InSite Vision Reaches Agreement to Sell ISV-403 to Bausch & Lomb
ALAMEDA, Calif. and ROCHESTER, N.Y., Dec. 19 /PRNewswire-FirstCall/ -- InSite
Vision Incorporated , an ophthalmic therapeutics, diagnostics and drug-delivery
company, and Bausch & Lomb today announced they have reached an agreement
whereby InSite Vision will sell its drug candidate ISV-403 for the treatment of
ocular infections to Bausch & Lomb.
Under the terms of the proposed transaction, InSite Vision will receive a cash
payment, reimbursement of certain ISV-403 product development expenses and a
percentage of future ISV-403 product sales in all licensed countries. Bausch &
Lomb will assume all future ISV-403 development and commercialization expenses
and, following a transfer period, will be responsible for all development
activities, with assistance from InSite Vision as appropriate. In addition, at
the closing of the transaction, the August 2002 ISV-403 licensing agreement and
the related Series A-1 Preferred Stock purchase agreement between Bausch & Lomb
and InSite Vision will be terminated and Bausch & Lomb will return to InSite
Vision for cancellation all shares of the Series A-1 Preferred Stock previously
issued. No further financial terms were disclosed.
The companies anticipate completing the transaction, which is contingent, among
other things, on receipt of third-party consents and the completion of certain
pre-closing items, before the end of 2003.
"This strategic transaction will allow us to pursue development of other
products in our portfolio," said S. Kumar Chandrasekaran, Ph.D., InSite Vision's
president and chief executive officer. "It provides immediate value to our
stockholders, while allowing InSite Vision to share in the potential future
commercial success of ISV-403." Bausch & Lomb indicated it expects to expense a portion of the purchase price in
the fourth quarter of 2003. The company also anticipates reversing a portion of
previously recorded restructuring reserves, with the net impact of the two items
resulting in no change to its previously issued guidance for the fourth
quarter.
About ISV-403 ISV-403 combines a fourth-generation fluoroquinolone, SS734, licensed from
Japan's SSP, Co., Ltd., with InSite Vision's patented drug delivery system,
DuraSite(R). Preclinical studies with ISV-403 indicated that this drug
candidate is effective against bacteria resistant to third generation
fluoroquinolone products. In August 2002, InSite Vision and Bausch & Lomb
entered a license agreement to develop and commercialize ISV-403 with InSite
responsible for all development activities. In April 2003, InSite Vision
initiated a Phase I clinical trial with ISV-403 to evaluate its systemic and
ocular safety and tolerability in normal volunteers. The following month,
InSite Vision received a notice of allowance from the U.S. Patent and Trademark
Office (USPTO) related to ISV-403 for the treatment of ocular infections.
About InSite Vision InSite Vision is an ophthalmic products company focused on glaucoma, ocular
infections and retinal diseases. In the area of glaucoma, the Company conducts
genomic research using TIGR and other genes. A portion of this research has
been incorporated into the Company's OcuGene(R) glaucoma genetic test for
disease management, as well as ISV-205, its novel glaucoma therapeutic. ISV-205
uses InSite Vision's proprietary DuraSite(R) drug- delivery technology, which
also is incorporated into the ocular infection products ISV-401 and ISV-403, and
InSite Vision's retinal disease program. Additional information can be found at
http://www.insitevision.com/ .
About Bausch & Lomb Bausch & Lomb is the eye health company, dedicated to perfecting vision and
enhancing life for consumers around the world. Its core businesses include soft
and rigid gas permeable contact lenses and lens care products, and ophthalmic
surgical and pharmaceutical products. The Bausch & Lomb name is one of the best
known and most respected healthcare brands in the world. Celebrating its 150th
anniversary in 2003, the Company is headquartered in Rochester, New York.
Bausch & Lomb's 2002 revenues were $1.8 billion; it employs approximately 11,500
people worldwide and its products are available in more than 100 countries.
More information about the Company can be found on the Bausch & Lomb Web site at
http://www.bausch.com/ .
This press release herein may contain, among other things, certain statements of
a forward-looking nature relating to future events or the future business
performance of InSite Vision. Such statements entail a number of risks and
uncertainties, including but not limited to: InSite Vision's ability to
complete the proposed sale of ISV-403 and the related licensing agreement with
Bausch & Lomb Incorporated, including satisfaction of all closing conditions,
including the consent of SSP; InSite Vision's immediate need for significant
additional funding to continue its operations, irrespective of whether the
proposed transaction with Bausch & Lomb is completed; 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, OcuGene,
ISV-401 and ISV-205, as well as ISV-403 to the extent the proposed transaction
with Bausch & Lomb is not competed; InSite Vision's ability to maintain and
develop additional collaborations and commercial agreements with corporate
partners, in addition to the proposed sale and licensing agreement with Bausch &
Lomb with respect to ISV-403, including those with respect to ISV-401 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 determinations
by the U.S. Food and Drug Administration, including those with respect to
OcuGene, ISV-401 and ISV-205, as well as ISV-403 to the extent the proposed
transaction with Bausch & Lomb is not completed. Reference is made to the
discussion of risk factors detailed in InSite Vision's filings with the
Securities and Exchange Commission, including its annual report on Form 10-K for
the 2002 fiscal year and Quarterly Report on Form 10-Q for the fiscal quarter
ended September 30, 2003. Any projections in this release are based on limited
information currently available to InSite Vision, which is subject to change.
Although any such projections and the factors influencing them will likely
change, InSite Vision undertakes no obligation to update the information, since
InSite Vision may only provide guidance at certain points during the year. Such
information speaks only as of the date of this release. Actual events or
results could differ materially and no reader of this release should assume
later that the information provided today is still valid.
This news release contains, among other things, certain statements of a
forward-looking nature relating to future events or the future business
performance of Bausch & Lomb. Such statements involve a number of risks and
uncertainties including those concerning global and local economic, political
and sociological conditions, currency exchange rates, government pricing changes
and initiatives with respect to healthcare products, product development and
rationalization, enrollment and completion of clinical trials, regulatory
approvals, the outcome of litigation, product introductions, the financial
well-being of key customers, development partners and suppliers, the successful
execution of marketing strategies, the continued successful implementation of
its efforts in managing and reducing costs and expenses, continued positive
relations with third party financing sources, as well as the risk factors listed
from time to time in the Company's SEC filings, including but not limited to the
current report on Form 8-K, dated June 14, 2002, and the Form 10-Q for the
quarter ended September 27, 2003.
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.
For further information, please contact: S. Kumar Chandrasekaran, CEO, or
Sandra Heine, Director of Finance, both of InSite Vision Incorporated,
+1-510-865-8800; or investors, Bruce Voss, , or Jody Cain, , both of
Lippert/Heilshorn & Associates, Inc., +1-310-691-7100, for InSite Vision
Incorporated; or media, Chenoa Taitt, , or Michael Hopkins, , both of
Lippert/Heilshorn & Associates, Inc., +1-212-838-3777, for InSite Vision
Incorporated; or investors, Daniel L. Ritz, +1-585-338-5802, , or media,
Margaret A. Graham, +1-585-338-5469, , both of Bausch & Lomb. DATASOURCE: InSite Vision Incorporated; Bausch & Lomb CONTACT: S. Kumar Chandrasekaran, CEO, or Sandra Heine, Director of Finance, both of InSite Vision Incorporated, +1-510-865-8800; or investors, Bruce Voss, , or Jody Cain, , both of Lippert/Heilshorn & Associates, Inc., +1-310-691-7100, for InSite Vision Incorporated; or media, Chenoa Taitt, , or Michael Hopkins, , both of Lippert/Heilshorn & Associates, Inc., +1-212-838-3777, for InSite Vision Incorporated; or investors, Daniel L. Ritz, +1-585-338-5802, , or media, Margaret A. Graham, +1-585-338-5469, , both of Bausch & Lomb Web site: http://www.lhai.com/ Web site: http://www.bausch.com/ Web site: http://www.insitevision.com/
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