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

FST-100, if approved, would be the first to treat both bacterial and viral eye infections, transforming treatment of acute conjunctivitis

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 Shire’s 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 Shire’s commitment to building a leadership position in ophthalmics.

“With 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,” said Flemming Ornskov, M.D., CEO, Shire. “Ophthalmics 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.”

Michael Weiser, M.D., Ph.D., Director, Foresight Biotherapeutics, added: “We’re 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, we’ve 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. We’re 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.”

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.

“As 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 I’m excited about the potential of FST-100,” said Edward Holland, M.D., Director, Cornea Services at the Cincinnati Eye Institute and Professor of Ophthalmology at the University of Cincinnati. “I’m 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.

FST-100 and Its Clinical Development Program

The phase 2 proof-of-concept efficacy and safety clinical trial program for FST-100 involved two studies in adenoviral conjunctivitis – one three-arm study and another two-arm pilot study. While the two-arm study showed a trend toward efficacy, there were too few subjects testing positive for a viral presence for the study to deliver meaningful results, and it was not statistically significant. In the three-arm study, patients were randomized to receive FST-100, PVP-I or vehicle four times daily for five days. Patients treated with FST-100 showed a statistically significant improvement in rates of clinical cure and viral eradication vs. vehicle at Day 6 (30.6% vs. 6.4%, p=0.0033). In the same trial, there was a trend toward clinical significance for FST-100 versus PVP-I (30.6% vs.18.0%, p=0.1432). The most common treatment emergent adverse events were corneal infiltrates (19%), punctate keratitis (22.4%) and eyelid edema (12.1%).

The phase 2 clinical data formed the basis of a meeting with the FDA, in which Foresight Biotherapeutics discussed the path forward to conduct a phase 3 clinical development program for FST-100 as a potential treatment for adenoviral conjunctivitis. Upon close of the transaction, Shire will take responsibility for the final development and implementation for the phase 3 clinical program for FST-100, to also include investigation for the treatment of bacterial conjunctivitis. Foresight Biotherapeutics conducted pre-clinical experiments evaluating bacterial killing speed of FST-100 against pathogens that may cause bacterial conjunctivitis, and the resulting data support further exploration.

Shire’s Commitment to Ophthalmics

In May 2014, Shire established its Ophthalmics Business Unit, solidifying its commitment to growing in this therapeutic area. Shire’s multi-faceted approach to discovery, development, and delivery in both rare diseases and specialty conditions includes our efforts to address unmet needs in eye care.

Shire’s growth in ophthalmics has been driven by a combination of strategic acquisitions and organic growth. The Company is focused on continuing to expand the ophthalmics portfolio to include treatment options for rare diseases and those for anterior and posterior eye conditions. Acquisitions in the last two years include SARcode Bioscience, Premacure AB, and BIKAM Pharmaceuticals, which has helped bolster Shire’s early-, mid- and late-stage ophthalmics pipeline. The Company currently has an ophthalmics pipeline of investigational products in dry eye, retinopathy of prematurity, autosomal dominant retinitis pigmentosa, glaucoma, and now adenoviral and bacterial conjunctivitis. The acquisition of Foresight Biotherapeutics positions Shire to potentially become a leader in providing treatments for ocular surface conditions, which encompass dry eye disease and infectious conjunctivitis.

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 focus on providing treatments in Rare Diseases, Neuroscience, Gastrointestinal and Internal Medicine and are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas, such as Ophthalmics.

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Statements included in this announcement that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject 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:

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and other risks and uncertainties detailed from time to time in Shire’s filings with the US Securities and Exchange Commission, including its most recent Annual Report on Form 10-K.