NASHVILLE, Tenn., Jan. 9, 2017 /PRNewswire/ -- Cumberland
Pharmaceuticals Inc. (NASDAQ: CPIX), a U.S. specialty
pharmaceutical company and Clinigen Group plc (AIM: CLIN,
'Clinigen'), the global pharmaceutical and services company,
announce an exclusive agreement to commercialize the oncology
support drug, Totect® (dexrazoxane hydrochloride) in the
U.S.
This is the second product Clinigen has licensed to Cumberland under the strategic alliance
established in 2015, following the launch of Ethyol®
(amifostine) in the U.S. in September
2016.
Totect is an FDA-approved emergency oncology intervention, which
is indicated to reverse the toxic effects of anthracycline
chemotherapy in case of extravasation. Extravasation occurs when an
injected medicine escapes from the blood vessels and circulates
into surrounding tissues in the body causing severe damage and
serious complications. Totect can reverse such damage without the
need for additional surgeries and procedures, enabling patients to
continue their essential anti-cancer treatment.
Under the terms of the agreement, Cumberland has been granted an exclusive U.S.
license and will manage all marketing, promotion, and distribution
of Totect in the U.S. Clinigen will retain responsibility for
manufacturing, regulatory and clinical management of the product.
Preparations are now underway for the U.S. launch of Totect later
this year.
Totect was acquired by Clinigen's Specialty Pharmaceuticals (SP)
division in 2016 to expand its dexrazoxane portfolio and enter the
U.S. market. Clinigen SP will continue to commercialize its
existing dexrazoxane products, Savene® and
Cardioxane®, in Europe
and other territories outside of the U.S.
"It's good to see another product emerge from our strategic
partnership with Clinigen as we continue to selectively expand our
line of marketed hospital brands," said A.J. Kazimi, Chief Executive Officer of
Cumberland Pharmaceuticals. "We are keen to help yet another group
of oncology patients with Totect, which reflects our mission of
delivering products that help improve patients' quality of
care."
Shaun Chilton, Chief Executive
Officer of Clinigen Group, added, "This agreement marks an
important milestone for Clinigen. Totect is the second Specialty
Pharmaceuticals product that we have exclusively licensed to
Cumberland as part of the
strategic alliance signed in 2015. Cumberland is a valuable partner, providing us
with the opportunity to expand our dexrazoxane portfolio into the
sizable U.S. market and enabling patients to access this vital
FDA-approved emergency support therapy."
About Totect® (dexrazoxane)
Totect is an anthracycline extravasation agent approved by the
United States Food and Drug Administration. Anthracyclines are used
to treat many types of cancer and are among the most common cancer
therapies.
Anthracycline extravasation occurs when there is accidental
leaking of the intravenously-administered medication into the
surrounding tissues. Anthracycline extravasation can result
in serious complications for cancer patients including tissue
necrosis with skin ulceration. In addition to tissue damage, an
anthracycline extravasation may cause damage to the nerves,
tendons, muscle and joints.
About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical
company focused on acquisition, development, and commercialization
of high-quality products that improve the quality of care for
patients. The Company has a diverse product portfolio with a focus
in the areas of hospital acute care and gastroenterology.
Cumberland's marketed products
include Acetadote® (acetylcysteine) Injection for
the treatment of acetaminophen poisoning, Caldolor®
(ibuprofen) Injection, the first injectable treatment for
pain and fever approved in the United
States, Kristalose® (lactulose) for Oral
Solution, a prescription laxative, Vaprisol®
(conivaptan) Injection, for the treatment of hyponatremia,
Omeclamox-Pak® for the treatment of H. pylori and
duodenal ulcer disease, and Ethyol® (amifostine) for
Injection, for the prevention of treatment related adverse
reactions in oncology patients. Cumberland is also dedicated to developing
innovative products that address unmet medical needs.
The Company's product candidates in clinical development
include: Hepatoren® (ifetroban) Injection for the
treatment of hepatorenal syndrome, Boxaban®
(ifetroban) Oral Capsule for patients suffering from aspirin
exacerbated respiratory disease, VasculanTM (ifetroban) Oral
Capsule for the treatment of systemic sclerosis and Portaban™
(ifetroban) Oral Capsule for the treatment of portal
hypertension.
For more information on Cumberland Pharmaceuticals Inc., please
visit www.cumberlandpharma.com.
About Clinigen Group
Clinigen Group plc (AIM: CLIN) is a global pharmaceutical and
services company with a unique combination of businesses focused on
providing access to medicines. Its mission is to deliver the right
medicine to the right patient at the right time. The Group consists
of five synergistic businesses focused in three areas of global
medicine supply; clinical trial, unlicensed and licensed
medicines.
Clinigen Clinical Trial Services is the global market leader in
the management and supply of commercial medicines for clinical
trials.
The Group is also the trusted global leader in ethically
sourcing and supplying unlicensed medicines to hospital pharmacists
and physicians for patients with a high unmet need, through three
of its divisions: Idis Managed Access runs early access programs
for innovative new medicines. Idis Global Access and Link
Healthcare work directly with healthcare professionals to enable
compliant access to unlicensed medicines on a global basis and
niche essential licensed and generic medicines across Australasia,
Africa and Asia (AAA region).
Clinigen Specialty Pharmaceuticals acquires global rights,
revitalises and markets its own portfolio of niche hospital
commercial products.
For more information, please visit www.clinigengroup.com.
Forward-Looking Statements
This press release contains forward-looking statements, which
are subject to certain risks and reflect Cumberland's current views on 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 Cumberland's
operations are subject to factors outside of its control, and any
one or combination of these factors could materially affect
Cumberland's results of
operations.
These factors include market conditions, competition, an
inability of manufacturers to produce Cumberland's products on a timely basis or
failure of manufacturers to comply with regulations applicable to
pharmaceutical manufacturers, maintaining an effective sales and
marketing infrastructure and other factors discussed in the
Company's most recent Form 10-K and subsequent 10-Q's as filed with
the SEC. There can be no assurance that results anticipated by the
Company will be realized or 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.
The Company does not undertake any obligation to publicly revise
these statements to reflect events after the date hereof.
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SOURCE Cumberland Pharmaceuticals Inc.