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Barnama
2 days ago
- Business
- Barnama
Extrovis AG and Dr. Reddy's announce the launch of the authorized generic of CARAC (fluorouracil cream), 0.5% in the U.S.
Baar, Switzerland; Aug 19 (Bernama) -- Extrovis AG, a global pharmaceutical company focused on research-driven innovation, and 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 Fluorouracil Cream, 0.5%, an authorized generic and therapeutic equivalent of Carac® (fluorouracil cream) 0.5%, in the US market, approved by the U.S. Food and Drug Administration (USFDA). Manufactured in Texas at one of Extrovis' facilities, Dr. Reddy's Fluorouracil Cream, 0.5%, is indicated for the topical treatment of multiple actinic or solar keratoses of the face and anterior scalp.
Toronto Star
3 days ago
- Business
- Toronto Star
Extrovis AG and Dr. Reddy's announce the launch of the authorized generic of CARAC (fluorouracil cream), 0.5% in the U.S.
Press Release Extrovis AG and Dr. Reddy's announce the launch of the authorized generic of CARAC (fluorouracil cream), 0.5% in the U.S. Baar, Switzerland; August 14, 2025 Extrovis AG, a global pharmaceutical company focused on research-driven innovation, and 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 Fluorouracil Cream, 0.5%, an authorized generic and therapeutic equivalent of Carac® (fluorouracil cream) 0.5%, in the US market, approved by the U.S. Food and Drug Administration (USFDA). Manufactured in Texas at one of Extrovis' facilities, Dr. Reddy's Fluorouracil Cream, 0.5%, is indicated for the topical treatment of multiple actinic or solar keratoses of the face and anterior scalp. ARTICLE CONTINUES BELOW 'This product generic launch marks a key milestone in our commitment to increasing patient access and long-term value creation for the U.S. healthcare system. Our partnership with Dr. Reddy's helps ensure that patients and healthcare providers in the United States have continued access to a high-quality and cost-effective product,' said Hans R. Kamma Co-CEO and Chief Strategy Officer of Extrovis AG. 'Dr. Reddy's brings deep expertise in commercialization and distribution within the U.S. market,' added Raghavendra Rao PV, Chief Financial Officer of Extrovis AG. 'This collaboration is aligned with our mission to strengthen pharmaceutical supply chains and serve public health needs responsibly.' The partnership reinforces Extrovis' strategy to extend the reach of its therapeutics while advancing long-term affordability and sustainability in healthcare. Dr. Reddy's Fluorouracil Cream, 0.5%, is supplied in a 30-gram tube for topical use only. Please click here to see the full prescribing information. Carac® is a trademark of Extrovis AG ……………………………………………………………………………………..…………………………………………………………………………………………………………………… ARTICLE CONTINUES BELOW ARTICLE CONTINUES BELOW About Dr. Reddy's 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: About Extrovis AG Extrovis AG is a Switzerland-based global biopharmaceutical company committed to developing and commercializing high-quality therapies for unmet and under-addressed medical needs. With R&D and manufacturing operations in the USA, Italy, Hungary, and India, Extrovis delivers innovative, differentiated products across key therapeutic areas. Backed by strong R&D capabilities, regulatory expertise, and a robust global quality framework, the company advances its mission to improve patient outcomes and expand access to essential health care products worldwide. For more information, log on to: ……………………………………………………………………………………………………………………………………………………… 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). The company assumes no obligation to update any information contained herein. Attachment CARAC (fluorouracil cream), 0.5%
Business Wire
23-07-2025
- Business
- Business Wire
Dr. Reddy's Q1FY26 Financial Results
HYDERABAD, India--(BUSINESS WIRE)--Dr. Reddy's Laboratories Ltd. (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY) today announced its consolidated financial results for the quarter ended June 30, 2025. The information mentioned in this release is based on consolidated financial statements under International Financial Reporting Standards (IFRS). Q1 FY26 Revenues ₹ 85,452 Mn [Up: 11% YoY; Flat QoQ] Gross Margin 56.9% [Q1FY25: 60.4%; Q4FY25: 55.6%] SG&A Expenses ₹ 25,647 Mn [Up: 13% YoY; 7% QoQ] R&D Expenses ₹ 6,244 Mn [7.3% of Revenues] EBITDA ₹ 22,784 Mn [26.7% of Revenues] Profit before Tax ₹ 19,047 Mn [Up: 1% YoY; Down 5% QoQ] Profit after Tax attributable to Equity Holders ₹ 14,178 Mn [Up: 2% YoY; Down 11% QoQ Expand Commenting on the results, Co-Chairman & MD, G V Prasad said: 'We delivered double-digit growth this quarter over the same period last year, reflecting our strength in branded markets and positive momentum in the Nicotine Replacement Therapy portfolio. The pricing pressure on Lenalidomide is expected to intensify in the U.S. generics market. We remain focused on strengthening our base business by delivery of our pipeline assets, improving overall productivity and business development.' All amounts in millions, except EPS All US dollar amounts based on convenience translation rate of 1 USD = ₹ 85.74 Expand Dr. Reddy's Laboratories Limited & Subsidiaries Revenue Mix by Segment for the quarter Particulars Q1FY26 Q1FY25 YoY Gr % Q4FY25 QoQ Gr% (₹) (₹) (₹) Global Generics 75,620 68,858 10 75,365 0 North America 34,123 38,462 (11) 35,586 (4) Europe 12,744 5,265 142^ 12,750 0 India 14,711 13,252 11 13,047 13 Emerging Markets 14,042 11,878 18 13,981 0 Pharmaceutical Services and Active Ingredients (PSAI) 8,181 7,657 7 9,563 (14) Others 1,651 212 678 132 1149 Total 85,452 76,727 11 85,060 0 ^Excluding Consumer healthcare (NRT) sales; YoY revenue growth is at 15% Expand Consolidated Income Statement for the quarter Particulars Q1FY26 Q1FY25 YoY Gr % Q4FY25 QoQ Gr% ($) (₹) ($) (₹) ($) (₹) Revenues 997 85,452 895 76,727 11 992 85,060 0 Cost of Revenues 429 36,825 354 30,383 21 441 37,797 (3) Gross Profit 567 48,627 541 46,344 5 551 47,263 3 % of Revenues 56.9% 60.4% 55.6% Selling, General & Administrative Expenses 299 25,647 265 22,691 13 281 24,055 7 % of Revenues 30.0% 29.6% 28.3% Research & Development Expenses 73 6,244 72 6,193 1 85 7,258 (14) % of Revenues 7.3% 8.1% 8.5% Impairment of Non-Current Assets, net - - 0 5 (160) 9 768 (100) Other (Income)/Expense, net (9) (739) (5) (470) 57 (29) (2,465) (70) Results from Operating Activities 204 17,475 209 17,925 (2) 206 17,647 (1) Finance (Income)/Expense, net (18) (1,570) (10) (837) 88 (27) (2,352) (33) Share of Profit of Equity Investees, net of tax (0) (2) (1) (59) (98) (1) (55) (98) Profit before Income Tax 222 19,047 220 18,821 1 234 20,054 (5) % of Revenues 22.3% 24.5% 23.6% Income Tax Expense 58 4,951 57 4,901 1 49 4,181 18 Profit for the Period 164 14,096 162 13,920 1 185 15,873 (11) % of Revenues 16.5% 18.1% 18.7% Attributable to Equity holders of the Parent Co. 165 14,178 162 13,920 2 186 15,939 (11) Attributable to Non-controlling interests (1) (82) - - - (1) (66) 24 Diluted Earnings per Share (EPS) 0.20 17.02 0.19^ 16.69^ 2 0.22 19.11 (11) ^Historical numbers re-casted basis the increased number of shares post share split. Expand Key Balance Sheet Items Particulars As on 30 th Jun 2025 As on 31 st Mar 2025 As on 30 th Jun 2024 ($) (₹) ($) (₹) ($) (₹) Cash and Cash Equivalents and Other Investments 853 73,169 797 68,299 1,115 95,599 Trade Receivables 1,110 95,137 1,055 90,420 946 81,088 Inventories 882 75,600 829 71,085 800 68,568 Property, Plant, and Equipment 1,199 1,02,784 1,140 97,761 943 80,813 Goodwill and Other Intangible Assets 1,255 1,07,572 1,267 1,08,613 483 41,374 Loans and Borrowings (Current & Non-Current) 567 48,644 545 46,766 358 30,675 Trade Payables 437 37,457 414 35,523 398 34,109 Equity 4,126 3,53,755 3,932 3,37,166 3,436 2,94,628 Expand Key Business Highlights for Q1FY26 Expanded partnership with Alvotech to co-develop, manufacture and co-commercialize pembrolizumab, a biosimilar candidate to Keytruda ®. Expanded collaboration with Sanofi to launch Beyfortus TM (Nirsevimab), a novel drug for preventing Respiratory Syncytial Virus (RSV) in India. Launched Sensimune in India, an immunotherapy product for house dust mite-induced allergies, in partnership with ALK-Abelló. ESG Highlights and other updates for Q1FY26 Improved rating by Carbon Disclosure Project (CDP) to 'A' in the Climate category, positioning us among the top 2% of the global companies assessed. We upheld our leadership status in the Water and Supplier Engagement categories. Received a Form 483 with two observations for Middleburgh API facility in New York. The USFDA has classified the inspection outcome as 'Voluntary Action Indicated (VAI)'. Received a Form 483 with two observations following GMP inspection conducted at CTO-5, our API facility in Miryalaguda, Telangana. All observations have been addressed and responded to within the stipulated timelines. Revenue Analysis Q1FY26 consolidated revenues stood at ₹85.5 billion, YoY growth of 11% and flat QoQ. Growth during the quarter was broad-based, aided by contributions from the acquired Consumer Healthcare portfolio in Nicotine Replacement Therapy ('NRT') and sustained performance in our branded markets. Global Generics (GG) Q1FY26 revenues at ₹75.6 billion, YoY growth of 10% and flat QoQ. North America Q1FY26 revenues at ₹34.1 billion, YoY decline of 11% and QoQ decline of 4%. The decline was primarily due to increased price erosion in certain key products including Lenalidomide. During the quarter, we launched five new products in the U.S. We filed one new Abbreviated New Drug Application (ANDA) with the USFDA during the quarter. Filings pending approval from USFDA - 73 includes: 70 ANDAs (43 are Paragraph IV applications, and 22 may have a 'First to File' status and 3 New Drug Applications (NDAs) filed under Section 505(b)(2) Europe Q1FY26 revenues at ₹12.7 billion, YoY growth of 142% and flat QoQ growth. This includes revenues from the acquired NRT business. NRT at ₹6.7 billion, QoQ growth of 12%. Germany at ₹3.2 billion, YoY growth of 13% and QoQ decline of 11%. UK at ₹1.7 billion, YoY growth of 10% and QoQ decline of 20%. Rest of Europe at ₹1.2 billion, YoY growth of 30% and QoQ growth of 9%. The growth in Europe was largely driven by revenues from the acquired NRT portfolio and incremental contributions from new product launches though partly offset by price erosion. QoQ performance remained stable as the impact of price erosion was balanced by gains from forex and increased volumes. During the quarter, we launched 13 new products in the region. India Q1FY26 revenues at ₹14.7 billion, YoY growth of 11% and QoQ growth of 13%. Growth for the quarter was driven by introduction of new products, price increases and commercial execution. As per IQVIA, our IPM rank was maintained at 10. During the quarter, we launched five new brands. Includes two Innovative assets Beyfortus (RSV Vaccine) & Sensimmune (Acarizex Slit) Emerging Markets Q1FY26 revenues at ₹14.0 billion, YoY growth of 18% and flat QoQ. YoY growth was largely driven by increased volumes of existing products, gains from new launches across multiple countries and favorable foreign exchange. QoQ performance remained stable as the gains from new product launches and favourable prices was largely offset by softer volume growth. Revenues from Russia at ₹7.1 billion, YoY growth of 28% and QoQ growth of 8%. YoY growth was due to higher volumes of existing products, new product introductions and favorable forex. QoQ gains reflect favourable forex, improved pricing and higher sales volumes. Revenues from other Commonwealth of Independent States (CIS) countries and Romania at ₹2.0 billion, YoY growth of 2% and QoQ decline of 20%. While YoY growth was supported by new product launches, whereas QoQ decline was due to lower volumes. Revenues from Rest of World (RoW) territories at ₹5.0 billion, growth of 13% YoY and flat QoQ. While YoY growth was due to higher sales volumes and new product launches, though partially moderated by price erosion, QoQ performance remained steady, as volume gains from existing products and recent launches were neutralized by price erosion. During Q1FY26, we launched 26 new products across countries. Pharmaceutical Services and Active Ingredients (PSAI) Q1FY26 revenues at ₹8.2 billion, YoY growth of 7% and QoQ decline of 14%. Growth during the quarter was driven by launch of new API products and favourable forex, partially offset by lower pricing and softer demand. Performance was further supported by growth in the pharmaceutical services business. QoQ decline was primarily attributable to seasonal volume softness. During the quarter, we filed 12 Drug Master Files (DMFs) globally. Income Statement Highlights: Gross Margin Q1FY26 at 56.9% (GG: 60.9%, PSAI: 13.2%), a YoY decline of 350 basis points (bps) and a QoQ improvement of 134 bps. YoY decline was primarily due to higher price erosion in generics segment and reduced operating leverage, partially offset by favorable product mix. Selling, General & Administrative (SG&A) Expenses Q1FY26 at ₹25.6 billion, YoY increase of 13% and QoQ growth of 7%. The YoY increase was driven by strategic investments in consumer healthcare business segment, including the NRT and Nestlé JV. Other SG&A expenses stayed mostly unchanged from last year, reflecting cost discipline across core operations. The QoQ reflects targeted investments to enhance brand visibility and expand coverage across branded markets. Research & Development (R&D) Expenses Q1FY26 at ₹6.2 billion. As % to Revenues – Q1FY26: 7.3% | Q1FY25: 8.1% | Q4FY25: 8.5%. R&D investments were focused on building a robust pipeline of high-value products, spanning complex generics, biosimilars, APIs and novel biologics with particular emphasis on oncology, peptides and injectables and aimed at developing first to market formulations. Net Finance Income/Expense Q1FY26 income at ₹1.6 billion compared to ₹0.9 billion in Q1FY25. Profit before Tax Q1FY26 at ₹19.0 billion, a YoY growth of 1% and a QoQ decline of 5%. As % to Revenues – Q1FY26: 22.3% | Q1FY25: 24.5% | Q4FY25: 23.6%. Income Tax Q1FY26 at ₹5.0 billion. As % to PBT – Q1FY26: 26.0% | Q1FY25: 26.0% | Q4FY25: 20.8%. Profit attributable to Equity Holders of Parent Company Q1FY26 at ₹14.2 billion, a YoY growth of 2% and a QoQ decline of 11%. As % to Revenues – Q1FY26: 16.5% | Q1FY25: 18.1% | Q4FY25: 18.7%. Diluted Earnings per Share (EPS) Q1FY26 is ₹17.02. Other Financial Highlights: EBITDA Q1FY26 at ₹22.8 billion, YoY growth of 5% and QoQ decline of 8%. As % to Revenues – Q1FY26: 26.7% | Q1FY25: 28.2% | Q4FY25: 29.1%. Others: Operating Working Capital: As on 30 th June 2025 at ₹133.3 billion. Capital Expenditure: Q1FY26 at ₹6.8 billion. Free Cash Flow: Q1FY26 at ₹4.5 billion. Net Cash Surplus: As on 30 th June 2025 at ₹29.2 billion Net Debt to Equity: As on 30 th June 2025 is (0.08) Annualized Return on Capital Employed (RoCE): Q1FY26 stood at 22.0% About key metrics and non-GAAP Financial Measures This press release contains non-GAAP financial measures within the meaning of Regulation G and Item 10(e) of Regulation S-K. Such non-GAAP financial measures are measures of our historical performance, financial position or cash flows that are adjusted to exclude or include amounts from the most directly comparable financial measure calculated and presented in accordance with IFRS. The presentation of this financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial information prepared and presented in accordance with IFRS. Our non-GAAP financial measures are not based on any comprehensive set of accounting rules or principles. These measures may be different from non-GAAP financial measures used by other companies, limiting their usefulness for comparison purposes. We believe these non-GAAP financial measures provide investors with useful supplemental information about the financial performance of our business, enable comparison of financial results between periods where certain items may vary independent of business performance, and allow for greater transparency with respect to key metrics used by management in operating our business. For more information on our non-GAAP financial measures and a reconciliation of GAAP to non-GAAP measures, please refer to "Reconciliation of GAAP to Non-GAAP Results" table in this press release. All amounts in millions, except EPS Net Cash Surplus and Debt to Equity Particulars As on 30 th Jun 2025 (₹) Cash and Cash Equivalents 9,004 Investments 64,165 Short-term Borrowings (38,381) Long-term Borrowings (Current & Non-current) (10,263) Less: Restricted Cash Balance – Unclaimed Dividend and others 292 Lease liabilities (Included in Short-term and Long-term Borrowings) (6,463) Equity Investments (Included in Investments) 1,476 Net Cash Surplus 29,220 Equity 353,755 Net Debt/Equity (0.08) Expand Computation of Capital Employed: Particulars As on Jun 30, 2025 Mar 31, 2025 Property Plant and Equipment 102,784 97,761 Intangibles 95,597 96,803 Goodwill 11,975 11,810 Investment in Equity Accounted Associates 4,938 4,811 Other Current Assets 31,768 30,142 Other Investments 6,481 10,391 Other Non-Current Assets 939 972 Inventories 75,600 71,085 Trade Receivables 95,137 90,420 Derivative Financial Instruments 38 (729) Less: Other Liabilities 47,254 48,788 Provisions 6,789 6,324 Trade payables 37,457 35,523 Operating Capital Employed 333,757 322,831 Average Capital Employed 328,294 Expand Computation of EBITDA Refer page no. 3 & 4. 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 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: 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, 2025 and our other filings with US SEC. The company assumes no obligation to update any information contained herein.
Economic Times
06-06-2025
- Business
- Economic Times
Dr. Reddy's shares rise over 1% on strategic collaboration with Alvotech for Keytruda Biosimilar
Live Events (You can now subscribe to our (You can now subscribe to our ETMarkets WhatsApp channel Shares of Dr. Reddy's Laboratories rose 1.4% to touch the day's high of Rs 1,307.65 on the BSE on Friday, June 6, after the company announced a strategic collaboration with Alvotech , a global biotech firm, to co-develop and commercialize a biosimilar candidate to Keytruda ( pembrolizumab ) for global markets.'Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines, and Dr. Reddy's Laboratories Ltd. (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY, along with its subsidiaries hereafter referred to as 'Dr. Reddy's'), today announced that the companies have entered into a collaboration and license agreement to co-develop, manufacture, and commercialize a biosimilar candidate to Keytruda (pembrolizumab) for global markets,' Dr. Reddy's said in an exchange a leading immunotherapy drug used in the treatment of various cancers, generated $29.5 billion in global sales in 2024, making it one of the most valuable targets in the biosimilars partnership represents a significant opportunity for Dr. Reddy's to enter the high-value biosimilar segment for oncology drugs, a category that continues to witness growing demand and heightened competitive the agreement, both parties will jointly develop and manufacture the biosimilar, sharing costs and responsibilities. Importantly, each company will retain the right to commercialize the product globally, subject to certain deal is expected to accelerate development timelines and expand the global market reach of the biosimilar.Róbert Wessman, Chairman and CEO of Alvotech, emphasized that the agreement will help deliver cost-effective, critical biologic medicines to patients worldwide by combining Dr. Reddy's commercial strength with Alvotech's R&D and manufacturing this collaboration, Dr. Reddy's further strengthens its pipeline in the biosimilars segment.'We are pleased to collaborate with Alvotech on the pembrolizumab biosimilar. This demonstrates our ability to develop and manufacture high-quality, affordable treatment options for patients across the world. Oncology has been a key focus area for us, and this collaboration will enhance our capabilities in this domain, as pembrolizumab represents one of the most critical therapies in immuno-oncology,' said Erez Israeli, CEO of Dr. Reddy' Reddy's Laboratories shares ended Thursday's session higher by 3% at Rs 1,289.90 on BSE.
Business Wire
05-06-2025
- Business
- Business Wire
Alvotech and Dr. Reddy's Enter into Collaboration to Co-Develop Biosimilar Candidate to Keytruda® (pembrolizumab)
HYDERABAD, India & REYKJAVIK, Iceland--(BUSINESS WIRE)--Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide ('Alvotech'), and Dr. Reddy's Laboratories Ltd., (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY, along with its subsidiaries hereafter referred to as 'Dr. Reddy's'), today announced that the companies have entered into a collaboration and license agreement to co-develop, manufacture and commercialize a biosimilar candidate to Keytruda® (pembrolizumab) for global markets. Keytruda® (pembrolizumab) is indicated for the treatment of numerous cancer types. In 2024, worldwide sales of Keytruda were US$29.5 billion [1]. The collaboration combines Dr. Reddy's and Alvotech's proven capabilities in biosimilars, thereby, speeding up the development process and extending the global reach for this biosimilar candidate. Under the terms of the agreement, the parties will be jointly responsible for developing and manufacturing the biosimilar candidate and sharing costs and responsibilities. Subject to certain exceptions, each party will have the right to commercialize the product globally. 'We are very pleased to enter into this collaboration for pembrolizumab with Dr. Reddy's. This agreement demonstrates Alvotech's ability to leverage its dedicated R&D and manufacturing platform for biosimilars, accelerating the expansion of our pipeline by pursuing growing global markets. It further enables us to increase the availability of cost-effective, critical biologic medications to patients world-wide,' said Róbert Wessman, chairman and CEO of Alvotech. "We are happy to collaborate with Alvotech for the pembrolizumab biosimilar. This demonstrates our ability to develop and manufacture high quality and affordable treatment options for patients worldwide. Additionally, oncology has been a top focus therapy area for us and this collaboration will further enhance our capabilities in oncology, as pembrolizumab currently represents one of the most critical therapies in immuno-oncology,' said Erez Israeli, CEO of Dr. Reddy's. Use of trademarks Keytruda® is a registered trademark of Merck Sharp & Dohme Corp. Sources [1] About Alvotech Alvotech is a biotech company, founded by Róbert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech's commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy's (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit None of the information on the Alvotech website shall be deemed part of this press release. For more information visit Alvotech's investor portal, and website or follow Alvotech on social media on LinkedIn, Facebook, Instagram, and YouTube. Alvotech Forward Looking Statements Certain statements in this communication may be considered 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements generally relate to future events or the future financial operating performance of Alvotech and may include, for example, Alvotech's expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, and market launches. In some cases, you can identify forward-looking statements by terminology such as 'may', 'should', 'expect', 'intend', 'will', 'estimate', 'anticipate', 'believe', 'predict', 'potential', 'aim' or 'continue', or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech's control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the ability to develop or co-develop future products, including the proposed biosimilar to Keytruda®; (2) the ability to maintain stock exchange listing standards; (3) changes in applicable laws or regulations; (4) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (5) Alvotech's estimates of expenses and profitability; (6) Alvotech's ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (7) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (8) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (9) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (10) the ability of Alvotech or its partners to gain approval from regulators for planned clinical studies, study plans or sites; (11) the ability of Alvotech's partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (12) Alvotech's ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (13) the success of Alvotech's current and future collaborations, joint ventures, partnerships or licensing arrangements; (14) Alvotech's ability, and that of its commercial partners, to execute their commercialization strategy for approved products; (15) Alvotech's ability to manufacture sufficient commercial supply of its approved products; (16) the outcome of ongoing and future litigation regarding Alvotech's products and product candidates; (17) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, conflicts in Ukraine, the Middle East and other global geopolitical tension, on the Company's business, financial position, strategy and anticipated milestones; and (18) other risks and uncertainties set forth in the sections entitled 'Risk Factors' and 'Cautionary Note Regarding Forward-Looking Statements' in documents that Alvotech may from time to time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. The recipient agrees that it shall not seek to sue or otherwise hold Alvotech or any of its directors, officers, employees, affiliates, agents, advisors, or representatives liable in any respect for the provision of this communication, the information contained in this communication, or the omission of any information from this communication. About Dr. Reddy's Laboratories Ltd: 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 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. Over the last 25 years, our Biologics team has developed into a fully integrated organization with robust capabilities in the development, manufacture and commercialization of a range of biosimilar products in oncology and immunology. We have a current portfolio of six commercial products marketed in India, with some products marketed in more than 30 other countries. In addition, we have several products in the pipeline in oncology and auto-immune diseases in various stages of development for global launches across developed as well as emerging markets. We are also ramping up manufacturing capacity to support our global expansion plans. In 2024, we launched our first biosimilar in the United Kingdom, Versavo® (biosimilar bevacizumab). This follows our launch of pegfilgrastim in the U.S and Europe through our partner. Our biosimilars business has a key role to play in driving both near-term and long-term growth. For more information, log on to: Dr. Reddy's 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, 2024. The company assumes no obligation to update any information contained herein. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product's label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products.
