Zalicus Licensee, Sanofi, Provides Status Update on Prednisporin (FOV1101)
Sanofi to Continue Product Development Under a Third-Party
Sublicense
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 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
future sublicensee.
About Zalicus
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.
Forward-Looking Statements
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.
