Dr K Anji Reddy, chairman of Dr Reddy's Laboratories, has named the NYSE listing, the generic Fluoxetine launch with 180-day exclusivity, Ragaglitazar's entry into phase-III clinical trial, a $55 million deal with Novartis for DRF-4185 and the filing of an NDA under section 505 (b) (2) for Amlodipine Maleate as some of the key and significant developments of the company in the financial year 2001-02.
Addressing the shareholders at the 18th Annual General Meeting of the company on Monday, Dr Reddy said these developments were the result of the sustained efforts to fulfill its vision of becoming a discovery-led global pharmaceutical company. On top of these developments comes a sound financial performance, the best since the company's inception.
The company, it may be recalled, had reported sales of Rs 1,557.80 crore for the year 2001-02 from Rs 984.10 crore in the previous year, an increase by 58 per cent and profit after tax (PAP) more than trebled to Rs 459.70 crore from Rs 144.50 crore over the previous year. The annual report was released almost a month ago.
Terming Ragaglitazar as an icon of India's drug discovery effort, Dr Reddy said it (DRF-2725) was a new generation dual-acting PPAR alpha-gamma agonist, which in pre-clinical and early clinical trials and in clinical proof-of-concept studies has shown potential to regulate blood glucose and diabetic dyslipdaemia. However, Novo Nordisk, the Danish pharmaceutical company to whom the drug was out licensed, had suspended the ongoing phase-III clinical trials, as long-term carcinogenecity studies revealed urine bladder tumours in rats and a mouse. While the result of further work on the tumour mechanism was awaited, Dr Reddy said, he was optimistic of the outcome.
Recalling the company had initiated drug discovery research way back in 1993, Dr Reddy said it had forged relentlessly ahead and built a strong research foundation in spite of widespread scepticism.
The company, he said, had a strong pipeline of products, which were at various stages of pre-clinical and clinical development. Its continued research focus in the area of PPAR agnostics had culminated in the identification of novel molecules that have predominantly PPAR-alpha activity. It was also probing these molecules further and it was believed that they might provide excellent lipid modulation while minimizing the risk associated with the purported PPAR-gamma-related side effects.
The company's anti-cancer molecule, DRF-1042, an orally active topoisomerase inhibitor, had completed phase-I studies in India. The phase-I data was promising because it conforms to some of the beneficial properties of the molecule observed in pre-clinical setting. There was complete remission and partial response in some stage IV refractory cancer patients in this trial. The company was planning to initiate multi-centre phase-IIa trials for this molecule in India.
The second anti-cancer molecule, DRF-1644, another topoisomerase inhibitor for intravenous use, had received an IND approval and phase-I trials would be initiated shortly, he said.
On the novel discovery effort in the anti-infective area, Dr Reddy said the company had short-listed several lead candidates that would combat a host of bacterial infections needing a wide spectrum of anti-bacterial activity. Equally satisfying was the progress of target discovery and validation efforts at the Atlanta facility of the company. The scientists there had identified several early pre-clinical candidates for further evaluation in the areas of restenosis, inflammation and transplant vascuolopathy. The company was in talks with potential partners for co-development of promising drug candidates in the area of restenosis and transplant vascuolopathy.
As concrete step in the realization of the company's desire to give back to the society, Dr Reddy's Foundation for Human and Social Development had several success stories of youth at the Livelihood Advancement Business School (LABS) and the confidence reposed in the Child and Police (CAP) project by the local citizens, governmental, national and international organisations were indeed very gratifying, Dr Reddy said.