CMS through its wholly-owned subsidiary signed a License Agreement (the “Agreement”) with Sun Pharma Advanced Research Company Ltd. (“SPARC”) for five innovative products (the “Products”) on 5 November 2019. According to the Agreement, the Group through its wholly-owned subsidiary will gain an exclusive license with the right to grant sublicenses under SPARC’s intellectual property rights and regulatory documentation to develop and commercialise the Products in Greater China (including Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan) (the “Territory”). The initial term of the Agreement shall be 20 years from the first commercial sale of the Products in the Territory and may be extended for additional 3 years increments if the wholly owned subsidiary of the Group meets certain conditions defined in the Agreement.
Through this collaboration, the Group’s product portfolio will be further enriched and extended upon occurrence of the perspective commercialisation of the Products in the Territory.
About the Products
TaclantisTM /PICS (Paclitaxel Injection Concentrate for Suspension)
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. The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application submitted by SPARC for review.
According to IQVIA data, in 2018, the sales of paclitaxel in Mainland China were about RMB5.04 billion (around USD716 million）, of which the albumin-bound products were about RMB641 million (around USD91.07 million). TaclantisTM offers patients and healthcare professionals a more convenient and better medication option.
XelprosTM (Latanoprost BAK-free) Ophthalmic Emulsion
XelprosTM (Latanoprost BAK-free) 0.005%, is a translucent ophthalmic emulsion, indicated for reduction of elevated intraocular pressure (IOP) 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 U.S. FDA and was commercialised in the USA in FY19.
According to IQVIA data, the sales of the products with the same active pharmaceutical ingredients were about RMB90 million (around USD12.79 million) in Mainland China in 2018.
PDP-716 (Brimonidine Once-a-day) Eye Drops
PDP-716 is once-a-day formulation of Brimonidine developed using SPARC’s TearActTM technology and is proposed for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension. PDP-716 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 USA. The study is randomizing patients and is expected to be completed in FY21.
According to IQVIA data, the sales of the products with the same active pharmaceutical ingredients were about RMB58 million (around USD8.24 million) in Mainland China in 2018.
SDN-037 Eye Drops
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. 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 USA. The study is randomizing patients and is expected to be completed in FY21.
There is currently no preparation of the reference steroid in Mainland China. If marketed, this product may become an exclusive product.
ElepsiaTM (Levetiracetam) XR 500mg/750mg/1000mg/1500mg Tablet
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 U.S. FDA in FY19. Generic strengths of Levetiracetam XR, 500mg and 750mg are also developed using SPARC’s WrapMatrix? technology and approved by the U.S. FDA in FY14.
According to IQVIA data, the sales of the products with the same active pharmaceutical ingredients were about RMB874 million (around USD124 million) in Mainland China in 2018.
SPARC is a global pharmaceutical company focused on continuously improving standards of care for patients globally through innovation in therapeutics and delivery. SPARC aims to consistently lower costs and improve operational efficiencies to advance availability and affordability of cures for patients across the world. More information about SPARC can be found at www.sparc.life.