Amgen (Europe) GmbH today announced that the European Commission (EC) has approved the extension of the marketing authorization for Mimpara® (cinacalcet) in the European Union (EU) for the reduction of hypercalcemia in patients with primary hyperparathyroidism (PHPT) for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
"Amgen is committed to providing treatment options for grievous illnesses where no other treatment options are available. We are pleased that the European Commission has approved the marketing authorization extension for Mimpara, as patients with PHPT and hypercalcemia, where surgery is not an option, may now benefit from this new treatment," said Willard Dere, M.D., senior vice president and international chief medical officer, Amgen. "The new indication is a positive demonstration of Mimpara´s favorable efficacy and safety profile in these patients."
The EC approval for Mimpara is based on a review by the Committee for Medicinal Products for Human Use (CHMP) of a positive benefit/risk assessment in a patient population that currently has no other long–term treatment options available to them. As part of the CHMP review, Amgen´s clinical efficacy and safety Mimpara data from patients with hypercalcemia due to PHPT in whom surgery was not a treatment option were evaluated. Following the review, the CHMP concluded that Mimpara fulfills an unmet medical need for this patient population with uncontrolled hypercalcemia and recommended the extension of Mimpara´s marketing authorization to the EC.
About PHPT
PHPT is an endocrine disorder caused by the enlargement of one or more of the four parathyroid glands and resulting in the release of excess parathyroid hormone (PTH). PTH regulates the amount of calcium and phosphorus in the body and plays an important role in several body systems including the skeletal, gastrointestinal, renal, muscular, and central nervous systems.
The majority of patients with PHPT requiring an intervention are treated surgically by parathyroidectomy. However, this is not a suitable treatment option for a small proportion of patients.
About Mimpara
Mimpara® (cinacalcet) (also known as Sensipar® in the United States, Australia, New Zealand and Canada) is a calcimimetic agent that is approved for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease receiving dialysis.
Calcimimetics amplify the action of calcium on the calcium–sensing receptors on the parathyroid gland, thereby decreasing the secretion of PTH. Mimpara is the first and only calcimimetic agent approved for use in dialysis patients to specifically bind to and directly modulate the calcium–sensing receptor on the surface of the chief cell of the parathyroid gland while simultaneously lowering blood calcium and phosphorus levels. In dialysis patients, Mimpara significantly reduces PTH levels while simultaneously lowering blood calcium and phosphorus levels. Mimpara binds to the parathyroid gland´s calcium–sensing receptors, making them more sensitive to calcium, which causes the gland to reduce its release of PTH.
The threshold for seizures may be lowered by reductions in calcium levels and, infrequently, seizures have been reported with use of Mimpara. The most commonly reported side effects are nausea and vomiting. In post–marketing safety surveillance, isolated, idiosyncratic cases of hypotension and/or worsening heart failure have been reported in patients with impaired cardiac function, in which a causal relationship to cinacalcet could not be completely excluded and may be mediated by reductions in serum calcium levels.
About Amgen
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.
Forward–Looking Statement
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 April 25, 2008 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 U.S. Food and Drug Administration (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.
