ISTA Pharmaceuticals, Inc.
Patent Term Adjustment Extends Intellectual Property Protection for ISTA's Bromfenac-Based Drug Candidates Through September 2025
IRVINE, CA, Mar 27, 2012 (MARKETWIRE via COMTEX) --ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA) today announced that the
United States Patent and Trademark Office has issued Patent No.
8,129,431 with claims covering PROLENSA(TM) (bromfenac ophthalmic
solution), ISTA's once-daily topical nonsteroidal anti-inflammatory
product for the treatment of ocular inflammation and pain following
cataract surgery. The patent was issued to ISTA's licensor, Senju
Pharmaceuticals Co. Ltd., and was granted a patent term adjustment
that extends the patent life originally set to expire January 2024 to
September 2025.
"The issuance of this patent broadens and further extends the
intellectual property position for pipeline products in our bromfenac
franchise," said Vicente Anido, Jr., Ph.D., President and Chief
Executive Officer of ISTA. "As noted earlier in the year, our
bromfenac franchise has multiple barriers to entry, including
Hatch-Waxman exclusivity and additional pending patents. This patent
should provide protection for not only our new product candidate
PROLENSA, but also a potential bromfenac adjunct therapy for
age-related macular degeneration (AMD)."
Dr. Anido continued, "The new, optimized formulation used for
PROLENSA enhances the penetration of bromfenac into ocular tissues,
allowing us to lower the concentration of bromfenac, while
maintaining the convenience of once-daily use currently prescribed
with BROMDAY. 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
the advantage of offering a lower concentration of the active
ingredient bromfenac with high efficacy and safety, we plan to
discontinue BROMDAY sometime after the successful launch of
PROLENSA."
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,
optimized 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 $370 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 $160 million in 2011. 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 the protections provided by patents
and statutory provisions, filing and acceptance for review of a new
drug application with the U.S. Food and Drug Administration,
potential commercial launch in 2013, future discontinuation of
BROMDAY, and potential for the use of bromfenac for AMD 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, 2011.
CONTACTS
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