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Dr. Reddy's Laboratories Limited (RDY) is a leading multinational pharmaceutical company headquartered in Hyderabad, Telangana, India. Founded by Kallam Anji Reddy, the company has grown to become one of the largest generic drug manufacturers globally. Dr. Reddy's offers a diverse product portfolio that includes not only generic medications but also injectables and active pharmaceutical ingredients (APIs).
Dr. Reddy's has a substantial footprint in North America, which accounts for approximately 50% of its generics sales. The company also serves markets in India (22% of generics sales), Russia (12%), and various European and Latin American countries. In North America, injectables constitute 25% of its sales, showcasing the company’s ability to innovate and meet various healthcare needs.
Within branded generic markets, particularly in India, Dr. Reddy's has secured a top-five position in critical therapeutic areas such as oncology and gastroenterology. The company’s strong brand reputation has empowered it to achieve significant success in these sectors.
Furthermore, Dr. Reddy's operates a robust API business, manufacturing over 150 APIs and distributing them in more than 75 countries worldwide. This extensive network highlights the company's commitment to quality and global health.
Dr. Reddy's continues to advance its mission through ongoing projects and innovations. Recent achievements, partnerships, and financial health indicators demonstrate a stable and growing enterprise. Investors keen to stay informed about the latest developments in Dr. Reddy's Laboratories can find up-to-date news from various sources, ensuring they remain well-informed on company performance and growth trajectories.
Coya Therapeutics (Nasdaq: COYA) reported its fiscal year 2022 results, highlighting key developments in its drug pipeline. The company achieved positive results in a clinical study of COYA 302 for ALS, showing halted disease progression over 6 months. Coya also entered into a worldwide agreement with Dr. Reddy's Laboratories (NYSE: RDY) to out-license its COYA 301 product candidate.
The company raised approximately $16.4 million from its IPO in January 2023, with cash and equivalents of $5.9 million as of December 31, 2022. However, Coya reported a net loss of $12.2 million for 2022, attributed to increased R&D and administrative expenses.
Coya Therapeutics, Inc. (NASDAQ: COYA) has entered into a worldwide agreement with Dr. Reddy’s Laboratories (NYSE: RDY) to develop COYA 302, an investigational combination biologic for neurodegenerative diseases. This product consists of COYA 301 and CTLA4-Ig (Abatacept), targeting chronic inflammation. Coya retains exclusive rights for commercialization in North America, Europe, and Japan, while Dr. Reddy’s can commercialize outside these territories. Coya plans to file an IND in the second half of 2023, aiming for a phase 1b/2 trial in Amyotrophic Lateral Sclerosis (ALS) shortly thereafter. The partnership is expected to enhance Coya’s development efforts.
Dr. Reddy's Laboratories SA, a wholly-owned subsidiary of Dr. Reddy's Laboratories Ltd., has signed a definitive agreement to acquire the U.S. generic prescription product portfolio from Mayne Pharma Group Limited for approximately $90 million in cash. The portfolio includes 45 commercial products, 4 pipeline products, and 40 approved non-marketed products, with a total revenue of $111 million reported for the last financial year. This acquisition aims to enhance Dr. Reddy’s presence in the women’s health market and accelerate access to affordable medications.
Dr. Reddy's Laboratories has launched a therapeutic generic version of Durezol® (Difluprednate Ophthalmic Emulsion 0.05%) in the U.S. market, following FDA approval. This product is aimed at enhancing the accessibility of ophthalmic treatments. The brand and generic had U.S. sales of approximately $40 million for the twelve months ending November 2022, according to IQVIA. Dr. Reddy's Difluprednate is available in 5 ml bottles, packaged in lots of 24. The company continues to emphasize its commitment to providing affordable healthcare solutions.
Dr. Reddy’s Laboratories (NYSE: RDY) announced the successful completion of clinical studies for its proposed rituximab biosimilar candidate, DRL_RI. This milestone paves the way for filing applications in the United States, European Union, and other highly regulated markets. The biosimilar is targeting various conditions, including rheumatoid arthritis and non-Hodgkin's lymphoma. DRL_RI has already received marketing approval in India and over 25 emerging markets. The company aims to commercialize the product in the U.S. through collaboration with Fresenius Kabi while pursuing direct commercialization in Europe and beyond.
Dr. Reddy’s has achieved a significant milestone with its tocilizumab biosimilar candidate, DRL_TC, demonstrating pharmacokinetic equivalence in a Phase 1 study. The trial confirmed safety, immunogenicity, and pharmacodynamic similarity to EU and U.S. reference products. Following this success, Dr. Reddy’s is initiating a global Phase 3 study to further evaluate DRL_TC's efficacy in patients with moderate to severe active rheumatoid arthritis. The company aims to improve accessibility to high-quality biosimilar treatments for patients worldwide.
Dr. Reddy’s Laboratories announced the recognition of its largest manufacturing facility in Bachupally, Hyderabad, as part of the Global Lighthouse Network by the World Economic Forum. This achievement follows a four-year digitization journey and the launch of Project 'OpsNext,' which implemented six Industry 4.0 technologies. The facility has reported significant improvements, including 43% manufacturing cost reduction, 30% decrease in production lead time, and 41% reduction in energy consumption. Dr. Reddy's aims to enhance operational efficiency and meet ambitious ESG goals by 2030.
Dr. Reddy’s Laboratories has launched Lenalidomide Capsules, a generic version of REVLIMID®, in the U.S. Approved by the USFDA, this launch grants the company 180-day exclusivity for 2.5 mg and 20 mg strengths. The launch supports greater patient access and follows a settlement with Celgene, allowing Dr. Reddy’s to market limited amounts of the drug until January 31, 2026, when the volume limitation will be lifted. The capsules are available in various strengths, catering to diverse patient needs.
Dr. Reddy's Laboratories has announced a licensing agreement with Slayback Pharma for Brimonidine Tartrate Ophthalmic Solution 0.025%, an OTC eye drop designed to relieve redness. This agreement grants Dr. Reddy's exclusive rights outside the U.S. and positions them to enter a market valued at approximately $130 million as of June 2022. Slayback's ANDA for the product is currently under U.S. FDA review, marking a significant addition to Dr. Reddy's growing OTC eyecare portfolio.
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