Reddy’s drops efforts on Novartis drug clone

Dr Reddy’s Laboratories has dropped plans of developing a generic version of Novartis’ anti-fungal skin/nails treatment drug Lamifil (terbinafine hydrochloride), which has estimated sales of $1 billion in its various variants.

The company is believed to have spent about Rs 25 crore on the development process so far, but with the drug indicating low levels of efficacy, it has been dumped, said sources familiar with the development.

Dr Reddy’s was developing terbinafine in the form of nail lacquer. The drug is a synthetic alllylamine antifungal and was available in the form of tablets by the innovator Novartis.

However, post its patent expiry in 2007 several players swung into action to make the generic terbinafine.

According to a company official, Dr Reddy’s had a plan to spend about $8 million on the clinical development of the product.
It was around this time last year the company had also said it was unable to take its much-hyped new chemical entity Balaglitazone forward as it wasn’t able to find partners for joining the development process.

The company had carried out research & development on the anti-diabetes molecule for about six years.

However, sources tracking the company said the dropping of candidates from development is a common phenomenon in the sector since the drugs, post development, have to comply with regulations on efficacy and side effects. “The company has a large pipeline of pre-clinical assets in the areas of pain and dermatology that would take care of the new product roll out for several years. Dropping of one product that was off-patent way back in 2007 should not have any significant impact on the profit and loss of the company,” the source said.