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
December, 2023
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 ☒ 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 ☒
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.
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DR. REDDY’S LABORATORIES LIMITED
(Registrant) |
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Date: December 6, 2023 |
By: |
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/s/ K Randhir Singh |
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Name: |
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K Randhir Singh |
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Title: |
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Company Secretary |
Exhibit 99.1
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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 |
December 6, 2023
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 “Coya
Therapeutics, Inc. and Dr. Reddy’s Laboratories enter into an Exclusive Collaboration for Development and Commercialization of COYA
302, an Investigational Combination Therapy for Treatment of Amyotrophic Lateral Sclerosis (ALS)”
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
Coya Therapeutics, Inc. and Dr. Reddy’s
Laboratories enter into an Exclusive Collaboration for Development and Commercialization of COYA 302, an Investigational Combination Therapy
for Treatment of Amyotrophic Lateral Sclerosis (ALS)
| · | Under the Agreement,
Dr. Reddy’s will obtain commercialization rights for COYA 302 in the United States, Canada, the European Union and the United Kingdom,
for patients with ALS |
| · | COYA will be responsible
for development, including the conduct of the Phase 2 clinical trial and for obtaining regulatory approval in the United States |
| · | COYA 302 is an investigational
combination biologic for subcutaneous administration, comprised of low-dose IL-2 and CTLA4-Ig (abatacept). COYA 302 has a dual mechanism
of action intended to suppress the chronic and sustained inflammation underlying certain neurodegenerative diseases. |
| · | In early 2023, Coya
entered into an in-licensing agreement with Dr. Reddy’s to license its proposed biosimilar abatacept for the development and commercialization
of COYA 302 |
HOUSTON, TEXAS; HYDERABAD, INDIA; BASEL, SWITZERLAND.
December 6, 2023 — Dr. Reddy's Laboratories SA, wholly-owned subsidiary of Dr. Reddy’s Laboratories Ltd. (BSE: 500124,
NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as “Dr. Reddy’s”), and Coya
Therapeutics, Inc. (NASDAQ: COYA) (“Coya”), today announced that they have entered into a development and license agreement
(the “Agreement”) for the development and commercialization of COYA 302, an investigational combination therapy for the treatment
of Amyotrophic Lateral Sclerosis (ALS).
Under the terms of the Agreement, Coya has granted
Dr. Reddy’s an exclusive license to commercialize COYA 302, a proprietary co-pack kit containing combination of low dose IL-2 and
CTLA-4 Ig (abatacept) in the United States, Canada, the European Union and the United Kingdom for ALS. This Agreement is in addition to
the in-licensing agreement with Dr. Reddy’s signed in early 2023[1]. Coya retains
the right to commercialize COYA 302 for patients with amyotrophic lateral sclerosis (ALS) in Japan, Mexico, and each country in South
America. Coya will have responsibility for the clinical development of COYA 302 and for seeking regulatory approval for COYA 302 for patients
with ALS in the United States.
| 1 | https://www.businesswire.com/news/home/20230317005028/en/Coya-Therapeutics-Inc.-Announces-anAgreement-with-Dr.-Reddy%E2%80%99s-Laboratories-Ltd.-to-License-its-proposed-biosimilar-Abatacept-for-theDevelopment-and-Commercialization-of-COYA-302-for-the-Treatment-of-Neurodegenerative-Di |
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Dr. Reddy’s will make a USD 7.5 million
upfront payment to Coya. Upon the first FDA acceptance of an investigational new drug (IND) application for COYA 302 for the treatment
of ALS, Dr. Reddy’s will pay Coya an additional USD 4.2 million. Upon dosing of the first patient in the first Phase 2 trial of
COYA 302 for the treatment of ALS in the United States, Dr. Reddy’s will pay Coya an additional USD 4.2 million. Coya anticipates
that the IND filing will be made in the first half of 2024. The Agreement also includes development and regulatory milestones up to USD
40 million should all such development and regulatory milestones be achieved. Additionally, Coya is eligible to receive sales-based milestone
payments of up to USD 677.25 million linked to tiers of cumulative net sales being achieved over several years (over the term of the agreement
subject to product commercial exclusivity). In addition, Dr. Reddy’s will pay Coya royalties based on a percentage net sales of
COYA 302 ranging from low to middle teens. Coya is not a related party to Dr. Reddy’s or its promoters/promoter group.
Marc Kikuchi, Chief Executive Officer of Dr.
Reddy’s North America, said: “Patients with ALS, commonly known as Lou Gehrig’s disease, have very few treatment
options. We are pleased to partner with Coya Therapeutics on this investigational therapy which may have a unique place in treating patients
with this progressive neurodegenerative disease. With this promising biologic product, we hope to reach many more patients around the
world in keeping with our aim of serving over 1.5 billion patients by 2030. Dr. Reddy’s biosimilars/biologics business is part of
our key strategic initiatives expected to drive both near-term and long-term growth.”
Dr. Howard Berman, Chief Executive Officer
of Coya, observed: “The Coya team is delighted to enter this exciting partnership with Dr. Reddy’s, a world class organization
that defines excellence in innovation and commercialization. While the agreement provides the financial resources to execute on the Phase
2 clinical program for COYA 302 in ALS, the strategic value of the partnership contributes much more than capital. We will benefit from
and leverage Dr. Reddy’s manufacturing expertise and growing commercial infrastructure both in the USA and worldwide as we plan
together for the future of COYA 302 in ALS, a devastating disease with a high unmet need.”
COYA 302
was developed out of the multi-year translational research collaboration between Coya and Houston Methodist in the laboratory of Dr. Stanley
Appel, an internationally renowned researcher and clinician. Houston Methodist is one of the leading hospital and academic research facilities.
About Coya 302:
COYA 302 is an investigational and proprietary
biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory
T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages. COYA 302 is comprised of proprietary low
dose interleukin-2 (LD IL-2) and CTLA-4 Ig, and is being developed for subcutaneous administration for the treatment of patients with
ALS. These mechanisms may have additive or synergistic effects.
In February of 2023 Coya announced results from
a proof-of-concept, open-label clinical study evaluating LD IL-2 and CTLA-4 Ig in small cohort
of patients with ALS, conducted at the Houston Methodist Research Institute (Houston, Texas) by
Stanley Appel, M.D., Jason Thonhoff, M.D., Ph.D., and David Beers, Ph.D. This study was the first-of-its-kind
evaluating this dual-mechanism immunotherapy for the treatment of ALS. Patients in the study received investigational treatment for 48
consecutive weeks and were evaluated for safety and tolerability, Treg function, serum biomarkers of oxidative stress and inflammation,
and clinical functioning as measured by the ALSFRS-R scale.
During the 48-week treatment period, the therapy
was well tolerated. The most common adverse event was mild injection-site reactions. No patient discontinued the study, and no deaths
or other serious adverse events were reported.
Patients' disease progression was measured using
the ALSFRS-R scale, a validated rating tool for monitoring the progression of disability in patients with ALS. The mean (±SD) ALSFRS-R
scores at week 24 (33.75 ±3.3) and week 48 (32 ±7.8) after initiation of treatment were not statistically different compared
to the ALSFRS-R score at baseline (33.5 ±5.9), suggesting significant amelioration in the progression of the disease over the 48-week
treatment period.
Treg suppressive function, expressed as percentage
of inhibition of proinflammatory T cell proliferation, showed a statistically significant increase over the course of the treatment period
and was significantly reduced at the end of the 8-week washout post-treatment period. Treg suppressive function at 24 weeks (79.9±9.6)
and 48 weeks (89.5±4.1) were significantly higher compared to baseline (62.1±8.1) (p<0.01), suggesting enhanced and durable
Treg suppressive function over the course of treatment. In contrast, Treg suppressive function (mean ±SD) was significantly decreased
at the end of the 8-week washout period compared to end-of-treatment at week 48 (70.3±8.1 vs. 89.5±4.1, p <0.05).
The study also evaluated serum biomarkers of inflammation,
oxidative stress, and lipid peroxides. The available data up to 16 weeks after initiation of treatment suggest a decrease of these biomarker
levels, which is consistent with the observed enhancement of Treg function. The evaluation of the full biomarker data is ongoing.
Coya 302 is an investigational product not yet
approved by the U.S. Food and Drug Administration or any other regulatory agency.
About Dr. Reddy’s biosimilars/biologics
programme:
A part of its key strategic initiatives, it is
expected to drive both near-term and long-term growth. Over the last 20 years, the team has developed into a fully integrated organisation
with robust capabilities in the development, manufacture and commercialisation of a range of biosimilar products in oncology and immunology.
The portfolio currently has six commercial biosimilar products marketed in India and over 27 Emerging Markets. In addition, there are
several products in the pipeline in oncology and auto-immune diseases in various stages of development for global launches across regulated
as well as emerging markets. Coya has successfully completed the Phase 2 study and initiated the Phase 3 study of DRL_TC, its proposed
biosimilar of tocilizumab via both the subcutaneous and intravenous routes, for global markets. Dr. Reddy’s proposed rituximab biosimilar
application has been accepted for review by the USFDA, EMA and MHRA. Coya has also ramped up manufacturing capacity to support its global
expansion plans.
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About Dr. Reddy’s Laboratories Limited:
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,
it is committed to providing access to affordable and innovative medicines. Driven by its purpose of ‘Good Health Can’t Wait’,
the company offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Its major therapeutic
areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Its 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, Dr. Reddy’s continues to plan and invest in the businesses of the future. As an early adopter of sustainability
and ESG actions, we released its first Sustainability Report in 2004. Its 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: https://www.drreddys.com/.
Investor Contact |
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Media Contact |
Richa Periwal |
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Usha Iyer |
richaperiwal@drreddys.com |
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ushaiyer@drreddys.com |
About Coya Therapeutics, Inc.
Headquartered in Houston, TX, Coya Therapeutics,
Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic
advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie
numerous conditions including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to a sustained
inflammation and oxidative stress resulting in lack of homeostasis of the immune system.
Coya’s investigational product candidate
pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs.
Coya’s therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. Coya’s
300 Series product candidates, COYA 301 and COYA 302, are biologic therapies intended to enhance Treg function and expand Treg numbers.
COYA 301 is a cytokine biologic for subcutaneous administration intended to enhance Treg function and expand Treg numbers in vivo, and
COYA 302 is a biologic combination for subcutaneous and/or intravenous administration intended to enhance Treg function while depleting
T effector function and activated macrophages. These two mechanisms may be additive or synergistic in suppressing inflammation. For more
information about Coya, please visit www.coyatherapeutics.com.
Investor Contact
David Snyder
david@coyatherapeutics.com
Hayden IR
James Carbonara
646-755-7412
James@haydenir.com
Media Contact
Anna Marie Imbordino
annamarie@quantum-corp.com
917-680-8765
Forward-Looking Statements
This press release contains “forward-looking”
statements that are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking
statements include all statements other than statements of historical fact contained in this presentation, including information concerning
our current and future financial performance, business plans and objectives, current and future clinical and preclinical development activities,
timing and success of our ongoing and planned clinical trials and related data, the timing of announcements, updates and results of our
clinical trials and related data, our ability to obtain and maintain regulatory approval, the potential therapeutic benefits and economic
value of our product candidates, competitive position, industry environment and potential market opportunities. The words “believe,”
“may,” “will,” “estimate,” “continue,” “anticipate,” “intend,”
“expect,” and similar expressions are intended to identify forward-looking statements.
Forward-looking statements are subject to known
and unknown risks, uncertainties, assumptions and other factors including, but not limited to, those related to risks associated with
the impact of COVID-19; the success, cost and timing of our product candidate development activities and ongoing and planned clinical
trials; our plans to develop and commercialize targeted therapeutics; the progress of patient enrollment and dosing in our preclinical
or clinical trials; the ability of our product candidates to achieve applicable endpoints in the clinical trials; the safety profile of
our product candidates; the potential for data from our clinical trials to support a marketing application, as well as the timing of these
events; our ability to obtain funding for our operations; development and commercialization of our product candidates; the timing of and
our ability to obtain and maintain regulatory approvals; the rate and degree of market acceptance and clinical utility of our product
candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; our commercialization,
marketing and manufacturing capabilities and strategy; future agreements with third parties in connection with the commercialization of
our product candidates; our expectations regarding our ability to obtain and maintain intellectual property protection; our dependence
on third party manufacturers; the success of competing therapies or products that are or may become available; our ability to attract
and retain key scientific or management personnel; our ability to identify additional product candidates with significant commercial potential
consistent with our commercial objectives; ; and our estimates regarding expenses, future revenue, capital requirements and needs for
additional financing.
We have based these forward-looking statements
largely on our current expectations and projections about future events and trends that we believe may affect our financial condition,
results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. Moreover,
we operate in a very competitive and rapidly changing environment, and new risks may emerge from time to time. It is not possible for
our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or
combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make.
In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed herein may not occur and
actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Although our
management believes that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future
results, levels of activity, performance or events and circumstances described in the forward-looking statements will be achieved or occur.
We undertake no obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time,
whether as a result of new information, future developments or otherwise.
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