Latest news with #Sovateltide
Yahoo
a day ago
- Business
- Yahoo
Pharmazz Inc. Secures $25 Million Strategic Equity Investment from Sun Pharmaceutical Industries Ltd.
Funding supports pivotal Phase 3 trial for sovateltide, a potential first-in-class therapy that could transform the treatment of acute cerebral ischemic stroke WILLOWBROOK, Ill., June 11, 2025 (GLOBE NEWSWIRE) -- Pharmazz, Inc. ("Pharmazz" or the "Company"), a late-stage biopharmaceutical company developing innovative therapies for unmet medical needs in critical care and neurology, has announced a $25 million equity investment from Sun Pharmaceutical Industries Limited (Reuters: Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries and/or associate companies), one of the world's leading pharmaceutical companies. This strategic investment brings Sun Pharma's total commitment in Pharmazz to $40 million (including a previous $15 million equity investment). 'We believe sovateltide has the potential to redefine the treatment of ischemic stroke, which has not seen a new FDA approved non-thrombolytic therapy in over 30 years. This investment means we are now fully funded to complete our pivotal Phase 3 study and execute on our mission to make this first in class therapy available to stroke patients,' said Emeritus Prof. Anil Gulati, CEO and Founder of Pharmazz. 'We deeply value Sun Pharma's continued partnership, which strengthens our ability to bring our therapies to patients worldwide.' The new funding will provide Pharmazz with the capital required to complete the pivotal U.S. Phase 3 clinical trial of sovateltide (known as Tycamzzi® and Tyvalzi™ in international markets), its lead drug candidate for treating acute cerebral ischemic stroke. Dr. Neil Marwah, President of Pharmazz, added, 'This investment gives us the operational runway to execute a complex, multi-country clinical trial and scale the company responsibly as we prepare for a potential public offering. We are thrilled to strengthen our partnership with Sun Pharma, whose continued support reflects deep confidence in our platform and our ability to execute.' Phase 3 Trial of Sovateltide for Stroke Covered by Special Protocol Assessment Sovateltide is a first-in-class endothelin-B receptor agonist to treat acute cerebral ischemic stroke that can be administered up to 24 hours after the onset of symptoms. Pharmazz has received agreement from the US Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the study design and statistical analysis plan of its Phase 3 clinical trial of sovateltide for the treatment of acute cerebral ischemic stroke patients. Pharmazz is initiating the Phase 3 RESPECT-ETB ( ID: NCT05691244) trial at 65 sites in the US, Germany, Spain, and the UK, designed to enroll 514 stroke patients. The primary endpoint is the proportion of patients demonstrating functional independence post-stroke, defined as a modified Rankin Scale (mRS) score of 0–2 at 90 days after stroke onset. Commercially Approved in India: Early Validation from 60,000+ patients Sovateltide was approved in 2023 in India and marketed by Sun Pharma under the brand name Tyvalzi™, offering compelling proof of concept for global commercialization. In a randomized, placebo-controlled, multicenter clinical trial conducted in 158 cerebral ischemic stroke patients conducted in India, the product was shown to be well tolerated and effective in improving neurological outcomes when administered within 24 hours of stroke symptoms. Patients on Sovateltide were 22.7% more likely to achieve functional independence at 90 days (as measured by mRS score 0–2; p=0.0045) Sovateltide delivered a 17.1% higher rate of favorable National Institutes of Health Stroke Scale (NIHSS) scores (p=0.0024) The ordinal shift in mRS and NIHSS score between control and sovateltide groups was favorable towards sovateltide across the entire range. Results represent the first statistically significant clinical data in stroke in 30 years, since the introduction of alteplase (tPA) Over 60,000 patients treated to date since commercial launch in India Targeting a Multibillion-Dollar Market with a Broader Therapeutic Window Stroke remains one of the leading causes of disability and death globally, with over 7 million ischemic strokes annually. Today, fewer than 15% of patients receive approved interventions, largely due to their narrow treatment window and strict eligibility criteria. Sovateltide's 24-hour dosing window and broader eligibility could expand access—particularly for underserved populations—and position it as a major advance in acute stroke care. If successful in Phase 3 and subsequently approved, sovateltide has strong commercial potential and is expected to be a foundational product in the Pharmazz emerging neurology franchise. About Sovateltide Sovateltide is a first-in-class drug to treat acute cerebral ischemic stroke, a condition in which the loss of blood supply to the brain prevents brain tissue from receiving oxygen and nutrients, resulting in potential brain damage, neurological deficits, or death. Sovateltide is unique because its action site is the neural progenitor cells. Sovateltide promotes neurovascular remodeling by forming new neurons (neurogenesis) and blood vessels (angiogenesis). Sovateltide also protects neural mitochondria and enhances their biogenesis. About Pharmazz, Inc. Pharmazz is a privately held company developing novel products in critical care medicine. Pharmazz, Inc. obtained marketing authorization for two of its first-in-class drug molecules, centhaquine and sovateltide, for hypovolemic shock and ischemic stroke, respectively, in India. In addition, the US Food and Drug Administration (FDA) has approved two phase III INDs for centhaquine as an agent for hypovolemic shock and sovateltide for cerebral ischemic stroke. Additional information may be found on the Company's website, 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. and global emerging markets. Sun Pharma's high-growth global specialty portfolio spans innovative products in dermatology, ophthalmology, and oncodermatology 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 Disclaimer: Statements in this "Document" describing the Company's objectives, projections, estimates, expectations, plans or predictions, or industry conditions or events may be "forward-looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. Contacts: Pharmazz, Inc. Investors Kabir Marwah MediaShruti Gulati Tel +1 630 780 6087 Tel +1 630 780 6087 E mail E mail produjo un error al recuperar la información Inicia sesión para acceder a tu portafolio Se produjo un error al recuperar la información Se produjo un error al recuperar la información Se produjo un error al recuperar la información Se produjo un error al recuperar la información
Entrepreneur
24-05-2025
- Business
- Entrepreneur
Sun Pharma to Acquire 22.7% Stake in U.S.-Based Pharmazz Worth $25 Million
The investment includes a mix of fresh equity and the conversion of a prior investment made through a Simple Agreement for Future Equity (SAFE). The new capital will be deployed in two tranches—$10 million by May, 2025, and $15 million by November, 2025, or on another mutually agreed date You're reading Entrepreneur India, an international franchise of Entrepreneur Media. Sun Pharmaceutical Industries has signed a definitive agreement to invest up to $25 million in U.S.-based biopharmaceutical company Pharmazz Inc., according to a regulatory filing by the company. The transaction will result in Sun Pharma acquiring approximately 22.7 per cent equity in Pharmazz on a fully diluted basis. The investment includes a mix of fresh equity and the conversion of a prior investment made through a Simple Agreement for Future Equity (SAFE). The new capital will be deployed in two tranches—$10 million by May, 2025, and $15 million by November, 2025, or on another mutually agreed date. The deal values Pharmazz at $5.88925 per share, while the SAFE conversion is priced at a 20 per cent discount, at $4.7114 per share. This investment provides Sun Pharma with not only an equity stake but also a strategic position in Pharmazz's global commercialization plans. Sun has already secured exclusive rights to license and distribute Sovateltide in select emerging markets. Under the terms of the new agreement, Sun Pharma will also receive an option to negotiate licensing rights for Sovateltide in developed markets. Pharmazz is developing two key drug candidates—Sovateltide for acute cerebral ischemic stroke and Centhaquine for hypovolemic shock. Both therapies are already approved in India and are marketed through partners under the brand names Tyvalzi and Lyfaquin, respectively. The company recorded a consolidated turnover of $3 million in FY 2023-24. The U.S. Food and Drug Administration (FDA) has granted both of Pharmazz's lead candidates approval for Phase-3 Investigational New Drug (IND) trials. In a significant regulatory milestone, Sovateltide has also received a Special Protocol Assessment (SPA) from the FDA, which outlines a clear and mutually agreed pathway for clinical development and regulatory review in the U.S. Pharmazz plans to initiate global Phase-3 trials shortly, targeting potential approvals in the U.S. and other international markets. Sun Pharma clarified that the deal is not a related-party transaction and that neither its promoters nor the promoter group hold any interest in Pharmazz.
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Business Standard
23-05-2025
- Business
- Business Standard
Sun Pharma to invest $25 million in Pharmazz Inc; raises stake to 22.7%
Sun Pharmaceutical Industries Ltd on Friday announced it will invest up to $25 million in US-based Pharmazz Inc, increasing its total stake in the biopharmaceutical company to 22.7 per cent. The investment, priced at $5.88925 per share in cash, will also trigger the conversion of an earlier Simple Agreement for Future Equity (SAFE) investment at a 20 per cent discount, translating to a conversion price of $4.7114 per share, the company said in a stock exchange filing. Sun Pharma stated that $10 million from the fresh investment, along with $7.5 million from the second SAFE tranche, will be infused by or before May 31, 2025. The remaining $15 million is expected to be invested by or before November 30, 2025, or on another mutually agreed date. Both drugs have been approved in India and are marketed via partners under the brand names Tyvalzi (Sovateltide) and Lyfaquin (Centhaquine). Sun Pharma currently holds exclusive rights to license and distribute Sovateltide in select emerging markets. Following this latest investment, the company will also gain the option to negotiate licensing rights for Sovateltide in certain developed countries. Pharmazz has received US FDA approval to conduct Phase-3 Investigational New Drug (IND) trials for both drugs. Notably, Sovateltide has also secured a Special Protocol Assessment (SPA) from the FDA, outlining a defined regulatory pathway. The company plans to initiate global Phase-3 trials to pursue approvals in the US and other international markets.
Economic Times
23-05-2025
- Business
- Economic Times
Sun Pharma to invest $25 mn in Pharmazz Inc; raises stake to 22.7 pc
Sun Pharmaceutical Industries Ltd on Friday said it has entered into an agreement with US-based Pharmazz Inc to invest up to USD 25 million, resulting in increasing its stake in the company to 22.7 per cent. The investment triggers conversion of earlier investment through SAFE (simple agreement for future equity) resulting in aggregate stake of up to 22.7 per cent in Pharmazz on a fully diluted basis, the company said in a regulatory filing. ADVERTISEMENT The first tranche of USD 10 million, along with the balance of USD 7.5 million out of SAFE tranche 2 investment, will be invested on or before May 31, 2025. The second tranche of USD 15 million will be invested on or before November 30, 2025 or such other mutually agreed date, it added. Pharmazz Inc is a biopharmaceutical company, developing two leading drug candidates, Sovateltide for treatment of acute cerebral ischemic stroke and Centhaquine for treatment of hypovolemic shock. Both products are approved in India and marketed through partners under brands Tyvalzi (Sovateltide) and Lyfaquin (Centhaquine), and are being developed for USA and other markets, it added. Subsequent to the investment, Sun Pharma will receive an option to negotiate licensing of Sovateltide for marketing and distribution in certain developed market countries. The company has already received exclusive right to licence Sovateltide for marketing and distribution in certain emerging market countries, it added. (You can now subscribe to our Economic Times WhatsApp channel)
Time of India
23-05-2025
- Business
- Time of India
Sun Pharma to invest $25 mn in Pharmazz Inc; raises stake to 22.7 pc
Sun Pharmaceutical Industries Ltd on Friday said it has entered into an agreement with US-based Pharmazz Inc to invest up to USD 25 million, resulting in increasing its stake in the company to 22.7 per cent. The investment triggers conversion of earlier investment through SAFE (simple agreement for future equity) resulting in aggregate stake of up to 22.7 per cent in Pharmazz on a fully diluted basis, the company said in a regulatory filing. The first tranche of USD 10 million, along with the balance of USD 7.5 million out of SAFE tranche 2 investment, will be invested on or before May 31, 2025. The second tranche of USD 15 million will be invested on or before November 30, 2025 or such other mutually agreed date, it added. Pharmazz Inc is a biopharmaceutical company , developing two leading drug candidates , Sovateltide for treatment of acute cerebral ischemic stroke and Centhaquine for treatment of hypovolemic shock. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Ethiopia: Jewelry On Sale For Half Price! (See Price List) Luxury Jewelry | search ads Undo Both products are approved in India and marketed through partners under brands Tyvalzi (Sovateltide) and Lyfaquin (Centhaquine), and are being developed for USA and other markets, it added. Subsequent to the investment, Sun Pharma will receive an option to negotiate licensing of Sovateltide for marketing and distribution in certain developed market countries. Live Events The company has already received exclusive right to licence Sovateltide for marketing and distribution in certain emerging market countries, it added.
