AI assistant
DR REDDYS LABORATORIES LTD — Capital/Financing Update 2019
Jun 10, 2019
30528_rns_2019-06-10_bd73730b-b662-4b3e-8edf-358083669a25.pdf
Capital/Financing Update
Open in viewerOpens in your device viewer
•·· Dr.Reddy's �;•
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 :[email protected] www.drreddys.com
June 10, 2019
Corporate Relationship Department BSE Limited Dalal Street, Fort Mumbai - 400 001 Fax Nos.: 022-22723121 / 22723719 / 22722037 /22722039
National Stock Exchange of India Ltd. "Exchange Plaza" Bandra-Kurla Complex, Bandra (East), Mumbai - 400 051 Fax Nos.: 022-26598120/ 26598237/ 26598238
Scrip Code: 500124
- Scrip Code: DRREDDY EQ
Dear Sirs,
Sub: Press Release
Please find enclosed a Press Release on "Dr. Reddy's Laboratories Limited through its wholly owned subsidiary, Dr. Reddy's Laboratories SA, announces positive topline results from Phase 2b study of PPC-06 in patients with moderate to severe plaque psoriasis"
This is for your information.
With regards,
\0[\ .] San�r,' ddar .__,u.nuc,ally Secretary Encl: As above
CC:- New York Stock Exchange Inc.(Stock Code: RDY)
Press Release
••• Dr.Raddy's ��•
DR. REDDY'$ LABORATORIES LTD.
8-2-337, Road No. 3, Banjara Hills, Hyderabad - 500034. Telangana, India.
CONTA-CT INVESTOR RELATIONS MEDIA RELATIONS AMIT AGARWAL MITALI SARKAR [email protected] [email protected] (PH: +91-40-49002135) (PH: +91-40- 49002121)
Dr. Reddy's Laboratories Limited through its wholly owned subsidiary, Dr. Reddy's Laboratories SA, announces positive topline results from Phase 2b study of PPC-06 in patients with moderate to severe plaque psoriasis
Hyderabad, India, June 10, 2019
For Immediate Release
Hyderabad, India, June 10, 2019 - Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as "Dr. Reddy's") announced positive topline results from its Phase 2b study of PPC-06 (formerly referred to as XP23829) in patients with moderate to severe plaque psoriasis. In the study, PPC-06 met both co-primary endpoints i.e. PASI-75 and IGA scores of O or 1 with at least a 2-point reduction from baseline, after 24 weeks of oral treatment. The detailed safety and efficacy data from the study will be presented in future dermatology conferences.
"PPC-06 is an oral molecule with a novel mechanism of action that has the potential to address unmet medical needs of psoriasis patients. The top line data we are reporting today support our belief that PPC-06 may become the first approved oral prodrug of Monomethyl Fumarate (MMF) for treatment of moderate to severe plaque psoriasis in the US. Further clinical development requirements will be discussed with the US FDA to support the approval of this product", said Anil Namboodiripad PWJ., Senior Vice President and Head, Proprietary Products Business.
PPC-06 is an extended release formulation of a fumaric acid ester (FAE), in-licensed from Xenoport, Inc. for further development to treat moderate to severe plaque psoriasis. A Phase 2b clinical study was conducted to evaluate the tolerability, safety and efficacy of three doses of PPC-06 over 24 weeks. This was a randomized, double blind, placebo-controlled, dose-finding multicenter efficacy and safety study conducted at 76 sites in the US. Patients had stable, moderate to severe plaque psoriasis for at least 6 months, with PASI (Psoriasis Area and Severity Index) scores 2:12, IGA (5-point Investigator's Global Assessment) scores 2:3, and psoriasis lesions involving 10% or more of the patient's Body Surface ¼ea (BSA) at study baseline. A total of 426 patients were randomized in a 1: 1: 1: 1 ratio into 4 treatment arms: 400 mg QD, 400 mg BID, 600 mg BID, and placebo. The co-primary end points of the study were PASI-75 (i.e. proportion of treated subjects achieving a 75% reduction in their PASI score over baseline) and IGA score ofO orl at week 24.
At week 24 analysis, PASI-75 was achieved by 44.3%, 47.2% and 39.7% patients in PPC-06 600 mg BID, 400 mg BID and 400 mg QD treatment groups respectively, against 20% of patients in the placebo group (p<0.05). Additionally 44.4%, 41.4% and 35.7% of patients in the PPC 06 600 mg BID and 400 mg BID and 400 mg QD groups, respectively, achieved an IGA score of O or 1 (IGA Clear) at week 24 against 22% of patients in the placebo group (p<0.05).
The most common adverse events (AE's) reported were lymphocytopenia, eosinophilia and gastro-intestinal (GI) disorders, such as diarrhea, nausea, abdominal pain and vomiting.
"Given the positive clinical data in this study, PPC-06 may have a potential to serve as an important therapeutic option for psoriasis patients in a market with limited oral treatments. We thank all the patients, investigators and study staff whose ongoing participation helped us achieve this target." said Sagar Munjal, MD, MS, Chief Medical i · Officer Promius Pharma/VP Clinical Development & Medical Affairs.
.l ; · · � ·•�. "'· .;,. ; ,;. ·o; Reddy'� U:b;,;,o,tes , .. : 1sSEiSci0124: Nse: oRREDDY. NvSE RD Yi Is '" ;,,; ;;;, Ph�, �IT�: i ·�, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Phamrnceutl�� � Active Ingredients, Global Generics and Proprietary Products - Dr. Reddy's offers a portfolio of products and services including APls, custo1fi"
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: w .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.
==> picture [75 x 68] intentionally omitted <==