Xelpros Approval Adds Spark To Sun’s Site Too?
Executive Summary
Xelpros may not be seen as a huge money-spinner, but its approval by the US FDA signals Sun Pharma's expanding interest in the US ophthalmology space. The clearance also potentially indicates that recent compliance issues at the company’s Halol site may not be all-encompassing.
Sun Pharma Advanced Research Co. Ltd. (SPARC) has finally received US FDA approval for Xelpros (latanoprost ophthalmic emulsion 0.005%), marking the culmination of a bumpy regulatory journey for the product with its fortunes linked to commercialization partner Sun Pharmaceutical Industries Ltd.’s Halol facility. (Also see " Little Spark Yet For Xelpros Amid New CRL " - Scrip, 4 Aug, 2015.)
SPARC is the listed spin-off R&D arm of Indian firm Sun Pharma.
The FDA green light for Xelpros, ahead of its November PDUFA date, is also being viewed by some as a signal that recent compliance observations at Halol may not materially hurt product approvals from the facility. SPARC had earlier contracted, as a fallback, an alternate manufacturing site for Xelpros in view of the compliance challenges at the Halol facility in India.
Xelpros, the first and currently only form of latanoprost not formulated with benzalkonium chloride (BAK), a preservative commonly used in topical ocular preparations, had been licensed to Sun Pharma in June 2015; the FDA approval will now trigger a milestone payment to SPARC.
Sun’s R&D arm is also entitled to milestone payments and royalties on commercialization of Xelpros in the US, though specifics around launch timelines by Sun Pharma were not immediately clear.
SPARC CEO Anil Raghavan underscored that the FDA approval is also a validation of the firm’s proprietary Swollen Micelle Microemulsion (SMM) technology, which helps to solubilize drugs that have limited or no solubility thus eliminating the need for BAK.
Xelpros Sales Potential
Xelpros, used for the reduction of elevated intraocular pressure (IOP, or pressure inside the eye) in patients with open-angle glaucoma or ocular hypertension, is projected to have peak annual sales potential of $50m.
SPARC had in 2016 indicated that about 10-16% patients on Xalatan (latanoprost) and other BAK-containing products develop ocular surface disease (OSD) symptoms, based on certain primary market research conducted through a third party. Latanoprost is the most widely prescribed prostaglandin for glaucoma.
Nomura said that it estimates that the overall addressable market for Xelpros is 2.0-3.5 million packs per year.
“Assuming a realization of $75 per pack, we estimate Xelpros’ addressable market at $150-250m. We expect Xelpros to achieve peak sales of $50m (achievable over the next three years), which would imply penetration of 20-33% of the addressable market,” Nomura said in a September 14 note.
This is the Sun group’s second FDA approval in the ophthalmology space on the trot. Last month, the US agency approved Sun’s therapy for dry eye disease, Cequa (cyclosporine ophthalmic solution 0.09%) , which came to the Indian firm via its acquisition of Ocular Technologies Sarl. Sun’s BromSite (bromfenac ophthalmic solution 0.075%) for inflammation and pain following cataract surgery is already on the US market. (Also see "First US Branded Ophthalmic Launch A ‘Milestone’ For Sun" - Scrip, 4 Dec, 2016.)
SPARC’s pipeline also includes other promising ophthalmology drugs such as PDP-716 (an improved formulation of brimonidine for once a day dosing) and SDN-037 (a novel formulation of an existing steroid utilizing its Micellar technology). “Ophthalmology is one of SPARC’s core area of focus. SPARC would continue to build our ophthalmology pipeline to address the unmet medical need of the patients,” SPARC told Scrip.
Allays Concerns Around Halol?
The FDA approval for Xelpros is also being indirectly viewed as general affirmation that recent compliance observations at Halol may not potentially set back all product approvals from the site.
Sun’s Halol site, which earlier this year received an EIR (Establishment Inspection Report) from the FDA, ending long-running scrutiny by the regulator, failed to make the compliance cut at a pre-approval inspection that ran from August 27-31. (Also see "Sun’s Halol Site Out Of Compliance Rut, Could Add Some SPARC Too" - Scrip, 13 Jun, 2018.)
The inspection ended with Halol receiving a Form 483, with six observations. A Form 483 is a notice of the agency’s inspectional observations that lists deficiencies in the quality system.
Nomura said that the Xelpros approval may help allay concerns over a possible delay in approvals from the site following the inspection.
Other analysts said that the FDA observations appeared more product-specific and the approval for Xelpros appeared to suggest that were no widespread concerns at the Halol site.
"The observations generally don’t appear to be encompassing the entire facility," Nimish Mehta, founder of Research Delta Advisors, told Scrip. On September 7, Sun had informed Indian bourses that it would be submitting its response to the FDA observations within 15 business days, and that it is committed to addressing the observations “promptly”.