Summary :
- SPARC has entered into an agreement with Visiox Pharma to grant exclusive worldwide rights for the development and commercialization of PDP-716 and SDN-03.
Sun Pharma Advanced Research Company gained 1.9% to Rs 254.75 after the company announced that it has entered into an agreement with Visiox Pharma to grant exclusive worldwide rights for the development and commercialization of PDP-716 and SDN-03.
PDP-716 is a novel, once daily, ophthalmic suspension of brimonidine tartrate while SDN-037 is a novel, twice-a-day, clear, micellar formulation of difluprednate.
SPARC Enter Agreement with Visiox
Under the terms of the license agreement, SPARC will be eligible to receive an upfront payment, milestone payments and royalty on sales, in addition to 10% equity in Visiox. The granted exclusive worldwide rights are except for India and Greater China.
Anil Raghavan, CEO of SPARC said, We are excited to enter into this collaboration. The collaboration with Visiox allows us to make PDP-716 and SDN-037 available to patients seeking to overcome the challenges associated with the currently marketed formulations of these drugs.
Michael Derby, Chairman of Visiox, said, We are excited to partner with SPARC to register these important products and commercially launch them so that patients may be able to benefit from them as soon as possible.
SPARC ‘s Drug
Sun Pharma Advanced Research Company is a pharmaceutical company focused on continuously improving standards of care for patients globally through innovation in therapeutics and delivery.
The company’s standalone net loss during Q2 FY22 was Rs 55.14 crore as compared to a net loss of Rs 83.49 crore in Q2 FY21. Standalone revenue from operations surged 57.99% to Rs 27.87 crore in Q2 FY22 as against Rs 17.64 crore in Q2 FY21.
SPARC Drug Journey
About PDP 716
Sun Pharma Advanced Research Company (SPARC) reported positive top-line results from its Phase 3 trial (CLR_16_33) for its investigational drug, PDP-716 ophthalmic suspension, for the treatment of open angle glaucoma or ocular hypertension. The trial met its pre-specified primary endpoint, demonstrating that PDP-716 dosed once daily is equivalent to Alphagan P 0.1 per cent dosed three times a day.
The primary endpoint of the trial was to evaluate the efficacy of once daily (QD) dosing of PDP-716 0.35 per cent compared with Alphagan P 0.1 per cent dosed three times a day (TID) in subjects with open-angle glaucoma or ocular hypertension. Equivalence in intraocular pressure was demonstrated across all nine required timepoints, showing that the two formulations of brimonidine are functionally equivalent.
The safety of once daily (QD) dosing of PDP-716 compared with Alphagan P 0.1 per cent dosed three times a day (TID) was also evaluated. Treatment emergent adverse events were similar with 38.8 per cent in the PDP-716 group vs. 33.2 per cent with Alphagan P 0.1 per cent group
“We are very pleased by these results for PDP-716. Once daily dosing of PDP-716 can significantly reduce the dosing frequency compared to currently marketed formulation and can have positive impact on quality of life for patients with Glaucoma. On behalf of everyone at SPARC, I would like to extend my sincere gratitude to the patients, families and investigators involved in this study,” said Anil Raghavan, CEO of SPARC.
About SDN-03.
SDN-037 is a novel long acting (twice-a-day) formulation of an U.S. FDA approved ophthalmic steroid for eye pain and inflammation after cataract surgery. Currently marketed steroidal eye drops require administration every 4 to 6 hours, but SDN-037 is administered only twice a day, which improves the dosing convenience. Meanwhile, the formulation of SDN-037 is clear compared to marketed formulation which is milky resulting in blurring of vision after administration.
On October 14, 2020, SPARC reported positive top-line results from its Phase III trial for SDN-037. The trial met its pre-specified primary and secondary objectives, SDN-037 was generally well-tolerated in this study with adverse events consistent with the known safety profile of difluprednate.
According to statistics, in 2016, ophthalmic surgery discharged 4.7 million patients nationwide, and the total cases of cataract surgery were 2.3 million, and refractive surgery a million. There is currently no preparation of the reference steroid in Mainland China. If marketed, this product may become an exclusive product.
“SPARC reported positive top-line results from its phase 3 trial for its investigational drug, SDN-037, for the treatment of inflammation and pain associated with ocular surgery. The trial met its pre-specified primary and secondary objectives,” the company said in a regulatory filing.
About SPARC
Sun Pharma Advanced Research Company (SPARC) is a clinical stage bio-pharmaceutical company focused on continuously improving standards of care for patients globally, through innovation in therapeutics and delivery. SPARC was formed in 2007 through a demerger from SUN PHARMA, a global leader in speciality generics.
SPARC had out-licensed Elepsia XR to a subsidiary of Sun Pharmaceutical Industries Ltd in July 2016.
About Visiox Pharma
VisionPharma is a multi-faceted healthcare organization with a proficient marketing team, state-of-the-art manufacturing facilities and R&D centres that are at par with international standards.
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