Two Wockhardt compounds in pre-clinical development stage

Our Corporate Bureau

Mumbai, June 3: The Mumbai-based Wockhardt has two of its compounds — WCK-771A and WCK-919 — in late pre-clinical development stage while its third compound, WCK-993A is at the toxicity study stage.

Wockhardt’s latest annual report stated: “The three Wockhardt NCEs are at various ‘late to mid pre-clinical stages’ and will open a huge opportunity with the IND (investigational new drug) filings expected in the next two years.”

The NCEs include two novel anti-bacterial entities with MSRA and VRE activity for treating sepsis and a novel broad spectrum anti-bacterial entity for pneumococcal infections.

Wockhardt is also in the process of seeking out-licensing arrangements with global pharma majors to partner it in regulatory approvals and marketing of these compounds. So far, an aggregate of 30 patents have been filed, including 15 in 2000, the report said.

The company has already filed a patent based on oncology depot injectible technology for a 30-day delivery system suitable for a series of peptides used in oncology.

The peptides are also being synthesised in-house and the launch of the first product in India is scheduled for early-2002, the report said.

Besides development of peptides and drug delivery systems, the company’s research is focused in the field of cardiology, urology, cardiovascular surgery, specialty infusion products and syrup based oral products.

During the year ended 2001, the company’s expenditure on R&D was Rs 40.25 crore, constituting 7.24 per cent of the total turnover.

Wockhardt is also exploring further opportunities in the US generic market and is currently in discussions for product-based alliances, the report said. The year under review saw Wockhardt receiving the US FDA approval for enalpril maleate tablets.

The company also filed drug master files for five bulk actives with the US FDA — nizatidine, fluconazole, ciprofloxacin, loratadine and doxazosin.