The Chennai based-Orchid has announced its plans to diversify into manufacture of high growth APIs and formulation products, including therapeutic groups such as cardiovascular, neuro-psychiatry and pain management products.
According to Orchid, this is to strengthen further growth for Orchid from 2008, and necessary laboratory and pilot scale US FDA compliant API/formulation facilities are being established at the company's select locations. With several blockbuster products going off patent annually in the advanced markets of EU and US in these product groups, the proposed therapeutic diversification would provide Orchid with a continuous generic product pipeline to further supplement future growth, said the sources.
It should be noted Pharmabiz was the first to report on Orchid's plans to add a state-of-the-art formulations manufacturing plant at its 25 acre Irungattukottai facility near Chennai for the manufacture of CNS and cardiovascular formulations as part of its plan to enter into diverse therapeutic groups. The plant is likely to be ready by middle of next year, for commencing the regulatory submissions process.
Sources said Orchid's core cephalosporin API business registered a turnover of Rs 140.85 crore (Rs 141.24 crore) for the quarter ended September 30, 2004. During the period, the continuing global price pressure in certain Pen-G based API products was countered through a product-market optimization plan, thereby helping the company register growth in operating margins.
In the field of formulation business, Orchid is integrating the sale of oral antibiotic products, with the retail 800 odd sales force covering 128000 doctors, to market its specialty products. The company has set up a critical care division for the sale of premium antibiotic products, especially injectables to hospitals. During the first half of this fiscal, more than 10 new formulations were introduced in the domestic market, and more are in the pipeline in this fiscal. In the international market, Orchid has done more than 100 product registrations in around 28 countries, and will improve the registration to more than 200 during this fiscal.
The company's US FDA compliant cephalosporin oral and sterile formulations facility at Irungattukottai, near Chennai has accelerated the filing of Abbreviated New Drug Applications (ANDAs) (9 ANDAs filed till date) for its identified cephalosporin products. These ANDAs cover both sterile and oral cephalosporin formulations, Inspections and approval for the facility and more filing of ANDAs for certain other identified formulations have been lined up for this fiscal.
Orchid's US drug discovery JV (Bexel Pharmaceuticals) recently completed the limited, proof-of-concept phase 2(a) trials on its novel anti-diabetic molecule, BLX-1002. The results of the trials are promising in terms of blood glucose and triglycerides reduction at specific dose levels. The company has commenced discussions with a few MNCs for evaluation of the molecule and possible out-licensing. Two novel new chemical entities (NCEs) from the JV, currently in the pre-clinical stage of evaluation are expected to move into Phase 1 clinical trials during the last quarter of this fiscal. Orchid's in-house New Drug Discovery (NDD) is working on lead molecules in the anti-infective and anti-inflammatory therapeutic segments. Both these leads are currently undergoing advanced pre-clinical trials and further optimization. Based on the outcomes, one molecule among these is expected to move into Phase 1 during this fiscal.
In the case of its joint venture in China, NCPC-Orchid Pharmaceuticals, sources said the JV, now in the first full-year of commercial operations, has achieved a turnover of USD 8 million for the period between April to September 2004.