Sucampo Announces Commercial Availability of RESCULA in U.S. Pharmacies
Will host investor call February 21 at 5:00 pm to give an update on commercial
plans for the launch of RESCULA
BETHESDA, Md. -- February 19, 2013
Sucampo Pharmaceuticals, Inc. (“Sucampo” or “the Company”) (NASDAQ: SCMP)
(SPI) today announced that RESCULA^® (unoprostone isopropyl ophthalmic
solution) 0.15% is now available by prescription across the United States. The
U.S. Food and Drug Administration (FDA) approved a sNDA for RESCULA for the
lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or
ocular hypertension on December 7, 2012.
“RESCULA is an important prostone-based treatment option for patients
suffering from open-angle glaucoma, which is the most common form of
glaucoma,” said Sucampo’s Chairman, Chief Executive Officer, and Chief
Scientific Officer Ryuji Ueno, M.D., Ph.D., Ph.D. “We have already received
positive feedback from many in the ophthalmology and optometry communities
regarding RESCULA’s unique mechanism of action as a BK channel activator, and
we are pleased that patients will now have access to the drug in order to help
treat this disease.”
According to the approved product labeling, RESCULA may be used as a
first-line agent or concomitantly with other topical ophthalmic drug products
to lower intraocular pressure. RESCULA is a BK (Big Potassium) channel
activator, which is different from other IOP lowering agents.
Company to Host Conference Call February 21 at 5:00 pm
In conjunction with this press release, Sucampo will host a conference call on
February 21 at 5:00 pm Eastern to give an overview of commercial launch plans
for RESCULA. To participate on the live call, please dial 800-798-2884
(domestic) or 617-614-6207 (international), and provide the participant
passcode 71967726, five to ten minutes ahead of the start of the call. A
replay of the call will be available within a few hours after the call ends.
Investors may listen to the replay by dialing 888-286-8010 (domestic) or
617-801-6888 (international), with the passcode 79910549.
Investors interested in accessing the live audio webcast of the teleconference
may do so at http://investor.sucampo.com and should log on before the
teleconference begins in order to download any software required. The archive
of the teleconference will remain available for 30 days.
About Unoprostone Isopropyl (RESCULA)
Unoprostone isopropyl is a member of Sucampo’s family of prostones and is a
synthetic docosanoid. Unoprostone isopropyl may have a local effect on BK (Big
Potassium) channels in the eye. BK channels are expressed in contractile
tissues like the trabecular meshwork. RESCULA may reduce elevated intraocular
pressure (IOP) by increasing the outflow of aqueous humor through the
trabecular meshwork. Complete details of the mechanism of action are unknown
at this time.
Important Safety Information
RESCULA is contraindicated in patients with hypersensitivity to unoprostone
isopropyl or any other ingredient in this product.
Warnings and precautions
Unoprostone isopropyl ophthalmic solution may gradually increase the
pigmentation of the iris. The pigmentation change is believed to be due to
increased melanin content in the melanocytes rather than to an increase in the
number of melanocytes. The long term effects of increased pigmentation are not
known. Iris color changes seen with administration of unoprostone isopropyl
ophthalmic solution may not be noticeable for several months to years.
Treatment with RESCULA solution can be continued in patients who develop
noticeably increased iris pigmentation. Patients who receive treatment with
RESCULA should be informed of the possibility of increased pigmentation which
is likely to be permanent.
Unoprostone isopropyl has been reported to cause pigment changes (darkening)
to periorbital pigmented tissues and eyelashes. The pigmentation is expected
to increase as long as unoprostone isopropyl is administered, but has been
reported to be reversible upon discontinuation of unoprostone isopropyl
ophthalmic solution in most patients.
RESCULA should be used with caution in patients with active intraocular
inflammation (e.g., uveitis) because the inflammation may be exacerbated.
Macular edema, including cystoid macular edema, has been reported. RESCULA
should be used with caution in aphakic patients, in pseudoaphakic patients
with a torn posterior lens capsule, or in patients with known risk factors for
To minimize contaminating the dropper tip and solution, care should be taken
not to touch the eyelids or surrounding areas with the dropper tip. Keep
bottle tightly closed when not in use. There have been reports of bacterial
keratitis associated with the use of multiple-dose containers of topical
RESCULA contains benzalkonium chloride, which may be absorbed by soft contact
lenses. Contact lenses should be removed prior to application of solution and
may be reinserted 15 minutes following its administration.
In clinical studies, ocular adverse events above 5% with use of RESCULA were
burning/stinging (22.4%), burning/stinging upon drug instillation (18.6%),
itching (13.2%), injection (11.6%), dry eyes (10.7%), foreign body sensation
(9.0%), abnormal vision (8.2%), lacrimation disorder (6.2%) and eyelid
disorder (5.8%). Approximately 10-14% of patients were observed to have an
increase in the length of eyelashes (≥ 1mm) at 12 months, while 7% of patients
were observed to have a decrease in the length of eyelashes. Corneal lesions
were reported in 2.3% of patients.
The most frequently reported nonocular adverse event associated with the use
of RESCULA in the clinical trials was flu-like syndrome, observed in
approximately 6% of patients.
Use in specific populations
Pregnancy Category C - There are no adequate and well-controlled studies in
pregnant women. Because animal studies are not always predictive of human
response, RESCULA should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus.
Pediatric Use - the safety and efficacy of RESCULA in pediatric patients have
not been established.
It is not known whether RESCULA is excreted in human milk. Because many drugs
are excreted in human milk, caution should be exercised when RESCULA is
administered to a nursing woman.
No overall differences in safety or effectiveness of RESCULA have been
observed between elderly and other adult populations.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is a global pharmaceutical company focused on
innovative research, discovery, development and commercialization of
proprietary drugs based on prostones. The therapeutic potential of prostones
was first discovered by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo’s Chairman,
Chief Executive Officer, Chief Scientific Officer, and co-founder. Prostones,
naturally occurring fatty acid metabolites that have emerged as promising
compounds with unique physiological activities, can be targeted for the
treatment of unmet or underserved medical needs. For more information, please
RESCULA is a registered trademark of R-Tech Ueno, Ltd, and has been licensed
Sucampo Forward-Looking Statement
This press release contains "forward-looking statements" as that term is
defined in the Private Securities Litigation Reform Act of 1995. These
statements are based on management's current expectations and involve risks
and uncertainties, which may cause results to differ materially from those set
forth in the statements. The forward-looking statements may include statements
regarding product development, product potential, future financial and
operating results, and other statements that are not historical facts. The
following factors, among others, could cause actual results to differ from
those set forth in the forward-looking statements: the impact of
pharmaceutical industry regulation and health care legislation; Sucampo's
ability to accurately predict future market conditions; dependence on the
effectiveness of Sucampo's patents and other protections for innovative
products; the risk of new and changing regulation and health policies in the
US and internationally and the exposure to litigation and/or regulatory
No forward-looking statement can be guaranteed and actual results may differ
materially from those projected. Sucampo undertakes no obligation to publicly
update any forward-looking statement, whether as a result of new information,
future events, or otherwise. Forward-looking statements in this presentation
should be evaluated together with the many uncertainties that affect Sucampo's
business, particularly those mentioned in the risk factors and cautionary
statements in Sucampo's most recent Form 8-K and 10-K, which the Company
incorporates by reference.
Sucampo Pharmaceuticals, Inc.
Silvia Taylor, 1-240-223-3718
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