25th Mar 2013 12:00
SHIRE PLC - Shire to Acquire SARcode BioscienceSHIRE PLC - Shire to Acquire SARcode Bioscience
PR Newswire
London, March 25
Shire to Acquire SARcode Bioscience, Expands Presence in Ophthalmology
Acquisition brings Shire a new phase 3 compound being investigated for thesigns and symptoms of Dry Eye Disease
Lexington, MA, US - March 25, 2013 - Shire plc (LSE: SHP, NASDAQ: SHPG) todayannounced that it will acquire SARcode Bioscience Inc., a privately heldbiopharmaceutical company based in Brisbane, California. This acquisitioncontinues to build Shire's presence in the ophthalmology therapeutic categoryand brings a new phase 3 compound - LIFITEGRAST - currently under developmentfor the signs and symptoms of dry eye disease, into Shire's portfolio. Shireanticipates launching LIFITEGRAST in the United States as early as 2016 pendinga positive outcome of the phase 3 clinical development program and regulatoryapprovals. Shire is acquiring the global rights to LIFITEGRAST and willevaluate an appropriate regulatory filing strategy for markets outside of theUnited States.
Some 25 million people in the United States suffer from dry eye disease, and,of the approximate 9 million patients who are candidates for prescription drugtreatment, approximately 10% are treated with the only currently approvedprescription product for dry eye disease, indicated to help increase the eyes'natural ability to produce tears, which may be suppressed by inflammation dueto chronic dry eye. However, there is no approved treatment indication whichincludes symptoms of dry eye (one of the most common complaints to eye carespecialists).
"The acquisition of SARcode is a demonstration of Shire's focus on continuingto build our research and development pipeline with innovative,well-differentiated assets that address significant unmet patient need," saidFlemming Ornskov, M.D., Shire's CEO Designate. "This acquisition and our recentacquisition of Premacure have the potential to provide the basis for anattractive ophthalmology business for our company, given the significant growthopportunities in this therapeutic area as well as Shire's proven expertise inspecialist markets."
The global ophthalmic pharmaceutical market, valued at approximately $13billion in 2012 with a compound annual growth rate of 4.5 percent, isconsistent with Shire's focus on the specialty market. There are approximately42,000 office-based ophthalmologists, optometrists and retinal specialists inthe United States.
Under the terms of agreement, Shire will make an upfront payment of $160million and SARcode shareholders will be eligible to receive additionalundisclosed payments upon achievement of certain clinical, regulatory, and/orcommercial milestones. The transaction is expected to close in the secondquarter, subject to regulatory approval in the United States, and othercustomary closing conditions.
The acquisition of SARcode will introduce a new late-stage phase 3 clinicalprogram to Shire's research and development portfolio. Shire is currentlyconducting a prioritization review of its portfolio to accommodate this newexpenditure in 2013.
Barclays acted as financial advisor to Shire and Davis Polk LLP acted as legalcounsel to Shire. J.P. Morgan Securities LLC acted as financial advisor toSARCode and Wilson Sonsini Goodrich & Roasati acted as legal counsel toSarcode.
LIFITEGRAST and its Clinical Development Program
LIFITEGRAST, a small-molecule integrin antagonist, is believed to work byreducing inflammation through binding inhibition of the proteins lymphocytefunction - associated antigen 1 (LFA-1) and intercellular adhesion molecule-1(ICAM-1), influencing T-cell activation and cytokine (protein) release. Theinteraction between these two proteins plays a key role in the chronicinflammation associated with dry eye. T-cells are important components of theimmune system that help control the body's response to a foreign or harmfulsubstance or stimuli. LIFITEGRAST is administered via a preservative-freetopical eye solution.
Three clinical trials - OPUS-1, OPUS-2 and SONATA - currently make up the phase3 clinical development program for LIFITEGRAST. OPUS-1, a safety and efficacystudy, concluded in 2012. In this study the co-primary endpoint of reducingsigns of dry eye was met. Although the co-primary endpoint of reducing symptomswas not achieved, this study was the basis of a positive meeting with the FDAand for the continuation of the phase 3 clinical program, including OPUS-2, asafety and efficacy study of both signs and symptoms of dry eye disease, whichis currently ongoing. In addition to the OPUS-2 clinical efficacy study,SONATA, a randomized, placebo-controlled safety study is also ongoing. Shire isexcited about the potential contribution of this product to the treatmentoptions for patients with dry eye disease.
About Dry Eye Disease
Dry eye disease varies in severity and etiology, and symptoms most commonlymanifest as ocular discomfort, eye dryness, and tear film instability due todecreased quality or quantity of tears. A major contributing factor towards thedevelopment of dry eye is inflammation caused by T-cell infiltration,proliferation and inflammatory cytokine production that can lead to reductionin tear film quality and ocular surface damage.
Some 25 million people are affected in the United States. This number isexpected to grow substantially in the next decade due to an aging population, acontributor to higher rates of dry eye disease.
For further information please contact:
Investor Relations Eric Rojas [email protected] +1 781 482 0999 Sarah Elton-Farr [email protected] +44 1256 894157 Media Jessica Mann (Corporate) [email protected] +44 1256 894 280 NOTES TO EDITORSShire enables people with life-altering conditions to lead better lives.
Through our deep understanding of patients' needs, we develop and providehealthcare in the areas of:
* Behavioral Health and Gastro Intestinal conditions * Rare Diseases * Regenerative Medicineas well as other symptomatic conditions treated by specialist physicians.
We aspire to imagine and lead the future of healthcare, creating value forpatients, physicians, policymakers, payors and our shareholders.
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FORWARD - LOOKING STATEMENTS - "SAFE HARBOR" STATEMENT UNDER THE PRIVATESECURITIES LITIGATION REFORM ACT OF 1995
Statements included in this announcement that are not historical facts areforward-looking statements. Forward-looking statements involve a number ofrisks and uncertainties and are subject to change at any time. In the eventsuch risks or uncertainties materialize, Shire's results could be materiallyadversely affected. The risks and uncertainties include, but are not limitedto, that:
* Shire's products may not be a commercial success; * revenues from ADDERALL XR are subject to generic erosion; * 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 and earnings; * Shire relies on a single source for manufacture of certain of its products and a disruption to the supply chain for those 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; * Shire uses third party manufacturers to manufacture many of its products and is reliant upon third party contractors for certain goods and services, and any inability of these third party manufacturers to manufacture products, or any failure of these third party contractors to provide these goods and services, in each case in accordance with its respective contractual obligations, could adversely affect Shire's ability to manage its manufacturing processes or to operate its business; * the development, approval and manufacturing of Shire's products is subject to extensive oversight by various regulatory agencies and 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 and fluctuations in buying or distribution patterns by such customers could adversely impact Shire's revenues, financial conditions 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 the distraction of senior management, significant legal costs and the payment of substantial compensation or fines; * adverse outcomes in legal matters and other disputes, including Shire's ability to obtain, maintain, 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;and other risks and uncertainties detailed from time to time in Shire's filingswith the U.S. Securities and Exchange Commission, including its most recentAnnual Report on Form 10-K.
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