Naproxen Sodium

EUR600K upfront payment upon signing the new amendment agreement EUR400K payment once launched in significant E.U. markets Deal also includes sales-based milestone payments, royalties and revenue pursuant to the supply agreement New amendment expands the agreement to all E.U. territories MONTREAL--(BUSINESS WIRE)-- Searchlight Pharma Inc. (“Searchlight” or the “Company”), a private Canadian specialty pharmaceutical company today announced that Orion Corporation (“Orion”) has launched Suvexx® in select countries covered in the 2020 exclusive license and supply agreement (the “License Agreement”) between Nuvo Pharmaceuticals (Ireland) DAC (“Nuvo Ireland”) and Orion, with the product launches continuing into 2024. Orion is headquartered in Espoo, Finland with its products marketed in over one hundred countries worldwide. In FY2022, Orion generated over EUR1.34 billion in net sales. Orion maintains its own commercial infrastructure in most key European markets with a focus on neurology, oncology, respiratory, pain and women’s health. Orion is a public company trading on the Nasdaq Helsinki exchange under the HEL:ORNBV and HEL:ORNAV ticker symbols. In December 2020, Searchlight’s wholly owned subsidiary, Nuvo Ireland entered into the License Agreement with Orion for the exclusive right to package, distribute, market and sell Suvexx in Finland, Sweden, Denmark, Norway, Poland, Hungary, Latvia, Lithuania and Estonia (the “Territory”). Under the terms of that agreement, Orion is responsible for obtaining and maintaining the marketing authorizations for Suvexx in the Territory and for managing all Territory specific commercial activities. The relevant acute migraine prescription treatment market in Europe was valued at over EUR220 million in the past 12 months based on Company estimates. Nuvo Ireland and Orion have also entered into an amendment to the original License Agreement for the exclusive right to package, distribute, market and sell Suvexx in all remaining E.U. countries outside of the original License Agreement Territory. Orion anticipates filing the marketing authorization application immediately and expects to commercially launch Suvexx in Austria, Belgium, the Czech Republic, France, Germany, Greece, Ireland, Italy, the Netherlands, Portugal, Slovakia, Spain, Switzerland and the U.K. during 2024, subject to receipt of marketing authorization and pricing approval. The signing of the amendment triggered an upfront payment of EUR600K by Orion to Nuvo Ireland. Under the terms of the amendment, Nuvo Ireland will be entitled to future sales-based milestone payments, royalties and revenues pursuant to the supply agreement between the parties. "The launch of Suvexx in Europe is another important milestone for Searchlight and a further indication of the value arising out of the acquisition of Miravo Healthcare earlier this year,” said Mark Nawacki, Searchlight’s President and Chief Executive Officer. “A key component of our growth strategy is to create options for the diversification of our business beyond its Canadian market search, acquisition and commercialization roots. In this vein, we are pleased to expand our Suvexx agreement to encompass the entirety of the E.U. market, and to work with Orion, a partner with proven therapeutic area expertise and an established commercial infrastructure, as a license and distribution partner across the E.U." About Suvexx Suvexx is a patent protected, fixed dose combination of naproxen sodium and sumatriptan that was originally developed by the Aralez Pharmaceuticals Inc. wholly owned subsidiary POZEN, Inc. (POZEN) in collaboration with Glaxo Group Limited, d/b/a GSK (GSK). The product is formulated with POZEN's patented technology (now owned by Searchlight) of combining a triptan, sumatriptan 85 mg, with an NSAID, naproxen sodium 500 mg and GSK's RT Technology in a single tablet. In 2008, the U.S. Food and Drug Administration (FDA) approved Treximet (the U.S. brand name for Suvexx) for the acute treatment of migraine attacks, with or without aura, in adults. Treximet is currently commercialized in the U.S. by Currax Holdings USA LLC. Searchlight owns the product and intellectual property rights to Suvexx in Canada and its wholly owned subsidiary Nuvo Ireland owns the intellectual property rights to Suvexx outside of Canada. About Orion Corporation Orion is a globally operating Finnish pharmaceutical company – a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and self-care products. The core therapy areas of its pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. Orion's net sales in 2022 amounted to EUR1.34 billion and the company had about 3,500 employees at the end of the year. Orion's A and B shares are listed on Nasdaq Helsinki. About Searchlight Pharma Searchlight Pharma Inc., headquartered in Montreal, is a leading Canadian-based specialty healthcare company that executes best-in-class search, acquisition, commercialization, and focused development of innovative and unique specialty healthcare products. Following its acquisition of Miravo Healthcare in March 2023, Searchlight’s core promoted products now focus on women’s health, dermatology, allergy, pain management and hospital specialty markets, and its team is committed to improving people’s lives by bringing the right products to market. Follow Searchlight, learn more about what it does, and get to know its product portfolio at View source version on businesswire.com: Contacts FOR MORE INFORMATION, PLEASE CONTACT: Mark Nawacki President & CEO info@searchlightpharma.com Source: Searchlight Pharma Inc. View this news release online at:

THURSDAY, July 20, 2023 (American Heart Association News) -- New guidelines detailing how to care for people with heart disease come with some easy-to-grasp warnings for patients. The chronic coronary disease guidelines from the American Heart Association and American College of Cardiology, published Thursday in the AHA journal Circulation, are no incremental update, said Dr. Salim Virani, chairperson of the expert panel that rewrote them. "It's actually a new guideline in that everything that needed to be evaluated in terms of evidence was reviewed, and all the recommendations were rewritten," said Virani, vice provost of research and a professor of medicine at Aga Khan University in Karachi, Pakistan. Coronary disease includes various conditions that trace back to the buildup of plaque in artery walls that limits blood flow to the heart. That includes coronary artery disease , angina, heart attack and care after a procedure to open a blocked heart artery. The guidelines cover topics ranging from exercise to cholesterol management to bypass surgery. "This is pulling everything together as a one-stop shop for providers who take care of these kinds of patients," said Dr. Kristin Newby, the writing panel's vice chairperson. From that "one-stop shop," here are six warnings for people with coronary disease – plus an overall message to embrace. Avoid trans fat "Trans fats aren't good for anybody," said Newby, a professor of medicine and cardiology at Duke University in Durham, North Carolina. But people with coronary disease need to be extra careful. Of all the fats and oils used in cooking, Newby said, trans fats are the most likely to cause plaque in the arteries. In people with existing disease, trans fat has been linked to higher risk of heart attack and stroke, higher death rates from those problems, and a higher risk of premature death. Artificial trans fats are liquid oils that have been turned into a solid. Margarine and shortening are common examples. The Food and Drug Administration has banned food manufacturers from using a once-common source of trans fat: partially hydrogenated vegetable oils. But in some places, trans fats still show up in restaurant deep-fat fryers and elsewhere. Trans fats also occur naturally in beef, lamb and butterfat, but the guidelines say these pose less risk than artificial trans fats. Companies are allowed to say a food is free of trans fats even if they have as much as half a gram. To avoid trans fats, check nutrition labels and skip fried food, processed baked goods and refrigerated dough. And look for terms such as "partially hydrogenated oils" in the ingredients list. Beware of secondhand smoke Smoking is a well-known cause of heart disease. But even if you're not smoking, you need to be careful. "Every effort should be made to avoid secondhand smoke, because it carries many of the same chemicals and irritants that we think lead to coronary disease," Newby said. It's a matter of accumulating risk, Virani said. "If you have heart disease, and then you add secondhand smoke on top of everything else that's going on, the risk really goes up." For people who have had a heart attack, that includes a higher risk of having another one. Avoiding secondhand smoke can be tough if you work at a place where smoking is allowed. But if you have a family member who smokes, Virani said, "at a minimum" you should ask them to smoke outside. Be careful with common drugs, including ibuprofen "A lot of times we all have this misperception that if something is available over the counter, it is safe," Virani said. "Patients who have heart disease should be very mindful, even if it's vitamins." The guidelines offer a specific warning about nonsteroidal anti-inflammatory drugs, also known as NSAIDs. These drugs include ibuprofen and naproxen sodium. "What we're talking about here is not kind of a one-time use because your muscles are sore after working out," Newby said. "What we're talking about is using them every day." NSAIDs pose two issues for people with coronary disease, Virani said. First, extended use has been linked to cardiovascular problems, including having a second heart attack. Second, NSAIDs can cause bleeding in the stomach and intestines. A heart patient may be on one or even two blood-thinning medications, Virani said. Combine those with NSAIDs, and "your risk of bleeding goes up tremendously." Occasional use is not a problem, he said. But he and Newby recommend acetaminophen as an alternative. Don't combine erectile dysfunction drugs with nitrates Nitrates – including nitroglycerin – are prescribed for angina, or chest pain. Phosphodiesterase type 5 inhibitors – including sildenafil and tadalafil – are used for erectile dysfunction. Mixing them can cause a potentially life-threatening drop in blood pressure. "It's not about not using them," Newby said. "It's just about being careful." Tadalafil, for example, can stay in the system up to 48 hours, and some nitrates are long-acting as well. Men should talk to their doctor about how long the drugs last in the system, and look for alternatives if necessary, the experts said. Don't use these weight loss drugs Sympathomimetic weight loss drugs such as phentermine and benzphetamine work by suppressing appetite. They also raise your heart rate and blood pressure, which can strain a heart already suffering from compromised blood flow, Virani said. The drugs might lead to irregular heartbeats as well, he said. One drug in this class, sibutramine, was taken off the U.S. market in 2010 but might be available outside the country or sold illegally. Avoid them all, Virani said. "We have much, much better and safer weight loss medications." Be careful with postmenopausal hormone therapy Estrogen and progestin are given to women to help with postmenopausal symptoms such as hot flashes. In the context of heart disease, it has issues. First, Newby said, although hormones have been extensively studied in hopes of showing they protect against heart disease, intensive research found no benefit. But hormone therapy does raise the risk of venous thromboembolism, a blood clot in a deep vein or a lung. "What we are suggesting to patients with chronic coronary disease is to actually have that conversation with their treating clinician to see what other alternatives exist," Virani said. Given their already-elevated risk, "they've got to be very careful." And now the good news … Managing chronic coronary disease can seem like a list of limitations. Virani said it should also be seen as a wealth of opportunities. "You know, 30 to 40 years ago, having chronic coronary disease was really just like, 'OK, you're just going to have another heart attack one of these days, and you may or may not survive,'" he said. But even in the past four to five years, new treatments have made it more manageable than ever if people work with their health care professionals and take their medications. "So, there's a lot of hope as well," he said. "It's not a death sentence anymore. You can have a pretty normal life span and good quality of life if you actually follow the recommendations." American Heart Association News covers heart and brain health. Not all views expressed in this story reflect the official position of the American Heart Association. Copyright is owned or held by the American Heart Association, Inc., and all rights are reserved. By Michael Merschel, American Heart Association News Posted July 2023