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Matrix Labs plans 5 drug filings with FDA

Our Bureau in Hyderabad
Business Standard, November 10, 2003

The Hyderabad-based Matrix Laboratories is planning to file five drug master files (DMFs) with the US Food and Drug Administration (FDA) during the current quarter.

The company has so far filed seven DMFs with the US FDA. Announcing this along with the second quarter financial results of the company, N Prasad, the chairman and chief executive officer, said the company had 30 products in the pipeline for launch in the regulated markets such as US, Europe and Canada before 2010, as and when patents expire for those products.

Prasad hoped that the company would get a significant share of business from the recently concluded agreement of William J Clinton Presidential Foundation with four companies (Ranbaxy, Cipla, and the South African Aspen Pharmacare besides Matrix) for supply of anti-AIDS bulk drugs for its initiative in African countries to offer treatment to two million patients in five years.

The value of anti-retroviral drugs under the programme is worth more than $400 million per annum. Matrix is expected to get a significant share of this business, considering that it is the principal supplier of APIs (bulk actives) to this programme, Prasad said.

The company has a portfolio of almost all the anti-retroviral drugs, numbering about 10. Matrix Labs has posted a net profit of Rs 32 crore on sales of Rs 136.42 crore for the second quarter of the current fiscal, as against a net profit of Rs 25 crore and sales of Rs 57.77 crore in the same period last year. The company made a provision of Rs 5 crore for current tax and Rs 2.5 crore for the deferred tax during the quarter.

For the first-half of the current fiscal, the company's net profit stood at Rs 62.78 crore on sales of Rs 257.5 crore as compared with that of Rs 44.39 crore and Rs 106.73 crore, respectively. On an equity base of Rs 12.34 crore, it works out to an annualised earnings per share (EPS) of Rs 102.

Of the total sales in the first-half, 55.84 per cent came from exports with a significant share from regulated markets.

While Citalopram, the company's blockbuster anti-depressant bulk active, contributed 28 per cent to the sales during the first-half, anti-retroviral drugs (anti-AIDS drugs) accounted for 20 per cent of the sales in the same period.

While the sales of Citalopram continue to grow in absolute numbers, there is a good contribution from several new products, Prasad said. With the withdrawal of patent infringement case against Lagap Pharmaceuticals by Lundbeck, the innovator of Citalopram, in October, Matrix hopes to achieve an increase in its Citalopram sales to Europe in the current fiscal


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