ALAMEDA, Calif., Apr 02, 2009 (BUSINESS WIRE) -- InSite Vision (NYSE Amex:ISV) today announced that it has signed an
exclusive international licensing and distribution agreement for AzaSite®
(azithromycin ophthalmic solution) 1% with Nitten Pharmaceutical Co.,
Ltd., one of the top ten Japanese ophthalmic pharmaceutical companies.
AzaSite contains a broad-spectrum antibiotic formulated with InSite
Vision's patented DuraSite® drug delivery vehicle to enhance
the retention time of the antibiotic on the surface of the eye. AzaSite
offers the benefit of a less frequent and more convenient dosing regimen
in a safe and effective therapy for the treatment of bacterial eye
infections.
Under the terms of the agreement, Nitten is responsible for securing
regulatory approval and has exclusive rights to commercialize AzaSite
for ocular bacterial infection in Japan and Taiwan. Nitten will pay
InSite one million U.S. dollars upon the execution of the license
agreement, followed by milestone payments of one million dollars upon
the first regulatory submission and one million dollars upon the first
regulatory approval. After approval, Nitten will also pay a double-digit
royalty on net sales of AzaSite in Japan and on net royalties from
Taiwan, where Nitten intends to use a partner to commercialize AzaSite.
InSite Vision will initially be responsible for manufacturing AzaSite.
"Nitten has a track record of success in marketing both branded and
generic ophthalmic products and is well-positioned to be our commercial
partner for AzaSite in Japan and Taiwan," said Louis Drapeau, Chief
Executive Officer of InSite Vision. "As we expand our international
partnerships to bring AzaSite to patients globally, Nitten represents
the type of established market leadership and commercial expertise
necessary to assure commercial success for AzaSite."
"We are pleased to license AzaSite considering the positive acceptance
this unique ocular antibiotic has experienced in the United States. We
believe there is a significant market opportunity in both Japan and
Taiwan for this product, and we look forward to establishing this
product in our markets as soon as possible," said Ayumi Uetake,
President of Nitten.
AzaSite was approved for bacterial conjunctivitis (pink eye) treatment
by the United States Food and Drug Administration (FDA) in April 2007,
and was commercially launched in the United States for the treatment of
bacterial conjunctivitis by Inspire Pharmaceuticals, Inc. in August
2007. AzaSite received regulatory approval from Health Canada on March
31, 2009. Inspire Pharmaceuticals is responsible for marketing AzaSite
in the U.S. and in Canada. InSite Vision is seeking additional
international partners for commercialization and distribution of AzaSite
outside of North America.
About Nitten
Nitten Pharmaceutical Co., Ltd, with headquarters in Nagoya, Japan, is a
private company established in 1919. It is one of the ten largest
ophthalmic pharmaceutical companies in Japan and employs more than 200
people with sales in excess of US $35,000,000.
About InSite Vision
InSite Vision is committed to advancing new and superior ophthalmologic
products for unmet eye care needs. InSite is recognized for the
discovery and development of novel ocular pharmaceutical products based
on its DuraSite® bioadhesive polymer core technology, an
innovative platform that extends the duration of drug delivery on the
eye's surface, thereby reducing frequency of treatment and improving the
efficacy of topically delivered drugs. By formulating the
well-established antibiotic azithromycin in DuraSite, InSite developed
the lowest-dosing ocular antibiotic for the treatment of bacterial
conjunctivitis (pink eye) available to the United States ophthalmic
market, AzaSite® (azithromycin ophthalmic solution) 1%.
AzaSite is marketed by Inspire Pharmaceuticals in the United States and
will be marketed by international partners in South Korea, four
countries in South America, Turkey and China upon approval in those
countries.
InSite's ophthalmic product development portfolio also includes ISV-502,
which is currently in Phase 3 pivotal trials for the treatment of eye
and eyelid infection and inflammation and additional product candidates
leveraging the company's core technologies. For further information on
InSite Vision, please visit www.insitevision.com.
Forward Looking Statements
This news release contains certain statements of a forward-looking
nature relating to future events, such as the timing of approval of
AzaSite in Japan and Taiwan, the expected success and market share of
AzaSite in Japan and Taiwan, the potential success of Nitten's
commercialization and marketing efforts, the benefits of AzaSite,
InSite's expected development and commercialization of additional
anti-infective therapies using DuraSite sustained delivery technology,
InSite's corporate goals, and the proposed indications and clinical
status of the company's other product candidates. Such statements entail
a number of risks and uncertainties, including but not limited to:
InSite Vision's ability to obtain additional funding to continue its
operations; its reliance on third parties, including Inspire and Nitten,
for the commercialization of AzaSite and its other products; the ability
of InSite Vision to enter into additional corporate collaborations for
AzaSite outside the U.S. and Canada and with respect to its other
product candidates; Nitten's ability to successfully obtain approval for
and market AzaSite in Japan; Inspire's ability to successfully market
AzaSite in the United States and Canada; the clinical results of
InSite's product candidates; InSite Vision's ability to expand its
technology platform to include additional indications; InSite Vision's
ability to maintain and develop additional collaborations and commercial
agreements with corporate partners, including those with respect to
AzaSite, ISV-502, AzaSite Xtra; and its ability to adequately protect
its intellectual property and to be free to operate with regard to the
intellectual property of others; and determinations by the FDA,
including those with respect to ISV-502. Reference is made to the
discussion of these and other risk factors detailed in InSite Vision's
filings with the Securities and Exchange Commission, including its
annual report on Form 10-K and its quarterly reports on Form 10-Q, under
the caption "Risk Factors" and elsewhere in such reports. Any
forward-looking statements or projections are based on the limited
information currently available to InSite Vision, which is subject to
change. Although any such forward-looking statements or projections and
the factors influencing them will likely change, InSite Vision
undertakes no obligation to update the information. Such information
speaks only as of the date of its release. Actual events or results
could differ materially and one should not assume that the information
provided in this release is still valid at any later date.
SOURCE: InSite Vision
InSite Vision
Louis Drapeau, 510-747-1220
Chief Executive Officer
mail@insite.com
or
Availe Communications
Ellen Rose, 650-387-8746 (Media inquiries)