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
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
Exhibit |
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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.
DR. REDDY’S LABORATORIES LIMITED (Registrant) | |||
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Date: February 7, 2020 | By: | /s/ Sandeep Poddar | |
Name: | Sandeep Poddar | ||
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 |
February 7, 2020
Corporate Relationship Department | National Stock Exchange of India Ltd. |
BSE Limited | “Exchange Plaza” |
Dalal Street, Fort | Bandra-Kurla Complex, Bandra (East), |
Mumbai – 400 001 | Mumbai – 400 051 |
Fax Nos.: 022-22723121 / 22723719 / | Fax Nos.: 022-26598120/ 26598237/ |
22722037 / 22722039 | 26598238 |
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Scrip Code: 500124 | Scrip Code: DRREDDY-EQ |
Dear Sirs,
Sub: Press Release
Please find enclosed a Press Release on “Dr. Reddy's Laboratories announces the launch of Trientine Hydrochloride Capsules USP, 250 mg, in the U.S. Market”
This is for your information.
With regards,
/s/ Sandeep Poddar |
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Sandeep Poddar |
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Company Secretary |
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Encl: As above
CC:- New York Stock Exchange Inc.(Stock Code: RDY)
Classification │ PUBLIC
| CONTACT | |
DR. REDDY'S LABORATORIES LTD. | Investor relationS | Media relationS |
8-2-337, Road No. 3, Banjara Hills, | AMIT AGARWAL amita@drreddys.com | Deep GHATAK deepghatak@drreddys.com (Ph: +91-40- 49002121) |
Dr. Reddy's Laboratories announces the launch of
Trientine Hydrochloride Capsules USP, 250 mg, in the U.S. Market
Hyderabad, India, February 7, 2020 | For Immediate Release |
Hyderabad, India and Princeton, NJ, USA, Febraury 7, 2020— Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Trientine Hydrochloride Capsules USP, 250 mg, a therapeutically equivalent generic version of Syprine® (trientine hydrochloride) Capsules, approved by the U.S. Food and Drug Administration (USFDA).
“We are pleased to provide this convenient alternative for patients, pharmacists and distribution partners,” explains Marc Kikuchi, Chief Executive Officer and Head of Dr. Reddy’s North America Generics. “Our product can be stored at room temperature (20°C to 25°C or 68°F to 77°F) throughout the product shelf life of 24 months.”
For more information, please refer to full Prescribing Information.
https://www.drreddys.com/medguide/Trientine-Hydrochloride-Capsules.pdf
The Syprine® brand and generic products had U.S. sales of approximately $94.2 million MAT for the most recent twelve months ending in December 2019 according to IMS Health*.
Dr. Reddy’s Trientine Hydrochloride Capsules USP, 250 mg are available in 100 count bottles.
Syprine® is a trademark of Alton Pharma.
*IMS National Sales Perspective: Retail and Non-Retail MAT December 2019 RDY-0719-255 |
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About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosiimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. 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.
The company assumes no obligation to update any information contained herein.
Exhibit 99.2
| 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 |
February 7, 2020
Corporate Relationship Department | National Stock Exchange of India Ltd. |
BSE Limited | “Exchange Plaza” |
Dalal Street, Fort | Bandra-Kurla Complex, Bandra (East), |
Mumbai – 400 001 | Mumbai – 400 051 |
Fax Nos.: 022-22723121 / 22723719 | Fax Nos.: 022-26598120/ 26598237 |
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Scrip Code: 500124 | Scrip Code: DRREDDY-EQ |
Dear Sirs,
Sub: Intimation
Please find attached a press release issued by our wholly owned subsidiary “Aurigene Discovery Technologies Limited” regarding amendment of collaboration with “Curis, Inc. (Nasdaq: CRIS)” for development and commercialization of CA-170.
With regards,
/s/ Sandeep Poddar |
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Sandeep Poddar |
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Company Secretary |
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CC:- New York Stock Exchange Inc. (Stock Code:RDY)
Classification | PUBLIC
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PRESS RELEASE
Curis and Aurigene Announce Amendment of Collaboration for the Development and Commercialization of CA-170
- Aurigene to fund and conduct a Phase 2b/3 randomized study of CA-170 in patients with non-squamous non-small cell lung cancer (nsNSCLC) -
- Aurigene to receive Asia rights for CA-170; Curis entitled to royalty payments in Asia -
LEXINGTON, Mass., February 7, 2020 /PRNewswire/ — Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that it has entered into an amendment of its collaboration, license and option agreement with Aurigene Discovery Technologies, Ltd. (Aurigene). Under the terms of the amended agreement, Aurigene will fund and conduct a Phase 2b/3 randomized study evaluating CA-170, an orally available, dual inhibitor of VISTA and PDL1, in combination with chemoradiation, in approximately 240 patients with non-squamous non-small cell lung cancer (nsNSCLC). In turn, Aurigene receives rights to develop and commercialize CA-170 in Asia, in addition to its existing rights in India and Russia, based on the terms of the original agreement. Curis retains U.S., E.U., and rest of world rights to CA-170, and is entitled to receive royalty payments on potential future sales of CA-170 in Asia.
In 2019, Aurigene presented clinical data from a Phase 2a basket study of CA-170 in patients with multiple tumor types, including those with nsNSCLC. In the study, CA-170 demonstrated promising signs of safety and efficacy in nsNSCLC patients compared to various anti-PD-1/PD-L1 antibodies.
“We are pleased to announce this amendment which leverages our partner Aurigene’s expertise and resources to support the clinical advancement of CA-170, as well as maintain our rights to CA-170 outside of Asia,” said James Dentzer, President and Chief Executive Officer of Curis. “Phase 2a data presented at the European Society for Medical Oncology (ESMO) conference last fall supported the potential for CA-170 to serve as a therapeutic option for patients with nsNSCLC. We look forward to working with our partner Aurigene to further explore this opportunity.”
“Despite recent advancements, patients with localized unresectable NSCLC struggle with high rates of recurrence and need for expensive intravenous biologics. The CA-170 data presented at ESMO 2019 from Aurigene’s Phase 2 ASIAD trial showed encouraging results in Clinical Benefit Rate and Prolonged PFS and support its potential to provide clinically meaningful benefit to Stage III and IVa nsNSCLC patients, in combination with chemoradiation and as oral maintenance” said Kumar Prabhash, MD, Professor of Medical Oncology at Tata Memorial Hospital, Mumbai, India.
Classification | PUBLIC
Murali Ramachandra, PhD, Chief Executive Officer of Aurigene, commented, “Development of CA-170, with its unique dual inhibition of PD-L1 and VISTA, is the result of years of hard-work and commitment by many people, including the patients who participated in the trials, caregivers and physicians, along with the talented teams at Aurigene and Curis. We look forward to further developing CA-170 in nsNSCLC.”
About Curis, Inc.
Curis is a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, including fimepinostat, which is being investigated in combination with venetoclax in a Phase 1 clinical study in patients with DLBCL. In 2015, Curis entered into a collaboration with Aurigene in the areas of immuno-oncology and precision oncology. As part of this collaboration, Curis has exclusive licenses to oral small molecule antagonists of immune checkpoints including, the VISTA/PDL1 antagonist CA-170, and the TIM3/PDL1 antagonist CA-327, as well as the IRAK4 kinase inhibitor, CA-4948. CA-4948 is currently undergoing testing in a Phase 1 trial in patients with non-Hodgkin lymphoma. In addition, Curis is engaged in a collaboration with ImmuNext for development of CI-8993, a monoclonal anti-VISTA antibody. Curis is also party to a collaboration with Genentech, a member of the Roche Group, under which Genentech and Roche are commercializing Erivedge® for the treatment of advanced basal cell carcinoma. For more information, visit Curis' website at www.curis.com.
About Aurigene
Aurigene is a development stage biotech company engaged in discovery and clinical development of novel and best-in-class therapies to treat cancer and inflammatory diseases and a wholly owned subsidiary of Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY). Aurigene is focused on precision- oncology, oral immune checkpoint inhibitors, and the Th-17 pathway. Aurigene currently has several programs from its pipeline in clinical development. Aurigene’s ROR-gamma inverse agonist AUR-101 is currently in phase 2 clinical development under a US FDA IND. Additionally, Aurigene has multiple compounds at different stages of pre-clinical development. Aurigene has partnered with many large and mid-pharma companies in the United States and Europe and has 15 programs currently in clinical development. For more information, please visit Aurigene’s website at http://aurigene.com/
Classification | PUBLIC
Forward-Looking Statements
Any statements in this press release including, without limitation, statements regarding any expectations of the potential for CA-170, including with respect to the potential activity, safety and tolerability of CA-170 and future studies with respect to CA-170 including any studies conducted or to be conducted by Aurigene constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Forward-looking statements may contain the words “believes,” “expects,” “anticipates,” “plans,” “seeks,” “estimates,” “assumes,” “will,” “may,” “could,” “predict,” “project,” “target,” or the negative of these terms or other similar expressions . These forward-looking statements include, among others, statements about Curis’s business, plans, prospects and strategies and its expectations regarding its collaboration, license and option agreement with Aurigene, as amended, including the second amendment (as described below). These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other important factors that may cause actual results to be materially different from those indicated by such forward-looking statements. For example, Curis faces a number of risks inherent in the research, development or commercialization of novel drugs to treat cancer and may not be able to successfully advance the development of its drug candidates in the time frames it projects, if at all. There can be no guarantee that the Aurigene collaboration, license and option agreement, amended, or the second amendment, will continue for its full term or that Curis or Aurigene will maintain the financial resources necessary to continue financing their respective portions of any research, development or commercialization costs. Curis will require substantial additional capital to fund its business and such capital may not be available on reasonable terms, or at all. Without sufficient additional funding, Curis will not be able to continue as a going concern and may be forced to delay, reduce in scope or eliminate some of its research and development programs, which could adversely affect its business prospects and its ability to continue operations. Substantial doubt about Curis’s ability to continue as a going concern may adversely affect Curis’s ability to access the substantial additional capital needed to continue operations. Curis faces substantial competition. Curis’s expectations with respect to the collaboration, license and option agreement, the second amendment and CA-170 could also be affected by risks and uncertainties relating to a failure of Curis or Aurigene to fully perform under the collaboration, option and license agreement or the second amendment and/or any early termination of such agreement or amendment, adverse results of any clinical trials and non-clinical studies that are the subject of the collaboration, including subsequent analysis of existing data and new data received from future studies, the content and timing of decisions made by the U.S. Food & Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies, and Curis’s or Aurigene’s inability to enroll patients in clinical trials that may be initiated under the collaboration. Curis may not obtain or maintain necessary patent protection and could become involved in expensive and time-consuming patent litigation and interference proceedings. Unstable market and economic conditions and unplanned expenses may adversely affect Curis’s financial condition and its ability to access the substantial additional capital needed to fund the growth of its business. Important factors that may cause or contribute to such differences include the factors set forth under the caption “Risk Factors” in Curis’s most recent Form 10-K and Form 10-Q and the factors that are discussed in other filings that Curis periodically makes with the Securities and Exchange Commission. In addition, any forward-looking statements represent the views of Curis only as of as of the date of this press release and should not be relied upon as representing Curis’s views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by law.
Contacts
Curis Investor Relations
Jane Urheim
Stern Investor Relations, Inc.
(212) 362-1200
jane.urheim@sternir.com
Aurigene Media Contact
Subir Dubey
Business Development
+91 80 7102 5571
subir_d@aurigene.com
Classification | PUBLIC
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