Zydus Lifesciences Ltd.

Lipid nanoparticles (LNPs) have become a powerful tool for delivering drugs and genes. This technology has been instrumental in the development of various cancer treatments and vaccines, including those for COVID-19. LNPs are also being explored for use in vaccines against other infectious diseases, demonstrating their broad potential in improving human health. Lipid nanoparticles (LNPs) are being investigated as a game-changer in drug delivery for a wide range of pharmaceuticals, from tiny molecules to complex biologicals. The key advantage lies in their ability to overcome challenges faced by traditional drug delivery methods. This makes some of us ask this question - what are Lipid nanoparticles? What are Lipid nanoparticles? Lipid nanoparticles (LNPs) are microscopic spheres of fatty molecules (lipids). They act as Trojan horses, carrying drugs or genetic material like messenger RNA (mRNA) inside them. LNPs are a promising tool in medicine because they can address some of the challenges medications face when entering the body. LNPs are typically between 10 and 1000 nanometers in diameter. A nanometer is one-billionth of a meter. LNPs are made of various lipids, including cholesterol, phospholipids, and ionizable lipids. These lipids help to stabilize the LNP and allow it to fuse with cells. What are the different types of the lipid nanoparticles market Liquid Lipid-Core LNP, Solid Lipid-Core LNP (Solid Lipid Nanoparticle), Nanostructured Lipid Carrier (NLC), Hollow LNPs are types of the lipid nanoparticles. There are also other emerging LNP types, such as liposomes (early versions of LNPs) and some hybrid variations. These may be used for specific applications or offer unique properties. This is the largest segment and focuses on LNPs used to deliver drugs for various diseases like cancer, infectious diseases, and others. Explore the Demo Study @ 1.Liquid Lipid-Core LNP Liquid Lipid-Core LNPs have a core composed of liquid lipids. This liquid can be arranged in various structures, including liquid crystalline phases. The shape and structure of lipid nanoparticles (LNPs) depend on the ingredients used and how they're made. Traditionally, scientists create LNPs by mixing water and oil solutions with a helper molecule (surfactant) using machines like high-pressure homogenizers or sound waves (ultrasonication). Alternatively, they can use solvents to separate and then combine the components 2. Solid Lipid-Core LNP These LNPs have a solid lipid core that can encapsulate both hydrophilic (water-loving) and hydrophobic (water-fearing) drugs. They offer good stability and controlled release properties but may have limitations in drug loading capacity. 3.Nanostructured Lipid Carrier (NLC) NLCs have a core matrix made from a blend of solid and liquid lipids, rather than just solid lipids like in SLNs. This unique structure offers some advantages. NLCs potentially hold more medication compared to SLNs due to the presence of liquid lipids. Additionally, the ability to control the ratio of solid and liquid lipids allows researchers to tailor NLCs for controlled drug release or targeting specific tissues. Read our related market research report’s key insights: Lipid Nanoparticles (LNPs) CDMO Market Lipid Nanoparticle Raw Materials Market Lipid-Nanoparticle Based Genomic Medicines Market Liposomal and Lipid Nanoparticle Drug Delivery Systems Market Nanoparticle Formulation Market mRNA Treatment Market So, what are the market dynamics of the lipid nanoparticles industry? Key Market Driving Factors: Advancements in Drug Delivery Technology Growing Demand for Innovative Therapeutics Rising Investment in R&D Success of LNP-based Therapies Focus on Addressing Challenges COVID-19 Vaccine Development Increasing Prevalence of Chronic Diseases Biocompatibility and Safety Patent Expirations and Generic Drugs Rising Healthcare Expenditure Market Restraints: High Production Costs Complex Formulation Process Limited Expertise and Technical Knowledge Stability and Shelf-life Concerns Competition from Alternative Technologies Trends: Expansion of mRNA-Based Therapeutics Gene Editing and Gene Therapy Targeted Drug Delivery Biodegradable and Sustainable LNPs The lipid nanoparticles sector is highly specialized, competitive and rapidly growing. Johnson & Johnson, Sun Pharmaceutical, CSPC, Teva, Fudan-Zhangjiang, Zydus Cadila, TTY Biopharma, Pacira, Luye Pharma, Echelon Biosciences, BroadPharm, Biopharma PEG Scientific Inc., NOF AMERICA CORPORATION, CordenPharma, International, Merck KGaA, Avanti Polar Lipids, Tebubio, Creative Biolabs are some of the prominent players in the industry. This can be attributed to the effectiveness of lipid nanoparticles in cancer treatment and the commercial success of recently developed screening tool for evaluating mRNA enclosed in lipid nanoparticle. In February 2024, University of Pennsylvania researchers in the United States have developed a unique high-throughput screening tool designed for evaluating mRNA enclosed in lipid nanoparticles. With the help of this cutting-edge platform, large libraries of LNPs intended for brain targeting may be quickly screened. Its application accelerates the development of gene editing treatments by assessing and fine-tuning LNPs meant for brain delivery. Similarly, in July 2023, a formulation technique from Cytiva has been made available to enable the seamless production of lipid nanoparticle medications at both the clinical and commercial stages. By streamlining the procedure, this method makes it possible to produce lipid nanoparticle-based drugs effectively and completely, from development to commercialization. Call: North America +1 551 226 6109 Email: diana.dsouza@insightaceanalytics.com

MIAMI, July 05, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO; FBIOP) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, today announced that its Board of Directors has paused the payment of dividends on the Company’s 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock (the “Series A Preferred Stock”) until further notice. In accordance with the terms of the Series A Preferred Stock, dividends on the Series A Preferred Stock will continue to accrue and cumulate until such dividends are authorized or declared. The Company will begin accruing the dividend as of July 1, 2024, and no dividend payment will be issued on July 31, 2024. The Company believes pausing the dividend is in the best interest of the Company and its stakeholders to maintain financial flexibility ahead of potentially significant inflection points. The pausing of these dividends will defer approximately $0.7 million in cash dividend payments each month. The Board intends to revisit its decision regarding the monthly dividend regularly and will assess the profitability and cash flow of the Company to determine whether and when the suspension should be lifted. The Series A Preferred Stock trades on the Nasdaq Capital Market under the “FBIOP” stock ticker symbol. Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “Across our portfolio, we could receive up to three regulatory approvals on NDAs and BLAs in the next 12 months for DFD-29, cosibelimab and CUTX-101, and potentially a fourth BLA filing as early as 2025 for CAEL-101. Based on its public statements, AstraZeneca has estimated that it expects the FDA to accept its BLA submission of CAEL-101 to treat AL amyloidosis for review as early as 2025, which could lead to approval and commercial milestone payments to Fortress. Additionally, Cyprium Therapeutics, our subsidiary company that developed CUTX-101, will retain 100% ownership over any priority review voucher that may be issued at NDA approval for CUTX-101. This is a pivotal time for the Company, and we are pausing the preferred dividend payments in order to maintain financial flexibility ahead of our multiple potential near-term milestones.” About Fortress Biotech Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue. The company has seven marketed prescription pharmaceutical products and over 20 programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Fortress’ portfolio is being commercialized and developed for various therapeutic areas including oncology, dermatology, and rare diseases. Fortress’ model is focused on leveraging its significant biopharmaceutical industry expertise and network to further expand and advance the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including AstraZeneca, City of Hope, Fred Hutchinson Cancer Center, Nationwide Children’s Hospital and Sentynl. For more information, visit www.fortressbiotech.com. Forward-Looking StatementsStatements in this press release that are not descriptions of historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. The words “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “might,” “plans,” “potential,” “predicts,” “should,” or “will” or the negative of these terms or other comparable terminology are generally intended to identify forward-looking statements. These forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include risks relating to: our growth strategy, financing and strategic agreements and relationships; the ongoing UTRF litigation and our indemnification of Caelum in connection therewith; our need for substantial additional funds and uncertainties relating to financings; our ability to identify, acquire, close and integrate product candidates successfully and on a timely basis; our ability to attract, integrate and retain key personnel; the early stage of products under development; the results of research and development activities; uncertainties relating to preclinical and clinical testing; uncertainties related to the timing and likelihood of a BLA being submitted for CAEL-101; our ability to obtain regulatory approval for products under development, including for DFD-29, cosibelimab and CUTX-101, for which submissions are pending; our ability to successfully commercialize products for which we receive regulatory approval; uncertainties related to the granting of any priority review voucher for CUTX-101; our ability to secure and maintain third-party manufacturing, marketing and distribution of our and our partner companies’ products and product candidates; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein. Company Contact:Jaclyn JaffeFortress Biotech, Inc.(781) 652-4500ir@fortressbiotech.com Media Relations Contact:Tony Plohoros6 Degrees(908) 591-2839tplohoros@6degreespr.com

Pertuzumab biosimilar developed by Zydus is a critical treatment for HER2 positive breast cancer and is being launched jointly by Zydus and Dr. Reddy’s in India The product will be marketed by Zydus under the brand name Sigrima ™ while Dr. Reddy’s will market it under the brand name Womab ® . AHMEDABAD & HYDERABAD, India I June 28, 2024 I Zydus Lifesciences Limited (including its subsidiaries/affiliates hereafter referred to as “Zydus”) a discovery-driven global lifesciences company 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”), a global pharmaceutical company, announced the execution of a licensing agreement to co-market Pertuzumab biosimilar in India. Pertuzumab is a critical treatment for HER2 positive breast cancer patients. The biosimilar has been developed in-house by the research team at the Zydus Research Centre (ZRC). Under the terms of this agreement, Dr. Reddy’s will receive semi-exclusive rights from Zydus to co-market the product in India. The product will be marketed by Zydus under the brand name Sigrima™. Dr. Reddy’s will market it under the brand name Womab®. Zydus will receive upfront licensing income and is eligible to receive milestone income based on achievement of pre-defined milestones. Speaking on the development, spokesperson from Zydus Lifesciences Ltd., said, “Our basket of cancer care therapies which includes cytotoxic, supportive and targeted drugs, has had a significant impact on patient survival and the quality of life. We are committed to providing comprehensive care for HER2-positive patients and with the launch of this critical drug, we will be offering all the three essential drugs, SigrimaTM, Pertuzumab biosimilar, VivitraTM the largest selling trastuzumab biosimilar and UjviraTM the world’s first antibody drug conjugate biosimilar of trastuzumab emtansine. Together, these treatments represent a significant advancement in HER2-targeted therapy. We are pleased to join hands with Dr. Reddy’s to expand the access to this novel medicine.” Spokesperson from Dr. Reddy’s, said, “Oncology is a key therapy area for us, and we are working to offer a diverse portfolio of offerings from standard of care, innovations in formulations, access to novel medicines and beyond-the-pill initiatives. We are happy to collaborate with Zydus to make this breast cancer drug available to patients in India. HER2 positive breast cancer patients require access to a combination of Trastuzumab and Pertuzumab, along with chemotherapy. We already offer biosimilar Trastuzumab (Hervycta®). With this product, we will be able to provide the complete standard of care to HER2 positive breast cancer patients in India.” Human epidermal growth factor 2 (HER2) is a protein that makes cells grow and divide. Some cancers have large amounts of HER2 protein and are known as HER2-positive cancers. These cancers tend to spread fast if not treated optimally. There is an estimate of over 2,30,000 new cases of breast cancer in 2025 and around 25% of these can be HER2-positive. Pertuzumab is an anti-HER2 monoclonal antibody (mAB) and it works by locking onto HER2 on the cancer cells, supressing HER2-mediated cell proliferation. Pertuzumab is recommended for both early and late stage HER2-positive breast cancers in combination with other drugs such as trastuzumab and chemotherapy. Its addition helps in different ways like shrinking the cancerous tumour, making the surgery less extensive, conserving the breast tissue, delaying the cancer coming back, halting the cancer spread, increasing the lifespan etc. Every HER2 positive patient needs to have access to combination of Trastuzumab and Pertuzumab, however, less than 5% patients have access to the same.1 With the launch of Pertuzumab in India, many more patients in need can benefit from the access to combination therapy. Appendix: 1. Breast cancer incidence: https://acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.35188#:~:text=Breast%20cancer%20is%20the%20most%20common%20cancer%20in%20India%2C%20accounting,estimated%20216%2C108%20cases%20by%202022.&text=The%20age%2Dstandardized%20incidence%20rate,over%20the%20past%2026%20years Breast cancer is the most common cancer in India, accounting for 28.2% of all female cancers, with an estimated 216,108 cases by 2022 HER2 positive: https://www.nature.com/articles/s41598-020-62618-3 Hormone receptor positive/HER2 negative, triple negative (TNBC) and hormone receptor any/HER2 positive cases were 55.2%, 24.2% and 20.6%, respectively. Access of Pertuzumab today: IPSOS Dec’23 Data About Zydus: Zydus Lifesciences Ltd. with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs 26,000 people worldwide, including 1,400 scientists engaged in R & D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. Zydus has been actively discovering and developing New Chemical Entities (NCEs) novel biologicals, several biosimilars and vaccines as a part of its innovation pipeline. Over the last decade, Zydus has introduced several innovative, first-in-class products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars. The group aspires to transform lives through path-breaking discoveries. For more details visit www.zyduslife.com 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. For more information, log on to: www.drreddys.com . SOURCE: Dr. Reddy’s