2014

SARcode Bioscience Announces Acquisition by Shire US Holdings Inc. Lead product, lifitegrast ophthalmic solution for the treatment of dry eye, will expand Shire's presence in ophthalmology

BRISBANE, Calif., March 25, 2013 /PRNewswire/ -- SARcode Bioscience, Inc., an ophthalmic biopharmaceutical company, announced today that it will be acquired by Shire US Holdings Inc., a global specialty biopharmaceutical company focused on enabling people with life-altering conditions to lead better lives.  SARcode's lead program, lifitegrast ophthalmic solution, is currently in Phase 3 studies for the treatment of signs and symptoms of dry eye.

"We are extremely pleased to have found a like-minded and visionary partner in Shire," commented Quinton Oswald, CEO of SARcode Bioscience. "They recognize the significant unmet need that exists in dry eye disease, and the great opportunity to provide lifitegrast to millions of dry eye sufferers in the US. Their expertise, particularly in specialty markets, coupled with their global presence and clinical support, will be a tremendous asset to the approval and ultimate commercialization of lifitegrast worldwide."  The SARcode team will remain in place to support the ongoing clinical and manufacturing programs through submission of the New Drug Application to the FDA. 

Under the terms of agreement, Shire will make an upfront payment of $160 million and SARcode shareholders will be eligible to receive additional significant undisclosed payments upon achievement of certain clinical, regulatory, and/or commercial milestones. The transaction is expected to close in the second quarter, subject to regulatory approval in the United States, and other customary closing conditions. 

"The acquisition by Shire validates the need for therapies designed specifically for dry eye, and also underscores the incredible growth prospect in eyecare," commented Robert Alexander, PhD, Director, Alta Partners. "Based upon the positive clinical and regulatory track record of SARcode, we believe the near-term milestones are attainable, and would result in an excellent venture-level multiple for all investors," he added.   Institutional investors in SARcode Bioscience include Alta Partners, Clarus Venture Partners, Rho Ventures and Sofinnova Ventures.

The ongoing lifitegrast clinical development program includes two pivotal Phase 3 studies, called OPUS-1 and OPUS-2.  The 700-patient OPUS-2 study, which commenced earlier this year, will aim to build on the positive sign and symptom data resulting from OPUS-1. The results from these two studies, along with data from an ongoing year-long safety study called SONATA, will support a planned New Drug Application.

About Lifitegrast

Lifitegrast is an investigational novel small-molecule integrin antagonist that was "purpose-built" to meet several specifications that would make it an ideal dry eye therapy candidate.  It was chosen from over one thousand synthesized molecules for its ability to specifically and potently block the lymphocyte function-associated antigen-1/intercellular adhesion molecule (LFA-1/ICAM-1) interaction, a validated target in the chronic dry eye inflammatory cycle central to T-cell activation, proliferation, migration, and inflammatory cytokine release at sites of ocular surface stress.   Lifitegrast was engineered to provide good penetration into target periocular tissues, but low absorption into the systemic circulation, allowing for local delivery while minimizing adverse side effects. The molecule is also highly soluble in water, permitting easy formulation into an ophthalmic solution. Lifitegrast ophthalmic solution is unpreserved and is administered in a single-use unit-dose vial.

Lifitegrast has been studied in over 900 subjects to date and has demonstrated statistical significance in several signs and symptoms of dry eye disease in some studies .  Dose-dependent improvements were observed in both corneal and conjunctival staining, key indicators of ocular surface health.  Lifitegrast also improved eye dryness and ocular discomfort, the two most commonly reported symptoms of dry eye. Lifitegrast was well tolerated and there were no unexpected or serious ocular adverse events. The most commonly reported ocular adverse events were initial instillation site complaints, and were generally mild and transient in nature.

About Dry Eye Disease

Dry eye disease is a prevalent and often chronic condition estimated to affect approximately 25 million people in the US and 370 million people worldwide. This number is expected to grow substantially in the next decade due to an aging population and increasing incidence of type-2 diabetes, both of which contribute to higher rates of this condition.  Dry eye disease is among the most common disorders treated by ophthalmologists throughout the world.  Dry eye varies in severity and etiology, and symptoms most commonly manifest as ocular discomfort, eye dryness, and tear film instability due to decreased quality or quantity of tears.  A major contributing factor towards the development of dry eye is inflammation caused by T-cell infiltration, proliferation and inflammatory cytokine production that can lead to reduction in tear film quality and ocular surface damage.

About SARcode Bioscience

SARcode Bioscience, Inc., founded in 2006, is an ophthalmic biopharmaceutical company based in Brisbane, CA.  SARcode's lead development program is a novel class of lymphocyte function-associated antigen-1 (LFA-1) antagonists for the treatment T-cell mediated inflammatory diseases. www.sarcode.com

SOURCE SARcode Bioscience, Inc.



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