Magazin
2011-03-23
Thousand Oaks, California (ots/PRNewswire) - Amgentoday announced new long-term data showing that during the fourth andfifth years of Prolia(R) (denosumab) treatment, postmenopausal womenwith osteoporosis receiving Prolia continued with further,statistically significant, year-over-year increases in lumbar spineand total hip bone mineral density (BMD), a key measurement of bonestrength. The overall adverse event profile was similar for thefourth and fifth years of consecutive Prolia treatment.
The data, which were presented at the annual European CongressOsteoporosis and Osteoarthritis (ECCEO11-IOF) in Valencia, Spain,showed that treatment with Prolia, the first and only approved RANKLigand inhibitor for the treatment of postmenopausal osteoporosis,resulted in robust BMD gains after five continuous years of treatment(13.7 percent for lumbar spine BMD and 7.0 percent for total hipBMD).
The FREEDOM Study and the 5-Year Prolia Data
The pivotal FREEDOM (Fracture REduction Evaluation of Denosumabin Osteoporosis every 6 Months) study established the efficacy andsafety of Prolia based on three years of data from approximately7,800 postmenopausal women. The open-label extension of FREEDOM isevaluating the long-term (up to 10 years) efficacy and safety ofProlia in 4,550 postmenopausal women. Seventy percent of eligiblewomen from the FREEDOM study continued enrollment in the extensionstudy; 2,343 women continued to receive Prolia treatment, and 2,207transitioned from placebo to Prolia.
Continued treatment with Prolia resulted in consistentyear-over-year gains in BMD at the lumbar spine and total hip. Inyears 4 and 5 respectively, women taking Prolia experienced further1.9 percent and 1.7 percent increases in lumbar spine BMD and further0.7 percent and 0.6 percent increases in total hip BMD (all P<0.0001compared with extension baseline).
The incidences of new osteoporotic fractures also remained lowfor women taking Prolia for five years.
The women who transitioned from placebo to Prolia in theextension study showed significant BMD increases during the first twoyears of Prolia treatment: 7.9 percent increase in lumbar spine BMDand 4.1 percent increase in total hip BMD (all P<0.0001 compared withextension baseline).
Rates of adverse events (AEs) were 83.4 percent for women whocontinued on Prolia and 82.8 percent for women transitioned fromplacebo to Prolia. Rates of serious AEs were 18.9 percent and 19.4percent for the two groups respectively. Two subjects in the groupthat transitioned from placebo to Prolia had AEs adjudicated toosteonecrosis of the jaw (ONJ) that healed without furthercomplications. One of these subjects continued Prolia, and onesubject discontinued. No atypical femoral fractures were reported ineither group.
Osteoporosis: Impact and Prevalence
Referred to as a "silent epidemic" by the InternationalOsteoporosis Foundation (IOF), osteoporosis is a global problem thatis increasing in significance as the population of the world bothincreases and ages. The World Health Organization has officiallydeclared osteoporosis a public health crisis, and the IOF is urginggovernments worldwide to make osteoporosis a healthcare priority.
Osteoporosis-associated fractures are a significant cause ofmortality and morbidity. In 2000, the number of osteoporoticfractures in Europe was estimated at 3.79 million, of which 890,000were hip fractures.(1) Since 2001, the incidence of hip fractures inEuropean countries has risen significantly.(2) In the United States(U.S.), the number of fractures due to osteoporosis is expected torise to more than three million by 2025.(3)
The direct medical cost of osteoporotic fractures in Europe isexpected to rise from euro 31.7 billion in 2000 to euro 76.7 billionin 2050.(4) In 2005, osteoporosis-related fractures were responsiblefor an estimated $19 billion in cost in the U.S., and this cost isexpected to rise to approximately $25 billion by 2025.(5)
About Prolia
Prolia is the first approved therapy that specifically targetsRANK Ligand, an essential regulator of osteoclasts (the cells thatbreak down bone).
Prolia is approved in the European Union (EU) for the treatmentof osteoporosis in postmenopausal women at increased risk offractures, and for the treatment of bone loss associated with hormoneablation in men with prostate cancer at increased risk of fractures.
Prolia is approved in the U.S. for the treatment ofpostmenopausal women with osteoporosis at high risk for fracture,defined as a history of osteoporotic fracture, or multiple riskfactors for fracture; or patients who have failed or are intolerantto other available osteoporosis therapy.
Prolia is available in 12 European countries, the U.S., Canadaand Australia. Applications in the rest of the world are pending.
Prolia is administered as a single subcutaneous injection of 60mgonce every six months. For further information on Prolia, pleasevisit: http://www.prolia.com.
Important EU Safety Information
The most common adverse reactions with Prolia were urinary tractinfection, upper respiratory tract infection, sciatica, cataracts,constipation, rash, pain in extremity. The most serious adversereactions were those of skin infections, predominantly cellulitis,reported more commonly in the Prolia group compared with placebo (0.4percent vs. 0.1 percent) in postmenopausal osteoporosis studies. Inbreast and prostate cancer studies, serious adverse reactions of skininfection were similar in the Prolia and placebo groups (0.6 percentvs. 0.6 percent). In the Phase 3 placebo-controlled clinical trial inpatients with prostate cancer receiving ADT, an imbalance in cataractadverse events was observed with Prolia compared with placebo (4.7percent vs. 1.2 percent). No imbalance in cataract adverse events wasobserved in postmenopausal women with osteoporosis or in womenundergoing aromatase inhibitor therapy for nonmetastatic breastcancer.
Prolia may lead to hypocalcaemia. Hypocalcaemia must be correctedby adequate intake of calcium and vitamin D before initiatingtherapy. ONJ has been reported rarely in clinical studies in patientsreceiving denosumab at a dose of 60 mg every 6 months forosteoporosis.
Important U.S. Safety Information
Prolia is contraindicated in patients with hypocalcemia.Pre-existing hypocalcemia must be corrected prior to initiatingProlia. Hypocalcemia may worsen, especially in patients with severerenal impairment. All patients should be adequately supplemented withcalcium and vitamin D.
In the pivotal study, serious infections leading tohospitalizations were reported more frequently in the Prolia-treatedpatient group. Serious skin infections, as well as infections of theabdomen, urinary tract and ear, were more frequent in patientstreated with Prolia. Patients should be advised to seek promptmedical attention if they develop signs or symptoms of severeinfection, including cellulitis. Endocarditis was reported morefrequently in the Prolia-treated patient group. Epidermal and dermaladverse events such as dermatitis, rashes, and eczema have beenreported. Discontinuation of Prolia should be considered if severesymptoms develop.
Prolia resulted in significant suppression of bone remodeling.The significance of these findings is unknown. The long-termconsequences of the degree of suppression of bone remodeling observedwith Prolia may contribute to adverse outcomes such as ONJ, atypicalfractures, and delayed fracture healing. ONJ has been reported inpatients with Prolia. Patients should be monitored for these adverseoutcomes. The most common adverse reactions (> 5 percent and morecommon than placebo) were back pain, pain in extremity,musculoskeletal pain, hypercholesterolemia, and cystitis.Pancreatitis has also been reported with Prolia.
Denosumab Commercialization Collaborations
In July 2009, Amgen and GlaxoSmithKline announced a collaborationagreement to jointly commercialize Prolia for postmenopausalosteoporosis in Europe, Australia, New Zealand and Mexico once theproduct is approved in these countries. Amgen will commercializeProlia's postmenopausal osteoporosis and potential oncologyindications in the U.S. and Canada and for all oncology indicationsin Europe and in other specified markets.
In addition, GlaxoSmithKline will register and commercializedenosumab for all indications in countries where Amgen does notcurrently have a commercial presence, including China, Brazil, Indiaand South Korea but excluding Japan. The structure of thecollaboration allows Amgen the option of an expanded role incommercialization in both Europe and certain emerging markets in thefuture.
Amgen and Daiichi-Sankyo Company Limited have a collaboration andlicense agreement for the development and commercialization ofdenosumab in Japan.
About Amgen
Amgen discovers, develops, manufactures, and delivers innovativehuman therapeutics. A biotechnology pioneer since 1980, Amgen was oneof the first companies to realize the new science's promise bybringing safe, effective medicines from lab to manufacturing plant topatient. Amgen therapeutics have changed the practice of medicine,helping millions of people around the world in the fight againstcancer, kidney disease, rheumatoid arthritis, bone disease, and otherserious illnesses. With a deep and broad pipeline of potential newmedicines, Amgen remains committed to advancing science todramatically improve people's lives. To learn more about ourpioneering science and vital medicines, visit http://www.amgen.com.
Forward-Looking Statements
This news release contains forward-looking statements that arebased on management's current expectations and beliefs and aresubject to a number of risks, uncertainties and assumptions thatcould cause actual results to differ materially from those described.All statements, other than statements of historical fact, arestatements that could be deemed forward-looking statements, includingestimates of revenues, operating margins, capital expenditures, cash,other financial metrics, expected legal, arbitration, political,regulatory or clinical results or practices, customer and prescriberpatterns or practices, reimbursement activities and outcomes andother such estimates and results. Forward-looking statements involvesignificant risks and uncertainties, including those discussed belowand more fully described in the Securities and Exchange Commission(SEC) reports filed by Amgen, including Amgen's most recent annualreport on Form 10-K and most recent periodic reports on Form 10-Q andForm 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and8-K for additional information on the uncertainties and risk factorsrelated to our business. Unless otherwise noted, Amgen is providingthis information as of March 23, 2011 and expressly disclaims anyduty to update information contained in this news release.
No forward-looking statement can be guaranteed and actual resultsmay differ materially from those we project. Discovery oridentification of new product candidates or development of newindications for existing products cannot be guaranteed and movementfrom concept to product is uncertain; consequently, there can be noguarantee that any particular product candidate or development of anew indication for an existing product will be successful and becomea commercial product. Further, preclinical results do not guaranteesafe and effective performance of product candidates in humans. Thecomplexity of the human body cannot be perfectly, or sometimes, evenadequately modeled by computer or cell culture systems or animalmodels. The length of time that it takes for us to complete clinicaltrials and obtain regulatory approval for product marketing has inthe past varied and we expect similar variability in the future. Wedevelop product candidates internally and through licensingcollaborations, partnerships and joint ventures. Product candidatesthat are derived from relationships may be subject to disputesbetween the parties or may prove to be not as effective or as safe aswe may have believed at the time of entering into such relationship.Also, we or others could identify safety, side effects ormanufacturing problems with our products after they are on themarket. Our business may be impacted by government investigations,litigation and products liability claims. We depend on third partiesfor a significant portion of our manufacturing capacity for thesupply of certain of our current and future products and limits onsupply may constrain sales of certain of our current products andproduct candidate development.
In addition, sales of our products are affected by thereimbursement policies imposed by third-party payors, includinggovernments, private insurance plans and managed care providers andmay be affected by regulatory, clinical and guideline developmentsand domestic and international trends toward managed care andhealthcare cost containment as well as U.S. legislation affectingpharmaceutical 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 othercompanies with respect to some of our marketed products as well asfor the discovery and development of new products. We believe thatsome of our newer products, product candidates or new indications forexisting products, may face competition when and as they are approvedand marketed. Our products may compete against products that havelower prices, established reimbursement, superior performance, areeasier to administer, or that are otherwise competitive with ourproducts. In addition, while we routinely obtain patents for ourproducts and technology, the protection offered by our patents andpatent applications may be challenged, invalidated or circumvented byour competitors and there can be no guarantee of our ability toobtain or maintain patent protection for our products or productcandidates. We cannot guarantee that we will be able to producecommercially successful products or maintain the commercial successof our existing products. Our stock price may be affected by actualor perceived market opportunity, competitive position, and success orfailure of our products or product candidates. Further, the discoveryof significant problems with a product similar to one of our productsthat implicate an entire class of products could have a materialadverse effect on sales of the affected products and on our businessand results of operations.
The scientific information discussed in this news release relatedto our product candidates is preliminary and investigative. Suchproduct candidates are not approved by the U.S. Food and DrugAdministration (FDA), and no conclusions can or should be drawnregarding the safety or effectiveness of the product candidates. Onlythe FDA can determine whether the product candidates are safe andeffective for the use(s) being investigated. Further, the scientificinformation discussed in this news release relating to newindications for our products is preliminary and investigative and isnot part of the labeling approved by the U.S. Food and DrugAdministration (FDA) for the products. The products are not approvedfor the investigational use(s) discussed in this news release, and noconclusions can or should be drawn regarding the safety oreffectiveness of the products for these uses. Only the FDA candetermine whether the products are safe and effective for these uses.Healthcare professionals should refer to and rely upon theFDA-approved labeling for the products, and not the informationdiscussed in this news release.
Editor's Note: Prolia(R) (denosumab) currently is notcommercialized in Spain.
CONTACT: Amgen, Thousand Oaks Ashleigh Koss: +1-805-313-6151 (U.S. media) Wendy Woods Williams: +41(41)3692-542 (E.U. media) Arvind Sood: +1-805-447-1060 (investors)
(1) "Facts and statistics about osteoporosis and its impact."International Osteoporosis Foundation. Accessed at http://www.iofbonehealth.org/facts-and-statistics.html#factsheet-category-22 on 4February 2011
(2) "Osteoporosis in the European Union in 2008: Ten years ofprogress and ongoing challenges." Accessed at http://www.iofbonehealth.org/publications/eu-policy-report-of-2008.html on 4 February 2011
(3) Burge R, et al. Incidence and economic burden ofosteoporosis-related fractures in the United States, 2005-2025. JBone Miner Res. 2007: 22::465-475
(4) "Facts and statistics about osteoporosis and its impact."International Osteoporosis Foundation. Accessed athttp://www.iofbonehealth.org/facts-and-statistics.html on 4 February2011
(5) "Fast Facts" National Osteoporosis Foundation. Accessed athttp://www.nof.org/node/40 on 4 February 2011
(Logo: http://photos.prnewswire.com/prnh/20081015/AMGENLOGO)
ots Originaltext: AmgenIm Internet recherchierbar: http://www.presseportal.de
Contact:U.S. media - Ashleigh Koss, +1-805-313-6151; E.U. media - WendyWoods Williams: +41(41)3692-542; investors, Arvind Sood: +1-805-447-1060
Prolia(R) (denosumab) Open-Label Extension Trial Showed Continued Increase in Bone Mineral Density Over Five Years of Treatment With Similar Safety Profile Observed in Pivotal Trial
The data, which were presented at the annual European CongressOsteoporosis and Osteoarthritis (ECCEO11-IOF) in Valencia, Spain,showed that treatment with Prolia, the first and only approved RANKLigand inhibitor for the treatment of postmenopausal osteoporosis,resulted in robust BMD gains after five continuous years of treatment(13.7 percent for lumbar spine BMD and 7.0 percent for total hipBMD).
The FREEDOM Study and the 5-Year Prolia Data
The pivotal FREEDOM (Fracture REduction Evaluation of Denosumabin Osteoporosis every 6 Months) study established the efficacy andsafety of Prolia based on three years of data from approximately7,800 postmenopausal women. The open-label extension of FREEDOM isevaluating the long-term (up to 10 years) efficacy and safety ofProlia in 4,550 postmenopausal women. Seventy percent of eligiblewomen from the FREEDOM study continued enrollment in the extensionstudy; 2,343 women continued to receive Prolia treatment, and 2,207transitioned from placebo to Prolia.
Continued treatment with Prolia resulted in consistentyear-over-year gains in BMD at the lumbar spine and total hip. Inyears 4 and 5 respectively, women taking Prolia experienced further1.9 percent and 1.7 percent increases in lumbar spine BMD and further0.7 percent and 0.6 percent increases in total hip BMD (all P<0.0001compared with extension baseline).
The incidences of new osteoporotic fractures also remained lowfor women taking Prolia for five years.
The women who transitioned from placebo to Prolia in theextension study showed significant BMD increases during the first twoyears of Prolia treatment: 7.9 percent increase in lumbar spine BMDand 4.1 percent increase in total hip BMD (all P<0.0001 compared withextension baseline).
Rates of adverse events (AEs) were 83.4 percent for women whocontinued on Prolia and 82.8 percent for women transitioned fromplacebo to Prolia. Rates of serious AEs were 18.9 percent and 19.4percent for the two groups respectively. Two subjects in the groupthat transitioned from placebo to Prolia had AEs adjudicated toosteonecrosis of the jaw (ONJ) that healed without furthercomplications. One of these subjects continued Prolia, and onesubject discontinued. No atypical femoral fractures were reported ineither group.
Osteoporosis: Impact and Prevalence
Referred to as a "silent epidemic" by the InternationalOsteoporosis Foundation (IOF), osteoporosis is a global problem thatis increasing in significance as the population of the world bothincreases and ages. The World Health Organization has officiallydeclared osteoporosis a public health crisis, and the IOF is urginggovernments worldwide to make osteoporosis a healthcare priority.
Osteoporosis-associated fractures are a significant cause ofmortality and morbidity. In 2000, the number of osteoporoticfractures in Europe was estimated at 3.79 million, of which 890,000were hip fractures.(1) Since 2001, the incidence of hip fractures inEuropean countries has risen significantly.(2) In the United States(U.S.), the number of fractures due to osteoporosis is expected torise to more than three million by 2025.(3)
The direct medical cost of osteoporotic fractures in Europe isexpected to rise from euro 31.7 billion in 2000 to euro 76.7 billionin 2050.(4) In 2005, osteoporosis-related fractures were responsiblefor an estimated $19 billion in cost in the U.S., and this cost isexpected to rise to approximately $25 billion by 2025.(5)
About Prolia
Prolia is the first approved therapy that specifically targetsRANK Ligand, an essential regulator of osteoclasts (the cells thatbreak down bone).
Prolia is approved in the European Union (EU) for the treatmentof osteoporosis in postmenopausal women at increased risk offractures, and for the treatment of bone loss associated with hormoneablation in men with prostate cancer at increased risk of fractures.
Prolia is approved in the U.S. for the treatment ofpostmenopausal women with osteoporosis at high risk for fracture,defined as a history of osteoporotic fracture, or multiple riskfactors for fracture; or patients who have failed or are intolerantto other available osteoporosis therapy.
Prolia is available in 12 European countries, the U.S., Canadaand Australia. Applications in the rest of the world are pending.
Prolia is administered as a single subcutaneous injection of 60mgonce every six months. For further information on Prolia, pleasevisit: http://www.prolia.com.
Important EU Safety Information
The most common adverse reactions with Prolia were urinary tractinfection, upper respiratory tract infection, sciatica, cataracts,constipation, rash, pain in extremity. The most serious adversereactions were those of skin infections, predominantly cellulitis,reported more commonly in the Prolia group compared with placebo (0.4percent vs. 0.1 percent) in postmenopausal osteoporosis studies. Inbreast and prostate cancer studies, serious adverse reactions of skininfection were similar in the Prolia and placebo groups (0.6 percentvs. 0.6 percent). In the Phase 3 placebo-controlled clinical trial inpatients with prostate cancer receiving ADT, an imbalance in cataractadverse events was observed with Prolia compared with placebo (4.7percent vs. 1.2 percent). No imbalance in cataract adverse events wasobserved in postmenopausal women with osteoporosis or in womenundergoing aromatase inhibitor therapy for nonmetastatic breastcancer.
Prolia may lead to hypocalcaemia. Hypocalcaemia must be correctedby adequate intake of calcium and vitamin D before initiatingtherapy. ONJ has been reported rarely in clinical studies in patientsreceiving denosumab at a dose of 60 mg every 6 months forosteoporosis.
Important U.S. Safety Information
Prolia is contraindicated in patients with hypocalcemia.Pre-existing hypocalcemia must be corrected prior to initiatingProlia. Hypocalcemia may worsen, especially in patients with severerenal impairment. All patients should be adequately supplemented withcalcium and vitamin D.
In the pivotal study, serious infections leading tohospitalizations were reported more frequently in the Prolia-treatedpatient group. Serious skin infections, as well as infections of theabdomen, urinary tract and ear, were more frequent in patientstreated with Prolia. Patients should be advised to seek promptmedical attention if they develop signs or symptoms of severeinfection, including cellulitis. Endocarditis was reported morefrequently in the Prolia-treated patient group. Epidermal and dermaladverse events such as dermatitis, rashes, and eczema have beenreported. Discontinuation of Prolia should be considered if severesymptoms develop.
Prolia resulted in significant suppression of bone remodeling.The significance of these findings is unknown. The long-termconsequences of the degree of suppression of bone remodeling observedwith Prolia may contribute to adverse outcomes such as ONJ, atypicalfractures, and delayed fracture healing. ONJ has been reported inpatients with Prolia. Patients should be monitored for these adverseoutcomes. The most common adverse reactions (> 5 percent and morecommon than placebo) were back pain, pain in extremity,musculoskeletal pain, hypercholesterolemia, and cystitis.Pancreatitis has also been reported with Prolia.
Denosumab Commercialization Collaborations
In July 2009, Amgen and GlaxoSmithKline announced a collaborationagreement to jointly commercialize Prolia for postmenopausalosteoporosis in Europe, Australia, New Zealand and Mexico once theproduct is approved in these countries. Amgen will commercializeProlia's postmenopausal osteoporosis and potential oncologyindications in the U.S. and Canada and for all oncology indicationsin Europe and in other specified markets.
In addition, GlaxoSmithKline will register and commercializedenosumab for all indications in countries where Amgen does notcurrently have a commercial presence, including China, Brazil, Indiaand South Korea but excluding Japan. The structure of thecollaboration allows Amgen the option of an expanded role incommercialization in both Europe and certain emerging markets in thefuture.
Amgen and Daiichi-Sankyo Company Limited have a collaboration andlicense agreement for the development and commercialization ofdenosumab in Japan.
About Amgen
Amgen discovers, develops, manufactures, and delivers innovativehuman therapeutics. A biotechnology pioneer since 1980, Amgen was oneof the first companies to realize the new science's promise bybringing safe, effective medicines from lab to manufacturing plant topatient. Amgen therapeutics have changed the practice of medicine,helping millions of people around the world in the fight againstcancer, kidney disease, rheumatoid arthritis, bone disease, and otherserious illnesses. With a deep and broad pipeline of potential newmedicines, Amgen remains committed to advancing science todramatically improve people's lives. To learn more about ourpioneering science and vital medicines, visit http://www.amgen.com.
Forward-Looking Statements
This news release contains forward-looking statements that arebased on management's current expectations and beliefs and aresubject to a number of risks, uncertainties and assumptions thatcould cause actual results to differ materially from those described.All statements, other than statements of historical fact, arestatements that could be deemed forward-looking statements, includingestimates of revenues, operating margins, capital expenditures, cash,other financial metrics, expected legal, arbitration, political,regulatory or clinical results or practices, customer and prescriberpatterns or practices, reimbursement activities and outcomes andother such estimates and results. Forward-looking statements involvesignificant risks and uncertainties, including those discussed belowand more fully described in the Securities and Exchange Commission(SEC) reports filed by Amgen, including Amgen's most recent annualreport on Form 10-K and most recent periodic reports on Form 10-Q andForm 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and8-K for additional information on the uncertainties and risk factorsrelated to our business. Unless otherwise noted, Amgen is providingthis information as of March 23, 2011 and expressly disclaims anyduty to update information contained in this news release.
No forward-looking statement can be guaranteed and actual resultsmay differ materially from those we project. Discovery oridentification of new product candidates or development of newindications for existing products cannot be guaranteed and movementfrom concept to product is uncertain; consequently, there can be noguarantee that any particular product candidate or development of anew indication for an existing product will be successful and becomea commercial product. Further, preclinical results do not guaranteesafe and effective performance of product candidates in humans. Thecomplexity of the human body cannot be perfectly, or sometimes, evenadequately modeled by computer or cell culture systems or animalmodels. The length of time that it takes for us to complete clinicaltrials and obtain regulatory approval for product marketing has inthe past varied and we expect similar variability in the future. Wedevelop product candidates internally and through licensingcollaborations, partnerships and joint ventures. Product candidatesthat are derived from relationships may be subject to disputesbetween the parties or may prove to be not as effective or as safe aswe may have believed at the time of entering into such relationship.Also, we or others could identify safety, side effects ormanufacturing problems with our products after they are on themarket. Our business may be impacted by government investigations,litigation and products liability claims. We depend on third partiesfor a significant portion of our manufacturing capacity for thesupply of certain of our current and future products and limits onsupply may constrain sales of certain of our current products andproduct candidate development.
In addition, sales of our products are affected by thereimbursement policies imposed by third-party payors, includinggovernments, private insurance plans and managed care providers andmay be affected by regulatory, clinical and guideline developmentsand domestic and international trends toward managed care andhealthcare cost containment as well as U.S. legislation affectingpharmaceutical 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 othercompanies with respect to some of our marketed products as well asfor the discovery and development of new products. We believe thatsome of our newer products, product candidates or new indications forexisting products, may face competition when and as they are approvedand marketed. Our products may compete against products that havelower prices, established reimbursement, superior performance, areeasier to administer, or that are otherwise competitive with ourproducts. In addition, while we routinely obtain patents for ourproducts and technology, the protection offered by our patents andpatent applications may be challenged, invalidated or circumvented byour competitors and there can be no guarantee of our ability toobtain or maintain patent protection for our products or productcandidates. We cannot guarantee that we will be able to producecommercially successful products or maintain the commercial successof our existing products. Our stock price may be affected by actualor perceived market opportunity, competitive position, and success orfailure of our products or product candidates. Further, the discoveryof significant problems with a product similar to one of our productsthat implicate an entire class of products could have a materialadverse effect on sales of the affected products and on our businessand results of operations.
The scientific information discussed in this news release relatedto our product candidates is preliminary and investigative. Suchproduct candidates are not approved by the U.S. Food and DrugAdministration (FDA), and no conclusions can or should be drawnregarding the safety or effectiveness of the product candidates. Onlythe FDA can determine whether the product candidates are safe andeffective for the use(s) being investigated. Further, the scientificinformation discussed in this news release relating to newindications for our products is preliminary and investigative and isnot part of the labeling approved by the U.S. Food and DrugAdministration (FDA) for the products. The products are not approvedfor the investigational use(s) discussed in this news release, and noconclusions can or should be drawn regarding the safety oreffectiveness of the products for these uses. Only the FDA candetermine whether the products are safe and effective for these uses.Healthcare professionals should refer to and rely upon theFDA-approved labeling for the products, and not the informationdiscussed in this news release.
Editor's Note: Prolia(R) (denosumab) currently is notcommercialized in Spain.
CONTACT: Amgen, Thousand Oaks Ashleigh Koss: +1-805-313-6151 (U.S. media) Wendy Woods Williams: +41(41)3692-542 (E.U. media) Arvind Sood: +1-805-447-1060 (investors)
(1) "Facts and statistics about osteoporosis and its impact."International Osteoporosis Foundation. Accessed at http://www.iofbonehealth.org/facts-and-statistics.html#factsheet-category-22 on 4February 2011
(2) "Osteoporosis in the European Union in 2008: Ten years ofprogress and ongoing challenges." Accessed at http://www.iofbonehealth.org/publications/eu-policy-report-of-2008.html on 4 February 2011
(3) Burge R, et al. Incidence and economic burden ofosteoporosis-related fractures in the United States, 2005-2025. JBone Miner Res. 2007: 22::465-475
(4) "Facts and statistics about osteoporosis and its impact."International Osteoporosis Foundation. Accessed athttp://www.iofbonehealth.org/facts-and-statistics.html on 4 February2011
(5) "Fast Facts" National Osteoporosis Foundation. Accessed athttp://www.nof.org/node/40 on 4 February 2011
(Logo: http://photos.prnewswire.com/prnh/20081015/AMGENLOGO)
ots Originaltext: AmgenIm Internet recherchierbar: http://www.presseportal.de
Contact:U.S. media - Ashleigh Koss, +1-805-313-6151; E.U. media - WendyWoods Williams: +41(41)3692-542; investors, Arvind Sood: +1-805-447-1060
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