Patients and prescribers need to be aware of adverse drug events to minimize the risk of their occurrence and the severity with which they appear. However, numerous studies show that being informed about adverse events can increase the possibility of suffering from them. Patients tend to overestimate the likelihood of experiencing the adverse events included in the label, and this can contribute to worsening the negative expectations which are at the root of the nocebo effect. In fact, patients can become anxious after reading the undesirable effects section of the leaflet and, in addition to suffering from the nocebo effect, might not take a drug they could benefit from due to the fear of experiencing adverse events. In addition, patients' attention can focus towards non-specific symptoms of daily living that can be misattributed to the drug and included in the labelling. This article proposes a number of suggestions to reduce the abovementioned unintended effects associated with labelling, namely, an increased focus on the excess risk of experiencing adverse events rather than crude incidence, using attribute framing to help patients to better understand the risk of experiencing adverse events, dividing the undesirable effect section of the leaflet into subsections according to the level of evidence supporting causal relationships and, finally, restricting the addition of non-specific adverse events that are also symptoms of daily living to only those where there is enough evidence to show they have been caused by the drug. More studies on how to minimize the nocebo effect induced by adverse event information should be performed, and these should be done in collaboration with health authorities, to reach a shared consensus on how to better present adverse event information in the label.

2012-08-01·Drug safety2区 · 医学

Using Resources for Scientific-Driven Pharmacovigilance

2区 · 医学

Article

作者: Furlan, Giovanni

Current regulations require a description of the overall safety profile or the specific risks of a drug in multiple documents such as the Periodic and Development Safety Update Reports, Risk Management Plans (RMPs) and Signal Detection Reports. In a resource-constrained world, the need for preparing multiple documents reporting the same information results in shifting the focus from a thorough scientific and medical evaluation of the available data to maintaining compliance with regulatory timelines. Since the aim of drug safety is to understand and characterize product issues to take adequate risk minimization measures rather than to comply with bureaucratic requirements, there is the need to avoid redundancy. In order to identify core drug safety activities that need to be undertaken to protect patient safety and reduce the number of documents reporting the results of these activities, the author has reviewed the main topics included in the drug safety guidelines and templates. The topics and sources that need to be taken into account in the main regulatory documents have been found to greatly overlap and, in the future, as a result of the new Periodic Safety Update Report structure and requirements, in the author's opinion this overlap is likely to further increase. Many of the identified inter-document differences seemed to be substantially formal. The Development Safety Update Report, for example, requires separate presentation of the safety issues emerging from different sources followed by an overall evaluation of each safety issue. The RMP, instead, requires a detailed description of the safety issues without separate presentation of the evidence derived from each source. To some extent, however, the individual documents require an in-depth analysis of different aspects; the RMP, for example, requires an epidemiological description of the indication for which the drug is used and its risks. At the time of writing this article, this is not specifically required by other documents. The author has identified signal detection (intended not only as adverse event disproportionate reporting, but including non-clinical, laboratory, clinical analysis data and literature screening) and characterization as the basis for the preparation of all drug safety documents, which can be viewed as different ways of presenting the results of this activity. Therefore, the author proposes to merge all the aggregate reports required by current regulations into a single document - the Drug Safety Master File. This report should contain all the available information, from any source, regarding the potential and identified risks of a drug. It should be a living document updated and submitted to regulatory authorities on an ongoing basis.

Bollettino chimico farmaceutico

Comparative in vitro evaluation of nimesulide-containing preparations on the Italian market.

Article

作者: Bonadeo, D ; Zema, L ; Foppoli, A ; Butler, D ; Giordano, F ; Maroni, A

Nimesulide is a quite popular non-steroidal anti-inflammatory drug (NSAID), which has been demonstrated to preferentially inhibit cycloxygenase-2 (COX-2), thus exerting milder gastrointestinal and renal side effects. Apart from the original products (Aulin and Mesulid), several copy and generic nimesulide-containing preparations are presently available on the Italian market. Generics are defined by the World Health Organization (WHO) as interchangeable multi-source pharmaceutical products and, according to international regulatory issues, their bioequivalence to an already marketed reference product has to be proven. Due to its physico-chemical properties, and in particular to the low solubility, nimesulide appears to be a critical molecule from a biopharmaceutical point of view. On the basis of these premises, the aim of the present work was to perform a comparative evaluation of tablets in vitro behaviour for the best-selling copy (Sulidamor) and generic (Nimesulide Dorom) in reference to the original products. The results provided by the dissolution test pointed out statistically significant differences in the in vitro behaviour displayed by the original products on one hand and by the copy as well as generic preparations in exam on the other.

项与 Helsinn Birex Pharmaceuticals Ltd. 相关的新闻（医药）

2023-06-12

·GlobeNewswire-Health Care

Helsinn announces publication of data evaluating impact of AKYNZEO® (fosnetupitant/palonosetron) on treatment outcomes and healthcare costs

Lugano, Switzerland, June, 12, 2023 - Helsinn Group (“Helsinn”), a fully integrated global biopharma company with a track record of over forty years of commercial execution and a strong focus in oncology and rare diseases, announces the publication of real-world evidence of AKYNZEO® (fosnetupitant with palonosetron) injection/for injection in the journal Advances in Therapy. The article, “Real-world Treatment Outcomes, Healthcare Resource Use, and Costs Associatedwith Antiemetics Among Cancer Patients on Cisplatin-based Chemotherapy”, evaluates the effect of AKYNZEO® on rates of chemotherapy-induced nausea and vomiting (CINV) events, inpatient and outpatient visits, as well as treatment costs. AKYNZEO® was compared to fosaprepitant/palonosetron (APPA) combination among patients who received cisplatin-based chemotherapy in the US. The study analyzed a medical and pharmacy claims data source which was created using the all-payer claims databases (APCD) compiled and maintained by the Agency for Healthcare Research and Quality. The dataset provides insight to nearly 80% of the US healthcare system, with patient-level data from all provider types. Referring to the details of the publication below, these real-world data showed that healthcare resource utilization, such as CINV-related visits were significantly lower after AKYNZEO® compared to fosaprepitant/palonosetron (APPA). CINV-related healthcare costs were also statistically and/or numerically lower for patients receiving AKYZNEO® compared to APPA. The study findings suggest that the downstream resource use and cost impact of AKYNZEO® and APPA is not equivalent. As clinicians are making therapeutic decisions on CINV prevention, the use of real-world data can contribute to thoughtful selection of therapy to result in better resource use and cost outcomes. Dr. Rudolph Navari, MD, PhD, FACP, Hematologist Oncologist and Lead Author commented: “Despite many available antiemetic options, CINV control remains suboptimal, which carries a substantial economic and quality of care burden. There remains a gap between expected and actual patient outcomes as clinicians translate trial data and clinical guidelines into practice. Real-world studies like ours generate evidence based on day-to-day clinical experiences and can enable practical improvements in oncology practices.” Details of the publication: Title: Real-world Treatment Outcomes, Healthcare Resource Use, and Costs Associated with Antiemetics Among Cancer Patients on Cisplatin-based ChemotherapyAuthors: Rudolph M. Navari, Winnie W. Nelson, Sofia Shoaib, Risho Singh, Weiping Zhang, William L. BaileyLink: https://link.springer.com/article/10.1007/s12325-023-02537-7 The study retrospectively analyzed claims data from 15,696 patients (421 AKYNZEO® and 15,275 APPA) who received cisplatin-based chemotherapy and the study antiemetic regimens between 1 January 2016 and 31 October 2020. Nausea and vomiting visit data were collected within 1 to 14 days after chemotherapy. A CINV-specific claim was defined as any post-chemotherapy claim during the 14-day follow-up period with nausea or vomiting in any position of the claim. In addition, all-cause and CINV-related HCRU for inpatient and outpatient settings were assessed, and costs were adjusted to 2021 US dollars. Logistic regression was used to evaluate the treatment outcomes in the follow-up period. Generalized linear models (GLM) were used to examine all-cause and CINV-related healthcare resource utilization and costs. Results from the study reported all-cause and CINV-related resource use and costs of AKYNZEO® and APPA: The mean number of all-cause inpatient visits per patient was lower among AKYNZEO® patients (4.83 vs. 5.41, p = 0.0195).The mean number of all-cause outpatient visits per patient was not statistically different between study groups (39.23 vs. 42.90; p = 0.0835).The mean number of CINV-related inpatient visits per patient was lower among AKYNZEO® patients (0.20 vs. 0.32, p<0.0001).The mean number of CINV-related outpatient visits per patient was lower among AKYNZEO® patients (1.32 vs. 2.49, p<0.0001).Mean all-cause inpatient costs per patient were not significantly different between study groups ($32,457 vs. $30,735; p = 0.0665).Mean all-cause outpatient costs per patient were significantly lower for AKYNZEO® ($83,070 vs. $126,263, p<0.0001).Mean CINV-related inpatient costs per patient were significantly lower for AKYNZEO® ($33 vs. $163, p<0.0001).Mean CINV-related outpatient costs per patient were not significantly different between study groups ($7,848 vs. $8,690, p = 0.4339). Limitations of this study include the potential errors in medical diagnostic coding in the insurance claims, the absence of clinical risk factors for nausea and vomiting in claims data, and the inability to track the use of low-cost medications such as olanzapine and dexamethasone. Lastly, statistical analyses for variables with a sample size less than 10 were not reported in accordance with the Agency for Healthcare Research and Quality's (AHRQ) data use agreement. About AKYNZEO® in the US INDICATION AKYNZEO® (netupitant 300mg/palonosetron 0.5mg) capsules was approved in October 2014 in the United States and is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO® (fosnetupitant 235mg/palonosetron 0.25) for injection was approved in April 2018 and AKYNZEO® injection was approved in May 2020 in the United States. Each is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. Limitations of Use: AKYNZEO® for injection and AKYNZEO® injection have not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy. AKYNZEO® is a combination of palonosetron, a serotonin-3 (5-HT3) receptor antagonist, and netupitant or fosnetupitant, substance P/neurokinin-1 (NK1) receptor antagonists: palonosetron prevents nausea and vomiting during the acute phase and netupitant/fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. IMPORTANT SAFETY INFORMATION Warnings and Precautions: Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving palonosetron, one of the components of AKYNZEO®, with or without known hypersensitivity to other 5-HT3 receptor antagonists. Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs. Serotonin syndrome can be life threatening. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue AKYNZEO® and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if AKYNZEO® is used concomitantly with other serotonergic drugs. Adverse Reactions: Most common adverse reactions for AKYNZEO®: headache, asthenia, dyspepsia, fatigue, constipation and erythema. Drug-drug Interactions: Use with caution in patients receiving concomitant medications primarily metabolized by CYP3A4 isoenzyme. The plasma concentrations of CYP3A4 substrates can increase when co-administered with AKYNZEO®. The inhibitory effect on CYP3A4 can last for multiple days. Dexamethasone doses should be reduced when given with AKYNZEO®. A more than two-fold increase in the systemic exposure of dexamethasone was observed 4 days after a single dose of netupitant or a single infusion of fosnetupitant. Consider the potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) when administering with AKYNZEO®. When administered with netupitant, the systemic exposure to midazolam was significantly increased. Avoid concomitant use of AKYNZEO® in patients on chronic use of a strong CYP3A4 inducer such as rifampin as this may decrease the efficacy of AKYNZEO®. Use in Specific Populations: Avoid use of AKYNZEO® in patients with severe hepatic impairment, severe renal impairment, or end-stage renal disease. Avoid use in pregnancy, limited data is available, may cause fetal harm. For more information about AKYNZEO® please see the full US Prescribing Information About Helsinn Helsinn is a fully integrated global biopharma company headquartered in Lugano, Switzerland. It is focused on improving the lives of cancer patients all over the world with a leading position in cancer supportive care and a focus on cancer therapeutics and rare diseases. Helsinn is a third-generation family-owned company, that since 1976 has been focused on improving the lives of patients, guided by core values of respect, integrity and quality. Helsinn’s unique business model enables it to in-license or acquire assets at a late stage of development. It has a commercial presence in 190 countries either directly, with operating subsidiaries in the U.S. and China, or via its network of long-standing trusted partners. Helsinn also has a fully integrated supply chain and product development through its subsidiary in Ireland, Helsinn Birex Pharmaceuticals Ltd. Helsinn plays an active and central role in promoting social transformation in favor of people and the environment. Sustainability is at the heart of everything we do, which is reinforced in the company’s strategic plan by a commitment to sustainable growth. To learn more about Helsinn please visit: www.helsinn.com For more information: Helsinn Media Contact: Paola Bonvicini, Group Head of Communication Lugano, Switzerland Tel: +41 (0) 91 985 21 21 Email: Info-hhc@helsinn.com For more information, please visit www.helsinn.com and follow us on Twitter and LinkedIn

上市批准临床结果

2023-01-24

·GlobeNewswire-Health Care

Helsinn and Immedica enter exclusive partnership for commercialisation of cancer supportive care products in core European markets

Helsinn and Immedica enter exclusive partnership for commercialisation of cancer supportive care products in core European markets LUGANO, Switzerland and STOCKHOLM, Sweden – January 24, 2023 – Helsinn Group (“Helsinn”), a fully integrated global biopharma company with a track record of over forty years of commercial execution and a strong focus in oncology and rare diseases, and Immedica Pharma AB, a pharmaceutical company focused on commercialisation of rare and specialty care products, today announce that the companies have entered an exclusive long-term license and distribution agreement for the commercialisation of two cancer supportive care products indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV) in core European markets: AKYNZEO® (Netupitant-Palonosetron fixed combination) and ALOXI® (Palonosetron). Under the licence and distribution agreement Immedica will commercialise AKYNZEO® in Portugal, Spain, France, Switzerland, the Netherlands, Belgium, Luxembourg and Liechtenstein, ALOXI® in Switzerland, Belgium, Liechtenstein. Anders Edvell, CEO of Immedica commented: “We are very pleased to have signed this agreement with Helsinn. Side-effects of cancer treatments have a significant impact on the quality of life of these severely ill patients. AKYNZEO® and ALOXI® are also an important addition to Immedica’s Oncology & Haematology portfolio.” Dr. Melanie Rolli, Helsinn Group CEO, commented: “This partnership will provide important treatment options for CINV across Europe. We look forward to working closely with Immedica in the months and years ahead to ensure more and more patients can access these important supportive care products.” About AKYNZEO® AKYNZEO® is the first and only 5-HT3 and NK1 receptor antagonist fixed combination approved in Europe in adults for the prevention of acute and delayed nausea and vomiting associated with cisplatin-based highly emetogenic chemotherapy and moderately emetogenic chemotherapy. AKYNZEO® is currently registered and available in more than 60 Countries About ALOXI® ALOXI® is approved in Europe in adults for the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. ALOXI® is also indicated in paediatric patients 1 month of age and older for the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. ALOXI® is currently registered and available in more than 40 Countries. About Immedica PharmaImmedica is a fast-growing private niche pharma group, headquartered in Stockholm, Sweden with commercial coverage across Europe and the Middle East. Immedica provides significant know-how and experience from commercialization of niche/specialty care products across Europe and the Middle East, and the company’s management team has an outstanding track record of operating niche pharma products internationally. Immedica has capabilities to provide optimal access of specialty care medicines to patients with significant medical needs, including key areas such as regulatory affairs, pharmacovigilance, medical affairs, pricing & reimbursement, quality, and product distribution. Immedica’s main owner is Impilo AB, a private Nordic investment company established in 2017, with more than SEK 10 billion in committed capital from leading Nordic and international investors. For more information visit www.immedica.com. About Helsinn Helsinn is a fully integrated global biopharma company headquartered in Lugano, Switzerland. It is focused on improving the lives of cancer patients all over the world with a leading position in cancer supportive care and a focus on cancer therapeutics and rare diseases. Helsinn is a third-generation family-owned company, that since 1976 has been focused on improving the lives of patients, guided by core values of respect, integrity and quality. Helsinn’s unique business model enables it to in-license or acquire assets at a late stage of development. It has a commercial presence in 190 countries either directly, with operating subsidiaries in the U.S. and China, or via its network of long-standing trusted partners. Helsinn also has a fully integrated supply chain and product development through its subsidiary in Ireland, Helsinn Birex Pharmaceuticals Ltd. Helsinn plays an active and central role in promoting social transformation in favor of people and the environment. Sustainability is at the heart of everything we do, which is reinforced in the company’s strategic plan by a commitment to sustainable growth.To learn more about Helsinn please visit: www.helsinn.com For more information: ImmedicaLinda HolmströmHead of Communicatione-mail: linda.holmstrom@immedica.comPhone: + 46 708 73 40 95 Helsinn Group Media Contact:Paola Bonvicini Group Head of Communication Lugano, Switzerland Tel: +41 (0) 91 985 21 21 Email: Info-hhc@helsinn.com For more information, please visit www.helsinn.com and follow us on Twitter and LinkedIn

引进/卖出上市批准

2023-01-10

·GlobeNewswire-Health Care

Helsinn closes financing agreement with Oberland Capital

Helsinn closes financing agreement with Oberland Capital Funding secured to expand the portfolio of late- and commercial-stage oncology and rare disease products through in-licensing or acquisitionDr Melanie Rolli recently appointed to lead and execute on Helsinn’s strategy Lugano, Switzerland, January 10, 2023 - Helsinn Group (“Helsinn”), a fully integrated, global biopharma company with a track record of over forty years of commercial execution and a strong focus in oncology and rare diseases, following the announcement of the newly appointed CEO, Dr Melanie Rolli, today announces a financing agreement with Oberland Capital Management LLC (“Oberland Capital”). Guided by its core values of respect, integrity and quality, Helsinn’s strategy focuses on being the partner of choice as a commercial-stage enterprise with a strong focus in oncology and rare diseases, able to reach patients worldwide through its integrated CMC/manufacturing/supply and commercial platform complemented by scientific and technological expertise. Riccardo Braglia, Executive Chairman of Helsinn, commented: “Helsinn has partnership agreements with over 40 long-standing partners worldwide in 190 countries, and is a partner of choice for the biotech and pharma sector due to its expertise and late-stage development and commercialization of oncology and rare disease products. With its strong position which supports the integrated CMC, manufacturing, supply and commercial platform complemented by scientific and technical expertise, Helsinn is positioned to get more products to patients worldwide.” Dr Melanie Rolli, recently appointed Chief Executive Officer at Helsinn, said: “I am pleased that we have secured this funding from Oberland Capital which will allow us to expand the portfolio of late- and commercial-stage oncology and rare disease products. With an underlying stable business and this additional financial strength, we are well positioned to identify and partner with companies that share our focus on extending and improving the lives of people with cancer all over the world.” William Clifford, Partner at Oberland Capital added: “We are excited to partner with Helsinn and support its strategy of in-licensing or acquiring oncology and rare disease products that address unmet medical needs. Our flexible investment structure is designed to enable Helsinn to expand its robust commercial platform and to generate significant operating leverage.” About Oberland Capital Oberland Capital is a private investment firm formed in 2013 with assets under management in excess of $3 billion, focused exclusively on investing in the global healthcare industry and specializing in flexible investment structures customized to meet the specific needs of its transaction partners. Oberland Capital’s broad suite of financing solutions includes monetization of royalty streams, acquisition of future product revenues, creation of project-based financing structures, and investments in traditional debt and equity. With a combination of deep industry knowledge and extensive structured finance experience, the Oberland Capital team has a history of creating value for its transaction partners. For more information, please visit www.oberlandcapital.com. About Helsinn Helsinn is a fully integrated global biopharma company headquartered in Lugano, Switzerland. It is focused on improving the lives of cancer patients all over the world with a leading position in cancer supportive care and a focus on cancer therapeutics and rare diseases. Helsinn is a third-generation family-owned company, that since 1976 has been focused on improving the lives of patients, guided by core values of respect, integrity and quality. Helsinn’s unique business model enables it to in-license or acquire assets at a late stage of development. It has a commercial presence in 190 countries either directly, with operating subsidiaries in the U.S. and China, or via its network of long-standing trusted partners. Helsinn also has a fully integrated supply chain and product development through its subsidiary in Ireland, Helsinn Birex Pharmaceuticals Ltd. Helsinn plays an active and central role in promoting social transformation in favor of people and the environment. Sustainability is at the heart of everything we do, which is reinforced in the company’s strategic plan by a commitment to sustainable growth. To learn more about Helsinn please visit www.helsinn.com For more information: Helsinn Media Contact: Paola Bonvicini Group Head of Communication Lugano, Switzerland Tel: +41 (0) 91 985 21 21 Email: Info-hhc@helsinn.com For more information, please visit www.helsinn.com and follow us on Twitter and LinkedIn

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