NASHVILLE, Tenn. and
BEDMINSTER, N.J., Jan. 4, 2022 /PRNewswire/ -- Cumberland
Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical
company, announced today that it has entered into and closed
on a definitive agreement to acquire the FDA-approved
oncology-supportive care medicine SANCUSO®
(granisetron transdermal patch), from Kyowa Kirin,
Inc. the U.S. affiliate of Japan-based Kyowa Kirin Co., Ltd. (Kyowa
Kirin, TSE: 4151), a global specialty pharmaceutical company
focused on discovering and delivering novel medicines.
SANCUSO is the first and only FDA-approved prescription patch
for the prevention of nausea and vomiting in patients receiving
certain types of chemotherapy treatment. The active drug in
SANCUSO, granisetron, slowly dissolves in the thin layer of
adhesive that sticks to the patient's skin and is released into
their bloodstream over several days, working continuously to
prevent chemotherapy-induced nausea and vomiting (CINV). It is
applied 24 to 48 hours before receiving chemotherapy and can
prevent CINV for up to five consecutive days. Alternative oral
treatments must be taken several times (day and night) to deliver
the same therapeutic doses.
"In 2020 there were nearly two million new cases of cancer in
the U.S. and each year over half a million Americans undergo
chemotherapy, with many suffering from the side effects of their
treatment. With SANCUSO, patients are given a simple, easy-to-apply
preventative solution that doesn't require swallowing any pills –
which can be difficult for patients experiencing nausea," said A.J.
Kazimi, chief executive officer at Cumberland Pharmaceuticals. "We
are honored to take responsibility for the brand and introduce it
through our commercial organization, ensuring that it is delivered
to the patients who need it."
Under the terms of the agreement, Cumberland will acquire U.S. rights to SANCUSO
and will assume full commercial responsibility for the product –
including its marketing, promotion, distribution, manufacturing and
medical support activities. Net sales of the brand in the U.S. were
over $14 million in 2020. The financial terms of the
acquisition include a $13.5 million
payment to Kyowa Kirin upon closing, up to $3.5 million in milestones and tiered royalties
of up to 10% on U.S. net product sales. Kyowa Kirin will retain
international rights, continuing to deliver the product to address
oncology patients' needs throughout the rest of the world.
"Since its launch in 2008, we have established SANCUSO as an
important supportive therapeutic solution for oncology patients
across the country," said Gary
Zieziula, president of Kyowa Kirin North America. "We
believe that Cumberland is well
positioned to optimize the value of the brand and ensure that this
unique product continues to deliver important therapeutic benefits
to oncology patients."
About Cumberland Pharmaceuticals
Cumberland
Pharmaceuticals Inc. is a specialty pharmaceutical company focused
on the delivery of high-quality, prescription brands designed
to improve patient care. The Company develops, acquires, and
commercializes products for the hospital acute care,
gastroenterology and rheumatology market segments. The Company's
portfolio now includes eight FDA-approved brands.
The Company also has a series of Phase II clinical programs
underway evaluating its ifetroban product candidate in patients
with cardiomyopathy associated with Duchenne Muscular Dystrophy
("DMD"), Systemic Sclerosis ("SSc"), and Aspirin-Exacerbated
Respiratory Disease ("AERD").
More information can be found on the Company's website at
www.cumberlandpharma.com.
About Kyowa Kirin
Kyowa Kirin strives to create and
deliver novel medicines with life-changing value. As a Japan-based global specialty pharmaceutical
company with a more than 70-year heritage, the company applies
cutting-edge science, including expertise in antibody research and
engineering, to address the needs of patients across multiple
therapeutic areas such as nephrology, oncology, immunology/allergy
and neurology. Across its four regions – Japan, Asia
Pacific, North America and
EMEA/International – Kyowa Kirin focuses on its purpose, to make
people smile, and is united by its shared values of commitment to
life, teamwork, innovation and integrity.
Learn more about the Company at www.kyowakirin.com.
About SANCUSO®
SANCUSO is the only
skin patch approved by the U.S. Food and Drug Administration for
the prevention of chemotherapy-induced nausea and vomiting (CINV)
in patients receiving moderately and/or highly emetogenic
chemotherapy. When applied 24 to 48 hours before receiving
chemotherapy, the SANCUSO patch slowly and continuously releases
the medicine contained in the adhesive through clean and intact
skin areas into the patient's bloodstream. It can be worn for up to
seven days in a row for chemotherapy regimens of up to five
consecutive days.
Learn more at www.sancuso.com.
Forward-Looking Statements
This press release contains
forward-looking statements, which are subject to certain risks and
reflect the companies' 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
the companies' operations are subject to factors outside of its
control, and any one or combination of these factors could
materially affect results of operations. There can be no assurance
that anticipated results associated with the brand 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 companies do not undertake
any obligation to publicly revise these statements to reflect
events after the date hereof. Investors should refer to filings
with the government securities agencies for more information,
including the risk factors associated an investment in each
company.
Please see SANCUSO Indication and Important Safety
Information below
Indication
SANCUSO® (granisetron
transdermal system) is indicated for the prevention of nausea and
vomiting in adults receiving moderately and/or highly emetogenic
chemotherapy regimens of up to five5 consecutive days.
Important Safety Information
Contraindications:
SANCUSO is contraindicated in patients with known hypersensitivity
to granisetron or to any of the components of the transdermal
system.
Warnings and Precautions:
Progressive Ileus and Gastric
Distention: SANCUSO may mask a progressive ileus and/or gastric
distention. This should be particularly considered before use of
SANCUSO in patients who have had recent abdominal surgery. Monitor
for decreased bowel activity, particularly in patients with risk
factors for gastrointestinal obstruction.
Serotonin Syndrome: The development of serotonin syndrome has been
reported with 5-HT3 receptor antagonists. Patients should be
monitored for the emergence of serotonin syndrome, especially with
concomitant use of SANCUSO and other serotonergic drugs. If
symptoms of serotonin syndrome occur, discontinue SANCUSO and
initiate supportive treatment. Patients should be informed of the
increased risk of serotonin syndrome, especially if SANCUSO is used
concomitantly with other serotonergic drugs.
Skin Reactions: In clinical trials with SANCUSO, application site
reactions were reported that were generally mild in intensity and
did not lead to discontinuation of use. The incidence of reactions
was comparable with placebo. If severe reactions, or a generalized
skin reaction occur (e.g., allergic rash, including erythematous,
macular, papular rash or pruritus), remove the SANCUSO transdermal
system.
Increased Drug Exposure with Use of External Heat Sources:
Prolonged exposure to heat results in increasing plasma
concentrations of granisetron during the period of heat exposure.
Do not apply a heat pad or heat lamp over or in the vicinity of the
SANCUSO transdermal system and avoid extended exposure to heat.
Phototoxicity with Ultraviolet Light Exposure: Granisetron may be
affected by direct natural or artificial sunlight, including
sunlamps. An in vitro study using Chinese hamster ovary cells
suggests that granisetron has the potential for photogenotoxicity.
To avoid a potential skin reaction, advise patients to cover the
application site of the transdermal system with clothing if there
is a risk of exposure to direct natural or artificial sunlight
throughout the period of wear and for 10 days following its
removal.
Adverse Reactions:
The most common adverse reaction (≥ 3%) is constipation.
You are encouraged to report suspected adverse reactions to Kyowa
Kirin, Inc. at 1-800-Sancuso or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
Please click here for full U.S. prescribing information.
SOURCE: Cumberland Pharmaceuticals Inc. and Kyowa
Kirin Inc.
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SOURCE Cumberland Pharmaceuticals Inc.; Kyowa Kirin Inc.