LA JOLLA, Calif., Feb. 5, 2014 /PRNewswire/ -- Regulus Therapeutics
Inc. (NASDAQ:RGLS) announced today that it has renewed its
strategic alliance with Sanofi to discover, develop, and
commercialize microRNA therapeutics to focus on specific orphan
disease and oncology targets. Regulus will lead development
of its fibrosis program targeting microRNA-21 ("miR-21") for the
treatment of Alport Syndrome, an orphan, life-threatening genetic
kidney disease with no approved therapy, and for its microRNA-21
("miR-21") program in oncology. Sanofi has retained its
interest in these microRNA-21 programs and has gained rights to
Regulus' preclinical program targeting microRNA-221/microRNA-222
("miR-221/222"). Regulus is responsible for advancing the
clinical candidates in these programs to proof-of-concept.
Sanofi shall have the exclusive option, exercisable after
proof-of-concept, to take over further development and
commercialization of each microRNA therapeutic program. At
this stage, Regulus will have the option to co-promote any microRNA
therapeutic product in the United
States.
"The renewal of our strategic relationship with Sanofi further
underscores the commitment of both companies to realize the
tremendous promise of RNA therapeutics and the possibility to
transform the field of drug discovery by targeting microRNAs," said
Kleanthis G. Xanthopoulos, Ph.D.,
President and CEO of Regulus. "We believe that Regulus' microRNA
therapeutic platform, coupled with our focus on orphan diseases and
oncology indications, combine perfectly with Sanofi's resources and
their proven capabilities as a global-healthcare leader to bring
innovative medicines to patients in need. We look forward to
advancing our programs together and building a meaningful clinical
portfolio."
The refocused relationship allows Sanofi and Regulus to continue
to collaborate on several meaningful microRNA therapeutic programs,
with a greater focus on orphan diseases and oncology. Under
the original agreement from 2010, Sanofi had rights on up to four
microRNA targets, which included Regulus' lead fibrosis program
targeting miR-21. In 2012, the companies expanded the
alliance to collaborate on an oncology program targeting
miR-21. In 2013, the companies entered into an option letter
agreement to allow for negotiation of the extended strategic
alliance announced today. Sanofi retained its interest in
developing microRNA-21 therapeutics for fibrosis and oncology
indications and now has opt-in rights to Regulus' miR-21 and
miR-221/222 program. If Sanofi chooses to exercise its option
on any of these programs, Sanofi will reimburse Regulus for a
significant portion of its preclinical and clinical development
costs. Regulus continues to be eligible to receive royalties
on microRNA therapeutic products commercialized by
Sanofi.
Additionally, Sanofi has increased its ownership stake in
Regulus through an additional $10
million common stock investment at $7.67 per share, which represents the
volume-weighted average share price over the last 30 trading
days.
About Regulus
Regulus Therapeutics Inc. (NASDAQ:RGLS) is a
biopharmaceutical company leading the discovery and development of
innovative medicines targeting microRNAs. Regulus is uniquely
positioned to leverage a mature therapeutic platform that harnesses
the oligonucleotide drug discovery and development expertise of
Alnylam Pharmaceuticals, Inc. and Isis Pharmaceuticals, Inc., which
founded the company. Regulus has a well-balanced
microRNA therapeutic pipeline entering clinical development, an
emerging microRNA biomarkers platform to support its therapeutic
programs, and a rich intellectual property estate to retain its
leadership in the microRNA field. Regulus intends to focus
its proprietary efforts on developing microRNA therapeutics for
oncology indications and orphan diseases and is currently advancing
several programs toward clinical development in oncology, fibrosis
and metabolic diseases. Regulus is also developing RG-101, a
GalNAc-conjugated anti-miR targeting microRNA-122, for the
treatment of chronic hepatitis C virus infection. Regulus'
commitment to innovation and its leadership in the microRNA field
have enabled the formation of strategic alliances with AstraZeneca,
GlaxoSmithKline and Sanofi. In addition, the Company has
established Regulus microMarkers™, a research and development
division focused on identifying microRNAs as biomarkers of human
disease, which is designed to support its therapeutic pipeline,
collaborators and strategic partners.
For more information, please
visit http://www.regulusrx.com.
Forward-Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995, including statements associated with Regulus' expectations
regarding future therapeutic and commercial potential of Regulus'
business plans, technologies and intellectual property related to
microRNA therapeutics being discovered and developed by
Regulus. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Words such
as "believes," "anticipates," "plans," "expects," "intends,"
"will," "goal," "potential" and similar expressions are intended to
identify forward-looking statements. These forward-looking
statements are based upon Regulus' current expectations and involve
assumptions that may never materialize or may prove to be
incorrect. Actual results and the timing of events could
differ materially from those anticipated in such forward-looking
statements as a result of various risks and uncertainties, which
include, without limitation, risks associated with the process of
discovering, developing and commercializing drugs that are safe and
effective for use as human therapeutics, and in the endeavor of
building a business around such drugs. These and other risks
concerning Regulus' programs are described in additional detail in
Regulus' SEC filings. All forward-looking statements
contained in this press release speak only as of the date on which
they were made. Regulus undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made.
SOURCE Regulus Therapeutics Inc.