Astellas Pharma Canada, Inc.

[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.

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.

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.