Latest news with #SunPharmaceutical
Associated Press
14 hours ago
- Business
- Associated Press
Pharmazz Inc. Announces Enrollment of First Patient in Phase 3 Clinical Trial of Sovateltide for Treating Patients with Cerebral Ischemic Stroke
The Phase 3 clinical trial of sovateltide, RESPECT-ETB, is expected to enroll over 500 patients with a primary endpoint of proportion of patients demonstrating functional independence at 90 days and is being conducted under a Special Protocol Assessment (SPA) with the FDA. Sovateltide, a potential first-in-class, highly selective endothelin-B (ETB) receptor agonist, has previously demonstrated significant improvement in stroke patients compared to standard of care in a Phase 3 trial that served as the basis for regulatory approval in India. Recent $25 million equity investment from Sun Pharmaceutical Industries Limited, provides sufficient capital to complete the Phase 3 trial. WILLOWBROOK, Ill., July 29, 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, today announced that the first patient has been enrolled and treated in the pivotal Phase 3 RESPECT-ETB clinical trial assessing the safety and efficacy of sovateltide for the treatment of acute cerebral ischemic stroke ( NCT05691244 ). Sovateltide represents a potential breakthrough as a first-in-class endothelin-B receptor agonist, uniquely promoting neurovascular remodeling—generating new neurons (neurogenesis), blood vessels (angiogenesis), and enhancing mitochondrial function. 'There has not been a new FDA approved non-thrombolytic therapy for stroke in over 30 years. We have already shown promising results in our previous Phase 3 study, which showed that sovateltide could be a meaningful advance over standard of care to promote a fast recovery and improve neurological outcomes in cerebral ischemic stroke patients,' said Emeritus Prof. Anil Gulati, CEO and Founder of Pharmazz. 'We have now treated the first patient in our US-based Phase 3 clinical trial and have sufficient capital to complete this study to further cement the potential for sovateltide to transform the treatment of cerebral ischemic stroke.' 'There is a massive and ongoing medical burden associated with ischemic stroke, which continues to be a leading cause of long-term disability, affecting hundreds of thousands of patients each year,' said Dr. Thomas Devlin, MD, PhD, FSVIN, physician executive of Neurosciences and medical director at CHI Memorial Stroke and Neuroscience Center, and principal investigator of the Phase 3 trial. 'Current treatment options remain limited, underscoring the critical need for novel therapies. Given the promising results already demonstrated with sovateltide, this rigorous Phase 3 study represents an important step toward addressing this urgent unmet medical need.' Phase 3 Trial of Sovateltide for Stroke Covered by Special Protocol Assessment Sovateltide is a first-in-class endothelin-B receptor (ETBR) 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 has now enrolled and treated the first patient in its Phase 3 trial, RESPECT-ETB ( ID: NCT05691244 ). The Phase 3 clinical trial is designed to enroll a total of 514 stroke patients at 65 sites in the US, Germany, Spain, and the UK. 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. About Sovateltide and Stroke Stroke is a leading cause of long-term disability in the United States, affecting more than 795,000 people each year, and reduces mobility in more than half of stroke survivors over the age of 651. 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 inducing the formation of new neurons (neurogenesis) and blood vessels (angiogenesis). Sovateltide also protects neural mitochondria and enhances their biogenesis. The Phase 3 trial that served as the basis for approval in India was published in 2024 and showed that the sovateltide group (n=80) had a significantly greater number of cerebral ischemic stroke patients with lower mRS and NIHSS scores at 90 days post-treatment than the control group (n=78).2 About Pharmazz, Inc. Pharmazz is a privately held company developing novel products in critical care medicine. Pharmazz, Inc. has obtained marketing authorization for two of its first-in-class drug molecules, centhaquine and sovateltide, for the treatment of 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, 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: 1 Centers for Disease Control. 2 Drugs. 2024 Nov 15;84(12):1637–1650. doi: 10.1007/s40265-024-02121-5
Bloomberg
5 days ago
- Business
- Bloomberg
Sun Pharma to Settle US Generics Pricing Case for $200 Million
Sun Pharmaceutical Industries Ltd. settled claims worth $200 million in an antitrust case in Pennsylvania alleging that the firm, along with others, colluded to fix prices of generic drugs. The units of India's number one drugmaker — Sun Pharmaceutical Industries Inc. and Taro Pharmaceuticals USA Inc. — will pay the suing consumers in exchange for a full release of all claims against them, the company said in a statement to Indian exchanges Thursday.
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Business Standard
14-07-2025
- Business
- Business Standard
Sun Pharma launches hair loss drug Leqselvi in US after patent settlement
The delay in Sun Pharma's launch of Leqselvi in the US was caused by a patent infringement case, which was later settled in a US court with Incyte Corp New Delhi Sun Pharmaceutical has launched a new medicine for severe alopecia areata, called Leqselvi, in the United States. Alopecia areata is a condition in which the immune system attacks hair follicles, leading to hair loss on the scalp as well as other parts of the body. 'Leqselvi is an important step forward for people living with severe alopecia areata,' said Richard Ascroft, CEO of Sun Pharma North America. 8 mg Leqselvi tablets for severe alopecia areata is now available by prescription across the US. The delay in Sun Pharma's launch of Leqselvi in the US was caused by a patent infringement case, which was later settled in a US court with Incyte Corp, as reported by Reuters. The drug underwent two clinical trials, THRIVE-AA1 and THRIVE-AA2, involving 1,223 adults between 18 and 65 years of age. The trials were conducted in the US, Canada, and Europe. Hair regrowth was measured over a period of 24 weeks using a scoring system known as the Severity of Alopecia Tool (SALT), according to the company's statement. Shrikant Akolkar, analyst at Nuvama Institutional Equities, said the drug could generate up to $400 million in sales by FY30, with peak sales potential of $900 million, and boost growth in Sun's key US market, according to Reuters. The National Alopecia Areata Foundation (NAAF) welcomed the launch. Its President, Nicole Friedland, said the new treatment offers hope to many people dealing with the emotional and social impacts of hair loss. Sun Pharmaceutical is also offering a 'Leqselvi Support Program' to help patients access the medicine. Eligible patients may be able to receive the drug for as little as $0 for up to two years. The program also includes personal guidance and support throughout the treatment process. 'The clinical evidence for Leqselvi is truly compelling, demonstrating consistent efficacy," said Arash Mostaghimi, Vice Chair of Clinical Trials and Innovation and Associate Professor of Dermatology at Brigham and Women's Hospital. However, Leqselvi does carry certain risks. It may cause side effects such as infections, acne, headaches, or more serious health issues. Doctors are advised to screen patients thoroughly before and during treatment. Alopecia areata affects nearly 2.5 per cent of people in the United States during their lifetime. According to figures cited in the company's release, the condition also affects a similar percentage of the global population. The scalp is the most commonly affected area, but hair loss can also occur on other parts of the body.
Bloomberg
11-07-2025
- Business
- Bloomberg
Glenmark-AbbVie Deal Lifts Optimism on India's Biotech Stocks
Glenmark Pharmaceuticals Ltd. 's licensing pact with AbbVie Inc. for its blood cancer drug is boosting optimism over Indian biotechnology stocks, with some brokerages calling it the largest such deal in the country. The agreement by the Indian firm's unit — which includes an upfront amount of $700 million and milestone payments of as much as $1.23 billion — sent the Glenmark stock as much as 20% higher to a record Friday. Peers such as Sun Pharmaceutical Industries Ltd. and Biocon Ltd. also gained following the announcement.
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Business Standard
25-06-2025
- Business
- Business Standard
Sun Pharma partner Philogen withdraws EU application for skin cancer drug
Experts believe that the drug still holds potential for future market entry, and the current development should be viewed as a temporary setback Anjali Singh Mumbai Listen to This Article Sun Pharmaceutical's European partner Philogen S.p.A has voluntarily withdrawn its marketing authorisation application for its investigational skin cancer therapy Nidlegy in the European Union (EU). The decision comes a year after the application was submitted to the European Medicines Agency (EMA) for the treatment of locally advanced, fully resectable melanoma. Analysts believe while this development may not have any immediate financial repercussions for Sun Pharma, it could influence the company's long-term strategic positioning, particularly in the European and Australian markets. 'The timing of this development is also unfavourable for the company, considering the setback earlier this month when another investigational
