Sovateltide

Centhaquine is a first-of-its-kind resuscitative agent to treat hypovolemic shock by increasing stroke volume and cardiac output due to an increase in (preload) venous blood return to the heart and a decrease in (afterload) due to arterial dilatationIndia is the first global territory where Centhaquine is being launched immediately WILLOWBROOK, Ill., March 22, 2024 (GLOBE NEWSWIRE) -- Pharmazz, Inc. ("Pharmazz"), a biopharmaceutical company developing and commercializing drug products to treat critically ill patients, announced that it has entered into a license agreement with Dr. Reddy's Laboratories Limited ("Dr. Reddy's"), a global pharmaceutical company, to commercialize a first-in-class innovative drug Centhaquine in India. Developed by Pharmazz for potential global use, Centhaquine is a resuscitative agent presently indicated for treating hypovolemic shock by Drugs Controller General of India (DCGI). As per the agreement, Dr. Reddy's has received exclusive rights to market and distribute Centhaquine in India. Pharmazz will be entitled to upfront payments and royalties. Dr. Reddy’s will market the product under the brand name Lyfaquin®, which it shall own. In addition to India, Dr. Reddy’s also receives marketing rights for Lyfaquin® from Pharmazz for Nepal. The inventor, Dr. Prof. Anil Gulati, M.D., Ph.D., who is the CEO and Chairman of the Board of Pharmazz, said: "India's emergence as a hub for developing and introducing innovative medicines is a remarkable achievement. It reflects the country's growing capabilities in research and development within the pharmaceutical sector. It is a large step for Pharmazz to partner with Dr. Reddy's, a leading global pharmaceutical company from India. For patients with hypovolemic shock, I believe Dr. Reddy's is the best partner for Pharmazz to market Centhaquine, an innovative, first-in-class novel resuscitative agent, in India." M.V. Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr. Reddy’s, said: “The partnership with Pharmazz and launch of this first-in-class drug marks the latest in our effort to enter into strategic collaborations to bring novel molecules to India to meet genuine unmet patient needs. The clinical studies for Lyfaquin® have demonstrated significantly better and promising outcomes, making it as a potential add-on drug in the management of hypovolemic shock and enhancing the current standard of care for its treatment in India.” Centhaquine is a frontline therapy used along with the standard of care and is well-positioned to a critical unmet need as a pharmacologically active resuscitative agent. A decrease in the volume of blood circulation from blood or fluid loss due to trauma, gastrointestinal bleeding, major surgery, postpartum hemorrhage, diarrhea, or vomiting can cause hypovolemic shock. About 1.9 million people worldwide die because of hemorrhagic shock every year, most dying within the first 6 hours. Centhaquine activates venous alpha2B adrenergic receptors to increase cardiac preload and activates central alpha2A adrenergic receptors to decrease cardiac afterload. Thereby, Centhaquine converts the venous unstressed blood volume to stressed blood volume and improves cardiac output and blood circulation, making it an ideal candidate for the resuscitation of patients with hypovolemic shock. Centhaquine was approved in India by Drugs Controller General of India following a successful Ph III clinical trial there, the results of which are published in a manuscript titled "A Multicentric, Randomized, Controlled Ph III Study of Centhaquine (Lyfaquin, as a Resuscitative Agent in Hypovolemic Shock Patients." The manuscript is published in DRUGS and is available at: https://link.springer.com/article/10.1007/s40265-021-01547-5. Pharmazz received permission from the U.S. Food and Drug Administration (FDA) to conduct a Phase III clinical trial of Centhaquine in hypovolemic shock patients. It assesses the safety and efficacy of Centhaquine in patients with hypovolemic shock. The Phase III randomized double-blind, placebo-controlled study will be conducted in 430 patients, where patients will receive either an intravenous infusion of 0.01 mg/Kg of Centhaquine or a placebo. All patients will receive the standard of care. A 28-day all-cause mortality is the primary endpoint. The Phase III clinical trial is registered at clinicaltrials.gov (NCT05251181), providing details of the trial design and all the endpoints. U.S. FDA clearance of our Phase III IND is an important milestone for Pharmazz and the potential future treatment of hypovolemic shock patients. 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 U.S. 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, www.pharmazz.com. Contacts: Pharmazz, Inc. Investors David CostelloMediaShruti Gulati Tel:+1 630 780 6087 Tel:+1 630 780 6087Email:david.costello@pharmazz.com Email:shruti.gulati@pharmazz.com About Dr. Reddy’s: 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 ahead 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. CONTACTS: Investor RelationsRicha PeriwalRichaperiwal@drreddys.com Media RelationsUsha IyerUshaiyer@drreddys.com

Sovateltide stimulates neural progenitor cells in the brain and promotes neurovascular remodeling by forming new neurons (neurogenesis) and blood vessels (angiogenesis). Sovateltide also protects neural mitochondria and enhances their biogenesis.Sovateltide is being marketed in India by Sun Pharmaceuticals under its brand name Tyvalzi™ and can be administered up to 24 hours after the onset of symptoms. WILLOWBROOK, Ill., Oct. 02, 2023 (GLOBE NEWSWIRE) -- Pharmazz, Inc. ("Pharmazz" or the "Company"), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, announced that it has received agreement from the U.S. 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 (Tycamzzi™) for the treatment of acute cerebral ischemic stroke patients. The protocol is titled "The Safety And Efficacy Of Sovateltide In Patients With Acute Cerebral Ischemic Stroke." The FDA completed its review and agreed that the study's design and planned analysis could adequately address objectives supporting regulatory submission and a future marketing application with the US FDA. The final determination for the approval of the marketing application is made after a complete review. The FDA previously approved the phase 3 IND application. This SPA agreement by the FDA provides a clear-cut regulatory path for sovateltide, our first-in-class drug for acute cerebral ischemic stroke. In addition, our SPA agreement with the FDA solidifies our trial's alignment with regulatory objectives and underscores the FDA's confidence in Sovateltide's potential. It's a seal of approval that offers our team and investors unique assurance. Sovateltide will fulfill an unmet medical need since no new drug other than rtPA has been approved for treating stroke for over two decades. The narrow time window of rtPA of 4.5 hours limits its use in most patients with cerebral ischemic stroke. Sovateltide is a true standout; it can be administered up to 24 hours following the onset of stroke symptoms, presenting a remarkable market advantage. This is a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical study to assess the safety and efficacy of sovateltide along with the standard of care in patients with acute cerebral ischemic stroke. The target population is adult patients aged 18 – 80 years of age with cerebral ischemic stroke presenting within 24 hours after the onset of symptoms with NIHSS score of ≥8 and <20 as well as NIHSS Level of Consciousness (1A) score <2 at the time of screening. This includes cerebral ischemic stroke patients who completely recovered from earlier episodes before having a new or fresh stroke. The primary endpoint is the proportion of acute cerebral ischemic stroke patients having a good functional outcome with a modified Rankin Scale (mRS) score of 0-2 on day 90 post-randomization. For an individual patient, the duration of the study will be 3 months (90 days), with 4 study visits. Five hundred and fourteen patients (257 in each treatment arm) will be randomized into 2 groups and stratified based on early vs. late enrollment (<12 hours vs. ≥12 hours) and by the use vs. non-use of rtPA. About Pharmazz, Inc. Pharmazz is a privately held company engaged in 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, U.S. Food and Drug Administration (FDA) has approved two phase 3 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, www.pharmazz.com. Contacts: Pharmazz, Inc. InvestorsMediaDavid CostelloShruti GulatiTel+1 630 780 6087Tel+1 630 780 6087E maildavid.costello@pharmazz.comE mailshruti.gulati@pharmazz.com