DARA BioSciences Completes Breast Cancer CAPTURE Registry

DARA BioSciences Completes Breast Cancer CAPTURE Registry 
CAPTURE: COMPLIANCE AND PREFERENCE FOR TAMOXIFEN REGISTRY -- Provides
Important New Insight into Aspects of Tamoxifen Therapy Adherence;
626 Patients Enrolled in Cancer Centers Nationwide 
RALEIGH, NC  -- (Marketwired) -- 12/03/13 --   DARA BioSciences, Inc.
(NASDAQ: DARA), an oncology supportive care specialty pharmaceutical
company dedicated to providing healthcare professionals a synergistic
portfolio of medicines to help cancer patients adhere to their
therapy and manage side effects arising from their cancer treatments,
announced completion of CAPTURE (Compliance and Preference for
Tamoxifen Registry). 
A total of 626 women who had been prescribed and were taking
tamoxifen therapy for breast cancer completed the CAPTURE survey,
providing investigators with valuable insight into adherence to
prescribed tamoxifen treatment; patient preference for a liquid
formulation of tamoxifen; and prevalence of difficulties in
swallowing among breast cancer patients taking tamoxifen tablets.
CAPTURE was initiated earlier in 2013 subsequent to DARA's
commercialization of Soltamox® (tamoxifen citrate) oral solution as
the only FDA-approved liquid formulation of tamoxifen citrate in the
United States. DARA and CAPTURE investigators anticipate presenting
these data at upcoming oncology conferences in 2014.  
"We expect data generated from the CAPTURE registry will enable
physicians to provide a more comprehensive clinical assessment,
thereby improving patient long-term adherence to tamoxifen therapy
based on specific patient parameters," said David J. Drutz, MD, CEO
and CMO of DARA BioSciences. "DARA initiated CAPTURE to illustrate
our commitment to the enhancement of oncology supportive care. By
working with investigators and their clinical teams at 17
participating oncology centers across the country, we are confident
that CAPTURE will help advance clinical practice to maximize
adherence to long-term tamoxifen therapy." 
The American Society of Clinical Oncology recently updated its
guidelines, recommending that increasing duration of tamoxifen
therapy (20mg per day for 10 years) should be discussed as an option
to reduce the risk of estrogen receptor (ER) positive breast cancer.
Based on the updated guidelines, long term adherence is of utmost
importance to support the best possible therapeutic outcomes.  
"Understanding key drivers for patients' long-term tamoxifen
adherence is of the utmost significance," stated Professor Stefan
Glück MD, PhD, FRCPC, Sylvester Distinguished Professor, Department
of Medicine, Division of Hematology/Oncology, Sylvester Comprehensive
Cancer Center and a member of the CAPTURE Scientific Steering
Committee. "CAPTURE will provide the oncology community important
information that positively will affect tamoxifen prescribing habits
and long-term patient adherence." Soltamox® offers an alternative
(oral liquid) form of delivery previously not available to patients
and prescribing physicians, and is bioequivalent to, and indicated
for the same FDA approved indications as the tablet form of
tamoxifen.  
The oncology centers that participated in the registry include
Advanced Medical Specialties, Blood and Cancer Center of East TX,
Breastlink Medical Group, Cancer Care Centers of South Texas, Cancer
and Hematology Centers of Western Michigan, Cedars Sinai Medical
Group, Florida Cancer Center, Highlands Oncology Group, Holy Cross
Hospital-Bienes Cancer Center, La Grange Oncology Associates, MacNeal
Hospital, Memorial Cancer Institute, Oncology Consultants, Tennessee
Oncology, PLLC, Sylvester Comprehensive Cancer Center, Weiss Memorial
Hospital, and West Suburban Medical Center. 
Dr. Drutz concluded, "DARA is working with the oncology community to
contribute to the improvement of patient care in a meaningful way.
DARA will continue our efforts to support advancement of patient care
by providing both patients and health care practitioners with novel
therapies, supportive programs, and clinical opportunities such as
CAPTURE."  
Tamoxifen is indicated for the treatment of ductal carcinoma in situ
(DCIS); as adjuvant treatment of node-positive breast cancer; in the
treatment of metastatic breast cancer; and for breast cancer risk
reduction in high risk women. Currently, there are more than 1.8
million prescriptions of tamoxifen written on an annual basis in the
United States. Between 30 and 70 percent of patients fail to complete
their prescribed course of treatment, thereby diminishing its
benefits in reducing the risk of breast cancer recurrence. Important
Safety Information and the complete Black Box Warning may be found
at: http://soltamox.com/prescribing-information. 
About DARA BioSciences, Inc.  
DARA BioSciences Inc. of Raleigh, North Carolina, is an oncology
supportive care pharmaceutical company dedicated to providing
healthcare professionals a synergistic portfolio of medicines to help
cancer patients adhere to their therapy and manage side effects
arising from their cancer treatments. 
DARA holds exclusive U.S. marketing rights to Soltamox® (tamoxifen
citrate) oral solution, the only liquid form of tamoxifen, used for
the treatment and prevention of breast cancer. Soltamox® offers a
choice to patients who prefer or need a liquid form of tamoxifen.
Gelclair® is an alcohol-free bioadherent oral rinse gel for rapid and
effective relief of pain associated with oral mucositis caused by
chemotherapy and radiation treatment. DARA licensed the U.S. rights
to Soltamox® from UK-based Rosemont Pharmaceuticals, Ltd., and
Gelclair® from the Helsinn Group in Switzerland. Under an agreement
with Innocutis, DARA also markets Bionect® (hyaluronic acid sodium
salt, 0.2%) a topical treatment for skin irritation and burns
associated with radiation therapy, in U.S. oncology/radiology
markets. For further information on Gelclair® and Bionect® and the
Full Prescribing Information please visit www.Gelclair.com and
www.Bionect.com. 
DARA is focused on expanding its portfolio of oncology supportive
care products in the United States, via in-licensing and/or
partnering of complementary late-stage and approved products. In
addition, the company wishes to identify a strategic partner for the
clinical development of KRN5500, currently in Phase 2 for the
treatment of chronic, treatment refractory, chemotherapy-induced
peripheral neuropathy (CCIPN). The FDA has designated KRN5500 as a
Fast Track Drug, and DARA is seeking orphan status for the treatment
of CCIPN. 
In 2014, DARA kicks off its new partnership with Alamo Pharma
Services, a subsidiary of Mission Pharmacal, in deploying a dedicated
20-person national sales team in the U.S. oncology market. In
addition to promoting DARA's products Soltamox® (tamoxifen citrate),
Gelclair® and Bionect®, this specialized oncology supportive care
sales team also will provide clinicians with access to three Mission
Pharmacal products: Ferralet® 90 (for anemia), BINOSTO® (alendronate
sodium effervescent tablet indicated for the treatment of
osteoporosis), and Aquoral® (for chemotherapy/radiation
therapy-induced dry mouth). 
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, and are subject to risks and
uncertainties. These statements are based on the current
expectations, estimates, forecasts and projections regarding
management's beliefs and assumptions. In some cases, you can identify
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"potential," "continue," and other similar terminology or the
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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, DARA's most recent Quarterly Report on
Form 10-Q, filed with the SEC on November, 13, 2013, and DARA's other
filings with the SEC from time to time. Those factors include risks
and uncertainties relating to DARA's ability to timely commercialize
and generate revenues or profits from Soltamox®, Gelclair®, Bionect®
or other products given that DARA only recently hired its initial
sales force and DARA's lack of history as a revenue-generating
company, DARA's ability to achieve the desired results from the
agreements with Mission and Alamo, FDA and other regulatory risks
relating to DARA's ability to market Soltamox®, Gelclair®, Bionect®
or other products in the United States or elsewhere, DARA's ability
to in-license and/or partner products, 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 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. 
Media Contact:
David Connolly
LaVoie Group
617-374-8800 ext. 104
dconnolly@lavoiegroup.com  
Investor Contact:
Jenene Thomas
DARA BioSciences
908-938-1475
jthomas@darabio.com
 
 
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