Full Press Release Details
National Stock Exchange of India Ltd. (Scrip Code: DRREDDY-EQ)
BSE Limited (Scrip Code: 500124)
Please find enclosed a Press Release on "Dr.
Reddy's successfully completes Phase 1 study of DRL_TC, a proposed biosimilar of tocilizumab."
This is for your information.
For Dr. Reddy's Laboratories Limited
| /s/ K Randhir Singh | |
| K Randhir Singh | |
| Company Secretary, Compliance Officer and Head-CSR |
| CC:- | New York Stock Exchange Inc.(Stock Code :RDY) |
| NSE IFSC Ltd. |
| CONTACT | |||
| DR. REDDY'S LABORATORIES LTD. | Investor relationS | Media relationS | |
| 8-2-337, Road No. 3, Banjara Hills, | |||
| Hyderabad - 500034. Telangana, India. | AMIT AGARWAL | USHA IYER | |
| amita@drreddys.com | ushaiyer@drreddys.com |
Dr. Reddy's successfully completes Phase 1
study of DRL_TC, a proposed biosimilar of tocilizumab
Hyderabad, India; December 19, 2022 -
Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; hereafter referred to as "Dr. Reddy's"),
a global pharmaceutical company, announced that its tocilizumab biosimilar candidate, DRL_TC, successfully met its primary and secondary
endpoints in a Phase 1 study. This Phase 1 study used a subcutaneous formulation to evaluate the pharmacokinetic equivalence, safety and
immunogenicity of Dr. Reddy's tocilizumab biosimilar candidate in comparison to reference products.
The Phase 1 study entitled A Single Dose, Double-Blind,
Two-Period, Crossover, Comparative Pharmacokinetic Study of Three Tocilizumab Products Administered by the Subcutaneous Route to Normal
Healthy Volunteers' met all primary and secondary endpoints. Pharmacokinetic equivalence of DRL_TC to the EU reference medicinal
product* and the U.S. reference product** was successfully demonstrated. The clinical trial also confirmed the similarity between DRL_TC
and the EU* and U.S.** reference products in terms of pharmacodynamic parameters and found no noteworthy differences in safety and immunogenicity
across these three treatment groups.
The successful outcome of this study represents an
important milestone in Dr. Reddy's commitment to making high-quality biosimilar products more accessible and affordable to healthcare
providers and patients around the world. Dr. Reddy's is developing the proposed tocilizumab biosimilar as both subcutaneous and
intravenous formulations.
| CONTACT | |||
| DR. REDDY'S LABORATORIES LTD. | Investor relationS | Media relationS | |
| 8-2-337, Road No. 3, Banjara Hills, | |||
| Hyderabad - 500034. Telangana, India. | AMIT AGARWAL | USHA IYER | |
| amita@drreddys.com | ushaiyer@drreddys.com |
Jayanth Sridhar, Global Head of Biologics at Dr. Reddy's,
said: "Tocilizumab is an important anti-rheumatic agent that has a unique place in treating patients with rheumatoid arthritis
and other diseases. We are excited to continue our journey in developing this biosimilar and making this product affordable to patients
across the globe. My congratulations to the team especially for the way they navigated multiple challenges during the COVID-19 period
in conducting the trial. We look forward to following this up with other agents that solve for critical patient needs in the auto-immune
The company is initiating a global Phase 3 study with the aim of comparing
the efficacy, safety, tolerability and immunogenicity of DRL_TC with the reference product in patients with moderate to severe active
rheumatoid arthritis.
*EU reference medicinal product is RoActemra
**U.S. reference product is Actemra
Actemra and RoActemra are registered trademarks of Chugai Seiyaku
Kabushiki Kaisha Corp., a member of the Roche Group.
About Dr. Reddy's biosimilars programme:
Dr. Reddy's biosimilars business is part of
our key strategic initiatives expected to drive both near-term and future growth. In 2007, Dr. Reddy's launched the world's
first biosimilar rituximab in India under the brand name Reditux. Over the last 20 years, our Biologics 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. We have a current portfolio of six commercial products marketed in India and over 25 Emerging Markets. In
addition, we have 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. This includes the imminent Biological Product Licence Application filing for Rituximab in
regulated markets. We are also ramping up manufacturing capacity to support our global expansion plans.
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.
| CONTACT | |||
| DR. REDDY'S LABORATORIES LTD. | Investor relationS | Media relationS | |
| 8-2-337, Road No. 3, Banjara Hills, | |||
| Hyderabad - 500034. Telangana, India. | AMIT AGARWAL | USHA IYER | |
| amita@drreddys.com | ushaiyer@drreddys.com |
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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, 2022. The company assumes no obligation to update any information