LEXINGTON, Massachusetts, August 3, 2015 /PRNewswire/ --
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.
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.
THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
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:
- Shire's products may not be a commercial success;
- product sales from ADDERALL XR and INTUNIV are subject to generic competition;
- the failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payers in a timely manner for Shire's products may affect future revenues, financial condition and results of operations;
- Shire conducts its own manufacturing operations for certain of its products and is reliant on third party contract manufacturers to manufacture other products and to provide goods and services. Some of the Shire's products or ingredients are only available from a single approved source for manufacture. Any disruption to the supply chain for any of the Shire's products may result in Shire being unable to continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis for some period of time;
- the manufacture of Shire's products is subject to extensive oversight by various regulatory agencies. Regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
- Shire has a portfolio of products in various stages of research and development. The successful development of these products is highly uncertain and requires significant expenditures and time, and there is no guarantee that these products will receive regulatory approval;
- the actions of certain customers could affect Shire's ability to sell or market products profitably. Fluctuations in buying or distribution patterns by such customers can adversely affect Shire's revenues, financial conditions or results of operations;
- investigations or enforcement action by regulatory authorities or law enforcement agencies relating to Shire's activities in the highly regulated markets in which it operates may result in significant legal costs and the payment of substantial compensation or fines;
- adverse outcomes in legal matters and other disputes, including Shire's ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on Shire's revenues, financial condition or results of operations;
- Shire faces intense competition for highly qualified personnel from other companies and organizations. Shire is undergoing a corporate reorganization and was the subject of an unsuccessful acquisition proposal and the consequent uncertainty could adversely affect Shire's ability to attract and/or retain the highly skilled personnel needed for Shire to meet its strategic objectives;
- failure to achieve Shire's strategic objectives with respect to the acquisition of NPS Pharmaceuticals, Inc. may adversely affect Shire's financial condition and results of operations;
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.
SOURCE Shire plc