Nostrum Pharmaceuticals Licenses Clinical Development and Worldwide Commercialization Rights From IMTECH, India for Novel, Next-Generation Thrombolytics With Clot Specific Activation and Re-occlusion Prevention Properties
Nirmal Mulye, Ph.D., President of Nostrum, said, "These novel, next generation thrombolytics are clot specific plasminogen activator proteins, and each one of these molecules has a uniquely different value-added properties such as longer half-life in blood circulation and re-occlusion prevention during heart attack. Moreover, these unique properties of the molecules will help to effectively mitigate a number of systemic side effects, such as bleeding, usually associated with the prevalent thrombolytic protein molecules in the market today." Dr. Mulye further said, "Our collaboration with CSIR is an example of successful public-private partnership. This is our third collaboration with IMTECH/ CSIR. Clearly they have been developing world-class technologies and setting an example of pursuing commercially viable innovations."
These new molecules were invented at IMTECH in the laboratory headed by Girish Sahni, Ph.D., who is also the director of IMTECH. Dr. Sahni said, "Re-occlusion of the blood vessel after thrombolytics treatment remains one of the main cause for patient death after the heart attack and continues to be both a practical and scientific challenge to reckon with." Dr. Sahni added, "My group at IMTECH had been working for a very long time to come up with an approach that will resolve the issue of blood vessel re-occlusion after thrombolytics treatment. I am glad that one of our new thrombolytic molecules has shown that promise in the laboratory experiments. Based on these results we are confident that it will develop into a world class drug with a most sought after property of not only clot specificity of activation but also re-occlusion prevention." Dr. Sahni further added, "Collaborating with Nostrum over the years has been a very fulfilling experience. They have demonstrated a true commitment to take forward our collaborations as seen by the remarkable pace at which they have taken forward the development of our first thrombolytic Clot Specific Streptokinase (CSSK)."
Nostrum will develop these new thrombolytics in association with one of its affiliates, Symmetrix Biotech Pvt. Ltd. ("Symmetrix"), which is based in Mumbai, India. Yatindra Prashar, Ph.D., Director and C.E.O. off Symmetrix, said, "Although these novel thrombolytics are at a very early stage of development, based on our experience with the CSSK development, especially the successful efficacy studies in monkeys, these novel molecules that are being licensed by Nostrum have the potential to develop into top selling drugs worldwide for thrombolytic treatment not only during heart attack but also stroke because of the greatly reduced risk of bleeding since these thrombolytics protect blood fibrinogen levels during the treatment."
Nostrum had earlier licensed Clot Specific Streptokinase ("CSSK") in July 2006 from IMTECH. Efficacy of CSSK bolus dose has been established in monkeys where it successfully re-perfused a freshly occluded artery while protecting blood fibrinogen levels, maintaining the normal blood pressure and not causing any incidence of bleeding. Currently, preclinical toxicological studies in monkeys are being carried out for CSSK, and human clinical trials are expected to begin by the middle of the year 2011. As with CSSK, these novel thrombolytics being licensed currently will also be developed as single bolus dose.
The license agreement was earlier signed by Dr. Mulye and Dr. Sahni in New Delhi. The signing function was presided over by Mr. Kapil Sibal, Minister of Science and Technology, Government of India, who said "It is great to see not only the new molecules being developed in India, which was not heard of not so long ago, but also they being licensed out at a high value to the international company like Nostrum Pharmaceuticals of USA. We hope that this collaboration grows stronger and these molecules are brought to the stage of developed drugs soon."
Prof. Samir Brahmachari, Director General, CSIR was also present. Dr. Brahmachari lauded the continuing cooperation between Nostrum and CSIR and emphasized the importance of high quality science resulting in high value products as exemplified with the development of these new thrombolytics in Dr. Sahni's laboratories at IMTECH. He said, "These new thrombolytics were developed as a result of singular focus that Dr. Sahni devoted to study the protein structure of these molecules and then devise an approach which makes them perform the desired function"
The size of the current agreement is close to USD 150 million in milestone payments plus royalties. This is the third licensing agreement between Nostrum and IMTECH/CSIR.
SOURCE Nostrum Pharmaceuticals, LLC