NanoString Eligible to Receive up to $45 million for Upfront,
Developmental and Regulatory Milestones, and Commercial Payments from
NanoString Technologies, Inc., (NASDAQ:NSTG) a provider of life science
tools for translational research and molecular diagnostic products,
today announced that it has entered into a collaboration with Celgene
Corporation to develop a companion diagnostic assay using the nCounter®
Analysis System to support the clinical validation of REVLIMID®
for treatment of Diffuse Large B-Cell Lymphoma (DLBCL). Under the terms
of the collaboration agreement, NanoString will develop, seek regulatory
approval for, and commercialize the diagnostic test and is eligible to
receive payments totaling up to $45 million of which $5.75 million is an
upfront payment, $17 million is for potential success-based
developmental and regulatory milestones, and the remainder is for
potential commercial payments.
DLBCL is a heterogeneous group of cancers classified together on the
basis of morphology, immunophenotype, genetic alterations and clinical
behavior, and represents the most common form of Non-Hodgkin Lymphoma.
According to the National Cancer Institute, DLBCL will represent
approximately 37 percent of the 70,000 new cases of Non-Hodgkin Lymphoma
this year. The subtypes of DLBCL have long been known to have varying
prognoses. Accordingly, the accurate and precise assignment of subtype
has the potential to become increasingly important with the emergence of
novel therapies, and repurposing of existing products, that have
selective clinical activity in specific subsets of patients.
In January 2014, researchers associated with the Lymphoma/Leukemia
Molecular Profiling Project (LLMPP) published a paper in the journal Blood
describing the development and validation of a biomarker assay based on
a 20-gene expression DLBCL subtype classifier using NanoString's
nCounter Analysis System. In this paper, titled "Determining
cell-of-origin subtypes of diffuse large B-cell lymphoma using gene
expression in formalin-fixed paraffin embedded tissue," the authors
concluded that the nCounter-based assay accurately and robustly assigned
subtypes of DLBCL from formalin-fixed paraffin-embedded tissue samples
with excellent site-to-site reproducibility and rapid turnaround time,
making it attractive for implementation in clinical trials and,
ultimately, patient management. NanoString has secured a license to the
relevant intellectual property to enable the collaboration.
Under the collaboration agreement with Celgene, NanoString will work to
develop an in vitro diagnostic (IVD) companion test to REVLIMID
that will be used to screen patients who are being enrolled in a pivotal
study of REVLIMID for the treatment of DLBCL. Upon successful completion
of the study, NanoString will pursue regulatory approval of the IVD in
key global markets. Pursuant to the terms of the agreement, NanoString
retains the flexibility to independently develop and commercialize
additional indications for the IVD assay.
"Biomarker-driven clinical trials are the future of clinical oncology.
Our collaboration with NanoString exemplifies our commitment to be at
the forefront of science. The nCounter platform is expected to enable
reproducible subtyping of patients in our pivotal REVLIMID DLBCL study
and will form the basis for companion diagnostic development," said
Jean-Pierre Bizzari, Executive Vice President of Clinical Development at
Celgene. "We are excited to work with NanoString's experienced team to
aid us in the development of a targeted treatment for patients with
The upfront payment and a portion of the success-based milestone
payments are intended to cover NanoString's costs for clinical
development of the IVD. Included in such $45 million, NanoString may
receive potential commercial payments in the event sales of the IVD do
not exceed certain pre-specified minimum annual revenues during the
first three years following regulatory approval.
"We are excited to work with Celgene to help improve the lives of
patients," said Brad Gray, President and Chief Executive Officer of
NanoString Technologies. "Similar to our development of the Prosigna™
Breast Cancer Prognostic Gene Signature Assay, which isbased on
the PAM50 gene signature, this new collaboration demonstrates the power
of our business model to leverage biomarker discovery and advance the
treatment paradigm, bringing the right therapy to the right patient at
the right time. In addition, this collaboration further validates the
nCounter Analysis System as the platform-of-choice for development of
IVDs based on multi-gene expression assays, as well as the quality of
our clinical and regulatory capabilities."
About NanoString Technologies, Inc.
NanoString Technologies provides life science tools for translational
research and molecular diagnostic products. The company's nCounter®
Analysis System has been employed in life sciences research since it was
first introduced in 2008 and has been cited in more than 400
peer-reviewed publications. The nCounter Analysis System offers a
cost-effective way to easily profile the expression of hundreds of
genes, miRNAs, or copy number variations, simultaneously with high
sensitivity and precision, facilitating a wide variety of basic research
and translational medicine applications, including biomarker discovery
and validation. The company's technology has now been applied to
diagnostic use. The Prosigna™ Breast Cancer Prognostic Gene
Signature Assay together with the nCounter Dx Analysis System is FDA
510(k) cleared for use as a prognostic indicator for distant recurrence
of breast cancer.
For more information, please visit www.nanostring.com.
This press release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of
the Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995.These forward-looking statements
include statements regarding plans for development, regulatory approval
and commercialization of an IVD assay for DLBCL, future payments that
may or may not be received by NanoString and NanoString's ability to
translate discoveries of research customers into in vitro diagnostics.
Forward-looking statements are subject to risks and uncertainties that
could cause actual results to differ materially and reported results
should not be considered as an indication of future performance. These
risks and uncertainties include, but are not limited to: risks
associated with keeping pace with rapidly changing technology and
customer requirements; risks regarding the company's ability to
successfully develop and commercialize new products; risks that new
market opportunities may not develop as quickly as expected; risks
associated with competition in marketing and selling products; risks of
increased regulatory requirements; as well as the other risks set forth
in the company's filings with the Securities and Exchange Commission.
These forward-looking statements speak only as of the date hereof.
NanoString Technologies disclaims any obligation to update these
The NanoString Technologies logo, NanoString, NanoString
Technologies, and nCounter are registered trademarks, and Prosigna is a
trademark of NanoString Technologies, Inc.Celgene and REVLIMID are
registered trademarks of Celgene Corporation.
Source: NanoString Technologies, Inc.