DARA BioSciences Announces Submission of KRN5500 to FDA for Orphan Designation

  DARA BioSciences Announces Submission of KRN5500 to FDA for Orphan

 DARA's KRN5500 is a Promising Drug for CCIPN – Meeting an Unmet Medical Need

Business Wire

RALEIGH, N.C. -- November 29, 2012

DARA BioSciences, Inc. (NASDAQ: DARA), a specialty pharmaceutical company
focused on oncology and oncology supportive care products, announced today it
has submitted an Orphan Drug Application to the U.S. Food and Drug
Administration (FDA) for KRN5500, a compound in development to treat a painful
form of chronic chemotherapy-induced peripheral neuropathy (CCIPN). The FDA
provides orphan drug status to products that treat rare conditions for which
there may be few adequate therapies. No approved treatments currently exist
for CCIPN. Orphan designation qualifies the drug developer for tax credits,
the waiver of the prescription drug user fee and seven-year market
exclusivity. DARA engaged consultants with extensive FDA experience to guide
the preparation of the Orphan Drug Application.

In October 2011, the FDA designated KRN5500 a "Fast Track" drug. The Fast
Track process expedites the development and review of drugs that treat serious
diseases and fill an unmet medical need. Fast track designation may support
accelerated approval of such drugs, and orphan designation would provide seven
year exclusivity on KRN5500 for the orphan indication.

KRN5500 is an intravenously administered, non-opioid analgesic with rapid
onset of action and prolonged pain mitigation, as demonstrated in both
pre-clinical and clinical studies. KRN5500 is being developed to treat the
painful form of CCIPN. Painful CCIPN is characterized by the persistence of
chemotherapy-associated pain for at least twelve weeks after chemotherapy has

Peripheral neuropathy is caused by nerve damage, a potential complication of
treatment with platins, taxanes and other cancer drugs. The disorder comprises
numbness and tingling of the arms and legs, including hands and feet. A subset
of these patients develops a chronic, painful form of the condition. The pain
can be extreme and continuous, and can be elicited by stimuli such as touch
and cold, which do not normally elicit a pain response. Painful CCIPN
interferes with activities of daily living and significantly reduces the
quality of life of cancer patients. Since CCIPN has no current approved
therapies, KRN5500 addresses a significant unmet medical need, especially
since people with cancer are living longer due to improved treatments and

DARA CEO, David J. Drutz, MD, stated, “Painful CCIPN can be truly
debilitating. Taking just a single step can cause tremendous pain. Currently,
clinicians treat CCIPN with a number of prescription medications, botanicals
and dietary supplements. However, none has been proven effective in
placebo-controlled clinical trials. In fact, several large trials testing many
of these products have failed to demonstrate any efficacy when compared to
placebo. Conversely, KRN5500 demonstrated statistical and clinical superiority
over placebo in a small Phase 2a clinical trial conducted in patients that had
both advanced cancer and the painful form of CCIPN. It is important to note
that each of the trial participants was also prescribed other pain
medications, none of which alone or in combination had resulted in a reduction
of pain due to CCIPN.”

Given the promising results from its Phase 2a trial, DARA is currently seeking
potential development partners, with the intention of initiating a Phase 2b
trial for KRN5500 in 2013 once collaboration has been established.

In addition to seeking orphan designation, DARA has simplified the formulation
of KRN5500 to make it easier to administer at the bedside. Instead of
requiring a two-step mixing process, the new formulation is a solution that
can be added directly to an IV bag. DARA has filed new patents for this
formulation and has established a drug supply chain to support future clinical

“KRN5500 fits well within DARA’s portfolio of cancer support products,” Dr.
Drutz continued. “Cancer supportive care is an underserved area with unmet
medical needs, as CCIPN illustrates. DARA’s mission is to bring therapies to
oncology patients beyond those specifically directed to the treatment of their

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. In September 2012, DARA entered into an exclusive agreement
with the Helsinn Group of Switzerland for U.S. commercial rights to
Gelclair^®, an FDA-cleared product for the treatment of oral mucositis. DARA
plans to launch Gelclair in the first quarter of 2013.

Prior to acquiring Oncogenerix, DARA was focused on the development of a
cancer-support therapeutic compound, KRN5500, for the treatment of neuropathic
pain 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 is working
with the National Cancer Institute (NCI) to design an additional clinical
trial under joint DARA-NCI auspices while continuing further Phase 2
development. DARA has submitted an Orphan Drug Application to the FDA for

In addition to its oncology products, DARA’s 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.


Contact for DARA BioSciences, Inc.:
The Del Mar Consulting Group, Inc.
Robert B. Prag, 858-794-9500
Alex Partners, LLC
Scott Wilfong, 425-242-0891
Press spacebar to pause and continue. Press esc to stop.