0001575872-20-000066.txt : 20200320 0001575872-20-000066.hdr.sgml : 20200320 20200320084147 ACCESSION NUMBER: 0001575872-20-000066 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20200320 FILED AS OF DATE: 20200320 DATE AS OF CHANGE: 20200320 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DR REDDYS LABORATORIES LTD CENTRAL INDEX KEY: 0001135951 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-15182 FILM NUMBER: 20730358 BUSINESS ADDRESS: STREET 1: 8-2-337, ROAD NO.3 BANJARA HILLS CITY: HYDERABAD STATE: K7 ZIP: 500-034 BUSINESS PHONE: 91 40 49002900 MAIL ADDRESS: STREET 1: 8-2-337, ROAD NO.3 BANJARA HILLS CITY: HYDERABAD STATE: K7 ZIP: 500-034 6-K 1 drr0202_6k.htm FORM 6-K

 

 

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

 

March, 2020

 

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

 

Exhibit
Number
  Description of Exhibits
   
99.1  

Press Release dated March 20, 2020 for Dr. Reddy's Laboratories announces the launch of Pyrimethamine Tablets USP, 25 mg, first-wave generic version of Daraprim® in the U.S. Market

 

 

 

  

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: March 20, 2020 By: /s/ Sandeep Poddar
    Name: Sandeep Poddar
    Title: Company Secretary

 

 

EX-99.1 2 drr0202_ex99-1.htm EXHIBIT 99.1

 

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

 

March 20, 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

 

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 Pyrimethamine Tablets USP, 25 mg, first-wave generic version of Daraprim® in the U.S. Market.”

 

This is for your information.

 

With regards,

  

/s/ Sandeep Poddar  
Sandeep Poddar  
Company Secretary  

 

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,
Hyderabad - 500034. Telangana, India.

AMIT AGARWAL

amita@drreddys.com
(Ph: +91-40-49002135)

APARNA TEKURI

aparnatekuri@drreddys.com

(Ph: +91-40- 49002446)

 

 

 

Dr. Reddy's Laboratories announces the launch of
Pyrimethamine Tablets USP, 25 mg, first-wave generic version
of Daraprim® in the U.S. Market

 

Hyderabad, India, March 20, 2020 For Immediate Release

 

 

 

Hyderabad, India and Princeton, NJ, USA. March 20, 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 Pyrimethamine Tablets USP, 25 mg, a therapeutic equivalent and first-wave generic version of Daraprim® (pyrimethamine) Tablets, approved by the U.S. Food and Drug Administration (USFDA). This product is the only AB-rated generic version Daraprim® (pyrimethamine) Tablets approved by the USFDA.

 

“I am extremely proud of our teams at Dr. Reddy’s and Cerovene whose hard work and efforts, coupled with significant financial investments over the past seven years journey, have helped bring this important product to market,” says, Marc Kikuchi, Chief Executive Officer, North America Generics, Dr.Reddy’s Laboratories. “Our team’s relentless pursuit of this difficult-to-procure reference drug and its active pharmaceutical ingredients—in addition to recent actions from the USFDA (https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic- daraprim?utm_campaign=FDA%20approves%20first%20generic%20of%20Daraprim%20%28pyrimethamine%29%20tablets&utm_medium=email&utm_source=Eloqua) —will benefit patients by providing a more affordable alternative to the brand.” According to Kikuchi, the company is offering this product at a substantial discount compared with the current brand price.

 

“The achievements of the Cerovene team to develop, file and manufacture Pyrimethamine Tablets is a testament to our dedication and commitment to be able to provide this product to the patients who need it most. We are pleased to collaborate with Dr. Reddy’s as our commercial partner to make this important drug available to patients in the U.S.,” says, Ray DiFalco, Co-Founder and Vice President of Operations for Cerovene. “This approval represents our continued commitment to develop and provide patients with greater choices and lower-cost alternatives for prescription pharmaceuticals.”

 

In a recent press release (https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-daraprim?utm_campaign=FDA%20approves%20first%20generic%20of%20Daraprim%20%28pyrimethamine%29%20tablets&utm_medium=email&utm_source=Eloqua) regarding the approval of this product, the USFDA reiterated its commitment to improve “the efficiency of the generic drug development, review and approval process, as well as closing loopholes that allow brand-name drug companies to delay the generic competition.” The approval and launch of Dr. Reddy’s Pyrimethamine is a testament to the agency’s actions, providing generic drug companies the opportunity to compete fairly in the marketplace.

 

Pyrimethamine is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.

 

The Daraprim® (pyrimethamine) brand had U.S. sales of approximately $10 million MAT for the most recent twelve months ending in January 2020 according to IQVIA Health*.

 

Dr. Reddy’s Pyrimethamine Tablets USP, are available in 25 mg dose in bottle count sizes of 30 and 100.

 

Important Safety Information

 

What Important Information Should I Know About Pyrimethamine Tablets USP, 25 mg?

 

·At the first appearance of a skin rash, stop use of Pyrimethamine and seek medical attention immediately

 

 

 

 

 

 

·Appearance of sore throat, paleness, purpura, or changes to the tongue may be early indications of serious disorders which require treatment with Pyrimethamine to be stopped and medical treatment to be sought
·Pyrimethamine should be kept out of the reach of infants and children as they are extremely susceptible to adverse effects from an overdose.
·Take your medicine as directed and do not exceed recommended doses
·If anorexia and vomiting occur, then they may be minimized by taking the drug with meals
·Concurrent administration of folinic acid is strongly recommended with treatment of toxoplasmosis in all patients
·If signs of folate deficiency develop, then Pyrimethamine should be discontinued

 

Who Should Not Use Pyrimethamine Tablets USP, 25 mg?

 

·Have known hypersensitivity to Pyrimethamine or to any component of the formulation
·Have documented megaloblastic anemia due to folate deficiency

 

What Should I Tell My Healthcare Provider Before Taking Pyrimethamine Tablets USP, 25 mg?

 

Before taking Pyrimethamine Tablets, tell your doctor if you:

 

·Have impaired renal function
·Have impaired hepatic function
·Have possible folate deficiency, such as individuals with malabsorption syndrome, alcoholism, or pregnancy, and those receiving therapy, such as phenytoin, affecting folate levels
·Take other antifolic drugs or agents associated with myelosuppression including sulfonamides or trimethoprim-sulfamethoxazole combinations, proguanil, zidovudine, or cytostatic agents (e.g., methotrexate), which may increase the risk of bone marrow suppression while concomitantly receiving Pyrimethamine
·Take lorazepam
·Have convulsive disorders
·Have heart conditions, especially irregular heartbeat
·Are pregnant or plan to become pregnant
·Are nursing or plan to breastfeed

 

What Are the Adverse Reactions of Pyrimethamine Tablets USP, 25 mg?

 

Call your doctor or get emergency help right away if you develop:

 

·Hypersensitivity reactions, occasionally severe (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and anaphylaxis), and hyperphenylalaninemia, can occur particularly when pyrimethamine is administered concomitantly with a sulfonamide
·Megaloblastic anemia
·Leukopenia
·Thrombocytopenia
·Pancytopenia
·Neutropenia
·Atrophic glossitis
·Hematuria (Blood in urine)
·Heart rhythm disorders
·Pulmonary eosinophilia

 

Anorexia and vomiting may also occur.

 

What Should I Avoid While Taking Pyrimethamine Tablets USP, 25 mg?

 

·Females of reproductive potential should avoid becoming pregnant during treatment
·Avoid breastfeeding while receiving Pyrimethamine

 

Please refer to the Package Insert for full prescribing information for Pyrimethamine Tablets USP, 25 mg.

For more information, ask your healthcare provider or pharmacist. You are encouraged to report negative side effects of prescription drugs. To report suspected side effects, call Dr. Reddy’s Laboratories Medical Information Hotline at 1-888-DRL-DRUG (1-888-375-3784) or via email to medinfo@drreddys.com or contact the USFDA at 1-800-FDA-1088 (1-800-332-1088) or online at http://www.fda.gov/safety/medwatch.

 

 

 

 

 

 

Indication and Usage for Pyrimethamine Tablets USP, 25 mg

 

·Treatment of Toxoplasmosis: Pyrimethamine is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.

 

Please see the full prescribing information.

https://www.drreddys.com/pi/Pyrimethamine_Tabs_USP_25mg_PROOF.pdf

 

Daraprim® is a trademark owned by or licensed to Vyera Pharmaceuticals, LLC

 

*IQVIA Retail and Non-Retail MAT January 2020.

 

RDY-0220-278

 

 

About Cerovene: Cerovene, Inc., a privately held company, is engaged in the research, development and manufacturing of pharmaceuticals. The company’s expertise in both solid and liquid dosage products, extends across a range of drug delivery technologies, including Pulse Release, Delayed and Sustained Release, Extended Release, Sustained Zero-Order Release, Matrix-Hydrogel Controlled Released, Enteric Coated, Tablet in Capsule and Coated Capsules. Cerovene developes, files and manufacturers both Branded and Generic pharmaceutical products. For more information visit www.cerovene.com

 

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, 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.

 

The company assumes no obligation to update any information contained herein.

 

 

 

 

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