Patients in Quebec now have access to DUPIXENT™ for the treatment of moderate-to-severe atopic dermatitis
* Quebec becomes the first province to list DUPIXENT™ for public reimbursement in adult patients
TORONTO, Oct. 22, 2019 /CNW/ - Patients living in Quebec will now have access, through the Régie de l'assurance maladie Québec (RAMQ), to DUPIXENT™ (dupilumab).1 DUPIXENT™ is used to treat adult patients with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.2 It is anticipated that additional jurisdictions will be adding DUPIXENT™ on their public formularies in the near future.
"People living with moderate-to-severe atopic dermatitis often experience chronic, intense, and sometimes unbearable symptoms that can significantly impact their daily lives," says Amanda Cresswell-Melville, Executive Director of the Eczema Society of Canada. "The Quebec reimbursement addresses the growing need for greater access to treatment options that can help to improve the lives of patients suffering with a more severe form of atopic dermatitis."
Atopic dermatitis, the most common form of eczema, is a chronic inflammatory disease.3 In its moderate-to-severe form, it is characterized by rashes that can potentially cover much of the body, and can include intense, persistent itching, skin lesions and skin dryness, cracking redness, crusting and oozing.4 Inadequately controlled atopic dermatitis can have a physical, emotional and psychosocial impact, causing sleep disturbance, symptoms of anxiety and depression, and feelings of isolation.5
"We are thrilled that Quebec patients in need will now have access to DUPIXENT™. DUPIXENT™ was previously only covered under private drug insurance in Canada, making this the first step in allowing for public funding of the first targeted therapy for moderate-to-severe AD," says Marissa Poole, General Manager, Sanofi Genzyme Canada. "Sanofi will continue to work in ensuring that DUPIXENT™ is available through the provincial, territorial and federal drug formularies."
Eligibility of public drug programs
RAMQ is the government health insurance board of Québec. RAMQ administers over 40 programs, including but not limited to the reimbursement of medical costs incurred by Quebeckers outside Québec.
The following persons are eligible for the Public Prescription Drug Insurance Plan:
DUPIXENT™ (dupilumab) – the first biologic therapy in Canada to target the root cause of atopic dermatitis (AD) was first approved by Health Canada on November 30, 2017 for the treatment of adult patients with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.6 Clinical studies showed an acceptable safety profile with a significant improvement in the condition of patients' skin and reduction in itch within the first four months of biweekly treatment.7 On September 18, 2019, DUPIXENT™ also received Health Canada approval for the treatment of adolescent patients aged 12 years and older with moderate-to-severe AD.8 The long-term safety profile of DUPIXENT™ observed in adolescents was consistent with that seen in adults with atopic dermatitis.9 DUPIXENT™ is jointly developed by Regeneron and Sanofi under a global collaboration agreement.
About Sanofi, Canada
Sanofi, Canada employs more than 2,000 people. In 2017, we invested in $123 million in R&D in Canada, creating jobs, business and opportunities throughout the country.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life
References
__________________
1 Dupixent™ (dupilumab) Product Monograph. Page 3. August 2019.
2 Dupixent™ (dupilumab) Product Monograph. Page 3. August 2019.
5 Eczema Society of Canada. (2017). Atopic Dermatitis Quality of Life Report (Moderate-to-Severe Disease – 2016/2017 Survey Results). Keswick, Ontario.
6 Dupixent™ (dupilumab) Product Monograph. Page 3. August 2019.
8 Dupixent™ (dupilumab) Product Monograph. Page 3. September 2019.
9 Dupixent™ (dupilumab) Product Monograph. Page 7. September 2019.
SOURCE Sanofi Canada
Scotiabank Brings #PathToImpact to Life During Small Business Week
Large-scale installation to run from October 21-25 in Toronto -
TORONTO, Oct. 21, 2019 /CNW/ - Scotiabank today unveils Path to Impact, an artful installation that brings to life the journey of starting and building a business in Canada. Standing up to 10 feet tall, the immersive installation will be open to the public in downtown Toronto during Small Business Week.
The installation will open from 8 a.m. to 8 p.m. ET from Monday, October, 21 to Friday, October, 25, at an outdoor space at 464 King St. West, near the busy intersection of King and Spadina. It includes first-person anecdotes from business owners and statistics about five key stages of the business journey, including:
The Big Idea: Business success starts with a big idea. Sometimes it's an idea so big that it's hard to process, but it will change everything.
Curveballs: This is the stage where thinking turns into doing at an extremely fast pace, and business owners face many curveballs along the way.
Doubt & Isolation: In this stage, business owners can feel stuck and question their vision.
Closing Doors: It is here when business owners feel like giving up but remember why they started in the first place, then persevere and keep going.
Impact: Finally, the big idea comes to life. Business owners look back on the journey and see how every step has led to impact.
"We know that many Canadian business owners go into business to make an impact on their community, yet often face a number of obstacles along the way. This art installation aims to bring that path to life in an interactive way, giving visitors a first-hand glimpse into that journey," said Jason Charlebois, Senior Vice President, Small Business for Scotiabank. "We're committed to working with businesses of all sizes to make their path to impact less of a struggle and more of a success."
Scotiabank offers business solutions to help business owners bring their own big ideas to life and to support them through every stage. Through a team of dedicated advisors, Scotiabank provides personal and business banking solutions, personalized advice, and dedicated programs that cater to a business owner's unique needs and future goals. This includes a multitude of solutions for small business owners such as the Select Account for Business and the Scotiabank Passport™ Visa Infinite* Business Card.
Scotiabank is also committed to empowering women-led businesses through The Scotiabank Women Initiative™, and providing tailored financial solutions for Canada's medical doctors with the Scotiabank Healthcare+ Physician Banking Program.
About Scotiabank Scotiabank is Canada's international bank and a leading financial services provider in the Americas. We are dedicated to helping our more than 25 million customers become better off through a broad range of advice, products and services, including personal and commercial banking, wealth management and private banking, corporate and investment banking, and capital markets. With a team of more than 100,000 employees and assets of over $1 trillion (as at July 31, 2019), Scotiabank trades on the Toronto Stock Exchange (TSX: BNS) and New York Stock Exchange (NYSE: BNS). For more information, please visit www.scotiabank.com and follow us on Twitter @ScotiabankViews.
™ Trademark of The Bank of Nova Scotia. *Visa Int./ Licensed user.
SOURCE Scotiabank
DON’T LOSE YOUR MOJO WHEN THE CLOCKS FALL BACK NOVEMBER 3rd
Neuropsychologist Offers Practical Tips to Prepare for Daylight Savings Time
That post-summer sluggishness usually kicks in every October as we head into fall. The temperatures drop and the one thing that makes winter’s rapid approach evident regardless of climate is the loss of daylight. For many, this loss of daylight also leads to a loss of energy, an uptick in short temper and even bouts of depression. So how can we ease into the rapidly approaching winter months? Dr. Sanam Hafeez, an NYC based licenses clinical psychologist and faculty member at the prestigious Columbia University Teachers College, offers practical tips to prepare for the clock change.
Before we get into the tips, it’s important to understand the clock change’s impact on our brains and therefore our bodies, so we understand what is actually going on. Dr. Sanam Hafeez explains that “a cell in the retinas of our eyes called a ganglion cell contains the photopigment melanopsin. When we are exposed to sunlight, melanopsin signals a pathway to cells in the hypothalamus specifically responsible for regulating our bodies biological functions. This process then triggers the pineal gland which is in charge of melatonin secretion which peaks at night and wears off during the day. In simpler terms, the less light exposure we get, more out of whack we feel.”
According to Dr. Hafeez, the following simple adjustments leading up to the clock falling back can make a significant difference for those who don’t struggle with more severe depression or bipolar disorder.
1. Avoid alcohol.
When the clocks are turned back in the fall, many bars stay open an additional hour. This is typically celebrated by people in their 20’s and 30’s who only pay for it the next day opting to sleep away their Sunday. Drinking alcohol before turning back the clocks can add more sluggishness the next morning. “Even with just a one-hour clock change, our body’s circadian rhythm is thrown off making our brains a bit confused. Alcohol only heightens these effects,” explains Dr. Hafeez. Imagine the double whammy of a hangover after the fall back clock change?
2. Enjoy physical activity during the daytime.
The more time spent outside in the daylight doing physical activity, the less sluggish you will feel once the clocks fall back. Fall is a great time to powerwalk or go for a run. If you’re an early riser then you will love the earlier sunrise at least for the next few weeks. “A lot of people shift their exercise routines to include more high energy group workouts in the evenings to give themselves something to look forward to as a way to shake off the workday. You really want to pay attention to when you feel most energized and align your exercise to that,” suggests Dr. Hafeez.
3. Don’t sleep in. Go to bed earlier instead.
In the days leading up to the clock change, add extra “wind-down” time before bed and get to bed an hour earlier. On the Sunday morning of the clock change, people mistakenly opt to sleep in. You really want to stick to the same wake-up time while getting to bed earlier. That’s the key according to Dr. Hafeez. “People think they are gaining an hour of sleep, they’re not because at bedtime they’re losing it. When you keep the wake-up time and get to bed earlier that extra hour isn’t felt as much the next day,” explains Dr. Hafeez.
4. Avoid watching the news before bed.
People think that getting to bed an hour earlier means it’s ok to watch TV in bed before sleep. TV or any kind stimulates the brain. Your favorite show causes you to focus when you’re trying to shut down stimulation. The news is even worse. You get wrapped up in the doom and gloom watching the news. “If you want to really make sure you still wake up refreshed, opt for tranquil music or guided meditations available on YouTube or an app, recommends Dr. Hafeez.”
5. Plan ahead! Consider taking Monday off!
For those who find their mood is negatively impacted after the fall clock change, consider taking Monday off and make it about self-care. Waking up early, taking advantage of the early light, enjoying a healthy breakfast, getting a massage or catching up on reading, tidying and whatever you feel necessary to feel good, do it. “People can feel the effects of the clock change for up to 3 weeks. Taking a day off to focus on your own well-being can become a nice post clock change ritual,” she says.
About the Doctor:
Dr. Sanam Hafeez PsyD is an NYC based licensed clinical psychologist, teaching faculty member at the prestigious Columbia University Teacher’s College and the founder and Clinical Director of Comprehensive Consultation Psychological Services, P.C. a neuropsychological, developmental and educational center in Manhattan and Queens. Dr. Hafeez masterfully applies her years of experience connecting psychological implications to address some of today’s common issues such as body image, social media addiction, relationships, workplace stress, parenting and psychopathology (bipolar, schizophrenia, depression, anxiety, etc…). In addition, Dr. Hafeez works with individuals who suffer from post-traumatic stress disorder (PTSD), learning disabilities, attention and memory problems, and abuse. Dr. Hafeez often shares her credible expertise to various news outlets in New York City and frequently appears on CNN and Dr.Oz.
Avicanna Announces Retail Launch of Pura Earth Derma-Cosmetics with Initial Roll-Out in Colombia
Pura Earth derma-cosmetics available in approximately 59 retail locations throughout Colombia, including Blind prestige beauty shops and Cromantic professional beauty markets
/NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES. ANY FAILURE TO COMPLY WITH THIS RESTRICTION MAY CONSTITUTE A VIOLATION OF UNITED STATES SECURITIES LAWS/
TORONTO, Oct. 21, 2019 /CNW/ - Avicanna Inc. ("Avicanna" or the "Company") (TSX: AVCN) (OTCQX: AVCNF), a biopharmaceutical company focused on the development, manufacturing and commercialization of organic and sustainable plant-derived cannabinoid-based products, is pleased to announce the retail launch of its Pura Earth™ derma-cosmetics line of CBD products, which are now available at approximately 59 high-end retail locations throughout Colombia, including Blind prestige beauty shops and Cromantic professional beauty markets.
Avicanna's Anti-Aging Treatment, Anti-Aging Serum, Clear Skin Treatment and Intensive Skin Conditioning Treatment, which are the first four of the nine Pura Earth product lines, are currently available at retail. Additionally the Pura Earth line will be offered on e-commerce platforms, including Percos, Cormantic, and Blind, as well as Avicanna's own platform, which is currently dedicated to Pura Earth.
The registration of the Pura Earth products as final products in Colombia will enable Avicanna to export such products into international jurisdictions that permit such products. Avicanna expects to launch the Pura Earth brand in additional international jurisdictions in early-2020.
The Pura Earth products were produced with Avicanna's proprietary formulations using cannabidiol ("CBD") isolate extracted by the Company's majority owned subsidiary, Santa Marta Golden Hemp S.A.S. ("SMGH"), from cannabis grown and cultivated by SMGH in Santa Marta, Colombia. SMGH's CBD isolate is derived from its USDA organic certified hemp (non-psychoactive cannabis). Additionally, the Pura Earth products will be supported by clinical data from studies conducted by the Centro de Atención e Investigación Médica CAIMED S.A.S. in collaboration with Avicanna.
"We are thrilled to start offering customers the world's first premium CBD skin care line with advanced formulations and substantiated claims through clinical evidence. The initial launch of Pura Earth in Colombia at these prestige beauty retailers is just the beginning of our global commercial strategy. Our vertically integrated operations have the scalability to support manufacturing a full range of premium CBD products and supply the global marketplace," stated Aras Azadian, Avicanna's Chief Executive Officer.
Colombia is one of the top four cosmetics markets in Latin America showing high growth rate in the cosmetics industry. The Latin America cosmetics industry is continuously expanding and has placed itself as one of the fastest growing and most vibrant cosmetic markets across the world. As per Goldstein Research, Latin America cosmetics market has reached a value of USD $31.98 billion in 2017 and is anticipated to grow at a CAGR of 4.49% during the forecast period 2017-2025.
About Pura Earth
Pura Earth is Avicanna's derma-cosmetic line which utilizes a combination of purified cannabidiol (CBD) and other synergistic botanical ingredients designed to naturally regulate and nourish the skin. The Pura Earth products are formulated with CBD cultivated under organic and sustainable conditions by Avicanna's subsidiary in Santa Marta, Colombia in the foothills of the Sierra Nevada Mountains. The Pura Earth product line was designed by Avicanna and optimized in partnership with the University of Toronto using Avicanna's proprietary formulations. The Pura Earth product line is manufactured by Altea Farmaceutica S.A. ("Altea") under Good Manufacturing Practices standards. In addition, Centro de Atención e Investigación Médica CAIMED S.A.S. is currently completing clinical studies on selected Pura Earth products in order to demonstrate their effectiveness with specific cosmetic endpoints, such as reduction of fine lines associated with aging, efficacy as a moisturizer for eczema prone skin, and reduction of sebum and redness attributed to acne.
About Avicanna
Avicanna is an Ontario corporation focused on the development, manufacturing and commercialization of plant-derived cannabinoid-based products through its two main business segments, cultivation and research and development.
Avicanna's two majority-owned subsidiaries, Sativa Nativa S.A.S. and Santa Marta Golden Hemp S.A.S., both located in Santa Marta, Colombia are the base for Avicanna's cultivation activities. These two companies are licensed to cultivate and process cannabis for the production of cannabis extracts and purified cannabinoids including cannabidiol (CBD) and tetrahydrocannabinol (THC).
Avicanna's research and development business is primarily conducted out of Canada at its headquarters in the Johnson & Johnson Innovation Centre, JLABS @ Toronto. Avicanna's scientific team develops products, and Avicanna has also engaged the services of researchers at the Leslie Dan Faculty of Pharmacy at the University of Toronto for the purpose of optimizing and improving upon its products.
Avicanna's research and development and cultivation activities are focused on the development of its key products, including plant-derived cannabinoid pharmaceuticals, phyto-therapeutics, derma-cosmetics and Extracts (defined as plant-derived cannabinoid extracts and purified cannabinoids, including distillates and isolates), with a goal of eventually having these products manufactured and distributed through various markets.
Stay Connected
For more information about Avicanna, visit www.avicanna.com, call 1-647-243-5283, or contact Setu Purohit, President by email info@avicanna.com.
Cautionary Note Regarding Forward-Looking Information and Statements
Certain information in this press release contains forward-looking statements. Such statements include but are not limited to the offering of the Pura Earth products on e-commerce platforms, the exportation of the Pura Earth Products into international jurisdictions, the expected launch date of the Pura Earth products internationally and the expected results of the clinical data supporting the Pura Earth products. This information is based on current expectations that are subject to significant risks and uncertainties that are difficult to predict, including the risk factors set out under the heading "Risk Factors" in the Company's long form final prospectus dated July 8, 2019. Actual results might differ materially from results suggested in any forward-looking statements. The Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements, unless and until required by securities laws applicable to the Company.
SOURCE Avicanna Inc.
For further information:
Over $3.5million Raised for Local Charities at the 30th Annual Scotiabank Toronto Waterfront Marathon
Trevor Hofbauer and Dayna Pidhoresky receive automatic pre-selection for Tokyo 2020 at the 2019 Scotiabank Toronto Waterfront Marathon
TORONTO, Oct. 20, 2019 /CNW/ - More than 26,000 people, from over 70 countries, took part in the 30th annual Scotiabank Toronto Waterfront Marathon this weekend, raising over $3.5 million for 190 charities, through the Scotiabank Charity Challenge.
Race highlights include:
Trevor Hofbauer and Dayna Pidhoresky were the top Canadians in the marathon distance, winning automatic pre-selection for Tokyo 2020 next August.
Kenya's Philemon Rono won the men's marathon, breaking the Canadian All-comers record, finishing in a time of 2:05:00.
Despite travel challenges, Kenya's Magdelyne Masai arrived in time to break the Canadian All-comers record, in a time of 2:22:16.
Filex Chemonges eclipsed the Ugandan National record, previously held by Stephen Kiprotich, set in 2015.
"We had a remarkable day to celebrate the 30th anniversary of the Scotiabank Toronto Waterfront Marathon," says Alan Brookes, Race Director of the Scotiabank Toronto Waterfront Marathon. "Since its inception, we wanted to build a marathon that Toronto and Canada would be proud of and this year, I think the city can take a bow. With the fastest ever marathons run in Canada for both men and women and two Canadians booking their tickets to Tokyo—what a day!"
"We are thrilled with the turnout at this year's Scotiabank Toronto Waterfront Marathon and thank all the runners for joining us and to all of the volunteers who helped make the Marathon such a success," says Mike Tasevski, Vice President of Global Sponsorships at Scotiabank. "We'd also like to thank the runners who have also raised funds for a variety of important charities, through the Scotiabank Charity Challenge. Thanks to them, we're helping many organizations that focus on young people in our community reach their infinite potential, a key priority for Scotiabank."
The Scotiabank Charity Challenge is a turnkey fundraising program that provides a simple and effective way to support local causes that make a big difference in people's lives. Participating charities keep 100 per cent of the proceeds raised, as Scotiabank pays for all transaction and credit card fees.
2019 Scotiabank Toronto Waterfront Marathon Results
#TOwaterfront42K, #ItsYourMoment, #InfinitePotential, and #RunScotia
About the Scotiabank Toronto Waterfront Marathon An IAAF Gold Label race, the Scotiabank Toronto Waterfront Marathon is Canada's premier, big-city running event, the Athletics Canada National Marathon Championships, the Marathon Trials for Tokyo 2020 and the Grand Finale of the 8-race Canada Running Series. In 2018 it attracted more than 25,000 participants from over 70 countries raised $3.5 million for 188 charities through the Scotiabank Charity Challenge and contributed an estimated $28 million to the local economy. The livestream broadcast was watched by more than 54,000 viewers from 146 countries. http://STWM.ca
About Scotiabank At Scotiabank, we aim to support organizations that are committed to helping young people reach their infinite potential. Young people are our future leaders and Scotiabank's goal is to help ensure that they have the necessary skills and resources they need to support their success. Together with our employees, the Bank supports causes at a grassroots level. Recognized as a leader for our charitable donations and philanthropic activities, in 2018, Scotiabank contributed more than $80 million to help our communities around the world.
Scotiabank is Canada's international bank and a leading financial services provider in the Americas. We are dedicated to helping our more than 25 million customers become better off through a broad range of advice, products and services, including personal and commercial banking, wealth management and private banking, corporate and investment banking, and capital markets. With a team of more than 100,000 employees and assets of over $1 trillion (as at July 31, 2019), Scotiabank trades on the Toronto Stock Exchange (TSX: BNS) and New York Stock Exchange (NYSE: BNS). For more information, please visit www.scotiabank.com and follow us on Twitter @ScotiabankViews.
SOURCE Scotiabank
Torn Tendon? How to Recover After an Injury
The human body has hundreds of tendons that are susceptible to damage from a trauma injury or from long-term overuse. Amateur and professional athletes or an aging individual is more likely to suffer from a torn tendon injury, and there are a variety of ways to recover from this issue. Here are five ways for you to treat and recover from a damaged tendon.
Elevating the Injured Body Part
Elevating the injured body part can help the blood to circulate better along with preventing any swollen tissues. Experts suggest using beds that will rise or stacks of pillows to elevate an arm or a leg during the recovery process. When you are elevating a leg or an arm, you shouldn’t feel a lot of discomfort. If it feels uncomfortable to prop up an injured body part, then you should avoid this treatment.
Compress the Damaged Body Part
You can wear a compression bandage or an elastic brace to help a torn tendon heal. Make sure to measure your injured knee, wrist or elbow carefully to find a brace that fits snugly but that isn’t too tight. Compression can alleviate your pain along with keeping the torn tendon in the correct position so that it will mend correctly.
Visit a Medical Specialist
If your ankle is injured, then you can experience a torn tendon. An ankle injury is serious because this part of the body is complicated with numerous tendons that are attached to muscles. When you have an ankle problem, mobility can become difficult, and if the injury takes too long to heal, then your daily life is disrupted. Experts recommend visiting an ankle doctorfor your tendon injury to have a faster recovery.
Resting during Your Recovery Process
You should avoid using the damaged body part too much while you are recovering. By sleeping more, your body’s glands will produce healing hormones that can help your torn tendon to repair faster. At the same time, as you begin to feel better, moving your leg, arm or shoulder can prevent any adhesions that can develop in your deeper tissues.
Heat and Ice Treatments for Torn Tendons
With your physician’s approval, you can use a heating pad or an ice pack on a damaged tendon. Remember that you should only use these treatments for a few minutes several times a day or night to avoid additional damage to the body’s tissues.
Cipher Pharmaceuticals Receives Health Canada Approval For Trulance® (Plecanatide)
OAKVILLE, ON, Oct. 18, 2019 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: CPH) ("Cipher" or "the Company") today announced it has received Health Canada approval, on October 10, 2019, for TRULANCE® (plecanatide), a Guanylate cyclase-C (GCC) agonist in the form of a once-daily tablet for the treatment of adults with irritable bowel syndrome with constipation ("IBS-C").
"We are pleased to announce TRULANCE® has achieved Health Canada approval and we are excited to be able to bring this new and effective treatment option to Canadians who suffer from this condition," said Craig Mull, Interim CEO of Cipher.
It is estimated that one in four Canadians has symptoms of constipation and an estimated 38% of Canadians report constipation within the previous 12 months1. According to IQVIA the total Canadian laxative and antispasmodic market (prescription and OTC) was valued at over CDN $200 million for the 12 months ending December 2018.
Consistent with its strategy to focus on partnering assets, Cipher is in the process of selecting a distribution partner for TRULANCE® that possesses the expertise and scale to successfully bring this novel product to market.
Cipher acquired the Canadian rights to develop, market, distribute and sell TRULANCE® from Bausch Health Companies Inc.
About Irritable Bowel Syndrome with Constipation (IBS-C)
Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by recurrent abdominal pain and associated with either a change in the frequency of stool, or a change in the form (appearance) of the stool. IBS can be subtyped by the predominant stool form: constipation (IBS-C), diarrhea (IBS-D) or mixed (IBS-M). Those within the IBS-C subtype experience hard or lumpy stools more than 25% of the time.
AboutTRULANCE®
TRULANCE® is a once-daily tablet approved by Health Canada for adults with IBS-C. With the exception of a single amino acid substitution for greater binding affinity, TRULANCE® is structurally identical to uroguanylin, a naturally occurring and endogenous human GI peptide. Uroguanylin activates GC-C receptors in a pH-sensitive manner primarily in the small intestine, stimulating fluid secretion and maintaining stool consistency necessary for regular bowel function.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals (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. For more information, visit www.cipherpharma.com.
Forward-Looking Statements This document includes forward-looking statements within the meaning of applicable 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 and statements relating to Cipher's acquisition of Cardiome Pharma Corp. ("Cardiome") pursuant to which Cipher acquired the Canadian business portfolio of Cardiome, including statements in respect of the anticipated strategic and/or financial benefits of the arrangement, anticipated regulatory approvals of products and the timing thereof. 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; our dependency on protection from patents that will expire; 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; products in Canada may be subject to pricing regulation; 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 and current uncertainty surrounding health care regulation in the U.S.; 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; products may not be included on list of drugs approved for use in hospitals; hospital customers may make late payments or not make any payments; 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; legacy risks from operations conducted in the U.S.; 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 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; 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; and our debt obligations will have priority over the common shares of the Company in the event of a liquidation, dissolution or winding up.
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 this MD&A and the Annual Information Form for the year ended December 31, 2018, 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.
(1) "Understanding the Prevalence and Impact of Constipation in Canada": A Special Report from the Canadian Digestive Health Foundation.
SOURCE Cipher Pharmaceuticals Inc.
Avicanna (TSX: AVCN) Announces Receipt of the First Colombian USDA Organic Certification for its Hemp Cultivation and Registration of 15 Additional Genetics
/NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES. ANY FAILURE TO COMPLY WITH THIS RESTRICTION MAY CONSTITUTE A VIOLATION OF UNITED STATES SECURITIES LAWS/
TORONTO, Oct. 18, 2019 /CNW/ - Avicanna Inc. ("Avicanna" or the "Company") (TSX: AVCN) (OTCQX: AVCNF), a biopharmaceutical company focused on the development, manufacturing and commercialization of organic and sustainable plant-derived cannabinoid-based products, is pleased to announce that Santa Marta Golden Hemp S.A.S. ("SMGH"), a majority owned subsidiary of the Company, has obtained a United States Department of Agriculture ("USDA") National Organic Program ("NOP") certification from Control Union Certifications, for its hemp cultivar, and has obtained registration for an additional 15 genetic strains of cannabis.
USDA Organic Certification
Receipt of a NOP certification from the USDA for the cultivation of hemp (non-psychoactive cannabis) makes SMGH the first producer to receive this certification in Colombia. As a result, SMGH's organic cultivation practices are now validated by the USDA, which positions the Company to provide certified organic hemp derivatives for use in supplements and food products produced or shipped to the United States. The USDA protects consumers by allowing certified growers to use the USDA organic logo on products that are grown without the use of synthetic fertilizers, pesticides or herbicides. Any products intended for medical purposes coming from this organic cultivated hemp are outside of the scope of this certificate and cannot be commercialized as "organic".
Aras Azadian, the Company's Chief Executive Officer, stated, "Receiving the USDA NOP certification marks a significant milestone in our commitment to help set the highest quality standards in organic and sustainable cannabis cultivation, as we take another step forward towards becoming a global leader in the CBD industry. We expect this achievement to facilitate our growth strategy, which includes the expansion of both our plant-derived active pharmaceutical ingredients ("APIs") and bulk CBD formulations, as well as our branded lines of finished derma-cosmetics and phyto-therapeutic products into the U.S. and European markets where the USDA certification is a premium differentiator for those product categories that allow hemp to be certified as organic."
About Organic Cultivation
Dedicated to environmental preservation, SMGH will cultivate 100% sun-grown USDA certified organic hemp. Implementing Good Agricultural and Collection Practices and promoting a living soil system, SMGH's plants will grow healthy. The use of chemical pesticides and herbicides is harmful for the consumer, the plant, and mostly the environment. Plants grown under the pressure of conventional practices don't develop to produce their full potential of nutrients and benefits. Chemicals used in conventional agriculture are responsible for poisoning water sources, damaging the soil and diminishing its ability to sequester carbon dioxide which is a major cause for global warming. SMGH strives to maintain its soils free from synthetic compounds as a compromise to our planet.
Registration of Additional Genetics
On October 18, 2019, Avicanna received confirmation that SMGH has obtained registrations for 11 strains of psychoactive cannabis and 4 strains of non-psychoactive cannabis. Following such registration, SMGH has a total of 14 registered strains of psychoactive cannabis and 5 registered strains of non-psychoactive cannabis. SMGH, can commence production of products containing each strain of non-psychoactive cannabis that has been registered and, upon receipt of a quota with respect to each registered psychoactive strain, SMGH will be able to commence production of products containing each strain of its registered psychoactive cannabis strains. In addition, such registration enables SMGH to market seeds of such registered genetics and export propagation material (upon receipt of necessary approvals).
"Achieving this additional registration not only expands Avicanna's genetic bank for commercial purposes but also reflects our commitment to work with a wide range of varieties that provide a new range of cannabinoids for our research and development projects. This registration will also enhance our capacity to continue improving and stabilizing high performance genetics as part of our breeding program," said Avicanna's Chief Agricultural Officer, Lucas Nosiglia.
About Avicanna
Avicanna is an Ontario corporation focused on the development, manufacturing and commercialization of plant-derived cannabinoid-based products through its two main business segments, cultivation and research and development.
Avicanna's two majority-owned subsidiaries, Sativa Nativa S.A.S. and Santa Marta Golden Hemp S.A.S., both located in Santa Marta, Colombia are the base for Avicanna's cultivation activities. These two companies are licensed to cultivate and process cannabis for the production of cannabis extracts and purified cannabinoids including cannabidiol (CBD) and tetrahydrocannabinol (THC).
Avicanna's research and development business is primarily conducted out of Canada at its headquarters in the Johnson & Johnson Innovation Centre, JLABS @ Toronto. Avicanna's scientific team develops products, and Avicanna has also engaged the services of researchers at the Leslie Dan Faculty of Pharmacy at the University of Toronto for the purpose of optimizing and improving upon its products.
Avicanna's research and development and cultivation activities are focused on the development of its key products, including plant-derived cannabinoid pharmaceuticals, phyto-therapeutics, derma-cosmetics and Extracts (defined as plant-derived cannabinoid extracts and purified cannabinoids, including distillates and isolates), with a goal of eventually having these products manufactured and distributed through various markets.
Stay Connected
For more information about Avicanna, visit www.avicanna.com, call 1-647-243-5283, or contact Setu Purohit, President by email info@avicanna.com.
Cautionary Note Regarding Forward-Looking Information and Statements
Certain information in this press release contains forward-looking statements. Such statements include but are not limited to the ability of the Company to use its organic hemp in supplements and food products, the expectation that the receipt of the NOP certification will allow the Company to accelerate growth, that SMGH will cultivate 100% sun-grown USDA organic hemp and that SMGH will be able to commence production of its registered psychoactive strains of cannabis. This information is based on current expectations that are subject to significant risks and uncertainties that are difficult to predict, including the risk factors set out under the heading "Risk Factors" in the Company's long form final prospectus dated July 8, 2019. Actual results might differ materially from results suggested in any forward-looking statements. The Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements, unless and until required by securities laws applicable to the Company.
SOURCE Avicanna Inc.
Garamendi and Hartzler Introduce Bill to Protect Service Members from Chinese-Controlled Generic Pharmaceutical Industry
Washington, DC—Today, Congressman John Garamendi (D-CA), Chairman of the Readiness Subcommittee within the House Armed Services Committee, and Congresswoman Vicky Hartzler (R-MO), Ranking Member of the Tactical Air and Land Forces Subcommittee within the House Armed Services Committee, introduced the "Pharmaceutical Independence Long-Term Readiness Reform Act" (H.R. 4710).
The legislation requires the Department of Defense to identify the vulnerabilities faced by our country’s dependence on Chinese pharmaceuticals, and to only purchase American-made raw materials, medicines, and vaccines for the military.
“Right now, China has the ability to attack the United States without firing a single shot by poisoning our servicemembers’ medicines or cutting off their supply.” Garamendi said. “The Chinese government is the principal developer of generic prescriptions, which account for approximately 90 percent of pharmaceuticals. China’s chokehold on the global pharmaceutical market leaves our servicemembers and our nation vulnerable to attack. We need to reinvigorate the United States industrial base to produce generic medicines and antibiotics domestically. Doing so will create thousands of new middle-class jobs and make our country safer. I appreciate Congresswoman Hartzler’s partnership in our effort to resolve this issue.”
“Put simply, China having control over the production of our military’s medicine poses a grave national security threat. Not only does it open the possibility of them deliberately manipulating our servicemember’s medical regimens and causing physical harm, but the Chinese government’s lack of proper oversight and regulatory standards on prescription drugs is also deeply alarming to me. We need to ensure that our military’s medicine is American-made,” Hartzler said.
The full text of the "Pharmaceutical Independence Long-Term Readiness Reform Act" (H.R. 4710) can be viewed here.
Coaster Introduces the Venture 500 ALEX to Support Pediatric Cancer Research
First of Kind “Mobile Lemonade Stand” Will Be Available for Rental and Purchase
[SAN FRANCISCO, CA] Today, Coaster Cycles unveiled a new model – the Coaster Venture 500 ALEX - inspired by its partnership with Alex’s Lemonade Stand Foundation (ALSF). This new model will be a key part of Coaster’s support to ALSF, a featured community partner of the Company. The limited edition mobile lemonade stand will operate at select locations in the Bay Area with all proceeds benefiting the Foundation.
Coaster manufactures and operates eco-friendly mobility products that provide transportation, delivery, and branding services for a range of clients, including Fortune 500s, governments, universities, events, and retailers. Coaster will offer the Coaster Venture 500 ALEX for direct purchase with proceeds benefiting ALSF.
Proudly made in the USA, Coaster builds all of its vehicles at its 24,000 sq. ft. facility in Missoula, MT. The Venture series offers a leading solution for food and beverage companies such as Starbucks, Aramark, Constellation, Pepsi, and many more. The Venture – and all Coaster Cycles - can operate in the bike lane, does not require a driver’ license, and helps reduce congestion and pollution.
“In building a partnership with ALSF, the product and mission alignment, potential for high scale impact, and our personal passion for the cause made it a perfect fit.” said Ben Morris, Founder and CEO of Coaster.
Our hope is that in making the Coaster Venture 500 ALEX available for purchase, and eventually rental, it will become a staple of concessions at concerts, sporting events, universities, corporate campuses and beyond, all in support of the Foundation.”
“We welcome the opportunity to work closely with Coaster. Like ALSF, Coaster is committed to providing resources for finding the best research and better, less toxic treatments for children fighting cancer,” said Liz Scott, co-executive director of ALSF and Alex’s mom.
In addition, as a Featured Community Partner, Coaster will support ALSF through a variety of charitable integrated programs. The company will make a donation that will help fund impactful research and family resources ($20) for every Coaster sold, offer clients the opportunity to add a donation to ALSF at checkout, organize Coaster service days in support of ALSF, and raise awareness of ALSF activities and fundraising initiatives.
About Alex's Lemonade Stand Foundation (ALSF)
Alex's Lemonade Stand Foundation (ALSF) emerged from the front yard lemonade stand of 4-year-old Alexandra “Alex” Scott, who was fighting cancer and wanted to raise money to find cures for all children with cancer. Her spirit and determination inspired others to support her cause, and when she passed away at the age of 8, she had raised $1 million. Since then, the Foundation bearing her name has evolved into a national fundraising movement. Today, ALSF is one of the leading funders of pediatric cancer research in the U.S. and Canada raising more than $175 million so far, funding nearly 1,000 research projects and providing programs to families affected by childhood cancer. For more information, visit AlexsLemonade.org.
About Coaster Cycles
Coaster Cycles' mission is to inspire communities and brands to move, connect and deliver with the world around them. Coaster manufactures and operates eco-friendly mobility products that provide transportation, delivery, and branding services for a range of clients, including Fortune 500s, governments, universities, events, and retailers. Proudly made in the USA, Coaster manufactures in a 24,000 sq. ft. facility in Missoula, MT. The company also operates fleets in Boston, New York and San Francisco and activates ad campaigns nationally.
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