Dr Reddys Laboratories Ltd 6-K, filed Dec 16, 2022
Dr Reddys Laboratories Ltd (RDY)
About this 6-K
Dr Reddys Laboratories Ltd filed this 6-K on December 16, 2022.
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, 2022
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.
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DR. REDDY’S LABORATORIES LIMITED (Registrant) | ||
| Date: December 16, 2022 | By: | /s/ K Randhir Singh |
| Name: K Randhir Singh | ||
| Title: 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, CIN : L85195TG1984PLC004507
Tel : +91 40 4900 2900 Fax : +91 40 4900 2999 Email : mail@drreddys.com www.drreddys.com |
December 16 2022
National Stock Exchange of India Ltd. (Scrip Code: DRREDDY-EQ)
BSE Limited (Scrip Code: 500124)
Dear Sirs,
Sub: Press Release
Please find enclosed a Press Release on “Aurigene Oncology Limited reports results of AUR101 in Phase II Study in Patients with moderate to severe psoriasis.”
Aurigene Oncology Limited (formerly known as Aurigene Discovery Technologies Limited) is a wholly owned subsidiary of the Company.
This is for your information.
Thanking you.
Yours faithfully,
For Dr. Reddy’s Laboratories Limited
| /s/ K Randhir Singh | |
| K Randhir Singh |
Company Secretary, Compliance Officer and Head-CSR
Encl: As above
CC:- New York Stock Exchange Inc.(Stock Code :RDY)
NSE IFSC Ltd.
 |
Aurigene Oncology Limited (Formerly Aurigene Discovery Technologies Limited) Phone: +91 80 7102 5444. Fax: +9180 2852 6285 |
Aurigene reports results of AUR101 in Phase II Study in Patients with moderate to severe psoriasis
Bengaluru, December 16, 2022— Aurigene Oncology, a development stage biotechnology company, today reported results of INDUS-3, a Phase IIb double blind placebo-controlled study of AUR101 conducted in the United States, in patients with moderate to severe psoriasis.
The INDUS-3 study, listed at clinicaltrials.gov with identifier NCT04855721, met its primary endpoint of PASI-75 response at 12 weeks at the 400 mg BID dose, when compared to placebo. The primary endpoint of PASI-75 at 12 weeks at the 200 mg BID dose and the 400 mg QD dose were not met. There were no safety issues identified in the study. Aurigene will be closing the clinical development of AUR101 in psoriasis.
“The magnitude of efficacy improvement with AUR101 (versus placebo) in psoriasis are not what we hoped for in the study. While the positive statistical results at 400 mg BID confirm the role of RORγ in psoriasis, other agents, such as IL-17 antibodies as well TYK-2 inhibitors, lead to better results. In view of this, we believe that AUR101 will not add desirable benefit to patients with moderate to severe psoriasis. Therefore, we have decided to stop the clinical development of AUR101 as an oral drug in psoriasis. Pursuing AUR101 for other indications with suitable partners remains an option.” said Murali Ramachandra, PhD, Chief Executive Officer of Aurigene.
About AUR-101
AUR-101 is a potent, oral RORϒt inverse agonist, with high selectivity across other ROR isoforms and nuclear hormone receptors and expected to confer a superior safety profile. AUR-101, with a good ADME/PK profile and high bioavailability, has demonstrated inhibition of IL-17A in whole blood from psoriasis patients and also very significant reduction in ear swelling and histopathology scores in two separate pre-clinical psoriasis models. In addition, AUR-101 has been found to be safe in preclinical toxicology evaluations, at several fold of efficacious exposures in humans and has also shown good pharmacodynamic modulation in earlier clinical trials.
About Aurigene Oncology Limited:
Aurigene Oncology Limited (formerly, Aurigene Discovery Technologies Limited) is a clinical stage biotech company committed to bringing novel therapeutics for the treatment of cancer and a wholly owned subsidiary of Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY). Based in Bengaluru and Kuala Lumpur, Aurigene is focused on developing innovative therapeutics addressing several hallmarks of cancer and has built comprehensive drug discovery and development capabilities, nurtured a growing team of passionate scientists, and collaborated with partners from across the world. Over the past two decades Aurigene has contributed to delivering 18 novel chemical entities which are currently in clinical development. Aurigene has also out-licensed several first-in-class and best-in-class compounds to pharma and biotech companies for global clinical development, while undertaking clinical POC studies for a few programs on its own. For more information, please visit Aurigene’s website at www.aurigene.com.
Aurigene
Contact:
Subir Dubey
Vice President and Head of Business Development
subir_d@aurigene.com
