Development of new drugs adjusted for the crisis
Investment Molecule
Leading pharmaceutical manufacturers have become more careful to finance the development of cancer drugsGalina Papernaya, "Time of News", 02/16/2010
(published on the "Remedium" website)
By mid-February, all the world's largest pharmaceutical manufacturers had published the financial results of 2009 and presented plans for further business development. According to the reporting data, it is clear that, despite the crisis, all pharmaceutical companies, without exception, significantly strengthened their positions last year. However, not the most favorable global economic environment forces even successful companies to spend their earnings with caution. This trend is especially noticeable in the field of long–term investments in the development of new drugs - R & D (Research & Development).
In absolute terms, investments in research and development in the field of new medicines have only increased over the past year, and the percentage of sales of almost all market leaders remained at the level of previous years. But on the other hand, the distribution of funds between the various directions of the search for new innovative medicines has significantly changed. According to experts, long-term investments in substances with very illusory prospects even at the laboratory stage (for example, in drugs for cancer and AIDS) have been replaced by interest in more productive investments, which also assume the maximum proximity of the experimental substance to clinical trials. This trend is especially noticeable in the set of cancer molecules, which a few years ago made up most of the R&D portfolios of all major pharmaceutical companies.
Some disappointment of investors (and researchers themselves) in the search for a cure for cancer was largely the result of scientific advances in this area. Scientists have come to the conclusion that the malignant lesion of each organ can be caused by dozens of different mechanisms, and for each of these types of disease, its own medicine is needed. It became clear that there would be no "blockbusters" – drugs effective immediately against a whole class of malignant neoplasms. And the future of oncopharmacology lies with highly specialized molecules acting in a personalized way on a particular subtype of cancer cells.
The uncontrolled "reproduction" of oncological diseases, as well as the fact that any personalized drug is designed for a rather narrow segment of consumers, although its development is in no way cheaper than the development of drugs of wider use, and led to a shift in the interests of developers in the field of rethinking already known drugs, searching for a new application for them. This is confirmed, for example, by the annual report published recently in Basel by the world leader in sales of cancer drugs and test systems of the Swiss Roche. It follows from the reports of the company's management that last year investments in R&D increased by 12% compared to 2008 and reached 9.9 billion Swiss francs (this is more than 20% of total sales). Now the portfolio of molecules that have reached the last stages of clinical trials includes 12 names (last year there were ten of them). Two new molecules are developments in the treatment of diseases of the central nervous system and metabolic disorders. The oncological direction, both in the past and this year, is represented by five substances, the work on the introduction of which has been going on for several years and is about to be completed. "In 2010, there will be a slight decrease in the level of investment, as clinical trials for some drugs have already passed the main stages," said Severin Schwan, Chief Executive Officer of Roche. "Justified "tuning" of already existing molecules makes them more selective, more accurate, more aggressive when exposed to a cancer cell while maintaining an acceptable level of safety, and this is the most important task and the most important result, since the patient's life depends on it," the head explained the company's research policy for "Time News". the medical department of the Moscow office of Roche Rustam Galeev.
The American pharmaceutical giant Pfizer invested $7.7 billion in the development of new drugs last year, which is 3% more than in 2008 ($ 7.5 billion). Nevertheless, research costs accounted for only 15.5% of the company's total sales last year ($50 billion). Oncology is also one of the priority areas of Pfizer's research activities, along with analgesics, antibiotics, drugs for the treatment of mental disorders, diabetes mellitus and Alzheimer's disease. After the acquisition of the biotech company Wyeth, which took place in October 2009, there was also an emphasis on the development of vaccines and biological drugs. This merger brought several promising molecules to the Pfizer line, ready to become full-fledged oncological drugs in the near future. Currently, the company has 11 such substances in the third stage of clinical trials, the scope of their application is liver, lung, leukemia, breast and prostate cancer. But if we compare the number of antitumor molecules in the third phase of clinical trials with the number of molecules of the same profile in the first stage, and most importantly, their ratio to molecules of other purposes, it becomes clear that the oncological direction is losing its attractiveness. So, if 40.7% (11 out of 27) of oncological molecules were tested at the last stage, then only 17.9% (seven out of 39) at the first stage. Considering that those substances that managed to go through the entire "clinic" were developed about 5-7 years ago (at the time of maximum interest in oncological developments on the part of investors), their current cooling to this scientific field will be fully reflected in the nomenclature of molecular portfolios of large companies only in a couple of years.
Oncology, like vaccines, is a priority for another, already European leader in the drug market – the French Sanofi Aventis. Currently, 21 new substances are represented in the company's portfolio of vaccines, 12 molecules in the oncological direction (only six of them have reached the last stage of clinical trials). In 2008, Sanofi Aventis Group's investments in research and development amounted to about 4.6 billion euros (approximately 16.6% of total sales). In 2009, the company's spending on R&D decreased by 1% relative to total sales and amounted to 15.6%. In absolute terms, spending on research has remained the same.
It is the strong division of vaccines and the experience of developing new substances for cancer drugs in total that can prove to be a decisive competitive factor for pharmaceutical companies in the market of new cancer drugs, many experts believe. The fact is that the dimmer the prospects for investing in the development of traditional chemotherapeutic agents, the more obvious the benefits of developing new generations of vaccines that can not only prevent, but also treat many types of cancer. The Chairman of the International Union for the Fight against Cancer, David Hill, on February 4, in his annual speech on the occasion of cancer Day, noted that a person can still prevent many cases of malignant neoplasms. The English physician named nine major oncogenic viruses, including the very common human papillomavirus in the population, which causes cervical cancer, and the hepatitis B virus, which causes liver cancer. By the way, effective vaccines exist and have been used for a long time against these two pathogens. "If it was announced that someone had invented a drug that cures 40% of all cancers, it would be a reason for justified rejoicing," said David Hill. "The fact is that we know a way to prevent 40% of diseases. And it's a tragedy that we don't use it."
The events of the last few months in the pharmacological R&D market allow us to hope that investors will return interest in investing in the development of drugs used by oncologists. "In 2008-2009, many investment funds went bankrupt, and it really became more difficult to sell developments, but those buyers who survived have now very actively started buying up promising projects," Oleg Korzinov, deputy head of the most successful Russian biotech Chemrar, told Vremya Novosti. According to him, competition between investors is intensifying in the development market. "If until recently there were a lot of cheap projects, now there are almost none," says Mr. Korzinov.
In addition, global investment priorities are more strongly tied to the size of market niches than to the economic and scientific conjuncture. Since oncological diseases do not fall below the second or third line in the ranking of the most common causes of death in developed countries, investments in new developments are guaranteed here, Oleg Korzinov is sure. According to the World Health Organization, developers of new molecules whose target is malignant cells really have nothing to worry about in the long run. According to preliminary estimates, by 2030, the number of annually registered cases of cancer in the world will increase by 45%, from 7.9 million people (2007 level) to 11.5 million. And the current restraint on the part of investors should be considered only as a temporary lull – even if it stretches for several years, it will inevitably be replaced by a new wave of investments. Moreover, despite the forecasts of the effectiveness of a particular remedy, patients are waiting for each fundamentally new oncological drug with great hope.
Portal "Eternal youth" http://vechnayamolodost.ru17.02.2010