Merck и Pharmacia - Vioxx и Celebrex

Merck и Pharmacia - Vioxx и Celebrex

Company Merck & Co. and Pharmacia Corp. publish detailed results of clinical trials on the side effects of drugs produced against arthritis. Drugs company Merck Vioxx and Celebrex company Pharmacia has won strong position in the pharmaceutical market, the United States regardless of the number of high-profile scandals caused by (the side effects of pills Celebrex) and its creators have good returns.

Yet Celebrex manufacturers want to prove that these drugs are safe for a person and not cause side effects than conventional arthritis treatment facilities belonging to a group of anti-drugs and of the prolonged admission side effect of stomach ulcers. If a company can persuade the authorities in the United States more secure Celebrex and produced by drugs and obtain a statement of the information on the labels of drugs, the sales volume of drugs Vioxx and Celebrex increase substantially.

The results of clinical trials on the side effects of Celebrex will be announced during the annual conference on the diseases of the digestive, held in San Diego. By mid-year the company planned to send test data side effects in the Office of Quality Control Food and Drug USA, FDA, in order to assign a Celebrex in a class of drugs, as well as the issuance of the certificate to increase security

According to Peter Wen, representation fund Warburg Pincus Global Health Sciences Fund, drugs "Vioxx and Celebrex" quite expensive, and therefore insurance companies refuse to pay for the acquisition of Celebrex and Vioxx, if they can prove that the treatment with cheaper traditional medicines has proven to be ineffective. However, if FDA approval for the printing of high-security drugs Vioxx and Celebrex to their labels, most insurance companies may make the inclusion of these drugs in the list of medicines covered.

Whether the drugs Vioxx and Celebrex as a drug increased security will Suppliers mentioned in television and print advertising. The analyst Carl Seiden of J.P. Morgan, in the event of success in dokazatelvste no side effects, in a year of Merck and Pharmacia will begin a more aggressive campaign drugs Vioxx and Celebrex, which will enable them to select a large share of the market for traditional medicines for arthritis.

FDA granted permission to use drugs Vioxx and Celebrex for the treatment of arthritis, the most common form of intervention arthritis, which affects about 21 million Americans. In addition, the drug Celebrex was approved as a means to relieve the short-term pain caused by rapid intervention, drug Celebrex was allowed to use for the treatment of rheumatoid arthritis, the less common form of arthritis caused by reduced immunity. The diseases affect some 2.1 million Americans. This year, the company Merck also plans to apply for permission to use the drug Celebrex for the treatment of rheumatoid arthritis.

Gross income from sales of the world's drugs Celebrex, appeared on the market in January 1999, up $ 1.5 billion The drug Vioxx went on sale after 4 months, its creators had revenue of $ 472 million

The medicines Vioxx and Celebrex can selectively block an enzyme called Cox-2 causes the inflammation of the tissue in the bone. Traditional means to block the provision of this enzyme, however, it is assumed that they are blocking an enzyme and Cox-1, leading to side effects of stomach ulcers and other gastrointestinal diseases.

According to statistics, the United States accounts for approximately 16,000 deaths a year is receiving traditional medicines for the treatment of arthritis.

Meanwhile, last year, when a decision was made to the approval of drugs Vioxxi Celebrex, the FDA designates them to the same class of drugs as traditional medicines, and a certificate of heightened security FDA has required extensive clinical trials.

Results 13-mesyachnyh test side effects of the company Pharmacia and to compare it with medication Celebrex drug Diclofenac and ibuprofen in a long reception, will be presented at the conference.

In tests on Vioxx and Celebrex side effects involved 6,800 patients with arthritis and 22,500 rheumatoid arthritis patients

Test results of Merck, which involved 8,500 patients with rheumatoid arthritis. These clinical trials were compared side-effects-Celebrex drug Vioxx off zffektam Naprogesic drugs for the same period, on average, 11 months.

Both companies have unveiled summaries of the results of clinical trials of drugs Vioxx Celebrex safety. Last month, Pharmacia company said that patients taking Celebrex daily 500 meters (a 3 times higher than the recommended dosage for arthritis patients, and 4 times higher dosage recommended for rheumatoid arthritis patients), showed less exposure to the gastrointestinal disease than patients taking ibuprofen or Diclofenac in standard doses.

On Sunday became known more detailed tests, in which stomach ulcers and other gastrointestinal complications was 1.1% of patients who took Celebrex, and 1.6% of patients taking standard drugs against arthritis. If the number of patients who received gastric ulcers (excluding other complications), and among patients who took Celebrex, their share was 0.8%, whereas the proportion of patients who received the disease as a result of receiving traditional products reached 1.5%. It should be noted that the figures indicate a positive trend, Vioxx and Celebrex, and not statistically significant.

According to the company Pharmacia, it is because about 12% of the patients participating in trials, in addition to drug Celebrex was still small doses of aspirin to prevent heart attacks and other cardiovascular diseases. In lieu of the consideration of this group of patients of patients who received gastric ulcers as a result of receiving Celebrex, was only 0.2% vs. 1.8% of patients taking other drugs.

The trials of the drug Vioxx were also mixed. In March, the company Merck reported that patients suffering from rheumatoid arthritis and receiving daily 60 m drug Vioxx and Celebrex, have shown much less exposure to the gastrointestinal disease than patients who Naprogesic. But among patients who took Celebrex, there were 6 times more heart attacks than patients who took Naprogesic (0.5% vs. 0.1%). Merck Company explained that the opening of that Naprogesic may have the ability to prevent the generation of blockages in blood vessels, and noted that there was no reason to believe that Celebrex causes heart attacks. Merck representative also noted that the previous drug testing was not detected any difference in the number of heart attacks that occur among patients taking different drugs.

According to the analyst from J.P. Morgan, FDA will issue a placement of high security labels drugs Celebrex and Vioxx, but the identification of these drugs in a class of medications unlikely. The analyst also believes that the drug Celebrex has great prospects for the certificate of increased security than Vioxx.

Another industry expert who wished to remain anonymous, said that the FDA will be very difficult to decide, since clinical trials of both companies have shown conflicting results and the decision in this case would be to leave things much as they Commentary on the subject from the FDA could be obtained.