Strengthens branded ophthalmic portfolio in US
Sun Pharmaceutical Industries’ subsidiary has entered into an agreement and plan of merger with InSite Vision, under which a Sun Pharma subsidiary has offered to acquire InSite Vision. InSite Vision focuses on developing new speciality ophthalmic products, including three late stage programmes. Sun Pharma is in the process of establishing a branded ophthalmic business in the US. This proposed acquisition of InSite Vision, coupled with the recent in-licensing of Xelpros (Latanoprost BAK-free eye drops) in June 2015, are steps in this direction. These deals give Sun Pharma access to four late stage branded ophthalmic products in the US.
Under the terms of the agreement and plan of merger, an indirect wholly-owned subsidiary of Sun Pharma will commence a tender offer for all of the issued and outstanding common stock of InSite Vision at a price of $0.35 per share in cash, a 30 per cent premium to the implied price per share under the terminated ‘Amended and Restated Agreement and Plan of Merger’ between InSite Vision and a competing bidder for InSite Vision’s common stock based on the stock price of the competing bidder as of September 11, 2015.
Commenting on the deal, Jerry St Peter, Vice President and Head of Sun Pharma’s US Ophthalmic Business said, “The potential addition of the InSite Vision portfolio serves as a significant step towards enhancing our branded speciality pipeline in the ophthalmic segment. InSite Vision will bring with it a pipeline of three late-stage clinical candidates, validated drug delivery technology and a track record of achieving US FDA approval for ophthalmic products.”
Kal Sundaram, Chief Executive Officer, North American Business, Sun Pharma said, “This potential acquisition is a part of our overall objective of transitioning to a speciality company. Besides dermatology, we have identified ophthalmics as one of the key segments for establishing our branded presence in the US.”
InSite Vision has developed DuraSite and DuraSite2 drug delivery platforms which are capable of extending the duration of drug retention, thus resulting in lower dosing frequency, and potentially enhanced efficacy. Based on this technology, InSite Vision has developed a pipeline of late-stage clinical candidates, and has recently filed a New Drug Application (NDA) with the US FDA for BromSite (0.075 per cent bromfenac) for the treatment of inflammation and prevention of pain associated with cataract surgery. It plans to file another NDA in 2017 for DexaSite (0.1 per cent dexamethasone) for the treatment of non-bacterial blepharitis, a common ocular condition for which there is no approved product currently available. Its AzaSite Plus is currently in phase III clinical development for the treatment of eye infections, and ISV-101 is in phase 1/2 clinical development for dry-eye disease and inflammation.
InSite Vision also has two commercialised products based on its innovative DuraSite platform approved for the treatment of bacterial eye infections, AzaSite (azithromycin ophthalmic solution) one per cent, and Besivance (besifloxacin ophthalmic suspension) 0.6 per cent, marketed by respective partners.