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关于Kyprolis：2012-07-20,FDA宣布批准Onyx公司的Kyprolis上市，用于多发性骨髓瘤，合作开发者为Ligand，合作方式为上市后利益分成，无专利分成。对比同类产品有日本武田的Velcade，Celgene公司的Revilmid & Thalomid。BSM同类药物三期临床宣布失败。第一年市场销售额为5.7亿美金。
Onyx公司2013-08-25 104亿美金收购Onyx。
新闻原稿如下：
Aug. 4, 2014 Amgen Announces Phase 3 ASPIRE Trial OfKyprolis® In Patients With Relapsed Multiple Myeloma Met Primary Endpoint Kyprolis Helped Patients Live 8.7 MonthsLonger Without Their Disease Worsening Results to Form Basis of RegulatoryFilings Beginning in 1H 2015 THOUSAND OAKS, Calif. and SOUTH SANFRANCISCO, Calif., Aug. 4, 2014 /PRNewswire/ -- Amgen (NASDAQ:AMGN) andits subsidiary, Onyx Pharmaceuticals, Inc., today announced that a plannedinterim analysis demonstrated that the Phase 3 clinical trial ASPIRE (CArfilzomib,Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasonefor the treatment of PatIents with Relapsed Multiple MyEloma)met its primary endpoint of progression-free survival (PFS). Patients treatedwith Kyprolis® (carfilzomib) for Injection in combinationwith Revlimid® (lenalidomide) and low-dose dexamethasone(KRd) lived significantly longer without their disease worsening (median 26.3months) compared to patients treated with Revlimid and low-dose dexamethasone(Rd) (median 17.6 months) (HR=0.690, 95 percent CI, 0.570, 0.834, p<0.0001).While the data for overall survival, a secondary endpoint, are not yet mature,the analysis showed a trend in favor of KRd that did not reach statisticalsignificance. The safety profile observed in thisstudy is consistent with the current U.S. Kyprolis label, including the rate ofcardiac events. Treatment discontinuation due to adverse events and on-studydeaths were comparable between the two arms. No new safety signals wereidentified. Results will be submitted forpresentation at the upcoming 56th Annual Meeting of the American Society ofHematology later this year. "We are excited about theseclinical results and the positive prospects they suggest for patients withmultiple myeloma," said Robert A. Bradway, chairman and chief executiveofficer of Amgen, adding, "Our mission at Amgen is to serve patients byadvancing medicines that address serious disease. Kyprolis is an importantbuilding block in our robust, differentiated pipeline." Bradway further explained, "Coupledwith our recent U.S. regulatory submissions for ivabradine and talimogenelaherparepvec and our upcoming regulatory submissions for evolocumab andblinatumomab, our pipeline continues to show notable progress." Results from the ASPIRE study will formthe basis for regulatory submissions throughout the world beginning in thefirst half of 2015. In the U.S., the data may support the conversion ofaccelerated approval to full approval and expand the current indication. "In the treatment of patients withmultiple myeloma, periods of remission become shorter following each treatmentregimen, underscoring the need for new options. The results of the ASPIREstudy demonstrate that Kyprolis can significantly extend the time patients livewithout their disease progressing," said Pablo J. Cagnoni, M.D.,president, Onyx Pharmaceuticals, Inc. "The ability of novel therapies toproduce deep and durable responses may, one day, transform this uniformly fataldisease to one that is chronic and manageable." Onyx conducted the ASPIRE study under aSpecial Protocol Assessment (SPA) from the U.S. Food and Drug Administration(FDA) and has received Scientific Advice from the European Medicines Agency(EMA) on the design and planned analysis of the study. About ASPIRE
Theinternational, randomized Phase 3 ASPIRE (CArfilzomib, Lenalidomide, andDexamethaSone versus Lenalidomide and Dexamethasone for the treatment ofPatIents with Relapsed Multiple MyEloma) trialevaluated Kyprolis in combination with lenalidomide and low-dose dexamethasone,versus lenalidomide and low-dose dexamethasone alone, in patients with relapsedmultiple myeloma following treatment with one to three prior regimens. Theprimary endpoint of the trial was progression-free survival, defined as thetime from treatment initiation to disease progression or death. Secondaryendpoints included overall survival, overall response rate, duration ofresponse, disease control rate, health-related quality of life, and safety.Patients were randomized to receive Kyprolis (20mg/m2 on days 1 and2 of cycle 1 only, then 27mg/m2 subsequently), in addition to a standarddosing schedule of lenalidomide (25mg per day for 21 days on, 7 days off) andlow-dose dexamethasone (40mg per week in 4 week cycles), versus lenalidomideand low-dose dexamethasone alone. The study randomized 792 patients at sites inNorth America, Europe, and Israel. About Multiple Myeloma
Multiple myelomais the second most common hematologic cancer and results from an abnormality ofplasma cells, usually in the bone marrow. In the U.S., approximately 70,000people are living with multiple myeloma and approximately 24,000 new cases arediagnosed annually.[1] Worldwide, nearly 230,000 people are living withmultiple myeloma and approximately 114,000 new cases are diagnosed annually.[2]In Europe, approximately 89,000 people are living with multiple myeloma, andapproximately 39,000 new cases are diagnosed annually.[3] About Kyprolis® (carfilzomib)for Injection
On July 20,2012, the FDA granted accelerated approval of Kyprolis®(carfilzomib) for Injection for the treatment of patients with multiple myelomawho have received at least two prior therapies including bortezomib and animmunomodulatory agent (IMiD), and have demonstrated disease progression on orwithin 60 days of completion of the last therapy. Approval was based onresponse rate. Clinical benefit, such as improvement in survival or symptoms,has not been verified. Kyprolis is marketed in the U.S. by OnyxPharmaceuticals, Inc., an Amgen subsidiary. Important Safety Information RegardingKyprolis® (carfilzomib) for Injection
Safety data havebeen evaluated in 526 patients with relapsed and/or refractory multiple myelomawho received single-agent Kyprolis. There were 37 deaths in the Phase 2studies, or 7% of patients. The most common causes of death, other than diseaseprogression, were cardiac (5 patients), end-organ failure (4 patients), andinfection (4 patients). Important warnings and precautions include cardiacarrest, congestive heart failure, myocardial ischemia; pulmonary hypertension,pulmonary complications, infusion reactions, tumor lysis syndrome,thrombocytopenia, hepatic toxicity and embryo-fetal toxicity. Death due to cardiac arrest has occurredwithin a day of Kyprolis administration. Patients with New York HeartAssociation Class III and IV heart failure, myocardial infarction in thepreceding 6 months, and conduction abnormalities uncontrolled by medicationswere not eligible for the clinical trials. These patients may be at greaterrisk for cardiac complications. Pulmonary arterial hypertension (PAH)was reported in 2% of patients treated with Kyprolis and was Grade 3 or greaterin less than 1% of patients. Dyspnea was reported in 35% of patients enrolledin clinical trials. Grade 3 dyspnea occurred in 5%; no Grade 4 events, and 1death (Grade 5) was reported. Infusion reactions, characterized by aspectrum of systemic symptoms including fever, chills, arthralgia, myalgia,facial flushing, facial edema, vomiting, weakness, shortness of breath,hypotension, syncope, chest tightness, or angina can occur immediatelyfollowing or up to 24 hours after administration of Kyprolis. Administration ofdexamethasone prior to Kyprolis reduces the incidence and severity ofreactions. Tumor lysis syndrome (TLS) occurred following Kyprolisadministration in < 1% of patients. Patients with multiple myeloma and ahigh tumor burden should be considered to be at greater risk for TLS. Thrombocytopenia following Kyprolisadministration resulted in a dose reduction in 1% of patients anddiscontinuation of treatment with Kyprolis in < 1% of patients. Cases of hepatic failure, includingfatal cases, have been reported (< 1%). Kyprolis can cause elevations ofserum transaminases and bilirubin. There are no adequate andwell-controlled studies in pregnant women using Kyprolis. Females ofreproductive potential should be advised to avoid becoming pregnant while beingtreated with Kyprolis. The most common serious adversereactions were pneumonia, acute renal failure, pyrexia, and congestive heartfailure. The most common adverse reactions (incidence of 30% or greater)observed in clinical trials of patients with multiple myeloma were fatigue,anemia, nausea, thrombocytopenia, dyspnea, diarrhea, and pyrexia. Seriousadverse reactions were reported in 45% of patients. About Amgen
Amgen iscommitted to unlocking the potential of biology for patients suffering fromserious illnesses by discovering, developing, manufacturing and deliveringinnovative human therapeutics. This approach begins by using tools likeadvanced human genetics to unravel the complexities of disease and understandthe fundamentals of human biology. Amgen focuses on areas of highunmet medical need and leverages its biologics manufacturing expertise tostrive for solutions that improve health outcomes and dramatically improvepeople's lives. A biotechnology pioneer since 1980, Amgen has grownto be the world's largest independent biotechnology company, has reachedmillions of patients around the world and is developing a pipeline of medicineswith breakaway potential. About Onyx Pharmaceuticals, Inc.
Based in SouthSan Francisco, California, Onyx Pharmaceuticals, Inc., an Amgen subsidiary, isa global biopharmaceutical company engaged in the development andcommercialization of innovative therapies for improving the lives of peoplewith cancer. The company is focused on developing novel medicines that targetkey molecular pathways. For more information about Onyx, visit the company'swebsite at www.onyx.com. Onyx Pharmaceuticals is on Twitter.Sign up to follow our Twitter feed @OnyxPharm at http://twitter.com/OnyxPharm. REVLIMID® is a registeredtrademark of Celgene Corporation. Forward-Looking Statements
This newsrelease contains forward-looking statements that are based on the currentexpectations and beliefs of Amgen Inc. and its subsidiaries (Amgen) and aresubject to a number of risks, uncertainties and assumptions that could causeactual results to differ materially from those described. All statements,other than statements of historical fact, are statements that could be deemedforward-looking statements, including estimates of revenues, operating margins,capital expenditures, cash, other financial metrics, expected legal,arbitration, political, regulatory or clinical results or practices, customerand prescriber patterns or practices, reimbursement activities and outcomes andother such estimates and results. Forward-looking statements involvesignificant risks and uncertainties, including those discussed below and morefully described in the Securities and Exchange Commission (SEC) reports filedby Amgen Inc., including Amgen Inc.'s most recent annual report on Form 10-Kand any subsequent periodic reports on Form 10-Q and Form 8-K. Pleaserefer to Amgen Inc.'s most recent Forms 10-K, 10-Q and 8-K for additionalinformation on the uncertainties and risk factors related to Amgen'sbusiness. Unless otherwise noted, Amgen is providing this information asof Aug. 4, 2014 and expressly disclaims any duty to update informationcontained in this news release. No forward-looking statement can beguaranteed and actual results may differ material from those Amgenprojects. Discovery or identification of new product candidates ordevelopment of new indications for existing products cannot be guaranteed andmovement from concept to product is uncertain; consequently, there can be noguarantee that any particular product candidate or development of a newindication for an existing product will be successful and become a commercialproduct. Further, preclinical results do not guarantee safe and effectiveperformance of product candidates in humans. The complexity of the humanbody cannot be perfectly, or sometimes, even adequately modeled by computer orcell culture systems or animal models. The length of time that it takesfor Amgen and its partners to complete clinical trials and obtain regulatoryapproval for product marketing has in the past varied and Amgen expects similarvariability in the future. Amgen develops product candidates internally andthrough licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputesbetween the parties or may prove to be not as effective or as safe as Amgen mayhave believed at the time of entering into such relationship. Also, Amgen orothers could identify safety, side effects or manufacturing problems withAmgen's products after they are on the market. Amgen's business may beimpacted by government investigations, litigation and product liabilityclaims. If Amgen fails to meet the compliance obligations in thecorporate integrity agreement between Amgen and the U.S. government, Amgencould become subject to significant sanctions. Amgen depends on thirdparties for a significant portion of its manufacturing capacity for the supplyof certain of its current and future products and limits on supply mayconstrain sales of certain of its current products and product candidatedevelopment. In addition, sales of Amgen's products(including products of Amgen's wholly-owned subsidiaries) are affected by thereimbursement policies imposed by third-party payers, including governments,private insurance plans and managed care providers and may be affected byregulatory, clinical and guideline developments and domestic and internationaltrends 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 thedevelopment, usage and pricing of Amgen's products. In addition, Amgencompetes with other companies with respect to some of its marketed products aswell as for the discovery and development of new products. Amgen believesthat some of its newer products, product candidates or new indications forexisting products, may face competition when and as they are approved andmarketed. Amgen's products may compete against products that have lower prices,established reimbursement, superior performance, are easier to administer, orthat are otherwise competitive with its products. In addition, whileAmgen and its partners routinely obtain patents for their products andtechnology, the protection of Amgen's products offered by patents and patentapplications may be challenged, invalidated or circumvented by its competitorsand there can be no guarantee of Amgen's or its partners' ability to obtain ormaintain patent protection for Amgen's products or product candidates. Amgen cannot guarantee that it will be able to produce commercially successfulproducts or maintain the commercial success of its existing products. Amgen's stock price may be affected by actual or perceived market opportunity,competitive position, and success or failure of its products or productcandidates. Further, the discovery of significant problems with a productsimilar to one of Amgen's products that implicate an entire class of productscould have a material adverse effect on sales of the affected products and onAmgen's business and results of operations. Amgen's efforts to integratethe operations of companies it has acquired may not be successful. Costsaving initiatives may result in Amgen incurring impairment or other relatedcharges on its assets. Amgen may experience difficulties, delays or unexpectedcosts and not achieve anticipated cost savings from its recently announcedrestructuring plans. Amgen's business performance could affect or limitthe ability of Amgen's Board of Directors to declare a dividend or theirability to pay a dividend or repurchase Amgen common stock. The scientific information discussed inthis news release relating to new indications for Amgen's products ispreliminary and investigative and is not part of the labeling approved by theU.S. Food and Drug Administration (FDA) for the products. The productsare not approved for the investigational use(s) discussed in this newsrelease, and no conclusions can or should be drawn regarding the safety oreffectiveness of the products for these uses. CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (Amgen media)
Danielle Bertrand, 650-266-2114 (Onyx media)
Arvind Sood, 805-447-1060 (investors) SOURCE Amgen | 
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发表于 2014-8-5 09:26:19
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