SHASUN RECOMBINANT STREPTOKINASE LIFOKINASE

Technology for recombinant streptokinase was licensed from Dr. Girish Sahani, Director:

Memorandum of Understanding Agreement was signed in Aug 2002 followed-up by technology demonstration at IMTECH, clone transfer & establishment of technology at Shasun until Jul 2003. Preclinical animal toxicology studies conducted at Indian Institute of Toxicology, Pune from Shasuns lab batches from Jul - Oct 2004 after detailed analytical characterizations. Process scaleup activities from 1 L lab-scale to 12 L pilot scale done from Jan 04 Mar 07 and from pilot to 100 L production scale from Sep 07 Apr 08. Phase-III clinical trials carried out at 7 centers across India from May 07 Mar 08. DR. GIRISH SAHNI has been Protein chemist & Molecular Biologist with numerous publications in leading journals (J. Biotech, Protein Sci, J.Chrom, J.Biol Chem, Med Chem Res etc.). He has been one of the leading researchers in the field of thrombolytics & understanding molecular mechanisms for novel drug design. He was granted product patent in U.S. & EU for novel clotspecific streptokinase (CS-SK) SHASUN STREPTOKINASE CLINICAL TRIAL RESULTS: OVERVIEW Phase-III double-blind, randomized study to demonstrate non-inferiority with StreptaseTM brand Adherence to ICH-GCP guidelines with comprehensible dossier available Study size: 122 randomized patients across 7 sites in India Primary Efficacy markers include: Resolution of ST-segment elevation by ECG by 60, Chest pain resolution by 90, Development of reperfusion arrhythmias

SHASUN STREPTOKINASE - CLINICAL TRIAL INVESTIGATORS

SITE No. SITES FINALIZED CITY PRINCIPAL INVESTIGATOR Dr. J.S. Sathyanarayana Murthy 11 Sri Ramachandra Medical Hospital Chennai M.D. (Gen Med), D.N.B. (Cardiology), FACC Dr. S. Selvamani 22 Meenakshi Mission Hospital Madurai M.B.B.S., D.N.B.(Gen Med), D.N.B. (Cardiology) Dr. G. G. Shetty 33 St John's Hospital Bangalore M.B.B.S., M.D. (Gen Med), D.M. (Cardiology) Dr. Shireesh Prabhakar Sathe 44 Deenanath Mangeshkar Hospital Pune M.B.B.S., M.D. (Gen Med), D.M. (Cardiology) Dr. Uday Mahorkar 55 Avanti Institute of Cardiology Nagpur M.B.B.S., D.N.B. (Cardiology), D.M. (Cardiology), M.D. (Medicine) 66 Bhagawan Mahaveer Jain Heart Center Dr. Ramesh Srinivasaiah Saligrama Bangalore M.B.B.S., M.D. (Medicine), D.M. (Cardiology) Dr. Golla N Prasad 77 Frontier Lifeline Pvt. Ltd. Chennai M.B.B.S., M.D. (Internal Medicine), D.N.B. (Cardiology)

MEDICAL MONITOR

Chennai

Prof. S. ThanikachalamM.D., D.M., Recipient of 2003 B.C. Roy National Award Professor Cardiology Madras Medical College, CMC Vellore, SRMC&RI

SHASUN STREPTOKINASE - CLINICAL TRIAL RESULTS: PRIMARY EFFICACY

SHASUN STREPTOKINASE:Formulation & Stability Many streptokinase brands have Human Serum Albumin (HSA) present in their formulation as a stabilizer. Shasuns rSK is inherently stable in the absence of albumin & this has been proven with the following stability studies:Long-term stability at 5 3C,Accelerated stability at 25 2C, Stress Testing at 37 2C, Stability after reconstitution at 5 3C.

Streptokinase Launch - Prithviraj Chauhan - July 9, 2009