Join VALENS GroWorks for Webinar That Dives into the Mind of the Canadian Cannabis Consumer
Kelowna, British Columbia- Valens GroWorks Corp. (CSE: VGW) (the “Company” or “Valens“), is hosting a free webinar to discuss the findings of a new study – The Future of Cannabis in Canada.
The study, conducted with Resonance Consultancy, a leading advisor on tourism, real estate and economic development, looks at how legalization has affected attitudes toward consumption, develops a profile of current cannabis consumers, and identifies how and where Canadians plan to consume cannabis in the future.
“This legal industry is so new, that everyone is clamoring for real industry data and market intelligence,” said Everett Knight, Executive Vice President of Strategy and Investments, Valens GroWorks. “So this webinar is for anyone who is interested in understanding exactly who the Canadian consumer is, including Canadian citizens, cannabis professionals, politicians, entrepreneurs and investors. As the first G7 Country to legalize cannabis, Canada has become closely watched by the rest of the world – so this information would even be helpful for the American and European marketplace.”
Legalization of cannabis in Canada has fundamentally changed how Canadians perceive and consume the plant. Among the 27 percent of Canadian adults who say they have consumed cannabis in the past year, 84 percent have consumed cannabis since legalization – which amounts to 23 percent of the Canadian public. Additionally, nearly one-third (23 percent) of Canadian adults are likely to use any form of cannabis in the next year.
“For anyone looking to participate in the market, be it as a consumer, an entrepreneur, an investor or as an advocate, should listen to the webinar,” said Mr. Fair. “We’ll be showcasing some of the high-level findings for the consumer today, as well as forecasting what the next year will bring. Canada is such a dynamic market, and the ‘Second Coming’ of cannabis legalization this October will bring added interest – and money – into the market.”
About Resonance Consultancy: Resonance Consultancy specializes in research, development strategy, place branding and place marketing that shapes the future of countries, cities, and communities. Based in Vancouver and New York, the 18 employees at Resonance have completed more than 100 research reports, development strategies, business plans and branding projects for real estate developers, tourism organizations and governments in more than 75 countries.
About Valens GroWorks: Valens GroWorks Corp. is a research-driven, Canadian cannabis company focused on downstream secondary extraction methodology, distillation and cannabinoid isolation and purification, as well as associated quality testing with three wholly-owned subsidiaries located in and around Kelowna, BC. Subsidiary Valens Agritech (“VAL”) holds a license to cultivate cannabis and produce cannabis oil under the Cannabis Act, as well as a license to conduct analytical testing for the cannabis industry. VAL currently has extraction processing and supply agreements with various leading producers across Canada. Subsidiary Valens Labs is a Health Canada licensed ISO 17025 accredited cannabis testing lab providing sector-leading analytical services and has partnered with Thermo Fisher Scientific to develop a Centre of Excellence in Plant Based Science. Subsidiary Valens Farms is in the process of becoming a purpose-built facility in compliance with European Union (EU) Good Manufacturing Practices (GMP) standards, ensuring the product from this facility can be exported anywhere in the world where Cannabis is nationally legal for medical or adult usage purposes. For more information, please visit http://valensgroworks.com. The Company’s investor deck can be found specifically at http://valensgroworks.com/investors/
For further information, please contact:
Scott Young Valens GroWorks Corp. Telephone: +1.705.888.2756
U.S. / Europe Investors KCSA Strategic Communications Phil Carlson / Elizabeth Barker VGW@kcsa.com 212.896.1233 / 212.896.1203
Media KCSA Strategic Communications Anne Donohoe adonohoe@kcsa.com 212.896.1265
Notice regarding Forward Looking Statements
This news release contains certain “forward-looking statements” within the meaning of such statements under applicable securities law. Forward-looking statements are frequently characterized by words such as “anticipates”, “plan”, “continue”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “potential”, “proposed”, “positioned” 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 Corporation 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.
The CSE or other regulatory authority has not reviewed, approved or disapproved the contents of this press release. We seek Safe Harbour.
NeuClone to Initiate Phase I Clinical Trial of Stelara® (Ustekinumab) Biosimilar, the Second Biosimilar from the 10-product Portfolio with Serum Institute
SYDNEY, May 15, 2019 - NeuClone Pharmaceuticals Ltd. (NeuClone), a clinical-stage biopharmaceutical company exclusively focused on developing high-quality biosimilar products, today announced it will initiate the Phase I clinical trial of its Stelara® (ustekinumab) biosimilar in the second half of 2019.
Stelara® (ustekinumab) is a human monoclonal antibody approved for treatment of moderate to severe plaque psoriasis in adults and children 12 years or older. It is also approved to treat active psoriatic arthritis and moderate to severe Crohn’s disease in adults. Stelara® (ustekinumab) is directed against interleukin-12 and -23, naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders. Johnson & Johnson reported global Stelara® sales of $5.2 billion for 2018. Stelara® continued its growth in the first quarter of 2019, up 32% from the first quarter of 2018.
NeuClone’s Stelara® (ustekinumab) biosimilar is called ‘NeuLara’. The multicentre Phase I trial of NeuLara will be conducted in Australia under the Clinical Trial Notification (CTN) scheme of the Therapeutic Goods Administration (TGA). The trial will be a three-arm, randomised, double-blind, single-dose study comparing the pharmacokinetics and safety of NeuLara, to US- and EU-sourced Stelara® in healthy volunteers.
“NeuLara is the second biosimilar to enter clinical development from our 10-biosimilar product portfolio with manufacturing partner Serum Institute of India”, said Dr Noelle Sunstrom, Chief Executive Officer at NeuClone. “Our Herceptin® (trastuzumab) biosimilar (called ‘NeuCeptin’) has recently completed dosing in a similar three-arm Phase I clinical trial in Australia. We look forward to the clinical progress of NeuLara and advancement of other earlier stage biosimilars including our biosimilars already announced of Prolia®/XGEVA® (denosumab), Synagis® (palivizumab) and Perjeta®(pertuzumab).”
NeuLara was developed at NeuClone’s facilities using the proprietary NeuMAX® technology and Right from the Start™ development approach. Extensive analytical testing is conducted throughout all stages of development, including X-ray crystallography confirmation of identical NeuLara and Stelara® structures (see Figure 1).
NeuClone representatives will attend the upcoming 2019 BIO conference in Philadelphia from 3-6th June and look forward to discussing biosimilar development and commercialisation opportunities with potential partners.
About NeuClone
NeuClone is Australia’s only biosimilar company focused exclusively on developing a pipeline of biosimilar monoclonal antibodies. Six biosimilar products have been disclosed in NeuClone's pipeline that reference Herceptin®, Stelara®, Synagis®, Prolia®/XGEVA®, Perjeta® and Humira®. NeuClone develops biosimilar products using its proprietary NeuMAX® platform that facilitates low-cost manufacture of biologics, while enabling the highest product quality. NeuClone is led by a highly experienced team with state of-the-art integrated facilities based in Sydney, Australia. For more information, please visit www.neuclone.com.
Stelara® and NeuLara X-ray Crystallography
X-ray crystallography is a powerful technique that allows three-dimensional imaging of complex proteins. NeuClone’s crystallographic data confirms the identical structures of Stelara® and NeuLara. NeuClone’s Right from the Start™ development approach incorporates X-ray crystallography in addition to testing several other critical quality attributes sought by regulators to confirm biosimilarity from the outset and throughout development. This difficult to achieve added dimension, sets NeuClone apart.
Figure 1: X-ray crystallography overlay of Stelara® and NeuLara (A) Fab fragment; and (B) Fc fragment. Comparisons between Stelara and NeuLara indicate structurally identical molecules.
Stelara® is a registered trademark of Johnson & Johnson.
Herceptin® is a registered trademark of Genentech Inc.
Prolia® and XGEVA® are registered trademarks of Amgen Inc.
Synagis® is a registered trademark of MedImmune Inc.
Perjeta® is a registered trademark of Genentech Inc.
Humira® is a registered trademark of AbbVie Inc.
ProMIS Neurosciences Announces First Quarter 2019 Results
Company continues to show significant progress on developing highly selective antibodies targeting root cause of Alzheimer's and Parkinson's diseases and ALS
TORONTO and CAMBRIDGE, MA, May 14, 2019 /CNW/ - ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, today announced its operational and financial results for the three months ended March 31, 2019.
"Over the course of the first quarter of 2019, the value of our unique discovery and development platform was further evidenced as we made considerable progress in expanding our portfolio of opportunities in neurodegenerative diseases," stated Eugene Williams, ProMIS' Executive Chairman. Antibody candidates selectively targeting toxic forms of alpha synuclein for Parkinson's disease (PD) and toxic, aggregated forms of TDP43 for amyotrophic lateral sclerosis (ALS) were identified and further characterized to support ongoing pharmaceutical partnering discussions."
Corporate Highlights
In January 2019, we completed a private placement of 9,560,000 common share units at a price of $0.23 per unit resulting in gross proceeds of approximately $2,198,800. Each unit consisted of one common share and one common share warrant. The common shares are subject to a four-month hold period from the date of issuance. The expiry of the warrant is subject to acceleration under certain conditions.
In February 2019, we announced the identification of several antibody drug candidates showing best-in-class selectivity for toxic forms of alpha synuclein compared to other therapeutic antibodies in development for PD.
Following this announcement, Dr. Neil Cashman, our CSO presented further results of the Company's PD program at the International AD/PD 2019 Conference on March 31. The data presented showed how our novel drug discovery and development platform created antibodies that: 1) selectively bind to toxic forms of alpha synuclein while sparing healthy forms of alpha synuclein that are critical for proper cell metabolism and communication, and 2) block the neurotoxicity and the spread of the toxic forms of alpha synuclein in vitro.
In January 2019, we appointed Timothy G. Rothwell to our Business Advisory Board. Mr. Rothwell is a highly accomplished pharmaceutical leader with more than 30 years of experience directing the development and commercialization of new therapies.
Financial Results
Results of Operations – Three months ended March 31, 2019 and 2018
Net loss for the three months ended March 31, 2019 was $2,446,577, compared to a net loss of $1,556,872 for the three months ended March 31, 2018, respectively. Included in the net loss amount for the three months ended March 31, 2019 were non-cash expenses of $263,872, representing share-based compensation and amortization of an intangible asset, compared to $329,011 for the three months ended March 31, 2018. The increase in the net loss in the three months ended March 31, 2019 reflects the costs associated with operating the Company's AD therapeutics program, increased contracted research and consultant salaries and associated costs, supporting its patent portfolio and general corporate expenditures.
Research and development expenses for the three months ended March 31, 2019 were $1,770,653, as compared to $698,007 in the three months ended March 31, 2018. The increase in research and development expense for the three months ended March 31, 2019 is primarily attributed to increased spending on external contract research organizations for internal programs, higher contracted research salaries and associated costs, patent costs, and higher share-based compensation.
General and administrative expenses for the three months ended March 31, 2019 were $675,924, as compared to $858,870 in the three months ended March 31, 2018. The decrease in general and administrative expense for the three months ended March 31, 2019 is primarily attributable to decreased share-based compensation offset by increased consultant salaries and associated costs.
Outlook
As a prelude to the first PMN310 clinical trial in AD, we anticipate using a novel biomarker approach that may show evidence of slowing of neuronal death early in the development program. To accomplish this, we plan to initiate a natural history evaluation of biomarker changes in untreated, early AD patients.
We will also continue to further characterize the potential benefits of our programs selectively targeting toxic aggregates of TDP43 in ALS and toxic forms of alpha synuclein in PD to further support ongoing pharmaceutical partnering discussions.
About ProMIS Neurosciences, Inc.
ProMIS Neurosciences, Inc. is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting toxic oligomers implicated in the development and progression of neurodegenerative diseases, in particular Alzheimer's disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson's disease (PD). The Company's proprietary target discovery platform is based on the use of two complementary thermodynamic, computational discovery engines -ProMIS and Collective Coordinates – to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. Using this unique precision approach, the Company is developing novel antibody therapeutics for AD, ALS and PD. ProMIS is headquartered in Toronto, Ontario, with offices in Cambridge, Massachusetts. ProMIS is listed on the Toronto Stock Exchange under the symbol PMN, and on the OTCQB Venture Market under the symbol ARFXF.
Company documents relating to the fiscal year 2018 annual report can be viewed on the System for Electronic Document Analysis and Retrieval (SEDAR) at the link below:
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release contains certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company's current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE ProMIS Neurosciences Inc.
For further information:
For media inquiries, please contact: Shanti Skiffington, shanti.skiffington@gmail.com, Tel. 617 921-0808; For Investor Relations please contact: Alpine Equity Advisors, Nicholas Rigopulos, President, nick@alpineequityadv.com, Tel. 617 901-0785
Distressed employees ineffective for eight days per month due to lost productivity
They may be at work, but employees struggling with mental health issues are less than half as effective as healthy people
TORONTO, May 14, 2019 /CNW/ - Distressed employees spend more than one third of their time at work being unproductive and average one full day off sick per month.
This revelation comes with the release of Workplace Well-being: A Summary of the 2018 Workplace Outcome Suite Annual Report, released in partnership with the International Employee Assistance Professionals Association (EAPA). The report is based on data from multiple employee assistance providers worldwide (not just from Morneau Shepell) and over 23,000 employee use cases.
According to the research, employees struggling with mental health or other well-being issues are unable to concentrate on their job, a symptom known as "presenteeism," for more than a third of the total scheduled work time (38 per cent) – or about eight total days per month. For context, it is more than twice as much as the typical "healthy" employee.
In addition, these employees are also absent from work for an average of 7.36 hours per month – almost one full working day.
The most common clinical issues behind the reduced productivity were related to mental health (i.e., depression, anxiety) or personal stress (40 per cent of cases), followed by relationship problems of marriage or family life (29 per cent), work and occupational issues (18 per cent), and alcohol misuse and drug problems (four per cent).
The report looks at the utilisation and effectiveness of employee assistance programs (EAPs) and found that about eight out of every 10 cases for counselling were self-referrals, with referrals from a family or other source at seven per cent, supervisor referrals at five per cent, and a mandatory referral from HR or the employer at only two per cent. Thus, 98 per cent of cases were people voluntarily using the EAP for counselling.
"The results of the research demonstrated that there is a good reason for employers to use an EAP to support distressed employees and enhance overall employee well-being," said Barb Veder, vice president and chief clinician, Morneau Shepell. "After use of EAP-provided counselling, problem rates were reduced for every aspect measured in the report where employees need support. Thus, EAPs help to reduce the risks associated with workplace problems."
Measured over a three-month period of distress, changes in the outcomes revealed that almost five days of productive work time were restored per case due to the use of EAP counselling. This result was worth an estimated US$1,731 per case. With typical annual levels of program use and cost, the return on investment for EAP counselling was estimated at $3.37:1.
After use of EAP-provided counselling, problem rates were reduced for the five outcomes measured in the report. Thus, EAPs help to reduce the risks associated with workplace problems.
Having a "problem" with work presenteeism was reduced from 56 per cent to 28 per cent of all cases.
Having a "problem" with life satisfaction was reduced from 38 per cent to 17 per cent of all cases.
Having a "problem" with work absenteeism was reduced from 34 per cent to 14 per cent of all cases.
Having a "problem" with work engagement was reduced from 31 per cent to 21 per cent of all cases.
Having a "problem" with workplace distress was reduced from 22 per cent to 13 per cent of all cases.
About Morneau Shepell Morneau Shepell is the leading provider of technology-enabled HR services that deliver an integrated approach to well-being through our cloud-based platform. Our focus is providing everything our clients need to support the mental, physical, social and financial well-being of their people. By improving lives, we improve business. Our approach spans services in employee and family assistance, health and wellness, recognition, pension and benefits administration, retirement and benefits consulting, actuarial and investment services. Morneau Shepell employs almost 5,000 employees who work with some 24,000 client organizations that use our services in 162 countries. Morneau Shepell is a publicly traded company on the Toronto Stock Exchange (TSX: MSI). For more information, visit morneaushepell.com.
SOURCE Morneau Shepell - Corporate
Canadians with chronic conditions must take healthy living plan a step further - May is MedicAlert Month
New survey shows more can be done to protect those with a chronic condition
TORONTO, May 14, 2019 /CNW/ - When asked what they do to protect their health, millions of Canadians who live with chronic conditions are more likely to pay for self-care choices such as gym memberships and organic foods than they are to be pro-active about managing their medical information, a recent survey commissioned by MedicAlert shows.
According to a Leger survey conducted by the country's leading emergency medical information services provider, only 11 per cent of Canadians suffering from asthma, heart conditions, diabetes or prediabetes, and/or food or drug allergies currently have MedicAlert service, which offers access to immediate critical data in times when these people are unable to provide it themselves. In looking at the healthy living plans of this population, the study shows they tend to focus more on the present by investing in immediate actions, with 69 per cent taking vitamins and supplements, 42 per cent purchasing organic foods, 23 per cent paying for gym memberships, and 10 per cent attending stress relief classes such as yoga or Pilates, as opposed to also considering how their condition could affect their future treatment by medical professionals.
"While it's critically important that Canadians living with chronic health conditions maintain a healthy lifestyle, many do not realize that the MedicAlert service is a logical and important complement to a pro-active health management plan." says surgeon and board member for MedicAlert, Dr. Linda Maxwell.
"When you are in an emergency or a position where you can't respond for yourself, MedicAlert is the most credible information source to make sure your conditions are known to first responders. MedicAlert employs trained medical professionals to review health information and propose the most important elements to inscribe on a person's ID, and has been endorsed by emergency responders across the country as the most reliable source for sensitive information in critical situations," says Dr. Maxwell.
Today, one in three Canadians live with a medical condition that needs to be communicated to an emergency responder (paramedic, ER doctor, police officer or firefighter) at the time of an emergency. In fact, of the people surveyed (suffering from asthma, heart conditions, diabetes or prediabetes, and/or food or drug allergies), 34 per cent reported having been in an emergency situation due to their condition.
May is MedicAlert Month in Canada. The country's largest membership-based registered charity is taking this opportunity to remind Canadians of the life-saving importance and affordability of the MedicAlert service ($5 per month) as a crucial and logical complement to any healthy living plan.
Last year, a similar survey was revealed that only 15 per cent of Canadians were highly confident that emergency services could find their medical history without their support or while they were unconscious. Additionally, one in three Canadians were unsure whether a family or friend would pick up their first phone call in an emergency. In stark contrast, when a call is placed to MedicAlert, the 24/7 Emergency Hotline is answered by a live agent and can relay a person's key medical information to emergency responders immediately.
MedicAlert is also ideal for safeguarding loved ones who may wander, such as those with Alzheimer's or autism. Unlike any other service, it can quickly reunite loved ones, or get someone the precise attention they need. Furthermore, persons with mental health challenges may experience frightening or traumatic encounters with those trying to help in times of crisis. A visible MedicAlert ID can help responders better approach the situation by having access to someone's detailed medical profile and contact information, which empowers them to make informed decisions while the service quickly notifies caregivers to inform them of the situation and whereabouts of their loved one.
As the most trusted and most recommended medical emergency information services provider by the emergency responder community, MedicAlert has provided Canadians with lifesaving service and protection for over 55 years.
For more information, visit medicalert.ca or call 1.800.668.1507.
About MedicAlert Foundation Canada
MedicAlert Foundation Canada (MAFCA) is the largest membership-based registered charity in Canada and it is the leading provider of emergency medical information services. MedicAlert's mission is to ensure that all Canadians have access to high-quality health information at time of need, and has protected more than one million Canadians since 1961.
MedicAlert® is backed by robust electronic health records maintained by medically trained professionals, a state-of-the-art secure database, and a 24/7 Emergency Hotline that answers calls from emergency responder personnel in 140 languages, all linked to customized identification products for Canadians with medical conditions and special needs. Globally recognized and respected, MedicAlert speaks for you, when you can'tTM.
Learn more about MedicAlert, how it works, and how you or a loved one can sign up to a service plan by visiting medicalert.ca or calling 1-800-668-1507.
Survey Methodology An online survey of 1564 Canadians was completed between April 19-22, 2019, using Leger's online panel. The margin of error for this study was +/-2.5%, 19 times out of 20.
SOURCE MedicAlert Foundation Canada
Affinity Living Group rolls out mandatory vaccines for more than 4,000 employees
May 14, 2019 – North Carolina-based Affinity Living Group is taking a major step toward safer practices by requiring mandatory influenza vaccinations for its more than 4,000 employees.
ALG manages more than 120 communities in six states, and will be providing free flu and other immunizations, including pneumococcal and shingles, administered by local CVS Pharmacists for each community it manages. ALG, headquartered in Hickory, NC., is the first long-term care provider in North Carolina to provide mandatory employee vaccinations on this scale.
“Affinity Living Group is taking the bold step of making this mandatory for all staff as we move forward,” said Dr. Kevin O’Neil, chief medical officer for ALG. “Probably the single greatest advance in the history of medicine has been the introduction of vaccines. When you look at the impact vaccines have had in protecting large numbers of individuals – it’s monumental.”
Mandating the immunization of its team members is an essential step toward preventing potentially life-threatening illnesses for the older adults who reside in ALG communities as well as its employees. The vaccines will be offered at no cost to the employees through a voucher program.
“At ALG, we are not only responsible for providing care to the seniors who live in our communities, but also for caring for the individuals that work at each of those communities and at our headquarters,” said Mary Raddant, vice president of human resources. “We want each of those employees to remain safe and healthy year-round, and ensuring that each employee receives the flu shot at no charge is one extra step toward that goal.”
Ahead of flu season, CVS Pharmacists will hold a flu clinic at their respective ALG community. Employees can redeem their flu shot vouchers during this clinic, or any time at any CVS Pharmacy location, including those located within Target stores. Through an opt-out program, residents will also be able to receive their flu shots during these ALG clinics, and citizens from the surrounding area are welcome to participate with proof of insurance.
This initiative is an additional precautionary measure exemplifying ALG’s commitment to caring for its residents and employees.
“Our residents are our top priority,” said CEO Charles Trefzger. “We will do whatever it takes to be certain they are provided the best care, and this initiative is just one example of the preventative measures we take to keep our residents and staff safe and healthy.”
Along with providing the flu shot itself, ALG plans to educate ALG staff and the broader community on the importance of receiving the flu vaccine, debunking myths surrounding the perceived dangers of the vaccine, along with how the flu clinic program works. CVS Pharmacists will also attend ALG community events to serve as an educational resource to residents, family members and other guests on why the flu vaccine is critical, especially in the senior living space.
“More than 30 thousand people a year die from influenza, and it’s more significant in the older age group,” O’Neil said. “It’s important for us as people who work in this field to understand the moral responsibility that we have to be vaccinated.”
For more information on this press release, contact Tiffany Fields, Communications Specialist, at tfields@affinitylivinggroup.com or (828) 442-3621.
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With more than 120 communities in 6 states, Affinity Living Group, based in Hickory, NC, is the largest senior housing provider in the southeastern United States. Affinity’s mission is to provide a full continuum of housing and care services for older adults, delivered by a team of passionate and respectful professionals, at locations throughout the United States. We strive daily to create the best life for all we serve.
ALG Chief Medical Officer Dr. Kevin O'NeilDr. Kevin O'Neil Bio: Dr. O'Neil holds certifications in Internal Medicine and Geriatric Medicine from the American Board of Internal Medicine. He is a Fellow of the American College of Physicians and a member of the American Geriatrics Society. He was awarded his Certified Medical Director (CMD) from the American Medical Directors Association, and also serves on the Board of Directors of AMDA's Society for Post-Acute and Long-Term Care Medicine. Hailed as a leader in the area of geriatric medicine and health, Dr. O'Neil also serves on the Board of Directors of the Senior Friendship Centers of Southwest Florida and First Step in Sarasota, Florida. Since joining ALG, Dr. O'Neil has visited many of its assisted living and memory care communities to offer training to staff and families. Dr. Kevin O'Neil is available for interviews related to this story and vaccinations overall on May 14-15, 2019.
Pharmascience Inc. launches Royalmount Laboratories, a new analytical service division in Montreal
MONTREAL, May 10, 2019 /CNW Telbec/ - Pharmascience Inc. is proud to announce the launch of its new division in Montreal, Royalmount Laboratories. Royalmount Laboratories specializes in contract research services for both local and international companies. This new division leverages Pharmascience's strength in bioanalytical operations with a new competency in Cannabis testing for third parties.
"Pharmascience has been testing pharmaceutical products for over 35 years and doing its own bioanalysis on clinical trials for over 25 years. Offering our expertise and regulatory knowledge in analytical and bioanalytical testing to now help clients obtain cannabis testing is a bold new business expansion driven by our continued internal drive to be at the technical foreground of new markets." said David Goodman, Chief Executive Officer at Pharmascience Inc.
In March 2019, Pharmascience's licence to test cannabis was transitioned to the new Cannabis Regulations. Fully equipped with state-of-the-art equipment supplied by Shimadzu Corporation, the cannabis testing laboratory has the capability and capacity to perform all Health Canada required tests, including the full spectrum of pesticides in both dried flower and oil products with Pharmascience's usual turnaround times.
"Our existing bioanalytical business has expanded significantly this past year. We completed a Food and Drug Administration audit confirming that our procedures meet FDA regulatory requirements in 2018. We are very excited to add cannabis testing to complement our existing bioanalytical operation. We hope to become Quebec's premier testing laboratory in the very near future." added Adrien Musuku, Royalmount Laboratories Director of Operations. The bioanalytical operation is currently working with external clients for the biological drug quantification in preclinical and clinical studies.
Founded in 1983, Pharmascience Inc. is the largest pharmaceutical employer in Quebec with 1,500 employees proudly headquartered in Montreal. Pharmascience Inc. is a full-service privately-owned pharmaceutical company with strong roots in Canada and a growing global reach with product distribution in over 60 countries. Ranked 56th among Canada's top 100 Research & Development (R&D) investors with over $43 million invested in 2018, Pharmascience Inc. is the 4th largest manufacturer of over-the-counter generic drugs in the country.
Pharmascience Inc. is a leading manufacturer and marketer of prescription generic, over-the-counter, and behind-the-counter products as well as FDA approved Canadian-made injectables. The company commercializes nearly 300 product families in 20 different dosage forms for over 2,000 products. In Canada alone, more than 45 million prescriptions a year are filled with Pharmascience products. Pharmascience, through its Royalmount Laboratories division also specializes in contract research services.
In 2018, the prestigious Forbes magazine ranked Pharmascience Inc. among its list of top 300 employers. Pharmascience Inc. has strong long-standing philanthropic ties with its communities, both locally and internationally. For more than 20 years, Pharmascience has been working through Health Partners International of Canada (HPIC) as a partner of choice to increase access to medicine. Pharmascience's total donations of essential medicine is close to $70 million.
Canadian innovation from BC, Ontario, and Quebec recognized at PwC Canada's V2R Awards
TORONTO, May 10, 2019 /CNW/ - British Columbia's Ministry of Health, GHGSat Inc., Sun Life Financial, and Vancouver Airport Authority were named winners of PwC Canada's 2019 Vision to Reality (V2R) Awards. The awards ceremony took place at the Arcadian Court in Toronto on May 9, 2019.
"Congratulations to all winners and finalists! They are a testament to the endless possibilities that come from thinking big," says Chris Dulny, Chief Innovation Officer, PwC Canada. "Innovation affects every part of our lives and we hope that these awards help spur further innovative thinking in the rest of the Canadian business community which can strengthen the country's economy."
The awards are open to organizations within the four categories and then judged by anindependent panel of judges. The four categories include The visionary (CA$0 - $50M), The builder (CA$50M - $1B), The reinventor (CA$1B+) and The accelerator (public sector).
The 2019 Vision to Reality Awards winners include: The visionary (up to $50M): GHGSat Inc. developed a nano-satellite technology to cost-efficiently detect and quantify greenhouse gas emissions from industrial facilities, anywhere in the world.
The builder ($50M-$1B): Vancouver Airport Authority created the world's first self-service biometric-enabled kiosks to expedite border clearance, reduce wait times for travelers, and allow officers to focus on maintaining border safety.
The reinventor ($1B+): Sun Life Financial developed Lumino Health, a digital platform, which empowers Canadians to find health-care providers and health innovations they need. By using credible ratings, cost information and other criteria, it ensures that Canadians find their best match in a quick and easy manner.
The accelerator: British Columbia's Ministry of Health developed a Home Health Monitoring (HHM) program that uses virtual care technology to enable remote monitoring of patients from the comfort of their homes.
For more information about V2R Awards, winners, and finalists, please clickhere.
About PwC Canada At PwC, our purpose is to build trust in society and solve important problems. More than 7,000 partners and staff in offices across the country are committed to delivering quality in assurance, tax, consulting and deals services. PwC Canada is a member of the PwC network of firms with more than 250,000 people in 158 countries. Find out more by visiting us at www.pwc.com/ca.
PwC refers to the Canadian member firm, and may sometimes refer to the PwC network. Each member firm is a separate legal entity. Please see http://www.pwc.com/structure for further details.
SOURCE PwC (PricewaterhouseCoopers)
Cipher Pharmaceuticals Reports First Quarter 2019 Financial Results
Revenue increased by 12% to $5.1 million
OAKVILLE, ON, May 10, 2019 /CNW/ - Cipher Pharmaceuticals Inc. (TSX:CPH) ("Cipher" or "the Company") today announced its financial and operating results for the three months ended March 31st, 2019. Unless otherwise noted, all figures are in U.S. dollars.
Q1 2019 Financial and Corporate Highlights (all figures compared to the relative prior year period, unless otherwise noted)
The Company continues to execute on its corporate strategy focusing on long-term growth. Utilizing cash flows from its profitable global licensing business, Cipher is building a diversified portfolio of prescription products with near term value catalysts. For 2019, the Company is focussed on execution against three priorities: achieving key milestones across the portfolio, optimizing resource deployment to strengthen EBITDA and cash and delivering organic growth and profitability in the Canadian business.
Key highlights during and subsequent to the quarter include:
Total revenue increased 12% to $5.1 million for the three months ended March 31, 2019 up from $4.6 million for the three months ended March 31, 2018.
Product revenue increased by 5% to $1.9 million for the three months ended March 31, 2019 up from $1.8 million for the three months ended March 31, 2018 (adjusted for foreign exchange fluctuations).
Net income from continuing operations increased to $0.8 million for the three months ended March 31, 2019 up from a loss of $1.0 million for the three months ended March 31, 2018.
Adjusted EBITDA increased 80% to $1.8 million for the three months ended March 31, 2019 up from $1.0 million for the three months ended March 31, 2018.
Generated $1.6 million in cash from operating activities while retiring $2.0 million in debt.
Q1 2019 Financial Review (All figures are in U.S. dollars)
Total revenue was $5.1 million for Q1 2019 compared to $4.6 million for Q1 2018. The year-over-year increase mainly reflects higher licensing revenue from Absorica®.
Licensing revenue for Q1 2019 was $3.3 million compared to $2.8 million for Q1 2018. Absorica licensing revenue was $2.7 million for Q1 2019, compared to $2.1 million for Q1 2018. Licensing revenue from Lipofen® products was consistent with the comparative period at $0.5 million. Licencing revenue from tramadol products (Conzip® and Durela®) was consistent with the comparative period at $0.1 million.
Product revenue was unchanged at $1.8 million for Q1 2019 compared to Q1 2018. Adjusting for the impact of foreign exchange in Q1 2019 compared to Q1 2018, product revenue would have increased by 5% to $1.9 million.
The increase was primarily driven by Epuris®, which generated revenue of $1.6 million in the period compared to $1.4 million in Q1 2018. According to IQVIA, Epuris total prescriptions for the quarter grew by 29.4% compared to Q1 2018 and achieved market share of more than 37% during the quarter, compared to 31% for the same period last year.
Total operating expenses decreased to $3.6 million for Q1 2019 compared to $5.8 million for Q1 2018. The decrease related to a $1.8 million impairment charge on intangible assets in Q1 2018 and a $0.4 million decrease in selling, general and administrative expenses related to transaction costs that were incurred in the comparative period.
Income from continuing operations was $0.8 million, or $0.03 per basic and diluted share in Q1 2019, compared to a loss from continuing operations of $1.0 million, or $0.04 per basic and diluted share in Q1 2018. Adjusted EBITDA for Q1 2019 increased to $1.8 million compared to $1.0 million in Q1 2018.
The Company had $7.9 million in cash at March 31, 2019 compared with $10.4 million at the end of 2018. The Company generated $1.6 million in cash from operating activities and used approximately $2.5 million in cash during the quarter for debt payments and a milestone payment. The Company had $15.5 million in debt at March 31, 2019.
Management Commentary
"The first quarter of 2019 was focussed on execution against key value catalysts for our business. We are pleased with the progress that we are making against our priorities for 2019. We are on track with the achievement of key milestones for our recent transactions, our lead brand within our Canadian Commercial business, Epuris is growing year to date at over 29% in total prescriptions and our EBITDA is strengthening through optimized resource deployment."
Outlook
Cipher anticipates several key milestones in 2019 that will continue the growth of its Canadian commercial platform, including:
Regulatory approval for plecanatide from Health Canada in Q4 2019
Regulatory approval for A-101 from Health Canada in Q4 2019
Commercial launch of XYDALBA (dalbavancin)
North American top line results for MOB-015 in Q4 2019
Advance DTR-001 through IND enabling studies
The Company expects its licensing business to continue to provide a solid base of high-margin royalty revenue.
Financial Statements and MD&A Cipher's Financial Statements for the three months ended March 31, 2019 and Management's Discussion and Analysis ("MD&A") for the three months ended March 31, 2019 are available on the Company's website at www.cipherpharma.com in the "Investors" section under "Financial Reports" and on SEDAR at www.sedar.com.
Notice of Conference Call Cipher will hold a conference call today, May 10, 2019, at 8:30 a.m. (ET) to discuss its financial results and other corporate developments. To access the conference call by telephone, dial (416) 764-8609 or (888) 390-0605 and use conference ID 57384393. A live audio webcast will be available at https://event.on24.com/wcc/r/1993654/201373E95BBD2B7681680DAEA05EDB66 or the Investor Relations section of the Company's website at http://www.cipherpharma.com. An archived replay of the webcast will be available for 90 days.
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 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)
Source: IQVIA
2)
EBITDA is a non-IFRS financial measure. The term EBITDA (earnings before interest, taxes, depreciation and amortization,) does not have any standardized meaning under IFRS and therefore may not be comparable to similar measures presented by other companies. Rather, these measures are provided as additional information to complement IFRS measures by providing a further understanding of operations from management's perspective. The Company defines Adjusted EBITDA as earnings before interest expense, income taxes, depreciation of property and equipment, amortization of intangible assets, loss on debt extinguishment, non-cash share-based compensation, changes in fair value of derivative financial instruments, impairment of intangible assets and goodwill and foreign exchange gains and losses from the translation of Canadian cash balances.
(IN THOUSANDS OF U.S. DOLLARS)
Three months ended March 31, 2019
Three months ended March 31, 2018
$
$
Income (loss) from continuing operations
816
(951)
Add back:
Depreciation and amortization
299
226
Interest expense, net
222
130
Income taxes
423
(141)
EBITDA
1,760
(736)
Change in fair value of derivative financial instrument
(12)
(321)
Loss (gain) from the translation of Canadian cash balances
(26)
41
Impairment of intangible assets
—
1,832
Share-based compensation
32
156
Adjusted EBITDA
1,754
972
SOURCE Cipher Pharmaceuticals Inc.
International Food & Beverage Companies Align with WHO Standard in Global Commitment on Industrially Produced Trans Fat
Twelve of the largest global food and beverage companies pledge to enhance their commitment to the World Health Organization’s goal of phasing out industrially produced trans fat from the global food supply by 2023.
Geneva, Switzerland, 7 May 2019 – After a constructive discussion hosted by WHO Director General Dr. Tedros Adhanom Ghebreyesus on 2 May 2019,members of the International Food and Beverage Alliance (IFBA) have taken a further step in progressing the commitments they first made to the WHO in 2008, with the adoption of an enhanced worldwide commitment to phase out industrially-produced trans fats (iTFAs) from their products.
At the end of 2018, IFBA members had met the target of their 2016 commitment to reduce iTFAs in their products to nutritionally insignificant levels (less than 1 gram of fat per 100 grams of product) across 98.5% of their products worldwide.
Now, they have committed to align their global standard with WHO’s recommendation for a maximum iTFA threshold in food products not exceeding 2 grams of iTFA per 100 grams of fat or oil by 2023. The new IFBA commitment includes McDonald’s, which was not part of the 2016 commitment.
In support of both WHO Guidelines recommending a maximum 1% total energy intake from all trans fat and an intake of saturated fat not exceeding 10% of total energy intake, IFBA member companies will seek wherever possible to avoid that reformulation efforts to meet this iTFA commitment result in increases in saturated fat content.
“Working closely with the WHO under Dr Tedros’ leadership, the CEOs of IFBA have made a strong commitment on industrially produced trans fats. This is a demonstration of effective partnerships, leveraging the authority of WHO and the scale and commitment of the private sector for tangible public health outcomes”, said Rocco Renaldi, IFBA Secretary-General. “We hope our commitment inspires our suppliers and partners along the value chain to join us too. We will share our know-how with governments, civil society and the broader industry to ensure that the objective can be met by all food manufacturers in all countries”, he added.
The text of IFBA’s statement can be accessed here.
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About The International Food & Beverage Alliance (IFBA): IFBA is an alliance of twelve multinational food and non-alcoholic beverage companies - The Coca-Cola Company, Danone, Ferrero, General Mills, Grupo Bimbo, Kellogg’s, Mars, McDonald’s, Mondelēz International, Nestlé, PepsiCo and Unilever – who share a common goal of helping people around the world achieve balanced diets and healthy lifestyles. IFBA is a non-commercial, non-profit-making organization in special consultative status with the UN’s Economic and Social Committee (ECOSOC).
