Zalicus Licensee, Sanofi, Provides Status Update on Prednisporin (FOV1101)
Sanofi to Continue Product Development Under a Third-Party Sublicense
CAMBRIDGE, Mass. -- October 25, 2012
Zalicus Inc. (NASDAQ: ZLCS), a biopharmaceutical company that discovers and
develops novel treatments for patients suffering from pain, today announced
that Sanofi provided an update on the development status of Prednisporin™
(FOV1101) during the course of Sanofi’s quarterly financial and R&D pipeline
update on October 25, 2012. Prednisporin is a fixed dose combination of
prednisolone acetate and cyclosporine A being developed for certain
ophthalmologic indications including persistent allergic conjunctivitis.
Prednisporin was licensed by Zalicus to Fovea Pharmaceuticals SA (now a
division of Sanofi) in January 2006.
Based on a recent review of prior Phase 2b results for Prednisporin, Sanofi
has reassessed the commercial profile for Prednisporin and has made the
decision to continue the development of Prednisporin under a sublicense
agreement to be entered into with a third party to be identified by Sanofi.
The terms of the Second Amended and Restated Research and License Agreement
between Zalicus and Sanofi allows Sanofi to sublicense its rights to develop
and commercialize Prednisporin on a global basis, and the milestones and
royalties due to Zalicus for successful development and commercialization of
Prednisporin would continue to apply in the event Sanofi sublicenses the
rights to Prednisporin.
"We are pleased that Prednisporin remains in the Sanofi clinical development
pipeline and anticipate that the proposed sublicense by Sanofi will allow for
the continued clinical development and potential commercialization of
Prednisporin," commented Mark H.N. Corrigan, MD, President and CEO of Zalicus.
About Prednisporin (FOV1101)
Zalicus entered into a research and license agreement with Fovea
Pharmaceuticals SA, now a division of Sanofi, in January 2006. Under the
agreement, Sanofi received an exclusive worldwide license to Prednisporin
(FOV1101) and agreed to fund the development of Prednisporin for certain
ophthalmic diseases. Sanofi has advanced Prednisporin into Phase 2b clinical
development for persistent allergic conjunctivitis. For Prednisporin, Zalicus
has received payments totaling $1.5 million, and is eligible to receive up to
$39 million in development and regulatory milestone payments. Zalicus is also
eligible to receive royalties on net sales of Prednisporin by Sanofi or any
Zalicus Inc. (Nasdaq: ZLCS) is a biopharmaceutical company that discovers and
develops novel treatments for patients suffering from pain. Zalicus has a
portfolio of proprietary clinical-stage product candidates targeting pain such
as Z160 and Z944, and has entered into multiple revenue-generating
collaborations with large pharmaceutical companies relating to other products,
product candidates and drug discovery technologies. Zalicus applies its
expertise in the discovery and development of selective ion channel modulators
and its combination high throughput screening capabilities to discover
innovative therapeutics for itself and its collaborators in the areas of pain,
inflammation, oncology and infectious disease. To learn more about Zalicus,
please visit www.zalicus.com.
This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 concerning Zalicus, the
product candidate Prednisporin (FOV1101), its potential, and Sanofi’s plans to
sublicense it for further clinical development and commercialization. These
forward-looking statements about future expectations, plans, objectives and
prospects of Zalicus and Prednisporin (FOV1101) may be identified by words
like "believe," "expect," "may," "will," "should," "seek," "plan" or "could"
and similar expressions and involve significant risks, uncertainties and
assumptions, including risks related to the clinical development of
Prednisporin (FOV1101), the ability of Sanofi to successfully sublicense
Prednisporin to a third party, and those other risks that can be found in the
"Risk Factors" section of Zalicus' annual report on Form 10-K on file with the
Securities and Exchange Commission and the other reports that Zalicus
periodically files with the Securities and Exchange Commission. Actual results
may differ materially from those Zalicus contemplated by these forward-looking
statements. These forward-looking statements reflect management’s current
views and Zalicus does not undertake to update any of these forward-looking
statements to reflect a change in its views or events or circumstances that
occur after the date of this release except as required by law.
(c) 2012 Zalicus Inc. All rights reserved.
Justin Renz, 617-301-7575
Gina Nugent, 617-460-3579
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