Sun Pharma Advanced Research Company Ltd

Sun Pharma Advanced Research Company Ltd. (SPARC) is a clinical stage biopharmaceutical company engaged in creating new drugs and delivery systems. The Company works on innovation and new product development for global markets. They undertake projects in research and technology for new chemical entities (NCEs) or new molecules, and novel drug delivery systems (NDDS). Sun Pharmaceutical Advanced Research Company Ltd was incorporated on March 1, 2006 as an innovative and development company. They commenced operations on March 22, 2006. As per Scheme of Arrangement, all assets and liabilities of the Innovative Research Development business including Novel Drug Delivery System (NDDS) division of Sun Pharmaceuticals Industries Research Development undertaking stands transferred and vested in the Company with effect from Appointed date on February 28, 2007. The demerger became effective on March 28, 2007. On Scheme being effective, the Company ceased to be subsidiary of Sun Pharmaceutical Industries Ltd., and the demerged Company.During the year 200910, the Department of Scientific and Industrial Research (DSIR), Government of India sanctioned a 15 year unsecured soft loan under their Drug and Pharmaceutical Research Programme for a project of the Company.During 2011, the Company announced USFDA approval for DOCEFREZ (docetaxel) for Injection. During 2014, the Company announced Govt. of India approval for Paclitaxel Injection Concentrate for Nanodispersion (PICN).On 1 December 2014, Sun Pharma Advanced Research Company Ltd. (SPARC) announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response letter to its New Drug Application (NDA) for Latanoprost BAKfree eyedrops. While the FDA did not seek any additional information for supporting clinical data, it sought additional information on certain labeling and other deficiencies for processing the NDA. On 4 March 2015, Sun Pharma Advanced Research Company Ltd. (SPARC) announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for ELEPSIA XR (Levetiracetam extendedrelease tablets 1000 mg and 1500 mg). ELEPSIA XR is indicated for adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy. The product will be manufactured by Sun Pharmaceutical Industries Ltd at its Halol (Gujarat) facility in India.On 9 June 2015, Sun Pharma Advanced Research Company Ltd. (SPARC) and Sun Pharmaceutical Industries Ltd. announced that SPARC has licensed out Xelpros (Latanoprost BAKfree eye drops) to a subsidiary of Sun Pharma for the US market. On 1 August 2015, Sun Pharma Advanced Research Company Ltd. (SPARC) announced that the U.S. Food and Drug Administration (USFDA) has issued a Complete Response letter (CRL) to its New Drug Application (NDA) for Xelpros, Latanoprost BAKfree eyedrops. SPARC submitted a response to an earlier CRL it had received from the USFDA, wherein no additional preclinical or clinical data was required. While the USFDA has accepted the clarifications and changes to the labeling, SPARC has now received another CRL from the USFDA seeking minor changes to the proposed labeling. SPARC hopes to address these requirements soon. This product is proposed to be manufactured at Sun Pharmaceutical Industries Ltd (SPIL)s Halol facility and the USFDA has indicated that a satisfactory resolution of the cGMP deficiencies at this facility is a prerequisite for the final approval of Xelpros. SPARC had recently outlicensed this product to a subsidiary of Sun Pharmaceutical Industries Ltd (SPIL).On 25 September 2015, Sun Pharma Advanced Research Company Ltd. announced that the U.S. Food and Drug Administration (USFDA) has issued a Complete Response letter (CRL) to its New Drug Application (NDA) for Elepsia XR (Levetiracetam extendedrelease tablets 1000 mg and 1500 mg). SPARC had earlier received a final approval from USFDA in March 2015 for this product and was evaluating several marketing partners for commercialization. However SPARC has now received a CRL from the USFDA rescinding its earlier approval, citing that the compliance status of the manufacturing facility was not acceptable on the date of approval. Elepsia XR is proposed to be manufactured at Sun Pharmaceutical Industries Ltd (SPIL)s Halol facility. SPIL is working with USFDA in resolving the cGMP deviations at the facility and has taken several corrective measures.On 31 December 2015, Sun Pharma Advanced Research Company Ltd. (SPARC) informed the stock exchanges that the management expects a possible further delay in the projected royalty income for the company from XELPROS (Latanoprost Ophthalmic Emulsion) and Elepsia XR (Levetiracetam extendedrelease tablets 1000 mg and 1500 mg). This follows a warning letter to Sun Pharmaceutical Industries Ltd (SPIL) from the USFDA for its facility located at Halol, Gujarat in India. XELPROS and Elepsia XR are proposed to be manufactured at (SPIL)s Halol facility.The Board of Directors of Sun Pharma Advanced Research Company Ltd. (SPARC) at its meeting held on 5 March 2016 approved rights issue of equity shares in the ratio of 5 equity shares for every 116 equity shares held as on the record date. The rights issue has been priced at Rs 245 per share. The company will raise upto Rs 250 crore from the rights issue.On 18 July 2016, Sun Pharma Advanced Research Company Ltd. (SPARC) and Sun Pharmaceutical Industries Ltd. announced a licensing arrangement for SPARCs ELEPSIA XR (Levetiracetam Extended Release tablets). As per the agreement, SPARC will license ELEPSIA XR (Levetiracetam Extended Release tablets) to a whollyowned subsidiary of Sun Pharma for the US market. SPARC will receive an upfront payment of US10 million from Sun Pharma. It is also eligible for certain additional milestone payments and defined royalties linked to any future sales of ELEPSIA XR.On 22 December 2016, Sun Pharma Advanced Research Company Ltd. (SPARC) informed the stock exchanges that the company has received a Complete Response Letter (CRL) from the USFDA for the New Drug Application (NDA) for Xelpros, Latanoprost BAKfree eyedrops. The CRL references the recent inspection of Sun Pharmaceutical Industries Ltd.s Halol manufacturing site by USFDA and indicates that satisfactory resolution of the deficiencies identified during the inspection is required before the final approval of Xelpros. There are no requirements of any additional data from USFDA in the CRL. SPARC had outlicensed Xelpros to a subsidiary of Sun Pharmaceutical Industries Ltd. in June 2015.On 19 May 2017, Sun Pharma Advanced Research Company Ltd. (SPARC) informed the stock exchanges that the company has received a Complete Response Letter (CRL) from the USFDA for its New Drug Application (NDA) for Elepsia XRTM, Levetiracetam extendedrelease tablets 1000 mg and 1500 mg. On 14 September 2018, Sun Pharmaceutical Industries Ltd. and Sun Pharma Advanced Research Company Ltd. (SPARC) announced U.S. Food and Drug Administration (USFDA) approval for the New Drug Application (NDA) of XELPROS (latanoprost ophthalmic emulsion) 0.005% for the reduction of elevated intraocular pressure (IOP, or pressure inside the eye) in patients with openangle glaucoma or ocular hypertension. This approval is from Sun Pharmas Halol (Gujarat, India) facility. Sun Pharma inlicensed XELPROS from SPARC in June 2015 and this approval will trigger a milestone payment to SPARC. SPARC is also eligible for milestone payments and royalties on commercialization of XELPROS in the US.In FY 201920, Company executed its 1st inlicensing agreement with Bioprojet (France) obtaining exclusive global rights of SCD044. It also established first commercial partnership with China Medical Systems Ltd., outlicensing commercial rights of five assets (XelprosTM, ElepsiaTM, TaclantisTM, PDP716 and SDN037). SPARCs vodobatinib was granted orphan drug designation for treatment of CML. During the year, SPARC also commenced the investigator initiated study of SCC138 in Lewy Body Dementia. It completed Phase I study of SCD044.During FY 202122, Company progressed on multiple collaborative projects and also acquired exclusive rights for antibody against a unique oncology target from Biomodifying Inc. It licensed the commercialization rights for PDP716 and SDN037 to Visiox Pharma, a specialty pharma company focused on ophthalmology. The commercialization of ElepsiaTM XR commenced in 2021. It licensed the global (excluding India and greater China) commercialization rights to Visiox Pharma. On January 06, 2023 the Company had allotted 4,91,92,121 equity shares against the conversion of equal number of warrants issued on preferential basis. Consequent to the said allotment, Shanghvi Finance Private Limited (SFPL) has ceased to be the Companys Holding Company effective from the said date as its percentage shareholding along with its subsidiaries in the Company reduced from 52.07% to 44.18%.During FY23, SPARC along with Visiox completed the NDA submission to the USFDA in August 2023. SezabyTM Commercialization was commenced by Sun Pharma in Jan 2023.