Dr Reddys Laboratories Ltd 6-K, filed Jan 13, 2023
Dr Reddys Laboratories Ltd (RDY)
About this 6-K
Dr Reddys Laboratories Ltd filed this 6-K on January 13, 2023.
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
January, 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
|
Exhibit |
Description of Exhibits | |
| 99.1 | Press Release dated January 13, 2023 regarding Dr. Reddy’s launches in-house palbociclib (PRIMCYV®) to widen access to high-quality breast cancer drug |
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: January 13, 2023 | By: | /s/ K Randhir Singh | |
| Name: | K Randhir Singh | ||
| Title: | Company Secretary | ||
Exhibit 99.1
 |
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 |
January 13, 2023
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 “Dr. Reddy’s launches in-house palbociclib (PRIMCYV®) to widen access to high-quality breast cancer drug.”
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.
| CONTACT | ||
| DR. REDDY'S LABORATORIES LTD. | Investor relationS | Media relationS |
|
8-2-337, Road No. 3, Banjara Hills, Hyderabad – 500034, Telangana, India. |
Richa Periwal richaperiwal@drreddys.com |
USHA IYER ushaiyer@drreddys.com |
Dr. Reddy’s launches in-house palbociclib (PRIMCYV®) to
widen access to high-quality breast cancer drug
| · | First-in-class CDK 4/6 inhibitor indicated in combination with an aromatase inhibitor for the first-line treatment of adult patients with HR+, HER2- metastatic breast cancer |
| · | Dr. Reddy’s has acquired trademark rights to the product for use in India from Pfizer Products India Pvt Ltd. |
| · | In-house manufacturing of API and finished drug at USFDA-approved facilities |
| · | Dr. Reddy’s among select companies to have conducted bioequivalence study and has already received tentative approval from the USFDA |
| · | PRIMCYV® will be retailed in India at an 85% reduction from the current MRP to widen patient access to the trusted brand and high-quality product |
| · | The company plans to roll out a unique Patient Assistance Programme (PAP) to support long-term therapy of patients on PRIMCYV®. |
Hyderabad, India; January 13, 2023 – Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; hereafter referred to as “Dr. Reddy’s”), announced that it has acquired the trademark rights of the breast cancer drug PRIMCYV® from Pfizer Products India Pvt Ltd for use in the Indian market.
PRIMCYV® is a targeted therapy containing the active constituent palbociclib, a first-in-class CDK 4/6 inhibitor indicated in combination with an aromatase inhibitor for the first-line treatment of adult patients with HR+, HER2- metastatic breast cancer. Since May 2022, Dr. Reddy’s has been marketing the drug in collaboration with Pfizer Products India Pvt Ltd under the brand name PRIMCYV® in India. The drug comes in the form of hard capsules in strengths of 75 mg, 100 mg and 125 mg.
Following the trademark rights acquisition, Dr. Reddy’s will manufacture the Active Pharmaceutical Ingredient (API) and finished drug at its state-of-the-art facilities approved by the United States Food and Drug Administration (USFDA). Dr. Reddy’s is amongst select companies in the world to have conducted a bioequivalence study and received tentative approval from the USFDA for palbociclib. The in-house product will be retailed in the Indian market at a reduction of 85% from the current MRP to increase affordability and access to palbociclib. Dr. Reddy’s plans to roll out a unique Patient Assistance Programme to support long-term therapy of the patients on PRIMCYV®.
| CONTACT | ||
| DR. REDDY'S LABORATORIES LTD. | Investor relationS | Media relationS |
|
8-2-337, Road No. 3, Banjara Hills, Hyderabad – 500034, Telangana, India. |
Richa Periwal richaperiwal@drreddys.com |
USHA IYER ushaiyer@drreddys.com |
Through leading brands such as Hervycta, Mitotax, Docetere, Nab Mitotax, PRIMCYV and others, Dr. Reddy’s has made a portfolio of reliable and high-quality medicines available to patients in India in keeping with its purpose of ‘Good Health Can’t Wait’.
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.
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, 2022. The company assumes no obligation to update any information contained herein.
