Date: 2015-08-03
Type of information: Company acquisition
Acquired company: Foresight Biotherapeutics (USA - NY)
Acquiring company: Shire (UK - USA)
Amount: $300 million
Terms: * On August 3, 2015, Shire announced 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. In May 2014, Shire established its Ophthalmics Business Unit, solidifying its commitment to growing in this therapeutic area. 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.
Details: 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.
Related: Ophtalmological diseases
