DARA BioSciences Establishes Vertically Integrated Commercial Platform for Specialty Oncology Care and Support Products
September 25 2012 - 7:00AM
Business Wire
DARA BioSciences, Inc. (NASDAQ: DARA), a specialty
pharmaceutical company focused on oncology and oncology support
products, announced today it has a completed 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.
DARA believes these agreements provide the company comprehensive
commercial coverage across the national oncology market.
As part of an integrated national network with annual sales of
over $1 billion in cancer therapeutics, DARA has significantly
enhanced its commercial scale and capabilities. Its distribution
network now consists of more than 45,000 retail pharmacies, mail
order pharmacies, and long-term care facilities. This network
provides DARA with established reimbursement and logistics
expertise, with more than 300 sales and marketing personnel
uniquely focused on oncology and oncology support products, and
further provides the company with additional partnering
opportunities.
DARA’s vertically integrated platform is headed by a team of
five U.S. regional business directors who will coordinate and
execute the commercialization of DARA’s growing suite of products.
Each director has more than 20 years of commercial experience, as
well as extensive expertise in product launches and niche product
marketing.
“Our goal is to become a leading oncology and oncology
supportive care company in the United States,” said David J. Drutz,
MD, DARA’s chief executive officer. “These partnerships represent
an important step toward that goal. The relationships we’ve
developed across commercial players provide benefits to DARA,
healthcare providers, patients, and caregivers alike. We have a
broad platform from which to educate people about our products and
their value. Through our specialty pharmaceutical relationships, we
have the ability to create a strong presence in all oncology market
segments. We provide flexibility to patients who receive
prescription medicine through mail order or retail pharmacies, as
well as make available to them financial support. Most importantly
we are establishing DARA as a long-term, committed player in
oncology and oncology supportive care.”
DARA’s robust platform supports the synergy within the company’s
portfolio, which includes commercial products that target
oncology-related skin damage, mouth and throat ulcers, in addition
to direct cancer treatments and a developmental compound that
targets neuropathic pain. This comprehensive network of partners is
rare among companies in the oncology supportive care area and
provides DARA a strong foundation for product introductions into
this underserved market.
DARA’s next launch will be Soltamox®, the first and only FDA
approved liquid form of tamoxifen citrate, which DARA expects to
launch in October to coincide with National Breast Cancer Awareness
Month. Following Soltamox, Gelclair® an oral mucositis treatment is
planned for launch in the first quarter of next year. The company
is currently marketing Bionect®, a treatment for skin irritation
and burns caused by radiation cancer therapy.
About DARA BioSciences,
Inc.
DARA is a specialty pharmaceutical company focused on the
development and commercialization of oncology treatment and
supportive care products. 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. Additionally, in
June 2012, DARA launched its first product, Bionect®, a topical
treatment for skin irritation and burns associated with radiation
therapy. Most recently, 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 study, and has been
designated as a Fast Track Drug by the United States Food and Drug
Administration. 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.
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 I 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.
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