Chugai Pharma Europe Ltd

On June 12, Swiss pharmaceutical company Helsinn Healthcare announced the renewal of its distribution and licensing agreement with Chugai Pharma Europe, the European subsidiary of Japanese pharmaceutical company Chugai, to promote AKYNZEO® (a combination drug containing netupitant and palonosetron) in the UK and Ireland. It is reported that AKYNZEO® was first approved in the United States by the FDA in 2014 as a medication used to treat chemotherapy-induced nausea and vomiting. It consists of two active ingredients: netupitant and palonosetron. Netupitant is a neurokinin NK1 receptor antagonist that selectively blocks the activation of NK1 receptors, reducing delayed nausea and vomiting caused by chemotherapy. Palonosetron is a serotonin 5-HT3 receptor antagonist that blocks the activation of 5-HT3 receptors, reducing acute nausea and vomiting induced by chemotherapy. The indication for AKYNZEO® primarily involves the prevention of acute and delayed nausea and vomiting associated with highly or moderately emetogenic chemotherapy in adults. It is typically used in conjunction with dexamethasone to enhance the preventive effect. The pharmaceutical forms of the drug include capsules and injections, with each capsule containing 300 mg of netupitant and 0.5 mg of palonosetron. The recommended dosage and administration of AKYNZEO® is to take one capsule orally at least one hour before the start of chemotherapy, and only once per chemotherapy cycle. However, use should be avoided or administered with caution under physician guidance in patients with severe hepatic impairment, severe renal impairment or end-stage renal disease, and pregnant or breastfeeding women. Common adverse reactions of AKYNZEO® include headache, constipation, fatigue, and stomach discomfort. AKYNZEO® is an effective supportive medication for chemotherapy, significantly improving the quality of life during chemotherapy by alleviating symptoms like nausea and vomiting. When using this medication, patients should follow the guidance and recommendations of their physician to ensure safe and effective use. Nausea and vomiting are common physical discomfort symptoms that can be caused by a variety of reasons. Nausea is a sensation of unease in the stomach that may be accompanied by an urge to vomit, while vomiting involves the forceful expulsion of stomach contents through the mouth. Nausea and vomiting can be symptoms of many different health conditions, including early pregnancy, concussion, cancer chemotherapy, and gastroenteritis. Both adults and children can experience these symptoms, and methods to alleviate nausea vary from person to person. However, some common home remedies include drinking clear liquids or chilled beverages, eating bland foods such as saltine crackers or white bread, avoiding greasy or sweet foods, eating slowly, having smaller, more frequent meals, not mixing hot and cold foods, sipping beverages slowly, avoiding activity after eating, not brushing teeth immediately after meals, and choosing foods that are tolerable to ensure a balanced diet. Chemotherapy-induced nausea and vomiting (CINV) are common side effects during chemotherapy processes, significantly affecting the quality of life for cancer patients undergoing treatment and are among the most feared adverse events associated with chemotherapy. CINV not only impacts the patient's day-to-day life but can also cause psychological stress, sometimes even leading patients to delay or refuse necessary chemotherapy treatments. The occurrence of CINV (Chemotherapy-induced Nausea and Vomiting) presents two peak periods: an acute phase within 1-2 hours post-chemotherapy, known as Acute CINV, and another peak occurring between 48-72 hours after chemotherapy, which can last several days, known as Delayed CINV. The incidence of Delayed CINV is approximately twice that of Acute CINV. However, during the delayed phase of chemotherapy, patients often no longer have direct contact with the oncology medical team, posing challenges for clinical management. Moreover, most antiemetic treatments are more effective against Acute CINV than Delayed CINV. The pathogenesis of CINV involves both the central and peripheral nervous systems. Chemotherapy drugs lead to the release of various neurotransmitters in the gastrointestinal tract, cerebral cortex, thalamus, vestibular areas, and the area postrema, which includes dopamine, endorphins, serotonin, and neurokinin, with substance P as a receptor ligand. 5-HT3 receptor antagonists (5-HT3 RAs) have shown effectiveness in controlling acute CINV but have limited efficacy in Delayed CINV. In recent years, the introduction of neurokinin-1 (NK-1) receptor antagonists has represented a relevant advancement in preventing CINV associated with highly and moderately emetogenic chemotherapy, particularly in the delayed phase. Anti-emetic drugs targeting the NK1R receptor include:  ·Aprepitant, the first NK1R receptor antagonist approved globally, was developed and clinically indicated by Merck. Aprepitant can be used in combination with other anti-emetics to prevent acute and delayed nausea and vomiting associated with the initial and repeat courses of high emetogenic cancer chemotherapy.  ·Fosaprepitant (L-758,298, MK-0517) is the second globally marketed NK1R receptor antagonist developed by Merck, with the initial indication still being chemotherapy-induced nausea and vomiting.  ·Rolapitant (SCH-619734) is a highly selective NK1R receptor antagonist originally developed by Schering Plough Corporation.  ·The mentioned combination of Netupitant/Palonosetron consists of the NK1R receptor antagonist Netupitant and the 5-HT3R antagonist Palonosetron. Developed by Helsinn Healthcare of Switzerland, it is indicated primarily for nausea and vomiting caused by chemotherapy. In the targeted antiemetic drugs treating GPCR-related targets, besides NK1R receptors, agents that interact with receptors like D2R, CB, and 5-HT, also represent significant market opportunities. As a relatively niche therapeutic avenue, currently, there are few GPCR-targeting antiemetic projects with marketing applications and clinical investigations. Prominent drugs include HR-20013, dronabinol hemisuccinate, and relamorelin. As reported, in December 2023, the CDE official site publicized that Suncadia Medicine, a subsidiary of Hengrui Pharmaceuticals, submitted an application for market approval of the injectable HR20013, which was accepted. HR20013 is a combination of NK-1RA and 5-HT3RA intended to be developed for the prevention of post-chemotherapy nausea and vomiting, with HR-20013 being an active component. Once administered, HRS5580 is rapidly converted into Rolapitant through non-CYP450 enzyme systems like thiol methyltransferase. Dronabinol is another product developed by INSYS Therapeutics as a non-selective CB receptor agonist. It is also used to treat nausea and vomiting induced by chemotherapy, especially when other antiemetic drugs have not been effective. Dronabinol functions by activating cannabinoid receptors in the brain, helping to reduce the sensation of nausea and decreasing the frequency of vomiting. It is typically available in the form of oral capsules, taken before chemotherapy to prevent nausea and vomiting. Although Dronabinol can effectively alleviate nausea and vomiting caused by chemotherapy, it may also have some side effects, including dizziness, dry mouth, fatigue, and confusion. Before using Dronabinol or any other medication, patients should discuss the potential benefits and risks with their healthcare professionals. How to obtain the latest research advancements in the field of biopharmaceuticals? In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!

Helsinn Group and Chugai Pharma Europe sign a partnership agreement renewal to commercialize AKYNZEO® in the UK and Ireland Lugano, Switzerland – June 12, 2024 – Helsinn Group (“Helsinn”), a global pharmaceutical company with a track record of over forty-five years of commercial execution and a strong focus in supportive care, oncology and dermato-oncology, and Chugai Pharma Europe Ltd (“Chugai”), the European subsidiary of Chugai Pharmaceutical Co, Ltd., one of Japan’s leading research-based pharmaceutical companies, today announced the signing of the Distribution and Licence Agreement renewal in the United Kingdom of Great Britain and Northern Ireland, and the Republic of Ireland, for AKYNZEO® (combination of netupitant-palonosetron), for the treatment of chemotherapy-induced nausea and vomiting (CINV) in adult patients. Troy Robinson, Managing Director at Chugai Pharma Europe, commented: “We are delighted to have signed this agreement with Helsinn and are proud to continue this collaboration. Oncology remains an important pillar of our Chugai business, and this agreement reflects our ongoing commitment to improving the quality of cancer care. Our joint efforts with Helsinn will ensure that we continue to support patients in the UK and Ireland throughout their cancer journey, providing access to AKYNZEO®, a valuable supportive care product.” Dr. Melanie Rolli, Helsinn Group CEO, commented: “This renewed partnership agreement with Chugai marks a significant milestone. Chugai has been an excellent partner for Helsinn over the past ten years. Our shared vision, values and unwavering dedication to supportive care will continue to fuel our collective journey in enhancing the quality of life for cancer patients in this crucial market. We look forward to exciting new opportunities that lie ahead with Chugai as we build upon our already robust and enduring foundation.” About AKYNZEO® AKYNZEO® is the first and only 5-HT3 and NK1 receptor antagonist fixed combination approved in adults for the prevention of acute and delayed nausea and vomiting associated with highly and moderately emetogenic chemotherapy. For additional information please see the EU Summary of Product Characteristics. About Chugai Pharma Europe Chugai Pharma Europe (CPE) is a regional business and wholly owned subsidiary of Chugai Pharmaceutical Co., Ltd., one of Japan’s leading research-based pharmaceutical companies and a member of the Roche Group. Established in 1993, CPE coordinates Chugai’s commercial, medical, and business activities in Europe, with a focus on oncology, rheumatology, and haematology. Headquartered in London, CPE also supports clinical research programmes for Japan, and explores co-development and in-licensing opportunities with an established network of partners. United by our purpose to shape a brighter, healthier future in Europe, our people are passionate about adding value to the medical community and human health. Supporting CPE to deliver advanced and sustainable patient-centric healthcare, and embody our core values to prioritize patient wellbeing, pursue innovation, and maintain the highest ethical and moral standards in everything we do. For more information, please visit https://www.chugai.eu/ or follow us on LinkedIn and x. About Helsinn Helsinn is a global pharmaceutical company that builds, manufactures, launches, and commercializes products to improve the quality of life for patients with cancer and chronic disease, with a focus on supportive care, oncology and dermato-oncology. Helsinn, headquartered in Lugano, Switzerland, has direct commercial operations in the U.S. and an extensive network of long-standing trusted partners enabling a commercial presence in more than 90 countries. Established in 1976, Helsinn is a third-generation family-owned company with broad pharmaceutical and technical expertise. Helsinn is proud of its history of operating with great integrity, passion and quality. The company is committed to continuously striving for innovation for its patients and embracing sustainable growth as a core element of its strategic vision. To learn more about Helsinn, please visit www.helsinn.com or follow us on LinkedIn and X. For more information: Helsinn Group Media Contact:Sabrina PerucchiGroup Communication ManagerLugano, Switzerland Tel: +41 (0) 91 985 21 21 Email: Info-hhc@helsinn.com Chugai Pharma Europe: Robert MackichanSenior PR & Communications Manager, EuropeLondon, UKTel: +44 (0) 20 8987 5600Email: r.mackichan@chugai-pharm.co.uk