Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 31 n° 301

Posts Tagged ‘sun pharma’

Sun Pharma Launches Ezallor Sprinkle (Rosuvastatin) in the U.S. for People Who Have Difficulty Swallowing

Posted by fidest press agency su mercoledì, 17 luglio 2019

Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” including its subsidiaries and/or associate companies) today announced the U.S. launch of Ezallor Sprinkle™ (rosuvastatin) capsules for the treatment of three types of elevated lipid disorders in people who have difficulty swallowing, a problem that is estimated to affect approximately 30-35% of long-term care residents.
Ezallor Sprinkle is indicated as an adjunct to diet for the treatment of adult patients with hypertriglyceridemia, as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (type III hyperlipoproteinemia), and as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or as monotherapy if such treatments are unavailable, to reduce LDL-C, total cholesterol, and ApoB in adult patients with homozygous familial hypercholesterolemia. Ezallor Sprinkle has not been studied in Fredrickson type I and V dyslipidemias.Ezallor Sprinkle is formulated as extended-release-coated pellets that may be sprinkled over soft food such as applesauce, can be swallowed whole, or administered via a nasogastric tube to facilitate long-term, once-daily administration. Ezallor Sprinkle joins Kapspargo Sprinkle™ (metoprolol succinate) extended-release capsules as the second product in the Sun Pharma portfolio designed for individuals in long-term care.Ezallor Sprinkle is contraindicated in patients with any known hypersensitivity to rosuvastatin, which may include rash, pruritus, urticaria, and angioedema; patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels, and females who are pregnant or breastfeeding. In the controlled clinical trials database, the most common adverse reactions with rosuvastatin were headache, myalgia, abdominal pain, asthenia, and nausea.

Posted in Estero/world news | Contrassegnato da tag: , | Leave a Comment »

Almirall and Sun Pharma enter into a License Agreement for Tildrakizumab in Europe for Psoriasis

Posted by fidest press agency su venerdì, 29 luglio 2016

psoriasiMumbai, India and Barcelona, Spain July 27, 2016 – Sun Pharma (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, Sun Pharmaceutical Industries Ltd and includes its subsidiaries or associate companies), and its wholly owned subsidiary and Almirall (Spanish Stock Exchange ticker: ALM) today announced a licensing agreement on the development and commercialization of tildrakizumab for psoriasis in Europe. Tildrakizumab is an investigational IL-23p19 inhibitor currently being evaluated in patients with moderate-to-severe plaque psoriasis.Under terms of the license agreement, Almirall will pay Sun Pharma an initial upfront payment of US $50 million. Phase-3 studies of tildrakizumab have recently been completed. Sun Pharma will be eligible to receive development and regulatory milestone payments and, additionally, sales milestone payments and royalties on net sales, the terms of which are confidential. Almirall will be able to lead European studies, and participate in larger Global clinical studies for psoriasis indication subject to the terms of the Sun Pharma – Merck agreements, as well as certain cost sharing agreements. Sun Pharma will continue to lead development of tildrakizumab for other indications, where Almirall will have right of first negotiation for certain indications in Europe.“Sun Pharma is committed to growing our dermatology franchise, with tildrakizumab as our lead investigational compound. We continue to build our pipeline and capabilities in this important therapeutic area of significant unmet need. We are proud to be partnering with a regional leader in dermatology, like Almirall, to bring tildrakizumab to the European market,” said Dilip Shanghvi, Managing Director, Sun Pharma. “This agreement with Almirall follows the recent announcement that tildrakizumab is the first IL-23p19 inhibitor to demonstrate positive results in Phase-3 clinical trials and is another step towards preparing for future regulatory milestones that will potentially enable us to bring a new treatment option to patients with moderate-to-severe plaque psoriasis.”“This agreement with Sun Pharma allows us to add a novel biologic for treatment of psoriasis to our extensive dermatology portfolio,” said Jorge Gallardo, President of Almirall. “This is an exciting time for the treatment of psoriasis, a disease which can take both a physical and emotional toll on patients’ lives. Emerging new investigational drugs, like tildrakizumab, are increasingly targeted and will potentially offer patients and physicians another alternative.”Additionally, the license agreement has a provision for possible co-promotion agreement at some point in the future, subject to certain conditions.
In May 2016, the two pivotal Phase-3 clinical trials of tildrakizumab met their primary endpoints for both evaluated doses with topline results shared via a separate press release. The co-primary efficacy endpoints were: the proportion of participants with Psoriasis Area Sensitivity Index 75 (PASI 75) response at week 12 compared to placebo and the proportion of participants with a Physician’s Global Assessment (PGA) score of clear or minimal with at least a 2 grade reduction from baseline at week 12 compared to placebo. The overall safety profile of tildrakizumab in both Phase-3 clinical trials was consistent with the safety data observed in previously reported studies. Additionally, the second study included an etanercept comparator arm, with a key secondary endpoint comparing tildrakizumab and etanercept on PASI 75 and PGA. Tildrakizumab 200mg was superior to etanercept on both PASI 75 and PGA endpoints at week 12, while the 100 mg dose showed superiority to etanercept on PASI 75 only.The preparations for submission of a Biologics License Application to the U.S. Food and Drug Administration are proceeding. The detailed findings from the Phase-3 clinical trials will be presented at upcoming scientific meetings.

Posted in Estero/world news, Medicina/Medicine/Health/Science | Contrassegnato da tag: , , | Leave a Comment »