Microsoft word - acetadote approved for marketing in australia 5-11-10.doc
FOR IMMEDIATE DISTRIBUTION
ACETADOTE® APPROVED IN AUSTRALIA FOR TREATMENT
OF ACETAMINOPHEN POISONING
Cumberland Pharmaceuticals partnering with Phebra Pty Ltd.
for Australian marketing and distribution
NASHVILLE, Tenn., (May 11, 2010) – Cumberland Pharmaceuticals Inc. (Nasdaq:CPIX) and
Phebra Pty Ltd.
today announced that Acetadote (acetylcysteine
) Injection has been granted
regulatory approval for marketing and sale in Australia. Acetadote, an injectable drug used to treat
acetaminophen (paracetamol) overdose, was approved by the Therapeutic Goods Administration
(TGA), the government agency responsible for regulating drugs and medical devices in Australia.
U.S.-based Cumberland Pharmaceuticals has granted an exclusive license to Phebra Pty Ltd., an
Australian-based specialty pharmaceutical company, for commercialization of Acetadote in
Australia. Phebra is now preparing for the Australian launch of the product, which it expects to
commence in the coming weeks.
“We are delighted to obtain TGA approval for Acetadote and to make this product available to
Australian hospitals,” said Dr. Mal Eutick, President and Chief Executive Officer of Phebra. “We
believe that using Acetadote to treat paracetamol poisoning offers a significant clinical benefit for
patients and their caregivers in comparison to alternative courses of treatment, and look forward to
communicating the product’s benefits to the Australian medical community.”
Acetadote is used in hospital emergency departments to prevent or lessen potential liver damage
resulting from an overdose of acetaminophen, a common ingredient in many over-the-counter pain
relief and fever reducing products. Since Cumberland Pharmaceuticals’ U.S. introduction of the
product in 2004, Acetadote has become a standard of care for treating acetaminophen poisoning.
Under their agreement, Phebra is responsible for ongoing regulatory requirements, marketing,
distribution and sales of Acetadote in Australia, New Zealand and the Asia Pacific while
Cumberland maintains responsibility for product formulation, development and manufacturing. In
exchange for the product license, Cumberland receives upfront and milestone payments, a transfer
price and royalties on future sales.
“Cumberland looks forward to working with Phebra to leverage their established distribution
network and hospital marketing experience to make this life-saving drug available to a broader
audience,” said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. “We believe
Acetadote will provide an important treatment alternative for patients in the Australian market.”
SOURCE: Cumberland Pharmaceuticals Inc.
Acetadote® Approved in Australia for Treatment of Acetaminophen Poisoning
) Injection is used in the emergency department to prevent or lessen
potential liver damage resulting from an overdose of acetaminophen (paracetamol), a common
ingredient in many over-the-counter painkillers. It is the only approved injectable product in the
United States for the treatment of acetaminophen overdose. Acetadote is contraindicated in patients
with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of
the preparation. Serious anaphylactoid reactions, including death in a patient with asthma, have
been reported in patients administered acetylcysteine intravenously. Acetadote should be used with
caution in patients with asthma, or where there is a history of bronchospasm. The total volume
administered should be adjusted for patients weighing less than 40 kg and for those requiring fluid
restriction. To avoid fluid overload, the volume of diluent should be reduced as needed. If volume is
not adjusted, fluid overload can occur, potentially resulting in hyponatremia, seizure, and death.
For full prescribing information, visit www.acetadote.net.
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, Caldolor® (ibuprofen
) Injection, the first injectable treatment for pain and fever available
in the United States, and Kristalose® (lactulose
) for Oral Solution, a prescription laxative.
Cumberland is dedicated to providing innovative products which improve quality of care for
patients. For more information on Cumberland Pharmaceuticals, please visit the company website at
Phebra Pty Ltd. 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 Acetadote 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 related to the companies,
including those set forth under the headings "Risk factors" and "Management's discussion and
analysis of financial condition and results of operations" in Cumberland’s Form 10-K filed with the
Acetadote® Approved in Australia for Treatment of Acetaminophen Poisoning
SEC on March 19, 2010. 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.
615-255-0068 [email protected] Media:
615-297-7766 [email protected] Phebra Contact
Phebra Pty Ltd
+61 418-98-22-87 [email protected]
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