Dr Reddy's Laboratories Limited (DRL) will initiate Phase II trials of its molecule DRF 10945 for the treatment of dyslipidemia within two months and is likely to initiate phase III trials of Balaglitazone during next year.
DRL is in talks with a company to partner to work on Balaglitazone by sharing the expenditure arising from the development. The deal will be finalised within one month, said Dr K Anji Reddy, chairman of DRL, while addressing the shareholders at the 21st annual general meeting held at Hyderabad on Wednesday, last week.
Balaglitazone (DRF 2593) is an insulin sensitizer, which acts as a partial PPAR gamma agonist for the oral treatment of patients with type 2 diabetes. Dr Reddy's licensed this molecule to Novo Nordisk in 1997. Novo Nordisk had terminated further clinical development of balaglitazone as the pre-clinical results did not suggest a sufficient competitive advantage for balaglitazone compared to similar marketed products within this therapeutic category.
He said Dr Reddy's has developed an innovative and unique model for financing and sharing the risk of development of new drugs. Several potential partners have evinced interest to participate in such a model. The company has charted out ways to develop new drug candidates, which would help to access the needed financial resources and minimize the impact on the profitability.
The company has now $ 175 million in the bank. DRL is mitigating the risk and the long lead times that are required to access the generic market in the US. "We have a robust pipeline and commercial launches are expected in the next financial year," Dr Anji Reddy added.
GV Prasad, executive vice chairman and CEO of DRL said the company's performance during last year was affected due to fall in global revenues and increased investments in R& D.
Generics market in the US is becoming more challenging, with growing competition between innovator and generic companies, increasing competition among large generic companies and emerging competition from companies in India, Eastern Europe and China. DRL will also focus on biologics segment in the coming years, Prasad added.