Company officials said, ``We expect to commence distribution by late January and have already received clearances from both the Drugs Controller General of India (DCI) and the local Food and Drugs Administration (FDA).'' Trials have been done in 100 patients at three centres in the country and the company will continue to monitor the product's progress over a period of time.

Wockhardt's hepatitis-B vaccine is based on the active ingredient made in joint venture with Rhein Biotech GmbH, Germany, and the Indian company is targeting sales of around Rs 10 crore in the first year. The vaccines are being manufactured at the state-of-the-art Aurangabad facility, capable of an output of ``a couple of million doses.''

Indications are that Wockhardt's vaccine will not be priced at the lower end of the market, though there could be an initial price differential at the time of launch (compared with SmithKline's Engerix). Biovac's exact pricing could, however, not be got.

Company officials also said that Wockhardt's recombinant erythropoetin (essentially used to treat anaemia caused by renal failure or during cancer treatment) has completed clinical trials and is seeking DCI approval.Officials had earlier last year stressed that Wockhardt has pilot scale capabilities for all kinds of biotech products in all the broad streams (including yeast and bacterial) of recombinant biotechnology.

The company is also working on two original lead molecules in the area of anti-bacterials and is optimistic on an Investigational New Drug Application (INDA) filing in the near future.

The company had, in January 1999, also indicated that it has five novel drug delivery formulations to be launched in 1999-2000, besides a pipeline of 15 new drugs and several line extensions slated for launch in 1999-2002.

Wockhardt has already developed processes for three new bulk drugs and has six in the pipeline for 1999-2002.

Insight
volume push likely

Wockhardt has finally decided to launch their hepatitis-B vaccine, although the expectation has been there for a long time. The product as it is being priced at the higher end of the market is not only expected to give volume push but also better realisation. What is interesting is that sales of Biovac-B will accrue to Wockhardt even as the joint venture with Rhein Biotech GmBH supplies the active ingredient. However, as far as the stock is concerned the new products through the company's R&D efforts hold the future.

Shishir Asthana