The Mumbai-based USV Ltd is setting up an injectibles manufacturing facility at its Daman manufacturing unit as the part of its efforts to foray into the biotech business, especially injectibles market in a big way. The new facility with an investment of Rs 55 crore will be operational by September 2008, informed company officials.

USV is in the final stage of commercialising the plant and the validation procedures are expected to commence soon. The company has already lined up a pipeline of 10 products including peptides for manufacturing, said Prashant Tewari, managing director, USV Ltd. The facility is coming up with a line capacity of 3000 vials per hour in German line.

"We are entering into the injectibles market by setting up the plant with global standard facility. This is a specialised market and there is enough competition we foresee in the segment. What we need is a combination of products focusing special segments and international quality standards to win the market," said Tewari. He averred that the high quality injectibles are a must to win the biotech field, on which the company is currently building up a considerable product portfolio.

The company is currently working on five programmes in biotherapeutics, and has four more products in pipeline. The current programmes, Human growth hormone (hGH), human brain natriuretic peptide (BNP), Platelet-derived growth factor (PDGF), Pegylated Granulocyte-Colony Stimulating Factor (PEG-GCSF), and Parathyroid Hormone (PTH), are on various stages of development. The company received Drug Controller General of India's (DCGI) nod to initiate clinical trials on hGH product and is expected to commence the human studies in three months. Tewari said that the first biotech product from USV, the hGH, will be ready for commercialisation in next 18 months.

The company has filed documents with the DCGI to commence clinical trials on Nesritide, the BNP product, even as the PTH and PDGF products are expected to commence pre-clinical studies in July, this year. The PEG-GCSF will go into the pre-clinical stage in the third quarter of current financial year, revealed Tewari.

With two peptide products in market, the company is currently conducting research on three more projects on peptide in endocrinology segment. However, the official refused to comment more on these programmes, as the products are in lab stage of development.

"We have identified excellent potential in biotech sector. It needs prolonged timeline for business operations and huge investments. But the potential is very high. For instance, the global hGH market itself is US$3 billion and its Indian market is Rs 10 crore. The cost of treatment using hGH will be around Rs 5 lakh, which is not affordable for the public at present. With our product, we can reduce the cost of treatment considerably, which will significantly change the market scenario of the product," Tewari averred.

The company will focus on developing products with pegylation technology, the process of covalent attachment of poly (ethylene glycol) polymer chains to another molecule, which will provide advantage of better profile and less side effects for its products, he added.

The Rs 730 crore USV Ltd, one of the world leaders in generic anti-diabetic active pharmaceutical ingredient metformin, is expected to record a growth of 21 per cent in the current financial year. Based on its marketing strength, USV has entered into a number of in-licensing deals with foreign based pharmaceutical companies.