In the business of discovery

Sudarshan Arora, President-NCE Research, Lupin reveals the nuances of NCE research in India and the company’s competencies in conversation with Katya Naidu.

Indian pharmaceutical industry is famous albeit for its generics rather than its innovation. However, it is very soon to judge Indian strengths in R&D as the Indian pharmaceutical research is still in its infancy. It is also a fact that the infancy is the time when a baby learns a lot and progresses the maximum. This is also true to this young, growing and restless industry. Bearing witness to the growing research culture in the pharma sector are companies like Lupin Laboratories who have made R&D their core focus.

Though Indian pharmacos have started considering research, we have been out of the R&D scenario for quite a while. What are the challenges that a pharma R&D company faces?

Few years ago very few Indian companies were investing in NCE research. As a result, the biggest problem faced by these companies was lack of talent since a lot of Indian scientists preferred to work abroad. This is no longer a case now. Today more and more Indian scientists working abroad are preferring to return to India and do cutting edge work for Indian companies.

In addition to manpower, R&D is also claims expenses in terms of infrastructure which is a basic necessary. How has Lupin dealt with these state-of-the-art R&D requirements?

Lupin Research Park (LRP) at Pune sprawls across 19 acres with a built up area of 1,50,000 square feet. It houses 320 scientists and is the hub of all research initiatives undertaken by the company. LRP has immensely contributed to timely product launches by mastering complex molecules and developing formulations in time. The company has attained capabilities to develop quality APIs at productivity levels rivalling the best, value-added finished products in the generic space based on platform technologies, besides leveraging strengths in NDDS, process and NCE research.

A novel approach !

Drug discovery is a long and arduous process. But a number of drug companies have started using new delivery systems to enhance the potential and utility of already proven drugs. What is your take on novel drug delivery systems?

Many of the problems associated with conventional formulations are related to the way the drug is delivered. Novel drug delivery technologies that optimise the release profile of an active ingredient can provide important clinical and patient benefits and also tangible economic advantages for the pharmaceutical company.

NDDS technologies can improve a product’s clinical and commercial value, Clinically, they improve the therapeutic efficacy, reduce adverse effects, enhance tolerability, identify new indications and facilitate dosing compliance. Drug delivery technologies make medicines more convenient and acceptable to patients. They can simplify the dosing regimen and improve administration.

Lupin has an edge in terms of novel drug delivery systems. Please tell about the NDDS activities of Lupin.

Lupin’s NDDS capability was proven by the launch of Ceff-ER in May 2003; world’s first once-a-day Cephalexin tablet and Odoxil OD; world’s first once-a-day Cefadroxil tablet. Also, company has filed seven patent applications for NDDS platforms in major areas.

Lupin’s NDDS focus in on oral controlled release systems, high dose/frequency/ pill burden drugs and patentable platforms and product specific technologies. Advance drug delivery systems (ADDS) focus on invasive to non-invasive drug delivery systems (injectable to oral) and pulmonary drug delivery systems.

Pains and gains

Though India is making inroads into discovery research, a number of companies are concentrating just on the discovery part and outsourcing other processes or out-licensing. What is Lupin’s policy in relation to this matter? Will the company focus only on R&D as its core activity? What are the company’s plans for the future?

Lupin’s R&D activity is vertically integrated, starting from process development of the API till the submission of dossiers for finished dosages. Lupin’s R&D activities are moving in great earnest and right direction. It is playing a pivotal role in selecting and developing molecules that are being commercialised successfully. The achievement of this activity could be gauged from the volume and diversity of its filings. During the year 2005-06, the company filed 18 ANDAs in US, nine MAAs in UK, six MAAs in Australia, three MAAs in New Zealand, two MAAs in France, three MAAs in Croatia and 343 dossiers for the rest of the world. It has also filed 64 patents during the year. The NCE research progress is encouraging. Four investigational new drugs addressing three different disease areas viz migraine, psoriasis and tuberculosis are in various phases of clinical development. Its NDDS initiatives are expected to open licensing opportunities in the near future.

What are the major therapeutic areas that Lupin is looking into and why?

The company has identified cardiovascular and anti-diabetics as prominent growth drivers and focuses on them through a dedicated business division. Further, being a major player in TB drugs in the past, the company also entered various segments like anti-TB, anti-infective, anti-asthma and CNS.

Lupin is making strong inroads into certain lifestyle segments like cardiovascular, diabetics and anti-asthma while it continues to be a well-recognised global leader in the anti-TB and anti-infectives segments.

One in all

Lupin has been very active in the public private partnership sphere. Is partnership the right way ahead in discovery research? Please enumerate the advantages and disadvantages of partnerships.

There are several diseases, which have now assumed a position of public health issue like malaria, TB and AIDS. Governments are obviously keen on developing new therapies to combat these diseases. For a corporate participating in Public Private Partnership Agreement (PPPA) the partnership gives access to funding for research as well as helps in testing clinical trials, if a molecule reaches the stage. As far as the government is concerned, any molecule developed out of PPPA could be available for mass treatment at much lower cost than one developed purely out of private research.

What is the way ahead for India in terms of NCE research? What are the competencies that the country should leverage to get an edge in the drug discovery?

India’s traditional strength has been process chemistry as well as ability of very high quality scientific talent at relatively lower cost. However, NCE research is enormously expensive process and as of now not many Indian companies have the financial wherewithall to take it to its logical conclusion and come out with a molecule that can be sold commercially.