Xelpros and Elepsia are near term commercialization opportunities for SPARC with peak sales potential of USD 50 million each in US market. Xelpros is used in treatment of chronic eye disease called Glaucoma, and Elepsia XR helps in treating seizures.
Sun Pharma Advanced Research Company (SPARC), on Thursday, said it has initiated site transfers and resubmission for two of its new drug applications (NDAs) Xelpros and Elepsia XR indicating more delay in commercialization of these products.
Both the products were originally produced at Sun Pharma's Halol plant. However, a warning letter issued by US FDA in December 2015 has blocked new approvals filed from the plant.Xelpros and Elepsia are near term commercialization opportunities for SPARC with peak sales potential of USD 50 million each in US market.
Xelpros is used in treatment of chronic eye disease called Glaucoma, and Elepsia XR helps in treating seizures.
While Xelpros provides Benzalkonium Chloride (BAK) free eye drops that reduces side-effects, Elepsia XR is a single tablet solution helping in better compliance.
Both the products were in-licensed by Sun Pharma from SPARC for commercialization.
“Our primary manufacturing partner is continuing with their plan of remediation to reverse their FDA compliant status,” said Anil Raghavan, Chief Executive Officer of SPARC providing update on company’s ongoing research operations in a conference call with analysts.
“Unfortunately we do not have a concrete timeline as such for this effort,” Raghavan said.
Raghavan said that as part of the Plan-B – his company has initiated alternate manufacturing sites for both the products and is in the process of resubmission of the applications.
“We intend to consult the agency to figure out the shortest possible route to get back to the cue, while we make progress of manufacturing at these locations,” Raghavan said.
SPARC declined to give resubmission timelines.
"We have to take batches from both these plants for these products. We need to have a significant amount of stability data coming from batches that we have. In Elepsia case we may have to do PK studies,” explained Raghavan on the regulatory process required for submission.
SPARC also said it’s in talks to out-license Baclofen GRS with partners. Baclofen is used in treatment of spasticity completed phase-3 studies and the data is expected to be out in October this year. The company plans to file an NDA in Q1 FY19. Baclofen has a potential of USD 100 million peak sales.
The company said it is consulting EU regulatory agencies to understand a path forward for approval of all 3 strengths for asthma drug Salmeterol – Fluticasone Dry Powder Inhaler.
SPARC is working on developing new drug delivery systems, complex chemistry and new chemical entities in therapeutic segments such as oncology, ophthalmology, CNS, pain management and dermatology.
The company recently raised Rs 500 crore from its promoters by issuing preferential warrants to spend largely on clinical studies.
SPARC promoted by Dilip Shanghvi was spun off from Sun Pharma as an independent entity focused on research and drug discovery in 2007.Shares of SPARC declined 7.37 percent to close at Rs.392.25 on BSE, while the benchmark Sensex gained 0.09 percent to end at 31,596.06 points.