Cumberland Pharmaceuticals Licenses Caldolor® (ibuprofen) Injection To Sandor
Medicaids Pvt. Ltd. For Commercialization In India
NASHVILLE, Tenn., Feb. 21, 2013
NASHVILLE, Tenn., Feb. 21, 2013 /PRNewswire/ --Cumberland Pharmaceuticals
Inc. (NASDAQ: CPIX) today announced that it has entered into an exclusive
agreement with Sandor Medicaids Pvt. Ltd., an India-based pharmaceutical
company, for the commercialization of Caldolor^® (ibuprofen) Injection in
Under the terms of the agreement, Sandor Medicaids Pvt. Ltd. is responsible
for seeking regulatory approval for Caldolor and, following approval, would
handle ongoing distribution and sales in the territory. Cumberland maintains
responsibility for product formulation, development and manufacturing, and
will provide finished product for sale. In exchange for the license to the
product, Cumberland will receive upfront and milestone payments, a transfer
price and royalties on future sales of Caldolor.
"We believe Caldolor can fill an unmet need in the hospital market in India,
and look forward to communicating its benefits to the medical community here,"
said Rajeev Sindhi, Managing Director for Sandor Medicaids Pvt. Ltd.
"Cumberland's strong clinical data and profile for use of the product should
help facilitate regulatory approval and encourage widespread hospital use in
Used primarily in hospitalized patients who are unable to receive oral
therapies, Caldolor is expected to be the first and only injectable ibuprofen
product available in India for the treatment of pain and fever, featuring
analgesic, antipyretic and anti-inflammatory properties.
"We are very pleased to expand our network of international partners for
Caldolor with this new agreement," said A.J. Kazimi, Chief Executive Officer
of Cumberland Pharmaceuticals. "Sandor has an established infrastructure to
handle commercialization of hospital pharmaceutical products, and we look
forward to working with them to make Caldolor available to a larger population
Caldolor is indicated for the management of mild to moderate pain and
management of moderate to severe pain as an adjunct to opioid analgesics, and
for the reduction of fever in adults. It is the first FDA approved intravenous
therapy for fever. Caldolor is contraindicated in patients with known
hypersensitivity to ibuprofen or other NSAIDs, patients with asthma,
urticaria, or allergic type reactions after taking aspirin or other NSAIDs.
Caldolor is contraindicated for use during the peri-operative period in the
setting of coronary artery bypass graft (CABG) surgery. Caldolor should be
used with caution in patients with prior history of ulcer disease or GI
bleeding, in patients with fluid retention or heart failure, in the elderly,
those with renal impairment, heart failure, liver impairment, and those taking
diuretics or ACE inhibitors. Blood pressure should be monitored during
treatment with Caldolor. For full prescribing information, including boxed
warning, visit www.caldolor.com.
Sandor Medicaids Pvt. Ltd is a medical and drug distribution firm. Since its
establishment in 1995 at Hyderabad, the company focuses on providing high
technology biomedical and biotechnology products to the Indian patient. Sandor
is recognized as a pioneer in bringing in"Point of Care" concept in the Indian
Health Care Industry. Sandor's marketing and distribution team is comprised
of experienced professionals from the Health Care Industry across the country.
They ensure the products of our partners reach the customers at the Right
Time, to the Right Place, in the Right form and for the Right Price.
A sub-network of 15 distribution centers ably supports Sandor's existing
efficient and effective COLD CHAIN DISTRIBUTION network in the 16 major cities
of the country. The entire network is centrally monitored from the Sandor Head
Office at Hyderabad Sandor offers a complete range of Logistics & Distribution
management, Regulatory services to manufactures in specialty drugs, medical
devices and hospital supplies industries.
Cumberland Pharmaceuticals Inc.is aTennessee-based specialty pharmaceutical
company focused on the acquisition, development and commercialization of
branded prescription products. The Company's primary target markets include
hospital acute care and gastroenterology.Cumberland's product portfolio
includes Acetadote^® (acetylcysteine) Injection for the treatment of
acetaminophen poisoning; Caldolor^® (ibuprofen) Injection, the first
injectable treatment for pain and fever available inthe United States; and
Kristalose^® (lactulose) for Oral Solution, a prescription
laxative.Cumberlandis dedicated to providing innovative products which
improve quality of care for patients. For more information, please visit the
company website atwww.cumberlandpharma.com.
Important Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that
reflectCumberland's current views with respect to future events, based on
what it believes are reasonable assumptions. No assurance can be given that
these events will occur. As with any business, all phases of operations are
subject to influences outside of the Company's control. Risk factors that
could materially affect results of operations include, among other things,
market conditions, intense competition from existing and new products, an
inability of manufacturers to produce Acetadote on a timely basis or a failure
of manufacturers to comply with stringent regulations applicable to drug
manufacturers, maintaining and building an effective sales and marketing
infrastructure, government regulation, the possibility that patent rights may
provide only limited protection from competition, and other factors related to
the Company including those under the headings "Risk factors" and
"Management's discussion and analysis of financial condition and results of
operations" inCumberland's Form 10-K filed with theSEConMarch 7, 2012.
There can be no assurance that the results or developments anticipated
byCumberlandwill be realized or, if realized, that they will have the
expected effects. Readers are cautioned not to place undue reliance on
forward-looking statements, which speak only as of the date
hereof.Cumberlandundertakes no obligation to release publicly any revisions
to these statements to reflect events or circumstances after the date hereof.
SOURCE Cumberland Pharmaceuticals Inc.
Contact: Elizabeth Davis, Investors, Cumberland Pharmaceuticals,
+1-615-255-0068, firstname.lastname@example.org, or Rebecca Kirkham, Media,
Lovell Communications, +1-615-297-7766, email@example.com
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