Advinus Therapeutics—A 'rare' and 'different' focus

Dr Rashmi Bharbhaiya, CEO and Managing Director

Advinus Therapeutics founded in 2005, with an investment of Rs 160 crore, is the first of its kind research-based pharmaceutical company in India to offer end-to-end development services to the global pharma, agro and biotech industry. The company today has revenues of more than $17 billion and a market capitalisation of more than $31 billion.

Dual approach

The company has adopted a two fold business model—drug discovery and development, to ensure that there is no dilution of the scientific and managerial focus because of downstream functions including manufacture, marketing and commercialisation of Active Pharmaceutical Ingredient (API) and finished formulations.

The discovery arm of Advinus integrates under one umbrella comprising expertise, experience, capabilities and infrastructure needed for drug discovery from hit to clinical development candidate with focus on metabolic and inflammatory diseases. It aims to generate its own drug candidates with the objective of out-licensing them at preclinical or clinical stage.

The company researches leads/ molecules given by other companies as well as its own leads. In order make sure that there is no conflict of interest, Dr Rashmi Bharbhaiya, CEO and Managing Director remarks, "For each of our collaborative programmes, we reserve a right to select targets we want to work on. We do not undertake collaborative work on targets that are being pursued in our internal programs. Above all, proprietary R&D focus provides a key differentiating factor for the company."

Besides this, the India advantage helps them to enhance the productivity and efficiency of its agrochemical and pharma R&D programs to unprecedented levels of cost-effectiveness and quality by bringing together demonstrated world class expertise with talent and economies of India. "We have a team that has over 160 years of experience of discovering and developing new drugs," informs Bharbhaiya. "By leveraging the India-advantage and our own talent, we provide a solution for a variety of problems that affect pharma R&D— speed, efficiency and cost-effectiveness being key advantages that attract biotech and pharma companies to collaborate with us," he adds.

The company's world-class state of the art development center in Bangalore provides services to global drug and agrochemical companies for developing new products. The centre offers end-to-end preclinical to early clinical development platforms. It also supports and supplements client resources in the areas of process development, drug metabolism and pharmacokinetics, clinical pharmacology, safety assessment, formulation development and analytical R&D.

Since R&D has a long gestation period, the company has a unique strategy to maintain positive cash flows. Revenues generated through its service unit and milestone payments as well as upfront payment received for drug discovery alliances contribute to the company's cash flows for its R&D activities, highlights Bharbhaiya.

Exploring new markets

The company is exploring opportunities in companies based in the US and Europe. Keeping this in mind it has tied up with Merck—one of the largest and most respected global pharma companies—for discovery and development of novel therapies for multiple targets in the area of metabolic diseases. They collaborated in November 2006 to develop clinically validated drug candidates in metabolic diseases, with Merck retaining the right to advance the most promising of these candidates into late-stage clinical trials. On this development Advinus has achieved two more milestones, one each in the two programs, under the drug discovery and development collaboration. The second milestone for one of the programs was achieved within four months of achieving the first milestone in November 2007.

In another initiative, Advinus has also entered into an alliance with Ahmedabad based Veeda Clinical Research to leverage each other's capabilities to create an integrated drug discovery through Phase II platform. The alliance offered packages involving preclinical and early clinical development, animal and human safety pharmacology, preclinical toxicology and pharmacology, clinical pharmacology as also microdosing capabilities to pick drug candidates on the basis of human PK data. The alliance seeks to leverage Veeda's biomarkers capabilities for preclinical and clinical applications. This tie-up has set new precedence in the emerging drug discovery industry in the country and will attract companies looking for preclinical and clinical services in the European and American geographies.

Being recognised globally the company has also been named as India's best emerging CRO in drug discovery services, according to a survey by Proximare, a management consulting firm based in New Jersey. One of the most accredited R&D centres in India, it has certification from AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care) International and the German, Dutch and Indian authorities for GLP compliance. All data generated by the centre is 21 CFR part 11 compliant.

Road ahead

Advinus has an interest in pursuing the discovery of novel therapies for neglected or developing world diseases such as malaria and dengue, to address the unfulfilled need in developing nations for safe, effective and affordable therapy. Bharbhaiya feels by devoting a small percent of their efforts for neglected diseases, they will be able to address public health issues of the country.