Orchid Chemicals & Pharmaceuticals Ltd. (Orchid) has identified a few promising lead molecules in cancer, inflammation, and infection therapeutic areas for further development in association with its US drug discovery partner Bexel Pharmaceuticals. With the prospects in the collaborative drug discovery programme, Orchid has also increased its stake in the JV from 50 per cent to 75 per cent to accelerate the development activities.
Currently, the R&D center of Orchid in Sholinganallur is working on oncology research, and several candidate leads were screened at the National Cancer Institute, USA. A few promising anti-cancer molecules have been selected for further development. Several leads are progressing in advanced pre-clinical stages in inflammation, cancer and anti-infectives, revealed the company.
With a view to fast track this drug discovery, the Board of Directors has approved a proposal to integrate and consolidate Orchid's drug discovery programme in inflammation and cancer, with the drug discovery IPR of Bexel. Transfer of such select IPR, together with funding and services support for clinical studies on the combined portfolio would give Orchid a higher stake of 75 per cent in the JV. So far, the JV was on 50:50 ratio.
"Given the expertise of the Bexel team in executing regulatory studies, clinical trials and out-licensing options, the Board felt that certain promising drug discovery molecules of Orchid in Inflammation and Cancer which are in advanced pre-clinicals, could be fast-tracked if integrated under Bexel's umbrella," said the company.
Pharmabiz had earlier reported that the JV is developing selected leads for a unique Non Cox- 2 Inhibitor anti-inflammatory drug and a novel anti-obesity drug. Apart from this, under the Orchid's platform, Orchid's in-house drug discovery centre was working on an Oxazolidinone anti-infective and a Cox-2 anti-inflammatory drug. Four leads are in the anti-inflammatory segment and six in the anti-infection category. The JV was planning to take at least one each lead molecules to the phase I stage, Pharmabiz reported a few months ago.
The JV also has successfully completed proof-of-concept phase 2(a) trials on its lead anti-diabetic molecule, BLX-1002. Discussions are being held with MNCs for a possible out-licensing deal, said sources.
Orchid said the company has identified several products in the non-penicillin, non-cephalosporin segment, in the CNS, CVS and anti-diabetic therapeutic segments to further enhance its growth from 2007. The company is establishing new bulk and formulation manufacturing infrastructure in Aurangabad and Irungattukottai (Chennai) to cater to these products. Regulatory filings for these products are expected to start from the first quarter of next fiscal. Following the earlier tie-ups with Apotex and Par Pharma for antibiotic products, Orchid is discussing marketing arrangements for these non-antibiotic products with certain large generic companies. Final agreements are likely to be inked soon.
On the regulatory process, the communication said Orchid increased the pace of regulatory filings in the Cephalosporin space with 5 DMF/ANDA filings during the quarter. Orchid has so far filed 15 US DMFs and 11 ANDAs to support its US generics thrust. Orchid's flagship product Cephalexin and sterile product Cefazolin have been approved by the US FDA. More US regulatory filings are underway. Orchid has been awarded Certificates of Suitability (CoS) from the European Directorate for the Quality of Medicines (EDQM) for nine of its products.
"Good progress in terms of R&D and manufacturing infrastructure has also been achieved in the Non-Penicillin, Non-Cephalosporin (NPNC) segment, the next growth horizon of Orchid. The dependence on the less-regulated markets will thus taper down from this fiscal and we hope to post strong and robust revenues when the regulated market business flows in from next fiscal," said K Raghavendra Rao, managing director, Orchid Chemicals & Pharmaceuticals Ltd.
Orchid achieved a turnover and operating income of Rs 172.26 crore for the quarter ended December 31, 2004 (Q3 FY 04-05) in comparison to Rs 172.86 crore registered during the corresponding third quarter of last fiscal. Gross profit before interest, depreciation and tax stood at Rs 42.24 crore compared to Rs 36.82 crore during the corresponding quarter of last year representing a growth of 15 per cent. Profit before tax was Rs 8.75 crore as compared to RS 7.52 crore registered during the corresponding quarter of last fiscal. Net profit after tax was Rs 5.76 crore.