DARA and HELSINN Announce U.S. Launch of Gelclair(R), an FDA-Cleared Oral Gel for the Treatment of Oral Mucositis

DARA and HELSINN Announce U.S. Launch of Gelclair(R), an FDA-Cleared Oral Gel 
for the Treatment of Oral Mucositis 
Gelclair Launch Expected to Provide Additional Commercial Revenue for
DARA in 2013 
RALEIGH, NC and LUGANO, SWITZERLAND  -- (Marketwired) -- 04/22/13 -- 
DARA BioSciences, Inc. (NASDAQ: DARA), a specialty pharmaceutical
company focused on oncology and oncology supportive care products,
and the Swiss pharmaceutical Helsinn Group, a leading player in the
cancer supportive care arena, announced today that DARA has
reintroduced Gelclair® into the U.S. market. Gelclair is manufactured
by the Helsinn Group and is an FDA-cleared product indicated for the
treatment of oral mucositis.  
Oral mucositis is a painful inflammation and ulceration of the
surface of the mouth and throat, which can result from a variety of
cancer treatments, including radiation therapy and chemotherapy.
Gelclair provides oral mucositis patients rapid and effective relief
of pain. Oral mucositis is common in cancer patients undergoing
chemotherapy or radiation therapy and occurs when the protective oral
mucosa is denuded, potentially resulting in pain, infection, weight
loss, decreased quality of life, treatment delay and increased
economic costs. 
David J. Drutz, MD, DARA's chief executive officer and chief medical
officer, stated, "We are thrilled to be launching Gelclair®, our
third product into the U.S. market, having recently introduced
Soltamox® (tamoxifen citrate) oral solution, the first and only
liquid version of tamoxifen citrate. We believe this underpins our
mission of becoming a leader in the oncology and oncology supportive
care market and exemplifies our commitment to executing against our
corporate plan." 
Helsinn Group Chief Executive Officer, Riccardo Braglia, said, "We
are pleased that DARA is launching Gelclair® in the United States and
importantly, that U.S. patients will again be able to benefit from
this treatment. We believe this is an important milestone in building
the long-term relationship between our companies. It will also add
the most important market worldwide to the other 30 where Gelclair is
already marketed in Europe, Latin America and Asia." 
Internally conducted market research involving over 100 oncology
physicians and nurses indicated strong familiarity with the Gelclair
brand from its earlier presence in the U.S. market; a continuing
preference for Gelclair over other products used to treat oral
mucositis; and the likelihood that Gelclair would be prescribed in
the majority of cases requiring an oral coating agent -- twice as
frequently as the next available option.  
To ensure patients and health care providers receive the highest
level of satisfaction, DARA has instituted, in partnership with
Onco360, a specialty single point of contact model, the Gelclair
Access Program, to provide product access and affordability for
patients together with ease of prescribing for health care providers. 
Onco360 is an oncology pharmaceutical services company that features
Board Certified Oncology Pharmacists (BCOP), and is dedicated to
advancing the continuum of pharmaceutical cancer care for patients.
Onco360 provides services to more than 1800 oncologists; 43 major
BlueCross/BlueShield programs; commercial, Medicare, and Medicaid
managed care payers; hospital systems; and several National
Comprehensive Cancer Network (NCCN) Centers of Excellence, such as MD
Anderson and Roswell Park, through its growing network of certified
and JCAHO-accredited OncoMed pharmacies. 
"Onco360 has developed specialized supportive care pharmacy programs
that present an outstanding pathway for the launch of Gelclair. We
are excited to work in partnership with DARA on this product launch
by not only running the best in class Gelclair Access Program, to
provide excellent service to patients and healthcare providers alike,
but to also support Gelclair uptake with our well respected national
sales team and proven oncology marketing programs," stated Burt
Zweigenhaft, CEO of Onco360. 
Dr. Drutz continued, "Partnering with Onco360, a leader in oncology
pharmacy services, is a very important and strategic relationship for
DARA, which we believe will enhance the availability and
affordability of Gelclair to patients nationwide. Hundreds of
thousands of cancer patients suffer from oral mucositis each year.
The exclusive agreement with Helsinn for rights to commercialize
Gelclair in the U.S. provides us with an important commercial product
in an area of significant medical need."  
About Onco360
Founded in 2005, Onco360 (www.onco360.com) has created a unique model
to better serve the needs of oncology and hematology physicians,
patients, payers, and manufacturers. In its focus to bring together
the four major groups involved in the continuum of oncology
pharmaceutical care, Onco360 has emerged as a unique and trusted
partner. Onco360 executive offices are located in New York, NY and
the company is licensed to deliver oncology pharmaceutical services
across most of the country. Onco360 currently operates five
dispensing pharmacies and provides a comprehensive inventory of oral,
injected, and infused cancer therapies, including limited
distribution products.  
About Helsinn Group
Helsinn is a privately owned pharmaceutical group with headquarters
in Lugano, Switzerland, and operating subsidiaries in Ireland, the
United States and China. Helsinn's business model is focused on the
licensing of pharmaceuticals, medical devices and nutritional
supplement products in therapeutic niche areas. Helsinn is an
important player in cancer supportive care. Helsinn Group in-licenses
early-to-late stage new chemical entities, completes their
development through the performance of pre-clinical /clinical studies
and Chemistry, Manufacturing, and Control (CMC) development, and
files and attains their market approvals worldwide. Helsinn's
products are out-licensed to its network of local marketing and
commercial partners, selected for their deep in-market knowledge and
know-how whom Helsinn assists and supports by providing a full range
of product and scientific management services, including commercial,
regulatory, financial, legal, and medical marketing advice. The
active pharmaceutical ingredients and the finished products are
manufactured according to the highest quality, safety, and
environmental standards at Helsinn's GMP facilities in Switzerland
and Ireland and supplied worldwide to its customers.  
Further information on Helsinn Group is available at www.helsinn.com 
About DARA BioSciences, Inc. 
DARA is a specialty pharmaceutical company focused on the development
and commercialization of oncology treatment and supportive care
products. DARA has comprehensive commercial coverage across the
national oncology market through a series of agreements with a number
of specialty pharmacy providers, leading group purchasing
organizations (GPOs), retail partners, reimbursement experts, and an
industry-leading third-party logistics provider. As part of an
integrated national network with annual sales of over $1 billion in
cancer therapeutics, DARA has significant commercial scale and
capabilities. Its distribution network consists of more than 45,000
retail pharmacies, mail order pharmacies, and long-term care
facilities. This provides DARA with established reimbursement and
logistics expertise, as well as partnering opportunities with more
than 300 sales and marketing personnel uniquely focused on oncology
and oncology support products. This comprehensive network of partners
is rare if not unique among companies in the oncology supportive care
area and provides DARA a strong foundation for product introductions
into this underserved market.  
DARA increased its focus in oncology through its January 2012
acquisition of Oncogenerix, Inc., which holds the exclusive U.S.
marketing rights to Soltamox®, 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 cannot tolerate existing solid tablet
formulations of this drug. DARA launched Soltamox in October 2012 to
coincide with National Breast Cancer Awareness Month. DARA has
exclusive U.S. rights to Soltamox through a license from Rosemont
Pharmaceuticals, Ltd. Additionally, in June 2012, DARA launched its
first product, Bionect®, 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. DARA also has exclusive U.S. commercial rights to
Gelclair®, an FDA-cleared product for the treatment of oral
mucositis, which DARA launched in April 2013. 
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.  
In addition to its oncology products, DARA's research and development
pipeline includes DB959, a novel, non-TZD dual delta/gamma PPAR
agonist for the treatment of type 2 diabetes and dyslipidemia. DARA
has completed Phase 1 testing of DB959 and is presently pursuing
opportunities to out-license this product. 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. Those factors include risks
and uncertainties relating to DARA's ability to timely commercialize
and generate revenues or profits from Bionect®, Soltamox®, Gelclair®
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.  
CONTACTS: 
For DARA BioSciences
Jenene Thomas
Head of Investor Relations
+1-908-938-1475
jthomas@darabio.com 
For Helsinn Group
Paola Bonvicini
Head of Communication & Press Office
PH +41 91-985-21-21
Info-hhc@helsinn.com
 
 
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