The Chennai-based Orchid Chemicals & Pharmaceuticals Ltd (Orchid), which registered a turnover of Rs 713.41 crore with a jump of 32 per cent rise in turnover during the last fiscal has achieved significant progress in its identified growth horizons of bulk actives, formulations and drug discovery, to become a Rs 1000 crore pharma conglomerate by year 2005.
Over the last few years, Orchid has invested heavily for setting up new infrastructure and for upgrading the existing infrastructure to comply with US FDA and other regulatory standards. Orchid has received many international regulatory approvals for its oral and sterile cephalosporin products, including the US FDA approval and seven Certificates of Suitability (CoS) approval from the European Directorate for the Quality of Medicines (EDQM).
The state of the art formulation plant coming up at Irungottukottai near Chennai for oral and sterile cephalosporins has progressed to taking exhibit batches of key products and the company is likely to soon start filing the Abbreviated New Drug Applications (ANDAs). Orchid recently filed its first ANDA for Cefazolin. The facility was inspected and approved by the US FDA in December 2003. This facility also forms the base for Orchid's entry into the U.S. generics market.
Further, the company has plans to raise up to USD 75 million to fund its long-term growth plans. This includes further diversification, strengthening its foray into the US generics and other regulated markets and setting up of additional US FDA complainant infrastructure for drug development. Additionally, the company will establish new US FDA compliant infrastructure to develop and manufacture drugs in diverse therapeutic groups, with emphasis on non-penicillin, non-cephalosporin products. Orchid has already drawn up project plans in this area based on select products, which offer considerable market potential. In addition, Orchid will utilize part-proceeds to accelerate drug discovery programmes, which have already generated interesting leads, now in advanced pre-clinical evaluation.
Orchid had made a strategic shift from the less-regulated markets to the high-margin regulated markets and this has significantly helped the company in improving its business and turnover. Its sale of cephalosporine bulk actives (oral & sterile) accounted for Rs 624.55 crore last year and in the formulation business, Orchid Healthcare and Mano Pharma have shown a significant increase in performance. By end-December 2003, Orchid's total patent applications in the various international patent offices and India-WTO system were at 184. Since the company was working on various NDD and NDDS, more applications are likely to be filed this year.
Orchid's NDD research programme in Chennai has been working on more lead molecules in the area of anti-infectives and anti-inflammation segments and have shown good promise in in-house pre clinical safety and efficacy tests, according to sources.
Orchid's US discovery JV (Bexel Pharmaceuticals Inc) that has been working on a novel anti-diabetic molecule (BLX-1002), has successfully completed its multiple dose phase 1(b) clinical trials in Europe and the phase 2(a) trials are likely to be completed within three months.