Cumberland Pharmaceuticals and Phebra Pty Ltd. Sign Exclusive Agreement for Commercialization of Caldolor(R) in Australia and New Zealand

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Thu Oct 29, 2009 12:26pm EDT

Cumberland Pharmaceuticals and Phebra Pty Ltd. Sign Exclusive Agreement for
Commercialization of Caldolor(R) in Australia and New Zealand




Nashville, Tenn., Oct. 29 /PRNewswire-FirstCall/ -- Cumberland Pharmaceuticals
Inc. (Nasdaq: CPIX) and Phebra Pty Ltd., an Australian-based specialty
pharmaceutical company, today announced they have entered into an exclusive
partnership for the commercialization of Caldolor® (ibuprofen) Injection in
Australia and New Zealand. An intravenous formulation of ibuprofen, Caldolor
is designed to treat pain and fever in the hospital setting. Cumberland
Pharmaceuticals received U.S. Food and Drug Administration approval for
Caldolor in June 2009.

Under the terms of the agreement, Phebra assumes responsibility for obtaining
any regulatory approval for the product, and would then handle all ongoing
regulatory requirements, product marketing, distribution and sales in the
territories. Cumberland will maintain responsibility for product formulation,
development and manufacturing. In addition to upfront and milestone payments
as well as a transfer price, Cumberland will receive royalties on future sales
of Caldolor. 

"We are pleased to partner with Phebra to make Caldolor available in Australia
and New Zealand," said A.J. Kazimi, Chief Executive Officer of Cumberland
Pharmaceuticals. "Phebra shares our focus on providing innovative products
that improve quality of care for hospitalized patients and address unmet
medical needs. With their strong distribution network and success in marketing
hospital injectables, we believe there is significant opportunity for Caldolor
to fill an important need in these countries."

Used primarily in hospitalized patients who are unable to receive oral
therapies, Caldolor would be the first and only injectable ibuprofen product
available in Australia and New Zealand for the treatment of pain and fever,
featuring analgesic, antipyretic and anti-inflammatory properties. More than
10 million single dose units of injectable narcotic analgesics are sold into
the Australian market each year, as part of a combined injectable analgesic
market valued in excess of Au$32Million(1).

"We are delighted to partner with Cumberland to bring this important product
to a broader, global audience," said Dr. Mal Eutick, President and Chief
Executive Officer of Phebra. "Based on data resulting from clinical trials for
Caldolor, we believe there is great opportunity to promote widespread usage
throughout Australia and New Zealand." 

A recently published study in Volume 31, Number 9 of the peer-reviewed journal
Clinical Therapeutics, entitled "A Multicenter, Randomized, Double-Blind,
Placebo-Controlled Trial of Intravenous Ibuprofen for the Management of
Postoperative Pain in Adults," concluded that postoperative patients receiving
Caldolor required less narcotic and experienced less pain compared to patients
receiving morphine alone. The World Health Organization has recommended a
multi-modal approach to pain management, with non-opioid analgesics such as
ibuprofen recommended as first-line treatment(2).

About Caldolor 

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. 

About Cumberland Pharmaceuticals 

Cumberland Pharmaceuticals Inc. is a Tennessee-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 and Kristalose® (lactulose) for Oral Solution, a
prescription laxative. The Company also recently launched Caldolor®
(ibuprofen) Injection, the first injectable treatment for pain and fever
available in the United States. Cumberland is dedicated to providing
innovative products which improve quality of care for patients. The Company
completed the initial public offering of its common stock in August 2009. For
more information on Cumberland Pharmaceuticals, please visit
www.cumberlandpharma.com. 

About Phebra 

Phebra is an Australian based specialty pharmaceutical company that develops
and markets critical medicines in Australia, New Zealand, Asia, Canada and
parts of Europe. For more information about Phebra please refer to the company
website at www.phebra.com.

Important Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that reflect
Cumberland's and Phebra's current views with respect to future events, based
on what they believe are reasonable assumptions. No assurance can be given,
however, that these events will occur. As with any business, all phases of
operations are subject to influences outside of the companies' 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 Caldolor on a timely basis
or a failure of manufacturers to comply with stringent regulations applicable
to pharmaceutical drug manufacturers, maintaining and building an effective
sales and marketing infrastructure, government regulation, the possibility
that marketing exclusivity and patent rights may provide only limited
protection from competition, and other factors discussed in Cumberland's
Registration Statement declared effective by the SEC on August 10, 2009. 
There can be no assurance that the results or developments anticipated by
Cumberland and Phebra will be realized or, even if substantially realized,
that they will have the expected effects. Readers are cautioned not to place
undue reliance on these forward-looking statements, which speak only as of the
date hereof. Cumberland and Phebra undertake no obligation to release publicly
any revisions to these forward-looking statements to reflect events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events. 

References

(1) IMS API/AHI Combined Australian National Sales Audits, September 2009,
MAT. Injectable Narcotic Analgesics single dose units of injectable products
from: N02A - Narcotic Analgesics. Combined Injectable Analgesics Market is
total value of injectable products from: N02A - Narcotic Analgesics, N02B -
Non-Narcotic Analgesics, M01A - Anti-Rheumatics Non-Steroidal [Dynastat®
only].

(2) World Health Organization. Pain relief and palliative care. In: Clinical
Management of HIV and AIDS at District Level. New Delhi, India: WHO Regional
Office for South-East Asia Web site.
http://www.searo.who.int/linkfiles/publications_ch11.pdf.  Updated April 26,
2006.  Accessed July 15, 2009.



SOURCE  Cumberland Pharmaceuticals Inc.

Investors, Angela Novak of Cumberland Pharmaceuticals, +1-615-255-0068,
investors@cumberlandpharma.com; or Media, Paula Lovell of Lovell
Communications, +1-615-297-7766, lovell@lovell.com; or Eve Williamson of
Phebra Pty Ltd., +61 418-98-22-87
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