Press Release
Ipsen and Medison Pharma Announce Health Canada Approval of Bylvay™ (odevixibat) for the treatment of pruritus due to Progressive Familial Intrahepatic Cholestasis (PFIC)
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Bylvay (odevixibat) is the first and only oral treatment available in Canada for the treatment of pruritus due to this rare genetic condition
ZUG, Switzerland and PARIS, Nov. 13, 2023 /PRNewswire/ — Today, Ipsen (Euronext: IPN) (ADR: IPSEY), a global biopharmaceutical company focused on transformative medicines in oncology, rare disease and neuroscience, and Medison Pharma ("Medison"), a global pharma company focused on providing access to highly innovative therapies to patients in international markets, are pleased to announce the Health Canada approval for Bylvay™ (odevixibat) for the treatment of pruritus in patients aged 6 months or older with Progressive Familial Intrahepatic Cholestasis (PFIC), a progressive and life-threatening liver disease. Bylvay is the first medication approved in Canada for the treatment of pruritus in patients aged six months or older with PFIC.
Medison and Ipsen are part of a multiregional partnership in both Canada and Israel to bring Bylvay, a highly innovative therapy for the treatment of pruritus due to PFIC, offering new hope for patients suffering from this rare disease, and their families.
"At Medison, accelerating patients’ access to innovative treatments is leading all that we do, so we are pleased and proud to bring Bylvay to patients in Canada," said Gil Gurfinkel, CEO at Medison Pharma. "We work hard, leveraging our multi-regional platform, to be the partner-of-choice for emerging biotech companies seeking to make their products available in international markets."
"Health Canada’s authorization of Bylvay brings an important medicine to Canadians living with PFIC and their families," said Stewart Campbell, Executive Vice President and President of North America, Ipsen. "Bringing new medicines to new markets where unmet need exists illustrates Ipsen’s mission to improve patient lives. We are pleased to work with Medison to get Bylvay to prescribers as soon as possible."
"I hope that the availability of Bylvay will immediately change the treatment paradigm for PFIC patients in Canada, providing physicians with a non-surgical option to help care for children with PFIC suffering from pruritus," said Dr. Binita Kamath, Division Head (interim), Gastroenterology, Hepatology and Nutrition, The Hospital for Sick Children in Toronto. "Being involved with the clinical investigation of odevixibat, I have firsthand experience with the value this therapy can offer families – including potentially better outcomes."
"Until today, surgery was the only treatment option available for PFIC patients," said Mr. Walter Perez, President, Progressive Familial Intrahepatic Cholestasis Advocacy and Resource Network and father of a child living with PFIC. "As families like mine know, managing symptoms of PFIC is very challenging. We are extremely pleased that a less invasive treatment option is now available."
About Bylvay™ (odevixibat)
Bylvay is a once-daily, non-systemic ileal bile acid transport inhibitor that acts locally in the small intestine and has minimal systemic exposure. It is approved in the U.S. for the treatment of pruritus in patients three months of age or older with PFIC, where it has orphan exclusivity. Bylvay was first launched as a treatment option for patients with PFIC in the U.S. in 2021, where it is supported by a program designed to assist with access to treatment and patient support. Bylvay also received regulatory approval in the E.U. for the treatment of PFIC in patients aged six months or older. It has launched in over nine countries and has secured public reimbursement across several major markets including Germany, Italy, the U.K., France and Belgium. In June 2023, Bylvay was also approved in the U.S. for the treatment of cholestatic pruritus in patients from 12 months of age with Alagille syndrome.
View full product monograph in Canada here.
Important Safety Information
Indication
Bylvay™ (odevixibat) is indicated for the treatment of pruritus in patients aged 6 months or older with progressive familial intrahepatic cholestasis (PFIC).
Limitation of use: Bylvay may not be effective in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in non-functional or complete absence of the bile salt export pump protein.
Contraindications
Odevixibat is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
Most Serious Warnings and Precautions
Liver test abnormalities: In clinical trials, increased levels of liver enzymes and bilirubin were observed in some patients receiving Bylvay. Assessment of hepatic laboratory tests (alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, alkaline phosphatase and total bilirubin) is recommended for all patients prior to initiating Bylvay, with monitoring per standard clinical practice.
Limited data are available in PFIC patients with cirrhosis or portal hypertension. Consider discontinuing Bylvay if a patient progresses to portal hypertension, cirrhosis or demonstrated hepatic decompensation.
Diarrhea has been reported as a common adverse reaction when taking Bylvay. Diarrhea may lead to dehydration. Patients should be monitored regularly to ensure adequate hydration during episodes of diarrhea. Interruption of treatment should be considered during acute episodes of diarrhea and/or vomiting that risk dehydration.
Fat-soluble vitamin deficiency: In clinical trials, decreased levels of fat-soluble vitamins A, D, E, and K (measured using international normalized ratio (INR)) and calcium were observed in some patients receiving Bylvay, as well as increased potassium levels. All observed decreases in calcium and increases in potassium were not considered to be clinically significant by the investigators.
Assessment of fat-soluble vitamin levels (Vitamins A, D, E), calcium, potassium and INR are recommended for all patients prior to initiating BYLVAY, with monitoring per standard clinical practice. Consider Bylvay discontinuation for fat-soluble-vitamin deficiency refractory to supplementation.
Other relevant warnings and precautions
- Conditions, medications, or surgical procedures that impair gastrointestinal motility, or enterohepatic circulation of bile acids
- Interaction with lipophilic medicinal products
- Pregnant women
- Women of child-bearing potential
- Nursing women
- Geriatrics – limited information in patients of 65 years
For more information
Please consult the Bylvay Product Monograph at https://www.medisonpharma.com/product-monographs/ for important information relating to adverse reactions, drug interactions and dosing information that has not been discussed in this piece. The Product Monograph is also available by calling 1-800-696-1341.
Bylvay does not require refrigeration and can be swallowed whole as a capsule, or opened and the pellets sprinkled onto soft food, or in liquid. This administration flexibility is a factor of importance for adherence in a pediatric patient population.
Health Canada’s approval of Bylvay was supported by data from PEDFIC 1the largest, global, Phase 3 trial ever conducted in PFIC. In PEDFIC 1, a randomized, double-blind, placebo-controlled study, Bylvay met both its pruritus (p=0.004) and serum bile acid (p=0.003) primary endpoints and was well tolerated with low incidence of diarrhea/frequent bowel movements (9.5 per cent of treated patients vs. 5.0 per cent of placebo patients). Bylvay was well tolerated with diarrhea/frequent stools being the most common treatment-related gastrointestinal adverse events. There were no serious treatment-related adverse events.
About Progressive Familial Intrahepatic Cholestasis (PFIC)
PFIC is a group of inherited liver diseases resulting from mutations in genes that impact bile secretion that are progressive and life-threatening. Typical onset of PFIC is in infancy or early childhood with a hallmark feature of this condition being severe and debilitating pruritus (itching), which has been shown to considerably reduce quality of life and can result in the need for liver transplantation.[i], [ii]
The estimated global incidence of PFIC is one in 50,000 to 100,000 people worldwide,[iii] resulting in a designation of this condition as extremely or ultra rare.[iv]
About Medison Pharma
Medison is a global pharma company focused on providing access to highly innovative therapies to patients in international markets. Medison is the first to create an international commercialization platform for highly innovative therapies, helping to save and improve lives by making the best available novel treatments accessible to patients in international markets. Medison has a track record of multi-territorial partnerships with leading pharmaceutical and biotech companies seeking to expand their global reach. To learn more visit www.medisonpharma.com
About Ipsen
Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With total sales of €3.0bn in FY 2022, Ipsen sells medicines in over 100 countries. Alongside its external-innovation strategy, the Company’s research and development efforts are focused on its innovative and differentiated technological platforms located in the heart of leading biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen has around 5,400 colleagues worldwide and is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com
For additional information, please contact:
Medison Pharma
Inbal Chen, Corporate Communications
M: +972 54 440 0784
E: [email protected]
Ipsen Contacts
Investors
Craig Marks Vice President, Investor Relations +44 (0)7584 349 193 | Nicolas Bogler Investor Relations Manager +33 6 52 19 98 92 |
Media | |
Jennifer Moore Senior Director, Global Corporate Communications +1 (347) 401-8583
Amy Wolf VP, Head of Corporate Brand Strategy & Communications +41 79 576 07 23
| Ioana Piscociu Senior Manager, Global Media Relations +33 6 69 09 12 96
|
Canadian media inquiries:
Dara Willis, Gage Communications
M: 416-836-9272
E: [email protected]
Ipsen’s forward-looking statements
The forward-looking statements, objectives and targets contained herein are based on Ipsen’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words ‘believes’, ‘anticipates’ and ‘expects’ and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen’s activities and financial results. Ipsen cannot be certain that its partners will fulfill their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen’s latest Universal Registration Document, available on ipsen.com.
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[i] Progressive Familial Intrahepatic Cholestasis Advocacy and Resource Network. Learn About PFIC Disease. https://www.pfic.org/learn-about-pfic-disease/. Accessed October 5, 2023.
[ii] Thompson, R., Arnell, H., et. al. Odevixibat treatment in progressive familial intrahepatic cholestasis: a randomized, placebo-controlled, phase 3 study. Lancet Gastroenterol Hepatol 2022; 7: 830–42.
[iii] Progressive Familial Intrahepatic Cholestasis Advocacy and Resource Network. Learn About PFIC Disease. https://www.pfic.org/learn-about-pfic-disease/. Accessed October 5, 2023.
[iv] Smith, C.I., Bergman, P., Hagey, D. Estimating the number of diseases – the concept of rare, ultra-rare, and hyper-rare. iScience. 2022; Aug 19; 25(8): 104698.
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Press Release
New Study Reveals Majority of Indians Prioritize Nutrition Over Taste, Surpassing Global Average
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Based on a recent survey of urban Indian consumers:
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Nine out of 10 consumers are searching for protein-rich food compared to seven out of 10 global shoppers. -
The top four qualities consumers look for when buying snacks are (1) natural, (2) heart-healthy, (3) protein-rich and (4) energy-source, all of which come before satisfying cravings. -
Nuts have emerged as one of the most popular snacking choices, with 86% of Indian shoppers report having purchased them in a span of 6 months. -
Urban Indians read nutrition labels more than the global average, reflecting a growing trend towards informed purchasing. -
69% of urban dwellers surveyed have the opinion that plant-based protein is just as good as meat-based protein, exceeding the global average of 55%.
Wonderful Pistachios, the world’s largest grower and processor of pistachios and distributor of California Pistachios in India, released today, World Nutrition Day, the findings of a new global study that sheds light on the snacking habits of urban Indians. The study, commissioned with Material, a leading global research consultancy, included 10 countries and over 12,400 respondents, revealed a new behavioural trend that urban Indian consumers prioritize nutrition over taste when it comes to snacking. This growing preference for healthy snacking emphasizes the importance of good nutrition for overall well-being.
For the India market specifically, the study delved into the snacking habits of 2,415 shoppers across six Indian cities, which represented a population of approximately 35.9 million consumers. Remarkably, a majority of urban Indians (58%) reported basing their food purchasing decisions on nutritional benefits more than taste, exceeding the global average of 52%. Delhi and Ahmedabad lead with over 60% of urban shoppers preferring nutrition in their food. Bengaluru and Chennai follow closely, indicating a nationwide shift towards smarter snacking preferences. In India, Millennials and Gen Z are leading the charge in health-conscious purchasing decisions, with more than 83% of consumers in these age groups reading nutritional labels before buying.
Indian consumers prioritize four key factors when shopping for nutritional snacks: natural (free of artificial colours and preservatives), heart-healthy, protein-rich, and provides energy. Nine out of 10 urban shoppers consciously seek protein-rich food options, compared to the global average of seven out of 10. The focus on nutrition has fueled the rise of nuts as a preferred snack choice, becoming essential to daily eating habits. The study found a staggering consumption of nuts, with 86% of Indian shoppers report purchasing them in a span of 6 months, compared to just 75% globally. With 6g of protein in per 28g serving, California Pistachios are a smart snack choice that provides benefits without sacrificing taste.
Shail Pancholi, Country Director, India, Wonderful Pistachios, commented on the study, saying, “Nuts were traditionally used as garnishes and consumed during festivals, but have now become a popular snack in India, indicating a notable shift in dietary habits. Pistachio consumption in India has doubled in the last six years, as consumer awareness of the nutritional benefits that pistachios offer has grown. Consumers are discovering that pistachios are naturally cholesterol-free, rich in plant-based protein and dietary fiber, and provide over 30 different vitamins and minerals.”
Interestingly, the study found that nuts are the second most preferred snack among urban Indian consumers, with 64% of Baby Boomers and 59% of Gen Z prioritizing nutrition over taste when selecting food. This indicates a growing focus on health across generations, with Baby Boomers focusing on senior wellness and Gen Z reflecting the rise of mindful purchasing. Though on opposite ends of the age spectrum, these two generations take the lead in seeking protein-rich options, as well as preferring natural snacks.
Mumbai tops most of the consideration sets when choosing a snack. Residents opt for natural ingredients (35% vs. the national average of 30%), heart-healthy options (33% vs. 30%), and protein (33% vs. 29%). Chennai residents look for energy-boosting snacks (31% vs. the national average of 29%).
The fact that 69% of urban Indians surveyed have the opinion that that plant-based protein is just as good as meat-based protein reflects a positive shift towards varied dietary preferences. Pistachios are a good source of high-quality complete protein, containing all nine essential amino acids. A 28g serving of pistachios provides 6g of protein, which is 11% of the recommended daily allowance (RDA) according to FSSAI.
The Wonderful Pistachios study unveils a compelling shift in Indian snacking habits. Nuts are evolving from festive treats to a daily snacking staple, fueled by a nationwide preference for more nutritious options. The trend transcends generations, resonating with Gen Z and Baby Boomers alike, underscoring the growing importance of mindful eating in urban India. As consumers increasingly seek natural, heart-healthy, protein-rich, and energy-boosting snacks, the future of Indian snacking appears to be firmly rooted in nutrition and well-being.
Wonderful Pistachios
Wonderful® Pistachios is the world’s largest grower and processor of pistachios, with a global presence in over 70 countries. As a vertically integrated operation, they are experts in every step of the process from tree to shelf, ensuring the highest-quality product every time. In tandem with its Grower Partners, Wonderful Pistachios harvests 125,000 sunny acres (50,000 hectares) of land in California that receive warm days and cool nights, which work in harmony with the rich, natural soils to create the perfect growing climate for high-quality pistachios. They ship 600 million pounds (204 million kg) of nuts worldwide from their advanced processing facilities to ensure the highest standards are met. When it comes to pistachios, Wonderful® Pistachios expertise is unmatched in scale and capacity, paired with warehouses and sales teams worldwide that are well-equipped to provide support at every step of the way.
California Pistachios
California Pistachios are grown and distributed by The Wonderful Company, the world’s largest vertically integrated pistachio processor and marketer located in California’s Central Valley. California Pistachios are Non-GMO, providing a smart, healthy choice for consumers around the world. Sun-ripened in the moderate Mediterranean climate of California, these distinctively green nuts pack taste and contain antioxidants and over 30 different nutrients. California Pistachios in India are available under leading brands and private labels at retail outlets, grocery stores, and online platforms.
For more information about California Pistachios India, please visit www.b2b.wonderfulpistachios.com
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SINGAPORE, May 31, 2024 /PRNewswire/ — Senior Minister of State for Communications and Information Tan Kiat How launched the Digital Enterprise Blueprint (DEB) at Asia Tech x Singapore (ATxSG) 2024 today. The Blueprint will enable SMEs to harness technology, optimise the way they work, and strengthen digital resilience and cybersecurity across the ecosystem. 50,000 SMEs are expected to benefit over the next five years through four key focus areas:
- Empower enterprises to be smarter by adopting AI-enabled solutions
- Enable enterprises to scale faster through cloud-based and integrated solutions
- Equip enterprises to be safer through improved cyber resilience
- Support enterprises to upskill workers to make full use of digital capabilities
Seven partners have come onboard to pledge their commitment, including Singapore Business Federation, Singapore Computer Society, SGTech, Amazon Web Services, Google, Microsoft and Salesforce.
In collaboration with IMDA and the TechSkills Accelerator for ITE and Polytechnics Alliance, SGTech is launching the Tech Apprenticeship Programme to expand the career pathways of graduates by providing access to industry apprenticeships that offer on-the-job training and development opportunities. Over the next two and a half years, SGTech aims to facilitate the placement of at least 300 apprentices who are fresh or mid-career professionals from polytechnic or ITE backgrounds, and drive the adoption of similar practices that promote more inclusive hiring and career agility.
IMDA and the Singapore Academy of Law (SAL) signed an MoU aimed at uplifting the legal sector’s productivity through the use of GenAI. As part of this partnership, GPT-Legal, a new large language model which is contextualised for Singapore’s legal sector, will be co-developed. The model will be integrated into SAL’s research platform LawNet, which is accessible by 75% of Singapore’s lawyers. SAL will also be penning an MoU with the National University of Singapore and AI Singapore to develop its AI capabilities and create a certification to recognise AI specialists in the legal profession.
Additionally, Tribe and Digital Industry Singapore announced a collaboration with NVIDIA to launch the Ignition AI Accelerator for AI startups to create and bring to market the next wave of advancement in AI solutions. This programme will nurture 15 high-potential startups, equipping them with well-rounded support covering business and technical needs. NVIDIA and Tribe will also collaborate with EnterpriseSG to offer qualified AI startups funding support through the Startup SG Tech scheme, and assist them through the IMDA Accreditation process.
Singapore hosted the final meeting of the UN Secretary-General’s Artificial Intelligence Advisory Body (AIAB) from 28-29 May. As part of the agenda, Singapore facilitated an engagement session between AIAB and the Digital Forum of Small States (Digital FOSS). Digital FOSS Fellows exchanged views with AIAB members on the topic of AI governance, particularly on the implications and challenges faced by small states. Through such efforts, Singapore aims to promote a more inclusive approach towards shaping global AI and digital governance.
Contact:
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SHENZHEN, China, May 31, 2024 /PRNewswire/ — By 2040, the burden of colorectal cancer (CRC) is projected to increase to 3.2 million new cases and 1.6 million deaths per year representing a 66% and 71% rise in new cases and deaths respectively relative to 2020.
To better address the global burden of CRC and reduce its impact, BGI Genomics has launched the second edition of its global CRC awareness report, covering 1,938 respondents from Brazil (306), China (367), Poland (300), Saudi Arabia (300), Thailand (362), and Uruguay (303):
CRC Screening Gaps Vary Globally: Nearly half (49.3%) of global respondents have never undergone CRC screening, with the highest proportions in Saudi Arabia (62.0%) and Poland (61.0%).
Preference for Fecal Testing Over Colonoscopy: Although colonoscopies are more recognized (33.4%), fecal tests at healthcare facilities are preferred (31.8%), reflecting a trend towards non-invasive methods.
Cost and Fear are Determinants of Screening Choice: Fear of colonoscopy (18.2%) and screening costs (17.7%) are major barriers to CRC screening. Poland (24.7%) and Uruguay (21.0%) show the highest fear of colonoscopy, while Thailand (24.5%) and Brazil (20%) indicate the most concern about costs.
Medical Advice and Family History Drive CRC Screening: Doctor’s recommendations are a major driver for CRC screening (30.5% globally), with Uruguay showing the highest adherence (44.1%). Additionally, those with a family history of CRC are more proactive in screening (64.5%), compared to the general population (35.0%).
Prof. Varut Lohsiriwat from Mahidol University offers his insights to this report. He suggested: “The essence of effective cancer screening lies in the acceptance and adherence of the patient to the screening method. The best screening method is the one that the patient accepts and adheres to because that’s the method that will actually benefit them.”
Dr. Zhu Shida, BGI Genomics Deputy GM, notes: “At BGI Genomics, we focused our efforts on developing advanced molecular biology testing techniques to close the gap [between acceptance and accessibility]. The ultimate goal is to transform colorectal cancer from a life-threatening disease into a manageable condition through widespread, early screening and intervention.”
For more region-level comparisons, access the full BGI Genomics 2024 State of CRC Awareness Report.
All data involved in this report come from the results of an online survey project conducted by BGI Genomics. It only surveys awareness related to colorectal cancer and does not involve personally identifiable data.
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New Study Reveals Majority of Indians Prioritize Nutrition Over Taste, Surpassing Global Average
Singapore Prepares Ahead to Leverage Artificial Intelligence for a Better Future
One in Six Globally Concerned About Colorectal Cancer Screening Costs
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