• 4 January 2011
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PPP: A push for affordable healthcare

From this issue onwards BioSpectrum begins a new feature series on PPPs. The series decodes the success of PPPs and its prospects. This month, in the first part of the series, we feature three case studies that exemplify the benefits of such partnerships

Innovation cannot be successful unless knowledge and information are shared. Recently, at the inauguration of the 7th India Health Summit 2010 in New Delhi, Mr Ghulam Nabi Azad, the Union Minister for Health & Family Welfare, Government of India, stated the need to look at public-private partnership (PPP) as a synergetic arrangement that ensures that the private sector also contributes to public health goals.

The minister said that a fine balance has to be worked out between profitability and corporate responsibility. He acknowledged that the PPP, in the context of health sector, can be a vital instrument for improving the health of the population, but partnership is not meant to be substitution for lesser provisioning of government resources nor abdication of government responsibility but as a tool for augmenting the public health system. He informed that over the last five years, the Indian government has invested $10 billion (45,000 crore) in the healthcare infrastructure — right from sub-center to district hospitals. Mr Azad also stressed upon the fact that healthcare, to be sustainable, has to be affordable.

Even India’s Prime Minister, Dr Manmohan Singh, recently urged the setting up of publicly-owned and privately-operated world-class R&D facilities, stressing on the importance of R&D innovation in the Indian biotechnology industry. Thus, PPPs are forming an indispensable part of the sector. In this regard, the Government of India along with the Department of Biotechnology, has launched various initiatives leading to tremendous opportunities for innovation. Ranging from Biotechnology Industry Partnership Program (BIPP), the Small Business Innovation & Research Initiative (SBIRI) to the New Millennium Indian Technology Leadership Initiative (NMITLI) and Special Drug Development Research Initiatives — have supported upstart firms with seed fund and have also promoted the flow of knowledge from national laboratories to the industries. The sharing of ideas, facilitating technology transfer and technical expertise, form an important part of PPPs and provide an environment for flourishing R&D. This makes PPP not a choice but a requirement. However, this can in turn lead to apprehensions about the misuse of proprietary material or knowledge, by the collaborators in a partnership.

Thus, the hurdles coming in the way of partnerships need to be addressed and should be mutually taken care of by the industry leaders and the heads of public institutes because PPPs have the potential to nurture and catalyze R&D. Harmonious PPPs have produced affordable drugs, have cut costs while substituting import and have even played vital roles during a pandemic.
Process technology for the first indigenous clot buster
Making Streptokinase affordable

The development of indigenous Streptokinase through successful PPP has slashed the drug price significantly

The collaborations between the Institute of Microbial Technology (IMTECH), Chandigarh with Cadila Pharmaceuticals, Ahmedabad; Strides Arcolab, Bangalore; and Shasun Chemicals & Drugs, Chennai; have led to the successful development of indigenous Streptokinase. This drug, for heart patients, was earlier wholly imported. Therefore, the development of this indigenous, cost-effective technology for large scale purification of this drug by biotechnological means is a laudable achievement.

The first version of Streptokinase was first transferred to Cadila Pharma and later introduced in the market. As a follow-up, recombinant strain was developed for high-level intracellular production of Staphylokinase in E. coli. This agent (a biogeneric) had previously shown promise as an improved clot buster in clinical trials abroad. A high-efficiency facile two-step protocol for purification of Staphylokinase has been developed. The complete technological package for the production for recombinant Staphylokinase has been transferred to Strides Arcolab. The licensee is working on development of the commercial scale process with IMTECH’s guidelines.

Further, the technological package (recombinant clones, fermentation parameters and down-stream processing to obtain drug-quality product) was successfully transferred in the year 2002-03 to Shasun Chemicals & Drugs, which specializes in bulk drug manufacture. The product has been launched in India on July 10, 2009, under the brand names ‘Lupiflo’ and ‘Klotbuster’.
Industry Impact: This drug which is cheaper than the other brands based on imported technologies has been well-received by the market, as is apparent from the regular royalty payments received by IMTECH. As a result of the introduction of this Indian brand, the overall price of Streptokinase has declined from about $80 (3500) to about $30 (1500) per dose of 1.5 million units.
This technology brought down the prices significantly and makes this vital life-saver drug available to even the most economically challenged consumer at affordable costs.

Way Forward: IMTECH scientists have generated a clot buster protein which shows strong promise as a ‘clot-specific’ thrombolytic drug. The technology package for the new thrombolytic has been transferred to a US firm, Nostrum Pharmaceuticals and primate studies have successfully been completed in November 2007, validating the proof-of-concept of this molecule. Work on scaling up animal and human testing is in progress. Based on the tie-up between Nostrum pharmaceuticals and IMTECH, the new, engineered clot buster will be developed and commercialized both in developing countries and other markets worldwide. It is expected to be commercialized by mid-2011.
An affordable dispensing system for Indian market
Developing indigenous dispensing system

Using PPP model to create indigenous dispensing system has reduced the cost involved in carrying out biotech applications in labs

Bangalore-based Customized Technologies manufactures the Rapidec Automated Dispensing System that can be used in all laboratories including chemical, life sciences, diagnostics and R&D centers. Accelerated by funds from the Small Business Innovation Research Initiative (SBIRI) scheme of the Department of Biotechnology (DBT), Government of India, this invention has led to the availability of cost- effective indigenous automated dispensing system in India, which is usually imported.

By using the funds to pioneer the product design, the company has saved significant importing cost. The low cost of the product promises to reduce the capital burden on diagnostics labs, hospitals and R&D facilities. It facilitates availability of affordable, high quality diagnostics to millions of people in the country.

Industry Impact: The product is user-friendly and robust with an open-ended software that allows for a variety of applications including PCR-preps, diagnostic sample preparations, precise and accurate dispensing and multi-well plate handling for cell culture, among others. It is easily programmable, versatile and can work with any pipetting system that is readily available in the market.

Way Forward: Since the automated dispensing system increases the productivity of the qualified, trained manpower involved in biotechnology, the product needs to evolve at every stage.
After the first prototype was delivered in July 2009, the newer models being developed now are lightweight and compact; and are designed to cater to specific diagnostic and biotech applications. The new prototypes are expected to be even lower in cost despite having the extra edge in terms of features.

The protocol-specific automated systems have also been developed under this project and the company continues to explore the prospects for their use with DEM Diagnostics. The company expects the revenue of $80,000-$100,000 (40-50 lakh) of the same for the financial year 2010-11.
develop inhibitors for treating TuBerculosis
Computational remedy for diseases

In a PPP initiative, IIT spin-off, LeadInvent is stepping up efforts to develop computational tools to tackle diseases

LeadInvent, a spin-off company from the Indian Institute of Technology’s (IIT), Supercomputing Facility for Bioinformatics and Computational Biology in New Delhi, has initiated research into the computational drug design and development of inhibitors for the treatment of tuberculosis. The company created by former IIT students used the software suite, Sanjeevini, created by the institute for customized computer-aided drug design. This project, along with another one on cancer, is being funded by the Small Business Innovation and Research Initiative (SBIRI).
The Foundation for Innovation and Technology Transfer, a wing of IIT Delhi, licensed the Sanjeevini software to LeadInvent and provided a soft loan as seed capital. Soon, the company emerged out of incubation and picked up a few government and industry-sponsored projects. It is now at a break-even stage.

Industry Impact: The accuracies realized by Sanjeevini in docking candidate molecules to targets and in estimating binding affinities to target are comparable to the state-of-the-art softwares in the field. LeadInvent is utilizing its proprietary technologies — SanjeeviniPro and BhageerathPro — to harness the advancements in computational tools for drug discovery.

Way Forward: Intense efforts are continuing in the lab to make the software faster, more user-friendly and as good as it can get. Concurrently, efforts are in progress to design novel anti-malarials with Sanjeevini. Progress on some of the on-going projects towards IPR generation on new molecules particularly for cancer and TB is very promising.

Leveraging compute power of SCFBio, IIT Delhi’s supercomputer dedicated to computational biology; LeadInvent provides a distinct advantage of high performance biocomputing. In fact, BhageerathPro has been demonstrated to scale almost linearly on 1024 processors of BlueGene architecture.

Mr Surojit Bose, COO, LeadInvent, says, “It has been a long time since our incubation almost three years ago and since then we have worked with many companies such as Ranbaxy, Novartis to name a few. For our second project on cancer, we are working with Dr Karunakaran of IIT Chennai. Funding from the SBIRI is a major boost for our initiatives.”

“The funding by SBIRI has brought us closer to AIIMS in doing the fundamental research. It is because of the quick access to world class facilities provided to us through this collaboration, otherwise it would have been impossible, “ concludes Mr Pankaj Sharma, CEO, LeadInvent.

Rahul Koul in New Delhi

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