ISTA Pharmaceuticals Completes Patient Enrollment in Phase 2 Clinical Study of BEPOSONE(TM) (Bepotastine Besilate -
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IRVINE, CA, Jan 30 (MARKET WIRE) --
ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA), today announced it has
successfully enrolled more than 600 patients in the Company's Phase 2
clinical study of its BEPOSONE(TM) nasal spray combining bepotastine
besilate with a steroid for the treatment of symptoms associated with
seasonal allergic rhinitis, the inflammation of the nasal passages caused
by allergies. The randomized, placebo-controlled, parallel-group
environmental study is evaluating the safety and efficacy of the
combination nasal spray, dosed twice daily, in patients presenting with
allergic rhinitis caused by one of the most potent seasonal allergy
triggers, Mountain Cedar pollen.
According to the trial protocol, patients will be treated in the
double-masked study for two weeks with one of four formulations:
bepotastine besilate-steroid combination nasal spray, a nasal spray
containing only one of the two active agents, or placebo nasal spray.
Patients, all of whom were enrolled in Texas, will grade both individual
nasal and ocular symptoms on a daily basis during the treatment period.
"Patient enrollment has been rapid and very successful in the Phase 2
trial. We have completed our objective of admitting at least 600 patients
in the study within a month of initiation," stated Timothy R. McNamara,
Pharm.D., Vice President of Clinical Research and Medical Affairs of ISTA
Pharmaceuticals. "The trial expands our bepotastine besilate nasal spray
program to include a bepotastine-steroid combination product since,
according to extensive conversations with clinicians, antihistamines and
steroids are often prescribed together for treatment of seasonal allergic
rhinitis. We expect to report results of the BEPOSONE Phase 2 trial in
the first half of 2012."
ABOUT THE ALLERGIC RHINITIS MARKET
According to the American Academy of
Allergy Asthma & Immunology (AAAAI), approximately 60 million Americans
are affected by allergic rhinitis, an inflammation of the nasal passages
caused by exposure to certain allergens, such as pollen from trees, grass
and plants, animal dander, feathers, dust mites and molds. Allergic
rhinitis is characterized by a number of symptoms, including sneezing,
nasal congestion, nasal itching and runny nose. The eyes, ears, sinuses
and throat also can be affected. Current treatments for allergic rhinitis
include antihistamines, mast cell stabilizers, anti-inflammatories, and
steroids. Based on data from IMS Health in the U.S., approximately 46.8
million prescriptions were filled for nasal allergy treatments in 2011,
resulting in sales of approximately $2.5 billion.
ABOUT BEPOTASTINE BESILATE
Bepotastine besilate is a non-sedating,
highly selective antagonist of the histamine H1 receptor. It has a
stabilizing effect on mast cells, and it suppresses the migration of
eosinophils into inflamed tissues. The compound's primary mechanisms of
action suggest that it is a potentially effective treatment for nasal
symptoms associated with seasonal allergic rhinitis.
Bepotastine besilate has been approved in Japan for systemic use in the
treatment of allergic rhinitis since 2000 and for urticaria/dermal
prurituses since 2002. It is marketed as an oral tablet in Japan by
Mitsubishi Tanabe Pharma Corporation (formerly Tanabe Seiyaku Co., Ltd.)
under the brand name TALION(R). TALION was co-developed by Tanabe Seiyaku
and Ube Industries, Ltd., who discovered bepotastine besilate. In 2001,
Tanabe Seiyaku granted Senju Pharmaceutical Co., Ltd., exclusive
worldwide rights, with the exception of certain Asian countries, to
develop, manufacture and market bepotastine besilate for ophthalmic use.
In 2006, ISTA licensed the exclusive North American ophthalmic rights to
bepotastine besilate from Senju. In 2007, ISTA licensed exclusive North
American rights to nasal dosage forms of bepotastine besilate from Tanabe
Seiyaku and obtained a future right to negotiate for a North American
license to oral dosage forms of bepotastine besilate for allergy
treatment.
ISTA's eye drop formulation of bepotastine besilate, BEPREVE(R)
(bepotastine besilate ophthalmic solution) 1.5%, was approved by the U.S.
Food and Drug Administration (FDA) in September 2009 for the treatment of
ocular itching associated with allergic conjunctivitis. BEPOSONE(TM)
(combination bepotastine/steroid product) and BEPOMAX(TM) (single agent
bepotastine product) nasal spray formulations for seasonal allergic
rhinitis are currently investigational drugs in clinical studies and are
not yet available for commercial use.
ABOUT ISTA PHARMACEUTICALS
ISTA Pharmaceuticals, Inc. is a fast growing
and the third largest branded prescription eye care business in the
United States with an expanding focus on allergy therapeutics. ISTA
currently markets four products, including treatments for ocular
inflammation and pain post-cataract surgery, glaucoma and ocular itching
associated with allergic conjunctivitis. The company's development
pipeline contains additional candidates in various stages of development
to treat dry eye, ocular inflammation and pain, and nasal allergies.
Headquartered in Irvine, California, ISTA generated revenues of $156.5
million in 2010. For additional information about ISTA, please visit the
corporate website at www.istavision.com.
BEPREVE(R), BEPOSONE(TM) and BEPOMAX(TM) are trademarks that are owned by
ISTA Pharmaceuticals, Inc. TALION(R) is a trademark of Mitsubishi Tanabe
Pharma Corporation.
FORWARD-LOOKING STATEMENTS
Any statements contained in this press
release that refer to future events or other non-historical matters are
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the Securities
Exchange Act of 1934, as amended. These forward-looking statements are
intended to qualify for the safe harbor from liability established by the
Private Securities Reform Act of 1995. Without limiting the foregoing,
but by way of example, statements contained in this press release related
to the completion of the Phase 2 study and the release of preliminary
data from the Phase 2 study in the first half of 2012 are forward-looking
statements. Except as required by law, ISTA disclaims any intent or
obligation to update any forward-looking statements. These
forward-looking statements are based on ISTA's expectations as of the
date of this press release and are subject to risks and uncertainties
that could cause actual results to differ materially. Important factors
that could cause actual results to differ from current expectations
include, among others, delays and uncertainties related to the FDA or
other regulatory agency approval or actions and such other risks and
uncertainties as detailed from time to time in ISTA's public filings with
the U.S. Securities and Exchange Commission, including but not limited to
ISTA's Annual Report on Form 10-K for the year ended December 31, 2010,
and its Quarterly Report on Forms 10-Q for the quarters ended March 31,
June 30 and September 30, 2011.
For Investor Relations:
Lauren Silvernail
949-788-5302
lsilvernail@istavision.com
Jeanie Herbert
949-789-3159
jherbert@istavision.com
Kathy Galante
Burns McClellan
212-213-0006
kgalante@burnsmc.com
For General Media:
Justin Jackson
Burns McClellan
212-213-0006
jjackson@burnsmc.com
Trade Media:
Tad Heitmann
BioComm Network
714-273-2937
theitmann@BioCommNetwork.com
Web Site: http://www.istavision.com
Copyright 2012, Market Wire, All rights reserved.
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