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Tuesday, Aug 27, 2002

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Dr Reddy's in healthy frame — To tap US market with branded formulations

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The Dr Reddy's Laboratories Chairman, Dr K. Anji Reddy, announcing the developments in the company's basic drug discovery programme at its 18th AGM in Hyderabad on Monday, as the Chief Executive Officer, Mr G.V. Prasad, and Chief Operating Officer, Mr K. Satish Reddy, look on.


NOTWITHSTANDING the setback suffered on account of suspension of clinical trials by Novo Nordisk on the dual acting diabetic molecule - DRF 2725 - also known as Ragaglitazar, Dr Reddy's Laboratories Ltd is bullish on its drug discovery programme.

The drug major is also steadfast on its strategy for the US generics market and would continue to challenge the patents of inventors in spite of recent reverses in the US Federal Courts on patent infringement disputes with various global pharmaceutical giants.

Declaring this at the 18th annual general meeting of the company here on Monday, the Chairman of Dr Reddy's Laboratories, Dr K. Anji Reddy, said he remained optimistic of the outcome of trials on DRF 2725. According to him, the Ragaglitazar developments hint at the risks inherent in the drug discovery process. "We have a strong pipeline of products that are at various stages of pre-clinical and clinical development."

DRF 4158, licensed to Novartis, is currently undergoing regulatory toxicology studies and is expected to enter phase-I clinical development later this year. The anti-diabetic molecule, DRF 2593, licensed to Novo Nordisk, is currently in late phase-II clinical trials.

In India, the company's anti-cancer molecule, DRF 1042, has completed phase-I clinical studies. According to Dr Anji Reddy, the phase-I data was promising because it confirms some of the beneficial properties of the molecule observed in pre-clinical setting.

"Indeed, I am happy to say that we saw complete remission and partial response in some stage-IV refractory cancer patients in this trial. We now plan to initiate multi-centre phase-II trials for this molecule in India. The second anti-cancer molecule, DRF 1644, another topoisomerase inhibitor for intravenous use, has received an IND approval and phase-I trials will be initiated shortly."

Stating that the progress of target discovery and validation efforts at the company's Atlanta facility were equally satisfying, Dr Reddy said the company identified several early pre-clinical candidates for further evaluation in the areas of restenosis, inflammation and transplant vascuolopathy.

"We are also in talks with potential partners for co-development of promising drug candidates in the area of restenosis and transplant vascuolopathy," Dr Reddy said, adding that "our R&D efforts will not only remain committed to sustain the strong pipeline but also advance more molecules through various clinical phases of development."

Marketing set-up in US

The Dr Reddy's Vice-Chairman and Chief Executive Officer, Mr G.V. Prasad, said the company was in the process of launching its first generic product through its own marketing set-up in the US shortly.

"Our US marketing team is now in place and this will enable us to move up the value chain as well as take us closer to the final customer. We are also making rapid progress in creating the speciality business in the US."

Stating that Dr Reddy's had carved out a detailed strategy to become a discovery-led global pharma company, Mr Prasad said the broad pathway included growing the company's core business of active pharmaceutical ingredients, branded formulations and generics by targeting high value and unique opportunities, creating a sales and marketing infrastructure in the US and certain other key markets, and investing and expanding the company's internal discovery pipeline by building a distinctive global research organisation and forming alliances.

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