Cosibelimab-ipdl

MUMBAI, India and PRINCETON, N.J., May 30, 2025 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or associated companies, "Sun Pharma")) today announced the successful completion of its acquisition of Checkpoint Therapeutics, Inc. ("Checkpoint"), an immunotherapy and targeted oncology company. As part of the acquisition, Sun Pharma acquires UNLOXCYT™, the first and only FDA-approved anti-PD-L1 treatment for advanced cutaneous squamous cell carcinoma. "This acquisition exemplifies Sun Pharma's commitment to supporting patients and growing its innovative therapies business," said Dilip Shanghvi, Chairman & Managing Director of Sun Pharma. "By adding UNLOXCYT™, we will be able to leverage our leadership in the onco-derm space to help patients access an important treatment option while growing our product portfolio." Financial Terms Sun Pharma has acquired all outstanding shares of Checkpoint at a price of $4.10 per share in cash, without interest, plus one non-tradable contingent value right (CVR) per share representing the right to receive up to an additional $0.70 in cash, without interest, if certain specified milestones are met, as set out in the terms and conditions of the contingent value rights agreement. About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050) Sun Pharma is the world's leading specialty generics company with a presence in specialty, generics and consumer healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the U.S. as well as global emerging markets. Sun Pharma's high-growth global specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multicultural workforce drawn from over 50 nations. For further information, please visit and follow us on LinkedIn & X (Formerly Twitter). About Cutaneous Squamous Cell Carcinoma Cutaneous squamous cell carcinoma ("cSCC") is the second-most common type of skin cancer in the United States, with an estimated annual incidence of approximately 1.8 million cases according to the Skin Cancer Foundation. Important risk factors for cSCC include chronic ultraviolet exposure and immunosuppressive conditions. While most cases are localized tumors amenable to curative resection, each year approximately 40,000 cases become advanced and an estimated 15,000 people in the United States die from this disease. In addition to being a life-threatening disease, cSCC causes significant functional morbidities and cosmetic deformities due to tumors that commonly arise in the head and neck region, and that invade blood vessels, nerves and vital organs, such as the eye or ear. UNLOXCYT™ INDICATION and IMPORANT SAFETY INFORMATION INDICATION UNLOXCYT™ (cosibelimab-ipdl) is indicated for the treatment of adults with metastatic cSCC or locally advanced cSCC who are not candidates for curative surgery or curative radiation. IMPORTANT SAFETY INFORMATION Severe and Fatal Immune-Mediated Adverse Reactions Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions. Immune-mediated adverse reactions, which can be severe or fatal, can occur in any organ system or tissue, and occur at any time after starting a PD-1/PD-L1 blocking antibody, including UNLOXCYT™. While immune-mediated adverse reactions usually manifest during treatment, they can also manifest after discontinuation of PD-1/PD-L1–blocking antibodies. Immune-mediated adverse reactions affecting more than one body system can occur simultaneously. Monitor closely for signs and symptoms of immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function tests at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue UNLOXCYT™ depending on the severity of the adverse reaction (see Dosage and Administration in Prescribing Information). In general, if UNLOXCYT™ requires interruption or discontinuation, administer systemic corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reaction is not controlled with corticosteroids. Immune-Mediated Pneumonitis UNLOXCYT™ can cause immune-mediated pneumonitis. In patients treated with other PD-1/PD-L1 blocking antibody, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 1% (3/223, Grade 2) of patients receiving UNLOXCYT™. Immune-Mediated Colitis UNLOXCYT™ can cause immune-mediated colitis, which may present with diarrhea, abdominal pain, and lower gastrointestinal bleeding. Cytomegalovirus infection/reactivation has occurred in patients with corticosteroid-refractory immune-mediated colitis treated with PD-1/PD-L1–blocking antibodies. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 0.4% (1/223, Grade 1) of patients receiving UNLOXCYT™. Immune-Mediated Hepatitis UNLOXCYT™ can cause immune-mediated hepatitis. Immune-Mediated Endocrinopathies Adrenal Insufficiency UNLOXCYT™ can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment per institutional guidelines, including hormone replacement as clinically indicated. Withhold or permanently discontinue UNLOXCYT™ depending on severity. Adrenal insufficiency occurred in 0.9% (2/223) of patients receiving UNLOXCYT™, including Grade 2 in 0.4% (1/223) of patients. Hypophysitis UNLOXCYT™ can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as clinically indicated. Withhold or permanently discontinue UNLOXCYT™ depending on severity. Thyroid Disorders UNLOXCYT™ can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement or medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue UNLOXCYT™ depending on severity. Hypothyroidism occurred in 10% (22/223) of patients receiving UNLOXCYT™, including Grade 2 in 5% (10/223) of patients. Hyperthyroidism occurred in 5% (12/223) of patients receiving UNLOXCYT™, including Grade 2 in 0.4% (1/223) of patients. Type 1 Diabetes Mellitus, Which Can Present with Diabetic Ketoacidosis UNLOXCYT™ can cause type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold or permanently discontinue UNLOXCYT™ depending on severity. Immune-Mediated Nephritis with Renal Dysfunction UNLOXCYT™ can cause immune-mediated nephritis. Immune-Mediated Dermatologic Adverse Reactions UNLOXCYT™ can cause immune-mediated rash or dermatitis. Bullous and exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS), have occurred with PD-1/PD-L1 blocking antibody. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/exfoliative rashes. Withhold or permanently discontinue UNLOXCYT™ depending on severity. Immune-mediated dermatologic adverse reactions occurred in 7% (15/223) of patients receiving UNLOXCYT™, including Grade 3 in 0.9% (2/223) of patients and Grade 2 in 4% (9/223) of patients. Other Immune-Mediated Adverse Reactions The following clinically significant immune-mediated adverse reactions occurred in <1% of the 223 patients who received UNLOXCYT™ or were reported with the use of other PD-1/PD-L1 blocking antibody. Severe or fatal cases have been reported for some of these adverse reactions. Cardiac/Vascular: Myocarditis, pericarditis, vasculitis. Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy. Ocular: Uveitis, iritis, other ocular inflammatory toxicities. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss. Gastrointestinal: Pancreatitis, including increases in serum amylase and lipase levels, gastritis, duodenitis. Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica. Endocrine: Hypoparathyroidism. Other (Hematologic/Immune): Autoimmune hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection. Infusion-Related Reactions UNLOXCYT™ can cause severe or life-threatening infusion-related reactions. Infusion-related infusion reactions were reported in 11% (24/223) of patients, including Grade 2 in 5.8% (13/223) of patients receiving UNLOXCYT™. Monitor patients for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion or permanently discontinue UNLOXCYT™ based on severity of reaction. Consider premedication with an antipyretic and/or an antihistamine for patients who have had previous systemic reactions to infusions of therapeutic proteins. Complications of Allogeneic HSCT Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1 blocking antibody prior to or after an allogeneic HSCT. Embryo-Fetal Toxicity Based on its mechanism of action, UNLOXCYT™ can cause fetal harm when administered to a pregnant woman. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus, resulting in fetal death. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with UNLOXCYT™ and for 4 months after the last dose. Common Adverse Reactions The most common adverse reactions (≥10%) were fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection. Please see full Prescribing Information. Sun Pharma Contacts: Investors Dr. Abhishek Sharma +91 22 4324 2929 [email protected] Media (Global) Gaurav Chugh +91 22 4324 5373 [email protected] Media (USA) James Freeman +1 978-808-6956 [email protected] SOURCE Sun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

New Delhi: What distinguishes India’s largest drug manufacturer, Sun Pharma , among its domestic peers might work against the company's future growth ambitions, on account of a new pricing model announced by the US President earlier this month. Speaking at a webinar hosted by ET Pharma over the new Most-Favoured Nation (MFN) pricing model, a market analyst voiced that while the Indian Pharma industry stands immune with generics, Sun Pharma, which has made specialty novel drugs as its key focus, might encounter some bumps on its future ambition track. “The proposed model is meant to play on the price differentiation of drugs and if it gets implemented it is going to be disruptive for the innovator pharma industry and cutting down prices by up to 50-60 per cent might push innovators into losses," said Vishal Mabchanda, a pharma analyst at Systematix Group. “Among the Indian companies, Sun Pharma that have an innovative portfolio, stands to get impacted," he added. According to an price differential analysis undertaken by the US department of Health and Human Services, using 2022 data, “US prices were closer to those in other countries—at 173 and 213 percent of international prices—when applying the overall and retail-dispensed, and for only brand-name drugs, US prices stands 308 per cent of prices in other countries.” However, at Sun Pharma's last earnings call for Q4 FY25, the company Chairman and MD, Dilip Shanghvi said that, “currently the order is at a voluntarily level and we have wait for greater clarity on this.” At the webinar, Nishith Sanghvi, Director, Corporates at India Ratings, also underlined that, the channels which procure drugs in US plays a major role in deciding the prices and notably, while announcing the order US President Donald Trump specifically voiced that the administration wants to remove the middle-men from the distribution chains. “The Secretary of Health and Human Services will establish a mechanism through which American patients can buy their drugs directly from manufacturers who sell to Americans at a “Most-Favored-Nation” price, bypassing middlemen,” the Factsheet on the order issued from the Whitehouse suggests. “When the order was announced, the market reaction reflected that the proposed order is highly unlikely to be implemented in its initial proposed format and it will likely be in a more diluted form,” Manchanda noted. Besides this, the chance of a legal challenge is always there on the horizon as seen in the past during Trump's first term-though the order was restricted to the government-funded Medicare program. Following the Ranbaxy fiasco, what is often described as Sun Pharma’s 'second stint' saw the Indian drugmaker shift its focus from the traditional generics ANDA pathway to novel innovations in specialty therapeutic segments. Over the last few years, driven by in-licensing agreements and in-house capabilities, the company has established a solid foundation in this segment. In the latest concluded quarter ended March this year, while the company reported a 19 per cent year-on-year (YoY) decline in its net profit , the global specialty sales went up by 8.6 per cent to $295 million (around ₹2,500 crore)--accounting for 19.9 per cent of the total quarterly sales. Moreover, for the full fiscal period, the specialty portfolio accounted for 19.7 per cent of the total global sales and generated $1,216 million (around ₹10,330 crore), up by 17.1 per cent against the previous fiscal. Expanding its specialty portfolio, the drugmaker is looking to launch two of its approved pipeline candidates--Leqselvi and Unloxcyt---in the near future. Leqselvi , a JAK 1/2 inhibitor was approved by the FDA in July 2024 for treatment of adults with severe alopecia areata (a type of hair loss). The company's plans were mired by a court ruling which blocked the drug launch in November 2024, but in April this year the US Court of Appeals for the Federal Circuit lifted the preliminary injunction and cleared its market entry. According to experts, “Sun Pharma’s Leqselvi higher dose of 8 mg twice daily, positions it in a stronger position as the higher dose will have a slightly better efficacy in comparison to Eli Lilly’s Olumiant which is taken at 2mg or 4mg per day for severe alopecia areata treatment.” A market assessment report published by GlobalData expects that, “total sales of Leqselvi is expected to reach $698.3 million (around ₹5,930 crore) in the US by 2033, accounting for approximately 35 per cent of the anticipated $2 billion (₹1,7000 crore) market for alopecia areata therapies in the country. Besides this, in March this year, the Indian drugmaker acquired a US-based immunotherapy and targeted oncology company, Checkpoint Therapeutics , with an upfront payment of up to $355 million (around ₹3000 crore). Unloxcyt (cosibelimab-ipdl) has received approval from the USFDA for the treatment of adults with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or curative radiation. Industry experts suggest that in the US, Onco-derma drugs have the highest profit margin among all therapeutic segments. Announcing, the company's Q4 FY25 results, Dilip Shanghvi said that, "The near-term pipeline in Global Specialty is promising, with products such as Leqselvi and Unloxcyt—the latter through our recently announced Checkpoint acquisition—offering significant improvements in patient care and we look forward to specialty drugs becoming an increasingly important part of our business." For FY25, the company's total revenue of ₹52,578 crore and the R&D spent (largely aligned for specialty projects) stands at ₹3,248 crore–accounting for nearly 6.2 per cent of total sales. While the administration is yet to convey the price targets, the recent developments reflect that with a majority in both houses and the commendation on the executive machinery, there is no holding back on the part of US. For the Indian drugmaker, identified with the unpredictable strategy of turning niche gaps into million-dollar bets, the road ahead may soon be shaped by equally unconventional policies and mounting unpredictability. By Abhijeet Singh ,