Novartis Option Agreement
Quark granted Novartis an option for an exclusive worldwide license to develop and commercialize QPI-1002 and any other p53-directed siRNAs controlled by Quark for any indication. Under an amended and restated option agreement, Novartis paid Quark an additional non-refundable option grant fee and has the right to exercise the option during or following the global pivotal Phase III study of QPI-1002 for the prevention of delayed graft function in kidney transplant patients. The study follows Type C and Type B meetings and EU Scientific Advice (EU SAWP). In parallel QPI-1002 is in a Phase II study for the prevention of AKI in patients undergoing major cardiovascular surgery. Quark is fully responsible for conducting these clinical trials. Upon exercise of the license, pursuant to the restated agreement, Quark is eligible to receive increased development and sales-based milestone payments for each indication and higher royalties from sales.
Pfizer License Agreement
Pfizer acquired an exclusive worldwide license to siRNA molecules that modify expression or function of our proprietary gene target, RTP801, including Quark’s lead siRNA PF-655 for ophthalmic and non–ophthalmic indications. PF – 655 is in Phase IIB is in patients with diabetic macular edema (DME) and Phase II in wet age-related macular degeneration (AMD). Pursuant to the agreement, Quark is eligible to receive various development and sales-based milestone payments for each indication and royalties from sales.
Biocon License and Collaboration
Biocon Ltd, Asia’s premier biotechnology company, and Quark entered into a Licensing and Collaboration agreement for the development of a range of siRNA based novel therapeutics. Under the agreement Quark has licensed to Biocon QPI-1007, a novel siRNA drug candidate for ophthalmic conditions, for India and other Asian markets. Quark and its partners are initiating a global Phase II/III pivotal clinical study for the treatment of non-arteritic anterior ischemic optic neuropathy (NAION) that follows Type C meeting with the FDA and approval of the Indian Central Drug Standards Control Organization (CDSCO).
In addition, Biocon has access to Quark’s innovative and proprietary siRNA technology platform for discovery, development and manufacturing of novel therapeutics for various unmet medical needs. The companies are currently collaborating in development of novel agents for lung transplantation and acute lung injury.
RiboQuark Joint Venture
Kunshan RiboQuark Pharmaceutical Technology Co., Ltd. (“RiboQuark”), is a Chinese-foreign equity joint venture and clinical stage pharmaceutical company, established by Suzhou Ribo Life Science Co., Ltd. (“Ribo”), a leading Chinese RNAi-based company and Quark Pharmaceuticals Inc. RiboQuark has raised its initial financing in a series A financing led by BVCF, China’s leading life sciences venture capital firm. In addition to BVCF, investors in the financing included SBI Incubation Co., Ltd., a subsidiary of SBI Group of Japan, Quark’s major shareholder, the Kunshan Industrial Technology Research Institute Investment Co., Ltd. and Kunshan Hongtu Hi-tech Venture Capital Management Co., Ltd.
RiboQuark’s lead product is QPI-1007, an ocular neuroprotectant RiboQuark has licensed from Quark to sell in China and several other countries. QPI-1007 is entering global Phase II.III studies in NAION. In addition, the joint venture is developing a pipeline of preclinical siRNA compounds licensed to the joint venture by the founding partners. The RiboQuark development programs include siRNAs for skin diseases (chemotherapy induced and androgenic alopecia to be developed in China for cosmetic application) and a siRNA therapeutic for Hepatitis B.