InSite Vision Announces Corporate Restructuring To Focus on Growth Opportunities and Conserve Resources
2008年12月2日 - 6:05AM
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InSite Vision Incorporated (AMEX:ISV) today announced a corporate
restructuring to focus on the company�s growth opportunities and
conserve resources. The restructuring will decrease the company�s
personnel by approximately 35 percent. InSite expects savings from
its restructuring efforts to reduce annual operating expenses by
approximately $2.0 million. A one-time charge of approximately
$450,000 is expected to be incurred in the fourth quarter of 2008.
Employees affected by restructuring will be eligible for a
severance package that includes severance pay and continuation of
benefits. �InSite Vision possesses strong core fundamentals,
including a marketed product with increasing sales and significant
growth potential, a promising late-stage product candidate
(ISV-502), and a powerful ophthalmology drug delivery platform.
Eliminating these positions, while a difficult step to take, will
significantly extend our existing cash runway as we focus on
supporting and growing global sales of AzaSite� and increasing
value in our portfolio of new product opportunities,� stated Louis
Drapeau, InSite�s Chief Executive Officer. �This restructuring is
one of several steps we will take in the coming months to drive a
new growth strategy that will enable us to fully realize the
potential of InSite�s product portfolio and technology platform.�
The company�s marketed product, AzaSite (azithromycin ophthalmic
solution) 1%, has experienced steady quarter-over-quarter growth,
reporting an increase of 16 percent in third quarter 2008 sales
over the second quarter of 2008; and 147 percent over the first
quarter of 2008. InSite recently announced the completion of
patient dosing in the first of two pivotal Phase 3 clinical trials
for ISV-502. A new topical combination antibiotic/corticosteroid
agent, ISV-502 is formulated in InSite's patented DuraSite�
sustained delivery vehicle to provide simultaneous anti-infective
and anti-inflammatory therapy for the treatment of lid margin
disease in adults. There is no existing FDA-approved drug indicated
to treat this condition. InSite is also exploring new product
opportunities based on its DuraSite drug delivery platform.
DuraSite can be customized to deliver a wide variety of potential
drug candidates. DuraSite is capable of residing on the surface of
the eye for four to six hours and gradually releasing drug to
ensure a sustained therapeutic dose. About InSite Vision InSite
Vision develops novel ocular pharmaceutical products using its
DuraSite bioadhesive polymer core technology to enable topical
delivery and sustained release of existing drug molecules for
reduced frequency of treatment and improved efficacy. By
formulating the well-established antibiotic azithromycin in
DuraSite, InSite developed the lowest-dosing ocular antibiotic
available to the United States ophthalmic market, AzaSite
(azithromycin ophthalmic solution) 1%, launched by Inspire
Pharmaceuticals in the United States for the treatment of bacterial
conjunctivitis (pink eye). In addition, InSite has signed licensing
and distribution agreements in South Korea, four countries in South
America, Turkey and China. The company is seeking other
international partners for commercialization and distribution of
AzaSite. InSite is pursuing the expansion of its portfolio of
anti-infective ophthalmic products to include ISV-502, which is
currently in Phase 3 pivotal trials for the treatment of eye and
eyelid infection and inflammation, currently an unmet need. In
addition, the company is investigating other product and
collaboration opportunities with both the DuraSite-azithromycin
platform and/or with DuraSite and other molecules. Forward Looking
Statements This news release contains certain statements of a
forward-looking nature relating to future events, including InSite
Vision�s company realignment and its plans to advance strategic
priorities that will position the company for growth and drive
value for patients and shareholders, InSite�s plans to advance its
AzaSite family of products, InSite�s plans regarding further
marketing and distribution of AzaSite outside its currently
licensed territories, InSite�s corporate goals, and InSite�s plans
for products outside of its AzaSite franchise. Such statements
entail a number of risks and uncertainties, including but not
limited to: InSite�s reliance on third parties, including Inspire,
for the commercialization of AzaSite and its other products;
InSite�s ability to identify and hire a permanent CEO and ability
to retain Mr. Drapeau and other key management now and in the
future; InSite�s ability to reap the benefits of its restructuring
and not damage its ability to effectively purse its business plan
with a reduced workforce; the ability of InSite to enter into
corporate collaborations for AzaSite outside its currently licensed
territories, and with respect to its other product candidates,
including ISV-502; Inspire�s ability to successfully market AzaSite
in the United States and Canada; the ability of InSite�s
international partners to obtain approval to market AzaSite outside
the U.S. and Canada; InSite�s ability to commence clinical trials
with respect to its various product candidates and the results of
such trials; the clinical results of InSite�s product candidates;
InSite�s ability to expand its technology platform to include
additional indications; InSite�s ability to compete effectively,
either alone or through its partners, with other companies offering
competing products or treatments; InSite�s ability to maintain and
develop additional collaborations and commercial agreements with
corporate partners, including those with respect to AzaSite,
ISV-502, and AzaSite Xtra; 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.
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