CSIR-IMTECH’s KNOW-HOW ON THROMBOLYTICS: NATURAL STREPTOKINASE (SK) –the first generation of CSIR’s clot busters
Streptokinase (SK), a clot dissolving protein of bacterial origin, is a drug used world-wide for the treatment of diverse circulatory disorders, especially myocardial infarction (M.I.). It is a 47kD protein composed of 414 amino acids produced by several strains of beta hemolytic streptococci. The unique feature of SK is its plasminogen (Pg) activation mechanism that is unlike urokinase and tissue plasminogen activator, which are enzymes & directly act on blood Pg. On the other hand SK activates Pg in an indirect manner by first forming a 1:1 complex with Pg (the “Partner Pg”) which rapidly becomes proteolytically active. This complex then acts on “substrate” Pg molecules in the circulation to convert them to plasmin (Pn), the active form of the pro-enzyme Pg. The Plasmin generated in the circulation rapidly dissolves the pathological clot occluding blood supply to the heart muscle in case of M.I.
The process know-how developed by IMTECH is a simple two-step one which gives high yield at an extremely economic / cost effective manner.
SK is still the best in the country/world in terms of cost-effectiveness:
Streptokinase, being an effective and cheaper drug in comparison to the other clot dissolving proteins has a good demand in third world nations. In addition, in case of Europe, where national health schemes prefer economically priced drug choices, SK continues increasingly favoured over expensive counter part drugs like TPA. Several studies have established that on a clinical level, SK is as effective in saving lives in M.I. when compared to TPA, despite the nearly ten-fold higher price of the latter.
Since the introduction of this first, “Indian” clot buster by Cadila Pharma Ltd., Ahmedabad, India, the prices have decreased by over 50 percent in India. This brand is competing very well with imported brands for over eight years
This product is manufactured in India at present by Cadila Pharmaceuticals Ltd. and sold under the brand name ‘STPase’. For several years only MNCs like Behring-werke (Germany) and Lederle (USA) were exclusive producers of this life-saver drug. Only in the recent past, a developing country like Cuba succeeded in producing recombinant Streptokinase from E.coli. Our process utilizes the natural host (a hyperproducer strain developed at IMTECH, Chandigarh) as well as a highly optimized downstream process for purification that yields injectable streptokinase at very high purity and process yield (approx. 60%).
Making a difference for India and for Developing Countries in the future:
This drug developed by IMTECH had a huge price competitive advantage over the other imported drugs available for similar therapeutic conditions in the market as its introduction brought down the market price of streptokinase by over 50 percent. Since nearly 30% of victims of heart attacks are saved by clot busters such as SK, this drug at affordable prices, has made a big contribution of life-saving at affordable prices, thus impacting society in a major way.
It is hoped that the technology for natural SK production will be helpful for many people throughout the world, where cardiac problems are increasing at an alarming pace.
The technology is ready for re-licensing, since the period of exclusivity with original licensee is over, and can be demonstrated at small scale initially, with full help for scale-up at site of manufacture with CSIR-IMTECH help and consultation.