ISTA Pharmaceuticals, Inc.
IRVINE, CA, Jan 06, 2012 (MARKETWIRE via COMTEX) --ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA), today announced that its
partner Senju Pharmaceuticals Co. Ltd. has received a Notice of
Allowance from the United States Patent and Trademark Office for
Application Serial No 10/525,006 titled, "Aqueous Liquid Preparation
Containing 2-Amino-3-(4-Bromobenzoyl) Phenylacetic Acid" with claims
that cover an optimized formulation of bromfenac. In October, ISTA
reported statistically significant Phase 3 results for its product
candidate, PROLENSA(TM) (bromfenac ophthalmic solution), which
incorporates this proprietary formulation of bromfenac.
The Notice of Allowance concludes the substantive examination of this
patent application and is expected to result in the issuance of a
U.S. patent following completion of administrative processes. The
patent is anticipated to issue in the first half of 2012 and expire
in 2024.
"This notice of allowance is important to further broaden the
intellectual property position for one of our key franchises," said
Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of
ISTA. "The bromfenac franchise has multiple barriers to entry --
existing Hatch-Waxman exclusivity for BROMDAY(TM) and Hatch-Waxman
exclusivity upon potential approval of PROLENSA, this new allowed
patent and additional patents pending. It is a critical step to our
continued leadership in the $367 million ophthalmic nonsteroidal
anti-inflammatory drug (NSAID) market in the U.S. Once issued, we
believe that this patent will provide protection for not only
PROLENSA, but also a potential bromfenac adjunct therapy for
age-related macular degeneration (AMD)."
Dr. Anido continued, "We anticipate filing a New Drug Application
(NDA) with the FDA for PROLENSA in the first half of 2012, with a
commercial launch following approval planned in early 2013. Because
PROLENSA has a lower-concentration of the active ingredient with high
efficacy and safety, we plan to discontinue our current once-daily
product, BROMDAY, sometime after the successful launch of PROLENSA.
This is the same commercial strategy we successfully implemented in
early 2011 for conversion of our twice-daily XIBROM(TM) prescriptions
to once-daily BROMDAY."
ABOUT PROLENSA(TM)
PROLENSA(TM) (bromfenac ophthalmic solution) is
being developed as a once-daily topical nonsteroidal
anti-inflammatory compound for the treatment of ocular inflammation
and pain following cataract surgery. PROLENSA incorporates a lower
concentration of bromfenac than the company's current once-daily
NSAID, BROMDAY (bromfenac ophthalmic solution) 0.09% in a new
formulation. From 2005 until 2011, ISTA marketed XIBROM (bromfenac
ophthalmic solution)(R) 0.09% in the U.S. for twice-daily use for the
treatment of postoperative inflammation and the reduction of ocular
pain in patients who have undergone cataract surgery. In October of
2010, ISTA received FDA approval for once-daily BROMDAY and
discontinued shipments of XIBROM in February 2011. ISTA acquired U.S.
ophthalmic rights to bromfenac in May 2002 under a license from Senju
Pharmaceuticals Co. Ltd. BROMDAY is currently the only once daily
treatment option in the $367 million U.S. ophthalmic nonsteroidal
anti-inflammatory market. PROLENSA is an investigational drug and 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.
BROMDAY(TM) (bromfenac ophthalmic solution) 0.09%, XIBROM (bromfenac
ophthalmic solution)(R) 0.09% and PROLENSA(TM) (bromfenac ophthalmic
solution) are trademarks of ISTA Pharmaceuticals, Inc.
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 filing of a new drug application
with the FDA, the FDA's actions with respect thereto, potential
launch of PROLENSA in 2013 and subsequent withdrawal of BROMDAY,
patent issuance, and the protections afforded by Hatch-Waxman
exclusivity and patents, 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 10-Q for quarters ended March 31, June 30, and
September 30, 2011.
For Investor Relations:
Lauren Silvernail
949-788-5302
[email protected]
Jeanie Herbert
949-789-3159
[email protected]
Kathy Galante
Burns McClellan
212-213-0006
[email protected]
For General Media:
Justin Jackson
Burns McClellan
212-213-0006
[email protected]
For Trade Media:
Tad Heitmann
BioComm Network
714-273-2937
[email protected]
Web Site: http://www.istavision.com