Expected Study Locations Announced for Pivotal Huntington Disease Clinical Trial
(KITCHENER, ON) DECEMBER 19, 2018 – Roche Pharmaceuticals announced today the expected locations of the clinical trial sites in Canada that will be participating in the Phase III GENERATION HD1 study. The locations that are anticipated to participate are:
Edmonton, Alberta - University of Alberta
Vancouver, British Columbia - University of British Columbia
Ottawa, Ontario - Ottawa Hospital
Toronto, Ontario - Centre for Movement Disorders
Halifax, Nova Scotia - Queen Elizabeth II Health Sciences Centre
Montreal, Quebec - Centre Hospitalier de l’Université de Montréal
This announcement comes just one year after the phase Ia/IIb trial showed that the drug successfully lowered the harmful huntingtin protein in spinal fluid that causes Huntington disease (HD) and was deemed initially safe and well tolerated.
The GENERATION HD1 study will evaluate the efficacy and safety of RG6042 treatment given once per month or once every two months (bi-monthly) over a period of 25 months (approx. two years). This global study will enrol up to 660 patients with manifest HD at 80-90 sites in approximately 15 countries around the world. The study will start to enrol by early 2019.
Participants of the study will be randomized to one of three treatment study arms: monthly, bi-monthly or placebo monthly. This means for every two participants randomized to RG6042, one will receive placebo. The study is designed to test the potential effects of RG6042 compared to placebo. The study is “double-blind” so neither the participant nor investigator or site staff will know which study arm the participant is assigned.
“This is a hopeful time for the HD community and this announcement is another positive step forward,” says Robin Markowitz, HSC’s CEO. “Roche’s decision to run clinical trials in Canada speaks to the calibre of our doctors and scientists, who are leading the way in HD research. It also speaks to the level of engagement within the Canadian HD community. I applaud the volunteers who have stepped up and who will continue to step up for research. Their bravery pushes us closer than ever towards meaningful treatments.”
If families have specific questions about participating in clinical trials we recommend they contact their local Movement Disorders or Huntington disease clinic. We will also continue to update the HSC website with the most current information at www.huntingtonsociety.ca/roche-rg6042-update.
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Huntington disease (HD) is a debilitating brain disorder that is fatal and incurable. About one in every 7,000 Canadians has HD and approximately one in every 5,500 is at-risk of developing the disease. Many more are touched by HD whether as a caregiver, a family member, or a friend. HD causes cells in specific parts of the brain to die. As the disease progresses, a person with Huntington disease becomes less able to manage movements, recall events, make decisions and control emotions. Many describe the symptoms of HD as having ALS, Parkinson’s and Alzheimer’s – simultaneously.
The Huntington Society of Canada(HSC) is a respected leader in the worldwide effort to end Huntington disease. HSC is the only Canadian health charity dedicated to providing help and hope for families dealing with Huntington disease across Canada.
INSTAGRAM “HEALTH FOODS” THAT ARE SURPRISINGLY UNHEALTHY OR CALORIC
From Whole Foods to pricey health food stores, cafes, and coffee shops, certain foods and ingredients have become trendy among health and calorie counting foodies. Who has not heard of matcha, Acai, cold-pressed juice, and gluten-free baked goods? In a perfect world, wouldn’t it be wonderful if we could find food and drinks that are delicious, healthy and not calorie laden? While certain Instagram accounts may have you convinced these “magic foods” exist, Dr. Niket Sonpal is a NYC gastroenterologist and assistant professor at Touro College of Osteopathic Medicine who cautions health enthusiasts to do a deeper dive into what they are eating and imbibing
Gluten-Free Baked Goods
Despite the fact that less than one percent of Americans are believed to have celiac disease, customers and food brands alike have gotten caught in the gluten-free food obsession. Dr. Sonpal explains that “To mimic the taste and texture of wheat gluten, companies will use corn, oat, and rice flours, which aren’t necessarily better for you.” One study found that participants who consumed rice-flour-based baked goods had higher levels of metals within their system than the control group, which is linked to rice’s natural arsenic and metal content.
Smoothie Bowls
Their vibrant colors and pleasant toppings give smoothie bowls the appearance of a well-balanced breakfast, but don’t be fooled: they are loaded with sugar. Unlike traditional smoothies that come in useful, portion-controlled bottles, smoothie bowls tend to be larger and have more surface area, which makes it easy to add additional toppings. For example, the Chunky Strawberry Bowl from Jamba Juice contains 590 calories and 58 grams of sugar.
Acai
Google “acai berry” and a wealth of purported benefits like weight loss and antiaging results will return. Does this trendy health food hail from Brazil really live up to the hype? Dr. Sonpal says that “While the fiber-rich fruit does tout more antioxidant properties than pomegranates and blueberries, many health claims don’t mention that it logs in 247 calories per 100 grams, 26 grams of which are carbohydrates.” The takeaway? Unless you are using acai at home and controlling your portions, an acai bowl could cost you almost 600 calories per serving!
Almond milk
The fact that it’s dairy-free and low in calories has made it the default milk among many people who try to eat healthily. Dr. Sonpal explains that “though unsweetened almond milk, like dairy milk, is a good source of calcium and vitamin D, it’s really low in protein. (Just 1 or 2g protein in a one-cup serving.)
Protein Bars
Protein bars, which are sometimes also energy bars, contain numerous artificial ingredients and have as much nutritional value as a milk chocolate bar. That said, some protein bars can be healthy if they contain healthy, whole, and very few ingredients that make up the bar. Dr. Sonpal cautions, “If you see upwards of 15 ingredients in your protein bar, I would say stay away from it.”
Avocado
If you look at all the salads, grain bowls, and other healthy dishes on Instagram, you'll probably notice that the people posting them seem to be eating a great deal of avocado. "Avocados are very nutritious and packed with healthy monounsaturated fats and fiber,” says Dr. Sonpal. Many Instagrammers go overboard. "An entire medium avocado contains 250 calories and 23g fat," Sonpal says. "Keep your serving size to a quarter of a medium avocado, which would be 60 calories and 6g of fat."
Veggie Chips
The pieces of actual veggies in veggie chips are so thin and processed that most of the nutrition from the vegetable is gone. “Instead, try whole-grain pretzels, baked corn chips, crackers made with seeds and nuts, or popcorn,” Dr. Sonpal suggests. To keep from turning a bag of chips or box of crackers into a meal, divide them up into sensible portions ahead of time.
Cold-pressed juices Cold pressed juices have risen in popularity over the past few years, and with the hefty price tag tacked on to them (one serving of juice can be as much as $12!) one would assume guzzling some would provide you with all the nutrients you could possibly need. Unfortunately for your wallets, and your diets, that is not the case. While made of whole, raw fruits and veggies, the fiber from these foods are often stripped during the juicing process. On top of that, fruits like apples can be added to cut the bitter flavor of leafy greens, which can bump the carbohydrate content up to 20-30 grams of carbs per juice! Dr. Sonpal warns that “because there is no fiber or protein in these juices, guzzling one can cause blood sugar levels to spike too, leaving you right back where you started: hungry and craving something nutrient dense.”
Matcha Lattes
Matcha is one food trend that has taken the center stage. Some restaurants offer matcha pancakes. While matcha is packed with antioxidants and provides detox health benefits that cannot be disputed, ordering up a latte may not be the magic elixir you bargained for. A 12-ounce matcha latte from a popular coffee chain packs 24 grams of sugar and will set you back 190 calories.
Agave Nectar
Agave syrup is derived from the sweet nectar of the Agave tequila plant and is often perceived as a “natural” alternative to processed cane or beet sugar or other zero-calorie sweeteners. The syrup is touted by manufacturers as a safer sweetener for diabetics because it is lower on the glycemic index (a measurement of how certain foods affect blood sugar levels), Dr. Sonpal says that “no reliable human studies exist reinforcing this claim. Agave syrup is just like any other sweetener- no better, no worse”.
About Dr. Niket Sonpal is a native of Long Island NY and a graduate of the Medical University of Silesia – Hope Medical Institute in Poland. After completing his residency in Internal Medicine at Lenox Hill Hospital, he was selected to be the 2013‐2014 Chief Resident at Lenox Hill Hospital–Northshore LIJ Health System. He is an Adjunct Assistant Professor at Touro College of Osteopathic Medicine and Clinical instructor at Kingsbrook Jewish Medical Center, Brooklyn. Dr. Sonpal has completed his Fellowship in Gastroenterology & hepatology at Lenox Hill Hospital and will continue his work in the field of medical student and resident test preparation. He now serves as the associate program director for the Internal Medicine Residency Program at Brookdale University medical center.
He is the co‐author for the best-selling Master the Boards: USMLE Step 2 CK, Master the Boards Step 3, And Master the Boards: Internal Medicine. He is also the Chief Operating Officer for Medquest Test Prep, Director of Medical Education for Picmonic Test Prep, and a recognized expert on medical test prep.
6 Benefits of Snail Slime for Your Skin
Expert Dermatologist Explains Why Snail Mucin is a Must for Anti-Aging
Snail slime, otherwise known as snail secretion filtrate (SSF) or snail mucin is naturally created by snails to protect, renew and restore themselves. It has become a popular ingredient in skincare offering great results when used on human skin.
Dr. Andrea Godoy is a Brazilian Dermatologist for former Victoria’s Secret bombshells Alessandra Ambrosio and Ana Beatriz Barros, and Lead Advisor for Brazilian Skin. Their skincare products include snail mucin, among other key ingredients. SSF has six main benefits for the skin and is a powerful anti-aging property, especially at clinical levels. Brazilian Skin extracts the SSF without causing any harm to the mollusk.
1. It optimizes overall skin health.
Packed with zinc, iron, manganese and copper peptides, plus incredibly high quantities of vitamins A and E, snail mucin helps to restore skin and heal it quickly.
Dr. Godoy explains that, “The beneficial ingredients within SSF are plentiful, they include: Allantoin which stimulates skin and regeneration healing, anti-irritation and smoothing actions, proteins which aid in skin nutrition and improving skin texture and luminosity. Snail mucin seals in moisture and allows active ingredients to penetrate the skin. It prevents dryness and makes the skin look dewy, with fewer allergenic ingredients.”
2. It’s a potent way to hydrate skin.
When we consider that 98% of SSF is comprised of water, it is excellent for dry skin which often has wrinkles and fine lines due to dryness.
3. Research shows it has anti-aging potential.
Beyond sealing in moisture, and helping skin to heal, new research has shown SSF may have anti-aging potential, too.
How do skin care companies like Brazilian Skin get the snail mucin from the snail into their products? Dr. Godoy states, “When snails are put under mild stress conditions, they excrete a thick fluid as a means to protect themselves.” When concentrated, this snail mucin aids human skin by hydrating, preventing aging and improving wrinkles and scars.
4. It’s a protection powerhouse.
When looking at ways to protect skin from premature aging, UV rays, pollution, dryness, it’s the copper and antimicrobial peptides along with hyaluronic acid, proteoglycans, and glycoprotein that makes snail mucin such a powerful skin shield.
When you use a serum that includes clinical levels of skin mucin, you’re going to see a difference in the overall appearance of your skin within a few days.
5. It fades scarring and stretch marks.
“There are two key components to snail filtrate that boost tissue repair and promote rapid cell renewal. First are fibrinolytic enzymes which can be thought of as cellular nourishment for the skin. The other is glycolic acid which serves as a natural exfoliant which handles the scars, fine lines, and wrinkles. When you look at these two components plus everything else found in snail filtrate, it’s obvious that it is a powerful ingredient,” Dr. Godoy illustrated.
6. It kills bacteria and blasts acne.
The little snail that could continues to amaze with the ability to kill bacteria that live on the skin’s surface causing acne. “Snail mucin is full of natural antibiotics so when using products with high concentrations of it, skin clears and remains clear with consistent use,” says Dr. Godoy.
With this abundance of naturally occurring benefits for a variety of skincare issues, it’s a no-brainer why snail mucin is more commonly featured as an ingredient in skincare products lately.
What does the research show?
In Brazilian Skin’s research on the benefits, results from a small study with varied ages, both men and women had skin moisturization increase 30-40% after using protelixan and skin elasticity increased by 17%.
While there is limited research on the anti-aging properties of snail mucin, Dr. Godoy believes the addition of SSF in Brazilian Skin products contribute to the drastically amazing results their skincare line achieves, specifically in regard to anti-aging. Along with Dr. Godoy, Wilson Chueire, Founder of Brazilian Skin, also believes this and affirms their Bratoxin formula, which features SSF, increases skin moisture by 54% over 24 hrs.
Product information:
Currently, Brazilian Skin’s regimen comes in the form of a Facelift Kit ($229.00) with three serums: the Age Reversing Bratoxin ® which is the daytime serum, the Triple Cell Complex Acai mask which delivers the best results when worn overnight, and Bratoxinsta ® a more direct wrinkle treatment serum that when applied to deeper wrinkles, radically reduces their appearance within 60 seconds.
Meet Dr. Andrea Godoy- A leading Brazilian Dermatologist
After graduating from the University of Medical Sciences of Santos in Brazil in 1999 with a Specialist Medical Degree in Dermatology, Dr. Godoy has spent years discovering the most cutting-edge technologies and treatments to keep her patients looking young and beautiful. She has traveled all over the world attending countless workshops, conventions and pieces of training (i.e. the Photo Dynamic Therapy in Milan, 2005.)
As a top Dermatologist for Brazilian Supermodels, Dr. Godoy has also co-authored “Foundations on Dermatology” and “Treatise on Dermatological Surgery, Cosmetic and Laser.”
The Day After Christmas: The Silent Killer
Christmas is a time of family, happiness, and joy. It is a day to relax, share love and exchange gifts with our friends and family, wishing each other success in the upcoming year. It is indeed a shining moment when we gather around the Christmas tree to open our presents. Besides gifts, a Christmas feast is an inevitable part of the celebration. We enjoy eggnog, canapes, chicken wings, cinnamon rolls, and all the other dishes that make this day special. It all seems magical. It feels like nothing can go wrong. But if we tell you that the day after Christmas is a day with the most heart attacks recorded of all the year, you wouldn’t be so quick to grab another piece of pie, would you?
People Tend to Be Less Responsible During Holidays
All this relaxation can turn into carelessness and can be costly, especially for older people and those with heart problems. Think about it this way: if you have cholesterol problems, you are probably disgusted with all the medications, recommended diets and other pieces of advice your doctor has given you over the years. It’s Christmas! You want to celebrate, relax, and forget about all that stuff. You want to have a few drinks with your friends, talk with them, and enjoy all the festivities the day has to bring.
Unfortunately, the illness doesn’t care about the holidays. Something that you would describe as giving yourself a little break, doctors call signing a death sentence. The change in your habits during the holidays can cause severe problems. Because of all this excitement, you probably forgot to go to the gym, or if it’s cold outside, you maybe didn’t even leave the house. You drank more alcohol than usual, and you certainly ate a lot more than you should have. Your heart is challenged to surpass all these unexpected obstacles, and very often, it can’t. The consequences can be fatal.
How Can You Prevent Unwanted Events?
You should pay extra attention to a few details so you can enjoy your Christmas while not putting your health in jeopardy. First of all, try to have a light breakfast. Some oatmeal combined with fresh fruit would be a great choice. For your lunch, sneak some garlic, avocados, salmon or walnuts onto your plate. These foods lower the cholesterol in your blood, and they will help you make a healthy balanced Christmas menu. Remember, it is important to be moderate in both eating and drinking.
It is OK to have a drink or two, but don't go too far. Have a glass of water between drinks and stop before you start feeling tipsy. Adding a food supplement during holidays is not a bad idea, either. Cholesterade is an excellent choice since it reduces bad cholesterol and triglycerides while increasing good cholesterol. It is 100 percent natural, and it tastes good too.
The tips above are pretty much essential for your health not only during Christmas but throughout the whole year. Try to be responsible, enjoy, relax, but don’t do something regretful. It will make your holidays even more enjoyable.
Lipofilling, Expanded Stem Cells Are a Valuable Alternative to Breast Implants
Autologous adipose-derived stem cells (ADSCs) expansion avoids fat resorption,allowing to maintain results achieved after fat grafting
4 years follow-up results of Bioscience Institute Liposkill Plus body shaping approachpresented at Las Vegas
LAS VEGAS, Dec. 19, 2018 /CNW/ - Easy availability of donor tissue, absence of scars, short recovery times: several advantages have made lipofilling a promising technique for breast augmentation, asymmetry correction and reconstruction, but fat resorption can severely limit results. Nowadays, an approach based on adipose-derived stem cells (ADSCs) injection allows to maintain the breast volume achieved after fat grafting. The first ever evidences of ADSCs advantages come from the 16th Annual IFATS Meeting organized by the International Federation for Adipose Therapeutics and Science in Las Vegas (USA), where Bioscience Institute presented the results of a 4-years follow-up of patients subjected to autologous expanded ADSCs implant for breast augmentation.
Breast volume MRI analysis was performed under the medical supervision of Bioscience Institute medical director, Roberto Viel, before and 4 years after ADSCs treatment, revealing that appropriate injection allows to maintain 100% of the volume achieved with fat grafting. When patient BMI increased, total breast volume increased too, reaching 109 to 135% of total breast volume achieved with fat injection, demonstrating fat graft behaves like fat in other parts of the organism.
Such results have been made possible by Liposkill Plus, a body shaping approach based on expansion of autologous ADSCs to be injected in patient's breast to obtain a double aesthetic goal: improving breast volume without breast implants and eventually removing fat from undesired deposits (e.g. abdomen, tights). ADSCs expansion is fundamental for long-lasting results, allowing to get the minimum right dose of cells for injection (100-150 thousand cells/ml of fat for a volume between 400 to 800 ml). «Cells expansion is the only technology available to achieve the correct ratio between cells and fat,» explained by Giuseppe Mucci, Bioscience Institute CEO. «Results are totally natural both aesthetically and to touch, and it is possible to reshape other parts of the body too, such as glutes. Moreover, some ADSC can be cryopreserved, allowing other uses in the future, such as skin aging treatment. With such features, Liposkill Plus represents a valuable alternative to traditional breast augmentation surgery.»
SOURCE Bioscience Institute S.P.A
10 WAYS TO AVOID HOLIDAY WEIGHT GAIN By Eddie Fatakhov (a.k.a. Dr. Fat-Off) M.D.
It probably comes as no surprise that the top resolution of last New Years Eve was to lose weight and be healthier. This resolution is a favorite the world over so, if you are one of the millions wanting to lose weight and make positive lifestyle changes in 2019 I have a simple tip… Start now! Gaining weight is much simpler than losing it so instead of saying “I’ll start making better choices in 2019” why not keep a few pounds off ahead of schedule? Here are 10 ways to avoid holiday weight gain during food-focused festivities, office parties, and holiday family gatherings. 1.) HOLIDAY PARTIES Holiday parties are in full swing so go to yours with a plan. A simple way to decrease temptation is to arrive late, leave early, and stay social in between (this will keep you away from snacks and fatty dips). 2.) SUGAR FREE IS KEYThe best way to make sure you avoid liquid sugar is to BYOSFB (bring your own sugar free beverage). 3.) PREGAME Before you go to any holiday gathering eat an apple with some peanut butter. This will help to give you some fullness and also take the edge off your overall hunger. 4.) MAKE THE BUFFET OKAY - If your party is at a restaurant with a buffet drink a full glass of water before you get in line. - Once you’re in line start with a small plate - Pick two items and only cover ⅔ of your plate- Keep drinking that water while you eat. - Chew chew chew. Take your time eating to allow your body to feel full.- Did I say keep drinking water?! 5.) AVOID THE “D” WORD Telling people you are on a diet during the holidays can backfire with food being put in your face accompanied by phrases like “It’s the holidays, it doesn’t count!” So instead of using the “D” word try “I can’t have that” or “I ate before I came.” 6.) LEAN MEAT IS YOUR LEAN FRIEND If there is an option to have lean meat like turkey or fish jump on it! These are also great options for family functions. Turkey wrapped celery with a pickle slice anyone? 7.) BRING YOUR VEGETABLES Adding lightly steamed vegetables to the meals you bring to parties is a simple and great way to add beneficial vitamins, minerals, and fiber to your holidays. 8.) FRUIT IS A DESSERT FOOD Look for the fresh fruit at parties or bring it to gatherings to give yourself a great alternative to pies, cakes, and cookies! 9.) STAND AND EAT After you get your plate of food stand and eat. Most likely you will eat less if you can’t plant yourself and focus solely on the food. 10.) DANCE & MINGLEBuild a little workout into your party time by staying active as much as possible. - If there is music get people to dance (you know you want to). - Work the room - try to socialize in the entire space as a way to keep moving. ABOUT DR. FAT-OFF… Eddie Fatakhov, M.D., a.k.a. Dr. Fat-off, is a Board-Certified Physician, Nutritionist, and Best-Selling Author of "The Doctors' Clinic-30 Program. His latest book is “Dr. Fat-Off Simple Life-Long Weight-Loss Solutions.” Email:eddie@drfatakhov.comOffice: 404-836-9906 Website: www.eddiefatakhovmd.com Facebook: https://www.facebook.com/fatakhovInstagram: http://instagram.com/eddiefatakhovmd/
Bayer receives European approval for hemophilia drug Jivi, but has stiff competition ahead, says GlobalData
Germany-based pharma major Bayer has recently received the European Commission approval for its hemophilia A long-acting injectable medicine Jivi. However, since Jivi is a late entrant to the long-acting hemophilia A market segment it will struggle to compete with the established therapies, says GlobalData, a leading data and analytics company.
The approval was based on results of the Phase II/III PROTECT VIII trial in which Jivi (a PEGylated recombinant Factor VIII) demonstrated good bleed protection in 74% of patients who were treated once weekly and 100% of patients who were treated every five days.
Jivi is the third hemophilia A treatment in Bayer's portfolio, besides Kogenate and Kovaltry. The trio boasted combined global sales of $726m by Q3 2018. GlobalData predicts sales of Jivi alone in the 7MM* to be $273m in 2026.
Tajekesa Chapman, Pharma Analyst at GlobalData, comments: “The treatment landscape is currently dominated by rFVIII replacement factors, the majority of which are short-acting. However, Jivi joins a growing market of long-acting rFVIII therapies that extend the half-life of these factors and allow for less frequent dosing, such as Bioverativ’s Elocta/Eloctate, Shire’s Adynovate/Adynovi and CSL Behring’s Afstyla.”
Like Adynovate, Jivi uses PEGylation to achieve an extended half-life of 17.9 hours to sustain high levels of FVIII. PEGylation involves the covalent attachment of polyethylene glycol (PEG) to the protein of interest, increasing its molecular weight and size and creating a hydrophilic cloud around the molecule. These changes may alter the half-life by reducing the susceptibility of the molecule to proteolytic activity and degradation.
Chapman adds: “However, the long-term use of these products has been questioned, particularly since large PEGs are not metabolized by the human body and therefore may incur safety issues due to the longevity of PEG in the body. Further, PEGylation is thought to change the surface charge of the protein, which interferes with some receptor-mediated clearance processes.”
Experts interviewed by GlobalData expressed contrasting opinions on the PEGylation strategy, as used in Adynovate, Jivi and Novo Nordisk’s pipeline product N8-GP (turoctocog alfa pegol), but the majority suggested that they would prefer to rely more on the non-PEGylated products, such as Elocta/Eloctate, in order to avoid potential safety issues.
Chapman concludes: “Jivi is a late entrant to the long-acting hemophilia A market segment, a disadvantage for its commercial positioning. Since it does not offer a more convenient dosing schedule, it will struggle to compete with the established long-acting factors for patient share, such as Elocta/Eloctate and other non-factor replacement therapies.
“Roche’s recently approved Hemlibra (emicizumab) is also expected to decrease the overall sales for the entire category of rFVIIIs. Bayer can soften these impacts by exploiting its presence in the hemophilia A market, with Kogenate and Kovaltry in its portfolio, to encourage uptake of Jivi among accustomed patients and gain a significant share of hemophilia A patients.”
7MM* US, France, Germany, Italy, Spain, the UK and Japan
Comments provided by Tajekesa Chapman, Pharma Analyst at GlobalData
This press release is written using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GlobalData’s team of industry experts.
About GlobalData
4,000 of the world’s largest companies, including over 70% of FTSE 100 and 60% of Fortune 100 companies, make more timely and better business decisions thanks to GlobalData’s unique data, expert analysis and innovative solutions, all in one platform. GlobalData’s mission is to help our clients decode the future to be more successful and innovative across a range of industries, including the healthcare, consumer, retail, financial, technology and professional services sectors.
SUNNIVA INC. ANNOUNCES CANNABIS TELEHEALTH SERVICE AGREEMENT BETWEEN NATURAL HEALTH SERVICES LTD AND HELLOMD TO EXPAND PATIENT REACH WITH ENHANCED MEDICAL CANNABIS SERVICES IN CANADA
VANCOUVER, BC – December 18, 2018 - Sunniva Inc. (“Sunniva”, the “Company”, “we”, “our” or “us”) (CSE:SNN) (OTCQB:SNNVF), a North American provider of cannabis products and services, announced today that its wholly owned subsidiary, Natural Health Services Ltd. ("NHS"), will partner with HelloMD, a leading online cannabis telehealth company, to offer telemedicine services to its patients to provide more Canadian communities with convenient access to medical cannabis advice.
NHS operates a network of seven clinics specializing in medical cannabis in four provinces and has approximately 105,000 registered patients. In this joint effort, HelloMD will provide its turnkey set of white-label services to NHS, affording existing and future NHS patients the added option and convenience of an online health care practitioner consultation. In addition, NHS will have the opportunity to extend its services to areas where they do not currently have clinics, to reduce wait times, and to offer the convenience of evening and weekend consultations.
“This partnership is about both companies focusing on what they do best,” said Larry Lisser, HelloMD’s SVP of Business Development. “HelloMD’s telehealth service extends access to practitioner-led advice to more Canadians, while our integration with the NHS platform enables their patients to seamlessly benefit from the educational services NHS is so well known for. This is a win for patients all around.”
NHS patients will be first directed to a co-branded landing page on the HelloMD platform. Those patients who receive a medical document from HelloMD will be seamlessly transferred to an NHS Patient Educator who in turn helps them to understand the various options available and assists them in the selection of a Licensed Producer from which to buy medical cannabis.
Dr. Mark Kimmins, Medical Director and Interim President of NHS commented, “Partnering with HelloMD enhances the NHS mission to improve the way Canadians access safe, regulated medical cannabis and education on how to use cannabis to improve health and quality of life. By utilizing the telehealth expertise of HelloMD, we will be able to increase our patient base and serve the needs of more Canadians.”
Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.
About HelloMD:
HelloMD has facilitated more than 100,000 virtual consults between medical cannabis patients and licensed practitioners. The company’s white-label solutions enable third parties to quickly deploy a turnkey telehealth solution, complete with the technology, practitioners and support personnel required to improve their own patient onboarding processes.
Sunniva, through its subsidiaries, is a vertically integrated cannabis company operating in the world’s two largest cannabis markets –California and Canada. Our ability to leverage our large-scale, purpose-built cGMP designed greenhouses, offering better quality assurance with cannabis products free from pesticides, uniquely positions Sunniva as a leading supplier of safe, high quality products at scale. Through our strategically positioned cultivation and extraction facilities in California, we are launching Sunniva branded products in various product categories including flower, pre-rolls, vape cartridges, and ultra pure concentrates. We have secured complaint distribution in California via our 100% ownership of LTYR Logistics, LLC that will ensure the placement of Sunniva branded products at licenced dispensaries throughout the state and we continue to aggressively pursue other upstream vertical opportunities have recently secured complaint distribution in California to assure the placement of Sunniva branded products throughout the state via 100% ownership of LTYR Logistics LLC and we continue to aggressively pursue other upstream vertical opportunities. Sunniva's management and board of directors have a proven track record for creating significant shareholder value both in the healthcare and biotech industries.
About Natural Health Services Ltd. (“NHS”)
NHS owns and operates a network of seven clinics in Canada specializing in medical cannabis under the Cannabis Act (Canada). NHS connects patients with safe and effective medical cannabis products through Licenced Producers. NHS has in-house physicians and nurse practitioners specializing in the endocannabinoid system providing expert consultation, education, and recommendations for patients. NHS’ proprietary technology infrastructure assists physicians, patients and LPs to comply with the rules of Health Canada. NHS currently has approximately 105,000 registered patients.
This news release includes statements containing certain "forward-looking information" within the meaning of applicable securities law ("forward-looking statements"), including, but not limited to, statements relating to the proposed benefits of the partnership between NHS and HelloMD. Forward-looking statements are frequently characterized by words such as "plan", "continue", "expect", "project", "intend", "believe", "anticipate", "estimate", "may", "will", "potential", "proposed" and other similar words, or statements that certain events or conditions "may" or "will" occur. These statements are only predictions. Various assumptions were used in drawing the conclusions or making the projections contained in the forward-looking statements throughout this news release. Forward-looking statements are based on the opinions and estimates of management at the date the statements are made and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. The Company is under no obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by applicable law.
Cipher Pharmaceuticals Announces A-101 40% Topical Solution Accepted for Review by Health Canada
MISSISSAUGA, ON, Dec. 18, 2018 /CNW/ - Cipher Pharmaceuticals Inc. (TSX:CPH) today announced that its New Drug Submission ("NDS") for A-101 40% topical solution ("A-101 40%") for the treatment of raised seborrheic keratoses ("SKs") has been accepted for review by Health Canada. Cipher acquired the exclusive Canadian rights to distribute and commercialize A-101 40% from Aclaris Therapeutics, Inc. (NASDAQ:ACRS) ("Aclaris") in April 2018.
A-101 40% is a U.S. Food and Drug Administration ("FDA")-approved product indicated for the treatment of raised SKs, which are commonly occurring non-cancerous skin growths that affect more than 9 million Canadian adults and can be an aesthetic skin concern. A-101 40% was approved by the FDA in December 2017 and is marketed by Aclaris in the U.S. under the tradename Eskata™.
"This is another significant milestone for Cipher as we continue to execute on our growth strategy and diversify our commercial portfolio," said Robert Tessarolo, President and CEO of Cipher. "Upon approval, we look forward to offering A-101 40% to dermatologists and their patients as a treatment that can clear raised SKs without cutting, burning or freezing the skin."
About Seborrheic Keratoses SKs are non-cancerous skin growths that affect an estimated 20% of the population and are most commonly seen in middle-aged and older adults. SKs vary in color from flesh-colored to pink, yellow, gray, tan, brown, or black; can range in size from a millimetre to a few centimetres wide; and typically have a slightly elevated, waxy or scaly appearance. The number and size of SKs tends to increase with advancing age. SKs frequently appear in highly visible locations, such as the face or neck, but can also appear anywhere on the body, except the palms, soles and mucous membranes.
About A-101 40% for the treatment of raised SKs A-101 40%, marketed under the trademark ESKATA by Aclaris in the U.S., is the first and only FDA-approved medication for the treatment of raised SKs. Aclaris has submitted a Marketing Authorization Application (MAA) for ESKATA in select countries in the European Union.
About Aclaris Therapeutics, Inc. Aclaris Therapeutics, Inc. is a dermatologist-led biopharmaceutical company committed to identifying, developing and commercializing innovative therapies to address significant unmet needs in dermatology, both aesthetic and medical, and immunology. Aclaris' focus on market segments with no FDA-approved medications or where treatment gaps exist has resulted in the first FDA-approved treatment for the raised seborrheic keratoses and several clinical programs to develop medications for the potential treatment of common warts, alopecia areata, and vitiligo. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn.
About Cipher Pharmaceuticals Inc. Cipher (TSX:CPH) is a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products. Cipher acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and markets those products either directly in Canada or indirectly through partners in Canada, the U.S., and South America. Cipher is focused on a three-pronged growth strategy – including acquisitions, in-licensing, and selective investments in drug development – to assemble a broad portfolio of prescription products that serve unmet medical needs. For more information, visit www.cipherpharma.com.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of certain securities laws, including the "safe harbour" provisions of the Securities Act (Ontario) and other provincial securities law in Canada and U.S. securities laws. These forward-looking statements include, among others, statements with respect to our objectives, goals and strategies to achieve those objectives and goals, as well as statements with respect to our beliefs, plans, expectations, anticipations, estimates and intentions. Forward-looking statements in this press release include statements with respect to the anticipated commercial launch of Trulance in late 2019, subject to the receipt of requisite regulatory approvals. The words "may", "will", "could", "should", "would", "suspect", "outlook", "believe", "plan", "anticipate", "estimate", "expect", "intend", "forecast", "objective", "hope" and "continue" (or the negative thereof), and words and expressions of similar import, are intended to identify forward-looking statements.
By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, which give rise to the possibility that predictions, forecasts, projections and other forward-looking statements will not be achieved. Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements. We caution readers not to place undue reliance on these statements as a number of important factors, many of which are beyond our control, could cause our actual results to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates and intentions expressed in such forward-looking statements. These factors include, but are not limited to, our ability to enter into in-licensing, development, manufacturing and marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect; our dependency on a limited number of products; integration difficulties and other risks if we acquire or in-license technologies or product candidates; reliance on third parties for the marketing of certain products; the product approval process is highly unpredictable; the timing of completion of clinical trials, regulatory submissions and regulatory approvals; reliance on third parties to manufacture our products and events outside of our control that could adversely impact the ability of our manufacturing partners to supply products to meet our demands; we may be subject to future product liability claims; unexpected product safety or efficacy concerns may arise; we generate license revenue from a limited number of distribution and supply agreements; the pharmaceutical industry is highly competitive; requirements for additional capital to fund future operations; dependence on key managerial personnel and external collaborators; no assurance that we will receive regulatory approvals in the U.S., Canada or any other jurisdictions; current uncertainty surrounding health care regulation in the United States; certain of our products are subject to regulation as controlled substances; limitations on reimbursement in the healthcare industry; limited reimbursement for products by government authorities and third-party payor policies; various laws pertaining to health care fraud and abuse; reliance on the success of strategic investments and partnerships; the publication of negative results of clinical trials; unpredictable development goals and projected time frames; rising insurance costs; ability to enforce covenants not to compete; risks associated with the industry in which it operates; we may be unsuccessful in evaluating material risks involved in completed and future acquisitions; we may be unable to identify, acquire or integrate acquisition targets successfully; inability to meet covenants under our long term debt arrangement; compliance with privacy and security regulation; our policies regarding returns, allowances and chargebacks may reduce revenues; certain current and future regulations could restrict our activities; additional regulatory burden and controls over financial reporting; reliance on third parties to perform certain services; general commercial litigation, class actions, other litigation claims and regulatory actions; the effects of our delisting from the NASDAQ Global Market (the "NASDAQ") and deregistration of our Common Shares under the U.S. Securities Exchange Act of 1934, as amended (the "U.S. Exchange Act"); the difficulty for shareholders to realize in the United States upon judgments of U.S. courts predicated upon civil liability of the Company and its directors and officers who are not residents of the United States; certain adverse tax rules applicable to U.S. holders of our Common Shares if we are a passive foreign investment company for U.S. federal income tax purposes; the potential violation of intellectual property rights of third parties; our efforts to obtain, protect or enforce our patents and other intellectual property rights related to our products; changes in U.S., Canadian or foreign patent laws; litigation in the pharmaceutical industry concerning the manufacture and supply of novel and generic versions of existing drugs; inability to protect our trademarks from infringement; shareholders may be further diluted if we issue securities to raise capital; volatility of our share price; the actions of a significant shareholder; we do not currently intend to pay dividends; our operating results may fluctuate significantly; our debt obligations will have priority over the Common Shares in the event of a liquidation, dissolution or winding up; and risks associated with the arrangement with Cardiome, including, among others, the failure to satisfy closing conditions and the absence of material adverse changes or other events which may give the parties a basis on which to terminate the arrangement agreement.
We caution that the foregoing list of important factors that may affect future results is not exhaustive. When reviewing our forward-looking statements, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. Additional information about factors that may cause actual results to differ materially from expectations, and about material factors or assumptions applied in making forward-looking statements, may be found in the "Risk Factors" section of our Annual Information Form and in our Management's Discussion and Analysis of Operating Results and Financial Position for the year ended December 31, 2017, and elsewhere in our filings with Canadian securities regulators. Except as required by Canadian securities law, we do not undertake to update any forward-looking statements, whether written or oral, that may be made from time to time by us or on our behalf; such statements speak only as of the date made. The forward-looking statements included herein are expressly qualified in their entirety by this cautionary language.
SOURCE Cipher Pharmaceuticals Inc.
For further information:
Stefan Eftychiou, Bristol Investor Relations, (905) 326-1888 ext. 60, stefan@bristolir.com
Findings establish “New normal” for when children reach full height
COLUMBIA, Mo. (December 17, 2018) ― Children born in the most recent century have bones that reach full maturity earlier – by nearly 10 months in girls and nearly seven months in boys – according to anew studyfrom the University of Missouri School of Medicine.
“Our findings show there is a “new normal” for timing when kids’ skeletons will reach full maturity,” said Dana Duren, PhD, director of orthopaedic research at the Thompson Laboratory for Regenerative Orthopaedics.
The research team, led by Duren, assessed the radiographs of more than 1,000 children born between 1915 and 2006. The team evaluated radiographs of the bones in the hands and wrists to determine the precise timing of the beginning and ending of a developmental process called epiphyseal fusion.
“We focused on epiphyseal fusion because it signals the end of the growth of the bone,” said Duren, who was the principal investigator. “It begins when the growth plate, which is cartilage at the end of the bone, starts to connect the epiphysis, or bone cap, to the long bone through small calcifications. Eventually, the growth plate completely calcifies and attaches, or fuses, to the long bone. When fusion is complete, so is the growth of that bone.”
The research team used radiographs gathered in the Fels Longitudinal Study, which is the world’s only century-long study of human growth and development, to track when fusion started and when it was complete in children born as far back as 1915. The results showed that the skeletons of children born in the 1990s are reaching fusion completion, and thus skeletal maturity, faster and sooner than children born in the 1930s.
These findings directly impact the timing of the clinical care of certain pediatric orthopaedic conditions, such as leg-length differences, scoliosis and the timing of using growth hormone.
Mel Boeyer, MS, predoctoral orthopaedic research fellow and co-author of the study, works closely with pediatric orthopaedic surgeons to understand how physicians time this care.
“The timing for the treatments of these conditions is a critical component to a good outcome,” said Boeyer. “What this research shows us is physicians will need to start looking for the beginning of epiphyseal fusion sooner than they once thought.”
The study does not address what might be the cause of this new normal. However, Duren and many of her colleagues think an increase in exposure to environmental hormones and hormone mimickers could be a contributing factor.
Their study, “Early Maturity as the New Normal,” was recently published by the journal Clinical Orthopaedics and Related Research. Research reported in this publication was supported by the National Institutes of Health. In addition to Duren and Boeyer, other study authors from the University of Missouri include Richard Sherwood, PhD, in the Department of Orthopaedic Surgery, and Chelsea Deroche, PhD, in the Department of Health Management and Informatics. The authors of the study declare that they have no conflicts of interest. The content is solely the responsibility of the authors and does not necessarily represent the official views of the funding agencies.
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About the MU School of Medicine
The MU School of Medicine has improved health, education and research in Missouri and beyond for more than 170 years. MU physicians treat patients from every county in the state, and more Missouri physicians received their medical degrees from MU than from any other university. For more information, visit http://medicine.missouri.edu/.
