NovaLead looks beyond the obvious
BioSpectrum - October 1, 2009
Apart from focusing on new chemical entities (NCEs) in oncology, NovaLead Pharma follows the drug repositioning model, wherein it screens existing drugs for new therapeutic uses.
The genesis of NovaLead Pharma can be traced back to the inception of its parent company, VLife Sciences Technologies in 2002. VLife Sciences Technologies focused on developing screening technologies, which in turn would accelerate the whole drug discovery process. During this course, the company developed a computer-aided drug development technology that allowed them to focus on a couple of in-house research projects, some of which included new chemical entities (NCEs) in disease areas like cancer.
In 2007, the drug discovery team was demerged from VLife Sciences Technologies to form NovaLead Pharma, now based in Pune. The business model of NovaLead is to develop its discoveries up to the proof of concept in animals and then out-license or partner with either pharmaceutical or biotechnology companies to generate revenues, which are milestone and royalty driven. Supreet Deshpande, CEO, VLife Sciences Technologies and the brainchild behind Novalead Pharma, says, “We decided to demerge our drug discovery process to finally develop the discoveries in human trials using the screening technologies developed from the parent company, VLife Sciences Technologies. What is different in this case is the manner in which we handle the discovery process.”
Initial investment of Rs 1.5 crore, came from personal funding of founders and angel investors. A venture capital investment was raised in April 2006, through Kotak Mahindra-Private Equity Group.
The company at present pursues two in-house research programs – NCE program in oncology and new indications program in unmet needs area. Along with Deshpande, co-founder and COO, Atul Aslekar who is also a part of the VLife Sciences Group, has the responsibility to lead technology development and sourcing to continuously improve on NovaLead drug discovery process. In the avenue of technology, NovaLead has come up with virtual screening technologies like VLife Amadeus screening platform and VLife Biblica knowledge compendium (developed along with VLife Sciences).
This business model, which Despande terms as the drug repositioning model, was followed by some pharma and biotech companies in the past. Drug repositioning has been gaining importance in the last few years as an increasing number of drug development and pharmaceutical companies see their drug pipelines drying up. They have realized that several promising technologies in the past have failed to deliver as assumed. Using drug repositioning, pharmaceutical companies have achieved a number of successes. For example; Pfizers’s Viagra in erectile dysfunction and Celgene’s Thalidomide in severe erythema nodosum leprosum.
NovaLead’s lead compounds in oncology, VLI27 and Galnobax, the new indication diabetic foot ulcers, have both been filed for Patent Cooperation Treaty (PCT) and are exclusive output from VLife’s technologies. The candidate pipeline of NovaLead Pharma has an interesting mix of new chemical entities and new indications for FDA approved drugs, majority of them qualifying for fast-track approval from the FDA.
Currently, there are six promising candidates in the pipeline, one in its human trial phase, two in their animal phase and three in the in-vitro phase. After the completion of phase I trials, NovaLead usually announces the discovery processes on the basis of the data available to attract prospective licensing partners. “We do not take the drugs to the market. Instead, after phase II, we sign licensing deals with companies who will in turn take it to the market for commercialization,” says Deshpande.
A drug for diabetic foot ulcer, Galnobax, will be the first to hit the market in another two-three years as estimated by Despande. But this depends on who will ultimately take the product to the market. In the preclinical trials, Galnobax has demonstrated 42 percent improvement in curing wounds in diabetic patients. At present, clinical trials for Galnobax is partly happening in India and the US, where 40 patients have been recruited.
With India positioning to become world’s diabetic capital, Despande is hopeful that the drug should hit the jackpot. “By 2011, it should be out-licensed, with the deal touching around $400-700 million (Rs 1,924-3,368 crore) mark,” he maintains. NovaLead is also looking at other therapeutic areas like age-related wrinkles, asthma and CNS-related diseases. The other two promising targets in the pipeline include colon and pancreatic cancers.
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