DARA BioSciences' KRN5500 Granted Orphan Drug Designation by FDA
for Treatment of Multiple Myeloma
Second Orphan Drug Designation Received in 2014 for Key
Development Asset
RALEIGH, NC--(Marketwired -
June 16, 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, today announced the U.S. Food and
Drug Administration (FDA) has granted Orphan Drug Designation to
the experimental compound KRN5500 for the treatment of multiple
myeloma.
KRN5500 is a novel, intravenous, non-opioid, non-narcotic
compound currently in Phase 2 clinical development. Earlier this
year, KRN5500 received orphan status to be developed for the
parenteral treatment of painful, chronic, chemotherapy-induced
peripheral neuropathy (CCIPN) that is refractory to conventional
analgesics in patients with cancer. In 2011, the FDA designated
KRN5500 as a Fast Track program which expedites the development
pathway and consideration for priority review. Orphan Drug
Designation provides DARA with seven years market exclusivity from
the time of approval, tax credits, and the waiver of PDUFA filing
fees, as well as access to federal grants.
"This second orphan drug designation for our key development
asset KRN5500 allows us to approach the actual treatment of
multiple myeloma, whereas the CCIPN designation is specific to
neuropathy. It is noteworthy in this regard that up to 20% of
myeloma patients have intrinsic peripheral neuropathy, an incidence
that increases to the range of 75% in patients treated with
neurotoxic drugs such as thalidomide or bortezomib. We believe this
myeloma-specific orphan designation enhances both the viability and
the future market opportunity for this valuable pipeline product,"
said David J. Drutz, M.D., Chief Executive Officer and Chief
Medical Officer of DARA BioSciences.
The favorable consideration of myeloma as an orphan indication
for KRN5500 was supported by a comprehensive publication in 2012 by
an independent group of academic investigators, which demonstrated
its therapeutic potential in both in vitro and in
vivo experiments in which KRN5500, a spicamycin derivative,
exhibited anti-myeloma effects through impairing both myeloma cells
and osteoclasts.
Dr. Drutz continued, "We greatly appreciate the expeditious
review and approval of this additional KRN5500 orphan designation
application by the FDA's Office of Orphan Product Development,
which provides an important step towards the potential treatment of
multiple myeloma and one of its major complications. This second
orphan drug designation underscores the value of this asset and
strengthens DARA's resolve and positioning in the ongoing pursuit
of partnering opportunities to assist in funding the clinical
advancement and development pathway of KRN5500."
Multiple myeloma is a hematologic cancer (or cancer of the
blood) and the second most common blood cancer after non-Hodgkin's
lymphoma. The American Cancer Society estimates that more than
24,000 new cases of the disease will be diagnosed in 2014. The FDA
grants orphan drug designation to therapeutics intended to treat
diseases that affect fewer than 200,000 people in the United
States.
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 two separate Orphan Drug Designations for the
treatment of multiple myeloma and 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.
Safe Harbor Statement
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
realize the desired benefits of Orphan Drug Designation and Fast
Track designation for KRN5500, 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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