Sun Pharma Advanced Research Company Ltd. (SPARC) has licensed out glaucoma medicine Xelpros (latanoprost BAK-free eye drops) to a subsidiary of Sun Pharma for the US market.
Under the licence agreement, SPARC will get an upfront payment of $ 3 million and other payment total of $ 16 million from Sun Pharma. In December 2014, the US FDA had issued a Complete Response Letter (CRL) to SPARC for its New Drug Application (NDA) for latanoprost BAK-free eye drops. This CRL has since been replied to and a response from the US FDA is awaited.
Latanoprost BAK-free is a preservative-free, once-a-day formulation of the glaucoma medication latanoprost using SPARC’s novel Swollen Micelle Microemulsion (SMM) technology.
Sun Pharma has recently appointed Jerry St. Peter as vice president and head, ophthalmology for Sun Pharma’s US business. Jerry has a successful commercial and general management track-record in specialty pharmaceutical companies with an extensive knowledge of the ophthalmology market. He will lead Sun's Ophthalmic business in the US and will commercialize Xelpros.
BAK is known to cause or aggravate ocular surface disease (OSD). prostaglandin analogues like latanoprost are the first line of treatment for glaucoma. Market estimates place latanoprost usage at as high as 55 per cent of the US glaucoma market. Swollen micelle microemulsion technology, or SMM, helps to solubilize drugs that have limited or no solubility, and cuts out the need for a preservative.