Atorvastatin Calcium

According to information from the U.S. clinical trial registry Clinicaltrials on December 10, Chinese company Heng Rui Pharma has launched its first Phase III clinical trial (SHR-1918-301) for the ANGPTL3 monoclonal antibody SHR-1918. This drug marks the first domestic ANGPTL3 monoclonal antibody to enter the Phase III clinical trial stage. SHR-1918 is an ANGPTL3 monoclonal antibody developed by Heng Rui Pharma, which works by inhibiting ANGPTL3 activity to lower triglycerides (TG) and low-density lipoprotein cholesterol (LDL-C) levels in serum. LDL-C and TG are significant risk factors for the development of atherosclerotic cardiovascular diseases. ANGPTL3 plays a key role in lipid metabolism regulation by inhibiting lipoprotein lipase and endothelial lipase, thereby reducing the clearance of TG and LDL-C. In September this year, Heng Rui Pharma announced the results of its first Phase I study (SHR-1918-101) at the European Society of Cardiology (ESC) annual meeting. The study showed that SHR-1918 (100-1200mg, subcutaneously) demonstrated good tolerance and pharmacokinetic characteristics in healthy subjects, with a peak time of 8.0-10.0 days and a half-life of 29.4-53.5 days. Additionally, SHR-1918 effectively and durably reduced LDL-C and TG levels: patients receiving doses of SHR-1918 of 300mg or higher had LDL-C levels reduced by over 30% (up to 49.1%), lasting more than 64 days; TG levels were reduced by over 50% (up to 82.8%), lasting more than 85 days. Given the potential of SHR-1918 for treating rare dyslipidemia disorders, the drug received breakthrough therapy designation for homozygous familial hypercholesterolemia (HoFH) from the Chinese National Medical Products Administration (NMPA) in September. The launched Phase III study is a multicenter, randomized, double-blind, placebo-controlled clinical trial (n=45), aimed at evaluating the efficacy and safety of SHR-1918 in treating homozygous familial hypercholesterolemia (HoFH). The primary endpoint is the percentage change in LDL-C levels from baseline at week 12. Homozygous familial hypercholesterolemia (HoFH) is a rare and severe genetic disorder where patients accumulate LDL-C in the blood due to defects or deficiencies in low-density lipoprotein receptors (LDLR), increasing the risk of heart disease and stroke. Currently, available treatment options for these patients include statins (simvastatin, atorvastatin, and rosuvastatin), ezetimibe, lomitapide, mipomersen, PCSK9 monoclonal antibodies (evolocumab and alirocumab), and evinacumab. Among these, evinacumab (Regeneron/Ultragenyx) is the only marketed ANGPTL3 monoclonal antibody, with global sales of $80.9 million in 2023.

TRENTON, N.J., July 3, 2024 /PRNewswire/ -- YOUR LEGAL RIGHTS MAY BE AFFECTED There is a proposed settlement in a class-action lawsuit filed against Pfizer Inc., Pfizer Ireland Pharmaceuticals, Warner-Lambert Company, and Warner-Lambert Company LLC (collectively, "Pfizer") and Ranbaxy Inc., Ranbaxy Laboratories Limited, and Ranbaxy Pharmaceuticals, Inc. (collectively, "Ranbaxy"). The lawsuit claims that Pfizer and Ranbaxy unlawfully kept generic versions of Lipitor off the market, so consumers and third-party payors paid more for brand and generic Lipitor than they should have. Pfizer and Ranbaxy deny they did anything wrong. There has been a settlement with Pfizer; the lawsuit against Ranbaxy is ongoing. No one is claiming that Lipitor is unsafe. Who is included in the Settlement? You may be included in the Settlement if you purchased, paid, and/or provided reimbursement for branded Lipitor or generic atorvastatin calcium and fall within any one of the following definitions: Third-Party Payor Class ("TPP Class") All entities that, for consumption by their members, employees, insureds, participants, or beneficiaries, purchased, paid, and/or provided reimbursement for some or all of the purchase price of branded Lipitor or generic atorvastatin calcium, in Arizona, California, Washington, D.C., Florida, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Oregon, South Dakota, Tennessee, West Virginia, or Wisconsin (the "Class States"), other than for resale, at any time during the period from June 28, 2011 through and until December 31, 2012. Consumer Class All individuals who purchased, paid, and/or provided reimbursement for some or all of the purchase price of branded Lipitor, in the Class States, without the use of a Pfizer co-pay card, from June 28, 2011 through November 29, 2011. All individuals who purchased, paid, and/or provided reimbursement for some or all of the purchase price of generic atorvastatin calcium, in the Class States, from November 30, 2011 through December 31, 2012. A more detailed notice, including the full class definitions, and who is not included, is available at . What does the Settlement provide? Pfizer will pay $35 million into a Settlement Fund that will pay (1) money to eligible Class Members; (2) notice and administration costs; (3) service awards to the class representatives who brought the lawsuit; and (4) attorneys' fees, costs, and expenses. The full text of the proposed Settlement Agreement is available at . How can I get a payment? If you believe you are a Class Member and want to obtain a share of the Settlement Fund, you will need to complete and return a Claim Form. The amount of your payment will depend on the amount of Lipitor or AB-rated generic versions of Lipitor you purchased and the number of claims that are filed. The Claim Forms, and information on how to submit them, are available on the Settlement website at . Claim Forms must be postmarked (if mailed) or received (if submitted online) on or before November 29, 2024. What are my rights? Even if you do nothing, you will be bound by the Court's decisions. If you want to keep your right to sue Pfizer yourself, you must exclude yourself from the Class by August 16, 2024. If you do not exclude yourself, you may object to the proposed settlement by August 16, 2024. The Court will hold a hearing on October 1, 2024 to decide whether to approve the Settlement, the plan for allocating the Settlement Fund to Class Members, a request for payment of attorneys' fees of up to 34% of the Settlement Fund, plus costs and expenses, and service awards to the class representatives. You or your own lawyer may appear and speak at the hearing at your own expense. The Court may change these deadlines or the hearing date (and time). Check the website below for updates. Please do not call the Court or the Clerk of the Court for information about the Settlement. Want More Information? Go to , call 1-888-831-7612, email [email protected] or write to Claims Administrator 54388, P.O. Box 2694, Portland, OR 97208-2694. The deadlines contained in this Notice may be amended by Court Order, so check the Settlement website for any updates. Please do not call the Court or the Clerk of the Court for information about the Settlement. SOURCE United States District Court for the District of New Jersey