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Pendopharm® signs an exclusive distribution agreement with Neuraxpharm for PrBuccolam® in Canada and announces its approval by Health Canada
Pendopharm® signs an exclusive distribution agreement with Neuraxpharm for PrBuccolam® in Canada and announces its approval by Health Canada

Yahoo

time5 days ago

  • Health
  • Yahoo

Pendopharm® signs an exclusive distribution agreement with Neuraxpharm for PrBuccolam® in Canada and announces its approval by Health Canada

MONTREAL, Aug. 4, 2025 /CNW/ - Pendopharm, a division of Pharmascience Inc., is pleased to announce that it has entered into an exclusive distribution agreement with Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, headquartered in Düsseldorf, Germany. Under the terms of the agreement, Pendopharm® will be responsible for the commercialization of Buccolam® (Midazolam Hydrochloride Oromucosal Solution) in Canada. Buccolam® is indicated for the treatment of prolonged, acute, convulsive seizures in children. Pendopharm® is pleased to announce that Health Canada has approved Buccolam®. About Epilepsy Epilepsy is a chronic neurological disorder characterized by recurrent seizures of various types and severity. These seizures result from abnormal electrical activity in the brain and can be triggered by a range of factors, including structural abnormalities, brain inflammation, physical injury, trauma, infection, or unknown causes. It is estimated that the underlying cause of epilepsy remains undetermined in up to 50% of patients diagnosed with epilepsy. 1 Nearly 1 out of 100 Canadians live with epilepsy, and approximately 13% of them are children and youth.1 Despite treatment with anti-seizure medications, some patients may experience prolonged acute convulsive seizures which require immediate intervention. Early treatment of acute seizures is critical to prevent escalation and improve patient outcomes.2,3 Benzodiazepines, are considered first-line therapy for managing prolonged seizures.4 Buccolam® is an oromucosal solution of midazolam (a benzodiazepine) supplied in a ready-to-use, pre-filled syringes for buccal (absorbed in the mouth) administration.5 "Prolonged convulsive seizures in pediatric patients can have significant short- and long-term impacts", said Dr. Aris Hadjinicolaou, Pediatric Neurologist at CHU Sainte-Justine. "Having access to a ready-to-use, on-label medication could facilitate timely intervention during seizures and may decrease the need for emergency medical services". "This partnership represents Pendopharm's commitment to bringing medicines that address unmet medical needs to Canadian patients," said Jad Isber, Vice President & General Manager of Pendopharm®. "We look forward to working with Canadian neurologists and pediatricians to make Buccolam available to all patients who may benefit from it." Dr. Maximilian von Wülfing, Chief Operating Officer of Neuraxpharm, said: "Through its network of strategic partnerships around the world, Neuraxpharm is committed to expanding access to market-leading medicines. Our collaboration with Pendopharm further strengthens our position as a global CNS specialist enabling us to deliver an epilepsy treatment designed to reduce hospitalizations and provide support to patients and their caregivers." About Pendopharm® Pendopharm, specialty division of Pharmascience Inc., is a leading Canadian specialty pharmaceutical company providing patients with innovative medicines that address unmet medical needs. Its areas of focus are gastroenterology, sports medicine & orthopedics, neurology and cardiology. Pendopharm® has extensive experience and knowledge to successfully manage its growing product portfolio. For more information, please visit For media inquiries, please contact MediaInquiries@ © 2025 Pendopharm, division of Pharmascience Inc. All rights reserved. About Pharmascience Inc. Pharmascience Inc. is one of the largest pharmaceutical manufacturers in Canada and is headquartered in Montreal, Canada. Pharmascience delivers high-quality medicines to over 50 countries worldwide. Pharmascience Inc.'s global presence and agile business development model provide healthcare communities around the world with the high-quality Canadian medicines to respond to patients' needs. About the Neuraxpharm Group Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. It has a unique understanding of the CNS market built over 40 years. Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline, partnerships and acquisitions. The company has c.1,000 employees and develops and commercialises CNS products through a direct presence in more than 20 countries in Europe, two in Latin America, one in the Middle East, one in Australia, and globally via partners in more than 50 countries. Neuraxpharm is backed by funds advised by Permira. Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratorios Lesvi) in Spain. For more information, please visit For more information, please contact: Neuraxpharm@ Pendopharm® and Design are registered trademarks owned by Finchley Research and Development Inc. Buccolam® is a registered trademark owned by Neuraxpharm, used under license by Pendopharm, a division of Pharmascience Inc. References: What is epilepsy? — Epilepsy Canada Epilepsie – consulted June 25th, 2025 Standard of Care and Role of Rescue Medications in Epilepsy Epilepsy Treatment | Treating Seizures | Epilepsy Foundation Seizure Rescue Medications | Types of Epilepsy Medications – consulted June 25th, 2025 Buccolam® Product Monograph. July 2025. Epilepsy in Canada - (gov Canada statistics) – consulted June 25th, 2025 SOURCE Pendopharm View original content to download multimedia:

'It's a mess': Calgary pharmacists scrambling to help patients amid nationwide painkiller shortage
'It's a mess': Calgary pharmacists scrambling to help patients amid nationwide painkiller shortage

Yahoo

time01-08-2025

  • Health
  • Yahoo

'It's a mess': Calgary pharmacists scrambling to help patients amid nationwide painkiller shortage

Canada is experiencing a nationwide shortage of some of the most widely prescribed painkillers, leaving Calgary pharmacists working to find creative solutions so patients aren't left in pain. Health Canada issued a notice this week warning that medications combining acetaminophen with codeine or oxycodone are in short supply. The shortage affects several widely used painkillers, including multiple strengths of Lenoltec (Tylenol 1, 2, 3 and 4). Acetaminophen with oxycodone is marketed in Canada by Teva Canada Limited, Apotex Inc. and Laboratoire Riva Inc. According to Health Canada, Teva is reporting a shortage due to manufacturing disruptions, while Apotex and Riva are facing shortages driven by increased demand. Acetaminophen with codeine is sold in different formats by Teva, Riva and Pharmascience Inc. Teva has reported shortages of Lenoltec, while Riva and Pharmascience are not officially short but cannot meet the surge in demand caused by Teva's supply issues, the notice states. 'As a result, acetaminophen with codeine or oxycodone may not always be available,' Health Canada said. At Luke's Drug Mart in Bridgeland, pharmacist David Brewerton said patients are 'frantic' as pharmacists work to mitigate the fallout of what he called a 'serious' shortage. 'We can't fill what we would like to be able to fill,' he said, noting the pharmacy only has 'tiny amounts' of Lenoltec in all strengths. 'We're looking anywhere from late August into October to get stock back in. 'We won't take a (prescription) transfer because we don't even have enough to supply the people that we're already supplying,' he said. 'It's a mess.' Brewerton noted the shortage is not new and has been going on for several months, forcing pharmacists to find solutions to mitigate the fallout. 'We've been finding workarounds in the majority of cases,' he said. 'Sometimes there are alternatives that we can put together that will match it. 'In other cases… there might be a different painkiller that they could use that would treat the same pain.' Pharmacists making adjustments, government looking for supply He notes drug shortages are not new, but said this one underscores the risks of relying heavily on a single manufacturer. 'The vast majority of the products we're talking about being short … is coming out of one company,' he said. 'If they're having a problem with what appears to be one particular ingredient that goes into making all those different types of tablets.. (and) suddenly they all go short, it's a domino effect.' He said the causes of drug shortages are 'incredibly varied' – from manufacturing disruptions to ingredient issues to worker strikes – and are difficult to predict. Diversifying supply, he said, is the best long-term safeguard. 'You want to diversify, so if there's a problem you're making up for it elsewhere,' he said. Health Canada said addressing the shortage is 'a top priority.' 'We recognize the importance of having acetaminophen with codeine or oxycodone products available for patients,' the notice states. 'We're communicating with health care providers, provincial and territorial governments, and distributors to coordinate the sharing of information about this shortage. 'We're also working with manufacturers and stakeholders to monitor the supply of acetaminophen with codeine or oxycodone and looking at options for increasing access to these products.' The Canadian Pharmacists Association has released a clinical guide to help pharmacies manage the shortage. In the meantime, local pharmacists like Brewerton are doing what they can to keep patients comfortable. 'Every pharmacist is having to deal with that right now. And we're all working on what we can do to make up whatever we need to do for patients,' he said. 'We'll do our best.'

KalVista Pharmaceuticals Enters into Licensing Agreement with Pendopharm to Commercialize Sebetralstat for HAE in Canada
KalVista Pharmaceuticals Enters into Licensing Agreement with Pendopharm to Commercialize Sebetralstat for HAE in Canada

National Post

time26-06-2025

  • Business
  • National Post

KalVista Pharmaceuticals Enters into Licensing Agreement with Pendopharm to Commercialize Sebetralstat for HAE in Canada

Article content -Sebetralstat has potential to become first oral on-demand treatment for HAE in Canada- Article content -Pendopharm brings proven track record in commercializing innovative therapies across multiple therapeutic areas with capabilities to launch sebetralstat in Canadian market- Article content Article content CAMBRIDGE, Mass. & SALISBURY, England — KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that its wholly-owned subsidiary, KalVista Pharmaceuticals, Ltd., has granted Pendopharm, a division of Pharmascience Inc., the exclusive rights to manage the regulatory approval process and commercialization of sebetralstat in Canada. Sebetralstat is an investigational, oral on-demand treatment for hereditary angioedema (HAE). Article content 'We look forward to collaborating with Pendopharm, whose deep knowledge of the Canadian market and proven track record make them a strong partner as we work to bring sebetralstat to people living with HAE,' said Ben Palleiko, CEO of KalVista. 'This partnership supports our broader goal of making sebetralstat available globally, as the first and only oral on-demand treatment that has the potential to transform HAE care.' Article content Financial terms of the agreement are not being disclosed. Article content About Sebetralstat Article content Sebetralstat is an investigational, novel oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). We have filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older and are investigating its use in children aged 2 to 11. If approved, sebetralstat has the potential to become the foundational therapy for HAE management worldwide. Article content About Hereditary Angioedema Article content Hereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected. All currently approved on-demand treatment options require either intravenous or subcutaneous administration. Article content About KalVista Pharmaceuticals, Inc. Article content KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. Our lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA. In addition, we have completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency and multiple other global regulatory authorities. Article content About Pendopharm Article content Pendopharm, a division of Pharmascience Inc., is a Canadian specialty pharmaceutical company that partners with various companies to bring treatments in areas such as rare diseases, gastroenterology, sports medicine, neurology, and cardiology to the Canadian market. For more information about Pendopharm, please visit Article content About Pharmascience Inc. Article content Headquartered in Montreal, Pharmascience Inc. is one of Canada's largest pharmaceutical manufacturers, supplying high-quality medicines to over 50 countries. Its global reach and agile development model ensure timely responses to patient needs worldwide. Article content Forward-Looking Statements Article content This press release contains 'forward-looking' statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: 'anticipate,' 'intend,' 'plan,' 'goal,' 'seek,' 'believe,' 'project,' 'estimate,' 'expect,' 'strategy,' 'future,' 'likely,' 'may,' 'should,' 'will,' and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timings or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2024, our quarterly reports on Form 10-Q, and our other reports that we make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments, or otherwise. Article content Article content Article content Article content Article content Contacts Article content

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