Shire Acquires Foresight Biotherapeutics Inc., Boosting Ophthalmics Portfolio with Late-Stage Asset

PRESS RELEASE

Lexington, Mass. ­ August 3, 2015 ­ Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that it has acquired New York-based, privately held Foresight Biotherapeutics Inc. for $300 million. With the acquisition, Shire acquires the global rights to FST-100 (topical ophthalmic drops combining 0.6% povidone iodine (PVP-I) and 0.1% dexamethasone), a therapy in late-stage development for the treatment of infectious conjunctivitis, an ocular surface condition commonly referred to as pink eye. This acquisition further strengthens Shire¹s late-stage pipeline, has a clear strategic fit with lifitegrast, which is in late-stage development for treatment of dry eye disease, another ocular surface condition, and further demonstrates Shire¹s commitment to building a leadership position in ophthalmics.

³With the acquisition of Foresight Biotherapeutics, Shire demonstrates its commitment to eye care while advancing its strategy of addressing high unmet medical need through transformative treatments for rare diseases and specialty medicines,² said Flemming Ornskov, M.D., CEO, Shire. ³Ophthalmics is a highly-attractive growth area for Shire and this acquisition allows us to strengthen our presence in this therapeutic area. It is highly synergistic with the planned lifitegrast commercial structure. FST-100 and lifitegrast, if approved, would address two of the leading reasons people seek eye care treatment.²

Michael Weiser, M.D., Ph.D., Director, Foresight Biotherapeutics, added: ³We¹re excited about the potential benefits of FST-100 for patients and the physicians who care for them. In our discussions with experts in the field, we¹ve heard their enthusiasm for the possibility of a treatment that could reduce inflammation while killing virus and bacteria without the risk of unnecessary antibiotic use. We¹re pleased that Shire has committed to moving this program forward in development, so FST-100 might become an important treatment option for patients with either viral or bacterial conjunctivitis.²

Currently no therapy exists to resolve both clinical signs and symptoms and eradicate adenovirus, which is the most common cause of viral conjunctivitis. Approximately 50 percent of infectious conjunctivitis cases have a viral etiology, and 65 to 90 percent of these are caused by adenovirus. Viral conjunctivitis is highly infectious and transmissible, causing lost work and school days as well as increased healthcare costs and risks from unnecessary antibiotic prescriptions.There are 5.9 million cases of infectious conjunctivitis annually in the United States and approximately 5.4 million cases in the EU annually.

If approved by regulatory agencies, FST-100 has the potential to become the first agent to treat both viral and bacterial conjunctivitis. This is important as it is frequently difficult to ascertain the etiology of the condition based on clinical presentation.

³As a researcher and clinician, I know first-hand the significant unmet patient need for an effective treatment for infectious conjunctivitis as well as the challenges associated with treating this condition, so I¹m excited about the potential of FST-100,² said Edward Holland, M.D., Director, Cornea Services at the Cincinnati Eye Institute and Professor of Ophthalmology at the University of Cincinnati. ³I¹m also pleased to know that Shire, with its research and commercial expertise, will further develop FST-100 with the goal of bringing it to market as a treatment option for this significant clinical problem."

Shire has acquired the global rights to FST-100 and will evaluate an appropriate regulatory filing strategy for additional markets outside the United States. Under the terms of the agreement, Shire will make a cash payment of $300 million to complete the acquisition of Foresight Biotherapeutics.