In a major boost to Dr Reddy's drug discovery programme, Swiss pharma major Novartis AG and Denmark-based diabetes health care major Novo Nordisk today announced an agreement on the commercialisation of NN-622, a compound currently being developed for the treatment of type 2 diabetes, also known as non-insulin dependent diabetes.
Dr Reddy's had licensed this molecule (code name DRF-2725 ) to Novo Nordisk in August 1998 against an upfront payment, milestone payment and royalties. NN-622 is currently in phase II clinical trials. Novo Nordisk expects to complete the clinical proof of concept trials (phase 2) later this year. If every thing goes well, the product will enter the market in late 2004 or early 2005. The compound is expected to be among the first to reach the market from a new generation of dual-acting sensitisers currently under development.
The development came close on the heels of Dr Reddy's agreement on directly licensing its insulin senstiser molecule, DRF-4158, to Novartis for development and commercialisation in return for fee up to $55 million, depending on the success of the molecule at different stages of development. This agreement was announced on May 29.
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Under the latest agreement between the two multinationals, Novartis acquires exclusive rights to commercialise the compound in the US, Canada and Mexico, with Novo Nordisk retaining certain detailing rights for the US.
Novo Nordisk continues to be responsible for the development and the global regulatory approval and the current agreement between Novo Nordisk and Novartis will not affect Dr Reddy's earlier pact with the former.
As per the agreement, Novartis will make upfront and milestone payments subject to the progress relating to the specified events, and will pay royalties, said a release issued by Novartis Pharma AG in New Jersy today. Commenting on the agreement, Pal Costa, president, Novartis Pharma, said, "the agreement provides a strong near-term opportunity for Novartis in the metabolic and cardiovascular diseases area."
Commenting on the development, Dr Anji Reddy, chairman, Dr Reddy's, said: " Novo Nordisk partnering with a strong company like Novartis should take our discovery, DRF-2725, to a commanding position in the North American market."
NN-622 is a PPAR (peroxisome proliferaor-activated receptor) alpha and gamma agonist, which in pre-clinical and early clinical trials has shown the potential to regulate blood glucose and diabetic dyslipidemia. Increasing scientific evidence indicates that targetting both high blood sugar levels and high lipid levels may improve treatment outcomes for type 2 diabetes patients.