Patient failure to take medications as prescribed (medication non-adherence) is now identified as an important cause of kidney transplant failure. The availability of new drugs that are taken once daily may improve patient adherence compared to older drugs that had to be taken twice per day. In this study, patients will be converted to a medication schedule where all medications are taken once daily with the goal of improving patient adherence and satisfaction.

Start Date01 Apr 2016

Sponsor / Collaborator

University of British Columbia

[+1]

NCT01913392

/ CompletedNot ApplicableIIT

Prospective, Clinical Study of the Effect of Bariatric Surgery, Laparoscopic Sleeve Gastrectomy, on the Pharmacokinetics of Immunosuppressive Drugs in the Morbidly Obese, Kidney Transplant Candidate

A prospective clinical trial will study the effects of laparoscopic sleeve gastrectomy in the potential renal transplant candidate who is denied acceptance due mainly to the morbid obesity.

Start Date18 Jul 2013

Sponsor / Collaborator

Maisonneuve-Rosemont Hospital

[+1]

NCT01702207

/ CompletedPhase 4IIT

A One-Year, Prospective, Randomized, Controlled Study Evaluating The Efficacy Of Switching From The Twice Daily Tacrolimus Formulation To The Extended Release, Once Daily Formulation To Reduce The Framingham Cardiovascular Risk Scores.

Current standard prophylactic immunosuppression in renal transplantation includes tacrolimus, a calcineurin inhibitor, dosed twice daily. In Canada, oral tacrolimus has been available as a twice daily formulation marketed as Prograf® since 1997. It has recently become available in an extended release formulation called Advagraf®, which is dosed once daily. Advagraf® has been demonstrated to be therapeutically equivalent to Prograf® in the renal transplant maintenance population, and as a result it has been is approved as an alternative to the twice daily formulation in these patients. There is an evolving and expanding positive clinical experience with Advagraf® in kidney transplantation and it has shown to be preferred by many patients, due to the diminished dosing frequency. In clinical trials, Advagraf® has been shown to have other potential benefits over Prograf® such as less inter and intra-patient variability, improved cardiovascular profiles, and improved kidney function. Compared to Prograf®, Advagraf® also has a lower Cmin or 'trough' concentration as well as a lower Cmax or 'peak' concentration. The purpose of this study is to convert stabilized renal transplant patients currently receiving Prograf® to Advagraf®, to investigate these potential therapeutic benefits.
The Framingham Risk Score and the Reynold's Risk Score are currently recommended by the Canadian Cardiovascular Society (CCS) to predict 10-year cardiovascular risk in the general population. Surrogate markers are widely used in clinical trials to shorten follow-up durations. In this study, the investigators will use the Framingham Risk Score and Reynold's Risk Score to quantify changes in estimated cardiovascular risk. The investigators also intend to examine novel inflammatory markers to investigate cardiovascular risk.
The investigators hypothesize that the more consistent drug exposure and lower Cmax noted with Advagraf® will decrease Framingham Risk Score, Reynolds Risk score as well as markers of inflammation in kidney transplant recipients.

Start Date01 Oct 2012

Sponsor / Collaborator

University of Saskatchewan

[+1]

100 Clinical Results associated with Astellas Pharma Canada, Inc.

0 Patents (Medical) associated with Astellas Pharma Canada, Inc.

Literatures (Medical) associated with Astellas Pharma Canada, Inc.

01 Nov 2023·European Urology Focus

Predicting Mirabegron Treatment Response in Patients with Overactive Bladder: A Post Hoc Analysis of Data from Clinical Trials

Article

Author: Kowalczyk, Alice ; Steup, Achim ; Herschorn, Sender ; Saskin, Refik ; Locke, Jennifer A ; Neu, Sarah ; Matta, Rano

BACKGROUNDMany patients discontinue overactive bladder (OAB) treatment because of unmet treatment expectations and/or tolerability issues.OBJECTIVETo develop a model for predicting the individual treatment response to mirabegron using patient baseline characteristics.DESIGN, SETTING, AND PARTICIPANTSThis was a post hoc analysis of data from eight global phase 2/3, double-blind, randomized, placebo- or active-controlled trials of mirabegron in adult patients with OAB.INTERVENTIONMirabegron 50 mg once-daily monotherapy for ≥12 wk.OUTCOME MEASUREMENTS AND STATISTICAL ANALYSISPrimary efficacy outcomes were the change in the mean number of micturitions and the number of incontinence episodes/24 h after 12 wk of treatment. Secondary efficacy outcomes were the change in the mean number of urgency episodes/24 h and the change in Symptom Bother score after 12 wk of treatment. Baseline demographic characteristics, OAB-related characteristics, and intrinsic and extrinsic factor variables were used to create multivariable linear regression models to predict the primary and secondary outcomes.RESULTS AND LIMITATIONSData for 3627 patients were included. The predicted effect of mirabegron 50 mg was an average of 2.5 fewer micturition episodes/24 h (95% confidence interval -2.85 to -2.14) and 0.81 fewer incontinence episodes/24 h (95% confidence interval -1.15 to -0.46) from baseline to week 12. A higher number of urgency episodes was predictive of a larger reduction in micturition episodes; body mass index (BMI) ≥30 kg/m², OAB symptoms for ≥12 mo, and incontinence at baseline were predictive of a smaller reduction. Mixed stress/urgency incontinence and more than five urgency episodes per day were predictive of greater reductions in incontinence episodes. Reductions in urgency episodes and Symptom Bother score were also predicted with mirabegron. Limitations include the exclusion of placebo groups from the analysis and the use of clinical trial rather than real-world data.CONCLUSIONSData from the predictive models provide new insights into the effects of modifiable factors (such as BMI) and nonmodifiable factors on treatment outcomes with mirabegron 50 mg.PATIENT SUMMARYThis study aimed to identify factors that could predict how patients with overactive bladder respond to mirabegron treatment to help doctors effectively treat this condition. Mirabegron treatment was associated with a lower number of urinations and occurrences of urinary incontinence per day. Factors associated with worse responses to the medication included being obese.

03 Jun 2017·Journal of Medical EconomicsQ4 · MEDICINE

Clinical and economic impact of mirabegron compared with antimuscarinics for the treatment of overactive bladder in Canada

Q4 · MEDICINE

Article

Author: Fatoye, Francis ; Hakimi, Zalmai ; Wagg, Adrian ; McCrea, Charles ; Berling, Malin ; Ramos, Barbara ; Nazir, Jameel

BACKGROUNDThe β₃-adrenoceptor agonist, mirabegron, and antimuscarinic agents provide similar efficacy for the treatment of overactive bladder (OAB), but mirabegron appears to be associated with better persistence, perhaps due to an absence of anticholinergic side-effects. This study estimated the expected costs associated with the management of OAB in Canada from a societal perspective by utilizing real-world evidence.METHODSAn economic model with monthly cycles and a 1-year time horizon was developed to depict a treatment pathway for a hypothetical cohort of 100 patients with OAB. At model entry, patients receive mirabegron or an antimuscarinic. Patients who do not persist may switch treatment, undergo a minimally invasive procedure, or remain symptomatic (uncontrolled). The model includes direct costs (e.g. physician visits) and indirect costs (e.g. lost productivity). A one-way univariate sensitivity analysis assessed a ±20% variation in each of the key model inputs.RESULTSAt 1 year, a greater proportion of patients persisted on treatment with mirabegron compared with antimuscarinics (33% vs 15-23%), and a smaller proportion switched treatment (17% vs 20-22%). The number of healthcare visits (292 vs 299-304), pads used (74,098 vs 77,878-81,669), and work hours lost (4,497 vs 5,372-6,249) were all lower for mirabegron vs antimuscarinics. The estimated total annual cost of treatment per patient with mirabegron was $2,127.46 Canadian dollars (CAD) ($5.82 CAD/day) compared with $2,150.20-$2,496.69 CAD ($5.89-$6.84 CAD/day) for antimuscarinics. The one-way sensitivity analysis indicated the results are robust.CONCLUSIONSImproved persistence observed in routine clinical practice with mirabegron appears to translate into benefits of reduced healthcare resource use, and lower direct and indirect costs of treatment compared with antimuscarinics. Overall, these data suggest that mirabegron may offer clinical and economic benefits for the management of patients with OAB in Canada.

01 Jan 2017·Canadian Journal of Kidney Health and Disease

Study of Cardiovascular Outcomes in Renal Transplantation: A Prospective, Multicenter Study to Determine the Incidence of Cardiovascular Events in Renal Transplant Recipients in Ontario, Canada

Article

Author: Howell, John ; Holland, David ; Jevnikar, Anthony ; Kim, S. Joseph ; Zaltzman, Jeffrey ; Knoll, Greg ; Ribic, Christine M. ; Gangji, Azim S. ; Lee, Brenda

Background: Renal transplant recipients (RTRs) are at significantly higher risk for morbidity and mortality compared with the general population, largely attributed to cardiovascular disease (CVD). Previous estimates of CVD events have come from health care databases and retrospective studies. Objective: The objective of this study was to prospectively determine the prevalence of risk factors and incidence of CVD events in a Canadian cohort of RTRs. Design: Study of Cardiovascular Outcomes in Renal Transplantation (SCORe) was a prospective, longitudinal, multicenter observational study. Setting: Adult RTRs were recruited from 6 participating transplant sites in Ontario, Canada. Patients: Eligible patients were those receiving a living or deceased donor renal transplant. Patients who received simultaneous transplant of any other organ were excluded. Measurements: Primary outcomes included myocardial infarction (MI) defined by American College of Cardiology (ACC-MI) criteria, and major adverse cardiac events (MACE), defined as cardiovascular (CV) death, ACC-MI, coronary revascularization, and nonhemorrhagic stroke. CV events were adjudicated by a single, independent cardiologist. Methods: CV and transplant-specific risk factors that predict MACE and ACC-MI were identified by stepwise regression analysis using the Cox proportional hazards model. Results: A total of 1303 patients enrolled across 6 transplant centers were followed for 4.5 ± 1.6 years (mean ± SD). Incidence of MACE was 7.0%, with significant independent predictors/risk factors including age, diabetes, coronary revascularization, nonhemorrhagic stroke, and renal replacement therapy (RRT). ACC-MI incidence was 4.0%, with significant independent predictors/risk factors including age, coronary revascularization, and duration of RRT in excess of the median value (2.91 years). Limitations: Patients were recruited from a single province, so may not reflect the experience of RTRs in other areas of Canada. Conclusions: Using a prospective design and rigorous methodology, this study found that the incidence of CV events after renal transplantation was elevated relative to the general Canadian population and was comparable with that reported in patient registries, thus helping validate the utility of retrospective analysis in this field. SCORe highlights the importance of monitoring RTRs for traditional cardiac and transplant-specific CV risk factors to help prevent CV morbidity and mortality. Further research is needed to investigate a broader range of potential risk factors and their combined effects on incident CV events.

News (Medical) associated with Astellas Pharma Canada, Inc.

30 Jan 2024

·www.biospace.com

XTANDI (enzalutamide) Receives Health Canada Approval as the First and Only Treatment for High-Risk Patients with Non-Metastatic Castration-Sensitive Prostate Cancer (nmCSPC)

[30-January-2024] MARKHAM, ON, Jan. 30, 2024 /CNW/ - Today, Astellas Pharma Canada, Inc. announced that Health Canada has approved a supplemental New Drug Application for XTANDI® (enzalutamide) in a new prostate cancer treatment setting. With this approval, XTANDI becomes the first and only androgen receptor pathway inhibitor (ARPI) approved for use with or without a GnRH analog therapy in patients with nmCSPC with biochemical recurrence at high risk for metastasis (high-risk BCR).i Health Canada granted a priority review of XTANDI in nmCSPC, which was further expedited as a result of XTANDI's inclusion in Project Orbis, an initiative of regulatory bodies, including Health Canada, with an aim to give patients faster access to promising cancer treatments around the world. Prostate cancer develops when abnormal cells form and grow in the prostate gland.ii Prostate cancer is considered nmCSPC if there is no detectable evidence of the cancer spreading to distant parts of the body (metastases) with conventional radiological methods (CT/MRI) and the cancer still responds to medical or surgical treatment to lower testosterone levels.iii Of men who have undergone definitive prostate cancer treatment, including radical prostatectomy, radiotherapy, or both, an estimated 20-40% will experience a biochemical recurrence (BCR) within 10 years.iv About 9 out of 10 men with high-risk BCR will develop metastatic disease, and 1 in 3 will die as a result of their metastatic prostate cancer.v "BCR is usually the first manifestation of recurrence following treatment for prostate cancer and some of these patients are at high risk of early metastases and eventual death from prostate cancer," said Dr. Fred Saad, Professor and Chairman, Department of Surgery, University of Montreal. "I welcome the approval of XTANDI as a promising earlier treatment option for eligible patients. This marks a significant step forward in addressing unmet needs for prostate cancer treatment." As the most common cancer among Canadian men, prostate cancer accounts for an average of 71 new diagnosis every day.vi It is estimated that about 1 in 8 Canadian men will develop prostate cancer during their lifetime and 1 in 30 will die from it.vii Approximately 98% of cases occur in men above the age of 50.viii This indication is based on the results of the EMBARK trial, the first Phase 3 registrational study to demonstrate a statistically significant improvement in metastasis-free survival (MFS) using the combination of XTANDI plus ADT and XTANDI as monotherapy in men with nmCSPC with high-risk BCR.ix Canadian patients contributed approximately 10% of enrollment in the EMBARK trial. "Astellas puts patients at the centre of our work. For more than 12 years, we have been advancing innovative treatments in hard-to-treat cancers with few or no current therapeutic options," said Frank Stramaglia, General Manager, Astellas Pharma Canada, Inc. "The latest indication for XTANDI is a clear demonstration of our ongoing commitment to patients and the physicians who treat them. With our recent acquisition of Propella Therapeutics, Inc., we strive to achieve even more in the investigation of targeted prostate cancer treatments for patients of the future." About XTANDI (enzalutamide) XTANDI is an - Androgen Receptor (AR) inhibitor that overcomes resistance to conventional antiandrogens by inhibiting AR signalling at multiple steps in the pathway.x Patients with nmCSPC with high-risk BCR may be treated with XTANDI with or without a gonadotropin-releasing hormone (GnRH) analog therapy.xi XTANDI has been prescribed to more than one million patients globally since 2012 including 33,200 to patients in Canada.xii XTANDI is a standard of care that has received regulatory approvals in more than 90 countries, including the United States, the European Union and Japan. In Canada, XTANDI is now approved for use in men in four prostate cancer disease states across five indications: Metastatic castration-resistant prostate cancer (mCRPC): chemotherapy naïve and post-docetaxel Non-metastatic castration-resistant prostate cancer (nmCRPC) Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). About EMBARK The approval is based on results from the Phase 3 EMBARK trial of XTANDI (enzalutamide) plus ADT (n=355), placebo plus ADT (n=358), and XTANDI as monotherapy (n=355) in men with nmCSPC with high-risk BCR. The EMBARK trial focused on men with high-risk BCR. Per the EMBARK protocol, patients with nmCSPC with high-risk BCR are those initially treated by radical prostatectomy or radiotherapy, or both, with a prostate-specific antigen (PSA) doubling time (PSA-DT) ≤ 9 months. High-risk BCR patients with a PSA-DT of ≤ 9 months have a higher risk of metastases and death. The study showed that treatment with XTANDI plus ADT reduced the risk of metastasis or death by 58% versus placebo plus ADT (Hazard Ratio [HR]: 0.42; 95% Confidence Interval [CI], 0.30–0.61; p<.0001) as assessed by the primary endpoint of metastasis-free survival (MFS). Detailed results from the primary analysis of EMBARK were presented as a plenary session during the 2023 American Urological Association (AUA) Annual Meeting and published in the New England Journal of Medicine. An analysis of health-related quality of life (HRQoL) in patients from the EMBARK trial were recently presented at the European Society of Medical Oncology (ESMO) Congress 2023 and subsequently published in NEJM Evidence. About Astellas Canada Astellas Pharma Canada, Inc. is a Canadian affiliate of Tokyo-based Astellas Pharma Inc., a pharmaceutical company conducting business in more than 70 countries around the world. At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients. What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people. Learn more: SOURCE Astellas Pharma Canada, Inc.

Clinical ResultPhase 3Drug ApprovalPriority ReviewAcquisition

15 Sep 2021

·www.biospace.com

Astellas Pharma Canada Named by the Canadian Society of Transplantation as Member of the Living Donor Circle of Excellence Program

As a leader in the field of transplantation, Astellas is recognized for its continued commitment to driving awareness and access to organ donation MARKHAM, ON, Sept. 15, 2021 /CNW/ - In conjunction with Living Donation Week, Astellas Pharma Canada, Inc. is proud to announce it has been named as a new member of the Canadian Society of Transplantation's (CST) Living Donor Circle of Excellence program. "I am pleased to welcome Astellas to a group of elite organizations that are committed to decreasing the financial barriers to living organ donation and to making real strides toward ensuring those in need receive a life-saving organ transplant," said Dr. Joseph Kim, President, CST. "The CST Living Donor Circle of Excellence program ensures organ donors are compensated for missed work associated with the transplantation process, and is a wonderful way to support these heroes in their quest to save a life." The Living Donor Circle of Excellence program is an initiative established by the American Society of Transplantation (AST), supported and promoted by the CST, which aims to eliminate the financial costs of living organ donation by recognizing companies whose policies support living donation. As financial hardships associated with living organ donation are often a major barrier for many donors, the program recognizes companies that have policies in place to support the wages for an employee, or the donor of an employee, who donates a kidney or a part of their liver. "Astellas has a legacy of more than 20 years supporting transplant medicine, and we are extremely proud to continue our industry-leading commitment to organ donation," said Frank Stramaglia, General Manager, Astellas Pharma Canada, Inc. "We hope our membership with the Living Donor Circle of Excellence helps increase awareness of transplantation and the option of a living donation, and most importantly we hope it inspires our employees who might be considering giving the gift of life." To learn more about CST's Living Donor Circle of Excellence program, visit . About Astellas Pharma Canada, Inc. Astellas Pharma Canada, Inc., headquartered in Markham, ON, is a Canadian affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information about Astellas Pharma Canada, Inc., please visit . SOURCE Astellas Pharma Canada, Inc.

30 Jan 2019

·www.biospace.com

Neos Therapeutics Announces Appointment of James Robinson to Board of Directors

Neos Therapeutics, Inc. announced the appointment of James Robinson to its board of directors. DALLAS and FORT WORTH, Texas, Jan. 30, 2019 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (Nasdaq: NEOS), a pharmaceutical company focused on developing, manufacturing and commercializing innovative extended-release (XR) products using its proprietary modified-release drug delivery and orally disintegrating tablet (ODT) technology platforms, today announced the appointment of James (Jim) Robinson to its board of directors. Mr. Robinson currently serves as the President and Chief Operating Officer of Alkermes plc. “We are delighted to welcome Jim to the board of directors. Jim’s strong commercial background will be instrumental as we accelerate our path to profitability with our new strategic plan to support the continued growth of our ADHD business,” said Jerry McLaughlin, Chief Executive Officer of Neos Therapeutics. Mr. Robinson currently serves as the President and Chief Operating Officer of Alkermes, where he leads the commercial, operations, business development, and human resources functions. Prior to joining Alkermes, he joined Astellas in 2005 as vice president of health systems, rising to President of Astellas Americas Operations in 2016. Prior to joining Astellas, he served as an executive at the former Schering-Plough Corporation, which was acquired by Merck & Company in 2009. Mr. Robinson is a member of The Commercial Club of Chicago and serves on the BioScience Council for ChicagoNEXT. He is a founding member of MATTER and is also on the Board of Directors for the Chicago Botanic Garden. Mr. Robinson received his Bachelor of Science degree from DePaul University. “It’s an exciting time to be joining the board of directors of Neos. The company recently unveiled a new optimized salesforce structure and territory realignment, and I look forward to contributing to the execution of this commercial growth strategy as well as to the overall growth of the company,” said Jim Robinson. About Neos Therapeutics Neos Therapeutics, Inc. (NASDAQ: NEOS) is a pharmaceutical company focused on developing, manufacturing and commercializing products utilizing its proprietary modified-release drug delivery technology platforms. Adzenys XR-ODT ® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information , including Boxed WARNING), Cotempla XR-ODT ® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information , including Boxed WARNING), and Adzenys-ER™ (amphetamine) extended-release oral suspension (see Full Prescribing Information , including Boxed WARNING), all for the treatment of ADHD, are three approved products using the Company’s extended-release technology platform. Additional information about Neos is available at . CONTACTS: Richard I. Eisenstadt Chief Financial Officer Neos Therapeutics (972) 408-1389 reisenstadt@neostx.com Sarah McCabe Investor Relations Stern Investor Relations, Inc. (212) 362-1200 sarah.mccabe@sternir.com Neos Therapeutics, Inc.

Executive ChangeAcquisition

100 Deals associated with Astellas Pharma Canada, Inc.

100 Translational Medicine associated with Astellas Pharma Canada, Inc.

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Pipeline Snapshot as of 31 May 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

NDA/BLA

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Gilteritinib Fumarate ( AXL x FLT3 )	Acute Myeloid Leukemia More	Approved
Enzalutamide ( AR )	Castration-sensitive prostate cancer More	Approved
Zolbetuximab ( CLDN18.2 )	Advanced Gastroesophageal Junction Adenocarcinoma More	Approved
Avacincaptad pegol ( C5 )	Age Related Macular Degeneration More	NDA/BLA
Alefacept ( CD2 )	Psoriasis More	Withdrawn

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