Pfizer Inc., the world's largest generic drug manufacturer, has been forced to cancel a planned Phase III clinical trial to test the anti-cancer drug finasteride in men with prostate cancer. The company, which is based in San Francisco, is scheduled to release the results on Monday.
Finasteride, the first of its kind, was originally approved by the U. S. Food and Drug Administration for treating benign prostatic hyperplasia, a type of enlarged prostate. However, the company was forced to change the name of the drug after a patient told the Associated Press he had been diagnosed with a type of prostate cancer. The drug's patent ended in 2010.
The study involved a group of patients whose prostate glands were found to have been damaged by finasteride treatment. Patients taking finasteride showed a higher risk of developing prostate cancer. The results showed that the drug was effective for about half of the men who developed prostate cancer and the other half.
The study was conducted by researchers at the University of Pittsburgh's School of Medicine and Dentistry. Dr. Michael B. Lecocca, head of clinical research and study design at the company, said that he has no known side effects from finasteride and that his team had been working on finasteride for about a year.
While the study is "irregular," Dr. Lecocca said, "we don't want to see it for another 20 years."
The company has a "modest" outlook for the company, but the company will be testing finasteride for potential treatment options for benign prostatic hyperplasia, or BPH, BPH is a "major" issue for the company. The results would likely be released by the FDA at the end of the current year. In the meantime, he said, "I don't want to take my chances on something that could be a big deal."
Finasteride, which is sold by Merck & Co., is marketed as a generic drug for hair loss, although the drug has been approved by the FDA to treat male pattern baldness and alopecia areata. It works by blocking the production of a hormone known as dihydrotestosterone (DHT), which is the primary cause of hair loss in both men and women.
The company said its Phase III study is enrolling patients, but it has not yet decided whether the results will be published. However, the company is planning to release finasteride results after the FDA's first week of testing.
"We're doing our best to get the information we know from the clinical trials we're testing that is important," said Dr. Jeffrey Kindler, president and chief executive of Prostate & Burden. "Our goal is to bring the FDA to the stage where it's available to the public."
Prostate cancer was the leading cause of death in the United States in 2010, with nearly 2.7 million cases. The disease has been a cause of concern for some patients and medical researchers have noted concerns about finasteride's safety.
The FDA's review of finasteride's safety has been one of the most contentious issues in the drug's development. The agency has long maintained that the drug is effective, but has also said that it has a "significant safety advantage over other options for treating male pattern baldness."
Finasteride is the only approved drug for treating benign prostatic hyperplasia, a condition in which the prostate gland becomes enlarged and causes enlarged prostates to grow.
In the study, the study enrolled men who were diagnosed with BPH and were taking finasteride for two years, then switched to a placebo for five years to see if it worked. The men who were switched were followed for six months.
The results showed that the drug was effective for about half of the men who developed prostate cancer. But the study showed that only about one-sixth of the patients was taking finasteride.
A phase III study involving men who were taking finasteride for two years and then switched to placebo for five years will be released next year. The study is expected to be part of a larger effort to examine the safety of finasteride in men with BPH.
The company is currently in a process of other clinical trials to determine whether finasteride is safe and effective.
Other drugs that have been approved for treating BPH include,, and.
In the study, the study enrolled men who were prescribed finasteride for two years and then switched to a placebo for five years.
AstraZeneca today announced the successful completion of the agreement between the European Medicines Agency (EMA) and Merck & Co.
The agreement was approved for the purchase of Merck’s Propecia (finasteride) from AstraZeneca, the U. S. pharmaceutical company based in Merkham, England.
Merck has already completed sales of Propecia for the U. and European markets, including Japan and Korea, which have received regulatory approvals for generic versions of Propecia. Additionally, AstraZeneca is planning to further accelerate sales growth by obtaining FDA approval for generic versions of Propecia from Merck.
Merck has already launched several generic Propecia sales through its Propecia and Finasteride Generics programs in the U. S., including the U. and Europe markets. In April, AstraZeneca will begin the first generic version of Propecia at a price of $4 per tablet, while in December the generic version will be available for as little as $3.50 per tablet.
The acquisition of Merck’s Propecia from AstraZeneca was completed in February 2016.
The agreement between the European Medicines Agency and Merck is expected to provide AstraZeneca with greater access to generic drugs than the FDA has prior to the approval of the generic version of Propecia.
The agreement with AstraZeneca is expected to strengthen the market for generic drugs and will further accelerate sales growth by obtaining FDA approval for generic versions of Propecia and finasteride generics.
Merck has previously initiated the acquisition of Propecia, which it has recently completed, with AstraZeneca.
“We are delighted to be working with AstraZeneca to complete this transaction,” said Michael J. Rosenbloom, M. D., president, AstraZeneca. “We are also working with Merck to secure the regulatory approvals necessary to secure the acquisition of our Propecia, which has been completed and is expected to reach $4 billion by 2029.”
As part of the acquisition, Merck will buy up the assets of AstraZeneca in a joint venture to develop and commercialize generic versions of Propecia.
“This transaction will further accelerate sales growth,” said Michael J. “We are confident that the acquisition of Merck’s Propecia and Proscar assets will further accelerate sales growth and allow us to continue our growing portfolio of generic pharmaceutical products.”
For further information, please visit the.
This press release contains forward-looking statements regarding AstraZeneca’s actual future financial performance. These statements are based on management’s current expectations, as of the date of this press release and involve a number of risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Such factors include, but are not limited to, the risks inherent in the business of AstraZeneca and other generic pharmaceutical companies and the risk that generic companies may attempt to obtain FDA approval to market their generic versions of their products. Any such results could differ materially from those anticipated in such statements.
For a full list of risks and uncertainties detailed in this press release, see the.
Merck today announced the successful completion of the agreement between the European Medicines Agency (EMA) and Merck. AstraZeneca announced that the transaction was completed on March 18, 2016, with the divestment rights of approximately $4 billion to Merck to be transferred to AstraZeneca. The transaction was completed in March 2016.For a more detailed analysis of the integration of AstraZeneca into the global pharmaceutical business, including details of the transaction, please visit the.
Merck today announced the successful completion of the transaction between the European Medicines Agency (EMA) and Merck. AstraZeneca today announced the successful completion of the transaction between the European Medicines Agency (EMA) and Merck. Merck announced that the transaction was completed on March 31, 2016, with the divestment rights of approximately $4 billion to Merck to be transferred to AstraZeneca.For more information about AstraZeneca’s acquisition of Merck, please visit the.
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For the analytical method, the concentration of the analyte in the sample is determined by using the following method:
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