[October 15, 2014] |
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ORA and SARcode Resolve Litigation
LEXINGTON & ANDOVER, Mass. --(Business Wire)--
Ora and SARcode have resolved litigation concerning Ora's intellectual
property and the parties have entered into a settlement agreement. Ora
has granted SARcode and its affiliates a non-exclusive worldwide license
to Ora's technology for use with Lifitegrast. Ora and SARcode's parent
company, Shire, look forward to exploring opportunities that may arise
to work together in the future.
SARcode Biosciences Inc. is a wholly-owned subsidiary of Shire.
About Ora, Inc.
Ora, Inc. is a global, full-service ophthalmic research and product
development firm. Over the past 30 years, it has helped clients earn 37
FDA approvals. Ora supports a wide array of organizations, from
start-ups to global pharmaceutical and device companies, to efficiently
and successfully bring their new products from concept to market. Ora's
pre-clinical and clinical models, unique methodologies and regulatory
strategies have been refined and proven across thousands of projects
both in the US and internationally. Ora brings together the world's most
extensive and experienced network of ophthalmic experts and R&D
professionals in order to maximize the value of new product initiatives.
About Shire
Shire enables people with life-altering conditions to lead better lives.
Our strategy is to focus on developing and marketing innovative
specialty medicines to meet significant unmet patient needs.
We provide treatments in Neuroscience, Rare Diseases, Gastrointestinal,
and Internal Medicine, and we are developing treatments for symptomatic
conditions treated by specialist physicians in other targeted
therapeutic areas, such as Ophthalmology.
THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION
REFORM ACT OF 1995
Statements included herein that are not historical facts are
forward-looking statements. Such forward-looking statements involve a
number of risks and uncertainties and are subjec to change at any time.
In the event such risks or uncertainties materialize, Shire's results
could be materially adversely affected. The risks and uncertainties
include, but are not limited to, that:
-
Shire's products may not be a commercial success;
-
revenues from ADDERALL XR are subject to generic erosion and revenues
from INTUNIV will become subject to generic competition starting in
December 2014;
-
the failure to obtain and maintain reimbursement, or an adequate level
of reimbursement, by third-party payors in a timely manner for Shire's
products may impact future revenues, financial condition and results
of operations;
-
Shire conducts its own manufacturing operations for certain of its
Rare Diseases products and is reliant on third party contract
manufacturers to manufacture other products and to provide goods and
services. Some of Shire's products or ingredients are only available
from a single approved source for manufacture. Any disruption to the
supply chain for any of Shire's products may result in Shire being
unable to continue marketing or developing a product or may result in
Shire being unable to do so on a commercially viable basis for some
period of time;
-
the development, approval and manufacturing of Shire's products is
subject to extensive oversight by various regulatory agencies.
Submission of an application for regulatory approval of any of our
product candidates, such as our planned submission of a New Drug
Application to the FDA for Lifitegrast, may be delayed for any number
of reasons and, once submitted, may be subjected to lengthy review and
ultimately rejected. Moreover, regulatory approvals or interventions
associated with changes to manufacturing sites, ingredients or
manufacturing processes could lead to significant delays, increase in
operating costs, lost product sales, an interruption of research
activities or the delay of new product launches;
-
the actions of certain customers could affect Shire's ability to sell
or market products profitably. Fluctuations in buying or distribution
patterns by such customers can adversely impact Shire's revenues,
financial condition or results of operations;
-
investigations or enforcement action by regulatory authorities or law
enforcement agencies relating to Shire's activities in the highly
regulated markets in which it operates may result in significant legal
costs and the payment of substantial compensation or fines;
-
adverse outcomes in legal matters and other disputes, including
Shire's ability to enforce and defend patents and other intellectual
property rights required for its business, could have a material
adverse effect on Shire's revenues, financial condition or results of
operations;
-
Shire faces intense competition for highly qualified personnel from
other companies, academic institutions, government entities and other
organizations. Shire is undergoing a corporate reorganization and the
consequent uncertainty could adversely impact Shire's ability to
attract and/or retain the highly skilled personnel needed for Shire to
meet its strategic objectives;
-
failure to achieve Shire's strategic objectives with respect to the
acquisition of ViroPharma Incorporated may adversely affect Shire's
financial condition and results of operations;
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the recommended combination with AbbVie Inc. ( " AbbVie" ) is subject
to a number of conditions, including approval by shareholders and
regulators
and other risks and uncertainties detailed from time to time in Shire's
filings with the Securities and Exchange Commission, including those
risks outlined in "Item 1A: Risk Factors" in Shire's Annual Report on
Form 10-K for the year ended December 31, 2013.
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