SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO
RULE 13A-16 OR 15D-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
November, 2024
Commission
File Number 1-15182
DR.
REDDY’S LABORATORIES LIMITED
(Translation of registrant’s name into English)
8-2-337, Road No. 3, Banjara Hills
Hyderabad, Telangana 500 034, India
+91-40-49002900
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F x Form 40-F ¨
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 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
¨ No x
If “Yes” is marked, indicate below the file number assigned
to registrant in connection with Rule 12g3-2(b): 82-________.
EXHIBITS
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.
| |
DR. REDDY’S LABORATORIES LIMITED
(Registrant) |
| |
|
|
Date:
November 28, 2024 |
By: |
/s/ K Randhir Singh |
| |
|
Name: |
K Randhir Singh |
| |
|
Title: |
Company Secretary |
Exhibit 99.1
 |
Dr. Reddy’s Laboratories Ltd.
8-2-337, Road No. 3, Banjara Hills,
Hyderabad - 500 034, Telangana,
India.
CIN : L85195TG1984PLC004507
Tel : +91 40 4900 2900
Fax : +91 40 4900 2999
Email : mail@drreddys.com
www.drreddys.com |
November 28, 2024
National Stock Exchange of India Ltd. (Stock Code: DRREDDY-EQ)
BSE Limited (Stock Code: 500124)
New York Stock Exchange Inc. (Stock Code: RDY)
NSE IFSC Ltd. (Stock Code: DRREDDY)
Dear Sir/Madam,
Sub: Press Release
Please find enclosed a Press Release on “Dr.
Reddy's launches Toripalimab in India, the first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma.”
This is for your information and record.
Thanking you.
Yours faithfully,
For Dr. Reddy’s Laboratories Limited
K Randhir Singh
Company Secretary, Compliance Officer & Head-CSR
Encl: As above
| |
CONTACT |
| DR. REDDY'S LABORATORIES LTD. |
Investor
relationS |
MEDIA RELATIONS |
8-2-337, Road No. 3, Banjara Hills,
Hyderabad - 500034. Telangana, India. |
RICHA PERIWAL
richaperiwal@drreddys.com |
USHA IYER
ushaiyer@drreddys.com |
Dr. Reddy's launches
Toripalimab in India, the first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma
| · | Only
immuno-oncology drug approved by various regulatory authorities around the world such as
the USFDA, DCGI, EMA, MHRA, NMPA and others for the treatment of adults with recurrent or
metastatic nasopharyngeal carcinoma (RM-NPC) |
| · | Combination
of Toripalimab and standard of care chemotherapy has shown a 48% reduction in risk of progression
or death |
| · | Launched
in India in the same year as its launch in the U.S., making India the third country in the
world to receive access to this New Biological Entity (NBE) |
Hyderabad, India; November 28, 2024 –
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred
to as “Dr. Reddy’s”), announced the launch of Toripalimab in India.
Toripalimab
is a New Biological Entity (NBE). It is the only immuno-oncology
drug approved by various regulatory authorities around the world such as the United States Food and Drug Administration (USFDA), European
Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), and others for the treatment of adults with recurrent
or metastatic nasopharyngeal carcinoma (RM-NPC). In 2023, Dr. Reddy’s entered into a license and commercialisation agreement with
Shanghai Junshi Biosciences Co. Ltd for Toripalimab. Under this agreement, Dr. Reddy’s obtained exclusive rights to develop and
commercialise Toripalimab in 21 countries including India, South Africa, Brazil and various countries in Latin America. Additionally,
the agreement allows Dr. Reddy’s to expand the scope of the license to cover Australia, New Zealand and nine other countries. With
this launch by Dr. Reddy’s, India becomes the third country in the world after China and the United States to receive access to
this next generation PD-1 inhibitor1. Dr.
Reddy’s will market it under the brand name Zytorvi® in India.
The
standard of care for RM-NPC in India before Toripalimab was chemotherapy (gemcitabine and cisplatin). Toripalimab is indicated as first-line
treatment of adults with metastatic or recurrent locally advanced NPC in combination with gemcitabine and cisplatin. This combination
has shown a 48% reduction in risk of progression or death2.
Additionally, Toripalimab has also been approved as monotherapy for the treatment of adults with recurrent unresectable or metastatic
NPC with disease progression on or after platinum-containing chemotherapy.
| 1 | Ravindranathan S, Wang X, et al. Characteristics of toripalimab:
a next generation anti-PD-1 antibody with potent T cell activation and enhanced clinical efficacy irrespective of PD-L-1 status. J Immunother
Cancer 2023;11(Suppl 1):A1–A1731 |
| 2 | Mai, HQ., Chen, QY., Chen, D. et al. Toripalimab or placebo
plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial. Nat Med 27, 1536–1543
(2021). |
M.V. Ramana, Chief Executive Officer, Branded
Markets (India and Emerging Markets), Dr. Reddy’s, said: “The launch of Toripalimab is a significant milestone for
patients diagnosed with nasopharyngeal carcinoma (NPC) in India. NPC is a rare form of head and neck cancer. However, the prognosis of
the disease for patients in advanced stages is poor, and India is among the top five countries in the world in terms of disease burden3.
As the next generation PD-1 inhibitor, Toripalimab has demonstrated superior outcomes for RM-NPC versus standard of care, thereby meeting
a significant unmet need for patients with NPC in India.
This launch is also a major milestone for us
as a company. Oncology has been a top focus therapy area for us. Our offerings aim to build an end-to-end ecosystem of care – access
to current standard of care cancer medicines across multiple countries globally, innovation in formulations, strategic collaborations
for novel innovative molecules particularly in India and other emerging markets, beyond-the-pill support such as nutrition and digital
tools. Our portfolio of standard of care small molecules and biosimilars across cancer types in India and other emerging markets has included
Reditux™, Versavo®, Lenangio™, and Hervycta™.
Additionally, under our innovation agenda,
access to novel molecules through collaborations is a key pillar, since access to meaningful innovation and the latest standard of care
remains a challenge for patients in emerging markets. Thanks to the relentless efforts of our cross-functional teams, we have been able
to launch Toripalimab in India in the same year as its launch in the U.S. We will continue to work hard to serve our patients and stakeholders
to remain their partner of choice, and progress towards our goal of serving over 1.5 billion patients by 2030.”
NPC is a malignant tumour that arises from the
epithelium of the nasopharynx. According to GLOBOCAN 2022 statistics, the number of newly diagnosed NPC cases in 2022 exceeded 120,000
worldwide. In India, there were 6,519 newly diagnosed cases of NPC in 20224. The highest age-adjusted rates for NPC were found
in the north-eastern states in India, with Kohima in Nagaland having an incidence of 19.4/100,000 population5.
Toripalimab
is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced
receptor internalisation (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability
to attack and kill tumour cells6.
About Dr. Reddy’s: Dr. Reddy’s
Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad,
India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good
Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars
and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology.
Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep
science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter
of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high
in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com.
Disclaimer: This press release may include statements
of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and
involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those
expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may",
"will", "should", "expects", "plans", "intends", "anticipates", "believes",
"estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking
statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general
economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels
and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition
and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the
impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets
addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics
or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings
with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements"
sections of our Annual Report on Form 20-F for the year ended March 31, 2024. The company assumes no obligation to update any information
contained herein.
| 3 | Chen YP, Chan AT, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal
carcinoma. The Lancet. 2019 Jul 6;394(10192):64-80. |
| 4 | Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L,
Piñeros M, Znaor A, Soerjomataram I, Bray F (2024). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency
for Research on Cancer. Available from: https://gco.iarc.who.int/today. |
| 5 | Mailankody, Sharada, et al. "Epidemiology of rare cancers
in India and South Asian countries–remembering the forgotten." The Lancet Regional Health-Southeast Asia 12 (2023). |
| 6 | Chen YP, Chan AT, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal
carcinoma. The Lancet. 2019 Jul 6;394(10192):64-80. |
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