NASHVILLE, Tenn. and
BURTON ON TRENT, England,
Sept. 25, 2017 /PRNewswire/
-- Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX,
'Cumberland') and Clinigen Group
plc (AIM:CLIN, 'Clinigen'), announced today the promotional
launch of Totect® (dexrazoxane hydrochloride), in the
U.S.
Totect is an FDA-approved hospital based emergency oncology
intervention drug, indicated to treat 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 limit such damage
without the need for additional surgeries and procedures and enable
patients to continue their essential anti-cancer treatment.
In preparation for the Totect launch, Cumberland has completed the training of its
sales and medical organization, stocked the product at wholesalers
serving hospitals nationwide, and recently introduced the product
website. Totect will be supported by Cumberland's hospital sales force.
"This is a significant next step for Cumberland as we build our position in
oncology supportive care while improving the quality of care for
patients in the U.S.," said A.J.
Kazimi, Chief Executive Officer of Cumberland
Pharmaceuticals.
Totect is Cumberland's second
oncology support product and complements its current portfolio of
specialty pharmaceuticals. Cumberland entered into an exclusive agreement
with Clinigen to commercialize Totect in the U.S. earlier this
year. Cumberland is managing all
marketing, promotion, and distribution of the product in the
U.S. Clinigen is responsible for manufacturing, regulatory, and
clinical management of the product.
Totect was acquired by Clinigen in March
2016 to expand its dexrazoxane portfolio and enter the U.S.
market. Clinigen will continue to commercialize its existing
dexrazoxane products, Savene® and
Cardioxane®, in Europe
and other territories outside of the U.S.
"The commercial launch of Totect in the U.S. is an important
milestone in the dexrazoxane revitalization strategy at Clinigen,"
said Simon Clayton, Commercial
Director, Specialty Pharmaceuticals Clinigen Group. "It will ensure
that patients in the U.S. can access this vital FDA-approved
emergency support therapy."
Notes to Editors
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.
For more information please visit www.totect.com.
About Cumberland Pharmaceuticals
Cumberland
Pharmaceuticals Inc. is a specialty pharmaceutical company
focused on the delivery of high-quality prescription brands to
improve patient care. The Company develops, acquires, and
commercializes brands for the hospital acute care,
gastroenterology, and oncology market segments.
The Company's portfolio of FDA approved brands includes:
- Acetadote® (acetylcysteine) Injection,
for the treatment of acetaminophen poisoning;
- Caldolor® (ibuprofen) Injection, for
the treatment of pain and fever;
- Kristalose® (lactulose) for Oral
Solution, a prescription laxative, for the treatment of chronic and
acute constipation;
- Omeclamox®-Pak, (omeprazole,
clarithromycin, amoxicillin) for the treatment of Helicobacter
pylori (H. pylori) infection and related duodenal ulcer
disease;
- Vaprisol® (conivaptan) Injection, to
raise serum sodium levels in hospitalized patients with euvolemic
and hypervolemic hyponatremia;
- Ethyol® (amifostine) Injection, for
the reduction of xerostomia (dry mouth) in patients undergoing
post-operative radiation treatment for head and neck cancer and the
renal toxicity associated with the administration of cisplatin in
patients with advanced ovarian cancer;
- Totect® (dexrazoxane hydrochloride)
Injection, for emergency oncology intervention, to treat the toxic
effects of anthracycline chemotherapy in case of extravasation
(drug leakage from the bloodstream into the tissues).
Cumberland's pipeline of
product candidates includes:
- Hepatoren® (ifetroban) Injection, a
Phase II candidate for the treatment of critically ill patients
suffering from liver and kidney failure associated with hepatorenal
syndrome ("HRS");
- Boxaban® (ifetroban) oral capsules, a
Phase II candidate for the treatment of asthma patients with
aspirin-exacerbated respiratory disease ("AERD");
- Vasculan™ (ifetroban) oral capsules, a Phase II
candidate for the treatment of patients with the systemic sclerosis
(SSc) form of autoimmune disease;
- Portaban™ (ifetroban) oral formulation, a Phase
II candidate for the treatment of patients with portal hypertension
associated with liver disease;
- Methotrexate (methotrexate) Injection, an
approval submission candidate for the treatment of active
rheumatoid, juvenile idiopathic and severe psoriatic arthritis, as
well as severe disabling psoriasis.
For more information on Cumberland's approved products, including full
prescribing information, please visit the individual product
websites, links to which can be found on the Company's website
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 through three areas
of global medicine supply; clinical trial, unlicensed and licensed
medicines.
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.