Patiromer sorbitex calcium

Veltassa® offers effective and well-tolerated long-term potassium control in chronic kidney disease and chronic heart failure patients 1-5 Zeria Pharmaceutical Co., Ltd. to market Veltassa® in Japan ST. GALLEN, Switzerland, Sept. 24, 2024 /PRNewswire/ -- CSL Vifor today announced that Japan's Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical Co., Ltd. (Zeria), marketing authorization approval for Veltassa® for the treatment of adult patients with hyperkalemia, a condition characterized by high levels of potassium in the blood. Veltassa® has now received marketing authorizations in 41 countries worldwide. "We are pleased that Veltassa® has been approved in Japan, and congratulate our trusted partner Zeria," said Hervé Gisserot, General Manager of CSL Vifor. "This milestone reflects our shared commitment to addressing the needs of over 300,000 patients in Japan affected by hyperkalemia6, particularly those with chronic kidney disease or heart failure. As we continue to deliver on our promise, we are excited to introduce a next generation hyperkalemia management therapy, designed to be broadly utilized across diverse patient groups." The approval is based on the marketing authorization application filing by Zeria, which was supported by positive clinical data from the Japanese clinical development program of ZG-801 (Veltassa®) conducted in patients with hyperkalemia in Japan. In 2018, CSL Vifor granted Zeria the exclusive right to develop and market Veltassa® in Japan. Zeria expects to begin to market Veltassa® following National Health Insurance price listing. About CSL Vifor CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent company, CSL (ASX: CSL; USOTC: CSLLY), headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor visit, . About hyperkalemia Hyperkalemia is a serious condition in which the amount of potassium in the blood exceeds the normal level (between 3.5 and 5.0 mmol/L)7. Usually, hyperkalemia remains asymptomatic. However, when the levels of potassium are very high or increase rapidly, people may experience heart palpitations, shortness of breath, chest pain, nausea, or vomiting 8, 9. The most common causes of high potassium include chronic kidney disease (CKD) and heart failure (HF). Medications used to delay progression of HF and CKD – renin-angiotensin aldosterone system inhibitor (RAASi) – may as well increase the risk of hyperkalemia10. About Veltassa® (patiromer) Veltassa® is a sodium-free exchange potassium binder which reduces high amounts of potassium in the blood and maintains the potassium at a normal level. Veltassa® acts within the gastrointestinal tract by exchanging potassium for calcium, primarily in the colon. The potassium is then excreted from the body through the normal excretion process. Veltassa® enables patients to manage chronic hyperkalemia, permitting them to stay on optimal and guideline-recommended doses of life-saving RAASi medications. Veltassa® has demonstrated to enable optimized RAASi therapy use across a range of placebo-controlled, randomized clinical trials in a variety of patient profiles 2,3,11. As of September 2024, Veltassa® has been approved in 41 countries worldwide, including in the U.S. and the EU. References: CSL Vifor Media Contact Thomas Hutter +41 79 957 96 73 [email protected] Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Pictured: Illustration of stacks of coins and a graph charting growth / iStock, Intpro In March 2023, Sanofi acquired the diabetes drug Tzield, along with its owner Provention Bio, for $2.9 billion. While not among the largest deals in the biopharma industry, it’s still a sizeable sum of money—especially for a treatment once discarded by another pharma giant. Initially developed by MacroGenics, the intravenous antibody treatment was scooped up by Eli Lilly in 2007, but Lilly dropped it three years later after a clinical trial in recently diagnosed type 1 diabetes patients failed to show a significant reduction in daily insulin dose or blood sugar levels in the treatment group compared to placebo. But it wasn’t the end of the road for Tzield. In 2018, MacroGenics licensed the drug to Provention for $6.1 million, according to SEC filings. In 2022, Sanofi took an interest, partnering with Provention to commercialize the drug. Late last year, the investment paid off—the FDA approved Tzield, and Sanofi moved forward with a complete acquisition of Provention and its drug. Such a convoluted history for therapeutics is not uncommon. Pharmaceutical companies may decide to sell the rights to their drug development programs when they have no intention of manufacturing the drug, or the research process doesn’t turn out as planned. However, sometimes the offloaded products perform better elsewhere, leading to big buyouts as companies try to expand their portfolios. The decision to license or sell a drug depends on profitability and a company’s strategic mission, said Andrew Lo, director of the Laboratory of Financial Engineering at MIT Sloan School of Management. “Even if a particular drug program is likely to be successful, and even if it generates a couple hundred million dollars a year in revenue, that might not be enough to justify putting the resources of the company to that drug because the same resources can be developing a billion dollar a year drug,” Lo told BioSpace. Similarly, if a company halves its work in a specific area, it may drop all products even if they’re successful. These decisions also depend on whether a company “believes” in the science of a drug, Lo said. Even if a drug doesn’t do well in clinical trials, another company may predict it will do well in the future and decide to buy it. In those cases, the original owner often retains an ownership stake in the product if it does well—to avoid the “egg on your face” of giving up a good product, as Lo described. As for acquisitions, those decisions depend on whether the acquiring company values all of the target company’s assets or just some. Lo said the trend of drugs changing hands would continue as some companies fall into financial need and sell their assets. “Stay tuned because the next six to 12 months are going to be periods of very active licensing deals and acquisitions." Here are a few more examples of drugs that ended up under the purview of large pharmaceutical companies after being dropped. 1. Momelotinib: Gilead’s Loss, GSK’s Gain First sale: YM Biosciences to Gilead Sciences for $510M (2012) Second sale: Gilead Sciences to Sierra Oncology for $3M (2018) Third sale: Sierra to GSK for $1.9B (2022) Momelotinib is a medication for patients with myelofibrosis, a form of bone marrow cancer. Gilead acquired the drug for $510 million in its 2012 acquisition of YM Biosciences, which had merged with Cytopia Limited in 2009. Gilead sold it to Sierra Oncology in 2018 for $3 million after clinical trials showed mixed results. Under the new ownership, the drug succeeded in clinical trials, and in June 2022, it was submitted to the FDA for approval. By then, GSK had already agreed to acquire the company for nearly $2 billion. Sierra awaits the agency’s decision, expected in June 2023. 2. Lebrikizumab: Roche’s Loss, Lilly’s Gain First sale: Roche to Dermira for $80M (2017) Second sale: Dermira to Eli Lilly for $1.1B (2020) Lebrikizumab is a monoclonal antibody used to treat atopic dermatitis. Dermira paid $80 million upfront to acquire the drug from Roche Group in 2017, and two years later, the FDA granted lebrikizumab fast-track designation. In 2020, Eli Lilly acquired Dermira for $1.1 billion. Lilly submitted the drug for approval in November 2022. 3. Zejula: Merck’s Loss, GSK’s Gain First sale: Merck to Tesaro for $7M (2012) Second sale: Tesaro to GSK for $5.1B (2019) Zejula (niraparib) is a poly ADP-ribose polymerase inhibitor that targets a family of proteins involved in cell response. Merck accepted $7 million upfront from Tesaro in 2012 to unload the drug from its portfolio. Five years later, the drug was approved for ovarian, fallopian tube or primary peritoneal cancer patients. Zejula’s success led GSK to acquire Tesaro for $5.1 billion in 2019. However, later concerns about PARP inhibitors led GSK to restrict the drug’s indications, even as the company explores Zejula’s utility for other cancer types. 4. Veltassa: Amgen’s Loss, Galenica’s Gain First sale: Amgen to Relypsa for $8.2M upfront (2009) Second sale: Relypsa to Galenica for $1.5B (2016) Veltassa (patiromer) is a drug developed for treating hyperkalemia, or high potassium in the blood. Relypsa, an offshoot of Amgen, received the rights to Veltassa from the parent company in 2009 for an upfront cost of $8.2 million. The drug was approved in 2015, and around the same time, Relypsa partnered with Vifor Fresenius Medical Care Renal Pharma—owned by Galenica—to commercialize the drug outside of the U.S. In 2016, Galenica fully acquired Relypsa for $1.5 billion and renamed the company CSL Vifor. 5. Cubicin: Lilly’s Loss, Merck’s Gain First sale: Eli Lilly to Cubist Pharmaceuticals for an undisclosed cost (1997) Second sale: Cubist to Merck for $8.4B (2014) In the late 1980s and early 1990s, Eli Lilly developed daptomycin, an intravenous antibiotic. However, the company suspended clinical trials after volunteers experienced adverse effects and discontinued its work on antibiotics altogether. Lilly then granted Cubist Pharmaceuticals the rights to develop and distribute daptomycin, which was approved in 2003 under the brand name Cubicin and 11 years later acquired by Merck for $8.4 billion. 6. Anidulafungin: Lilly’s Loss, Pfizer’s Gain First sale: Eli Lilly to Vicuron for $14M (1999) Second sale: Vicuron to Pfizer for $1.9B (2005) Vicuron obtained the antifungal drug anidulafungin from Eli Lilly in 1999 for $14 million. Initial Phase III clinical trials were successful, but in 2004 the FDA said a New Drug Application for the drug didn’t have enough data to support its efficacy, leading to lawsuits by shareholders per SEC filings. A year later, Pfizer acquired Vicuron for $1.9 billion. After submitting additional clinical data and adding another indication, the drug was approved in 2006 under the brand name Eraxis. Nadia Bey is a freelance reporter in North Carolina. She can be reached at beynadiaa@gmail.com.