not Novartis. The company plans to expand its research and is going to hire additional staff for this. In 2010 she increased her R&D expenses by 10%, which allowed her to take 4th place in the rating, and in the future this strategy will allow the company to enter the top 3 representatives of the R&D direction in the world. In 2011, Novartis also plans to employ an additional 200-300 researchers and expand its laboratories in Cambridge (Massachusetts, USA) – it is expected that the associated costs will amount to $ 600 million. Thus, the company is not planning major cuts this year. Expenses for the Novartis R&D company in 2010 reached $ 6.1 billion, for comparison, this figure in 2009 amounted to $ 5.7 billion.

Previously, Novartis' R&D strategy resembled firing a cannon at sparrows - a large number of various drugs are being developed to treat many diseases, while the company is trying to cover all promising areas. Now it is planned to "conduct targeted fire" – to make the treatment more individualized. A striking example of such an approach to R&D development, according to Daniel Vasella, chairman of the company's management board, could be SOM230 (pasireotide), which is now in the final phase of research and has shown good results in the treatment of Itsenko-Cushing's disease, a hormonal disorder. It should be noted that today no drug intended for the treatment of this disease has yet been approved.

Novartis currently has 147 projects at the clinical research stage. At the same time, in 2010, the company submitted 16 products for consideration by the FDA, 4 of which received approval. Among them are drugs that the company has high hopes for: Lucentis (ranibizumab) and Afinitor/Certican (everolimus).

The success of Novartis allows us to count on the fact that in the near future some of the most recent launchies will receive the status of blockbusters. So, recently in the USA and Europe, the drug Gilenya (fingolimod) for oral use, intended for the treatment of multiple sclerosis, was approved. Merck KGaA, its closest competitor, has also developed an oral drug for the treatment of multiple sclerosis, cladribine, which is expected to be approved in the first quarter of 2011. Thus, Novartis managed to get approval for its drug earlier than its competitor Merck KGaA. In addition, the regular authorities are considering Novartis' application for approval of indacaterol, a drug intended for the treatment of chronic obstructive pulmonary disease. Another drug of the company – QVA149 – for the treatment of obstructive pulmonary disease is also in the final stage of clinical trials and has prospects of becoming a megablockbuster. In 2011, Novartis also applied for approval by the European regulatory authorities of the meningococcal vaccine Bexsero and in the near future plans to submit to the FDA an application for the drug ACZ885 (kanakinumab), intended for the treatment of inflammatory diseases.

In 2010, Johnson & Johnson was forced to withdraw several drugs from the market, but this did not prevent it from achieving success in the R&D direction. To do this, Johnson & Johnson used a proven strategy: the acquisition of successful companies engaged in innovative developments. This strategy has been working for a long time and is bearing fruit. So, in 1999, the company acquired Centocor and thus obtained the rights to market the drug Remicade /Remicade (infliximab), which eventually made Johnson & Johnson one of the most successful companies in the R&D segment. In 2010, great interest was aroused by the positive results of the final phase of clinical trials of the drug abiraterone, which allowed the company to apply for its approval to the regulatory authorities of the USA and the EU. The rights to this drug were obtained by Johnson & Johnson as a result of the purchase of Cougar, which in turn received this drug under a license agreement with BTG.

A similar situation is with telaprevir, a blockbuster drug developed by Vertex and intended for the treatment of hepatitis C. Johnson & Johnson has acquired the rights to sell the drug in Europe, since the probability of its approval in the United States is not too high. This drug cost the company $ 545 million, which should be paid in stages. In addition, in 2009 Johnson & Johnson acquired shares of the Irish company Elan for a total of $1.5 billion. At that time Elan was developing the drug bapineuzimab for the treatment of Alzheimer's disease together with Pfizer.

In January 2011, Bayer and Johnson & Johnson plan to jointly promote Xarelto/Xarelto (rivaroxaban), a thrombolytic for oral use, on the market. In November, the results of the latest study of this drug were published, indicating its benefits in the treatment of warfarin. Thus, Xarelto reduces the risk of strokes and is thus safer. According to the forecasts of Marijn Dekkers, executive director of Bayer, the sales volume of this drug may reach $ 2.5 billion, ahead, respectively, of its competitor – the drug Pradaxa (dabigatran etexilate, Boehringer Ingelheim GmbH).

Tibotec Pharmaceuticals, a subsidiary of Johnson & Johnson, in February announced the start of phase III clinical trials of TMC435, a hepatitis C virus protease inhibitor developed jointly with Medivir. In addition, success in R&D development has also befallen the company "Crucell N.V.", recently acquired by Johnson & Johnson. Back in the fall of 2009, the joint development of a flu vaccine began, after which Johnson & Johnson bought the company. The total amount of the transaction amounted to $ 2.4 billion. It is clear that Johnson & Johnson knows a lot about making such deals.

Last year, the CEO of GlaxoSmithKline, Andrew Witty, outlined some good reasons for reengineering the company's R&D division, since in the period 1998-2007, GlaxoSmithKline invested $ 3 billion annually, and this did not bring significant results. In 2010, the company invested about $6 billion in the R&D segment. The question arises, will these costs pay off?

During the reorganization, the division developing medicines for the drug therapy of rare diseases was expanded. Measures were also taken to expand the company's presence in emerging markets and the vaccine market. In 2011, GlaxoSmithKline planned that the cost of developing innovative drugs would amount to 14% of the company's turnover. In February 2011, the management of GlaxoSmithKline reported that 30 names of medicines, 10 of which are new chemical compounds or vaccines, are in phase III clinical trials or at the stage of application review by regulatory authorities. In 2011, according to the company's management, it is expected to start phase III clinical trials of 15 more drugs, including drugs for the treatment of type I and II diabetes mellitus, oncological and rare diseases.

The vast majority of the company's innovative products are new molecules. One of them is currently at the stage of approval of the application to the FDA. In the near future, it is planned to approve the drug in the EU, Canada, Australia, Switzerland and Russia. The company expects that revenues from sales of this drug will amount to $ 5 billion.

The R&D budget of Sanofi-aventis in 2010 was also supplemented by research expenses of Genzyme, acquired by Sanofi-aventis, which amounted to $847 million. It is planned that medicines will continue to be produced under its own brand "Genzyme" and the company will become a division of "Sanofi-aventis" specializing in the development of medicines for rare diseases. However, all profits from Genzyme developments will be taken into account in the financial results of Sanofi-aventis.

Christopher Viehbacher, CEO of Sanofi-aventis, revised the company's R&D strategy, during which he abandoned development in some areas so that the company could focus more resources on other relevant and promising projects. A number of acquisitions were made, initiated by K. Viebacher, – purchases of TargeGen for $635 million and BiPar Sciences for $500 million. The latter is engaged in the creation of promising drugs, and its acquisition was due to the difficulties that arose during the phase III clinical trials of the drug iniparib for the treatment of breast cancer, developed by Sanofi-aventis. To expand the product portfolio, Sanofi-aventis took advantage of outsourcing and turned to Covance for help. It was decided to focus the work of Sanofi-aventis in the R&D segment on the creation of licensing agreements and alliances with biotech companies, as well as to pay more attention to the company's activities in emerging markets.

In early February 2011, Sanofi-aventis announced that its product portfolio includes 55 projects under development and 13 in Phase III clinical trials/at the stage of regulatory approval. Representatives of the company note that this year it is expected to complete clinical trials of 5 drugs under development. Thus, the drug lixisenatide for the treatment of diabetes mellitus is currently undergoing phase III clinical trials, during which the advantages of therapy with this drug compared to Byetta have been demonstrated/Baeta (exenatid). Two-year phase III clinical trials of teriflunomide for multiple sclerosis also ended successfully, demonstrating a reduction in the number of relapses compared to placebo, as well as a reduction in the risk of disability.

Also, Sanofi-aventis, together with Regeneron, conducts clinical trials of aflibersept for the treatment of oncological diseases. The final results of these studies will be available in mid-2011. Sanofi-aventis is developing a vaccine for the treatment of Dengue fever, and is also building a new plant in order to be able to meet future demand for the product. Studies of ombrabulin are considered promising. It is planned to replenish the company's product portfolio thanks to the developments of Genzyme. Representatives of the biotech company reported that by the end of 2013, regulatory authorities are expected to approve three drugs: Lemtrada (alemtuzumab) for the treatment of multiple sclerosis, mipomersen for use in hypercholesterolemia and eliglustat tartrate for the treatment of Gaucher type I disease.

2010 was not the most successful year for the company. The management of AstraZeneca made a strong–willed decision to stop the research of its nerve growth inhibitor - medi578 after the failures that befell similar drugs from other companies. Previously, it was predicted that the sales volume of drugs of this class could amount to $ 11 billion per year.

This money turned out to be a mirage, as well as the proceeds from sales of the drug zibotentan, used in the treatment of prostate cancer. The results obtained during the phase III studies of this drug were disappointing, already 2 months after the company wrote off $ 445 million spent on motavizumab. This drug was created with the expectation that it could replace Synagis (palivizumab, MedImmune) on the market, and was obtained by AstraZeneca after the takeover of the company. Also, hopes for 400 million in revenue from sales of Recentin (cediranib) did not justify themselves. Back in May 2010, the company had to abandon its plans to position the drug as a drug for the drug therapy of colon cancer, after unsatisfactory results of phase III clinical trials.

AstraZeneca has not registered a single drug since 2003, until Onglyza, a drug for the treatment of diabetes mellitus, was approved in 2009/Onglyza (saxagliptin). After that, at the beginning of 2010, the company announced its plans to reduce 1800 employees of the R&D division and focused on the development of the most popular medicines. During this reorganization, the company abandoned research in the field of creating drugs for the treatment of thrombosis, acid reflux, ovarian and bladder cancer, systemic scleroderma, schizophrenia, bipolar disorder, depression, hepatitis C and some vaccines. It was also planned to close the research center in Wilmington, which conducts research in the initial phases, and the research programs conducted in Boston, another research center of the company, will be expanded. At the same time, the company expects that it will be able to secure the approval of several promising drugs already in 2011.

The management of AstraZeneca had high hopes for the approval of the future blockbuster thrombolytic Brilinta (tikagrelor), which was received by the FDA without much enthusiasm – the regulatory authorities requested additional data, which significantly slowed down the process. This was an unexpected nuisance for the company, although the application for approval of the drug is still under consideration by the FDA – hour X is scheduled for July 20. In addition, AstraZeneca, together with Bristol-Myers Squibb, are developing a drug dapagliflozin, an SGLT2 inhibitor designed for the treatment of diabetes mellitus. At the same time, the company managed to convince the experts of the FDA committee of the possibility of using vandetanib for the treatment of thyroid cancer, despite the fact that the application for its use in lung cancer was rejected. The final decision of the regulatory authorities on this drug is scheduled to be received on April 7.

In June 2010, AstraZeneca and Targacept announced the beginning of phase III clinical trials of TC-5214 for the treatment of depression.

Like most representatives of this rating in 2010, "Eli Lilly" has significantly increased its R&D budget. At the same time, the company did not receive a result corresponding to the invested funds, which caused the disappointment of investors.

In 2010, the company's R&D budget amounted to almost $ 5 billion - 11% higher than expenses for 2009. In 2011, it is planned that investments will remain at the same level. But this does not mean that "Eli Lilly" will be able to avoid abbreviations. In December 2010, the company's representatives announced the impending closure of their research center in Singapore, which would entail the dismissal of 130 employees of the company and the transfer of all research programs to Indianapolis. Recall that in 2009, the company made significant cuts, laying off about 5,500 employees.

An unpleasant surprise for the company was the rejection in August 2010 of an application for approval of a drug for drug therapy of Alzheimer's disease – semagacestat. According to the results of clinical trials, the drug did not contribute to slowing the progression of the disease, but, on the contrary, led to a deterioration in the condition of patients. It should be noted that neurology is one of the most difficult areas for creating new medicines, and many companies are curtailing research in this area and turning their eyes to areas with a more predictable result, which means that they are likely to justify the invested funds. But still some companies, for example, Johnson & Johnson, continue to work hard in this direction.

Now the company is conducting clinical trials of the drug Bydureon (exenatide), designed to replace the company's earlier product for the treatment of diabetes mellitus on the market – Byetta/Baeta (exenatid). Bydureon was developed by the company in collaboration with Amylin and Alkermes. Unfortunately, for the management of Eli Lilly, the approval process of the drug does not go as smoothly as expected – in the fall of 2010, regulatory authorities requested new data on clinical trials and initiated the inclusion of stroke in the list of possible complications when taking the drug. In addition, the results of a comparative study of the effectiveness of Bydureon and Victoza (liraglutide, Novo Nordisk) were disappointing.

Difficulties also arose in the process of clinical trials of tasisulam, a drug intended for the treatment of late–stage melanoma - researchers recorded 12 fatal cases. Also in development now is the drug Cymbalta (duloxetine hydrochloride).

In early 2009, Eli Lilly and Bristol-Myers Squibb suspended phase III clinical trials of the drug netcitumumab after it became known that its use was associated with an increased risk of thrombosis in patients who had just started taking the drug. This risk is somewhat lower for patients who have already received 2 courses of treatment with netcitumumab in combination with Alimta/Alimta (pemetrexed for injection) and cisplatin, and studies can be continued in this group. It is also planned to continue testing among patients who took the drug in combination with cisplatin and Gemzar/Gemzar (gemcitabine).

The strategy of "Eli Lilly" is ambiguous, and until concrete results are obtained, it is too early to say anything. To do this, the company's innovative drugs must receive FDA approval, which is not expected in the near future.

In 2010, Bristol-Myers Squibb invested 18.3% of sales revenue in innovative developments – this is a lot of money. In addition, it is expected that in 2011 investments in R&D will be even more significant. At the same time, the research of the Bristol-Myers Squibb company is characterized by high productivity even in comparison with the giants of Big Pharma.

Bristol-Myers Squibb completed 2010 with a large list of medicines in the last stage of research, including such promising drugs as ipilimumab (for the treatment of skin cancer), brivalib (for liver diseases), XL-184 (for the treatment of cancer), dapagliflozin (created jointly with AstraZeneca" and intended for the treatment of diabetes mellitus), belatacept (used after organ transplantation) and the thrombolytic apixaban. The company is also working on the approval of additional indications for use for Sprycel drugs/ Sprycel (dasatinib), Orencia (abatacept) and Onglyza. The company's management plans that the launch of 5 drugs from the currently in the final stage of clinical trials will take place in 2012.

Apixaban, developed by the company together with Pfizer, has demonstrated its superiority over acetylsalicylic acid in preventing strokes in patients with a high risk of atrial fibrillation during clinical trials. In the fall of 2010, information was published about the discontinuation of drug trials in a group of patients with acute coronary syndrome, which was caused by an increased number of cases of bleeding. However, this fact only excludes one group of patients from the number of potential consumers of the product, and the drug still has every chance of becoming a blockbuster.

The company has applied for approval of ipilimumab, a monoclonal antibody drug that affects CTLA-4 T-lymphocyte receptors. The company received this drug as a result of the takeover of Medarex and, despite the delay in its approval, this drug has every chance of becoming a blockbuster. In addition, Bristol-Myers Squibb has high hopes for the drugs brivanib and belatacept, the approval of which the company's representatives expect in the near future.

In September last year, Bristol-Myers Squibb and AstraZeneca reported encouraging results of phase III clinical trials of the drug dapagliflozin for the treatment of type II diabetes mellitus. Thus, it was found that when treated with the drug in combination with metformin, it is not inferior to glipizide in terms of the degree of reduction in the level of glycosylated hemoglobin. In addition, dapagliflozin contributed to the reduction of excess body weight in patients.

It may seem that the executives of the Bristol-Myers Squibb company are rare lucky people, and they do not know the word "failure". But this is not the case. For example, Bristol-Myers Squibb, together with Eli Lilly, were forced to partially terminate the final stage of clinical trials of netsitumumab, a drug for the treatment of oncological diseases. Failure also befell the company during the development of XL184, now better known as cabozantinib, Bristol-Myers Squibb was forced to return the drug to Exelixis, from which it had previously acquired a license for it.

Today, Bristol-Myers Squibb is forced to work actively to be ready for the competition that Plavix will face in the near future/Plavix (clopidogrel bisulfate). Despite minor setbacks, Bristol-Myers Squibb continues to be very successful in the R&D field.

Creating a new drug is a time–consuming process and requires luck.

Portal "Eternal youth" http://vechnayamolodost.ru11.04.2011