6-K
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 August 2007
Commission File Number 1-15182
DR. REDDYS 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 registrants home country), or under the rules of the home country
exchange on which the registrants 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 registrants
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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Press Release
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[DR. REDDYS LOGO] |
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Dr. Reddys Laboratories Ltd. |
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7-1-27 Ameerpet |
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Hyderabad 500 016 India |
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Tel: 91 40 373 1946 |
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Fax: 91 40 373 1955 |
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www.drreddys.com |
Copenhagen, Denmark and Hyderabad, India, August 1, 2007
Rheoscience and Dr. Reddys commence the first Phase III trial of Balaglitazone (DRF 2593)
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Balaglitazone is a novel TZD candidate for the treatment of diabetes mellitus |
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First Global Phase III clinical trials of a Dr. Reddys new chemical entity |
Copenhagen, Denmark and Hyderabad, India, August 1, 2007: Rheoscience A/S and Dr. Reddys
Laboratories (NYSE:RDY) today announced that the first patient has been dosed in a Phase III study
with Balaglitazone (DRF2593-307), which is an insulin sensitizer that acts as a partial PPAR
(peroxisome proliferator-activated receptor) gamma agonist. The study is the first in a series of
planned Phase III trials which will investigate the safety and efficacy of Balaglitazone, as an
oral anti-diabetic drug.
Balaglitazone is a second generation of PPAR gamma agonist with only partial agonistic properties,
which in clinical phase II studies have shown to have glucose lowering capabilities and to be
body-weight neutral. In preclinical experiments, balaglitazone has been shown to cause less fluid
retention than full PPAR gamma agonists.
In the trial, Balaglitazone will be tested in a 6 month double-blinded, randomised,
placebo-controlled multicenter trial in which type 2 diabetes patients will be given daily doses of
either 10 or 20 mg of Balaglitazone versus the active comparator Actos® (45 mg/day) as an add on to
stable insulin treatment. The primary clinical end-point of the study is a glucose lowering effect
assessed as a change in haemoglobin A1c (HbA1c) levels the preferred standard measure of a
patients blood glucose control over time. The study is designed to show non-inferiority to Actos®.
As a secondary end point, major emphasis will be focused on assessing the safety profile, including
its impact on weight gain and oedema.
A complete Phase III programme has been designed in which the glucose lowering effects of
Balaglitazone will be tested either alone, or in combination with a number of other oral agents
such as metformin and sulfonylurea.
Balaglitazone is being developed under a co-development agreement between India based Dr. Reddys
and Rheoscience in Denmark. Rheoscience will retain the marketing rights to European Union and
China and Dr. Reddys will retain the marketing rights in the territories of United States and rest
of the world. Rheoscience shall obtain all necessary regulatory approvals on behalf of Dr. Reddys
in the United States.
About Rheoscience
Rheoscience is a Danish biopharmaceutical company focused on the discovery and development of novel
pharmaceutical products for the treatment of metabolic diseases such as diabetes and obesity.
Rheoscience has unparalleled experience in developing drugs for metabolic disorders and draws on
this to advance its own pipeline of innovative compounds and to underpin its successful, profitable
contract research business.
Rheosciences lead product is the oral anti-diabetic drug, balaglitazone, which is entering Phase
III clinical trials for the treatment of type 2 diabetes, a disease that affects approximately 6%
of the global adult population aged 20-79 years. Balaglitazone is being co-developed with Dr
Reddys.
Rheosciences pipeline also includes an advanced pre-clinical program around a mimic of an
intestinal hormone that makes people feel full after eating and is intended for the treatment of
obesity.
About Dr. Reddys
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Dr. Reddys Laboratories was established in 1984 in Hyderabad, India, and is a global
pharmaceutical company with proven research capabilities. Dr. Reddys conducts research in the
areas of diabetes, cardiovascular, anti-infectives, inflammation and cancer. The Indian based
company produces finished dosage forms, active pharmaceutical ingredients and biotechnology
products which are marketed globally, with focus on India, US, Europe and Russia.
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.
Dr. Reddys Contact Information:
Investors and Financial Analysts:
Nikhil Shah at nikhilshah@drreddys.com or on +91-40-23731946 ext. 308
Media:
Mythili Mamidanna at mythilim@drreddys.com or on +91-40-66511620
Rheoscience Contact Information:
Philip Just Larsen, Chief Executive Officer, Rheoscience A/S,
Contact: +45 44501 960
Notes to the editor:
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Balaglitazone is an insulin sensitizer that acts as a partial PPAR (peroxisome
proliferator-activated receptor) gamma agonist being developed for the treatment of type 2
diabetes. Balaglitazone is a novel compound and belongs to the class of thiazolidinediones
(TZD) |
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Type 2 diabetes is the most common form of diabetes. In type 2 diabetes, either
the body does not produce enough insulin or the cells ignore the insulin. |
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Type 2 diabetes is a disease that affects approximately 6% of the global adult
population aged 20-79 years. and represents an area with significant unmet medical need.
The World Health Organization (WHO) estimates that more than 180 million people worldwide
have diabetes. This number is likely to more than double by 2030 |
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SIGNATURES
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.
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DR. REDDYS LABORATORIES LIMITED
(Registrant)
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By: |
/s/ V. Viswanath
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Date: September 18, 2007 |
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Name: |
V. Viswanath |
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Title: |
Company Secretary |
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