SHASUN RECOMBINANT STREPTOKINASE – LIFOKINASETechnology 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 Shasun’s 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 clot-specific streptokinase (CS-SK)

SHASUN STREPTOKINASE CLINICAL TRIAL RESULTS: OVERVIEW

Phase-III double-blind, randomized study to demonstrate non-inferiority with StreptaseTM brandAdherence 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

11 Sri Ramachandra Medical Hospital Chennai

Dr. J.S. Sathyanarayana Murthy

M.D. (Gen Med), D.N.B. (Cardiology), FACC

22 Meenakshi Mission Hospital Madurai

Dr. S. Selvamani

M.B.B.S., D.N.B.(Gen Med), D.N.B. (Cardiology)

33 St John's Hospital Bangalore

Dr. G. G. Shetty

M.B.B.S., M.D. (Gen Med), D.M. (Cardiology)

44 Deenanath Mangeshkar Hospital Pune

Dr. Shireesh Prabhakar Sathe

M.B.B.S., M.D. (Gen Med), D.M. (Cardiology)

55 Avanti Institute of Cardiology Nagpur

Dr. Uday Mahorkar

M.B.B.S., D.N.B. (Cardiology),

D.M. (Cardiology), M.D. (Medicine)

66 Bhagawan Mahaveer Jain Heart Center Bangalore

Dr. Ramesh Srinivasaiah Saligrama

M.B.B.S., M.D. (Medicine), D.M. (Cardiology)

77 Frontier Lifeline Pvt. Ltd. Chennai

Dr. Golla N Prasad

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 AwardProfessor Cardiology – Madras Medical College, CMC – Vellore, SRMC&RI

SHASUN STREPTOKINASE - CLINICAL TRIAL RESULTS:

PRIMARY EFFICACY

SHASUN STREPTOKINASE:Formulation & StabilityMany streptokinase brands have Human Serum Albumin (HSA) present in their formulation as a stabilizer.Shasun’s 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