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DR REDDYS LABORATORIES LTD Regulatory Filings 2011

Jun 3, 2011

30528_ffr_2011-06-03_6b8436b7-c217-4196-b2da-5882e4014734.zip

Regulatory Filings

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FORM 6-K

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934

For the Month of May 2011

Commission File Number — 1-15182

DR. REDDY’S LABORATORIES LIMITED

(Name of Registrant)

7-1-27, Ameerpet Hyderabad, Andhra Pradesh 500 016, India +91-40-23731946

(Address of Principal Executive Offices)

Indicate by check mark whether registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F þ Form 40-F o

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): o

Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): o

Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes o No þ

If “Yes” is marked, indicate below the file number assigned to registrant in connection with Rule 12g3-2(b):

Not applicable.

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Table of Contents

(1) Press Release, “Dr. Reddy’s launches pegfilgrastim in India under the brand name ‘Peg-grafeel TM ’,” May 10, 2011.

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Press Release
Dr. Reddy’s Laboratories Ltd.
7-1-27 Ameerpet
Hyderabad 500 016 India
Tel: 91 40 373 1946
Fax: 91 40 373 1955
www.drreddys.com
Dr. Reddy’s launches pegfilgrastim in India under the brand name ‘Peg-grafeel TM ’
- The only affordable pegfilgrastim in India

Hyderabad, India, May 10, 2011: Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) announced today the launch of Peg-grafeel™ — Dr. Reddy’s brand of pegfilgrastim. Peg-grafeel™ has been approved in India to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Pegfilgrastim is a pegylated long-lasting variant of filgrastim. One injection of pegfilgrastim can replace up to 14 injections of filgrastim, which must be administered daily. It can be administered once per chemotherapy cycle, providing convenience to the patient while eliminating many of the additional costs of treatment.

Dr. Reddy’s Peg-grafeel™ is priced at an MRP of Rs. 8,865 and represents a breakthrough in the pricing of this complex molecule. It is priced at approximately 25% of the originator brand in India, and is priced 95% lower than the US price for pegfilgrastim. This breakthrough in pricing has been enabled by Dr. Reddy’s vertically integrated global manufacturing network. Peg-grafeel™ is manufactured using Dr. Reddy’s ‘PEGtech’ brand of activated mPEGs which are synthesized at its facilities located in Mexico and the UK.

Commenting on the launch, GV Prasad, Vice-Chairman and CEO, Dr. Reddy’s said, “Peg-grafeel™ will offer patients in India an important alternative. An affordable pegfilgrastim will redefine the way patients undergoing treatment with chemotherapy can reduce the duration of neutropenia and highlights our commitment to provide affordable and innovative medicines to patients in India. We also intend to market Peg-grafeel™ globally, on our own and through partners.”

Notes to the editor:

| • | Pegfilgrastim was first approved for use in 2002 by the US FDA. Since its introduction it
has quickly replaced filgrastim as the standard of care in most of the world due to its
convenient (once per chemotherapy cycle) dosing schedule. |
| --- | --- |
| • | Pegfilgrastim was first introduced in India in 2007, and currently several brands of
pegfilgrastim are available. However, in India, pegfilgrastim is an expensive alternative to
filgrastim, priced up to Rs. 34,000 for a single injection. As a result, filgrastim remains
the standard of care in India. |
| • | Neutropenia is the condition in which a patient has a lower than normal white blood cell
count and is a common side effect of many chemotherapy regimens. Having a low white blood cell
count leaves patients vulnerable to life threatening infections. Febrile neutropenia is a
potentially fatal condition where a patient with neutropenia develops a fever due to an
infection. Filgrastim and pegfilgrastim are medicines that stimulate the body to produce white
blood cells, thereby reducing the duration of neutropenia and the incidence of febrile
neutropenia in patients undergoing treatment with chemotherapy. |

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| • | PEGtech is Dr. Reddy’s brand for its extensive range of activated mPEGs. The mPEG alcohol
manufactured in Mexico is supplied to Dr. Reddy’s c-GMP facility in Mirfield, UK where
commercial scale activation is carried out. |
| --- | --- |
| • | Pegfilgrastim, developed by Amgen Inc. was approved for use in 2002 and is sold as
Neulasta ® in US and EU. |
| • | Pegfilgrastim is marketed in India by F. Hoffmann-La Roche Ltd. as Neulastim ® since 2007.
It is currently also sold by Intas, and Gennova/Emcure. Brands include Neupeg™, Pegasta™ and
Pegex™. |

Disclaimer

This press release includes forward-looking statements, as defined in the U.S. Private Securities Litigation Reform Act of 1995. We have based these forward-looking statements on our current expectations and projections about future events. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially. Such factors include, but are not limited to, changes in local and global economic conditions, our ability to successfully implement our strategy, the market acceptance of and demand for our products, our growth and expansion, technological change and our exposure to market risks. By their nature, these expectations and projections are only estimates and could be materially different from actual results in the future.

About Dr. Reddy’s

Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services and Active Ingredients , Global Generics and Proprietary Products — Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars, differentiated formulations and NCEs. Therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management, anti-infective and pediatrics. Major markets include India, USA, Russia and CIS, Germany, UK, Venezuela, S. Africa, Romania, and New Zealand. For more information, log on to: www.drreddys.com

CONTACT INFORMATION

Investors and Financial Analysts:

Kedar Upadhye at [email protected] / +91-40-66834297 Raghavender R at [email protected] / +91-40-66511529 Milan Kalawadia (North America) at [email protected] / +1-908-203-4931

Media:

Rajan S at [email protected] / +91-40- 66511725

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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

By: /s/ Sandeep Poddar
Date: June 3, 2011 Name: Sandeep Poddar
Title: Company Secretary

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