Sun Pharma to acquire US-based Ocular Technologies for $40 million

Sun Pharmaceutical Industries Ltd on Wednesday announced the signing of definitive agreements by its wholly owned subsidiary for the acquisition of 100-per cent of Ocular Technologies, Sarl (OTS), a portfolio company of US-based Auven Therapeutics, an international private equity company focused on accelerated development of breakthrough therapeutic drugs.

Sun Pharma will pay Auven $40 million upfront, plus contingent development milestones and sales milestones as well as tiered royalty on sales of `Seciera' as consideration for this acquisition.

OTS owns exclusive, worldwide rights to Seciera (cyclosporine A, 0.09 per cent ophthalmic solution).

Seciera is currently in a Phase-3 confirmatory clinical trial for the treatment of Dry Eye Disease, an inflammatory ocular disease affecting approximately 16 million people in the United States alone. Seciera is a patented, novel, proprietary formulation of cyclosporine A 0.09 per cent.

It is a clear, preservative-free, aqueous solution. In a completed Phase 2b/3 clinical trial in 455 patients, Seciera demonstrated a rapid onset of action and was well tolerated by the study population. Based on the published data in literature, the efficacy and safety endpoints in these trials compared favorably to other formulations of cyclosporine A.

''This potential acquisition signifies continued momentum in enhancing our global branded specialty portfolio.'' commented Dilip Shanghvi, managing director, Sun Pharma. ''Coupled with our existing pipeline consisting of `BromSite', `DexaSite' and `Xelpros', this initiative will enable Sun Pharma to significantly expand its ophthalmic presence and reach millions of patients globally,'' he added.

''This is an important milestone for us'' said Jerry St. Peter, Vice President and Head, Sun Ophthalmics.

''As a specialty business dedicated solely to the needs of eye care practitioners and their patients, Sun Ophthalmics is excited at the potential to expand our existing portfolio. We hope to bring Seciera, to ophthalmologists and optometrists globally and participate in a dynamic market that is estimated to reach almost $5 billion worldwide by 2020.''

''The arrival of a potential novel cyclosporine formulation for patients suffering from Dry Eye Disease is very exciting,'' noted Kendall E Donaldson, MD, MS, associate professor of ophthalmology and co-director Cornea Fellowship, Bascom Plamer Eye Institute. ''Dry Eye Disease is a complex, chronic condition that affects patient's quality of life, often significantly. As practitioners, we require as many tools in our armamentarium as possible to afford patients the best chance at effective, lasting treatment and improved quality of life. The positive clinical trial results for Seciera, indicates great potential for patients and practitioners alike.''

The transaction is subject to approval of the US Federal Trade Commission as required under the Hart-Scott-Rodino Act and other closing conditions, and is expected to be completed by end of 2016.

Dry Eye Disease, as defined by the National Health Institute (NHI), occurs when the eye does not produce tears properly, or when the tears are not of the correct consistency and evaporate too quickly. In addition, inflammation of the surface of the eye may occur along with dry eye. If left untreated, this condition can lead to pain, ulcers, or scars on the cornea, and some loss of vision. The positive clinical trial results for Seciera is expected to result in commercial launch of a potential novel cyclosporine formulation in near future, thus helping patients suffering from this disease.

Dry eye can make it more difficult to perform some activities, such as using a computer or reading for an extended period of time, and it can decrease tolerance for dry environments, such as the air inside an airplane. Other names for dry eye include dry eye syndrome, keratoconjunctivitis sicca (KCS), dysfunctional tear syndrome, lacrimal keratoconjunctivitis, evaporative tear deficiency, aqueous tear deficiency, and LASIK-induced neurotrophic epitheliopathy (LNE).