TIDMCLIN
Clinigen Group plc
25 September 2017
RNS Reach
25 September 2017
Clinigen and Cumberland launch Totect(R) in the U.S. for
emergency oncology intervention
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the
global pharmaceutical and services company and Cumberland
Pharmaceuticals Inc. (NASDAQ: CPIX, 'Cumberland'), a U.S. specialty
pharmaceutical company, announced today the promotional launch of
Totect(R) (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 Totect's 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.
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(R) and Cardioxane(R), in Europe and other territories
outside of the U.S.
Simon Clayton, Commercial Director, Specialty Pharmaceuticals of
Clinigen said:
"The commercial launch of Totect in the U.S. is an important
milestone in the dexrazoxane revitalization strategy at Clinigen.
It will ensure that patients in the U.S. can access this vital
FDA-approved emergency support therapy."
A.J. Kazimi, Chief Executive Officer of Cumberland
Pharmaceuticals said:
"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."
-Ends-
Contact Details
Clinigen Group plc Tel: +44 (0) 1283 495010
--------------------------------------------- -------------------------------
Shaun Chilton, Group Chief Executive
Officer
Martin Abell, Group Chief Financial
Officer
Simon Clayton, Commercial Director,
Specialty Pharmaceuticals
--------------------------------------------- -------------------------------
Numis Securities Limited Tel: +44 (0) 20 7260 1000
--------------------------------------------- -------------------------------
Michael Meade / Freddie Barnfield (Nominated
Adviser)
James Black / Tom Ballard (Corporate
Broking)
--------------------------------------------- -------------------------------
RBC Capital Markets - Joint Broker Tel: +44 (0) 20 7653 4000
--------------------------------------------- -------------------------------
Marcus Jackson / Elliot Thomas / Jack
Wood
--------------------------------------------- -------------------------------
Instinctif Partners (Media Relations
- Clinigen) Tel: +44 (0) 20 7457 2020
--------------------------------------------- -------------------------------
Melanie Toyne-Sewell / Alex Shaw /
Deborah Bell Email: clinigen@instinctif.com
--------------------------------------------- -------------------------------
Cumberland Pharmaceuticals (Investor
Relations) Tel: +1 (615) 255-0068
--------------------------------------------- -------------------------------
Erin Smith, Corporate Relations
--------------------------------------------- -------------------------------
Lovell Communications (Media Relations
- Cumberland) Tel: +1 (615) 297-7766
--------------------------------------------- -------------------------------
Rebecca Kirkham
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Notes to Editors
About Totect(R) (dexrazoxane)
Totect is an anthracycline extravasation agent approved by the
U.S. 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 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.
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(R) (acetylcysteine) Injection, for the treatment of
acetaminophen poisoning;
-- Caldolor(R) (ibuprofen) Injection, for the treatment of pain and fever;
-- Kristalose(R) (lactulose) for Oral Solution, a prescription
laxative, for the treatment of chronic and acute constipation;
-- Omeclamox(R)-Pak, (omeprazole, clarithromycin, amoxicillin)
for the treatment of Helicobacter pylori (H. pylori) infection and
related duodenal ulcer disease;
-- Vaprisol(R) (conivaptan) Injection, to raise serum sodium
levels in hospitalized patients with euvolemic and hypervolemic
hyponatremia;
-- Ethyol(R) (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(R) (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(R) (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(R) (ifetroban) oral capsules, a Phase II candidate
for the treatment of asthma patients with aspirin-exacerbated
respiratory disease ("AERD");
-- Vasculan(TM) (ifetroban) oral capsules, a Phase II candidate
for the treatment of patients with the systemic sclerosis (SSc)
form of autoimmune disease;
-- Portaban(TM) (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.
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.
SOURCE: Cumberland Pharmaceuticals Inc.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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