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AbbVie’s MAVIRET® now listed on the Newfoundland and Labrador formulary

  • MAVIRET® is an 8-week, pan-genotypic treatment for adults and adolescent patients 12 to 18 years of age with chronic hepatitis C virus (HCV) infection without cirrhosis and who are new to *1
  • MAVIRET is approved for use in patients across all stages of chronic kidney disease (CKD).
  • MAVIRET is now available and reimbursed across

 

MONTREAL (Quebec), January 14, 2020 – AbbVie (NYSE: ABBV), a global, research and development- based biopharmaceutical company announced today that MAVIRET® (glecaprevir/pibrentasvir tablets) is now listed on the Newfoundland and Labrador Formulary. MAVIRET is a once-daily ribavirin-free treatment for adults and adolescent patients 12 to 18 years of age with chronic hepatitis C virus (HCV) infection across all major HCV genotypes (GT1-6).2 It is an 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment.*

 

“As a nurse practitioner, I see firsthand the devastating effects hepatitis C has in our communities and on those living with this disease. But we can change the narrative because we have all the right tools to eliminate this disease. We have the understanding, knowledge, resources and treatments like MAVIRET, to educate and treat everyone living with hepatitis C,” says Kimberley A. Burt RN, BN, NP, Provincial

Immunodeficiency Nurse Practitioner, Eastern Health, St. John’s, Newfoundland.

 

MAVIRET is listed on the Newfoundland and Labrador Formulary for treatment-naive or treatment- experienced adult patients with chronic hepatitis C genotype 1,2,3,4,5 or 6 infection.3

 

“Our vision is to work together to create a province without hepatitis C. To achieve this goal, we have to continue to raise awareness, educate, support people living with and/or affected by hepatitis C, as well as advocate for change,” explains Gerard Yetman, Executive Director, AIDS Committee of Newfoundland and Labrador. “We strongly believe that the newer treatments, such as MAVIRET, will have a positive impact and help us fulfill our mandate to eliminate hepatitis C from our province.”

 

MAVIRET’s efficacy and safety were evaluated in nine phase II-III clinical trials, in over 2300 patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection and with compensated liver disease (with or without cirrhosis).

An estimated 250,000 people in Canada are living with chronic hepatitis C but as many as 44% are not aware that they have it.4 Left undiagnosed and untreated, chronic hepatitis C can lead to cirrhosis, liver cancer or liver failure. Currently, hepatitis C is the leading indication for liver transplant in Canada.5 AbbVie supports a range of efforts to help elevate and prioritize HCV elimination because we know achieving the shared goal of elimination by 2030 will take more than medicine. It will take transparent and collaborative partnerships with all stakeholders – industry, healthcare providers, healthcare systems, patient groups and their support networks. Joint efforts and maximizing the time we have left will enable us to reach this goal.

 

 

About MAVIRET®

MAVIRET is approved in Canada for the treatment of chronic hepatitis C virus (HCV) in adults and adolescent patients 12 to 18 years of age across all major genotypes (GT1-6).6 MAVIRET is a pan- genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100 mg), an NS3/4A protease inhibitor, and pibrentasvir (40 mg), an NS5A protein inhibitor. MAVIRET is taken once daily as three oral tablets.6

 

MAVIRET is an 8-week, pan-genotypic treatment that makes a virologic cure** possible in patients without cirrhosis who are new to treatment.*1 These patients represent the majority of people infected with HCV. MAVIRET is also approved in patients with specific treatment challenges, including those with compensated cirrhosis, who are carriers of one of the major genotypes, and those who previously had limited treatment options, such as patients with severe CKD, post-liver and post-renal transplant recipients*** and those patients with genotype 3 HCV infection.6 MAVIRET is approved for use in patients across all stages of CKD.6

 

Glecaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) to develop HCV protease inhibitors and therapeutic regimens that include protease inhibitors.

 

* Patients without cirrhosis and new to treatment with direct-acting antivirals (DDAs), (i.e., either treatment-naive or did not respond to previous interferon-based treatments (pegylated interferon [peg IFN] +/- ribavirin or sofosbuvir–ribavirin +/-peg IFN).

** Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.

***MAVIRET is recommended for 12 weeks in liver or kidney transplant recipients who are HCV GT1-6 treatment-naive or HCV GT-1, -2, -4, -5 or -6 PRS (IFN or peg IFN, ribavirin and/or sofosbuvir)-treatment experienced. A 16-week treatment duration should be considered in transplant patients who are HCV GT-1 NS5A inhibitor experienced (but NS3/4A inhibitor-naive) or HCV GT-3 PRS- treatment experienced.

 

About AbbVie Care

Canadians prescribed MAVIRET can be enrolled in AbbVie Care, AbbVie’s signature care program. The program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, personalized education and ongoing disease management support throughout the treatment.

 

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to

developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

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Media:

Kim Hogan AbbVie Canada

kim.hogan@abbvie.com

514-243-8186

 

 

1 Decisions Resources Group. Hepatitis C virus: disease landscape & forecast 2016. January 2017.

2 CADTH Canadian Drug Expert Committee Recommendation – Final. www.cadth.ca/sites/default/files/cdr/complete/SR0523_Maviret_complete-Jan-25-18.pdf. Accessed January 2020.

3 Newfoundland and Labrador. Department of Health and Community Services. https://nlpdp.bell.ca/default.aspx. Accessed June 2019.

4 Canadian Network on Hepatitis C (CanHepC). Blueprint to inform hepatitis C elimination efforts in Canada. www.canhepc.ca/sites/default/files/media/documents/blueprint_hcv_2019_05.pdf. Accessed January 2020. 5 The Canadian Liver Foundation. www.liver.ca/how-you-help/advocate/. Accessed January 2020.

6 AbbVie Corporation MAVIRET (glecaprevir/pibrentasvir tablets) Product Monograph. Date of Preparation: August 16, 2017. Date of Revision: June 25, 2019. www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/MAVIRET_PM_EN.pdf. Accessed January 2020.

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AbbVie Receives Health Canada Approval of RINVOQ® (upadacitinib), an Oral Medication for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis

  • Approval supported by efficacy and safety data from the pivotal Phase 3 SELECT rheumatoid arthritis (RA) program, one of the largest registrational Phase 3 programs in RA with approximately 4,400 patients evaluated across five studies1-5
  • About one in every 100 adult Canadians, or approximately 300,000 people, are living with rheumatoid arthritis, the majority of whom don’t achieve remission6,7

 

MONTREAL, QC, January 7, 2020 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that Health Canada has approved RINVOQ® (upadacitinib) for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate (MTX). RINVOQ is a

15 mg, once-daily oral Janus kinase (JAK) inhibitor and may be used as monotherapy or in combination with MTX or other nonbiologic disease-modifying anti-rheumatic drugs (DMARDs).

 

“While there has been tremendous progress in the treatment of rheumatoid arthritis over the past two decades, too many patients still don’t reach remission and continue to suffer from pain, fatigue and morning joint stiffness,” said Dr. Edward Keystone, MD, FRCPC, Professor of Medicine, University of Toronto. “RINVOQ had one of the largest Phase 3 clinical trial programs in rheumatoid arthritis, and this medicine has the potential to significantly improve signs and symptoms of the disease.”

 

Gaétane Lepire, who lives with rheumatoid arthritis, explained the impact the disease has had on her life: “It affected me because I had pain in my feet, my knees, my back and my hands 24 hours a day, seven days a week. I tried to function as if everything were okay, but it affected me, and sometimes I couldn’t do the things I was used to doing. I had trouble getting out of bed, going up and down three steps, getting in and out of the car, etc.”

 

“Rheumatoid arthritis affects 1 in 100 Canadians and causes disability in many. RINVOQ has

 

 

 

 

 

 

 

 

Designed to help accommodate the physical limitations of people living with RA, the packaging for RINVOQ includes a bottle cap with a wide, easy-to-grip texture and an embedded tool that punctures the foil liner to simplify medication access.

 

“For many people living with arthritis, the act of opening a medicine bottle or picking up a tablet can be extremely difficult, and AbbVie designed the RINVOQ tablet, bottle and cap with this in mind,” said Ken Gagnon, Vice President, Corporate Partnerships, The Arthritis Society. “We are pleased to give this medication our Ease of Use designation, which recognizes products that are designed to make life easier for people with arthritis.”

 

“AbbVie has been dedicated to discovering and delivering innovative therapies for people living with rheumatic diseases for nearly two decades,” added Stéphane Lassignardie, Vice President and General Manager, AbbVie Canada. “We are proud to expand our portfolio of treatment options for Canadians living with RA, particularly by offering people the convenience of a medication taken orally, in a once-daily extended-release tablet.”

 

About the Phase 3 SELECT Rheumatoid Arthritis Program

 

The Health Canada approval of RINVOQ was supported by data from the global Phase 3 SELECT rheumatoid arthritis program, which evaluated nearly 4,400 patients with moderate to severe active rheumatoid arthritis in five pivotal studies.1-5

 

The studies include assessments of efficacy, safety and tolerability across a variety of patients, including those who were methotrexate naïve or had an inadequate response to methotrexate (MTX), patients who were intolerant to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), and patients who failed or were intolerant to biologic disease-modifying anti-rheumatic drugs (DMARDS).1-5

 

  • SELECT-EARLY was a 48-week trial in 947 patients with moderately to severely active rheumatoid arthritis who were naïve to
  • SELECT-MONOTHERAPY was a 14-week monotherapy trial in 648 patients with moderately to severely active rheumatoid arthritis who had an inadequate response to
  • SELECT-NEXT was a 12-week trial in 661 patients with moderately to severely active rheumatoid arthritis who had an inadequate response to conventional synthetic disease modifying anti-rheumatic
  • SELECT-COMPARE was a 48-week trial in 1,629 patients with moderately to severely active rheumatoid arthritis who had an inadequate response to
  • SELECT-BEYOND was a 12-week trial in 499 patients with moderately to severely active rheumatoid arthritis who had an inadequate response or intolerance to biologic disease-modifying anti-rheumatic

 

 

 

 

 

 

 

 

About RINVOQ® (upadacitinib)8

RINVOQ® (upadacitinib) is a 15 mg, once-daily oral medication in an extended-release tablet. It is a Janus kinase (JAK) inhibitor that interferes with the JAK-STAT signaling pathway, which is thought to play a role in inflammatory response.

 

RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. RINVOQ may be used as monotherapy or in combination with other nonbiologic DMARDs.

 

For important safety information, please consult the RINVOQ Product Monograph at www.abbvie.ca.

 

About AbbVie Care

Canadians prescribed RINVOQ will have the opportunity to be enrolled in AbbVie Care, AbbVie’s signature care program. The program is designed to provide a wide range of customized services such as reimbursement and financial support, pharmacy services, lab work reminders and coordination, as well as personalized education and ongoing disease management support from a dedicated AbbVie Care nurse, throughout the treatment journey.

For more information, consult www.abbviecare.ca.

 

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbviecanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

 

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References:

 

1 Genovese MC, et al. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2513-2524. doi: 10.1016/S0140- 6736(18)31116-4. Epub 2018 Jun 13.

 

2 Smolen JS, et al. Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3 study. Lancet. 2019. May 23. doi: 10.1016/S0140-6736(19)30419-2. Epub 2019

May 23.

 

3 Fleischmann R, et al. Upadacitinib versus placebo or adalimumab in rheumatoid arthritis and an inadequate response to methotrexate: Results of a Phase 3, Double-Blind, Randomized Controlled Trial. Arthritis and Rheumatology. 2019. Jul 9. doi: 10.1002/art.41032.

 

4 van Vollenhoven R, et al. A Phase 3, Randomized, Controlled Trial Comparing Upadacitinib Monotherapy to MTX Monotherapy in MTX-Naïve Patients with Active Rheumatoid Arthritis. 2018 ACR/ARHP Annual Meeting; 891.

 

5 Cohen S, et al. Safety profile of upadacitinib in Rheumatoid Arthritis: Integrated analysis from the SELECT Phase 3 Clinical Program. EULAR 2019; THU0167.

 

6 Arthritis Society, What is rheumatoid arthritis. Available at: https://arthritis.ca/about-arthritis/arthritis- types-(a-z)/types/rheumatoid-arthritis, Accessed December 11, 2019.

 

7 Ajeganova S. and Huizinga T. Sustained remission in rheumatoid arthritis: latest evidence and clinical considerations. Ther Adv Musculoskelet Dis. 2017 Oct;9(10):249-262. doi: 10.1177/1759720X17720366.

 

8 RINVOQ Product Monograph. Available at:

http://www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/RINVOQ_PM.pdf. Accessed January 6, 2020.

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Revive Therapeutics Provides Update on its Clinical Development Plan For Rare Liver Diseases

TORONTO, Jan. 06, 2020 – Revive Therapeutics Ltd. (“Revive” and the “Company”) (CSE: RVV), a cannabis life sciences company focused on novel cannabinoid-based treatments for rare inflammatory diseases, is pleased to provide an update on the Company’s clinical development plan for Autoimmune liver diseases, which includes Cannabidiol in the treatment of Autoimmune Hepatitis.

“Revive is leveraging its unique intellectual property portfolio and is focusing its efforts on building a pipeline of cannabinoid-based treatments for rare inflammatory diseases targeting multi-billion dollar markets,” said Michael Frank, Chief Executive Officer of Revive.  “Our initial focus is advancing the clinical development of Cannabidiol in the treatment of Autoimmune Hepatitis towards a first-in-kind human clinical trial under a U.S. Investigational New Drug that will pave the way for pursuing our objectives in expanding our product pipeline of novel cannabinoid-based treatments for rare Autoimmune liver diseases and in bringing novel, targeted cannabinoid therapies to patients that need them most.”

Revive aims to build a portfolio of cannabinoid-based drugs for the treatment of rare inflammatory diseases with its initial focus on Autoimmune liver diseases (AILD).  AILD are relatively rare diseases that are comprised of namely four indications including Autoimmune hepatitis (AIH), primary biliary cirrhosis, primary sclerosing cholangitis, and immunoglobulin G4 related cholangitis.  These are chronic diseases that result in significant morbidity and mortality.

Revive will focus on the clinical development of Cannabidiol (CBD) in the treatment of AIH with plans to submit an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in 1H 2020 for a proposed Phase 1/2a clinical study to determine the recommended dose of CBD for future clinical studies, to assess its safety, efficacy and clinical benefit, as well as to support a New Drug Application (“NDA”).  The Company aims to have a pre-IND meeting with the FDA to obtain feedback of Revive’s intended clinical development plan, including a proposed Phase 1/2a study design.

Revive’s program is to meet a clear unmet medical need in patients with AIH.  AIH is a rare inflammatory condition of the liver that can affect all ages and gender across the world.  If not treated properly, may cause liver fibrosis or cirrhosis, liver failure requiring a liver transplant, and even death.  The prevalence of AIH is estimated at 75,000 patients in the U.S.  The current standard of care for AIH is the use of steroids alone or steroids combined with azathioprine.  It has been noted in medical literature that the current standard of care when used in a certain period of time has caused severe treatment-related side effects in 13%, treatment failure in 9%, incomplete response in 13%, and relapse after drug withdrawal up to 86% of patients with AIH (Source: World J Gastroenterol. 2010 Feb 28; 16(8): 934–947).  Therefore, given the unwanted outcomes associated with a steroid-based therapy, an alternative steroid-free treatment option such as CBD, with its known safety profile, may provide a potential solution for an improved treatment strategy for those patients unresponsive to, intolerant of, or non-adherent with a steroid-based therapy for AIH.

Revive has an exclusive license from South Carolina Research Foundation for its intellectual property for the use of CBD, either in synthetic or natural form, in the treatment of autoimmune hepatitis (U.S. patent No. 8242178).  Also, the FDA has granted to Revive orphan drug designation for CBD in the treatment of AIH, which provides valuable incentives that could accelerate the approval process, including seven-year market exclusivity, tax credits on U.S. clinical trials, fast-tracking of regulatory proceedings, and exemption from certain fees, such as waiver of filing fees under the Prescription Drug User Fee Act (PDUFA), and orphan drug grants.

Additionally, the Company will now not be proceeding with the subscription receipt private placement offering announced on November 12, 2019.

ABOUT REVIVE THERAPEUTICS LTD.

Revive Therapeutics Ltd. is a cannabis life sciences company focused on the research, development and commercialization of novel cannabinoid-based products.  The Company’s novel cannabinoid delivery technology is being advanced to fill the medical needs for diseases and disorders such as pain, inflammation, and wound care.  Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory and liver diseases.  For more information, visit www.ReviveThera.com.

For more information please contact:

Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: (905) 605-5535
Email: mfrank@fbn.436.myftpupload.com
Website: www.revivethera.com

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Neither the Canadian Securities Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release.

Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. Because of the risks, uncertainties and assumptions contained herein, investors should not place undue reliance on forward looking-information. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that may cause actual results to differ materially from those anticipated by these forward looking statements include: uncertainties associated with the merger; uncertainties associated with reaching a definitive agreement to merge; uncertainties associated with obtaining regulatory approvals; the need to establish additional corporate collaborations, distribution or licensing arrangements; the Company’s ability to raise additional capital if and when necessary; intellectual property disputes; increased competition from pharmaceutical and cannabis-centered companies; changes in equity markets, inflation, and changes in exchange rates; and other factors as described in detail in the Company’s Management’s Discussion & Analysis for the year ended June 30, 2019, the Company’s Annual Information Form for the year ended June 30, 2018, and continuous disclosure filings, all of which may be viewed on SEDAR (www.sedar.com).  Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement.  Except as required by law, Revive disclaims any intention and assumes no obligation to update or revise any forward-looking statements to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking statements or otherwise.

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ATAI Life Sciences Partners with Neuronasal Inc. to Develop Novel Treatment for mild Traumatic Brain Injury (mTBI)

BERLIN and WEXFORD, Pa., Jan. 6, 2020 /PRNewswire/ — ATAI Life Sciences AG (“ATAI” or the “Company”), a global biotech platform that envisions an end to mental illnesses, today announced that it has partnered with Neuronasal Inc., to develop a short-term treatment for mild Traumatic Brain Injury (mTBI) or concussion.

Neuronasal’s potentially ground-breaking, proprietary treatment includes the intranasal delivery of low doses of N-acetylcysteine (NAC) to patients with acute mTBI. NAC is a well-established compound that has been used safely for decades, mostly as a mucolytic and to treat acute paracetamol intoxication. NAC is a precursor of cysteine, stimulating the synthesis of glutathione which in turn is the most abundant endogenous antioxidant, known to prevent oxidative damage to cellular components. In addition, NAC itself has direct antioxidant, anti-inflammatory, and free radical scavenging effects. Finally, NAC acts as an inhibitory glutamatergic modulator. All of these mechanisms are important in the context of mTBI.

Concussions and other forms of mTBI represent a significant unmet medical need. With no currently approved treatments, patients often suffer acute symptomatology including headache, nausea, fatigue, depression, anxiety and irritability. In fact, approximately half of the 2.5 million people who are concussed every year in the United States alone develop long-term cognitive impairment. Also, the ongoing NINDS-funded track-TBI initiative has recently revealed that concussion is associated with substantial increases in the rates of major depressive disorder, post-traumatic stress disorder, and other psychiatric and non-psychiatric conditions.

“It’s clear that concussions and other mTBIs are more than just uncomfortable,” said Dr. Matthias Luz, Chief Medical Officer of ATAI Life Sciences. “In the hours and days after trauma, these injuries trigger a pathophysiological cascade that can result in significant, life-limiting conditions if not adequately addressed.”

Typically, concussions are the result of physical trauma that disrupts brain tissue and blood supply, followed by focal vascular leakage, inflammation, the formation of reactive oxygen species (ROS) and the release of excessive amounts of glutamate. This, in turn, exhausts the pool of intracellular glutathione in brain and induces glutamate-mediated neuro-excitotoxic damage. In more severe cases, neuronal atrophy and necrosis can occur as well.

NAC has the potential to disrupt the deleterious chain of events following mTBI. In soldiers exposed to explosive blast injury, NAC treatment, as compared to placebo, increased the probability of symptom resolution at 7 days from 41.9 to 86.2% when administered within 24 hours post-blast.

A particular problem with the use of NAC is the blood-brain barrier which effectively shields the brain from many drugs including NAC. When administered orally, several grams of NAC are required to reach the requisite drug concentrations in brain, doses which often cause significant side effects like nausea and diarrhea. Intravenous drug administration allows for slightly lower doses but requires several days of inpatient care and often leads to dizziness and headache.

By contrast, Neuronasal’s intranasal approach enables direct nose-to-brain delivery, allowing for significantly lower doses and outpatient treatment. Given its apparent efficacy in disrupting the underlying neurochemical cascade, intranasal NAC has the potential to induce a fundamental shift in the natural course of the condition for hundreds of thousands of people.

“Neuronasal has the potential to transform the way we treat those most at risk of mTBI, with applications in sports, the military, and daily life,” said Thomas Bradshaw, CEO of Neuronasal. “Unsurprisingly, we’ve seen incredible interest from everyone from the Department of Defense to the National Collegiate Athletic Association.”

A pilot study exploring the effects of intranasal NAC administration on regional brain glutathione concentrations in healthy volunteers is expected to begin in February.

About ATAI Life Sciences
ATAI Life Sciences AG is a global biotech platform and company builder founded by Christian Angermayer. Based in Berlin, London and New York, its vision is to cure mental health disorders, enabling people to live healthier and happier lives. www.atai.life

Company Contact:
Allan Malievsky
ATAI Life Sciences
Phone: +1 (917) 974-1371
Email: Allan@ATAI.life

Investor Contact:
Allison Soss
KCSA Strategic Communications
Phone: +1 (212) 896-1267
Email: ATAI@KCSA.com

SOURCE ATAI Life Sciences

Related Links

https://www.atai.life

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Revive Therapeutics Provides Update on its Cannabis-based Pharmaceutical Initiatives

TORONTO, Dec. 19, 2019 – Revive Therapeutics Ltd. (“Revive” and the “Company”) (CSE: RVV), a cannabis life sciences company focused on the research, development, and commercialization of novel cannabinoid-based products, is pleased to provide an update on its cannabis-based pharmaceuticals initiatives in its objective in offering novel therapies for unmet medical needs in large and rare disease markets.

“Revive has a robust cannabis pharma focused patent portfolio, targeting multi-billion dollar disease markets, which includes exclusive rights to issued U.S. patents based on a unique drug delivery technology and the use of Cannabidiol for the potential treatment of a rare liver disease,” said Michael Frank, Chief Executive of Revive.  “We are pursuing drug development strategies that we believe will result in lower development costs and market exclusivity for our cannabis-based pharmaceutical products while expediting the clinical development and regulatory pathway of our products and paving the way for partnering with global pharmaceutical and medical focused cannabis companies.”

Revive intends to build a unique cannabis-based pharmaceutical product portfolio leveraging its novel drug delivery technology that aims to deliver both synthetic cannabinoids and natural extracts of cannabis in a potential number of ways such as topical gels, creams or ointments, oral or transdermal patches, and oral dosages.  The delivery technology is a natural, non-toxic, biodegradable and biocompatible composite that combines a tannin material, which is derived from a plant group having antibacterial, antifungal, antioxidant and wound healing properties, and a chitosan material, which is derived from the crustacean group having blood-clotting and antimicrobial properties.  The delivery technology has rapid onset of action and controlled or sustained release potential capabilities and may allow to combine multiple cannabinoids or cannabis extracts in one formulation.

The Company seeks to develop novel drug products leveraging its drug delivery technology and targeting multi-billion dollar market opportunities in pain, inflammatory skin disorders (i.e. acne, psoriasis), wound healing applications (i.e. battle wounds, scarring), and liver diseases (i.e. non-alcoholic fatty liver disease).  Specifically, there are over 100 described liver diseases affecting at least 30 million people alone in the U.S., and the global market for liver disease treatment is projected to reach approximately $19.5 billion by 2022 according to Allied Market Research titled, “World Liver Disease Treatment Market – Opportunities and Forecast, 2014 – 2022”.

As for its rare disease pharmaceutical product pipeline, Revive has been granted by the U.S. Food and Drug Administration (“FDA”) two orphan drug designations for cannabidiol (“CBD”) in the treatment of autoimmune hepatitis, a rare liver disease, and CBD in the prevention of ischemia and reperfusion injury (“IRI”) resulting from solid organ transplantation, such as liver, kidney, heart and lung.  Revive aims to build a portfolio of FDA orphan drug designations of cannabinoids that are complementary to Revive’s cannabis-based pharmaceuticals initiatives that support the long-term potential of cannabinoid prescription medicines for rare diseases and disorders, which the Company believes has been validated by the FDA approval of the GW Pharmaceuticals plc EPIDIOLEX®.

The Company will announce a number of pharmaceutical-based initiatives from its drug delivery technology and orphan drug product pipeline as they progress in the near-term.


ABOUT REVIVE THERAPEUTICS LTD.

Revive Therapeutics Ltd. is a cannabis life sciences company focused on the research, development and commercialization of novel cannabinoid-based products. The Company’s novel cannabinoid delivery technology is being advanced to fill the medical needs for diseases and disorders such as pain, inflammation, and wound care.  Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory and liver diseases.  For more information, visit www.ReviveThera.com.

For more information please contact:

Michael Frank – Chief Executive Officer
Revive Therapeutics Ltd.
Tel: (905) 605-5535
Email: mfrank@mifranconsulting.com
Website: www.revivethera.com


CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Neither the Canadian Securities Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release.

Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. Because of the risks, uncertainties and assumptions contained herein, investors should not place undue reliance on forward looking-information. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that may cause actual results to differ materially from those anticipated by these forward looking statements include: uncertainties associated with the merger; uncertainties associated with reaching a definitive agreement to merge; uncertainties associated with obtaining regulatory approvals; the need to establish additional corporate collaborations, distribution or licensing arrangements; the Company’s ability to raise additional capital if and when necessary; intellectual property disputes; increased competition from pharmaceutical and cannabis-centered companies; changes in equity markets, inflation, and changes in exchange rates; and other factors as described in detail in the Company’s Management’s Discussion & Analysis for the year ended June 30, 2019, the Company’s Annual Information Form for the year ended June 30, 2018, and continuous disclosure filings, all of which may be viewed on SEDAR (www.sedar.com).  Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement.  Except as required by law, Revive disclaims any intention and assumes no obligation to update or revise any forward-looking statements to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking statements or otherwise.

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Revive Therapeutics Announces New Leadership Appointment and Board Change

TORONTO, Dec. 18, 2019 – Revive Therapeutics Ltd. (“Revive” and the “Company”) (CSE: RVV), a cannabis life sciences company focused on the research, development, and commercialization of novel cannabinoid-based products, is pleased to announce that all the resolutions put forward by the Company at its annual general meeting of shareholders (the “AGM”) held on December 18, 2019 were approved at the AGM.

 

At a meeting of the board of directors of the Company held immediately following the AGM on December 18, 2019, Mr. Michael Frank was elected Chairman of the Board and appointed Chief Executive Officer of the Company. Mr. Carmelo Marrelli remains as Chief Financial Officer of the Company. Mr. Craig Leon and Mr. Fabio Chianelli, previously Chief Executive Officer and President respectively, are no longer officers of the Company per resolutions passed by the board of directors. Furthermore, Mr. Leon, Mr. Chianelli and Mr. Carlo Sansalone have stepped down from the board of directors, and Mr. Christian Scovenna and Mr. Andrew Lindzon were elected as new members of the board of directors.

 

The Company’s board of directors currently consists of five directors. Each director elected at the AGM will hold office until the next annual meeting or until a successor is duly elected or appointed.

 

Mr. Frank, the Company’s Chairman and Chief Executive Officer, has a strong background in operations, business development, M&A and the capital markets. Mr. Frank is currently the President of Mifran Consulting, providing advisory services to emerging technology companies in a number of key verticals. In the past, Mr. Frank has served as the CEO and Director of Sprylogics International and the Internet of Things Inc., as well as holding senior management positions at Ernst & Young, Data General, and NCR. Mr. Frank has had successful exits in the technology sector including one to Intuit Corporation, and has been instrumental in advising several early stage software companies including a number in the cannabis sector over the last few years. Additionally, Mr. Frank has consulted to Revive’s senior management team on various strategic initiatives.

 

Mr. Joshua Herman, a director of the Company, is the Chief Executive Officer of Herman Holdings Limited. Mr. Herman was a corporate accountant at Hennick Herman for 8 years where he focused on advising clients on various transactional, accounting and tax issues. In 2015, Mr. Herman began early-stage investing in the medical marijuana industry, where he has since become a prolific and well known investor. In 2017, Mr. Herman founded Herman Holdings in order to capitalize on the top investment opportunities he has access to within the cannabis space.

 

Mr. Christian Scovenna is a highly-experienced C-Suite Executive with over twelve years of capital market experience. In his most recent engagement with Mojave Jane Brands Inc. (formerly, High Hampton Holdings Corp.) (CSE: JANE), he was instrumental in building the company as one of the original founders and was a key member of the management team as interim CEO and Senior VP Corporate Finance while also serving on the board as a director. As Managing Director at a boutique firm, Mr. Scovenna led six portfolio companies within the group where he focused on raising capital and business development. He also spent four years with Frontier Merchant Capital Group as Director & Senior VP of Operations and served as Managing Partner with Lions Edge Capital. Over the years, Mr. Scovenna has been successful in completing numerous M&A activities and capital raises. He currently serves as Director & Sr. VP of Corporate Development for Pasofino Gold Limited (formerly Enforcer Gold Corp.) (VEIN-TSX.V) and Tevano Payment Systems (Private Co.) as VP Of Corporate Development.

 

Mr. Andrew Lindzon, a director of the Company, is a seasoned professional and investor with an excellent track record. He earned an LLB from Osgoode Hall (1984) and is CEO of Ashlin Technology Solutions since 1985. Ashlin provides North American companies with technology products and services to improve business processes.

 

ABOUT REVIVE THERAPEUTICS LTD.

 

Revive Therapeutics Ltd. is a cannabis life sciences Company focused on the research, development and commercialization of novel cannabinoid-based products. The Company’s novel cannabinoid delivery technology is being advanced to fill the medical needs for diseases and disorders such as pain, inflammation, and wound care. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory and liver diseases. For more information, visit www.ReviveThera.com.

 

For more information please contact:
Michael Frank – Chief Executive Officer
Revive Therapeutics Ltd.
Tel: (905) 605-5535
Email: mfrank@mifranconsulting.com
Website: www.revivethera.com

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

Neither the Canadian Securities Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release.

 

Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. Because of the risks, uncertainties and assumptions contained herein, investors should not place undue reliance on forward looking-information. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that may cause actual results to differ materially from those anticipated by these forward looking statements include: uncertainties associated with the merger; uncertainties associated with reaching a definitive agreement to merge; uncertainties associated with obtaining regulatory approvals; the need to establish additional corporate collaborations, distribution or licensing arrangements; the Company’s ability to raise additional capital if and when necessary; intellectual property disputes; increased competition from pharmaceutical and cannabis-centered companies; changes in equity markets, inflation, and changes in exchange rates; and other factors as described in detail in the Company’s Management’s Discussion & Analysis for the year ended June 30, 2019, the Company’s Annual Information Form for the year ended June 30, 2018, and continuous disclosure filings, all of which may be viewed on SEDAR (www.sedar.com). Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. Except as required by law, Revive disclaims any intention and assumes no obligation to update or revise any forward-looking statements to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking statements or otherwise.

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AbbVie reaches an agreement with the pan-Canadian Pharmaceutical Alliance (pCPA) for the Combination VENCLEXTA® With Rituximab as a Treatment for Patients With Chronic Lymphocytic Leukemia (CLL)

  • Following the signing of an agreement between AbbVie and the pan-Canadian Pharmaceutical Alliance (pCPA)i, Quebec is the first province to reimburse the combination
  • VENCLEXTA® + rituximab is a regimen that includes a targeted oral agent that should be continued for two years after initial five weeks ramp-up

 

Montreal (Quebec), December 18, 2019 –AbbVie (NYSE: ABBV), a global research and development- based biopharmaceutical company, today announced that an agreement has been reached with the pan-Canadian Pharmaceutical Alliance (pCPA) for VENCLEXTA® in combination with rituximab, a treatment for patients with Chronic Lymphocytic Leukemia (CLL) who have received at least one prior therapy.

 

“VENCLEXTA in combination with rituximab is an effective treatment option. VENCLEXTA plus rituximab also have the benefit of a finite treatment approach, meaning patients can stop their therapy after two years of treatment and continue to benefit,” said Dr. Sarit Assouline MD, MSc, FRCPC, Senior Investigator, Lady Davis Institute, Associate Professor, Department of Oncology, McGill University. “It’s great news that patients in Quebec will now have access to this treatment.”

 

On the Régie de l’assurance maladie du Québec’s Liste des médicaments, VENCLEXTA is listed in combination with rituximab, for the treatment of relapsed or refractory chronic lymphocytic leukemia in patients who have received at least one prior therapy.ii For full criteria, consult the list of medications in effect.

 

“The pCPA agreement for VENCLEXTA plus rituximab is positive news for Canadians living with CLL,” says Elizabeth Lye, Director of Research & Programs, Lymphoma Canada. “Receiving a diagnosis of CLL or any cancer is always shocking and overwhelming, therefore knowing that there are effective treatments available provides reassurance to people facing this uncertain journey.”

 

CLL, which is typically a slow-progressing cancer of the bone marrow and bloodiii, is one of the most common types of leukemia in adults. In Canada, CLL accounts for approximately 1,745 newly diagnosed cases of leukemia each year and is responsible for more than 600 deaths a year.iv

 

“We are thrilled with the positive outcome of our discussions with the pan-Canadian Pharmaceutical Alliance and that Quebec is the first province to list VENCLEXTA in combination with rituximab. We are looking forward to making this treatment available to all Canadians across the country,” says Stéphane Lassignardie, Vice-President and General Manager, Abbvie Canada. “With a strong commitment to developing innovative therapies for patients and contributing to longer-term healthcare sustainability, AbbVie is committed to providing solutions that bring significant clinical and economic value to patients, healthcare practitioners and our healthcare system.”

 

VENCLEXTA continues to be investigated in CLL and other hematological diseases. VENCLEXTA is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

 

About the MURANO Study

A total of 389 patients with relapse / refractory (R/R) CLL who had received at least one prior therapy were enrolled in the international, multicenter, open-label, randomized (1:1) MURANO study (NCT02005471). The study was designed to evaluate the efficacy and safety of VENCLEXTA in combination with rituximab (194 patients) compared with bendamustine in combination with rituximab (195 patients). The median age of patients in the trial was 65 years (range 22-85).v The MURANO study is unique in its design with the intention for patients to stop therapy after 24 months.

 

About AbbVie Care

Canadians prescribed VENCLEXTA can be enrolled in AbbVie Care, AbbVie’s signature care program. The program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment. For more information, please visit www.abbviecare.ca.

 

About AbbVie

AbbVie is a global, research and development-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

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Media Inquiries:

Muriel Haraoui muriel.haraoui@abbvie.com 514.717.3764

i Pan-Canadian Pharmaceutical Alliance: Completed Negotiations. As of October 31, 2019. https://www.canadaspremiers.ca/wp-content/uploads/2019/11/PCPA_completed_negotiations_2019-10.pdf. Accessed December 2019.

ii Régie de l’assurance maladie du Québec. Liste des médicaments. http://www.ramq.gouv.qc.ca/fr/publications/citoyens/publications-legales/Pages/liste-medicaments.aspx. Accessed December 2019.

iii Lymphoma Canada. Chronic lymphocytic leukemia. www.lymphoma.ca/lymphoma/lymphoma-101/types- lymphoma/cll. Accessed December 2019.

iv Canadian Cancer Statistics. Chronic lymphocytic leukemia statistics. www.cancer.ca/en/cancer- information/cancer-type/leukemia-chronic-lymphocytic-cll/statistics/?region=on. Accessed December 2019.

v VENCLEXTA product monograph, AbbVie Corporation. Date of Preparation: September 27, 2016. Date of Revision: December 2, 2019. www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/VENCLEXTA_PM_EN.pdf. Accessed

December 2019.