Shire has made its second acquisition in a month in the eye disease area with the purchase of the USA's SARcode Bioscience.
Under the terms of the deal, Shire is paying $160 million upfront to get hold of the privately-held, California-based group. The price could rise depending on the achievement of certain clinical, regulatory and/or commercial milestones.
The primary attraction of SARcode is Lifitegrast which is in Phase III trials for the signs and symptoms of dry eye disease. It is a small-molecule integrin antagonist and is administered via a preservative-free topical eye solution.
In one of three late-stage studies, OPUS-1 which concluded in 2012, one co-primary endpoint (reducing signs of dry eye) was met, but the other (reducing symptoms) was not achieved. However, Shire notes that this study was the basis of a positive meeting with the US Food and Drug Administration and two other trials, OPUS-2 and SONATA, are ongoing.
Shire added that it is "excited about the potential contribution of this product to the treatment options" for dry eye disease, which affects 25 million people in the USA. Of the nine million of them who are candidates for prescription drug treatment, about 10% are treated with the only currently approved product for dry eye disease, Allergan's Restasis (cyclosporine ophthalmic emulsion). However, there is no approved treatment indication which includes symptoms of dry eye, which Shire says is one of the most common complaints to eyecare specialists.
If all goes to plan in those studies, Shire hopes to launch Lifitegrast in the USA as early as 2016; it is also evaluating "an appropriate regulatory filing strategy" in other markets. The company added that as the acquisition of SARcode will introduce a new Phase III programme to its R&D pipeline, it is currently conducting a "prioritisation review of its portfolio to accommodate this new expenditure in 2013".
Flemming Ornskov, who takes over from Angus Russell as Shire's chief executive at the end of April, said the deal "and our recent acquisition of Premacure have the potential to provide the basis for an attractive ophthalmology business for our company, given the significant growth opportunities in this therapeutic area as well as Shire’s proven expertise in specialist markets".
Through the purchase of Sweden-based Premacure, announced a fortnight ago, Shire is getting access to a Phase II treatment for a potentially blinding eye disorder that affects premature babies.