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Sun Pharmaceutical Industries and Israel-based Moebius Medical announced today the publication of two articles in Osteoarthritis and Cartilage, the official journal of the Osteoarthritis Research Society International (OARSI), highlighting MM-II, a novel non-opioid product for the treatment of symptomatic knee osteoarthritis.
MM-II is based on a proprietary suspension of large, empty, multilamellar liposomes designed to reduce joint friction and wear, thereby alleviating pain. The two publications offer complementary insights into MM-II's clinical efficacy and mechanism of action, underscoring its potential therapeutic value.
The first publication presents results from a Phase 2b randomized, double-blind, placebo-controlled trial (NCT04506463), which enrolled 397 patients across the US, Europe and Asia. Findings demonstrate that a single injection of MM-II provided clinically meaningful pain relief through 26 weeks, with a favorable safety and tolerability profile.
The second publication, titled “Empty large liposomes reduce cartilage degeneration in osteoarthritic rats by forming a lubricative coating,” details MM-II's unique mechanism of action. The research shows that MM-II forms a lubricative layer over cartilage surfaces, reducing friction and slowing cartilage degeneration. The authors suggest that the results of the clinical trial may be mediated through the coating of the cartilage surfaces, though additional mechanisms may contribute to the long term pain reduction seen in Phase 2b study.
“The data from these publications show that MM-II has the potential to provide durable pain relief for patients,” said Prof. Thomas J Schnitzer, MD, PhD, a rheumatologist and professor of Medicine at Northwestern University and lead author of the clinical trial manuscript. “With limited treatment options, lack of novel treatment approaches, and concerns around opioid use, MM-II may offer a promising alternative to hyaluronic acid and steroid treatments.”
Shortly after the oral argument concluded, on 09 April 2025, the U.S. Court of Appeals for the Federal Circuit ruled in favour of the Company and vacated the preliminary injunction effective immediately.
While the litigation between Incyte Corporation and the Company continues, the preliminary injunction is no longer in effect.
The Company is no longer under a court order that delays or restricts the Company from launching LEQSELVI™. The Company will disclose LEQSELVI™ launch plans in due course of time.
Sun Pharmaceutical Industries has launched Fexuprazan tablets 40 mg in India under the brand name “FEXUCLUE®”. FEXUCLUE®, a novel potassium competitive acid blocker (PCAB), is approved as a new treatment for adults with Erosive Esophagitis of all grades.
Sun Pharma has obtained rights from Daewoong Pharmaceutical Co Ltd, Korea, a biopharmaceutical company, to manufacture and commercialise FEXUCLUE®(Fexuprazan) in India. As per agreement terms, Daewoong will be entitled to upfront and milestone payments, including royalties.
Sun Pharma has obtained the rights from Daewoong Pharmaceutical, a South Korean biopharmaceutical company, to manufacture and commercialize FEXUCLUE in India. As part of the agreement, Daewoong will receive upfront and milestone payments, as well as royalties.
Kirti Ganorkar, CEO of India Business, Sun Pharma, said, “Erosive esophagitis is a serious condition that greatly affects patients' quality of life. Despite available treatments, there remains a significant unmet need in its management. FEXUCLUE is a best-in-class treatment option with the potential to bridge this gap. At Sun Pharma, we are committed to introducing innovative medicines that enhance patients' quality of life.'
Sun Pharmaceuticals Industries is a leading global pharmaceutical company with a specialty and generic presence and India's top pharma company.
The pharma major’s consolidated net profit increased 15.04% to Rs 2,903.38 crore on a 10.46% rise in revenue from operations to Rs 13,675.46 crore in Q3 FY25 over Q3 FY24.
Shares of Sun Pharmaceuticals Industries fell 3.47% to Rs 1,650 on the BSE.