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Mergers and Acquisitions

Date: 2013-03-25

Type of information: Company acquisition

Acquired company: SARcode Bioscience (USA)

Acquiring company: Shire (UK-USA)

Amount: upfront payment of $160 million and additional significant undisclosed payments upon achievement of certain clinical, regulatory, and/or commercial milestones

Terms:

Shire has announced that it will acquire SARcode Bioscience Inc., a privately held biopharmaceutical company based in Brisbane, California. This acquisition continues to build Shire’s presence in the ophthalmology therapeutic category and brings a new phase 3 compound – lifitegrast– currently under development for the signs and symptoms of dry eye disease, into Shire’s portfolio. Shire anticipates launching lifitegrast in the United States as early as 2016 pending a positive outcome of the phase 3 clinical development program and regulatory approvals. Shire is acquiring the global rights to lifitegrast and will evaluate an appropriate regulatory filing strategy for markets outside of the United States.
Under the terms of agreement, Shire will make an upfront payment of $160 million and SARcode shareholders will be eligible to receive additional 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.

Details:

Lifitegrast, a small-molecule integrin antagonist, is believed to work by reducing inflammation through binding inhibition of the proteins lymphocyte function – associated antigen 1 (LFA-1) and intercellular adhesion molecule-1 (ICAM-1), influencing T-cell activation and cytokine (protein) release.  The compound 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.
Three clinical trials – OPUS-1, OPUS-2 and SONATA – currently make up the phase 3 clinical development program for  lifitegrast. OPUS-1, a safety and efficacy study, concluded in 2012. In this study the co-primary endpoint of reducing signs of dry eye was met. Although the co-primary endpoint of reducing symptoms was not achieved, this study was the basis of a positive meeting with the FDA and for the continuation of the phase 3 clinical program, including OPUS-2, a safety and efficacy study of both signs and symptoms of dry eye disease, which is currently ongoing. 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.

Related:

Ophtalmological diseases

Is general: Yes