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
Sun Pharma Advanced Research Company Ltd. (SPARC) and Sun Pharmaceutical Industries Ltd. (Sun Pharma) announced that SPARC has licensed out Xelpros (Latanoprost BAK-free eye drops) to a subsidiary of Sun Pharma for the US market.
In addition to up-front payment of $3 million, SPARC will receive certain other milestone payments, both totaling to $16 million from Sun Pharma. It is also eligible for certain defined royalties and additional milestone payments linked to the actual sales performance of Xelpros.
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.
Anil Raghavan, CEO, SPARC said, “SPARC is excited at this licensing deal for Xelpros because it allows us to commercialise the first-class science we’ve been doing at our research labs. Xelpros is a much safer product that greatly improves the standards of glaucoma care.”
Commenting on the in-licensing, Kirti Ganorkar, Senior Vice President, Business Development, Sun Pharma said, “The in-licensing of Xelpros will facilitate Sun Pharma’s entry into the branded ophthalmology segment in the US. This is a part of Sun Pharma’s strategy to strengthen its presence in the US specialty segment.”
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.
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