TIDMCLIN
Clinigen Group plc
09 January 2017
9 January 2017
Clinigen and Cumberland Pharmaceuticals enter exclusive U.S.
commercialisation agreement for Totect(R)
Clinigen Group plc (AIM: CLIN, 'Clinigen'), the global
pharmaceutical and services company and Cumberland Pharmaceuticals
Inc. (NASDAQ: CPIX, 'Cumberland'), a U.S. specialty pharmaceutical
company announce an exclusive agreement to commercialise the
oncology support drug, Totect(R) (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(R) (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 commercialise its
existing dexrazoxane products, Savene(R) and Cardioxane(R), in
Europe and other territories outside of the U.S.
Shaun Chilton, Chief Executive Officer of Clinigen said:
"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."
A.J. Kazimi, Chief Executive Officer of Cumberland
Pharmaceuticals said:
"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. 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."
-Ends-
Contact Details
Clinigen Group plc Tel: +44 (0) 1283
495010
Shaun Chilton, Group Chief
Executive Officer
Martin Abell, Group Chief Financial
Officer
Tel: +44 (0) 20 7260
Numis Securities Limited 1000
Michael Meade / Freddie Barnfield
(Nominated Adviser)
James Black / Tom Ballard (Corporate
Broking)
Tel: +44 (0) 20 7418
Peel Hunt LLP - Joint Broker 8900
James Steel / Dr Christopher
Golden
Instinctif Partners (media Tel: +44 (0) 20 7457
- Clinigen) 2020
Melanie Toyne-Sewell / Jen
Lewis Email: clinigen@instinctif.com
Cumberland Pharmaceuticals
(Investor) Tel: +1 (615) 255-0068
Erin Smith, Corporate Relations
Lovell Communications (media
- Cumberland) Tel: +1 (615) 297-7766
Rebecca Kirkham
Notes to Editors
About Totect(R) (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 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.
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(R)
(acetylcysteine) Injection for the treatment of acetaminophen
poisoning, Caldolor(R) (ibuprofen) Injection, the first injectable
treatment for pain and fever approved in the United States,
Kristalose(R) (lactulose) for Oral Solution, a prescription
laxative, Vaprisol(R) (conivaptan) Injection, for the treatment of
hyponatremia, Omeclamox-Pak(R) for the treatment of H. pylori and
duodenal ulcer disease, and Ethyol(R) (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(R) (ifetroban) Injection for the treatment of
hepatorenal syndrome, Boxaban(R) (ifetroban) Oral Capsule for
patients suffering from aspirin exacerbated respiratory disease,
VasculanTM (ifetroban) Oral Capsule for the treatment of systemic
sclerosis and Portaban(TM) (ifetroban) Oral Capsule for the
treatment of portal hypertension.
For more information on Cumberland Pharmaceuticals Inc., please
visit 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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