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Amgen, Takeda and Millennium Provide Update on Phase 3 Trial of Motesanib in Patients With Non-Small Cell Lung Cancer

Thursday, November 20, 2008 General News
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THOUSAND OAKS, Calif., Nov. 19 Amgen(Nasdaq: AMGN) and Millennium: The Takeda Oncology Company, a subsidiary ofTakeda Pharmaceutical Company Limited (TSE: 4052), today announced thatenrollment in the Phase 3 MONET1 trial evaluating motesanib (AMG 706) incombination with paclitaxel and carboplatin for the first-line treatment ofadvanced non-small cell lung cancer (NSCLC) has been temporarily suspendedfollowing a planned safety data review of 600 patients by the study'sindependent Data Monitoring Committee (DMC). Motesanib is part of a broadco-development program between Amgen and Takeda.
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The DMC recommended that enrollment in the study, which allowed bothsquamous and non-squamous NSCLC patients, be suspended based on an observationof higher early mortality rates in the motesanib group compared to the placebogroup. In addition, the DMC recommended that the patients with squamous NSCLCimmediately discontinue motesanib therapy based on an observation of a higherincidence of hemoptysis. The DMC did not recommend discontinuation ofmotesanib therapy for the patients with non-squamous NSCLC. The DMC willreview updated data after three months.
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Amgen, in collaboration with Takeda Bio Development Center, isimplementing both of the DMC's recommendations and notifying worldwideregulatory agencies, including the U.S. Food and Drug Administration (FDA),European Medicines Agency (EMEA), and Japan's Pharmaceuticals and MedicalDevices Agency (PMDA), as well as motesanib clinical investigators.

"While we are disappointed in this outcome, it is consistent with dataseen with some other anti-VEGF therapies and appears to constitute a classeffect of these types of agents," said Roger M. Perlmutter, M.D., Ph.D.,executive vice president of Research and Development at Amgen. "Patientsafety is our top priority, hence we have acted quickly to implement therecommendations of the DMC. Working with our development partner, Takeda, wewill continue to evaluate the therapeutic potential of motesanib innon-squamous NSCLC and metastatic breast cancer, as well as in other solidtumors."

"NSCLC continues to be an area where new and effective therapies areneeded. We look forward to the follow up recommendations from the DMC in orderto chart the best path forward for the development of this molecule," saidNancy Simonian, M.D., chief medical officer, Millennium: The Takeda OncologyCompany.

MONET1 (Motesanib NSCLC Efficacy and Tolerability Study) Trial Design

This Phase 3, multicenter, randomized, placebo-controlled, double-blindtrial has enrolled 1,100 of 1,240 planned patients with advanced NSCLC.Patients with either squamous or non-squamous NSCLC were allowed in thisstudy. Squamous NSCLC is a histological subtype of NSCLC and accounts forapproximately one-third of the study population. The primary endpoint isoverall survival, and secondary endpoints include progression-free survival,objective response rate in patients with measurable disease, duration ofresponse and safety. Patients were randomized 1:1 to receive carboplatin andpaclitaxel administered every three weeks with or without 125 mg motesanibtaken daily.

About Motesanib

Co-developed by Amgen, Takeda Pharmaceutical Company, and Millennium: TheTakeda Oncology Company, motesanib is an investigational, highly selective,oral agent that is being evaluated for its ability to inhibit angiogenesis bytargeting vascular endothelial growth factor receptors 1, 2 and 3 (VEGFR1-3).It is also under investigation for its potential direct anti-tumor activity bytargeting a family of proteins called tyrosine kinases, includingplatelet-derived growth factor receptor (PDGFR), and stem cell factor receptor(c-kit), two proteins involved in cell proliferation.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative humantherapeutics. A biotechnology pioneer since 1980, Amgen was one of the firstcompanies to realize the new science's promise by bringing safe and effectivemedicines from lab, to manufacturing plant, to patient. Amgen therapeuticshave changed the practice of medicine, helping millions of people around theworld in the fight against cancer, kidney disorder, rheumatoid arthritis, andother serious illnesses. With a deep and broad pipeline of potential newmedicines, Amgen remains committed to advancing science to dramaticallyimprove people's lives. To learn more about our pioneering science and ourvital medicines, visit http://www.amgen.com.

About Takeda

Located in Osaka, Japan, Takeda Pharmaceutical Company Limited (TSE:4502)is a research-based global company with its main focus on pharmaceuticals. Asthe largest pharmaceutical company in Japan and one of the global leaders ofthe industry, Takeda is committed to striving toward better health forindividuals and progress in medicine by developing superior pharmaceuticalproducts. Additional information about Takeda is available through itscorporate website, http://www.takeda.com.

About Millennium

Millennium: The Takeda Oncology Company, a leading biopharmaceuticalcompany based in Cambridge, Mass., markets VELCADE, a novel cancer product,and has a robust clinical development pipeline of product candidates.Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical CompanyLtd. in May, 2008. The Company's research, development and commercializationactivities are focused in oncology. Additional information about Millennium isavailable through its website, http://www.millennium.com.

Forward-Looking Statement

This news release contains forward-looking statements that are based onmanagement's current expectations and beliefs and are subject to a number ofrisks, uncertainties and assumptions that could cause actual results to differmaterially from those described. All statements, other than statements ofhistorical fact, are statements that could be deemed forward-lookingstatements, including estimates of revenues, operating margins, capitalexpenditures, cash, other financial metrics, expected legal, arbitration,political, regulatory or clinical results or practices, customer andprescriber 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, including Amgen's most recent annual report on Form 10-K and mostrecent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen'smost recent Forms 10-K, 10-Q and 8-K for additional information on theuncertainties and risk factors related to our business. Unless otherwisenoted, Amgen is providing this information as of Nov. 19, 2008 and expresslydisclaims any duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results maydiffer materially from those we project. Discovery or identification of newproduct candidates or development of new indications for existing productscannot be guaranteed and movement from concept to product is uncertain;consequently, there can be no guarantee that any particular product candidateor development of a new indication for an existing product will be successfuland become a commercial product. Further, preclinical results do notguarantee safe 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 animal models. Thelength of time that it takes for us to complete clinical trials and obtainregulatory approval for product marketing has in the past varied and we expectsimilar variability in the future. We develop product candidates internallyand through licensing collaborations, partnerships and joint ventures.Product candidates that are derived from relationships may be subject todisputes between 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, weor others could identify safety, side effects or manufacturing problems withour products after they are on the market. Our business may be impacted bygovernment investigations, litigation and products liability claims. Wedepend on third parties for a significant portion of our manufacturingcapacity for the supply of certain of our current and future products andlimits on supply may constrain sales of certain of our current products andproduct candidate development.

In addition, sales of our products are affected by the reimbursementpolicies imposed by third-party payors, including governments, privateinsurance plans and managed care providers and may be affected by regulatory,clinical and guideline developments and domestic and international trendstoward managed care and healthcare cost containment as well as U.S.legislation affecting pharmaceutical pricing and reimbursement. Governmentand 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 as for thediscovery and development of new products. We believe that some of our newerproducts, product candidates or new indications for existing products, mayface competition when and as they are approved and marketed. Our products maycompete against products that have lower prices, established reimbursement,superior performance, are easier to administer, or that are otherwisecompetitive with our products. In addition, while we routinely obtain patentsfor our products and technology, the protection offered by our patents andpatent applications may be challenged, invalidated or circumvented by ourcompetitors and there can be no guarantee of our ability to obtain or maintainpatent protection for our products or product candidates. We cannot guaranteethat we will be able to produce commercially successful products or maintainthe commercial success of our existing products. Our stock price may beaffected by actual or perceived market opportunity, competitive position, andsuccess or failure of our products or product candidates. Further, thediscovery of significant problems with a product similar to one of ourproducts that implicate an entire class of products could have a materialadverse effect on sales of the affected products and on our business andresults of operations.

The scientific information discussed in this news release related to ourproduct candidates is preliminary and investigative. Such product candidatesare not approved by the U.S. Food and Drug Administration (FDA), and noconclusions can or should be drawn regarding the safety or effectiveness ofthe product candidates. Only the FDA can determine whether the productcandidates are safe and effective for the use(s) being investigated. Further,the scientific information discussed in this news release relating to newindications for our products is preliminary and investigative and is not partof the labeling approved by the FDA for the products. The products are notapproved for the investigational use(s) discussed in this news release, and noconclusions can or should be drawn regarding the safety or effectiveness ofthe products for these uses. Only the FDA can determine whether the productsare safe and effective for these uses. Healthcare professionals should referto and rely upon the FDA-approved labeling for the products, and not theinformation discussed in this news release.CONTACT: Amgen, Thousand Oaks Trish Hawkins, +1 805-447-5631 (US media) Arvind Sood: +1 805-447-1060 (investors) Millennium: The Takeda Oncology Company Lisa Adler +1 617-444-3285 (US media) Takeda Tomoyuki Ooue, Ph: +81-(3)-3278-2301 (Japanese investors) Toshiyuki Ikeuchi, Ph: +81-(3)-3278-2037 (Japanese media) (Logo: http://www.newscom.com/cgi-bin/prnh/20081015/AMGENLOGO)

SOURCE Amgen
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