DR. REDDY'S LABORATORIES LIMITED
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 September 2005
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):
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):
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.
Table of Contents
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Notice to Stock Exchange, dated September 1, 2005, of Grant of Stock Options. |
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Notice to Stock Exchange, dated September 2, 2005, of Postal Ballot for disposal of the
formulations manufacturing facility at Goa. |
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Press Release, Dr. Reddys Announces the Formation of Perlecan Pharma, September 28, 2005. |
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Press Release, Dr. Reddys Announces Indias First Major Drug Co-Development and
Commercialization Deal, September 29, 2005. |
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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 |
DR. REDDYS ANNOUNCES THE FORMATION OF PERLECAN PHARMA
PERLECAN PHARMA RAISES USD 52.5 MILLION AS INITIAL EQUITY CAPITAL
Perlecan Pharma: Indias First Integrated Drug Development Company
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Perlecan Pharma gets equity capital commitment of U.S.$52.5
million for funding the clinical development of Perlecan Pharma
assets; Perlecan Pharma to receive the first tranche of U.S.$26
million; Dr. Reddys to ultimately hold majority stake in Perlecan
Pharma subject to various conditions |
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Indias leading Private Equity Investors ICICI Venture and
Citigroup Venture Capital International Mauritius Limited lead
investment in Perlecan Pharma equity |
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Dr. Reddys to transfer all rights and title, including the
development and commercialization rights of 4 NCE assets to
Perlecan Pharma in the area of Metabolic Disorders and
Cardiovascular |
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Perlecan provides Dr. Reddys Drug Discovery program, a model, to
rapidly advance its existing as well as future NCE assets through
Phase II trials and seek out-licensing, co-development or joint
commercialization opportunities thereby enhancing the value of the
pipeline. Further, it also enables Dr. Reddys to aggressively
accelerate its new discoveries to clinical development in the
areas of Metabolic Disorders and Cardiovascular |
Hyderabad, India, September 28, 2005: Dr. Reddys Laboratories (NYSE:RDY) today announced the
formation of Indias first integrated drug development Company Perlecan Pharma Private Limited
with equity capital commitment of USD 52.5 million from Indias leading venture capital investors,
Citigroup Venture Capital International Growth Partnership Mauritius Limited (Citigroup Venture)
and ICICI Venture Funds Management Company (ICICI Venture) and Dr. Reddys.
Perlecan Pharma will be engaged in the clinical development and out-licensing of NCE assets.
Perlecan Pharmas early priorities will be to advance the clinical development of NCE assets
received from Dr. Reddys through Phase II and thereafter seek out-licensing, co-development or
joint commercialization opportunities. Perlecan will build on its initial pipeline through a
combination of in-licensing and alliancing opportunities. Perlecan will be managed by an
independent Board and an Executive management team.
Commenting on the formation of Perlecan, Dr. Anji Reddy, Chairman, Dr. Reddys Laboratories, said,
These are exciting times for Indian Pharmaceutical Companies and we are pleased to announce the
formation of Indias first integrated drug development company. The formation of Perlecan acts as a
precursor to many more exciting partnerships in the area of drug discovery and development for the
Indian pharmaceutical industry. We have made significant progress in the last decade in building a
strong drug discovery platform and look forward to further building on this foundation to realize
Perlecan Pharmas potential. This partnership marks an important milestone for the Company and will
put Dr. Reddys at the forefront of drug discovery and development over the next decade. We are
pleased to welcome the involvement of Citigroup Venture and ICICI Venture, who bring important
skills and experience to the new company. We value their support and confidence in future potential
of Perlecan.
Citigroup Venture and ICICI Venture will contribute USD 22.5 million each and Dr. Reddys will
contribute USD 7.5 million towards Perlecan Pharmas initial equity capital. Perlecan will
immediately issue warrants to Dr. Reddys, which will be exercised inter alia based on the
development milestones.
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Perlecan Pharma provides Dr. Reddys Drug Discovery program, a model, to rapidly advance its
existing as well as future NCE assets through Phase II trials and seek out-licensing,
co-development or joint commercialization opportunities thereby enhancing the value of the
pipeline. Further, it also enables Dr. Reddys to aggressively accelerate its new discoveries to
clinical development in the areas of Metabolic Disorders and Cardiovascular.
In connection with this transaction, Dr. Reddys and Perlecan Pharma will enter into agreements
covering the transfer of all titles and rights including the development and commercialization
rights of 4 NCE assets to Perlecan Pharma and provision of support services, supply of clinical
development quantities and commercial quantities to Perlecan on an arms-length basis. The details
of the 4 NCE assets are provided in the table below.
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Therapeutic |
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Development |
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Compound |
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Remarks |
DRF 10945
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Metabolic
disorders
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Phase I completed
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Non-fibrate predominantly PPAR
alpha agonist for the
treatment of
dyslipidemia |
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Clinical trials in Canada |
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RUS 3108
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Cardiovascular
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Phase I in progress
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Perlecan inducer for the treatment
of atherosclerosis |
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Clinical trials in Europe |
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DRF 11605
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Metabolic
disorders
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Preclinical
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Pan PPAR
(α,δ,γ)
agonist for the
treatment of obesity
and dyslipidemia |
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Toxicology studies in progress |
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DRF 16536
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Metabolic
disorders
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Preclinical
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AMPK modulator for the treatment of
dyslipidemia |
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Late stage preclinical discovery |
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Commenting on the partnership, Renuka Ramnath, CEO and managing Director, ICICI Venture, said, We
are pleased to build on our long-standing partnership with Dr. Reddys to create Indias first
integrated drug development company. We believe that Dr. Reddys proprietary discovery platforms in
Metabolic Disorders and Cardiovascular will lead to development of innovative discoveries. These
therapeutic areas continue to be of major clinical relevance and address important patient needs.
We now have the charge of advancing promising NCEs through clinical trials, the success of which is
important for the long-term success of Dr. Reddys and to the promise of addressing unmet metabolic
and cardiovascular therapy needs across the world. Through Perlecan, we will extend these new
discoveries into clinical development and unlock the value of the pipeline through focused
diversification of NCEs and intelligent market alliances including out-licensing to large innovator
pharmaceutical companies. We are excited about being able to back this innovative drug development
model, which we believe will create a win-win situation for all participants.
Perlecan Pharma will have the first right of refusal on future pipeline of Dr. Reddys at fair
market value. Dr. Reddys will be offered commercial rights to Russia, India, China and other
countries in the Commonwealth of Independent states at fair market value for all NCE assets of
Perlecan Pharma.
Commenting on the partnership, Ajay Relan, Managing Director, Citigroup Venture Capital
International, said, The decision to partner with Dr. Reddys demonstrates our confidence in the
progress of Dr. Reddys to date in discovering and developing innovative drugs in Metabolic
Disorders and Cardiovascular segments. Perlecan Pharma, represents a unique and extremely promising
strategy to rapidly advance the clinical development of Dr. Reddys discoveries and we are quite
excited to be a part of Perlecan Pharma.
The exact financial terms and conditions of the agreement with financial investors have not been
disclosed.
About Dr. Reddys
Established in 1984, Dr. Reddys Laboratories (NYSE: RDY) is an emerging global pharmaceutical
company with proven research capabilities. The Company is vertically integrated with a presence
across the pharmaceutical value chain. It produces finished dosage forms, active pharmaceutical ingredients and biotechnology products and markets them globally, with
focus on India, US, Europe and Russia. The Company conducts research in the areas of diabetes,
cardiovascular, anti-infectives, inflammation and cancer.
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About ICICI Venture
ICICI Venture, incorporated in 1988, as a wholly owned subsidiary of ICICI Bank, is the most
experienced and largest private equity and venture fund management company in India with funds.
Since its inception, ICICI Venture has managed assets in excess of Rs. 44 billion (US$ 1 billion).
Over the last 15 years, ICICI Venture has been successful in identifying trends well ahead of the
curve; be it retail, media and entertainment, information technology, real estate or
pharmaceuticals and biotechnology. During this period ICICI Venture launched and managed 8 funds,
with each fund having a distinct investment theme. ICICI Venture today has some of the best known
and managed companies in India in its portfolio.
About Citigroup Venture Capital International
Citigroup Venture Capital International Mauritius Limited (CVCIML) is an investment company
incorporated under the laws of Mauritius and is a wholly owned subsidiary of Citigroup Venture
Capital International Growth Partnership Mauritius Limited, also a company incorporated in
Mauritius. CVCIML is registered under the Companies Act 2001 of Mauritius and has been granted a
license by Financial Services Commission, Mauritius. CVCIML is also registered, subsequent to
approval by the Reserve Bank of India, as a foreign venture capital investor under the Securities
and Exchange Board of India (Foreign Venture Capital Investor) Regulations, 2000. CVCIML is a
company within the structure of the Citigroup Venture Capital International Growth fund (the Fund).
The Fund is a $1,606 million private equity fund whose investors include several private investors
and Citigroup (which is a significant, but a minority investor). The Funds target areas of
investment are Asia and Emerging Europe. Citigroup Venture Capital International Partnership G.P.
Limited (a subsidiary of Citigroup) is the General Partner of the Fund.
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.
Contact Information
Investors and Financial Analysts: Nikhil Shah at nikhilshah@drreddys.com or on +91-40-55511532
Media: M Mythili at mythilim@drreddys.com or on +91-40-55511620
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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 |
DR. REDDYS ANNOUNCES INDIAS FIRST MAJOR DRUG CO-DEVELOPMENT AND COMMERCIALIZATION DEAL
Co-development and Commercialization of Balaglitazone (DRF 2593) with Rheoscience
Hyderabad, India, September 29, 2005: Dr. Reddys Laboratories (NYSE: RDY) announced today that the
Company has entered into a co-development and commercialization agreement with Denmark based
Rheoscience A/S for the joint development and commercialization of balaglitazone (DRF 2593), a
partial PPAR-gamma agonist, for the treatment of type 2 diabetes.
Under the terms of the agreement, Rheoscience shall fund all the costs associated with the Phase
III clinical trials of DRF 2593 and Dr. Reddys shall pay Rheoscience a pre-determined amount
towards its share of the development costs. 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. On receiving final approval from the U.S.FDA, Dr.
Reddys is to make a pre-determined milestone payment to Rheoscience. The agreement will be valid
for a period of ten years from the date of commercialization. The financial terms and conditions of
the agreement have not been disclosed.
Under the terms of the agreement, if the partners choose to commercialize the product on their own,
then there is a staggered royalty on sales payable by the partners to each other. However, if the
partners choose to commercialize the product through a third party, then each partner is entitled
to share a pre-determined percentage of the net proceeds of commercialization received by it with
the other partner. Dr. Reddys will also retain the right to supply clinical development and
commercial quantities on arms-length basis.
Commenting on the co-development deal, GV Prasad, Chief Executive Officer, Dr. Reddys
Laboratories, said, We are excited about our first co-development deal for the joint development
and commercialization of balaglitazone (DRF 2593). This deal provides Dr. Reddys with an
opportunity to commercialize NCEs in key markets thereby transforming Dr. Reddys into an
innovation driven business. This deal together with the announcement of Perlecan yesterday reflects
our commitment to accelerate the discovery efforts as well as clinical development programs toward
realizing our vision of becoming a discovery-led global pharmaceutical Company. The addition of
balaglitazone, a partial PPAR-gamma agonist, would expand the treatment options available to the
physicians globally for management of type 2 diabetes. The PPAR class of drugs are of major
clinical relevance and have the potential to address important unmet needs of the millions of
patients suffering from various metabolic disorders, including diabetes worldwide. Rheoscience
brings in significant development expertise required to take drugs intended for treatment of
metabolic disorders all the way to final registration for clinical use and we are looking forward
to a successful relationship with them.
About Dr. Reddys
Established in 1984, Dr. Reddys Laboratories (NYSE: RDY) is an emerging global pharmaceutical
company with proven research capabilities. The Company is vertically integrated with a presence
across the pharmaceutical value chain. It produces finished dosage forms, active pharmaceutical
ingredients and biotechnology products and markets them globally, with focus on India, US, Europe
and Russia. The Company conducts research in the areas of diabetes, cardiovascular,
anti-infectives, inflammation and cancer.
About Rheoscience
Rheoscience A/S is an independent biopharmaceutical company providing novel drug targets as well as
state of the art discovery services in the field of obesity and diabetes. Based on unique
competencies Rheoscience and its partner, Nordic Bioscience A/S,
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embrace development expertise
required to take drugs intended for treatment of metabolic and endocrine disorders from early
discovery phases to final registration for clinical use.
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.
Contact Information
Dr. Reddys:
Investors and Financial Analysts: Nikhil Shah at nikhilshah@drreddys.com or on +91-40-55511532
Media: M Mythili at mythilim@drreddys.com or on +91-40-55511620
Rheoscience
Philip Just Larsen, CEO, Tel: +45 4450 1960
Rheoscience A/S, Glerupvej 2, 2610 Rødovre, Denmark
www.rheoscience.com
Notes to Editor:
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Balaglitazone (DRF 2593), a partial PPAR-gamma agonist, belongs to
the class of blockbuster glitazones like pioglitazone (Actos®, Eli
Lilly and Takeda) and rosiglitazone (Avandia®, GSK) and is
indicated for management of Type 2 diabetes. In USA, during the
period 2002-2004 pioglitazone sales increased by 35% to $1.8
billion and that of rosiglitazone by 25% to $1.4 billion (IMS
Sales). |
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The U.S.FDA now requires pharmaceutical companies to conduct a
two-year carcinogenicity studies for new drugs in the PPAR class
before initiating any long-term human studies. Balaglitazone is
currently in the last phase of its 2-year carcinogenicity studies. |
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Balaglitazone is the most advanced molecule from its class in the
pipeline. In Phase II clinical trials, 20 mg of balaglitazone was
comparable to the top dose, 45 mg, of pioglitazone. Further,
balaglitazone owing to its partial PPAR-gamma agonistic property
may offer a better safety profile compared to currently marketed
glitazones. |
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Earlier in 1997, Dr. Reddys had licensed balaglitazone to Novo
Nordisk and in 2004, Novo Nordisk returned this molecule to Dr.
Reddys due to their portfolio related reasons. |
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Notice To Stock Exchange
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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 |
September 1, 2005
The Secretary / The Executive Director
Mumbai Stock Exchange
National Stock Exchange
New York Stock Exchange
Sub: Grant of Options under Dr. Reddys Employees Stock Option Scheme, 2002.
Dear Sir,
Pursuant to clause 25 of the listing agreement, we hereby intimate you that the Company has granted
8,300 stock options to the employees of the Company at an exercise price of Rs.5, which is the par
value of the shares of the Company.
The shares covered by such options are 8,300.
The vesting period of these options is 25% options each year over a period of four years. The
options may be exercised within a period of five years from the date of vesting.
Please take the above information on record.
With regards,
/s/ V. Viswanath
V Viswanath
Company Secretary
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Notice To Stock Exchange
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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 |
September 2, 2005
The Secretary / The Executive Director
Mumbai Stock Exchange
National Stock Exchange
New York Stock Exchange
Sub: Postal Ballot for disposal of the formulations manufacturing facility at Goa
Dear Sir,
Pursuant to Section 192A of Companies Act, 1956 read with the Companies (Passing of Resolution by
Postal Ballot) Rules, 2001, the Company despatched the draft resolution along with the explanatory
statement for disposal of the Companys formulations manufacturing facility situated at Goa and the
postal ballot forms to the shareholders of the Company on August 1, 2005 under certificate of
posting. The last date for receiving the postal ballot mandate by the scrutinizer was not later
than the close of working hours on Wednesday, August 31, 2005.
Mr. B Satya Reddy, Practicing Company Secretary was appointed as scrutinizer for conducting the
postal ballot process in a fair and transparent manner.
The Scrutinizer has submitted his report to the Chairman of the Company after completion of the
scrutiny. According to the postal ballot results, the resolution under Section 293(1)(a) of the
Companies Act, 1956 for disposal of the Companys formulations manufacturing facility situated at
Goa has been passed.
Please take the above information on record.
With regards,
/s/ V. Viswanath
V Viswanath
Company Secretary
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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 |
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(Registrant)
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By: |
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/s/ V. Viswanath |
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Date: October 3, 2005
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Name:
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V. Viswanath |
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Title:
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Company Secretary |
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