Jubilant Life Sciences Ltd, an integrated global Pharmaceuticals and Life Sciences Company, has announced that its wholly own subsidiary Jubilant Pharma Limited, through one of its units Jubilant DraxImage Inc. Montreal Canada, has received U.S. Food and Drug Administration approval for RUBY-FILL®, for its New Drug Application (NDA) pursuant to section 505 (b)(2) filing. This approved new drug application provides for the use of RUBY-FILL® for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.
The product is expected to be launched in the current quarter (third quarter of financial year 2017) under the company’s registered brand name RUBY-FILL® for which the current estimated US market size is US$76mn and has a potential to grow up to US$250mn annually in the next five years.
RUBY-FILL® Rubidium Rb 82 Generator and Elution System
Shown here is the RubyFill Cart with computer display containing the RUBY-FILL® Generator and Elution System which is specifically designed for use with the RUBY-FILL® Generator. This integrated system is the only PET Cardiology system capable of personalized, accurate delivery of patient doses of Rubidium Rb 82 chloride injection utilizing any one of three dose delivery modes.
RUBY-FILL’s®state of the art computer controlled interface underwent rigorous software verification and FDA review. It allows for improved user experience and efficiency with flexible and unique patient dosing options which can be defined for specific clinical question. The system also provides enhanced patient and healthcare professional safety features along with automated QC and volume tracking as compared to currently available options in the PET Myocardial Perfusion Imaging (MPI) segment. Also, Rubidium-82 MPI has been clinically demonstrated in published peer reviewed journals to have superior sensitivity, specificity and accuracy versus current SPECT MPI studies. Importantly, RUBY-FILL® has significantly lower patient radiation exposure as compared to current Single Photon Emission Computed Tomography (SPECT) MPI procedures which have 5-20 times the patient radiation exposure as compared to RUBY-FILL®.
Commenting on the occasion, Mr. Shyam S. Bhartia, Chairman and Mr. Hari S. Bhartia, Co- Chairman and Managing Director, Jubilant Life Sciences Limited said: “We are very excited to receive the much-awaited USFDA approval for RUBY-FILL®, a cutting-edge technology for PET MPI for diagnosis of coronary artery disease. RUBY-FILL® expands DraxImage’s nuclear medicine portfolio and is a testimony to our innovation and capability to launch one of our differentiated and niche pipeline products in our Specialty business. This approval is highly anticipated by the medical community and is expected to give further boost to the revenues and profitability of the company along with the robust existing product base.”
About Jubilant Life Sciences Limited
Jubilant Life Sciences Limited is an integrated global Pharmaceutical and Life Sciences Company engaged in Pharmaceuticals, Life Science Ingredients and Drug Discovery Solutions. The Pharmaceuticals segment, through its wholly owned subsidiary Jubilant Pharma Ltd, is engaged in manufacture and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile and Non Sterile products through 6 USFDA approved facilities in India, US and Canada. The Life Science Ingredients segment is engaged in Specialty Intermediates, Nutritional Products and Life Science Chemicals through 5 manufacturing facilities in India. The Drug Discovery Solutions segment provides proprietary in-house innovation and collaborative research and partnership for out-licensing through 3 world class research centres in India and US. Jubilant Life Sciences Ltd has a team of around 6,500 multicultural people across the globe and is committed to deliver value to its customers spread across over 100 countries. The Company is well recognized as a ‘Partner of Choice’ by leading pharmaceuticals and life sciences companies globally. For more info: www.jubl.com.