Independent Data Monitoring Committee Recommends Resuming Enrollment of Non-Squamous NSCLC Patients in the Motesanib MONET1 Trial
THOUSAND OAKS, Calif. and CAMBRIDGE, Mass., Feb. 11 and OSAKA, Japan (Feb.
12, 2009) /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN), Millennium: The
Takeda Oncology Company, and its parent company Takeda Pharmaceutical Company
Limited (TSE:4052) today announced the Independent Data Monitoring Committee
(DMC) for the MONET1 trial has recommended the trial resume enrollment of
patients with non-squamous non-small cell lung cancer (NSCLC) following a
three-month enrollment suspension. MONET1 is a Phase 3 study evaluating
motesanib (AMG 706) in combination with paclitaxel and carboplatin for the
first-line treatment of advanced NSCLC. Motesanib is part of a co-development
program between Amgen, Millennium and Takeda.
The recent DMC guidance recommends the trial be re-opened only to patients
with non-squamous cell histology. Non-squamous cell NSCLC is a histological
subtype of NSCLC representing approximately two-thirds of the study
population. Amgen, Millennium and Takeda plan to follow this recommendation
which will require modifications to the study design of MONET1. Enrollment
will resume once these changes are sanctioned by appropriate global health
authorities.
In November 2008 the DMC recommended treatment discontinuation in subjects
with squamous histology, and enrollment suspension in subjects with
non-squamous histology. This recommendation was based on an observation of
higher early mortality rates in the motesanib group compared to the placebo
group and a higher incidence of hemoptysis in the squamous population.
Patients with non-squamous NSCLC receiving motesanib were allowed to continue
treatment during the temporary suspension.
"We endorse the DMC's decision to include only patients with non-squamous
cell tumors in MONET1," said Roger M. Perlmutter, M.D., Ph.D., executive vice
president of Research and Development at Amgen. "This decision gives us
confidence we have selected the right patient population to explore the
clinical potential of motesanib in non-small cell lung cancer."
"NSCLC continues to be an area where new and effective therapies are
needed, and we are optimistic about the potential of motesanib in patients
with non-squamous NSCLC," said Nancy Simonian, M.D., chief medical officer,
Millennium: The Takeda Oncology Company. "We are pleased with the DMC
recommendation and will work with appropriate regulatory agencies and
investigators to resume enrollment as soon as possible."
MONET1 (Motesanib NSCLC Efficacy and Tolerability Study) Trial Design
The primary endpoint is overall survival, and secondary endpoints include
progression-free survival, objective response rate in patients with measurable
disease, duration of response and safety. Patients were randomized 1:1 to
receive paclitaxel and carboplatin administered every three weeks with or
without 125 mg motesanib taken daily.
About Motesanib
Co-developed by Amgen, Takeda Pharmaceutical Company and Millennium: The
Takeda Oncology Company, motesanib is an investigational, highly selective,
oral agent that is being evaluated for its ability to inhibit angiogenesis by
targeting vascular endothelial growth factor receptors 1, 2 and 3 (VEGFR1-3).
It is also under investigation for its potential direct anti-tumor activity by
targeting a family of proteins called tyrosine kinases, including
platelet-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 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.
About Takeda
Located in Osaka, Japan, Takeda Pharmaceutical Company Limited (TSE:4502)
is a research-based global company with its main focus on pharmaceuticals. As
the largest pharmaceutical company in Japan and one of the global leaders of
the industry, Takeda is committed to striving toward better health for
individuals and progress in medicine by developing superior pharmaceutical
products. Additional information about Takeda is available through its
corporate website, http://www.takeda.com.
About Millennium
Millennium: The Takeda Oncology Company, a leading biopharmaceutical
company based in Cambridge, Mass., markets VELCADE, a first-in-class
proteasome inhibitor, and has a robust clinical development pipeline of
product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda
Pharmaceutical Company Limited in May 2008. The Company's research,
development and commercialization activities are focused in oncology.
Additional information about Millennium is available through its website,
http://www.millennium.com.
Forward-Looking Statements
This news release contains forward-looking statements that are based on
Amgen'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 Amgen's business. Unless otherwise
noted, Amgen is providing this information as of Feb. 11, 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 Amgen projects. 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 Amgen to complete clinical trials and obtain
regulatory approval for product marketing has in the past varied and Amgen
expects similar variability in the future. Amgen develops 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 Amgen may have believed at the time of entering into such
relationship. Also, Amgen or others could identify safety, side effects or
manufacturing problems with Amgen's products after they are on the market.
Amgen's business may be impacted by government investigations, litigation and
products liability claims. Amgen depends on third parties for a significant
portion of its manufacturing capacity for the supply of certain of its current
and future products and limits on supply may constrain sales of certain of its
current products and product candidate development.
In addition, sales of Amgen's 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 Amgen's products. In addition, Amgen competes with other
companies with respect to some of its marketed products as well as for the
discovery and development of new products. Amgen believes that some of its
newer products, product candidates or new indications for existing products,
may face competition when and as they are approved and marketed. Amgen's
products may compete against products that have lower prices, established
reimbursement, superior performance, are easier to administer, or that are
otherwise competitive with its products. In addition, while Amgen routinely
obtains patents for its products and technology, the protection offered by its
patents and patent applications may be challenged, invalidated or circumvented
by its competitors and there can be no guarantee of Amgen's ability to obtain
or maintain patent protection for its products or product candidates. Amgen
cannot guarantee that it will be able to produce commercially successful
products 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 product
candidates. Further, the discovery of significant problems with a product
similar to one of Amgen's products that implicate an entire class of products
could have a material adverse effect on sales of the affected products and on
Amgen's business and results of operations.
The scientific information discussed in this news release related to
Amgen's 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 Amgen's products is preliminary and
investigative and is not part of the labeling approved by the U.S. Food and
Drug Administration (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.
CONTACT: Amgen, Thousand Oaks
Christine Regan: 805-447-5476 (media)
Arvind Sood: 805-447-1060 (investors)
Millennium: The Takeda Oncology Company
Lisa Adler +1 617-444-3285 (US media)
Takeda
Seizo Masuda (011-81) 3-3278-2037 (Investors and Media)
(Logo: http://www.newscom.com/cgi-bin/prnh/20081015/AMGENLOGO)
(Logo: http://www.newscom.com/cgi-bin/prnh/20081119/TAKEDALOGO)
(Logo: http://www.newscom.com/cgi-bin/prnh/20081119/MILLENIUMLOGO)
SOURCE Amgen
