RDY

Business Context and Reporting Period

This Form 6-K filing by Dr. Reddy's Laboratories Ltd. covers the month of August 2010. The report primarily disseminates a press release dated August 9, 2010, announcing the launch of a new biosimilar product in India.

Key Financial Metrics

The filing text does not provide specific financial results for Dr. Reddy's Laboratories Ltd., including revenue, profit, cash flow, margins, debt, or liquidity for the reporting period. The document focuses exclusively on a product launch announcement.

External market data cited in the press release includes:

• Annual global sales of darbepoetin alfa in 2009: $2.65 billion (Source: Amgen 2009 Annual Report).
• US sales of darbepoetin alfa in 2009: $1.25 billion (Source: Amgen 2009 Annual Report).

Material Changes and Product Launch

The material event reported is the launch of Cresp^®, the world's first generic darbepoetin alfa and the only one available in India. Key details include:

• Indication: Approved for the treatment of anemia due to chronic kidney disease and anemia due to chemotherapy.
• Product Advantage: Darbepoetin alfa has a longer half-life (up to 3 times) than epoetin alfa, allowing for reduced dosing frequency.
• Formulations: Available in vials and prefilled syringes (PFS).
• Pricing Strategy: Positioned to offer significant monthly savings compared to the originator brand (Eprex^®) and other biosimilar epoetin therapies in India.

Outlook, Management Commentary, and Risks

Management Commentary:

• GV Prasad (Vice-Chairman and CEO) stated the launch redefines anemia treatment in India and underscores the company's commitment to affordable, innovative medicines.
• Cartikeya Reddy (SVP and Head of Biologics) highlighted the launch as a demonstration of development capabilities in biosimilars, following the success of Reditux^TM (the first biosimilar monoclonal antibody).

Pipeline and Strategy:

• Current portfolio includes Grafeel^TM (biosimilar filgrastim) and Reditux^TM (biosimilar rituximab).
• The biosimilar pipeline includes a pegylated molecule in late-stage clinical trials, two products in late-stage development scheduled for clinical trials, and several in early-stage development.

Risks and Contingencies:

• The filing includes a standard disclaimer regarding forward-looking statements.
• Risks cited include changes in local and global economic conditions, ability to implement strategy, market acceptance and demand for products, growth and expansion, technological change, and exposure to market risks.

Investor Verification Checklist

• Verify the regulatory approval status and commercial availability of Cresp^® in India.
• Assess the competitive landscape for anemia treatments in India, specifically pricing comparisons between Cresp^® and originator brands like Eprex^®.
• Monitor the progress of Dr. Reddy's biosimilar pipeline, particularly the pegylated molecule and late-stage development products.
• Review subsequent quarterly financial reports to determine the revenue impact of the Cresp^® launch.