23.04.2008 12:30:00
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InSite Vision Appoints New Vice President of Operations
InSite Vision Incorporated (AMEX:ISV) today announced that Surendra
Patel has joined the company in the newly-created position of Vice
President, Operations.
Mr. Patel will be responsible for the strategic direction and oversight
of all operational activities for the company, including the expansion
of commercial contract manufacturing for international sales of AzaSite®,
InSite’s topical anti-infective ophthalmic
product; the on-site production of clinical supplies for testing product
candidates; and the planning and preparation of commercial capability
for future products.
"We welcome Surendra Patel at a time when we
anticipate the need for expanding our operations to accommodate growing
international sales of AzaSite and to prepare for our next product,
ISV-502 (AzaSite Plus), currently in pivotal Phase 3 trials,”
said S. Kumar Chandrasekaran, Chairman and Chief Executive Officer. "Surendra’s
30 years of experience with commercial manufacturing and drug
development in the biopharma industry, combined with his management
experience of both in-house operations and contract manufacturing, will
contribute greatly to our ability to execute our strategy of growing the
company to a multiple-product organization.”
Mr. Patel has more than 30 years of development and operational
experience in various management positions at pharmaceutical and
biotechnology companies, including Syntex, Roche Bioscience, Oread Inc.,
DrugAbuse Sciences, and most recently, at Nektar Therapeutics where he
served as Senior Director, Manufacturing Operations since 2002. While at
Nektar he managed clinical and commercial manufacturing operations,
plant maintenance, and calibration and warehouse operations that
included the direction of more than 100 in-house personnel, and played a
strategic role in the selection of domestic and international contract
manufacturing sites.
Experience at other companies includes the development of commercial and
clinical manufacturing processes and sites; management of clinical trial
material supply chains for development programs; selection and technical
support for contract drug development and manufacturing; management of
quality assurance compliance and quality assurance operations;
manufacturing and packaging technology transfer between manufacturing
plants; validation; and formulation and process development. Mr. Patel
has a Bachelor of Science degree in pharmaceutical formulation from De
Montford University, Leicester, United Kingdom.
About InSite Vision
InSite Vision develops novel topical anti-infective products, including
AzaSite® (azithromycin ophthalmic solution) 1%
which was launched in the United States by Inspire Pharmaceuticals for
the topical treatment of bacterial conjunctivitis (pink eye). InSite has
filed a New Drug Submission (NDS) with Health Canada seeking regulatory
approval to market AzaSite in Canada. In addition, InSite signed
licensing and distribution agreements with Shin Poong Pharm in South
Korea; and with Bioceutica, Inc. for four countries in South America;
and 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 (AzaSite Plus™)
in Phase 3 pivotal trials as a product candidate directed at treating
eye and eye lid infections, currently an unmet need particularly
prevalent among the growing elderly population. In addition, InSite is
evaluating the use of its product platform for ear infections with the
product candidate, AzaSite Otic™ in
preclinical development. The company is also developing AzaSite Xtra, an
anti-infective eye product designed to assist in penetrating
international markets. Additional information is available about the
company at: http://www.insitevision.com.
Forward Looking Statements
This news release contains certain statements of a forward-looking
nature relating to future events, such as the value brought to the
company by Mr. Patel, and InSite’s plans for
products outside of its AzaSite franchise, both within and outside of
the ophthalmic market. 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; the ability of InSite Vision to enter
into corporate collaborations for AzaSite outside the U.S. and Canada
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 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, AzaSite
Plus, AzaSite Xtra and AzaSite Otic; 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 AzaSite Plus and AzaSite Otic. 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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