First USFDA approval for Sun Pharma's Halol plant after warnings

This speciality drug, Sun claimed, is the first and only form of latanoprost that is not formulated with benzalkonium chloride

Sun Pharmaceutical Industries on Friday said it got approval for a glaucoma drug from the US Food and Drug Administration (USFDA) filed from its Halol plant in Gujarat, which had been under scanner for some time now.
 
Sun Pharma’s stocks reacted positively to the development and gained 2.35 per cent during day’s trade and ended at Rs 665.1 apiece on the BSE.
 
The abbreviated new drug application (ANDA) for this opthalmic drug was filed from the Halol plant, which was in trouble earlier this month after it received six adverse observations from the US drug regulator, two months after the FDA had lifted its previous warning.
 
The observations such as inadequate laboratory facilities, lack of procedures for cleaning and maintenance of equipment had led to a 1.8 per cent fall of the Sun’s stocks on September 7.

After the USFDA observations, analysts had expected the product approvals from the site to get delayed.  The speciality eye drug, Xelpros, is from the Sun Pharma Advanced Research Company (SPARC), a clinical stage bio-pharmaceutical firm formed in 2007 through a demerger from Sun Pharma.
 
Sun Pharma had in-licensed the product from SPARC in June 2015. This approval would lead to a milestone payment to SPARC, which is eligible to get royalties on commercialisation of Xelpros in the US. The drug will be commercialised in the US by Sun Ophthalmics, the branded ophthalmic division of Sun Pharma.

 
Xelpros is an opthalmic emulsion that helps to reduce intraocular pressure or pressure inside the eye in patients with open-angle glaucoma or ocular hypertension. Sun Pharma had indicated that sales from Xelpros was estimated to be in the range of $50-75 million over two to three years.
 
More than 2.25 million Americans older than 40 years have open-angle glaucoma. “Worldwide, glaucoma is the second-leading cause of blindness, surpassed only by cataracts; more than 2 million people around the world will develop open-angle glaucoma each year, and more than 3 million are bilaterally blind (in both eyes) from open-angle glaucoma,” said a company statement.
 
This speciality drug, Sun claimed, is the first and only form of latanoprost (glaucoma treatment drug) that is not formulated with benzalkonium chloride, a preservative commonly used in ocular formulations which causes allergic reactions in some patients. Xelpros has been developed using SPARC’s proprietary technology, Swollen Micelle Microemulsion.

 
Anil Raghavan, chief executive officer, SPARC, said: “Approval of Xelpros by USFDA is a significant milestone for the firm. It is also a validation of our SMM technology, which helps to solubilise drugs that have limited or no solubility, thus eliminating the need for benzalkonium chloride.”
 
The site contributed around 35 per cent of its consolidated sales in the last fiscal year. It was under the regulatory scanner since 2014 and got approval in July from the regulator following clearance for an oncology injectable, with a market size of $35 million. The plant received a warning letter in December 2015 and no products had been approved from the plant since 2014. Analysts expect Halol plant's resolution could add to $100 million revenue annually.