Mumbai: The development work by Novartis Pharma AG, Switzerland, on Dr Reddy's Laboratories' anti-diabetes agent is progressing "well and as per schedule," says company chairman K Anji Reddy.
Dr Reddy's had licensed out the development and commercialisation of its insulin sensitiser, DRF-4158, in type II diabetes to Novartis in May 2001 for upfront and milestone payments and royalties of $55 million. "We are very bullish on DRF-4158 and its development process by Novartis," says Reddy.
DRF-4158 is stated to belong to a new class of anti-diabetic drugs called insulin sensitisers, and is the second-generation dual acting peroxisome proliferator activated receptor alpha and gamma agents for the potential treatment of Type 2 diabetes.
Dr Reddy's received a high-point payment of $5 million from Novartis in August 2001 after the USFDA approved the license agreement between the two companies. Dr Reddy's is expecting a milestone payment soon from Novo Nordisk, the world's largest diabetes drug-maker, for another anti-diabetes compound, DRF-2725.
Novo Nordisk has commenced Phase 3 clinical trials on DRF-2725 that Nordisk has codenamed NN622, say company sources. Novartis was in collaboration with Nordisk for commercialising DRF-2725 in the US, Canada and Mexico, but it walked out of the deal in October 2001. DRF-2725 is also a PPAR for Type 2 diabetes.
Reddy says his company's US subsidiary, Reddy US Therapeutics, had validated three molecular targets. "Reddy US is meant for research in biopharamaceutics, and it has validated the molecular targets, getting proof of concept in animals for cell proliferation that can cause cancer, and restenosis, which causes arteries to clog after surgery."
Reddy US, based in Atlanta, was formed in November 1999. Reddy says while the denial of the 180-day marketing exclusivity by the FDA on the company's generic Omeprazole was a setback, Dr Reddy's is working on other drug patent challenges in the US. But he declined to give details. "We accepted the FDA's ruling." The FDA was given the marketing exclusivity to Andrx Corp, a generic drug-maker in the US.
AstraZeneca, an Anglo-Swedish drug giant, sells Omeprazole as Prilosec, which is indicated for the treatment of gastro and duodenal ulcers. Prilosec is AstraZeneca's $4-billion brand. But Andrx is yet to launch the generic Prilosec, as AstraZeneca's lawsuit against four companies including Andrx and Dr Reddy's, is pending in a New York court.