DARA BioSciences Observes National Neuropathy Awareness Week
Company Supports Awareness in Conjunction With North Carolina
Biosciences Organization and N.C. Gov. McCrory
RALEIGH, NC--(Marketwired -
May 15, 2014) - 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 its support for Neuropathy
Awareness Week which is being observed during the week of May 12,
2014 and sponsored in the U.S. by The Neuropathy Association
(www.neuropathy.org).
"We support The Neuropathy Association in its mission to help
and heal people with peripheral neuropathy," said David J. Drutz,
M.D., Chief Executive Officer and Chief Medical Officer of DARA
BioSciences. "As a member of The North Carolina Biosciences
Organization (NCBIO), which is the trade association for
North Carolina's life science community, we were able to
sponsor a proclamation in North Carolina in support of Neuropathy
Awareness Week signed by Governor Pat McCrory. We are proud to
support groups like the Neuropathy Association which provide
neuropathy awareness, education, support, advocacy and research to
the public and health care providers."
Peripheral neuropathy is a disorder of the peripheral nerves --
the motor, sensory and autonomic nerves that connect the spinal
cord to muscles, skin and internal organs. It usually affects
the hands and feet, causing weakness, numbness, tingling and
pain. Peripheral neuropathy's course is variable; it can come
and go, slowly progressing over many years, or it can become severe
and debilitating. However, if diagnosed early, peripheral
neuropathy can often be controlled.
Peripheral neuropathy is common. It is estimated that
upwards of 20 million Americans suffer from this illness. It can
occur at any age, but is more common among older adults.
Approximately 8 - 9 percent of Medicare recipients have peripheral
neuropathy as their primary or secondary diagnosis, according to a
1999 survey. The annual cost to Medicare exceeds $3.5
billion.
Peripheral neuropathy has always been present, but has not
received much attention. Its extent and importance have not yet
been adequately recognized. It is apt to be misdiagnosed, or
thought to be merely a side effect of another disease like diabetes
or cancer or kidney failure. The development of new therapies
has unfortunately been slow and underfunded.
Earlier this year, the U.S. Food and Drug Administration (FDA)
granted Orphan Drug Designation to DARA's KRN5500, a novel,
non-opioid, non-narcotic intravenous product currently in Phase 2
clinical development for the parenteral treatment of painful,
chronic, chemotherapy-induced peripheral neuropathy (CCIPN) that is
refractory to conventional analgesics.
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 both
Soltamox® (tamoxifen citrate) oral solution and
Gelclair®. 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%).
Soltamox® (tamoxifen citrate) oral solution, the only liquid
form of tamoxifen, is indicated for the treatment of metastatic
breast cancer, the adjuvant treatment of node-positive breast
cancer in postmenopausal women, the reduction in risk of invasive
breast cancer in women with ductal carcinoma in situ (DCIS), and
for the reduction of the incidence of breast cancer in women at
high risk for breast cancer. 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.
Tamoxifen Important
Safety Information
Tamoxifen citrate is contraindicated in women who require
concomitant coumadin-type anticoagulant therapy, in women with a
history of deep vein thrombosis or pulmonary embolus, and in women
with known hypersensitivity to the drug or any of its
ingredients.
Serious and life-threatening events associated with tamoxifen in
the risk reduction setting (women at high risk for cancer and women
with DCIS) include uterine malignancies, stroke and pulmonary
embolism.
The most common adverse reactions to tamoxifen treatment are
(incidence > 20%)
hot flashes, fluid retention, vaginal discharge, vaginal bleeding,
vasodilatation, nausea, irregular menses, weight loss, and
musculoskeletal events.
Tamoxifen carries the following Boxed Warning:
WARNING -- For Women with Ductal Carcinoma in Situ (DCIS) and
Women at High Risk for Breast Cancer: Serious and
life-threatening events associated with tamoxifen in the risk
reduction setting (women at high risk for cancer and women with
DCIS) include uterine malignancies, stroke and pulmonary embolism.
Incidence rates for these events were estimated from the NSABP P-1
trial (see CLINICAL PHARMACOLOGY, Clinical Studies, Reduction in
Breast Cancer Incidence In High Risk Women). Uterine
malignancies consist of both endometrial adenocarcinoma (incidence
rate per 1,000 women-years of 2.20 for tamoxifen vs. 0.71 for
placebo) and uterine sarcoma (incidence rate per 1,000 women-years
of 0.17 for tamoxifen vs. 0.0 for placebo)*. For stroke, the
incidence rate per 1,000 women-years was 1.43 for tamoxifen vs.
1.00 for placebo**. For pulmonary embolism, the incidence rate
per 1,000 women-years was 0.75 for tamoxifen versus 0.25 for
placebo**. Some of the strokes, pulmonary emboli, and uterine
malignancies were fatal. Health care providers should discuss
the potential benefits versus the potential risks of these serious
events with women at high risk of breast cancer and women with DCIS
considering tamoxifen to reduce their risk of developing breast
cancer. The benefits of tamoxifen outweigh its risks in women
already diagnosed with breast cancer.
*Updated long-term follow-up data (median length of follow-up is
6.9 years) from NSABP P-1 study. See WARNINGS, Effects on the
Uterus-Endometrial Cancer and Uterine Sarcoma in Prescribing
Information. **See Table 3 under CLINICAL PHARMACOLOGY, Clinical
Studies in Prescribing Information.
The full Prescribing Information for Soltamox is available at
www.soltamox.com/prescribing-information.
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. Gelclair
should not be used by patients with a known or suspected
hypersensitivity to the product or any of its
ingredients. 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. Bionect should not be used by patients with known
hypersensitivity to any of its ingredients. 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 has granted DARA Orphan Drug Designation for the treatment of
painful, chronic chemotherapy-induced peripheral neuropathy that is
refractory to conventional analgesics (CCIPN).
In early 2014, DARA kicked 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,
Gelclair and Bionect, this specialized oncology supportive care
sales team also provides 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).
Important Safety Information and full Prescribing Information
for Mission Pharmacal's products may be found at: www.Ferralet.com,
www.Binosto.com, and www.Aquoral.com.
For more information please visit our web site at
www.darabio.com.
Forward-Looking Statements
All statements in this press release that are not historical are
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, and are subject to risks
and uncertainties. Forward-looking statements are based on the
current expectations, estimates, forecasts and projections
regarding management's beliefs and assumptions. In some cases, you
can identify forward looking statements by terminology such as
"may," "will," "should," "hope," "expects," "intends," "plans,"
"anticipates," "contemplates," "believes," "estimates," "predicts,"
"projects," "potential," "continue," and other similar terminology
or the negatives of those terms. Such forward-looking statements
are subject 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 February 4, 2014, 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,
DARA's ability to raise sufficient capital and on favorable terms
and the stockholder dilution that may result therefrom, 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, 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.
All forward-looking statements are expressly qualified in their
entirety by this cautionary notice. You are cautioned not to place
undue reliance on any forward-looking statements, which speak only
as of the date of this release. We have no obligation, and
expressly disclaim any obligation, to update, revise or correct any
of the forward-looking statements, whether as a result of new
information, future events or otherwise.
Media Contact: David
ConnollyLaVoieHealthSciences617-374-8800, Ext.
108dconnolly@lavoiegroup.comCorporate Contact:Jim PolsonFTI
Consulting312 553 6730Jim.polson@fticonsulting.com
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