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ISTA Pharmaceuticals Expands Its Pipeline in Allergy
Treatments
ISTA acquires exclusive North American rights to bepotastine
for nasal allergy
IRVINE, Calif., Sept. 26 /PRNewswire-FirstCall/ -- ISTA
Pharmaceuticals, Inc. (Nasdaq: ISTA), announced today it has
licensed exclusive North American rights to nasal dosage forms
of bepotastine, an investigational product for the treatment of
allergy symptoms, from Tanabe Seiyaku Co., Ltd. Last year, ISTA
obtained exclusive North American rights to ophthalmic allergy
applications of bepotastine and has been developing an ocular
formulation of bepotastine to treat the symptoms of ocular
itching that accompany reactions to allergens. Following the
previously announced positive Phase II/III clinical results the
Company received with its ocular formulation, which showed
bepotastine had a positive impact on nasal allergy symptoms,
ISTA made the decision to add nasal bepotastine to its pipeline.
"As allergies affect both the eyes and the nose, we acquired the
North American rights to nasal dosage forms of bepotastine to
provide us the opportunity to offer both nasal and ocular
formulations to patients. As many of you know, we have close
relationships with the ophthalmic community, and, based upon our
interactions with our thought leaders, we determined that
complementing our ophthalmic formulation with a nasal
formulation of bepotastine would potentially allow patients to
experience relief from both ocular and nasal allergy symptoms,"
stated Vicente Anido, Jr., President and CEO of ISTA. "Further,
the medical community has experience treating ocular allergy
symptoms with a nasal formulation antihistamine.
"As we now have four product candidates in our pipeline, T-Pred™,
ecabet sodium, ophthalmic bepotastine and nasal bepotastine,
that will be of interest to a broader audience, we will look to
maximize the value of our assets beyond the non-ophthalmic
community by exploring options to work with others to expand our
sales reach. However, it is our intention that ISTA will remain
committed to the ophthalmologist and retain our ophthalmic
specialist focus."
ISTA anticipates completing the formulation of nasal bepotastine
in 2008 and entering into clinical development in late 2008 or
early 2009. Bepotastine has three primary mechanisms of action.
It is a non-sedating, selective antagonist of the histamine 1
(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 are believed to make
it an effective treatment for the symptoms of ocular and nasal
allergies.
Under the terms of ISTA's license agreement with Tanabe, ISTA
will pay an upfront payment to Tanabe of $2 million, additional
payments based on achievement of development and approval
milestones, and royalties on future product sales. ISTA is
responsible for all costs associated with developing nasal
bepotastine for North America, including clinical trials, FDA
filings, manufacturing, and, if the product is approved,
marketing and sales activities. ISTA also obtained the right to
develop other nasal bepotastine products, including a fixed
combination with a steroid, and a future right to negotiate for
a North American license to oral dosage forms of bepotastine for
allergy treatment.
Conference Call
ISTA will host a conference call with a simultaneous webcast on
September 26 at 5 PM Eastern Time to discuss today's
announcement regarding ISTA's license of exclusive North
American rights to nasal dosage forms of bepotastine. To access
the live conference call, U.S. and Canadian participants may
dial (800) 599-9795; international participants may dial (617)
786-2905. The access code for the live call is 89370716. To
access the 24-hour audio replay, U.S. and Canadian participants
may dial (888) 286-8010; international participants may dial
(617) 801-6888. The access code for the replay is 21178468. This
conference call will also be webcast live and archived on ISTA's
website for 30 days at
http://www.istavision.com.About Bepotastine
Bepotastine was approved in Japan for use in the treatment of
allergic rhinitis and uriticaria/pruritus in July 2000 and
January 2002, respectively, and is marketed by Tanabe Seiyaku
Co., Ltd., under the brand name TALION. TALION was co-developed
by Tanabe Seiyaku and Ube Industries, Ltd., who discovered
bepotastine. 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 for ophthalmic use. ISTA licensed the
North American rights to ophthalmic allergy applications of
bepotastine from Senju in 2006.
About ISTA
ISTA Pharmaceuticals is an ophthalmic pharmaceutical company.
ISTA's products and product candidates addressing the $3.2
billion U.S. prescription ophthalmic industry include therapies
for inflammation, ocular pain, glaucoma, allergy, and dry eye.
The Company currently markets three products and is developing a
strong product pipeline to fuel future growth and market share.
The Company's product development and commercialization strategy
is to launch a new product every 12 to 18 months, thereby
continuing its growth to become the leading niche ophthalmic
pharmaceutical company in the U.S. For additional information
regarding ISTA, please visit ISTA Pharmaceuticals' website at
http://www.istavision.com. About Tanabe
TANABE SEIYAKU CO., LTD. is one of the leading Japanese
pharmaceutical companies that specializes in developing and
marketing pharmaceutical products such as diltiazem (Herbesser®)
and imidapril (Tanatril®) to treat
cardiovascular diseases. Diltiazem is sold in more than 110
countries and imidapril is sold in Asian and European countries.
For more information, please visit the web site at
www.tanabe.co.jp. Currently, Tanabe decided to merge with
Mitsubishi Pharma Corporation to form Mitsubishi Tanabe Pharma
Corporation as of October 1, 2007, and the new company's web
site will also be available from October at
www.mt-pharma.co.jp. Forward-Looking Statements
Any statements contained in this press release that refer to
future events or other non-historical matters are
forward-looking statements. Without limiting the foregoing, but
by way of example, statements contained in this press release
concerning prospects related to ISTA's strategic initiatives,
the future performance of ISTA's products, including the
potential for both the ocular and nasal formulations of
bepotastine, bepotastine development plans, including projected
timelines for formulation completion and clinical development,
and ISTA's goals of bringing a new product to market every 12 to
18 months and becoming the leading niche ophthalmic
pharmaceutical company in the U.S., 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: the
inherent uncertainty associated with financial projections and
estimates, timely and successful implementation of ISTA's
strategic initiatives; delays and uncertainties related to
ISTA's research and development programs (including without
limitation the difficulty of predicting the timing or outcome of
bepotastine product development efforts); the timing, scope, and
outcome of the FDA or other regulatory agency approval or
actions; uncertainties and risks regarding market acceptance of
and demand for ISTA's approved products, the impact of
competitive technologies, products, and pricing; uncertainties
and risks related to ISTA's ability to properly manage its
growth; uncertainties and risks related to the continued
availability of third-party sourced products and raw materials
on commercially reasonable terms, or at all; uncertainties and
risks related to successful compliance with FDA and/or other
governmental regulations applicable to ISTA's facilities,
products, and/or business; uncertainties and risks related to
the scope, validity, and enforceability of patents related to
ISTA's products and technologies and the impact of patents and
other intellectual property rights held by third parties; 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, 2006 and its Quarterly
Reports on Form 10-Q for the quarters ended March 31, 2007 and
June 30, 2007.
Source
ISTA Pharmaceuticals, Inc.
Contact
Vince Anido, Ph.D., +1-949-788-5311, vanido@istavision.com, or
Lauren Silvernail, +1-949-788-5302, lsilvernail@istavision.com,
both of ISTA Pharmaceuticals; or Investors, Juliane Snowden,
jsnowden@burnsmc.com, or Media, Nicki Kahner, nkahner@burnsmc.com,
or Justin Jackson, jjackson@burnsmc.com, all of Burns McClellan
for ISTA, +1-212-213-0006
Web site
http://www.istavision.com |