December 13, 2016
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Sun Pharma continues rapid expansion in eye care technologies

The company's latest acquisition is Ocular Technologies and its lead candidate Seciera to treat dry eye disease.

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Sun Pharmaceutical Industries in Mumbai, India, continues its rapid expansion into the ocular space with the announced acquisition of Ocular Technologies, whose lead candidate is the eye drop Seciera to treat dry eye disease, which is currently in a phase 3 clinical trial.

Ocular Technologies Sarl is a portfolio company of Auven Therapeutics, an international private equity firm based primarily in Lausanne, Switzerland.

The definitive acquisition agreement was inked Oct. 26 and is expected to close by the end of the year.

Jerry St. Peter

There is a $40 million upfront payment to Ocular Technologies by Sun Pharma, plus the opportunity for development and sales milestones and tiered royalties.

“Sun Pharma has made this strategic move to enter into the dynamic and growing dry eye therapeutic segment, which has very few players,” Jerry St. Peter, vice president and head of Sun Ophthalmics, a division of Sun Pharma that was created about 18 months ago, said.

“Within the next 5 years, dry eye therapy is expected to exceed $5 billion annually worldwide,” St. Peter said. “Furthermore, in the U.S. alone, the eye drop Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan) is on pace to reach $1.5 billion in revenue this year and the eye drop Xiidra (lifitegrast ophthalmic solution 5%, Shire) is expected to attain $1 billion in U.S. sales within 5 years, according to analysts’ forecasts.”

Despite these predictions, St. Peter said there are unmet needs in dry eye treatment options for clinicians and patients alike.

Unique formulation

“Seciera is a unique formulation of cyclosporine A,” St. Peter said. “The formulation platform is a novel, patented nanomicellar drug delivery technology.”

In a completed FDA phase 2b/3 clinical trial of 455 patients, the clear, preservative-free, aqueous solution (cyclosporine A 0.09%), taken twice a day, demonstrated a rapid onset of action and was well-tolerated, according to St. Peter.

The confirmatory phase 3 trial of Seciera is fully enrolled, and results are anticipated early next year. St. Peter declined to speculate on an expected approval date.

Sun Pharma will likely mine Ocular Technologies’ patented nanomicellar technology to treat other eye conditions as well.

Previous transactions

To date, the track record of Sun Pharma’s growth in eye care has been rapid.

In November 2015, the company acquired InSite Vision, including BromSite (bromfenac ophthalmic solution 0.075%), an NSAID that received FDA approval in April for the prevention of pain and the treatment of inflammation in patients undergoing cataract surgery.

“This is a unique indication,” St. Peter said. “No other nonsteroidal has this indication.”

The InSite transaction also included the eye drop DexaSite (dexamethasone 0.1% in DuraSite), which is currently in phase 3 development for blepharitis.

Furthermore, last year, Sun Ophthalmics in-licensed the prostaglandin glaucoma drug Xelpros from the Sun Pharma Advanced Research Center. “The benzalkonium chloride preservative-free formulation features our novel and patented swollen micelle microemulsion drug delivery technology,” St. Peter said.

Going forward, St. Peter said Sun Pharma will remain opportunistic and continue to build on its strategic direction.

“This includes organic internal development, opportunity for mergers and acquisitions, and in-licensing,” he said. – by Bob Kronemyer

Disclosure: St. Peter reports he is vice president and head of Sun Ophthalmics, a division of Sun Pharma.