DARA BioSciences Grants T3D Therapeutics Exclusive Worldwide Rights to Develop
and Commercialize DB959
Agreement Underpins DARA's Strategy to Focus on the Commercialization
of Oncology Supportive Care Products
RALEIGH, NC -- (Marketwired) -- 06/18/13 -- DARA BioSciences, Inc.
(NASDAQ: DARA), a specialty pharmaceutical company focused on
oncology supportive care products, announced today that it has
granted T3D Therapeutics, Inc. the exclusive worldwide rights to
develop and commercialize DB959. DB959 is an oral, highly selective,
dual nuclear receptor agonist whose primary target is PPARd
(peroxisome proliferator activated receptor delta). DARA had
previously developed DB959 through Phase 1 clinical trials for the
treatment of diabetes and dyslipidemia.
David J. Drutz, MD, DARA's Chief Executive Officer and Chief Medical
Officer, stated, "We are very pleased to have reached an agreement
with T3D Therapeutics to enable the further development of DB959.
This program no longer fits into the strategic focus of DARA as we
have shifted our corporate attention to the commercialization of
oncology supportive care products. The T3D Therapeutics team,
including John Didsbury, who was Chief Scientific Officer of DARA
from 2005 to 2009, is comprised of leading experts in the field of
PPAR science and are extremely familiar with the compound. We believe
they will apply the necessary resources to explore DB959 in multiple,
potential high-value indications. Importantly, the agreement affords
DARA upfront considerations as well as future potential revenue based
on progression of the DB959 developmental program."
DARA previously reported that it was actively seeking to out-license
DB959 as part of its strategic plan to focus on the commercialization
of oncology supportive care products.
John Didsbury, Ph.D., Founder and Chief Executive Officer of T3D
Therapeutics, commented, "The T3D Therapeutics team has a long
history with DB959, and we plan to develop it as a transformational
new therapy for the treatment of Alzheimer's disease. Unlike other
therapies in development that target a single pathology, typically
the reduction or prevention of beta amyloid plaque buildup, T3D
expects DB959 will afford a multidimensional opportunity, with the
potential to improve several Alzheimer's disease pathologies
including addressing beta amyloid plaque issues. Positive
improvements in disease pathologies such as neuro-inflammation,
neuronal cell loss, neurotransmitter deficits, tau neurofibrillary
tangles, and insulin resistance / lowered cerebral glucose metabolism
also are anticipated."
Didsbury continued, "With today's highly competitive diabetes and
dyslipidemia market, we believe that DB959 will be better positioned
to address unmet medical needs for new central nervous system (CNS)
therapies. Given the neuroprotectant potential of DB959's mechanism
of action and the growing evidence of metabolic disorders
contributing to CNS diseases, we are excited to commence an
aggressive development program for DB959."
About T3D Therapeutics
T3D Therapeutics Inc. is a privately-held Research Triangle Park,
NC-based company incorporated in 2013. The company is committed to
develop and commercialize disease remedial therapeutics for the
treatment of Alzheimer's disease and other CNS disorders. T3D-959
(DB959), its lead product candidate, has successfully concluded Phase
1 clinical trials. The company is supported by expert advisors
including Dr. Lawrence Friedhoff the founder and developer of
AriceptÂ®, the market leading drug for treating Alzheimer's disease
and Dr. Warren Strittmatter. Dr. Strittmatter is recognized for his
ground-breaking research in Alzheimer's and Huntington's disease. He
received the Alzheimer's Association Zenith Award and was recognized
by the Institute for Scientific Information as the "Top 20
Scientists" in Neuroscience and Behavior for the decade 1992-2002.
About DARA BioSciences, Inc.
DARA is a specialty pharmaceutical company focused on the development
and commercialization of oncology treatment and supportive care
DARA increased its focus in oncology through its January 2012
acquisition of Oncogenerix, Inc., which holds the exclusive U.S.
marketing rights to SoltamoxÂ®, a novel oral liquid formulation of
tamoxifen citrate, which is widely used in the treatment and
prevention of breast cancer. Soltamox is the only FDA-approved oral
liquid version of tamoxifen citrate and fulfills a vital clinical
need for patients who prefer a liquid formulation or cannot tolerate
existing solid tablet formulations of this drug. DARA has exclusive
U.S. rights to Soltamox through a license from Rosemont
In June 2012, DARA launched its first product, BionectÂ®, a topical
treatment for skin irritation and burns associated with radiation
therapy. DARA has rights to market Bionect in the US
oncology/radiology markets under license from Innocutis. Soltamox was
launched formally as DARA's second commercial product in December
2012, coincident in timing with the 35th Annual San Antonio Breast
Cancer Symposium. In late April, 2013, DARA launched its third
product, GelclairÂ®, an FDA-cleared product for the treatment of oral
mucositis for which DARA also has exclusive U.S. commercial rights
through a license from Helsinn Group in Switzerland.
DARA is also developing a cancer-support therapeutic compound,
KRN5500, for the treatment of chronic chemotherapy-induced peripheral
neuropathy (CCIPN) in patients with cancer. This product is an
excellent fit with DARA's strategic oncology focus, has successfully
completed a Phase 2a clinical trial, and has been designated a Fast
Track Drug by the FDA. DARA has created an improved, potentially
commercializable formulation of this drug and is in active partnering
discussions regarding further clinical development. DARA has also
submitted an Orphan Drug Application to the FDA for the use of this
drug in painful CCIPN.
For more information please visit our web site at www.darabio.com.
Safe Harbor Statement
All statements in this news release that are not historical are
forward-looking statements within the meaning of the Securities
Exchange Act of 1934, as amended. Such forward-looking statements are
subject to factors that could cause actual results to differ
materially for DARA from those projected. Important factors that
could cause actual results to differ materially from the expectations
described in these forward-looking statements are set forth under the
caption "Risk Factors" in DARA's most recent Annual Report on Form
10-K, filed with the SEC on March 28, 2013. Those factors include
risks and uncertainties relating to DARA's ability to timely
commercialize and generate revenues or profits from BionectÂ®,
SoltamoxÂ®, GelclairÂ® or other products given that DARA only recently
hired its initial sales force and DARA's lack of history as a
revenue-generating company, FDA and other regulatory risks relating
to DARA's ability to market Bionect, Soltamox, Gelclair or other
products in the U.S. or elsewhere, DARA's ability to develop and
bring new products to market as anticipated, DARA's current cash
position and its need to raise additional capital in order to be able
to continue to fund its operations, the current regulatory
environment in which DARA develops and sells its products, the market
acceptance of those products, dependence on partners, successful
performance under collaborative and other commercial agreements,
competition, the strength of DARA's intellectual property and the
intellectual property of others, the potential delisting of DARA's
common stock from the NASDAQ Capital Market, risks and uncertainties
relating to DARA's ability to successfully integrate Oncogenerix and
other risk factors identified in the documents DARA has filed, or
will file, with the Securities and Exchange Commission ("SEC").
Copies of DARA's filings with the SEC may be obtained from the SEC
Internet site at http://www.sec.gov. DARA expressly disclaims any
obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to
reflect any change in DARA's expectations with regard thereto or any
change in events, conditions, or circumstances on which any such
statements are based. DARA BioSciences and the DARA logo are
trademarks of DARA BioSciences, Inc.
Head of Investor Relations
John Didsbury, Ph.D.
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