DARA BioSciences Enters Into Distribution Agreement for Gelclair(R) and
Soltamox(R) With Prime Therapeutics Specialty Pharmacy
Collaboration Supports DARA's Corporate Strategy and Expands the
Commercial Potential for DARA's Two Lead Products
RALEIGH, NC -- (Marketwired) -- 04/03/13 -- DARA BioSciences, Inc.
(NASDAQ: DARA), a specialty pharmaceutical company focused on
oncology and oncology supportive care products, announced today that
it has signed an agreement with Prime Therapeutics Specialty Pharmacy
LLC for distribution of its two lead proprietary products, GelclairÂ®
(oral bioadhesive gel) for patients with oral mucositis and SoltamoxÂ®
(tamoxifen citrate) oral solution to treat breast cancer patients.
Based in Orlando, Fla., Prime Therapeutics Specialty Pharmacy LLC is
a wholly owned subsidiary of Prime Therapeutics LLC, a pharmacy
benefit manager (PBM) serving nearly 20 million people. Prime
Therapeutics is collectively owned by 13 Blue Cross and Blue Shield
Plans, subsidiaries or affiliates of these plans.
Prime Therapeutics Specialty Pharmacy delivers medication to members
and provides ongoing support through member education and guidance
from experienced pharmacists and nurses to help manage the specialty
condition and the pharmacy benefits.
"We are excited to work with DARA to be a preferred pharmacy for
distribution of Gelclair," said Rachelle Wan, vice president of
specialty solutions at Prime Therapeutics. "Both Gelclair and
Soltamox help cancer patients better adhere to their prescribed
medications and improve tolerance to therapy, all helping to continue
uninterrupted cancer treatment."
DARA's chief executive officer and chief medical officer, David J.
Drutz, MD stated, "Working in partnership with a premier supplier of
health care services such as Prime Therapeutics Specialty Pharmacy is
a significant opportunity to provide education to and raise awareness
with appropriate patients managed by Prime's pharmacy, as well as
provide availability and accessibility to the unique supportive care
opportunities offered by both Soltamox and Gelclair." Drutz
continued, "Our goal is to ensure we reach patients that could
benefit from our products, and we are convinced our strategic
collaboration with Prime Therapeutics Specialty Pharmacy is an
important step in achieving this mission."
DARA intends to introduce Gelclair to the market in April 2013.
Gelclair provides oral mucositis patients rapid and effective relief
of pain. Oral mucositis (OM) is common in cancer patient undergoing
chemotherapy or radiation therapy. Oral mucositis occurs when the
protective oral mucosa is denuded, which may result in pain,
infection, weight loss, decreased quality of life, treatment delay
and increased economic costs.
Soltamox was launched at the end of 2012 and is the only FDA-approved
tamoxifen citrate oral solution, fulfilling a vital clinical need for
patients who either cannot tolerate existing solid tablet
formulations of this drug or prefer liquid medications to help with
daily compliance with long-term therapy.
About Prime Therapeutics Specialty Pharmacy
Prime Therapeutics Specialty Pharmacy LLC is dedicated to making it
easier for members to obtain specialty medicines and manage complex
conditions. The company offers a full suite of specialty pharmacy
services, from care management to insurance billing to delivery of
specialty medicines. Based in Orlando, Fla., Prime Therapeutics
Specialty Pharmacy LLC is wholly owned by Prime Therapeutics LLC.
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 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 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, 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. DARA also has exclusive U.S. commercial rights to
GelclairÂ®, an FDA-cleared product for the treatment of oral
mucositis, which DARA plans to launch 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, 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
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
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 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.
Investor Relations + Corporate Communications Advisor
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