Raymond James Strengthens Healthcare, Biotechnology, and Cannabis Research: Rahul Sarugaser Joins Canadian Team
TORONTO, July 11, 2019 /CNW/ - Raymond James Ltd., the Canadian arm of North American investment dealer Raymond James Financial Inc., today announced that Rahul Sarugaser has joined its Canadian Equity Research team as Managing Director, Equity Analyst, Healthcare, Biotechnology & Cannabis.
"Rahul brings a combination of extensive medical sector expertise and financial analysis into this important role," says Daryl Swetlishoff, Head of Research at Raymond James Ltd. "Our focus will be on covering Canadian growth-oriented firms pursuing enhanced medical solutions in the biotechnology, healthcare, wellness, medical devices, and cannabis fields."
Rahul holds a PhD and MASc in Biomedical Engineering from the University of Toronto, and an MBA from the University of Oxford.
Also joining Rahul is Michael Freeman, Equity Research Associate. Michael has solid engineering and biotechnology industry experience and holds an MASc in Chemical Engineering from the University of Toronto.
Raymond James is strongly positioned in the Healthcare sector across North America, with a team of 45 dedicated Healthcare investment bankers and 15 research analysts covering over 260 Healthcare companies. "With changing technologies and ground breaking scientific discoveries, the Healthcare industry is evolving rapidly," says Rahul Sarugaser. "Partnering with Raymond James' powerful Healthcare team creates an exciting opportunity to uncover differentiated investment ideas for our Institutional and Private Client investors alike."
Raymond James is a leading North American independent full service investment dealer offering an extensive range of professional investment services and products, including: private client services, financial and estate planning services, portfolio management, insurance, equity research, investment banking, and institutional sales and trading. Through its network of approximately 7,900 financial/investment advisors across Canada, the United States, and key international centres, Raymond James manages more than US$796 billion in client assets under administration. The firm also has over 65 research analysts covering more than 1,300 companies in Canada, the United States, and internationally.
SOURCE Raymond James Ltd.
ESPEROCT® is now approved in Canada for the Treatment of Hemophilia A in both Children and Adults
New treatment can help Canadians living with hemophilia A better manage their bleeding episodes
TORONTO, July 12, 2019 /CNW/ - Novo Nordisk announced today that Health Canada has approved ESPEROCT® (Antihemophilic Factor VIII (Recombinant, B-Domain Truncated), PEGylated) for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:
Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
On-demand treatment and control of bleeding episodes
Perioperative management of bleeding.1
"Canadians living with hemophilia A are at risk of bleeding for longer periods of time. If not treated appropriately, those bleeding episodes, particularly into joints and muscles, can be painful, lead to joint damage and muscular atrophy over the patient's lifetime and in some cases can be life threatening," said Dr. Anthony Chan, OOnt, Professor of Paediatrics, McMaster University. "ESPEROCT® has been shown to be effective in reducing the risk of bleeding episodes among patients."
Health Canada's approval is based on the findings from three multinational, open-label, non-controlled trials in male subjects with severe hemophilia A, which is defined as having less than 1 per cent of the normal level of factor VIII in the blood.2,3 All subjects were previously treated, having received other FVIII products for more than 150 exposure days for adolescents and adults and more than 50 exposure days for pediatric subjects.4
"The Canadian Hemophilia Society advocates for access to the widest possible range of coagulation therapies and welcomes the regulatory approval of this additional option for the treatment of hemophilia A," said Paul Wilton, President, Board of Directors, Canadian Hemophilia Society.
Overall, ESPEROCT® was shown to provide effective prophylaxis and maintain a low median ABR of 1.18 when dosed at 50 IU/kg every 3-4 days in adults and adolescents (those aged 12 years and over) and a median ABR of 1.95 in children under 12 years of age when dosed twice weekly at 60 IU/kg (50-75 IU/kg).5
Across the clinical trials and age groups, ESPEROCT® was well tolerated and had no safety concerns identified.6 The safety profile of ESPEROCT® is similar to what has been reported for other long-action FVIII products.7
About Hemophilia A
Hemophilia A is an X-linked, recessive disorder caused by a deficiency of functional plasma clotting factor VIII (FVIII), which may be inherited or arise from spontaneous mutation.8 One out of three cases for the estimated 2,500 Canadians living with hemophilia A are caused by a new genetic mutation. 9,10 The most common symptom associated with hemophilia is a bleeding problem, which can lower the overall quality of life for many patients.11
About ESPEROCT®
ESPEROCT® (turoctocog alfa pegol, N8-GP) is an extended half-life factor VIII molecule for replacement therapy in people with hemophilia A. In adults, the half-life for ESPEROCT® was determined to be 19 hours compared to 12 hours for unmodified FVIII products, using the chromogenic assay.12
About Novo Nordisk
Novo Nordisk is a global healthcare company with 95 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, hemophilia, growth disorders and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs approximately 43,200 people in 79 countries, and markets its products in more than 170 countries. For more information, visit novonordisk.ca, Twitter and YouTube.
CAN YOU BIOHACK YOUR BRAIN FOR A BETTER RELATIONSHIP?
Neuroscience Expert Shares Fascinating Link Between Brainwave Training & Its Effect on Romance & Emotional HealthDating and relationships are hard work - especially in 2019. The changing face of modern romance has led to some pretty depressing stats: A recent survey found that more than 50% of sexually active individuals are dissatisfied with their sex lives; only 30% of Internet daters are in search of true love as opposed to hookups; and a staggering 23% of women aren’t happy in their relationships! It's no wonder nearly half of all marriages today end in divorce.Before you lose all faith in modern romance and turn your back on love, there may be some hope. Though some argue technology is the leading culprit in romantic demise, new tech has also given us incredible insight into love and relationships. According to Neuroscience expert Dr. Patrick Porter, there is a fascinating link between brainwaves and romance.We can't see it, but brains hum with these waves of electrical activity. At the root of all our thoughts, emotions, and behaviors is the communication between neurons within our brains. Changing our brainwaves has a dramatic effect on our physical, mental, and emotional health."Brainwave training has been found to help people de-stress and achieve emotional balance. It is proven to help people who struggle with stress, anxiety, difficulty sleeping, fatigue, - all of which are extremely important factors when it comes to romance and relationships..."...says Dr. Porter, who recently presented research along with Arianna Huffington at the National Biohacking Conference in Los Angeles. According to research, sleep plays a major role in relationships. When we sleep poorly, the parts of our brain devoted to emotional empathy don’t function as well. Sleep loss causes social withdrawal and loneliness and it helps us to be less angry and aggressive. Not surprisingly, anxiety and stress can also negatively impact your relationship. It can lead to inappropriate suspiciousness or paranoia, overthinking, being indecisive, and an appropriate need for reassurance and support.Though there are several methods of brainwave entrainment, one of the most effective is "braintapping" which uses auditory and visual stimulation to synchronize and balance brainwaves. As the light and sound frequency changes, so does the frequency in the brain. Brainwave training stabilizes the limbic system which is involved in motivation, emotion, learning, and memory. Your body is calmed, your breathing becomes rhythmic, your hands warm, and your muscles relax. "The light and sound stimulation boost brain levels of serotonin, beta-endorphins, and norepinephrine. These are the same chemicals that are released during attraction and make us giddy, energetic, and euphoric," says Porter. Brainwave training and biohacking have made tremendous advances in treating mental health conditions which are closely tied to relationships. Although in the past, brainwave training and biohacking have received criticism for being unregulated, biohackers argue that's exactly why it needs to be studied and have close attention by the public. Dr. Porter is sharing the fascinating link between brainwave training and its impact on romance and emotional health and he can also explain why balancing brainwaves may improve your love life.IN AN INTERVIEW OR ARTICLE, DR. PORTER CAN DISCUSS:Brainwaves and relationships: the science of love.The fascinating link between brainwave training and its impact on romance and emotional health.Why balancing brainwaves may improve your love life.Biohacking - the latest trend in health and wellness.How to biohack your brain with light, sound, and vibration.What mainstream biohacking means for the healthcare industry. ABOUT DR. PATRICK PORTER:Dr. Patrick K. Porter, PhD, is an award-winning author and speaker who has devoted his career to neuroscience and brainwave entrainment. As the creator of BrainTap Technology™, Porter has emerged as a leader in the digital health and wellness field. BrainTap’s digital tools and mind development apps use Creative Visualization and Relaxation, a biohacking technique that has made tremendous advances in treating mental, physical, and emotional health issues. Braintap has been praised for helping people overcome stress and insomnia, lose weight, stop smoking, manage pain, accelerate learning, and much more. FOR MORE INFORMATION, VISIT: www.braintap.com
Bhang Commences Trading on the CSE Under the Symbol ‘BHNG’
Miami, Florida, July 11, 2019 – Bhang Corporation (“Bhang” or the “Company”) (CSE: BHNG), a cannabis house of brands with an extensive, award-winning portfolio of products, announced today that, further to its news release on July 9, 2019, it will begin trading on the Canadian Stock Exchange (“CSE”) as Bhang Inc. under the stock symbol “BHNG” on July 11, 2019.
“We’re proud to announce this major milestone for Bhang and the industry, as we see a national cannabis brand begin trading on the CSE. This public listing fuels our strategy to meet the growing demand for today’s most innovative cannabis products,” Scott Van Rixel, CEO of Bhang, said. “While our model is not reliant upon accessing the capital markets, our going public transaction will allow us to evaluate new opportunities to accelerate our growth, build our industry-leading house of brands and increase shareholder value.”
Bhang Expanding as a Leading “House of Brands”
Founded in 2010, Bhang has continued to build on its award-winning edibles product line and today has an expansive portfolio of over 100 cannabis, hemp-derived cannabidiol (CBD) and terpene products (which are sold through its licensees and/or by Bhang directly). International distribution and expansion to more geographies is anticipated in 2019. Bhang also has a robust pipeline of new products ready to be launched in the next 12 months as it builds a powerful “House of Brands.”
Bhang Corporation Highlights:
• Bhang is one of the first and most recognized, diversified and established brands in cannabis having won over 30 awards including one of the most awarded cannabis chocolate bars in the world.
• The existing Bhang brand will serve as the foundation for the Company’s “House of Brands” vertical expansionprogram, which includes a full suite ofTHC, hemp-derived CBD, and terpene products, and a CBD brokerage. All of this is driven by Bhang’s product quality, leadership, innovation and longevity which will continue to drive trust in the marketplace.
• Bhang’s expansive product portfolio combined with its well-established distribution and licensing network position Bhang to capture significant market share across multiple target demographics. Some of the large target markets currently addressed with the Company’s eight active brands and 100-plus products include: the cannabis and hemp-derived CBD market, the performance-athletics market, and the nicotine-cessation market. The Company will be launching eight more brands with new products over the coming months that will address several larger and underserved end-markets as well.
• Bhang’s soon-to-be introduced terpene products will enable Bhang to gain valuable, retail shelf space and leverage the sales pipeline for other products when regulations permit.
• Bhang has top-tier manufacturing/distribution partnerships with Trulieve in Florida, Origin House/Cresco in California, and a 50/50 joint-venture with Indiva for Canadian and select worldwide distribution. Vertically-integrated operators’ decisions to partner with Bhang is yet another indication of the strength of the Bhang brand and the quality of the products. In total, there are currently over 1,000 stores selling Bhang’s brands and this number is expected to exceed 2,000 by the end of the year.
• Bhang’s unique low CAPEX/OPEX business model provides multiple revenue stream opportunities including license revenues, wholesale revenues, direct to consumer revenues through bhangcbd.com, and revenues from its CBD brokerage business.
• Bhang leverages its long-term cannabis industry relationships via its CBD brokerage business, helps satisfy some of the tremendous demand for CBD that currently exists and, in the process, reduces its input costs via the large volume purchase discounts it receives.
• Bhang is opportunistically evaluating M&A growth opportunities and joint ventures with top manufacturers and leaders in their respective consumer segments.
• Bhang has carefully assembled a management team that can carry out the Company’s strategy. The team possesses a combination of experience in the CPG/alcohol/retail sector as well as deep cannabis expertise, making the senior team uniquely positioned to execute on this growing opportunity.
Bhang Senior Management Team
Scott J. Van Rixel, Founder, Chairman & Chief Executive Officer.
Cannabis Trailblazer. Brand Architect.
High Times Top 100 in cannabis recipient. Mr. Rixel has a proven track record in innovative product & brand design from over two decades with major retailers. He is a founding member of the National Cannabis Industry Association and a European certified Chef de Cuisine and Master Chocolatier.
Tom Stein, President
Mr. Stein is an experienced adult beverage industry leader and executive with focus in execution, distribution, finance, marketing, and M&A. He is a seasoned entrepreneur with a successful management and operational track record. Prior to Bhang, he served in the role of Vice President at Edrington (brands including The Macallan, Highland Park, The Glenrothes, and The Famous Grouse), Director of Sales at Palm Bay and Distributor Manager at Diageo.
Jamie Pearson, Chief Operating Officer and Corporate Secretary
Ms. Pearson is a rare second-generation cannabis executive with decades of experience in global operations, deal structuring and negotiation as a former real-estate executive. She was voted one of the High Times most influential women in cannabis. She is fluent in German and English, responsible for European RTM & global operational roll-out across market sectors.
Samantha Collins, Chief Marketing Officer
Ms. Collins is an award-winning brand marketer who held leadership positions at Diageo and Treasury Wine Estates. She has a proven track record of success growing global brands across multiple demographics and geographies. She is responsible for Bhang’s global brand strategy, brand positioning, innovation and expansion.
Jeremy Applen, Chief Science and Procedures Officer
Mr. Applen is a quality management and cannabis system implementation design expert. He served on advisory panels to Association of Public Health Laboratories and Centers for Disease Control and Prevention. Mr. Applen is the Vice Chairman ASTM Committee D37 on cannabis.
Stephen Gledhill, Chief Financial Officer
Mr. Gledhill has over 25 years of financial-control experience and acts as CFO and Corporate Secretary for multiple publicly-traded companies, several of which he was instrumental in scaling-up and taking public. Mr. Gledhill has served as the Senior Vice President and CFO of Borealis Capital Corporation, a Toronto-based merchant bank as well as Vice President of Finance of OMERS Realty Corporation (ORC), the real estate entity of the Ontario Municipal Employees Retirement System.
About Bhang
Bhang is committed to delivering exceptional sensory experiences to consumers at every point in their cannabis journey through its award-winning portfolio of brands. Bhang is a trusted cannabis house of brands with an extensive portfolio of over 100 cannabis, hemp-derived CBD and terpene products, including chocolates, pre-rolls, vapes, gums, beverages, gummies and mouth sprays, among others, that are sold by its licensees and/or by Bhang directly. Since 2010, Bhang has mastered the art of harnessing mutually-beneficial partnerships to bring safe, consistent and delicious products to consumers. Learn more at bhangnation.com
Certain statements contained in this news release may constitute forward-looking information. Forward-looking information is often, but not always, identified by the use of words such as “anticipate”, “plan”, “estimate”, “expect”, “may”, “will”, “intend”, “should”, and similar expressions. Forward-looking information involves known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those anticipated in such forward-looking information. The Company’s actual results could differ materially from those anticipated in this forward-looking information as a result of regulatory decisions, competitive factors in the industries in which the Company operates, prevailing economic conditions, and other factors, many of which are beyond the control of the Company. The Company believes that the expectations reflected in the forward-looking information are reasonable, but no assurance can be given that these expectations will prove to be correct and such forward-looking information should not be unduly relied upon. Any forward-looking information contained in this news release represents the Company’s expectations as of the date hereof, and is subject to change after such date. The Company disclaims any intention or obligation to update or revise any forward-looking information whether as a result of new information, future events or otherwise, except as required by applicable securities legislation.
This press release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities in the United States. The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act") or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available. Not for distribution to U.S. Newswire Services or for dissemination in the United States. Any failure to comply with this restriction may constitute a violation of U.S. Securities laws.
Neither the CSE nor its Market Regulator (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.
CBD As It Was Meant to Be: Study Showing Potential Effects of CBD Oil on the Liver Could Lead Consumers to Rely on This California-Based Nanotech Company
California-based Infused By EpicTM offers high-potency Nano CBD formulation designed to bypass liver directly to bloodstream for maximum results in 10 minutes or less
Santa Barbara, CALIF – (July 12th, 2019): As new cutting-edge research reveals potential effects of CBD on the liver, Infused By EpicTM presents a CBD delivery method engineered to safely bypass the digestive system entirely. A leader in the Nano Materials space, Infused By EpicTM specializes in targeted delivery of CBD and other phytocannabinoids, food grade supplements and nutraceuticles through the bloodstream, making it easy for manufacturers and product lines to formulate safe Nano CBD ingredients with up to 5x efficacy and nearly 100% potency into their existing product lines. Now, amidst possible concerns about the long-term side effects of a substance widely praised for its health and wellness benefits, Infused By EpicTM offers a powerfully proactive solution.
In April 2019, Molecules published a study conducted by a research team at the University of Arkansas for Medical Sciences aimed at discovering the long-term effects of CBD oil on the liver. CBD oil, which is processed through the digestive system, must filter through the liver before reaching the bloodstream. At this point, consumers can begin to feel its effects, although at a greatly reduced potency. The results of the University of Arkansas study, which were also covered by Forbes, suggested that certain dosage levels of CBD oil may be toxic to the liver over long periods of time. Even drug company GW Pharmaceuticals saw its best selling CBD-oil based oral solution, Epidiolex, having to note "hepatocellular injury" on their warning label.
Studies show that a highly potent, bio-available form of CBD designed to bypass the digestive system and liver, like Infused By EpicTM enables more complete absorption of oral, sublingual, transdermal, and other CBD delivery systems. Formulated as a water-soluble nanoparticle, the California-based nanotechnology company effectively shrinks the size of each high-grade CBD particle, bypassing the inefficient and slow filtration process of the digestive system.
When consumers eat, drink, or apply them topically, products containing Infused By EpicTM studies show that this delivers up to 5x efficacy of nearly 100% potent CBD directly to the bloodstream. As a result, users can expect to feel powerful healing benefits and the onset of desired effects for mitigation of pain, anxiety, and sleeplessness within 10 minutes or less and without the risk of long-term liver damage. When mixed into any food, beverage, or topical product, Infused by Epic™ is the perfect raw ingredient and an ideal addition to a lifestyle of health and wellness.
Learn more about the all-new line of delectable EPIC Vegan Gummies and Infused By EpicTM liquid and powder bulk formulations at InfusedByEpic.com, available now to product manufacturers as an additive to their current products. Also, discover a wide variety of Infused By EpicTM products such as tinctures, capsules, sprays, transdermal creams and pain roll ons available for white label purchase, all guaranteed to deliver maximum potency and the highest-quality consumer wellness benefits. For more information, visit www.InfusedByEpic.com.
About Infused By Epic™:
Infused By EpicTM technology transforms traditional isolate and distilled CBD extracts into a nano-encapsulated water-soluble liquid or powder for easy addition to any water-based delivery system (including creams, gels, food and beverages). Founded by medical technological innovator CEO Diana Starr Langley and nanotechnology expert COO Kalon Baird, Infused By EpicTM guarantees EFFICIENCY of potent CBD delivery to the bloodstream across all routes (up to 5x efficacy in 10 minutes or less with oral, transdermal, sublingual, ocular, etc.); the PREDICTABILITY of a reliable, repeatable experience; and CONTROLLED dosing in a finished product with homogeneou
During Chemotherapy, Cancer Patient Experiences Best Skin of Her Life
Developed by leading skincare scientist Dr. Hal Simeroth, Ph.D., Stemology safe, effective enough to deliver powerful, all-natural skin renewal during chemotherapy
LOS ANGELES, California – (July 1, 2019): During devastating chemotherapy treatment, Stemology skincare restores youthful glow, self-confidence, and hope to cancer survivor Kristen Williams. Stemologyformulates the “world’s most powerful all-natural anti-aging skincare products,” blending the latest in stem cell research and modern technology to achieve beautiful results, naturally. Now, one customer shares her experience with a skincare collection safe enough for compromised immune systems and effective enough to deliver powerful results during chemotherapy.
Just one year ago, Stemology founder and creator Dr. Hal Simeroth, Ph.D. learned that his daughter, Kristen Williams, had been diagnosed with lymphoma. Due for 12 rounds of chemotherapy over a period of 6 months, it was not long before Williams experienced noticeable changes to her body. “I was only two treatments in when my skin and hair started a downward spiral. All of a sudden, I had the driest, flakiest skin, all the time. The fine lines on my face turned to full-fledged wrinkles, I looked 100 years old, and, frankly, I just looked sick.”
Knowing about the botanically-based, scientific approach of Stemologyfrom her father, Williams added the Moisture Complete with SRC-7 and Cell Revive Serum Complete with SRC-7 to a strict regimen of safe, 100% natural skincare. “Immediately, my skin felt softer” Williams explains, “I didn’t feel like a lizard anymore!” In just one week, Williams’ skin was positively glowing. “The dryness, flakiness, and deep wrinkles were gone - even the little lines around my lips.” After a month of regular use, Williams saw powerfully hydrated, softer, even-toned skin with smaller pores and less redness. “I know it sounds crazy,” she exclaims, “but my skin looked better with Stemology on chemo than it did on a typical day!”
Along with incredible changes to her skin, Williams began to rediscover her own self-confidence and vitality. Soon, others began to notice the dynamic transformation as well. “My husband commented on my skin all the time,” Williams says, “and the first time I saw myself in a photo, I did a double take - my skin was radiant with a glow it didn’t have before. And this was all during chemo!”
Today, Williams is gratefully cancer-free and still devotedly relying on Stemology to keep her skin looking and feeling its best. Her only regret is that she had not begun using her go-to products sooner. “I recommend Stemology to everyone, especially my brothers and sisters out there in the fight against cancer - God knows how much you need to feel normal and good during those tough days.”
Developed by Dr. Hal Simeroth, Ph.D., a leader in the field of skin research, Stemology represents more than 40 years of cutting-edge expertise. Engineered to work with the body’s natural skin renewal processes, the complete skincare line delivers the essential elements necessary for powerful repair and rejuvenation for that vibrant, youthful glow. See more radiant, healthy skin in just a few applications with the full skincare regimen, including the Moisture Complete with SRC-7 ($75) and Cell Revive Serum Complete with SRC-7 ($110), available exclusively at www.StemologyProducts.com. Contact Leigh-Anne Anderson of Anderson PR to schedule an interview with Stemologycreator Dr. Hal Simeroth, Ph.D.
About Stemology:
At Stemology, our philosophy is simple: combine the best of both science and nature to produce immediate, visible results. Using the latest technology and nothing but naturally-derived, ethically-sourced ingredients that meet NPA (Natural Product Association) standards, our expert team of scientists makes sure that every active ingredient is backed by sound scientific evidence and formulated for maximum potency. We take great pride in providing industry-leading products and a superior buyer experience to our growing number of loyal customers throughout the United States, Canada, Mexico, the Middle East, and most of the Asia Pacific region. For more information, visit www.StemologyProducts.com.
Midwifery Investment an Important Step in Healthcare Reform
ST JACOBS, ON, July 8, 2019 /CNW/ - Today, Minister of Health Christine Elliott announced that the Ontario government will invest in improving access to midwifery care. The announcement includes additional funding to invest in the growth of midwifery. With this funding, midwives will be able to provide care for up to 3400 new families and welcome up to 90 new graduates. Additionally, the Ministry is committed to expanding the scope of practice for midwifery to allow midwives to prescribe more medications, making it easier for people in Ontario to access the health care they need.
"Investing in midwifery is smart and moves us closer on the path of health reform that seeks to provide quality, cost-effective care that delivers excellent outcomes. Midwifery is an excellent example of care that supports seamless transitions between community and hospital, is available 24/7, and provides care that places the patient at the centre," states Elizabeth Brandeis.
"The midwifery work of supporting health and well-being for a pregnant person and welcoming a newborn into a family is sacred work," says Ellen Blais, Director of Indigenous Midwifery at the Association of Ontario Midwives. "Indigenous midwives are a powerful counter-force against the deep impacts and trauma of colonialism and residential schools and are needed in every Indigenous community."
Investments, such as this, which improve access to midwifery care are critical, as 4 in 10 people who need midwifery care are turned away because of provider shortage. However, investments must also extend to providers to ensure fairness and sustainability. Earlier this year, provincial cuts to the College of Midwives meant a higher fee burden was downloaded to front-line care providers. Last September, the Human Rights Tribunal of Ontario found that midwives have been underpaid because of the gendered nature of their profession. A ruling from the Tribunal, which will seek to close the pay equity gap for midwives, is expected this fall.
"We cannot value midwifery care and undervalue the midwife who provides that care. The two are inextricably linked," states Elizabeth Brandeis, President of the Association of Ontario Midwives. "The government has acknowledged that the provider experience is a critical part of the current health system transformation; on this we agree. Ensuring midwives are valued and respected for the hard work they do is a critical component of ensuring a high value health care system."
There are over 900 midwives in Ontario, serving 89 communities across the province. This year, over 29,000 families will have the care of a midwife. 368 newborns have been born with the care of an Indigenous midwife through the Indigenous Midwifery Program since 2017. Over 240,000 Ontario families have received midwifery care in the past 15 years. With a proven safety record, midwives are experts at providing high quality, evidence-based primary care to clients and their newborns in their homes, and birth centres, and at over 100 hospitals in Ontario. They provide care that Ontario families deeply value. Evidence is clear that the health of communities begins with a fully integrated, culturally safe model of care with families at the centre.
SOURCE Association of Ontario Midwives
Ipsen and Servier announce initial Phase 1/2 clinical data evaluating liposomal irinotecan (ONIVYDE®) as an investigational first-line treatment for metastatic pancreatic cancer at ESMO 21st World Congress on Gastrointestinal Cancer
– Treatment emergent adverse events Grade 3 or higher were reported by 20 of 32 patients from the 50/60[*] dose pooled patient analysis; no patient reported Grade 3 or higher fatigue or peripheral neuropathy (primary endpoint) –
– Approximately three quarters of patients (71.9%) achieved disease control at week 16, while 34% had a response (secondary endpoint) –
LAVAL, QC, July 5, 2019 /CNW Telbec/ - Ipsen (Euronext: IPN) (ADR: IPSEY) and Servier announced today preliminary data from the Phase 1/2 study of the investigational use of liposomal irinotecan (ONIVYDE®) in combination with 5- fluorouracil/leucovorin (5-FU/LV) and oxaliplatin (OX) in study patients with previously untreated metastatic pancreatic ductal adenocarcinoma cancer (PDAC) at the ESMO 21st World Congress on Gastrointestinal Cancer in Barcelona, Spain, 3–6 July 2019. The results, which were presented as a short oral presentation, included preliminary safety and efficacy data from an ongoing multicenter, open-label, dose-escalation study, which aims to determine the maximum tolerated dose and the recommended dose to be used in future clinical studies.
"Pancreatic cancer is aggressive and difficult to treat. With most patients going undiagnosed until the disease has spread and the prognosis is poor, some physicians may be reluctant to consider novel treatment options," said Zev Wainberg, M.D., lead investigator and associate professor of medicine, University of California Los Angeles. "It's critical that physicians have more treatment options for their patients, particularly in the first line of therapy."
"ONIVYDE® is the first and only FDA and EMA approved second-line treatment for metastatic pancreatic cancer following gemcitabine-based therapy, and the initial data presented today provides a first look into the use of this investigational therapy earlier in the treatment sequence," said Yan Moore, M.D., Ipsen's Senior Vice President, Head of Oncology Therapeutic Area. "We look forward to further analyses of these early data, with the aim of evolving the standard of care in metastatic pancreatic cancer."
"It is vitally important to advance research of new treatment options for advanced pancreatic cancer patients, a goal Servier shares with Ipsen," said Patrick Therasse, MD PhD, Head of Servier Research and Development Oncology.
ONIVYDE® is a topoisomerase inhibitor indicated in combination with 5-FU/LV for metastatic pancreatic cancer after disease progression following gemcitabine-based therapy. The ongoing Phase 1/2, open-label trial (NCT02551991) was designed to assess the safety, tolerability and dose-limiting toxicities (DLTs) of the study drug, liposomal irinotecan, in combination with 5-FU/LV and OX, known as NAPOX, for the first-line treatment of study participants with metastatic pancreatic cancer. Secondary objectives were to assess clinical efficacy, defined by overall response rate (ORR), disease control rate (DCR) and best overall response (BOR). Preliminary analyses of median progression-free survival and median overall survival were not mature enough for evaluation.
As of the 19 February 2019 data cut off, a total of 56 study patients (median age = 58 (39-76) years) were enrolled and dosed at 15 sites across the US, Spain and Australia. The interim analysis was conducted after all study participants in the four dose exploration cohorts had completed their second scheduled tumor evaluation at 16 weeks. Study participants from the Part 1A–cohort B (n=7) dose exploration phase and study participants from the Part 1B–dose expansion phase (n=25) received the selected dose level of liposomal irinotecan 50 mg/m2 [free-base equivalent; FBE], LV 400 mg/m2, 5-FU 2400 mg/m2, and OX 60 mg/m2. These 32 patients made up the pooled population (PP) analysis (n=29 mPDAC; n=3 locally advanced pancreatic PDAC).
Safety Results:
No reported Grade 3 or higher fatigue or peripheral neuropathy.
One study participant in the Part 1A–cohort B dose exploration phase reported a DLT (febrile neutropenia).
Treatment emergent adverse events (TEAEs) Grade 3 or higher were reported by 20 of 32 study patients in the 50/60 PP and included: neutropenia (n=9); febrile neutropenia (n=4); hypokalemia (n=4); diarrhea (n=3); nausea (n=3); anemia (n=2); vomiting (n=2).
Four study patients in the 50/60 PP reported TEAEs leading to discontinuation (n=4/32), with 23 study patients requiring dose adjustment due to AEs.
At data cut-off, 15/32 study patients in the 50/60 PP remained on treatment.
Efficacy Results:
BOR (Best Overall Response) was: one complete response (CR; study participant diagnosed with locally advanced Stage III disease), 10 partial responses (PR) in 31.3% (10/32) and 15 stable diseases (SD) in 46.9% (15/32) (sum of CR+PR+SD = 81.3%).
71.9% (23/32) of study patients in the 50/60 PP achieved disease control at 16 weeks.
Overall, 34% of study patients had a response.
ABOUT ONIVYDE® (irinotecan liposome injection)
ONIVYDE® is an encapsulated formulation of irinotecan available as a 43 mg/10 mL** single dose vial. This liposomal form is designed to increase length of tumor exposure to both irinotecan and its active metabolite, SN-38.
Ipsen has exclusive commercialization rights for the current and potential future indications for ONIVYDE® in the US. Servier is responsible for the development and commercialization of ONIVYDE® outside of the U.S. and Taiwan under an exclusive licensing agreement with Ipsen.
ONIVYDE® is approved by the FDA and the EMA in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. Limitation of Use: ONIVYDE® is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.
IMPORTANT SAFETY INFORMATION - UNITED STATES BOXED WARNINGS: SEVERE NEUTROPENIA and SEVERE DIARRHEA
Fatal neutropenic sepsis occurred in 0.8% of patients receiving ONIVYDE®. Severe or life-threatening neutropenic fever or sepsis occurred in 3% and severe or life-threatening neutropenia occurred in 20% of patients receiving ONIVYDE®in combination with 5-FU and LV. Withhold ONIVYDE®for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment.
Severe diarrhea occurred in 13% of patients receiving ONIVYDE® in combination with 5-FU/LV. Do not administer ONIVYDE to patients with bowel obstruction. Withhold ONIVYDE® for diarrhea of Grade 2–4 severity. Administer loperamide for late diarrhea of any severity. Administer atropine, if not contraindicated, for early diarrhea of any severity.
CONTRAINDICATION ONIVYDE® is contraindicated in patients who have experienced a severe hypersensitivity reaction to ONIVYDE® or irinotecan HCl
Warnings and Precautions Severe Neutropenia: See Boxed WARNING. In patients receiving ONIVYDE/5-FU/LV, the incidence of Grade 3/4 neutropenia was higher among Asian (18/33 [55%]) vs White patients (13/73 [18%]). Neutropenic fever/neutropenic sepsis was reported in 6% of Asian vs 1% of White patients
Severe Diarrhea: See Boxed WARNING. Severe and life-threatening late-onset (onset >24 hours after chemotherapy [9%]) and early-onset diarrhea (onset ≤24 hours after chemotherapy [3%], sometimes with other symptoms of cholinergic reaction) were observed
Interstitial Lung Disease (ILD): Irinotecan HCl can cause severe and fatal ILD. Withhold ONIVYDE I patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation. Discontinue ONIVYDE in patients with a confirmed diagnosis of ILD
Severe Hypersensitivity Reactions: Irinotecan HCl can cause severe hypersensitivity reactions, including anaphylactic reactions. Permanently discontinue ONIVYDE in patients who experience a severe hypersensitivity reaction
Embryo-Fetal Toxicity: ONIVYDE can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during and for 1 month after ONIVYDE treatment
Adverse Reactions
The most common adverse reactions (≥20%) were diarrhea (59%), fatigue/asthenia (56%), vomiting (52%), nausea (51%), decreased appetite (44%), stomatitis (32%), and pyrexia (23%)
The most common Grade 3/4 adverse reactions (≥10%) were diarrhea (13%), fatigue/asthenia (21%), and vomiting (11%)
Adverse reactions led to permanent discontinuation of ONIVYDE in 11% of patients receiving ONIVYDE/5- FU/LV; The most frequent adverse reactions resulting in discontinuation of ONIVYDE were diarrhea, vomiting, and sepsis
Dose reductions of ONIVYDE for adverse reactions occurred in 33% of patients receiving ONIVYDE/5 FU/LV; the most frequent adverse reactions requiring dose reductions were neutropenia, diarrhea, nausea, and anemia
ONIVYDE was withheld or delayed for adverse reactions in 62% of patients receiving ONIVYDE/5-FU/LV; the most frequent adverse reactions requiring interruption or delays were neutropenia, diarrhea, fatigue, vomiting, and thrombocytopenia
The most common laboratory abnormalities (≥20%) were anemia (97%), lymphopenia (81%), neutropenia (52%), increased ALT (51%), hypoalbuminemia (43%), thrombocytopenia (41%), hypomagnesemia (35%), hypokalemia (32%), hypocalcemia (32%), hypophosphatemia (29%), and hyponatremia (27%)
Drug Interactions
Avoid the use of strong CYP3A4 inducers, if possible, and substitute non-enzyme inducing therapies ≥2 weeks prior to initiation of ONIVYDE
Avoid the use of strong CYP3A4 or UGT1A1 inhibitors, if possible, and discontinue strong CYP3A4 inhibitors ≥1 week prior to starting therapy
Special Populations
Pregnancy and Reproductive Potential: See WARNINGS & PRECAUTIONS. Advise males with female partners of reproductive potential to use condoms during and for 4 months after ONIVYDE treatment
Lactation: Advise nursing women not to breastfeed during and for 1 month after ONIVYDE treatment
Please see full U.S. Prescribing Information for ONIVYDE®.
About the Phase 1/2 Study
The Phase 1/2, open-label, comparative trial is designed to assess the safety, tolerability and dose-limiting toxicities of irinotecan liposomal injection ((ONIVYDE®) in combination with 5- fluorouracil/leucovorin (5-FU/LV) and oxaliplatin (OX) as a first-line treatment for metastatic pancreatic ductal adenocarcinoma cancer patients. The study has enrolled 56 patients at 15 sites across the United States, Spain and Australia. It is being conducted in two parts:
Part 1a: a safety run-in as initial dose exploration
Part 1b: dose expansion of the nal-IRI + 5FU/LV + oxaliplatin regimen
The study's primary endpoint is safety and tolerability. Secondary assessments of clinical efficacy include overall response rate, disease control rate and best overall response. For more information visit clinicaltrials.gov and use identifier NCT02551991.
About Ipsen Ipsen is a global specialty-driven biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas – Oncology, Neuroscience and Rare Diseases. Its commitment to Oncology is exemplified through its growing portfolio of key therapies for prostate cancer, neuroendocrine tumors, renal cell carcinoma and pancreatic cancer. Ipsen also has a well-established Consumer Healthcare business. With total sales over €2.2 billion in 2018, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen's R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US). The Group has about 5,700 employees worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information on Ipsen, visit www.ipsen.com.
About Servier Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). With a strong international presence in 149 countries and a turnover of 4.2 billion euros in 2018, Servier employs 22,000 people worldwide. Entirely independent, the Group reinvests 25% of its turnover (excluding generics) in research and development and uses all its profits for development. Corporate growth is driven by Servier's constant search for innovation in five areas of excellence: cardiovascular, immune-inflammatory and neurodegenerative diseases, cancer and diabetes, as well as by its activities in high-quality generic drugs. Servier also offers eHealth solutions beyond drug development. Becoming a key player in oncology is part of Servier's long-term strategy. Currently, there are twelve molecular entities in clinical development in this area, targeting gastro-intestinal and lung cancers and other solid tumors, as well as different types of leukemia and lymphomas. This portfolio of innovative cancer treatments is being developed with partners worldwide, and covers different cancer hallmarks and modalities, including cytotoxics, proapoptotics, immune targeted therapies, to deliver life-changing medicines to patients.
Ipsen's Forward Looking Statement The forward-looking statements, objectives and targets contained herein are based on the Group'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 the Group'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 the Group's expectations regarding future events, including regulatory filings and determinations, and the outcome of this study or other studies. 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 the Group. 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 product 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. The Group must face or might face competition from generic products 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 the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favorable results obtained during pre-clinical 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 product concerned. There can be no guarantees a product will receive the necessary regulatory approvals or that the product 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 health care legislation; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Group'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 the Group's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group's activities and financial results. The Group cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of the Group's partners could generate lower revenues than expected. Such situations could have a negative impact on the Group's business, financial position or performance. The Group 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. The Group'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 the Group's 2018 Registration Document available on its website (www.ipsen.com).
___________________________________________ * 50/60 expressing 50 mg/m2 Onivyde / 60 mg/m2 oxaliplatin ** 43 mg/10 mL corresponding to Irinotecan expressed as free base
Major breakthrough to optimize the success of in vitro fertilization
Clinique ovo reports a major breakthrough for women with an indication of in vitro fertilization.
MONTREAL, July 4, 2019 After several years of development, clinique ovo launches on the market a new endometrial receptivity test: adhesio RT.
In adjunction to the conventional Assisted Reproductive Technologies (ART), this test enables a personalized embryo transfer by identifying the propitious moment where the woman's endometrium is receptive. adhesio RT was driven by an original scientific approach by employing materno-fetal dialog and thus increasing pregnancy potential after an embryo transfer. This test allows physicians to determine the precise moment when the woman is best suited to receive the embryo so that it can implant in the uterus.
This medical advancement was possible thanks to the Industrial Research Assistance Program (IRAP) of the National Research Council of Canada (NRC).
The adhesio RT test made its debut in front of a packed auditorium at the annual meeting of the ESHRE (European Society of Human Reproduction and Embryology) in Vienna on June 25th 2019, by Dr Jacques Kadoch co-founder of Clinique ovo and medical director of ovo r&d. His presentation aroused much interest amongst the entire scientific committee.
'Embryo implantation in the endometrium remains the most misunderstood portion of fertility. Consequently, the adhesio RT test is a major achievement of our scientific team that will undoubtedly optimize chances of success in in vitro fertilization' explains Dr Kadoch.
About clinique ovo: Since its inception in 2003, clinique ovo has offered its services to more than 89 000 patients in fertility, prenatal screening, preservation of umbilical cord blood or more generally, in women's health. Since 2007, all research activities are structured by the ovo r&d department.
Today, clinique ovo launches on the market a new endometrial receptivity test adhesio RT, which adds to the numerous tests already offered at the clinic.
