ALAMEDA, Calif.--(BUSINESS WIRE)--Feb. 16, 2007--InSite Vision
Incorporated (AMEX:ISV) today announced the signing of a licensing
agreement with Inspire Pharmaceuticals (NASDAQ:ISPH) for the United
States and Canada. The agreement provides for the commercialization by
Inspire of AzaSiteTM (1% azithromycin), InSite's topical
anti-infective product currently under NDA review by the FDA for the
treatment of bacterial conjunctivitis; commonly referred to as "pink
eye". The global market opportunity for topical, ocular anti-infective
products currently exceeds one billion dollars.
Under the terms of the agreement, InSite grants exclusive rights
to Inspire to commercialize AzaSite for ocular infection in the U.S.
and Canada. AzaSite contains the drug azithromycin, a broad-spectrum
antibiotic formulated with DuraSite®, InSite's patented
drug-delivery vehicle. If approved, it is anticipated that AzaSite
will become the first ocular antibiotic with a once daily dosing
regimen after an initial loading dose, which may increase patient
compliance and therapeutic efficacy.
The agreement provides that Inspire Pharmaceuticals will pay
InSite Vision an upfront license fee of $13 million and an additional
$19 million milestone payment contingent on regulatory approval by the
FDA. Inspire will also pay a royalty on net sales of AzaSite in the
U.S. and Canada, if approved by regulatory authorities. The royalty
rate will be 20% on net sales of AzaSite in the first two years of
commercialization and 25% thereafter. InSite Vision will use a portion
of the license fee to repay its senior secured notes, with a principal
balance of $6.3 million, issued in December 2005 and January 2006.
S. Kumar Chandrasekaran, Ph.D., InSite Vision's Chief Executive
Officer stated, "The AzaSite license agreement and related
collaboration with Inspire represents the first step in realizing the
global opportunity provided by our azithromycin/DuraSite drug-delivery
platform. This platform will allow us to pursue additional
anti-infective products and indications worldwide, supported by our
expanded patent portfolio for both the AzaSite and DuraSite
technologies.
"Our corporate partnership with Inspire also represents a
consistent and mutually focused business strategy, designed to
maximize this unique opportunity for the shareholders of both
companies. We are truly delighted to be aligned with Inspire
Pharmaceuticals in the pursuit of this large and attractive revenue
market represented by ocular anti-infective therapies."
InSite Vision will discuss this licensing agreement during a
conference call scheduled for 12:00 PM EST on February 16, 2007. To
access the conference call, U.S. participants may call (877) 407-0778
and international participants may call (201) 689-8565. All callers
will have to enter the account number 286 and conference ID number is
232277. A live webcast and replay of the call will be available on
InSite's website at www.insitevision.com. A telephone replay of the
conference call will be available until February 20, 2007 at midnight
EST. To access this replay, U.S. participants may call (877) 660-6853
and international participants may call (201) 612-7415.
About Azithromycin
Azithromycin is a semi-synthetic antibiotic that is derived from
erythromycin and has been available under the trade name Zithromax®
(Pfizer) since 1992. Azithromycin has been the most commonly
prescribed antibiotic in the United States, with an excellent safety
and efficacy profile that is most notable for its once-a-day dosing
feature. However, the drug had never been formulated as an ophthalmic
eye drop for topical dosing because of an unfavorable stability
profile.
Over the past few years, InSite Vision has been investigating
ocular drug formulations that utilize DuraSite, their patented drug
delivery system. DuraSite is a synthetic polymer that stabilizes small
molecules like azithromycin in an aqueous matrix. A 1% solution of
azithromycin in DuraSite (AzaSite) was developed and has been
evaluated in Phase 3 multi-center clinical trials. The data indicates
that AzaSite is a broad-spectrum antibiotic with an enhanced killing
capacity for pathogens previously resistant to azithromycin, but with
a safety profile that maintains many of the same well-known benefits.
About Bacterial Conjunctivitis
Bacterial conjunctivitis is a common ocular surface disease
characterized by inflammation of the delicate skin and mucosa on the
inside of the eyelids. The bacterial infections are contagious and
generally accompanied by irritation, itching, foreign body sensation,
watering, mucus discharge and redness (pink eye). The bacterial form
of the disease is more common in children than adults. In children,
the most common bacterial species associated with acute conjunctivitis
are Hemophilus influenzae, Streptococcus pnuemoniae , and
Staphylococcus species. Among adults, bacterial conjunctivitis can be
an important concern in contact lens wearers. The disease is
self-limiting in most cases and usually resolves in 8-10 days. Topical
antibiotics are often prescribed to control the public health risk of
contagion and to shorten the duration of the disease.
Clinical Trials
InSite Vision has submitted an electronic NDA filing in a modified
Common Technical Document (CTD) format to the FDA for regulatory
review. This submission incorporates the positive results from the
recently completed Phase 3 clinical trials, pre-clinical studies,
chemistry, manufacturing and controls. InSite previously announced the
completion of these two Phase 3 studies, including a vehicle
controlled study versus AzaSite, and a study comparing 0.3% tobramycin
versus AzaSite. The results of these trials showed that AzaSite was
safe, well tolerated and efficacious in the treatment of bacterial
conjunctivitis.
The NDA submission contains data from the two Phase 3 clinical
trials in which 698 patients were treated with AzaSite. Data from
these studies demonstrated that when AzaSite was administered twice
daily on the first two days, then once daily on days 3-5, it provided
clinically and statistically significant improvements in clinical
resolution of symptoms, and bacterial eradication compared to placebo,
and was equivalent in clinical resolution and bacterial eradication
when compared to tobramycin administered four times a day.
Supply and Manufacturing
InSite Vision has signed a manufacturing supply agreement with
Cardinal Health for the manufacture of topical AzaSiteTM (1%
azithromycin) commercial units. Cardinal Health manufactured the
clinical trial supplies used in InSite Vision's two Phase 3 bacterial
conjunctivitis clinical trials, and also the registration batches used
for the AzaSite New Drug Application (NDA) filing.
About InSite Vision Incorporated
InSite Vision is an ophthalmic company focused on developing
therapies that treat ocular infections, glaucoma and retinal diseases.
InSite Vision's lead product is AzaSite, which targets infections of
the eye. AzaSite contains the drug azithromycin, a broad-spectrum
antibiotic formulated with DuraSite, InSite Vision's patented
drug-delivery vehicle, which offers the benefit of a low-dosing
regimen, attractive to both the eye-care patient and physician.
Pending the approval of its NDA with the FDA, InSite Vision currently
expects AzaSite to be commercially launched in the United States
during 2007, while seeking to expand this "technology platform" to
include additional product candidates and indications for the
worldwide market.
In the glaucoma area, InSite Vision continues to focus genomic
research on the TIGR gene, among other genes in its genomic portfolio.
A portion of this research has been incorporated into InSite Vision's
commercially available OcuGene® glaucoma genetic test for disease
management, which is a prognostic tool designed to detect a genetic
marker (mt-1) in the promoter region of the glaucoma-related TIGR
gene.
Additional information can be found at our website,
www.insitevision.com.
This news release and the webcast provided for hereunder contains,
among other things, certain statements of a forward-looking nature
relating to future events or the future business performance of InSite
Vision, such as the Company's ability to obtain FDA approval of its
NDA for AzaSite, the potential benefits and indications for AzaSite,
the potential market size for AzaSite, future milestone payments and
royalties that may be received by the Company, the Company's product
development plans and future indications for same, the timing of
commercial launch of AzaSite and the Company's ability to continue its
operations and fund same. Such statements entail a number of risks and
uncertainties, including but not limited to: InSite Vision's ability
to obtain substantial additional funding to continue its operations;
the results of InSite Vision's clinical trials; the ability to obtain
FDA approval of its AzaSite NDA from the FDA for the commercialization
of AzaSite and its other product candidates and the timing of same;
the ability of InSite Vision to maintain its collaboration with
Inspire enter into a corporate collaboration for its other product
candidates; Inspire's ability to successfully market AzaSite, the
ability to launch AzaSite and the timing of such a launch; InSite
Vision's ability to expand its technology platform to include
additional indications, products and patent options; the effects of
its expense control activities on its operations and product
development; its ability to obtain regulatory approval and market
acceptance of its products and product candidates, including its
OcuGene glaucoma genetic test, AzaSite, ISV-205 and ISV-014; InSite
Vision's ability to maintain and develop additional collaborations and
commercial agreements with corporate partners, including those with
respect to AzaSite and ISV-205; its reliance on third parties for the
development, marketing and sale of its products; the initiation and
results of preclinical and clinical studies; its ability to adequately
protect its intellectual property and to be free to operate with
regard to the intellectual property of others; determinations by the
FDA, including those with respect to OcuGene, AzaSite and ISV-205 as
described in detail in and including the other risks described 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.
Note to Editors: OcuGene® is written with a "small cap" G; if
doing so is not possible, please use an upper case G. InSite Vision
Incorporated, InSite Vision, DuraSite® and OcuGene® are trademarks
of InSite Vision Incorporated. Other trademarks that may be mentioned
in this release are the intellectual property of their respective
owners.
CONTACT: Ashton Partners
Barry Hutton, 888-857-7839
www.ashtonpartners.com
SOURCE: InSite Vision Incorporated
