SPARC enters into licensing deal with CMS to develop and commercialise products

Sun Pharma Advanced Research Company (SPARC) has announced a grant of exclusive licenses to a subsidiary of China Medical System Holdings Limited (CMS) to develop and commercialise multiple products in Mainland China, Hong Kong, Macao and Taiwan.

The licensing deal with CMS includes XelprosTM (Latanoprost BAK-free) ophthalmic emulsion; ElepsiaTM (Levetiracetam) XR 1000mg/1500mg tablets, along with generic strengths of Levetiracetam XR, 500mg and 750mg; TaclantisTM / PICS (Paclitaxel Injection Concentrate for Suspension); PDP-716 (Brimonidine once-a-day) eye drops; and SDN-037 eye drops.

The initial term of the agreement shall be 20 years from the date of first commercial sale of each product in the territory and may be further extended as per mutual agreement between the parties.

“This collaboration is a significant milestone as this is the first licensing deal by SPARC for China. China is the third largest pharmaceutical market in the world and holds significant commercial opportunity for SPARC”, said Anil Raghavan, CEO, SPARC.

As per the agreement, SPARC is eligible to receive upfront payment, milestone payments and royalty on net sales of the products in territories.

XelprosTM (Latanoprost BAK-free) 0.005%, is a translucent ophthalmic emulsion, indicated for reduction of elevated intraocular pressure in patients with open-angle glaucoma, or ocular hypertension. The recommended dosage of XelprosTM is one drop in the affected eye(s) once daily in the evening. XelprosTM was approved by the USFDA and was commercialised in the USA in FY19.

ElepsiaTM XR is a novel product designed as an extended release formulation of Levetiracetam 1000mg/1500mg, indicated as adjunctive therapy for the treatment of partial onset seizures in patients 12 years of age and older, developed using SPARC’s WrapMatrixTM technology and approved by the USFDA in FY19. Generic strengths of Levetiracetam XR, 500mg and 750mg are also developed using SPARC’s WrapMatrixTM technology and approved by USFDA in FY14.

TaclantisTM /PICS (Paclitaxel Injection Concentrate for Suspension) is a Cremophor and Albumin-free formulation of Paclitaxel. TaclantisTM is expected to have indications same as that of Abraxane i.e. metastatic breast cancer (MBC), locally advanced or metastatic non-small cell lung cancer (NSCLC) and metastatic adenocarcinoma of the pancreas. Since it is Cremophor-free, it can be diluted in either a PVC or non-PVC sterile infusion bag with an appropriate volume of 5% w/v Dextrose injection. Premedication to prevent hypersensitivity is generally not needed prior to administration of TaclantisTM. USFDA has accepted the New Drug Application submitted by SPARC for review.

PDP-716 is once-a-day formulation of Brimonidine developed using SPARC’s TearActTM technology and is proposed for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. It provides dosing convenience to patients compared to currently marketed product that requires thrice-a-day dosing.

SPARC has initiated the pivotal Phase III study of PDP-716 for registration in the USA. The study is randomizing patients and is expected to be completed in FY21.

SDN-037 is a novel long acting (twice-a-day) formulation of an USFDA-approved ophthalmic steroid for eye pain and inflammation after cataract surgery. Currently, marketed steroidal eye drops require administration every four to six hours. Apart from providing dosing convenience, SPARC’s formulation is clear compared to marketed formulation, which is milky, resulting in blurring of vision after administration.

SPARC has initiated the pivotal Phase III study of SDN-037 for registration in the USA. The study is randomising patients and is expected to be completed in FY21.