The Chennai based Orchid Chemicals & Pharmaceuticals Ltd. (Orchid) said it has so far filed 184 patent applications and was planning to file more patents in the coming months since research was progressing to develop various New Drug Discovery (NDD) and Novel Drug Delivery System (NDDS).
According to company sources, additional patent filings covering process, NDD molecules and formulations have been made, and by end-December 2003, Orchid's total patent applications in the various international patent offices and India-WTO system stood at 184. Since the company was working on various NDD and NDDS, more applications are likely to be filed in the coming months. Orchid's NDD research programme in Chennai has been working on more lead molecules in the area of anti-infectives and anti-inflammation segments. These have shown good promise in in-house pre clinical safety and efficacy tests.
Commenting on its novel anti-diabetic molecule BLX - 1002, developed in association with its US joint venture partner Bexel Pharmaceuticals, sources said the drug was undergoing Phase I human clinical trials in Europe. The drug, an orally active small molecule for treatment of Type-2 diabetes, had successfully completed pre-clinical tests and evaluation of the results and clinical protocols by the Independent Ethics Committee (IEC). BLX 1002 molecule is distinctive in its class for not only its exceptional efficacy and safety, but also its unique anti-weight gain property, claimed the company sources.
The sources also said Orchid's sterile API product, Cefazolin, produced at its Alathur facility was approved by the USFDA during the last quarter period and this was the first sterile product approval for Orchid. The company also had its fourth Certificate of Suitability (CoS) approval for another API Cefixime during the last quarter.
In the formulation business, the company posted a growth of 54 per cent during the third quarter of 2003-04 in comparison to the corresponding quarter of last fiscal. Orchid's specialty formulations business, operated through Mano Pharma division, has shown significant growth in the last quarter and the company has made many international registrations to boost exports, noted company sources. Eyeing the lucrative US generics market, Orchid was working on to file many Abbreviated New Drug Applications (ANDA). The state of the art formulation plant coming up at Irungottukottai near Chennai for oral and sterile cephalosporins, has progressed to send exhibit batches, said the sources.