The FDA issues Complete Response Letters to request additional information needed to complete the review of applications for product approval.
The Complete Response Letter related to the Prolia applications requested several items, including further information on the design of Amgen's previously submitted post-marketing surveillance program. This letter does not require additional pre-marketing clinical trials to complete the review of the treatment indication. The FDA has requested a new clinical program to support approval of Prolia for the prevention of postmenopausal osteoporosis indication.
The FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary for Prolia and must include a medication guide, a communication plan, and a timetable for submission of assessments of the REMS. The FDA acknowledged receipt of Amgen's previously submitted proposed REMS materials. The FDA has also requested all updated safety data related to Prolia.
Amgen is reviewing the Complete Response Letter and will work with the FDA to determine the appropriate next steps regarding these applications.
Amgen expects to receive a separate response for its application for Prolia in the treatment and prevention of bone loss due to hormone ablation in breast and prostate cancer patients.
"We are confident that we can quickly respond to the FDA's requests for the treatment of postmenopausal osteoporosis indication and plan to do so in the near term," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "Amgen is fully committed to working with the FDA to make Prolia available to patients in the near future."
Amgen also has submitted Prolia for approval in postmenopausal osteoporosis and bone loss in breast and prostate cancer patients due to hormone ablation therapy in the European Union, Switzerland, Australia and Canada. Amgen is working closely with regulatory agencies in each of these regions to make Prolia available to patients around the world.
Often referred to as the "silent epidemic," osteoporosis is a global problem that is increasing in significance as the population of the world both increases and ages. In the U.S. today, nearly eight million women suffer from osteoporosis.(i) The World Health Organization (WHO) has recently identified osteoporosis as a priority health issue along with other major non-communicable diseases.
The economic burden of osteoporosis is comparable to that of other major chronic diseases; for example, in the U.S., the costs associated with osteoporosis-related fractures are equivalent to those of cardiovascular disease and asthma.(ii iii iv) It has been reported that osteoporosis results in more hospital bed-days than stroke, myocardial infarction or breast cancer.(v)
Bone Loss Due to Hormone Ablation
In the U.S., prostate cancer is the most common cancer in men and breast cancer is the most common cancer in women. It is common for prostate cancer and breast cancer patients to receive hormone ablation therapies that can lead to a decrease in bone mass and increased risk of fractures. Currently there are no approved therapies for bone loss in patients undergoing hormone ablation for either prostate or breast cancer.
In February 2009, the FDA accepted the BLA, submitted by Amgen for Prolia for the treatment and prevention of osteoporosis in postmenopausal women and treatment and prevention of bone loss in women and men receiving hormone therapy for either breast cancer or prostate cancer. The FDA has provisionally approved the trade name Prolia in these proposed indications, for which the drug is administered twice yearly subcutaneously at a 60mg dose. The trade name is only for these indications and may not apply for other indications of denosumab.
Prolia is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone). Prolia is being investigated for its potential to inhibit all stages of osteoclast activity through a targeted mechanism. It is being studied in a range of other bone loss conditions including rheumatoid arthritis, and cancer treatment-induced bone loss (in breast cancer and prostate cancer patients), as well as for its potential to delay bone metastases and inhibit and treat bone destruction across many stages of cancer.
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.
This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K.
Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of Oct. 19, 2009, and expressly disclaims any duty to update information contained in this news release.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.
The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the FDA, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Further, the scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the FDA for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.
i. http://www.nof.org/osteoporosis/diseasefacts.htm, accessed, 3/18/2009: Main bullet #5
ii. Burge R, et al. J Bone Miner Res. 2007; 22:465-475
iii. "Osteoporosis Fast Facts." Washington (DC): National Osteoporosis Foundation. Accessed on February 24, 2009 at http://www.nof.org/osteoporosis/stats.html.
iv. "Economic Cost of Cardiovascular Diseases." Dallas (TX): American Heart Association. Accessed on February 24, 2009 at http://www.americanheart.org/statistics/10econom.html
v. Lippuner K, et al. "Incidence and direct medical costs of hospitalisations due to osteoporotic fractures in Switzerland." Osteoporosis International.1997;7:414-
CONTACT: Amgen, Thousand Oaks
David Polk: (805) 447-4613 (media)
Sarah Reines: (805) 447-9783 (media, osteoporosis)
Arvind Sood: (805) 447-1060 (investors)
SOURCE Amgen Inc.