Archana Shukla

Mumbai: Glenmark Pharmaceuticals is poised to launch 5 generic products every quarter this year in the US and will be filing about 25 abbreviated new drug applications (ANDAs) with the US Food and Drugs Administration (FDA) this year.

“Based on our generics filings, we expect the contribution from our US business to be around 30% of total sales in FY09,which will continue to go up in the next few years,” Glenn Saldanha, chairman and managing director told DNA Money.

ANDA is an application made to seek FDA’s approval to sell a generic version of an existing licensed medication or approved patented drug. Glenmark posted strong earnings for FY08 with its US generics business contributing about 23-25%.

“We would launch at least 20 products and file a minimum of 25 ANDAs in FY09 and this would be an ongoing process for the next few years,” he said.

Glenmark already has a portfolio of 28 generic products and 34 ANDAs pending FDA approval.

The US market has been characterised by price pressures due to increased competition in the generics space, which has led to lower margins for companies, but Glenmark is set to buck the trend as it will be targeting niche therapeutic areas.

High-value speciality hormones, modified-release dermatology and oncology products are its focus areas.

An analyst with a Mumbai-based research firm,who did not wish to be named, said niche therapeutics would be an earnings driver for Glenmark as their margins are pretty high because of less competition.

The company also plans to file 15 drug master files (DMFs) in the US in this fiscal, which it feels would work as a vertical integration for the company.

A DMF is a document submitted to the FDA and provides confidential detailed information about an applicant company’s facilities, processes in the manufacturing, processing, packaging and storing of one or more human drugs.

“These are broad-based filings, based on the drug and not specific to any therapeutic area,” Saldanha said.

Glenmark plans to market proprietary products in the US and is also looking to acquire a late-stage clinical product and start marketing it.

To get a headstart for its specialty business, Glenmark is looking to acquire a front-end company in the US, in the next 12-18 months.

Clearly, the US will be the fulcrum of the company’s growth.

Analysts too feel strongly about the US contribution, looking at the strong product pipeline for the key market Amod Karanjikar and Ranjan Varghese, analyst with Edelweiss Securities, said they expect Glenmark’s US business to contribute about 40% to its growth over the next two years.

“We believe the company will achieve about 51% CAGR in revenue from the US generics market in the three fiscal years to the present,” they said in a note on Tuesday.

Source : DNA