Dr Reddys Laboratories Ltd 6-K, filed Dec 9, 2021
Dr Reddys Laboratories Ltd (RDY)
About this 6-K
Dr Reddys Laboratories Ltd filed this 6-K on December 9, 2021.
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, 2021
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: December 9, 2021 | By: | /s/ Vivek Mittal | |
| Name: | Vivek Mittal | ||
| Global General Counsel and Compliance | |||
| Title: | Officer | ||
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 |
December 9, 2021
| 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 |
| Scrip Code: 500124 | Scrip Code: DRREDDY-EQ |
Dear Sirs,
Sub: Press Release
Please find enclosed a Press Release on “Prestige BioPharma and Dr. Reddy’s announce partnership to commercialize trastuzumab biosimilar in select countries in Latin America and Southeast Asia”
This is for your information.
With regards,
| /s/ Vivek Mittal | |
| Vivek Mittal | |
| Global General Counsel and Compliance Officer |
Encl: As above
CC:- New York Stock Exchange Inc.(Stock Code :RDY)
NSE IFSC Ltd.
 |
 |
Prestige
BioPharma and Dr. Reddy’s announce partnership to
commercialize trastuzumab biosimilar in select countries in Latin America
and Southeast Asia
Singapore, SINGAPORE, and Hyderabad, INDIA; 09 December 2021: Prestige BioPharma Ltd. (KRX: 950210) and Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, hereafter referred to as “Dr. Reddy’s”) today announced that the two companies have entered into a binding agreement for an exclusive partnership for the supply and commercialization of Prestige BioPharma’s proposed trastuzumab biosimilar in select countries in Latin America and Southeast Asia.
Prestige BioPharma’s trastuzumab (HD201) is a proposed biosimilar to Roche’s Herceptin® and can be prescribed for the treatment of HER2 positive breast and metastatic gastric cancer. Trastuzumab targets human epidermal growth factor 2 (HER2). In some types of cancer cells, HER2 is overexpressed and stimulates the growth of the cancer cells. Trastuzumab works by selectively binding to HER2, thereby stopping the growth of these cancer cells.
The license agreement grants Dr. Reddy’s the exclusive rights to commercialize the proposed biosimilar in select countries in Latin America and Southeast Asia. Under this partnership, Prestige BioPharma will be responsible for sustainable commercial supply of HD201 from its manufacturing facilities in Osong, South Korea, while Dr. Reddy’s will be responsible for local registrations, marketing and sales in the licensed territories.
Lisa S. Park, CEO of Prestige BioPharma, commented: “We are delighted to establish a partnership with Dr. Reddy’s for key Latin American and Southeast Asian markets. Dr. Reddy’s is the ideal partner to commercialize our lead biosimilar in these territories. With this collaboration, we look forward to further strengthening the value of our biosimilar programs in global markets.”
M.V. Ramana, CEO – Branded Markets (India & Emerging Markets), Dr. Reddy’s, said: “In keeping with our purpose of accelerating access to affordable and innovative medicines, we are happy to bring this life-saving drug to patients in need. Our partnership with Prestige BioPharma will help us combine their established expertise in the area of biosimilars with our commercial strengths and growth ambition in these markets. This is in line with our stated intention to create a portfolio of oncology products and expand our biosimilar offerings in Emerging Markets.”
About Prestige BioPharma Limited:
PRESTIGE BIOPHARMA LTD (PBP) is a Singapore-based biopharmaceutical company with operations in USA and Korea, specialising in the discovery and development of biosimilars, novel antibodies and vaccines. PBP strives to become a global innovator through the development of first-in-class mAbs including PBP1510 anti-PAUF mAb for pancreatic cancer that recently obtained orphan designation from FDA, EMA and MFDS. PBP's rich portfolio of biosimilars in various stages including HD204 bevacizumab in global Phase 3, PBP1502 adalimumab in Phase 1 and others, is aimed to provide affordable quality medicines to those who need. PBP’s business also includes alliance vaccine development and production, starting with the partnered commercial production of COVID-19 vaccines. For more information, please visit www.prestigebiopharma.com.
|
|
| Investor Relations | Corporate Communication |
| Bumjoon Kim | Yujin Suh |
| Bumjoon.kim@pbpsg.com | yujin.suh@pgpsg.com |
About Dr. Reddy’s:
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its businesses, Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars 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.
| Investor Relations | Corporate Communication |
| Amit Agarwal | Usha Iyer |
| amita@drreddys.com | ushaiyer@drreddys.com |
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 |
December 9, 2021
| 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 |
| 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 Valsartan Tablets, USP in the U.S. Market”
This is for your information.
With regards,
| /s/ Vivek Mittal | |
| Vivek Mittal | |
| Global General Counsel and Compliance Officer |
Encl: As above
CC:- New York Stock Exchange Inc.(Stock Code :RDY)
NSE IFSC Ltd.
| DR. REDDY'S LABORATORIES LTD. | CONTACT | |
| Investor relationS | Media relationS | |
| 8-2-337, Road No. 3, Banjara Hills, | AMIT AGARWAL | USHA IYER |
| Hyderabad - 500034. Telangana, India. | amita@drreddys.com | ushaiyer@drreddys.com |
Dr. Reddy's
Laboratories announces the launch of
Valsartan Tablets, USP in the U.S. Market
| Hyderabad, India, December 09, 2021 | For Immediate Release |
Hyderabad, India and Princeton, NJ, USA. December 09, 2021 - Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Valsartan Tablets, USP, a therapeutic equivalent generic version of Diovan® (valsartan) Tablets approved by the U.S. Food and Drug Administration (USFDA).
The Diovan® brand and generic market had U.S. sales of approximately $150 million MAT for the most recent twelve months ending in October 2021 according to IQVIA Health*.
Dr. Reddy’s Valsartan Tablets, USP are available in 40 mg in bottle count size of 30, and 80 mg, 160 mg and 320 mg tablets in bottle count sizes of 90.
Please click here for full prescribing information including boxed warning: https://www.drreddys.com/pil/150084612-Valsartan-Tablets_Outsert-v_10.pdf
|
WARNING: FETAL TOXICITY · When pregnancy is detected, discontinue Valsartan as soon as possible. (5.1) · Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1)
|
| Diovan is a trademark owned or licensed by Novartis Corporation |  |
| *IQVIA Retail and Non-Retail MAT October 2021 |
RDY-1021-377
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its businesses, Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars 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, 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, 2021. The company assumes no obligation to update any information contained herein.