Health Canada Approves New Indication for STELARA®* (ustekinumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis
In the Phase 3 pivotal trial, nearly 44 per cent of patients receiving STELARA® subcutaneous (SC) injections every 8 weeks were in clinical remission at one year
TORONTO, Jan. 27, 2020 /CNW/ - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has approved STELARA® (ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). The approval for this new indication is based on the pivotal Phase 3 UNIFI clinical trial which achieved its primary endpoint of clinical remission. Results from UNIFI demonstrate that treatment with STELARA® both induced and maintained clinical remission in a significantly greater proportion of adult patients with moderately to severely active UC compared to placebo.1
Ulcerative colitis is a chronic and progressive inflammatory disease of the digestive tract.2 It is one of the main forms of inflammatory bowel disease (IBD),3 a disease that affects 270,000 Canadians,4 one of the highest rates of IBD worldwide.5 While symptoms vary, the disease can be characterized by bloody diarrhea, abdominal pain and cramps, but can also include mild fever, anemia, fatigue, loss of appetite and weight loss.6
"There still remains significant unmet need in UC as the disease affects each patient differently, and it can be more difficult to achieve remission than in other immune disease states," says Dr. Hillary Steinhart, gastroenterologist, Mount Sinai Hospital Inflammatory Bowel Disease Centre.** "This new indication for STELARA® offers patients with moderately to severely active UC the possibility of durable remission and relief from the often painful and debilitating symptoms of the disease."
In patients with UC, two proteins (or cytokines) in the body called interleukin (IL)-12 and IL-23 that are involved in the immune system are dysregulated, which triggers an inflammatory response. STELARA® is the first and only biologic therapy for UC that blocks IL-12 and IL-23 cytokines. The IL-12 and IL-23 pathway has been shown to play a key role in controlling mucosal inflammation and immune responses.7 Since receiving Health Canada approval in December 2008 for the treatment of adults living with moderate to severe plaque psoriasis, STELARA® has received approval for four additional indications: adolescent patients with moderate to severe plaque psoriasis, adults with active psoriatic arthritis, adults with moderately to severely active Crohn's disease (CD), and now adults with moderately to severely active ulcerative colitis.
About the UNIFI Trial The UNIFI trial included an initial Induction study (UNIFI-I) where patients received a single dose of STELARA® 6 mg/kg intravenous (IV) infusion, followed 8 weeks later by a Maintenance study (UNIFI-M) where patients received STELARA® 90 mg subcutaneous (SC) injections every 8 or 12 weeks for 44 weeks. Both studies demonstrated the safety and efficacy of STELARA® as a treatment option for patients with moderately to severely active UC, and the design and complete results were recently published in the New England Journal of Medicine.8
In the Induction study, 16 per cent of patients receiving STELARA® achieved clinical remission in just 8 weeks.9 In addition, STELARA® provided patients with rapid relief of their symptoms as 62 per cent of patients receiving STELARA® experienced a clinical response at week 8. In the Maintenance study, 44 per cent of patients receiving STELARA® every 8 weeks were in clinical remission at one year. STELARA® also helped patients achieve clinical remission without the use of corticosteroids. At one year, 42 per cent of patients treated with STELARA® were in corticosteroid-free clinical remission.10
The overall safety profile of STELARA® in UC was consistent with what has been observed across all approved indications of STELARA®.
About Ulcerative Colitis IBD is believed to involve a genetic predisposition and a trigger in the environment that are combined to set off inflammation in the gut.11 In UC, inflammation invades the inner lining of the bowel tissue, and typically affects the colon (large intestine).12Rates are similar for men and women, and the peak onset is usually between 15-45 years of age.13
About STELARA® (ustekinumab) STELARA® is indicated in Canada for the treatment of adults living with Crohn's disease, ulcerative colitis, psoriasis, and active psoriatic arthritis, as well as for adolescent patients with psoriasis.14
STELARA® blocks the action of two proteins in the body called interleukin (IL)-12 and IL-23. In people with psoriasis, psoriatic arthritis, Crohn's disease or UC, their immune system may attack parts of their body, and that attack uses IL-12 and IL–23. STELARA® can block the IL-12 and IL-23 from causing the immune system to attack the skin, nails, joints or the digestive tract.15
Common side effects reported with STELARA® include, upper respiratory infections (such as the common cold), infections of the nose and throat, sore throat, dizziness, headache, diarrhea, nausea and vomiting, itching, back pain, muscle aches, joint pain, tiredness, redness and pain at the injection site, sinus infections.16
For full Product Monograph and more information about STELARA®/ STELARA® IV, please visit www.janssen.com/canada.
About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
**Dr. Steinhart was not compensated for any media work. He has been compensated as a consultant.
Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding STELARA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Inc., any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2018, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
References
1
Sands, B.E. et al. Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis. New England Journal of Medicine. 2019; 381:1201-1214.
STELARA® Product Monograph. Janssen Inc. Updated January 23, 2020.
15
STELARA® Product Monograph. Janssen Inc. Updated January 23, 2020.
16
STELARA® Product Monograph. Janssen Inc. Updated January 23, 2020.
SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson
Canada Health Infoway Selects Simeio for Identity, Access and Consent as a Service (IACaaS)
TORONTO, Jan. 27, 2020 /CNW/ - Canada Health Infoway (Infoway) is pleased to announce that it has selected Simeio Solutions (Simeio) as the technical solution provider for the new Identity, Access and Consent as a Service (IACaaS). Infoway and its collaborators across Canada will leverage these services to provide Canadians with improved access to health care services, and greater control over their digital health information.
"Digital identity is the starting point for enabling Canadians to better manage their health care," said Michael Green, President and CEO, Infoway. "Simeio's innovative approach, advanced capabilities and capacity will enable Infoway to offer Canadian solution developers an innovative patient-centric user experience for identity, access and consent. This will give Canadians greater convenience and more control over their personal health information."
The Simeio solution will be part of Infoway's ACCESS Health program that is uniting industry, health care providers, provinces, territories and Canadians to redefine where and how Canadians access digital health services and their personal health information.
Simeio will support the development of an identity service, which when incorporated or federated with existing products and services will enable users to control how they retrieve their digital health records and who else can access them.
Key components of IACaaS:
Development and provisioning for a pan-Canadian identity system
Authentication for patient-facing digital health care applications
Creation and deployment of a pan-Canadian health care consent management service for digital health identifiers and associated personal health records.
"This is one of Simeio's largest deployment within the health care industry," said Asif Mohamed Savvas, Senior Vice President, Simeio Solutions. "Working with Infoway gives us a greater footprint and enhances our capabilities, strengthening our position as a leading customer identity and access management (CIAM) and identity and access management (IAM) provider. With this nationwide deployment of identity, access and consent, Canadians have a path to improving their health outcomes through enhanced digital health care. We're providing a single set of identity credentials, for secure data management and retrieval."
About Canada Health Infoway
Infoway helps improve the health of Canadians by working with partners to accelerate the development, adoption and effective use of digital health across Canada. Through our investments, we help deliver better quality and access to care, and more efficient delivery of health services for patients and clinicians. Infoway is an independent, not-for-profit organization funded by the federal government. Visit https://www.infoway-inforoute.ca/en/.
Coffee with a Cannabis Farmer offers new educational opportunities
CARPINTERIA, CA – While cannabis-related headlines are mostly about NIMBY grudge matches in the Tri-Counties, one company has positioned itself as a cannabis industry leader through its educational programs on the health and wellness benefits of the plant.
Carpinteria-based KopSun LLC’s latest learning opportunity is Coffee with a Cannabis Farmer. Here’s how it works: 10 community members gather with a cannabis farmer, who fields questions and concerns from attendees in a relaxed and congenial environment, around a large dining table drinking coffee and enjoying pastries. So far, the kaffeeklatsch has been very popular and waiting lists have become necessary.
“KopSun’s mission is to educate consumers on this long misunderstood and much maligned plant so they may have the confidence to purchase products for themselves and their families,” said Tina Fanucchi-Frontado, KopSun CEO. “Coffee with a Cannabis Farmer is a natural extension of our Leaf Learning classes.”
In session for close to two years, the company’s Leaf Learning program is more traditional in style with lecture, Q&A, guest speakers, and video with the basic Leaf Learning course taking about 2 hours. KopSun began its educational programming in Carpinteria and has expanded its footprint with the goal of conducting educational programs all the way to Santa Maria.
While Leaf Learning focuses on the applications of cannabis, such as help arthritis, insomnia, and other disorders, Coffee with a Cannabis Farmer is about cultivating the plant. Botany and logistics are common topics, but discussions at the kaffeeklatsch are as varied as the attendees and the farmers.
Though thought to be a no-brainer, education has not been embraced by all. Small, yet vocal, groups object to cannabis on all levels. Two such Santa Barbara County-based anti-cannabis organizations, Concerned Carpinterians and Purple Visors, have vowed numerous times on record at public meetings to challenge or appeal all cannabis cultivation licenses. These groups are believed to be responsible for the cancellation of two Basic CBD and Cannabis courses scheduled for Santa Barbara City College’s School of Extended Learning last fall. The cancellation decision was overturned, and the courses will be taught in February with a more thorough curriculum.
“We are hoping some of the anti-cannibers will consider attending one of our upcoming Tea & Terpenes events,” said Fanucchi-Frontado. “
About KopSun LLC
Dedicated to health, KopSun LLC supports the cannabis lifestyle with education and empowerment. KopSun is based in Carpinteria, Calif. and is an avid and staunch supporter of its community. For more information, visit www.KopSun.com, email info@KopSun.com, or call (805) 881-1218.
Coffee with a Cannabis Farmer 2020 dates (last Friday of the month)
Jan. 31
Feb. 28
March 27
April 24
May 29
June 26
July 31
Aug. 28
Sept. 25
Oct. 30
Nov. 20 (third Friday due to Thanksgiving Holiday)
Leaf Learning at Carpinteria Woman’s Club 2020 dates
Jan. 22
Feb. 26
March 25
April 22
May 27
June 24
July 22
Aug. 26
Sept. 23
Oct. 28
Nov. -Holiday-
Dec. -Holiday-
Divorce as Seen through the Eyes of a Child By Hara Wachholder, LMHC
I have often heard the saying, “You were probably too young to remember this, but . . .” I can honestly say that I can recall quite a bit from my childhood even though I can’t seem to recall what I had for breakfast yesterday. I remember a lot, including some things that I wish were fuzzy. I know this sounds strange, but I remember my dad leaving. I was barely two years old, so obviously I was at an age when I could not fully comprehend what I was experiencing at the time, but I already knew I missed my dad and I wanted him to come home. Divorce is a topic I am very familiar with, both personally and professionally. There are countless people who seek counseling in various areas of their life and to me; that is just another day at the office. However, my story hits a different type of nerve for me. It is a story that I had processed in my own therapy, but this is the first time I am sharing it with the public, so (deep breath) . . . here we go.
As I mentioned before, my dad left when I was about eighteen months old. Just as I was trying to adapt to these changes as best as a toddler could, I met my dad’s new “friend” and her kids. I remember she took my hand and walked me around where she worked. I am sure a lot was going on behind the scenes between my parents, but again I was too young to put things together at the time. Fast forward to age four or five, I was introduced to a new friend: anger! Oh, and nightmares. Plenty of them. One recurring nightmare was my dad leaving me. I would wake up screaming and crying, filled with a mixture of sadness, anger, shame, and guilt. My mom would come running into my room to comfort me as I sobbed against her shoulder. Looking back now, I realized that the word that truly defined what I was feeling was powerless. My mom decided that she needed to do everything in her power to help me. So, she went to the bookstore and found several books that were supposed to help kids deal with their parents’ divorce. She would read them to me, but they often told stories of children that I could not relate to, or they were often telling me how I should feel, rather than allowing me the space to access my own feelings. It was frustrating and overwhelming.
It is fascinating how quickly we can adapt. I started to get used to going back and forth between my two homes. However, it was only for a short period of time that I felt “okay.” Fast forward again to around age ten. Just as I was starting to accept all the changes including separate homes, blended families, and different sets of rules, I had to endure a long and terrifying custody battle. I felt like my parents were playing tug of war with me in the middle! The anger that I thought had disappeared came back in full force and even brought additional feelings, including shame, grief, sadness, low self-esteem, people-pleasing tendencies, just to name a few. That voice I was working so hard on developing was silenced as I decided to just say or do what I thought would please my parents as well as others. I not only lost my voice, but I lost myself.
That’s when my mom introduced me to a journal. What started out as doodling tiny drawings in a lined notebook became pages and pages filled with my innermost thoughts and feelings as I got older. I also learned some interesting techniques from my mom. She created “games” for us to play including what we called “give me the bad stuff,” which is where I would think of all the different things that were bothering me, shout, “I don’t like this,” while bundling them up into an invisible ball, and then handing them to my mom who would then pretend to throw them out the door or window. My mom would tell me that I am just a kid, so I did not need to hold on to all this “yucky stuff” inside. It was the first time in a while that I felt like I had a voice. It was wonderful! I would also scream into or hit my pillow as if it were a punching bag. Pretty creative stuff, right? As my mom always says, “It takes a village,” and boy was she right! I lucked out by having such an amazing support system at my elementary school. My guidance counselor established a support group for children of divorced or divorcing parents, and it truly helped to normalize what I was feeling. I was able to speak to peers my own age going through the same things, which was helpful as many of my close friends could not relate to what I was experiencing. I was given safe, nonjudgmental outlets to express myself, and little by little I felt better.
So why am I sharing my story? Well, today as a therapist I now listen to other children’s stories. Divorce is definitely not pretty, but it does not have to be so ugly! Whether the parents decide to “stay together for the children” or go their separate ways, children are getting pulled into the chaos. Sometimes, children will pretend they don’t know what is going on or act as if they don’t care, but trust me when I say it all leaves an impact.
My book, My Parents Are Getting a Divorce . . . I Wonder What Will Happen to Me, is an interactive workbook that was created by my mother and me during the terrifying custody battle that took place between my parents. I felt it was imperative that I assist as many children as possible to help them explore and uncover their innermost thoughts and feelings regarding their parents’ divorce. Within the pages of the book, children are encouraged to write and draw as well as ask questions to get in touch with what is inside that needs to be healed.
###
Hara Wachholder, LMHC is a licensed mental health counselor with the State of Florida and received her master’s degree in counseling from Nova Southeastern University. It was after the resolution of the long-winded custody battle between her parents that Hara recognized her calling to help others going through the same struggle. Hara Wachholder is currently the clinical director for a family therapy center located in Fort Lauderdale, Florida.
Gold and Platinum selling Canadian rock star — not to mention author, songwriter, manager, producer, and human and animal rights activist — Bif Naked has unveiled a new venture under her expansive wing with the launch of her new organic CBD boutique, MonaLisaHealing.com. Bif is available for phoners now and select in-person interviews in the Toronto area.
Touted as the ‘Renaissance of CBD’, the online e-com shop celebrated its North American debut throughout both Canada and the U.S. in the Fall of 2019.
Specializing in premium organic, triple lab tested and verified all-hemp cannabidiol, MonaLisa Healing is set to extend their exclusive product line to the United Kingdom and Europe this February, and Australia and New Zealand in April.
The store currently offers a range of 30mL CBD tinctures in varying potencies, ranging from 750mg - 3000mg for $79.99 - $199.99 CAD respectively.
“I finally followed my own advice,” Bif says of the passion-driven project developed with her longtime team at Her Royal Majesty’s Entertainment. She will discuss the premiere endeavour at Vancouver’s 2020 The Wellness Show this Saturday, February 1st and Sunday, February 2nd — each at 2:00 p.m. — for the panel “An Enlightening Discussion” (Saturday) and talk “Personally Taking Control & Managing Our Health Outcome” (Sunday).
As detailed in her highly personal, Internationally best-selling memoir, I Bificus, the Canadian ‘Princess of Everything’ — and notably, a vegan who lives a straight-edge lifestyle — has arm-wrestled breast cancer, heart surgery, and kidney failure.
And it’s not as if she isn’t busy elsewhere; Bif is set to release a brand new single, “JIM” this February 14th — ahead of a highly-anticipated next studio album — as well as podcast series, New Riot Girls, and a book of poetry and illustrations later this year. A book designed to help empower patients and their families while navigating cancer treatments and the Canadian healthcare system, is also in the works.
For the entirety of her prolific career — and woven in a way only one of the country’s most unforgettable and inspiring women could accomplish — Bif has documented her journey in a deeply personal, highly relatable and inclusive way, covering topics that allow her truths to be a source of empowerment for fans.
Her mindful approach to MonaLisa Healing is proving to be no different.
Priding themselves as a company that leads with integrity, MonaLisa Healing walks the talk through their equal commitment to fair trade agreements and fair consumer pricing.
“So many people, including myself, are used to popping over-the-counter drugs for almost everything,” Bif says, citing muscle pain, migraines, anxiety, depression, insomnia, and chronic pain as just a handful of the many ailments she means. “There’s a long list of issues that keep us from thriving, all while lining the pockets of companies pushing unnatural pharmaceuticals on us, and our families.
“And yet, it’s absolutely no secret that CBD, according to real-life testimonials, has the proven potential to positively affect these issues, and many more.
“I enjoy speaking directly to health care professionals regarding patient advocacy, as well as to patients and families who are surviving and thriving.
“They are all my mentors… They inspire me.
“I believe in the goodness of people, and in everyone’s ability to move forward, taking care of each other, and getting stronger together.
“In that, we want to ensure the benefits of CBD are available to everyone, no matter their socioeconomic status,” she continues. “There’s a lot of price gouging in the CBD world and one thing important to me is the belief that great health should be available to every single person within communities around the world, not just an elite market who can afford speciality products and services."
Just because it’s available at such an accessible price point doesn’t mean the quality should be compromised, or customers should throw ‘caution to the wind,’ she adds. These core tenets are so uncompromisable, the company publishes the product’s independently lab tested and triple-verified results directly on their website for transparency, and offers a worry-free, 30-day money-back return policy for customer reassurance.
“Each of us at MonaLisa Healing has our own story behind our passion for CBD, and we want to share that with as many people as possible,” says Bif. “We use our products ourselves, as do our own families and pets!
“We faithfully endorse CBD as a product, and believe it can help people live a healthier, happier life.”
// ABOUT BIF NAKED
As one of Canada’s most unique, recognizable and beloved entertainment industry icons, Bif Naked reigns rock supreme as a Gold and Platinum selling recording artist, prolific songwriter, dynamic producer, and intuitive artist manager.
Contributor to such national publications as the Globe and Mail and the Huffington Post, and as seen on shows such as Buffy the Vampire Slayer and The Tonight Show with Jay Leno, Bif Naked is an Internationally best-selling author of her 2016 memoir, I Bificus (HarperCollins Canada), and a highly engaged public speaker and human rights, animal rights, anti-poverty and social justice activist.
Officially a cancer survivor, Bif Naked has surmounted breast cancer, kidney failure, and heart surgery. Inspired by her myriad of life experiences and ardent interest in wellness, she has recently launched MonaLisa Healing, a premium, organic all-hemp CBD boutique available in Canada, the United States, and soon to the United Kingdom, Europe, Australia, and New Zealand.
Bif Naked’s new single, “JIM” is set for release February 14, 2020, ahead of her eleventh studio album. She has an exclusive podcast in the works, New Riot Girls, as well as a book of poetry and illustrations, also set for release this year. She is penning a book on the navigation of cancer care within the Canadian healthcare system, dedicated to empowering patients and their families.
MonaLisaHealing.com is an International brand specializing in organic, premium quality, and triple lab tested and verified all-hemp cannabidiol.
Launched in British Columbia in September 2019, MonaLisa Healing is currently available in Canada and the United States. International launches serving the United Kingdom and Europe are set for February 2020, and Australia, and New Zealand this April 2020.
MonaLisa Healing is a wholly owned subsidiary of iGEN Ventures Corp.
10 HEALTHY SPINE TIPS FOR SITTING IN A SENATE SEAT
Senate transactions are meant to be collegial and cooperative, but impeachment can cause increased stress on the body, and ultimately be a pain in the back and neck! The seats in the senate are not always the most comfortable. With 80% of Americans suffering from back pain, the thought of 12 hours of meeting can be discouraging. Luckily, the pain associated with sitting in a senate seat can be greatly reduced, and in many cases avoided.American author, Dr. Ken Hansraj, an orthopedic spine surgeon, offers these sitting tips to help keep your spine comfortable and healthy while sitting on a senate seat: Check Your Posture: Sitting for prolonged periods can strain your back, and your positioning can make it even worse. To provide yourself with the most relief, make sure your back is aligned against the back of the seat. Keep your shoulders straight and avoid rounding forward. Both feet should be firmly resting on the floor Smart Preparation: Reduce the stress in the senate seat by planning ahead. Properly fitted suits and dresses made of lightweight, comfortable, breathable materials make all the difference in the world. Light-weight, properly fitted materials diminish the stresses all day. Ill-fitted clothes will hurt in the morning and worsen as the day goes on. Travel Light: Resist the urge to over-pack and reduce the stress on your shoulders and spine. Choose a light briefcase, backpack or a travel bag with wheels and a handle for rolling.Tilts: Consider placing a small lumbar support pillow or rolled up sweater or jacket to be placed behind your back. Keep your head centered looking fairly much straight ahead. It’s all in the legs: Keep your legs out in the extended position. The bent or flexed position leads to your leg veins being stagnant and may lead to a blood clot. It is important to get up and walk, stretching the legs and arms at least once an hourStretch: When all else fails keep moving! Simple stretches of the neck, shoulders, and back will help keep the blood flowing. Blood brings important nutrients and oxygen to the structures of the back. This helps to stimulate the soft tissues in your back and keeps them from stiffening, which can reduce aches. Even a few seconds of stretching and moving is better than not doing anything at all! Breathe: Place your hands on your abdominal area and feel your belly move as you inhale and exhale. Do this as many times a day as possible to improve your posture and overall spinal health.Intention: Realize that the senate is the world’s greatest deliberative body. Watch your intentions. “I am participating in American history” is a better intention than “Ugh, I’m a prisoner on this seat.”Best Hours: Face it! Some of our best hours of our lives are spent at work. Be thoughtful about it. Choose a sitting posture that is safe, ergonomic, comfortable and that is pain-free. See Opportunity in Delays: Expect delays. Look for the opportunities to practice deep belly breathing in good posture. Anger and frustration lead to shallow breathing, stiff muscles and pain.
About Dr. Kenneth K. Hansraj:
American author Dr. Ken Hansraj is the author of the internationally bestselling book, Keys to an Amazing Life: Secrets of the Cervical Spine, (January, 2013), which he was inspired to write to help people globally understand matters about the spine. Dr. Hansraj is also the author of Bloodless Spine Surgery: Pictures and Explanations. His goal with each of his books is to bring years of accumulated expert medical knowledge to the public at-large in an easy-to digest format and to help countless individuals with ongoing spinal and health issues.
Dr. Ken Hansraj is TV and media trained and has extensive experience with national outlets such as CNN, HLN, CBS, FOX, NBC, ABC, NPR and has been featured globally. Cision® estimates his current media impressions at 9+ Billions.
Immuno-oncology drugs and agents with novel MoAs to further influence treatment paradigms in cancer indications in 2020, says GlobalData
As 2020 commences for the pharmaceutical industry, Fern Barkalow, PhD, Senior Director of Oncology and Hematology, as well as members of her analyst team at leading data and analytics company GlobalData comment on some of the key trends that will continue to influence clinical development in both solid tumors and hematological cancers in 2020, including the influence of immuno-oncology (IO) drugs on treatment paradigms and increased clinical research into drugs with new mechanisms of action for various cancers.
Dr. Barkalow notes that market analyses underway on her team at GlobalData have revealed a major role for IO drugs, particularly combination approaches, in reshaping the treatment paradigm in several cancer indications.
Elena Tzima, MS, Oncology Analyst at GlobalData, comments: “The treatment paradigm in renal cell carcinoma (RCC) is shifting from tyrosine kinase inhibitor (TKI) monotherapy to immune checkpoint inhibitor combinations. Immune checkpoint inhibitors are increasingly taking over the first-line of therapy. Although TKIs will not disappear from the treatment algorithm they will be overtaken by immune checkpoint combinations in first line and will be pushed down to later lines of treatment.”
On the other hand, ongoing market research at GlobalData in bladder cancer has revealed variable trends predicted for uptake of the checkpoint inhibitors in the 7MM that are due in part to cost issues but also a result of the introduction of novel therapies in an area that has just recently seen a large increase in approvals of targeted therapies.
Barath Muralidharan, MBS, Oncology Analyst at GlobalData, notes: “We will see increasing use of checkpoint inhibitors for bladder cancer in Japan and the EU for advanced disease despite the pushback from payers for these premium priced drugs. However, in the US, there will continue to be a slight decline in overall sales of checkpoint inhibitors due to the launch of Balversa and Padcev in 2019, which according key opinion leaders interviewed by GlobalData, will see increasing adoption in the treatment of advanced bladder cancer in 2020.”
Dr. Barkalow continues: “While IO drugs will certainly continue to dominate oncology drug development, 2020 will see a high degree of clinical research in other drug classes with new mechanisms of action, which promise to go a long way to fulfilling unmet needs for more therapy options in certain cancers.”
Sakis Paliouras, PhD, Oncology Analyst at GlobalData, comments: “Since 2017, the previously-limited options for acute myeloid leukemia (AML) patients upon relapse have been enriched with agents of greater tolerability. Starting in 2020 and over the next 5-10 years, more novel drugs with different mechanisms of action will be proceeding to late-stage development and be poised to enter the AML treatment landscape. This should allow sequential treatment and extension of patients' survival over multiple lines of therapy."
Another area of high unmet need, triple negative breast cancer (TNBC), will see developments in 2020 as both checkpoint inhibitors and novel antibody-drug conjugate drugs gain approvals.
Adam Pearson, PhD, Oncology analyst at GlobalData, comments that: “Checkpoint inhibitors will move closer towards becoming the standard of care in first-line metastatic TNBC patients who are PD-L1 positive, with further approvals expected in 2020 for Tecentriq, and a probable approval for Keytruda in this population of patients.”
Not only will there be more checkpoint inhibitor options leading to further uptake in TNBC patients.
Dr. Pearson also notes that: “In 2020, we are expecting to see approval for the antibody-drug conjugate, sacituzumab govitecan in later lines of therapy in TNBC after previously being rejected on issues related to ‘chemistry, manufacturing, and control matters’. GlobalData has noted enthusiasm from key opinion leaders concerning this drug and it will likely be approved in Q1 2020. Sacituzumab govitecan will be a welcome addition to the increasingly personalized arsenal to tackle triple negative breast cancer and provide a drug, with a novel mechanism of action, to treat a historically difficult to treat cancer.”
Dr. Barkalow concludes: “As we enter this next decade, the shift away from chemotherapies and even some targeted therapies as standard of care in a variety of cancer indications, towards safer and more effective IO combinations and therapies of novel mechanisms of action will be even more pronounced than in previous years, which is good news for patients as well as drug development stakeholders.
Ontario continues to improve access to treatment for children and adolescents living with ADHD who are prescribed INTUNIV XR®*
Ontario publicly reimburses INTUNIV XR® (guanfacine hydrochloride extended-release tablets) for both adjunctive and monotherapy treatment of children and adolescents with ADHD
TORONTO, Jan. 24, 2020 /CNW/ - Takeda Canada Inc. is pleased to announce that effective January 31, Ontario will publicly reimburse INTUNIV XR® (guanfacine hydrochloride extended-release tablets) for the treatment of attention deficit/hyperactivity disorder (ADHD) symptoms in children and adolescents (6 to 17 years old) in the following settings:
As an adjunctive therapy to psychostimulants;
As monotherapy in patients who have significant intolerance to psychostimulants and who have had an inadequate response to either atomoxetine or other non-stimulant alternative(s).
INTUNIV XR® is a selective alpha2A-adrenergic receptor agonist.1 In Ontario, this funding provides an additional treatment option for children and adolescents (6 to 17 years old) in whom response to stimulant therapy has been suboptimal.1
"ADHD is a complicated and chronic disease, and I've seen first-hand how challenging it is for parents and their children to find a treatment plan that works for them," said Heidi Bernhardt, President and Executive Director of the Centre for ADHD Awareness Canada. "I applaud the government of Ontario for granting families access to an additional treatment option to help their children manage their ADHD."
ADHD is among the most prevalent mental health conditions in childhood.2 Five to nine per cent of children and adolescents in Canada are living with ADHD,3 a condition that can cause poor school performance, behavioural challenges, and difficulties at home and with friends.2 Medication plays an important role4 in managing common symptoms including inattention, hyperactivity and impulsivity.2
"Takeda is committed to providing innovative treatment options to Canadians with ADHD," said Gamze Yüceland, General Manager, Takeda Canada Inc. "We are pleased to learn that the Ontario government will improve access for patients by listing INTUNIV XR® as both a standalone and combination therapy on the Ontario Drug Formulary."
About INTUNIV XR® INTUNIV XR® (guanfacine hydrochloride extended-release tablets) is an oral, once-daily treatment for attention deficit/hyperactivity disorder (ADHD). Its active ingredient, guanfacine, is a selective alpha2A-adrenergic receptor agonist.1
INTUNIV XR® was approved by Health Canada in July 2013 as monotherapy for the treatment of ADHD in children aged 6 to 12 years, and as adjunctive therapy to psychostimulants for the treatment of ADHD in children, aged 6 to 12 years, with a sub-optimal response to psychostimulants.5 In September 2015, Health Canada extended both indications for INTUNIV XR® to include adolescents aged 13-17.6
The efficacy of INTUNIV XR® in the treatment of ADHD was established in two placebo-controlled monotherapy pivotal trials in pediatrics, and in one placebo-controlled monotherapy trial in adolescents (aged 13-17 years). A fourth study further evaluated the safety and efficacy of INTUNIV XR® as adjunctive therapy to psychostimulants.1
INTUNIV XR® is also publicly reimbursed in the province of Quebec as part of the RAMQ (Régie de l'assurance maladie du Québec) "Exceptional medications" section of the List of Medications,7 in association with a psychostimulant, for the treatment of children and adolescents suffering from attention deficit disorder with or without hyperactivity, for whom it has not been possible to properly control the symptoms of the disease with methylphenidate and an amphetamine used as monotherapy. Before it can be concluded that the effectiveness of these drugs is sub-optimal, they must have been titrated at optimal doses.8
About ADHD Attention deficit/hyperactivity disorder is a neurodevelopmental disorder characterized by the presence of hyperactive-impulsive and/or inattentive symptoms that cause impairment and were present before the age of 7 years.1For an ADHD diagnosis, the symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work), and at home.1Approximately 75 per cent of patients continue to meet the diagnostic criteria as the child moves into adolescence, and over half of patients will continue to present with clinically significant impairment into adulthood.2
About Takeda Canada Inc. Takeda Canada Inc. is the Canadian marketing and sales organization of Takeda Pharmaceutical Company Limited, headquartered in Japan. Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Gastroenterology (GI), Rare Diseases and Neuroscience. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.
Novacap to Sell Majority Stake in Intelerad Medical Systems
Novacap, founders, and management shareholders will reinvest alongside new partner
MONTREAL, Jan. 23, 2020 /CNW Telbec/ - Novacap, the Canadian-based private equity firm, announced today that it has entered into a definitive agreement for the sale of a majority stake in Intelerad Medical Systems ("Intelerad"), a global provider of medical imaging software and enterprise workflow solutions to Hg, a U.K.-based private equity firm specialized in software and service businesses.
The transaction is expected to close in the first quarter of 2020, following the satisfaction of customary regulatory approval.
With over 400 employees and offices in Canada, USA, UK and Australia, Intelerad specializes in diagnostic viewing, reporting and collaboration solutions for radiologists. The company, who serves over 300 hospitals, imaging centers, clinics and radiology groups, enables increased productivity and streamlined medical imaging workflows. Intelerad's solutions are instrumental at improving its clients' efficiency while allowing them to deliver superior outcomes for both patients and healthcare providers.
Under the ownership of Novacap, Intelerad made significant investments in all areas of the business, including in research and development, to position the company as a leading global provider of medical imaging software, managed services and AI-augmented workflow solutions and to strengthen its customer-first focus. Over the last 4 years, Intelerad more than doubled its revenue, with the ongoing addition of new clients and the accelerated growth of its existing customer-base, which includes some of the largest hospitals, health systems and imaging service providers around the world. During the same period, the number of employees grew from 277 to over 400 today.
In 2018 under the leadership of Paul Lepage, newly appointed CEO of Intelerad, the company acquired Seattle-based Clario Medical, the provider of the state-of-the-art Clario SmartWorklistTM which intelligently manages reading workflows and optimizes reading quality and efficiency, and is being used as the backbone of the largest radiology practices and imaging centers.
"In 2016, Novacap TMT IV fund invested in Intelerad, confident that we would accelerate the growth of the business while allowing the development of best in class enterprise medical imaging solutions, supported by Intelerad's intrapreneurial culture. Today, I strongly believe that we surpassed our initial objectives, and helped define the strategic roadmap sustaining a strong growth. I am proud and convinced that the management team with the new ownership will continue to contribute to the future company's success,'' said François Laflamme - Senior Partner at Novacap - TMT.
"From the day Novacap came on board, it was clear to us founders that the team had the passion, expertise and dedication necessary to bring Intelerad to great heights. Novacap has exceeded our expectations, and we thank them and the Intelerad team for their hard work in bringing us to this enviable position today. We look forward to working with Hg to make a difference in healthcare." said Randall Oka, co-founder of Intelerad.
Paul Lepage, Chief Executive Officer at Intelerad, said: "Partnering with an Hg-led consortium will give us access to a huge pool of knowledge in global healthcare technology and the opportunity to significantly advance the company's strategy. We are thrilled to continue focusing on our customers success and creating superior outcomes for healthcare providers and their patients with such talented people. I welcome our new investors, and also thank the Novacap team and our colleagues who all worked so hard to get us into this strong position, as well as our customers and partners for their continued trust over the last 20 years. Looking forward to exciting times ahead."
Novacap was advised by Piper Jaffray, Deloitte and McMillan
ABOUT NOVACAP Founded in 1981, Novacap is a leading Canadian private equity firm with $3.6 billion of assets under management. Its distinct investment approach, based on deep operational expertise and an active partnership with entrepreneurs, has helped accelerate growth and create long-term value for its numerous portfolio companies. With an experienced management team and substantial financial resources, Novacap is well-positioned to continue building world-class businesses. Backed by leading global institutional investors, Novacap's deals typically include leveraged buyouts, management buyouts, add-on acquisitions, IPOs, and privatizations. Over the last 38 years, Novacap has invested in more than 90 companies and completed more than 130 add-on acquisitions. The company has offices in Toronto, Ontario and Brossard, Quebec. For more information, please visit www.novacap.ca.
ABOUT HG Hg is a European investor in software and services businesses, with increasing global presence, having built a team of 200 people over 25 years. Hg is a specialist investor, committed to building businesses that change the way we all do business, through deep sector specialisation and dedicated operational support. Hg partners with the businesses and management teams it invests in. Hg has over 30 operational professionals providing practical support to management teams to help them realise their growth ambitions. Hg shares best-practice 'playbooks' and leverages Hg's executive and portfolio network as a powerful tool for knowledge sharing across comparable businesses. Based in London, Munich and New York, Hg has funds under management of approximately $12 billion serving some of the world's leading institutional and private investors. For further details, please visit the Hg website: https://hgcapital.com/
ABOUT INTELERAD MEDICAL SYSTEMS Founded in 1999, Intelerad is a medical imaging software provider that specialises in diagnostic viewing, reporting and collaboration solutions. Headquartered in Montreal, Intelerad has over 400 employees located in various offices in Toronto and Calgary (CA), Seattle (US), Hertfordshire (UK) and Melbourne (AU). The company serves over 300 healthcare organizations around the world, with a particular strength in radiology groups, imaging centers, clinics and reading groups as well as a strong presence in hospital radiology departments.
SOURCE Novacap Management Inc.
Health Canada Approves KEYTRUDA® (pembrolizumab) as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma (RCC)
Approval Based on Results of KEYNOTE-426, Where KEYTRUDA® in Combination with Axitinib Reduced the Risk of Death by Nearly Half Compared to Sunitinib
Renal cell carcinoma (RCC) is the most common form of kidney cancer, representing 80 per cent of all cases1
The five-year survival rate for advanced RCC is currently estimated to be 8 per cent2
KIRKLAND, QC, Jan. 23, 2020 /CNW/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that Health Canada has approved KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with Inlyta® (axitinib), a tyrosine kinase inhibitor, for first-line treatment of patients with advanced renal cell carcinoma (RCC). The approval is based on findings from the pivotal Phase 3 KEYNOTE-426 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for KEYTRUDA® in combination with axitinib (KEYTRUDA®-axitinib combination) compared to sunitinib.
For Canadians living with advanced renal cell carcinoma, the cancer has spread beyond the kidney to other areas of the body.3 While the five-year survival rate for patients living with Stage 1 RCC is currently estimated to be 81 per cent, those living with advanced (Stage 4) RCC face an 8 per cent chance of survival.4
"It's important that Canadians living with renal cell carcinoma, an aggressive form of cancer, have access to new treatment options that are well tolerated and can improve survival outcomes," said Dr. Sebastien Hotte, medical oncologist at McMaster University. "The approval of pembrolizumab, or KEYTRUDA®, in combination with axitinib, is an important advancement in treatment that physicians can now consider in managing patients newly diagnosed with advanced RCC."
"For kidney cancer patients whose cancer has spread beyond the kidney and metastasized in other parts of the body, their disease is much more aggressive. For these patients, there is a need for additional treatment options," Dr. Pierre Karakiewicz, medical oncologist at the Centre hospitalier de l'Université de Montréal (CHUM). "Health Canada's approval of pembrolizumab in combination with axitinib represents an important advancement in the treatment of kidney cancer that helps extend survival outcomes for patients living with advanced renal cell carcinoma."
In the Phase 3 KEYNOTE-426 trial, KEYTRUDA® in combination with axitinib demonstrated a statistically significant reduced risk of death by 47% compared to sunitinib (HR=0.53 [95% CI, 0.38-0.74]; p=0.00005). For progression-free survival (PFS), the KEYTRUDA®-axitinib combination showed a reduction in the risk of progression of disease or death of 31% compared to sunitinib (HR=0.69 [95% CI, 0.57-0.84]; p=0.00012). The objective response rate (ORR), an additional efficacy outcome measure, was 59% for patients who received the KEYTRUDA®-axitinib combination (95% CI, 54-64) and 36% for those who received sunitinib (95% CI, 31-40) (p<0.0001). The observed safety profiles of pembrolizumab plus axitinib were as expected on the basis of the known profiles of these drugs, although the incidence of grade 3 or 4 elevations in liver enzyme levels in the pembrolizumab-axitinib group was higher than previously observed when each agent was used as monotherapy.5
This is the first indication for KEYTRUDA® in advanced RCC, and the first anti-PD-1 therapy as part of a combination regimen that significantly improved OS, PFS and ORR versus sunitinib in patients with advanced RCC.
"We welcome Health Canada's decision to offer a new evidence-based treatment option to patients living with advanced renal cell carcinoma," said Stephen Andrew, Executive Director of Kidney Cancer Canada. "This immuno-oncology combination represents an important milestone in our community and offers new hope to patients and their caregivers."
About Kidney Cancer In most cases, kidney cancer starts in the cells that line the tubules, which are tiny tubes that collect the waste materials and chemicals from the blood moving through the kidneys.6 This type of cancer is known as renal cell carcinoma (RCC), accounting for 80 per cent of all cases.7RCC is considered advanced when the cancer has metastasized, or spread, beyond the primary cancer site.8 The five-year relative survival rate for patients suffering from advanced, metastatic (Stage 4) kidney cancer is estimated to be 8 per cent.9
In 2019, an estimated 7,200 Canadians were diagnosed with kidney cancer and 1,900 Canadians died from kidney cancer.10 Known risk factors for kidney cancer include smoking, hypertension, obesity, and occupational exposure to some chemicals.11
About KEYTRUDA® KEYTRUDA® is an anti-PD-1 therapy that works by increasing the ability of the body's immune system to help detect and fight tumour cells. KEYTRUDA® is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumour cells and healthy cells.
KEYTRUDA® was first approved in Canada in 2015 and currently has 14 indications in several disease areas, including advanced renal cell carcinoma (RCC), bladder cancer, non-small cell lung carcinoma (NSCLC), classical Hodgkin lymphoma and melanoma.
Merck's Research Program Merck has the industry's largest immuno-oncology clinical research program. There are currently more than 750 trials studying pembrolizumab across a wide variety of cancers and treatment settings. This clinical program seeks to understand the role of pembrolizumab across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with this medication, including exploring several different biomarkers.
Our Focus on Cancer Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck Oncology, helping people fight cancer is our passion and supporting accessibility to our cancer medicines is our commitment. Our focus is on pursuing research in immuno-oncology and we are accelerating every step in the journey – from lab to clinic – to potentially bring new hope to people with cancer.
About Merck Canada For over a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships.
Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer's disease and infectious diseases including HIV and Ebola. For more information about our operations in Canada, visit www.merck.ca and connect with us on YouTubeand Twitter.
Forward-Looking Statement of Merck & Co. Inc., Kenilworth, NJ, USA This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
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 in the United States and internationally; 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 company'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 company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2017 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).
De P., Otterstatter, M.C., Semenciw, R., et al. Trends in incidence, mortality, and survival for kidney cancer in Canada, 1986-2007. Cancer Causes Control 2014;25(10):1271-1281.
De P., Otterstatter, M.C., Semenciw, R., et al. Trends in incidence, mortality, and survival for kidney cancer in Canada, 1986-2007. Cancer Causes Control 2014;25(10):1271-1281.
